Evaluation of Integrated Management of Neonatal and...
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Evaluation of Integrated Management of Neonatal and
Childhood Illnesses (IMNCI) Program in India: An IPEN Study
Operational Manual For
PHASE ONE: BASELINE ASSESSMENT
IndiaCLEN Program Evaluation Network (IPEN) Clinical Epidemiological Unit
All India Institute of Medical Sciences
New Delhi, India
Supported by:
Ministry of Health and Family Welfare, Government of India,
Departments of Health and Family Welfare (Haryana, Karnataka, Madhya Pradesh, Maharashtra, Meghalaya, Rajasthan, Orissa, Uttar Pradesh)
UNICEF, USAID, WORLD BANK &
INTERNATIONAL CLINICAL EPIDEMIOLOGY NETWORK (INCLEN)
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Investigating Team
Principal Investigator
Dr. Narendra K. Arora
Team Leader, IPEN
Professor
Division of Gastroenterology, Hepatology & Nutrition
Department of Pediatrics
All India Institute of Medical Sciences
New Delhi.
Co-Principal Investigators
1 Dr C. S. Pandav
Professor and Head
Department of Community Medicine
All India Institute of Medical Sciences
New Delhi
2 Dr R.M. Pandey
Professor and Head
Department of Biostatistics
All India Institute of Medical Sciences
New Delhi
3 Dr Rema Devi
Associate Professor,
Department of Community Medicine
Trivandram Medical College
Thiruvanantpuram
4. Dr. Rakesh Lodha
Associate Professor,
Department of Pediatrics
All India Institute of Medical Sciences
New Delhi
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Central Coordinating Team Members
Dr. A.P. Dubey Professor & Head Department of Pediatrics Maulana Azad Medical College New Delhi
Dr. Vivek Adhish Reader Department of Community Health National Institute of Health & Family Welfare New Delhi
Dr. Siddarth Ramji Professor, Division of Neonatology Department of Pediatrics Maulana Azad Medical College New Delhi
Dr. Harish Chellani Professor, Division of Neonatology Department of Pediatrics Safdarjung Hospital & Vardhman Mahaveer Medical College New Delhi
Dr. Sanjay Chaturvedi Professor Department of Community Medicine University College of Medical Sciences & Guru Teg Bahadur Hospital New Delhi
Dr. Rajib Dasgupta Assistant Professor Centre of Social Medicine & Community Health Jawaharlal Nehru University New Delhi
Dr. K.Suresh Public Health Consultant New Delhi
Ms. Sneh Rewal Consultant Child Development & Nutrition UNICEF New Delhi
Dr. Kiran Goswami Additional Professor, Centre for Community Medicine All India Institute of Medical Sciences New Delhi
Dr. K.K Ganguly Assistant Director General Reproductive Health & Nutrition Division Social Behavior Research Unit Indian Council of Medical Research New Delhi
Dr. S.K. Pradhan Professor & Head, Dept. of Preventive & Social Medicine Lady Hardinge Medical Colleg New Delhi
Dr. Panna Choudhary Consultant Pediatrician Maulana Azad Medical College & Lok Nayak Hospital New Delhi
Dr. Arti Maria Senior Specialist, Division of Neonatology, Department of Pediatrics Maulana Azad Medical College New Delhi
Dr. R.M. Pandey Professor and Head Department of Biostatistics All India Institute of Medical Sciences New Delhi
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Central Coordinating Team Members
Dr. Arvind Saili Professor, Division of Neonatology Department of Pediatrics Kalawati Saran Childrens Hospital & Lady Hardinge Medical College New Delhi
Dr. Vidya Surwade Senior Program Consultant International Clinical Epidemology Network New Delhi
Dr M. Lakshman Senior Program Consultant International Clinical Epidemology Network New Delhi
Dr Manoj K Das Program Consultant International Clinical Epidemology Network New Delhi
Dr. Leena Sushamt Program Consultant International Clinical Epidemology Network New Delhi
Ms. Vaishali Deshmukh Research Officer International Clinical Epidemology Network New Delhi
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Extended Central Coordinating Team Members Prof. Faruque Ahmed Principal & Dean Khaja Bandamawaz Institute of Medical Sciences Raza (B) Gulbarga Karnataka
Dr. Rema Devi Associate Professor Dept. of Community Medicine Trivandram Medical College Thiruvanantpuram Kerala
Dr. K.R John Professor Dept. of Community Health Christian Medical College & Hospital Vellore Tamilnadu
Dr. P.V Kotecha Professor & Head Dept. of Preventive & Social Medicine Govt. Medical College Vadodara Gujarat
Dr. Vishwajeet Kumar Project Director Rachna Shivgarh Project CARE India Lucknow Uttar Pradesh
Dr. Thomas Mathew Professor & Head Dept. of Community Medicine T.D. Medical College Alappuzha Kerala
Dr. Sandip K. Ray Professor Dept. of Community Medicine Medical College Kolkata West Bengal
Dr. Lalit Sankhe Lecturer Dept. of Preventive & Social Medicine Grant Medical College & J.J.Hospital Mumbai Maharastra
Dr. Shivananda Director Indira Gandhi Institute of Child Health Bangalore Karnataka
Dr. Arun K. Singh Assistant Professor & Head Dept. of Neonatology SSKM Hospital & IPGIMER Kolkata West Bengal
Dr. Saradha Suresh Coordinator, Unit for Evidence Based Medicine Medical Education Cell Madras Medical College Chennai Tamilnadu
Dr. S.C. Mohapatra Professor & Head Dept. of Community Medicine Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh
Dr. Bhadresh Vyas Associate Professor Dept. of Pediatrics M.P. Shah Medical College & G. G. Hospital Jamnagar Gujarat
Dr. Ranbir Singh Associate Professor Dept. of Pediatrics Regional Institute of Medical Sciences Imphal Manipur
Dr. M.S. Prasad Consultant and Head Department of Peadiatrics Safdarjang Hospital & Vardhman Mahaveer Medical College New Delhi
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National Experts Dr. Abhay Bang Director SEARCH,Shrodgram Gadchiroli Maharastra
Dr. A. K. Dutta Professor & Head Dept. of Pediatrics Kalawati Saran Children's Hospital & Lady Hardinge Medical College New Delhi
Dr. Abhay Indrayan Head Department of Biostatistics and Medical Informatics Delhi University College of Medical Sciences New Delhi
Dr. Vinod Paul Professor Division of Neonatology Dept. of Pediatrics All India Institute of Medical Sciences New Delhi
Dr. K Ramchandran Statitatican Chennai Tamil Nandu
Dr. H.P.S Sachdev Consultant Sitaram Bhartia Institute of Science and Research New Delhi
Dr. R. N. Salhan Medical Superintendent Safdarjung Hospital & Vardhman Mahaveer Medical College New Delhi
Dr. T. Sundarraman Director State Health Resource Centre Raipur Chhatisgarh
Dr Dilip Mahalanabis Director Society for Applied Studies Kolkota West Bengal
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International Advisory Board Members Dr. Robert Black Professor Department of International Health Bloomberg School of Public Health Johns Hopkins University Baltimore USA Dr. Abdullah Baqui Associate Professor Department of International Health Bloomberg School of Public Health Johns Hopkins University Baltimore USA Dr. Jennifer Bryce Senior Scientist Department of International Health Bloomberg School of Public Health Johns Hopkins University Baltimore USA Dr. Simon Cousens Professor Department of Epidemiology and Medical Sciences London Institute of Hygiene and Tropical Medicine University of London London United Kingdom
Dr. Antonio Cunha
Professor Department of Pediatrics Universidade Federal Do Rio de Janeiro Rio de Janeiro Brazil
Dr. Elizabeth Nabiwemba Lecturer Child Health Makerere University Kampala Uganda
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ABBREVIATIONS
AIIMS All Indian Institutes of Medical Sciences
ANM Auxiliary Nurse Midwife
AWW Anganwadi Worker
ASHA Accredited Social Health Activist
ARI Acute Respiratory Infection
CSSM Child Survival and Safe Motherhood
CBO Community Based Organization
CCO Central Coordinating Office
CCT Central Coordinating Team
CDMO Chief District Medical Officer
CEU Clinical Epidemiology Unit
CHC Community Health Centre
CSSM Child Survival and Safe Motherhood
DHO District Health Officer
DGHS Director General of Health Services
DM District Magistrate
EAG Empowered Action Group
FGD Focus Group Discussion
GDP Gross Domestic Product
GOI Government of India
Hb Hemoglobin
HWs Health Workers
ICD International Classification of Diseases
ICDS Integrated Child Development Services
ICR Intelligent Character Reading
IMCI Integrated Management of Childhood Illness.
IMNCI Integrated Management of Neonatal and Childhood Illness.
IPEN IndiaCLEN Program Evaluation Network
IndiaCLEN Indian Clinical Epidemiology Network
IMR Infant Mortality Rate
INCLEN International Clinical Epidemiology Network
JHU Johns Hopkins University
LHV Lady Health Visitor
MCE Multi-Country Evaluation
MDG Millennium Developmental Goal
MICS Multi Indicator Cluster Survey
MOH FW Ministry of Health and Family Welfare
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MO Medical Officer
MMR Maternal Mortality Rate
MSS Mahila Swarojgar Samiti
NFHS National Family Health Survey
NGO Non-Governmental Organization
NRHM National Rural Health Mission
NMR Neonatal Mortality Rate
OBC Other Backward Class
OPD Out Patient Department
ORS Oral Rehydration Solution
ORT Oral Rehydration Therapy
PAHO Pan American Health Organization
PHN Public Health Nurse
PHC Primary Health Centre
PMC Partner Medical College
PI Principal Investigator
PPS Probability Proportionate to Size
PRI Panchayati Raj Institutions
RAP Rapid Appraisal Procedure
RCH Reproductive and Child Health Program
RA Research Assistant
RCHO Reproductive and Child Health Officer
SC Scheduled Cast
ST Scheduled Tribes
SI Senior Investigator
SHGs Self Help Groups
TBA Trained Birth Attendants
UIP Universal Immunization Program
UNICEF United Nations International Children’s Fund
USAID United Sates Agency for International Development
U-5 MR Under-Five Mortality Rate
VA Verbal Autopsy
WHO World Health Organization
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Table of Contents
Sl. no
Contents Page No.
I Executive Summary 1 II Evaluation of Integrated Management of Neonatal and Childhood
Illnesses (IMNCI) Program in India: An IPEN Study 1 Genesis of IMCI Strategy 8 2 Overview of Multi Country Evaluation (MCE) 9 3 Child Health Programs in India 11 4 IMCI to IMNCI in India: Background and Rationale 13 5 The Relationship between Child Survival and Equity 14 6 IMNCI Strategy in India 17 7 IMNCI in the Context of Public/ Private Health Framework of India 19 8 Impact model 21 9 Conceptual Framework of the Study Phases 24 10 Expected Outcomes 25 11 IndiaCLEN Program Evaluation Network (IPEN) 25 12 Description of Study Phases 26 13 Detailed Research Plan for Phase I 30 14 Identification of Study States and Districts 31 15 Development of Study Instruments 33 16 Qualitative Component 34 17 Verbal Autopsy and Tracking of Events before Death & Recovery from
Illness 36
18 Qualitative Data Management and Analysis 39 19 Qualitative Research Team at Regional Centers 40 20 Qualitative Component Design 40 21 Field Operation 44 22 Generic Health Facility Observation 49 23 Skill Observations 50 24 Data Management 52 25 Summary of Cluster Level Activities 53 26 Ethical Considerations 54 27 Independence of IPEN during the Study 54 28 Sharing Data for Policy Making and Program Refinement 55 29 Project Administration 55 30 Networking Monitoring 58 31 Quality Assurance 59 32 Limitations and Challenges 61 33 Timeline of Phase I IMNCI-IPEN Study (Baseline Study) 63 34 References 64 35 Annexure 67
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List of Figures and Tables
Figures
Page No.
Figure-1: India-Infant Mortality Rate 12 Figure-2: Child Survival & Equity 15 Figure-3: Impact Model (IMNCI-IPEN Study) 23 Figure 4: Conceptual Framework of IMNCI Evaluation Study 24
List of Tables
Page No.
Table-1: Intervention and Comparison Districts for Baseline Survey 5, 33 Table-2: Baseline Assessment of Child Survival Indicators: Qualitative Component
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Table-3: Sample size of Live Births for Estimating NMR, IMR and U5MR 41 Table-4: Prevalence of Cough, Fever and Diarrhea as Indicators of Child Morbidity in India
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Table-5: Sample Size of Estimating Morbidity Density (Per District) 43 Table-6: Sample Size for Quantitative Survey 44 Table-7: Composition of Survey Teams 45 Table-8: Responsibility of each team members during cluster survey 46 Table-9: Summary of Cluster Level Activities 53 Table 10: List of Regions and Corresponding Partner Institutions 57
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List of Annexure
List of Annexure
Page No.
Annexure-1: Selected Districts and States for IMNCI: IPEN Study 67 Annexure-2: Profile of Intervention & Comparison Districts 68 Annexure-3: General Instruction for Interviewing 72 Annexure-4: Instruction for Conducting Focus Group Discussions 75 Annexure-5: Common Instructions to Fill-up Cluster Survey Instruments 76 Annexure-6: Instruction for Conducting Verbal Autopsy 77 Annexure-7: Instruction for Conducting Tracking of Events 79 Annexure-8: Summary of Field Operations 81 Annexure-9: Instructions for Household Screening 82 Annexure-10: Household Screening Log Sheet 85 Annexure-11: Household Screening Referral Sheet 86 Annexure-12: Instructions for Household Survey 87 Annexure-13: Household Survey Log Sheet 89 Annexure-14: Household Survey Referral Sheet 90 Annexure-15: Guidelines for Generic Observation at Health Facility 91 Annexure-16: Guidelines for Skill Observations 92 Annexure-17: Guideline for Filling ICR Sheets 96 Annexure-18: Indicators 97 Annexure-19: Team Composition 105 Annexure-20: Plan for Cluster Activity 106 Annexure-21: Monitoring Sheet of Cluster Schedules Received at RC’s Office 107 Annexure-22: Regional Telephone Monitoring Sheet 108 Annexure-23: Plan and Progress of Team Activity at a Glance 109 Annexure-24: Regional Network Progress at a Glance 110 Annexure-25: CCO Monitoring Sheet (Daily Network Progress) 111 Annexure-26: CCO Data Processing Activities at a Glance 112 Annexure-27: Quality Assurance visit by CCT members (Qualitative Component)
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Annexure-28: Quality Assurance visit by CCT members (Quantitative Component)
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Annexure-29: Network Dynamics 120 Annexure-30: Team Member Details 121 Annexure-31: Random Number Table 122 Annexure-32: List of Festivals and Calendar 123 Annexure-33: Land Measure Conversion table 124 Annexure-34: Unique ID Scheme for Instruments 125
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Evaluation of Integrated Management of Neonatal and Childhood Illnesses
(IMNCI) Program in India: An IPEN Study
I- EXECUTIVE SUMMARY
Problem Statement
It is estimated that 2.1 million children in India die before reaching 5 years of age [1].
These children account for approximately one-fifth of the worldwide deaths occurring in this
age group. Infant mortality in India has declined over the past four decades, from 146 per
1000 live births to 72 per 1000 live births [2]; however this decline has slowed during the
past 8-10 years [1]. Most of the reduction in mortality over the last decade has been in
children between the age of 1 month and 5 years. Currently almost 2/3rd of infant mortality is
comprised of neonates, most of who die within the first week of life [1]. In an effort to
address high neonatal death rates, along with stagnating IMR and under-five mortality, the
Integrated Management of Neonatal and Childhood Illnesses (IMNCI) program will be
implemented in India. The IMNCI program aims to improve child survival rates by extending
the interventions/services in homes, communities, and the health care system. IMNCI will
focus specifically on the management of acute respiratory infections (ARI), diarrhea,
measles, malaria and malnutrition, which are the main causes of childhood deaths in India.
Furthermore, for the first time under a public health program special focus will be given to
the management of newborns. This will be an important endeavor for the India’s health care
system, as infant mortality is a sensitive indicator of inequities in health and health care in a
country.
Purpose of This Evaluation Study
The purpose of this study is to assess the extent to which IMNCI improves the
management of childhood illnesses, health system logistics and community involvement in
child survival activities in India. The study will examine these factors across 16
geographically and socio-culturally diverse districts of eight states in India at different levels
of the health infrastructure. This evaluation is of global importance because India is the only
country in the world to include a neonatal component in the IMCI strategy. Additionally, this
study is relevant to improving child survival and achieving many of the Millennium
Development Goals set forth by the United Nations. Findings from the study may be
considered for improving existing national strategies to reduce under-five child morbidity,
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mortality, and related inequities in India. The study is also likely to emerge with useful
lessons for other lower and middle income countries.
Context of Study
The IMNCI strategy will be implemented in a phased manner in approximately 125
districts in India. During the implementation stage, some districts will not have the IMNCI
program at all, some will be in the training stages of IMNCI, and some will have fully
implemented the IMNCI strategy. The proposed study will take advantage of this natural
situation and identify two sets of districts: a set of districts where IMNCI implementation will
commence in 2007 (the Intervention districts) and another set of districts where IMNCI
implementation will commence in 2009-2010 (the Comparison districts).
Goal of Evaluation
The IMNCI program is to be implemented in rural areas of the proposed districts
under the National Rural Health Mission (NRHM). Hence the study will be undertaken in
rural parts of the intervention and comparison districts to tailor public health programs to
meet the needs of India’s children via policies, health system reforms, and community
interventions. The study will be accomplished in three phases. Each phase of the evaluation
study has different objectives that will contribute to the overall purpose of the study.
Childhood morbidity and mortality, health systems performance and community participation
in child survival activities will be assessed during Phase I and III. Attempts will be made to
capture the process of implementing child survival programs during Phase II
Objectives of Three Study Phases
Phase I (12 months)
To identify baseline estimates for the prevalence of childhood illnesses covered under
IMNCI, child mortality in the study districts and causes of neonatal, infant and under-five
mortality, care seeking and referral pathways in communities, determinants of health seeking
behavior of the community including prevention of childhood illnesses, availability of health
facilities, quality of care in public and private health care facilities in the study districts, reach
of public services and determinants of inequity and inequality, estimate skills of prescribers
in public and private sector and paramedical health providers to handle sick children under-
five years.
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Phase II (24-36 months)
Phase II will document different strategies adopted by the state health departments
and the process of implementation of the child survival programs in intervention and
comparison districts. Attempts will also be made to capture events or interventions (health
and non-health) that are likely to confound outcomes of child survival programs during study
period.
Phase III (12 months)
Phase III will reassess various child survival indicators and compare baseline and end
line findings to determine the change in childhood mortality and morbidity, health system
logistics and community involvement in child survival activities in intervention and
comparison districts; the management of childhood sickness at the household and health
facility levels, and involvement of private sector in child survival programs.
Identification of Study States and Districts
Selection of the study states
States selected for this study will represent for different levels of health system
governance and performance, health statistics, socio-cultural and geographic location. Four
Empowered Action Group (EAG) states (Uttar Pradesh, Madhya Pradesh, Rajasthan, and
Orissa) and three non-Empowered Action Group (non-EAG) states (Karnataka, Haryana,
Maharashtra) and one northeastern state (Meghalaya) will participate in this study as shown
in Table 1. Empowered Action Group states were formed by the Ministry of Health and
Family Welfare in 2001. The purpose of the groups is to give attention to health and family
welfare programs in states that are low on related socio-demographic indices. States selected
for this study will allow comparisons for difficult levels of health system governance and
performance, health statistics, socio-cultural and geographic location to be represented.
Selection criteria for study states are as follows:
1. Recently formed EAG states not included;
2. Non-EAG states dispersed over all regions of the country;
3. States with good performance and low IMR (< 40/1000 live birth) were excluded
because of potentially less visible impact of IMCNI implementation;
4. Availability of functional IndiaCLEN Program Evaluation Network partner
institution in the state to participate in the study.
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Selection of the study districts
GOI has planned to implement IMNCI program in 125 districts in a phased manner,
which creates a unique opportunity for a natural experiment. Districts where the
implementation of IMNCI occurs in the first stage (2007) will serve as Intervention
Districts for the present study. Districts where IMNCI implementation occurs later (2009-
2010) will be termed Comparison Districts.
In order to minimize confounding by status of health systems and governance
variables, a pair of districts is selected from each selected study state.
Matching of the selected districts was done considering the following criteria:
1. Demographic profile: (a) Sex ratio; (b) Proportion of population (age 0-6 years); (c)
Scheduled caste (SC) and Scheduled tribe (ST) population (%); (d) Minority
population (%)
2. Literacy status: (a) Male; (b) Female
3. Population density
4. Health indicators: (a) Routine immunization; (b) Infant mortality rate (IMR).
The list of study districts selected in the eight states is given in Table-1 and represented on
map of India in Annexure-1. The comparative demographic features of selected pairs of
Intervention and Comparison districts according to state are listed in Annexure 2.
Table 1 - Intervention and Comparison districts for Baseline Survey
State status State Intervention districts*
Comparison districts**
Uttar Pradesh Kanauj Mathura Madhya Pradesh Morena Tikamgarh
Rajasthan Baran Chittorgarh
EAG States
Orissa Nayagarh Sonpur Maharashtra Amravati Parbhani Karnataka Gulbarga Gadag
Non-EAG States
Haryana Kaithal Mewat North-eastern State Meghalaya Ri Bhoi Jaintia Hills
*Intervention districts: The districts for immediate implementation of IMNCI program (2007).
**Comparison districts: The districts with ongoing RCH-I child health activities and IMNCI
program to be implemented in 2009-2010.
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Summary of Study Phases
Phase I
The baseline assessment consists of combination of qualitative and quantitative
methods. This phase of evaluation will be undertaken during 2006-2007.
Qualitative Component:
There are several aspects of health systems, program implementation and care seeking
behavior of clients that are context specific and currently not well understood. To explore
these, evaluation research methods will be used in the form of in-depth interviews and focus
group discussions.
Quantitative Component:
The study will be restricted to rural populations (as per the National Census 2001) of
the selected districts. Cluster survey design using probability proportionate to size (PPS)
technique will be adopted.
Phase II
Study teams will not be involved in the implementation of child health programs
under IMNCI. It is important to emphasize that study investigators will not be involved in
the process of implementing IMNCI in any of the study areas so as to minimize bias. In
addition to process documentation, a separate study on health economics will be undertaken
in the second phase. There will be two cycles of process evaluation: First in 2008 and second
in 2009. The primary data will be collected by conducting sample survey in all study districts.
Secondary data will be obtained from program managers. Based on information gathered
from primary and secondary data, (both qualitative and quantitative), saturation index for
IMNCI program in intervention districts will be determined before proceeding for end line
evaluation.
Major external events/ activities that are likely to effect health systems specifically as
they relate to child survival will be documented in all study districts during this phase. What
is observed and documented during the implementation process will be discussed when the
baseline is compared with the end line. In case of a natural disaster or civil disturbance an
additional baseline survey will be done in the affected area within a span of 6 months. This
will be done to document setbacks to the health system as a result of the event and also serve
as the comparison parameter for end line survey. It is assumed that industrial and economic
interventions are unlikely to have a major impact on the implementation of child health
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programs within the study period. NGO/ CBO and other civil society activities related to
health in the area will be documented and lists will be updated on yearly basis.
Phase III
Variables for the end line study will be identical to those used in the base line survey.
allowing the study to capture changes in the process of managing childhood sickness and
child survival indicators after the implementation of IMNCI in intervention districts and with
RCH-I strategy in comparison districts.
Intervention districts with IMNCI are not likely to be in the same phase of saturation
with IMNCI activities in 2009-2010. But as a principle, end line evaluation will be
undertaken only after more than 70% of the rural communities have access to IMNCI based
strategy of child sickness care for at least 12 months. Therefore, the end line evaluation is not
expected to begin before early 2010. Indicators of IMNCI-program saturation will be decided
in consultation with International Advisory Board and State Health Departments during
Phase II of the study
Interaction with Program Managers and Expected Outcomes
The proposed evaluation study is designed to be an “action-oriented operational
research study” with built in mechanisms for constant feedback to decision makers and
program managers at various levels. The information collected from the baseline will be
shared with GOI so that implementation of child survival programs including IMNCI can be
improved. Particularly useful information will pertain to: skills of providers in areas that will
be emphasized during training, unique needs of the private sector and methods to fulfill those,
as well as perceptions of program managers at district and state level. Equally important are
issues related to community care seeking practices and equity as well as access to public
heath services. The recommendations related to these areas will help redefine strategies for
implementing the community component of child survival programs. The results will be
shared with State and Central program managers with follow up advocacy at all levels
including district officers. Efforts are being made to have a formal structure (a program
managers group) to share and engage policy makers and program managers so that findings
can be translated into action.
We have requested Central and State governments to have meetings with programme
managers to share findings and take stock of implementation status. Some of the major
threats to Phase II will be: (1) different pace of implementation of IMNCI and (2) variable
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quality of training and strengthening of health systems under IMNCI program. The primary
purpose of proposed regular interaction with program managers will be to review IMNCI
implementation process in intervention districts and identify steps for minimizing above
mentioned threats.
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II. Evaluation of Integrated Management of Neonatal and Childhood Illnesses (IMNCI)
Program in India: An IPEN Study
Overview
1. Genesis of the IMCI Strategy
Most illnesses contributing to under-five deaths are preventable. Only a few, mostly
developing countries, account for a large proportion of child deaths worldwide.
Internationally, there has been a call to reduce burdens contributing to infant, neonate, child
morbidity and mortality such as the World Summit for Children (1990) and the Millennium
Development Goals (2001). From this, the Integrated Management of Childhood Illnesses
(IMCI) strategy was developed by WHO, UNICEF and other agencies, institutions and
individuals, to address issues related to morbidity and mortality among children under-five
years of age.
Child mortality is a complex issue and both effective treatment and preventive
interventions are needed to reduce it. Such interventions should also be able to address equity
issues related to child health and mortality; several of these challenges lie outside of the
realm of health sector [12]. This will require achieving maximum programmatic coverage
and developing adequate care delivery approaches that could decrease health disparities
within and between communities. Ideally, interventions to reduce under-five morbidity and
mortality should be capable of covering large populations and achieving high levels of
implementation in low-income countries [3]. IMCI uses training efforts at different levels of
the health system and community to improve case management of childhood illness. Training
covers both preventative and curative interventions. Addressing the health areas covered by
IMCI is likely to help many communities to reduce disparities in child survival as well as
achieve Millennium Development Goals.
The World Health Organization has outlined the primary components of IMCI as [4]:
1. Improvement of case-management and referral skills of health staff through
provision of locally adapted guidelines
2. Improvement of the health system required for effective management of childhood
illnesses
3. Improvement of family and community practices related to managing childhood
illnesses
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2. Overviews of Multi-Country Evaluation (MCE)
WHO and the Johns Hopkins School of Public Health conducted ongoing Multi
Country Evaluations (MCE) of the IMCI strategy to identify its impact on the management of
childhood illnesses and the overall strengths and weaknesses of the strategy
(http://www.who.int/imci-mce). Specific site studies took place in Bangladesh, Brazil,
Tanzania, Peru and Uganda.
2.1 Tanzania [5, 6, 7]
Implementation of IMCI began in 1996 and the evaluation began in 1997 in two
districts using facility based IMCI (Morogoro Rural and Rufiji) and two districts that were
not (Kilombero and Ulanga). The districts were compared using a non randomized,
observational design that employed household, demographic, and facility level surveys in a
sample of 75 government health facilities. Quality of case-management for illness in children,
availability of drugs and vaccines, supervision for case management, and to assess indicators
of children’s health was assessed. Interviews were conducted with health care groups, and
plans and budgets were reviewed. The economic cost of health care was also assessed. The
evaluation found that when focusing specifically on case-management, children treated by
IMCI trained health care providers received better care on indicators of classification,
treatment, counseling and communication, and case assessment [5]. Based on the assessment
the child mortality rate was 13% lower in IMCI districts than in non IMCI districts, sick
children were more likely to be correctly classified in IMCI districts, but there was no
difference in care-seeking by care givers between districts with IMCI and comparison
districts [6]. However, the evaluation concluded that health systems support for IMCI
regarding referral was still needed [7].
2.2 Peru [8]
A nationwide ecological analysis of IMCI took place between 1996 and 2000. Health
indicators used in the evaluation were: impact on mean height for age, under-five mortality
rate corrected for under registration, utilization of health services, and vaccine coverage.
Correlations between mortality and malnutrition levels with environmental and
socioeconomic variables were all significant. However, there was not an association between
IMCI implementation and impact utilization and coverage factors. In Peru, funding support
was provided to various components of IMCI by separate funding agencies in different
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districts. Therefore it was difficult to assess the overall impact in the given district in terms of
reduction in child mortality.
2.3 Uganda [9]
The study took place in 10 districts and the methodology consisted of a baseline
demographic and household survey, health facility survey and community monitoring. There
was ongoing documentation of IMCI and contextual factors, data collection on cost-sharing,
and a second follow-up health facility survey. A pre and post dose response analysis found
that:
• While scaling up, quality of training needs special attention.
• Only 17% of children seen by IMCI-trained health workers got vaccines.
• There was a stable increase of drug supplies and basic equipment after the
implementation of IMCI.
• IMCI-trained workers performed better than workers who were not yet trained in
IMCI.
However in Uganda, utilization of health facilities did not increase after training of
health providers. Post training follow up and supervision was poor. In Uganda, though there
had been substantial progress towards implementation of IMCI, the strength of
implementation was not sufficient to produce a significant change in childhood deaths.
2.4 Brazil [10]
In an evaluation of health facilities where IMCI had been implemented and where
IMCI had not yet started a health facility survey was conducted. Performance of health
workers trained and not trained in IMCI through a health facility was compared in 4 states
(23 municipalities with strong IMCI implementation and 23 without). Methods included skill
observations, exit interviews, and documentation of availability of drugs, vaccines, and
equipment. In accordance with findings from other MCE sites in Tanzania and Uganda, this
study found significant differences in the assessment of the sick child, classification of
illness, and treatment of the child between IMCI trained and non-IMCI trained health
workers; but some indicator levels remained low even after IMCI training. Better availability
of medicines was also reported. However, the survey found that IMCI was concentrated in
the better-off municipalities and that health worker performance varied between states.
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2.5 Bangladesh [11]
The IMCI evaluation in Bangladesh began in 2000 and final assessments will
conclude in 2007. For the MCE site in Bangladesh 20 facilities were randomly selected for
IMCI intervention using a two-cell randomized design. A component was also added to the
study that documented the program and provided a summary of health facility utilization and
referrals. Instruments included a household demographic survey, a health and morbidity
survey on under-five children, a verbal autopsy survey, a social autopsy, and a health facility
survey at first-level facilities. The baseline assessment found that during the first two years of
IMCI implementation there was a fourfold increase in the number of severe cases seeking
care from IMCI facilities, but the rates of compliance with referrals was low.
2.6 Summary of Lessons from MCE of IMCI
In summary, MCE identified that emphasis on the following areas is needed for
successful implementation of IMCI strategy to achieve the desired impact on child survival:
• High program coverage in appropriate segments of the population
• Maintenance of quality of services for higher utilization of services
• Improvement in care seeking practices of community
• Sustained and higher quality supervision and monitoring
• The development of a public/ private health care system partnership
3. Child Health Programs in India
In India until 1977, health programs focused on family planning, but eventually the
need to reduce neonatal and child mortality became a priority. In 1983, the National Health
Policy gave more focus to maternal and child health needs. By 1985, programs were created
to advocate for universal immunization of six* preventable childhood illnesses, clean delivery
practices, and skilled birth attendants. These strategies evolved into the Child Survival and
Safe Motherhood (CSSM) program in 1992. CSSM, funded by World Bank and UNICEF,
yielded notable success in improving the health status of pregnant women and under-five
children. Eventually, CSSM was integrated into the Reproductive and Child Health (RCH)
program in 1997. Government of India, Ministry of Health and Family Welfare introduced as
a horizontal approach to the reduction of infant and child morbidity and mortality to India’s
health system. As a result of efforts like this, over time there was a substantial decline in IMR
as seen in Figure 1. Health indicators for neonates and children under-five in India still need
* Diphtheria, Pertussis, Childhood Tuberculosis, Poliomyelitis, Measles and Neonatal Tetanus
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improvement, especially if India is to reach the Millennium Development Goal regarding
under-five mortality by 2015. This alone would require a reduction from 87 to 41 deaths per
1,000 births [3]. .
The National Rural Health Mission (NRHM) was launched in April 2005 and will
run for 7 years (2005-12) as a strategy to improve the health system and health status of
India. The Mission seeks to provide universal access to equitable, affordable and quality
health care which is accountable and responsive to the needs of the people reduces child and
maternal deaths, as well as stabilizes population growth and the nation’s sex ratio. In this, the
Mission will help achieve goals set under the National Health Policy and the Millennium
Development Goals. It is anticipated that the National Rural Health Mission (NRHM) will
accelerate achievement in respect of MMR and IMR. The NRHM will target 18 States (Uttar
Pradesh, Bihar, Rajasathan, Madhya Pradesh, Chhattisgarh, Uttaranchal, Jharkhand, Orissa,
Assam, Manipur, Meghalaya, Nagaland, Mizoram, Arunachal Pradesh, Sikkim, Tripura,
Himachal Pradesh, and Jammu & Kashmir) all of which have weak public health indicators
and/ or weak health infrastructure. Mother and child health programs will continue to be the
major focus of public health activities under NRHM.
Figure 1- India- Infant Mortality Rate
India-Infant Mortality Rate (deaths/1,000 live births)
505254565860626466
2000 2001 2002 2003 2004 2005
Year
IMR
Figure 1: Source: CIA World Factbook January 1, 2005 http://www.indexmundi.com
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4. IMCI to IMNCI in India: Background and Rationale
It is not uncommon in resource poor settings for several diseases to go untreated due
to lack of first level health care services [6]. Thus, a program that strengthens the case-
management aspect of health care is required at the primary level. Presently, several
programs exist to address each of the five diseases within the IMNCI realm; such as the Oral
Rehydration Therapy (ORT) program which aims to avoid deaths due to diarrhea. However,
most children have two or more of the above-mentioned diseases simultaneously. An overlap
means that single diagnosis may not be possible or appropriate, and treatment may be
complicated by the presence of several illnesses in addition to malnutrition.
For this reason, India decided to adopt IMCI and address the overall health of a child
with interventions in homes, communities, and facilities for children under-five, and also
incorporate a neonatal component to it because neonatal mortality is extremely high at around
43 deaths per 1000 births [13]. Appropriate home care such as optimal feeding practices, use
of insecticide treated materials to prevent malaria, and appropriate treatment of infections can
help prevent childhood deaths in a setting like that of India.
In recent years, empiric evidence has emerged indicating the critical need for a
neonatal component in any child survival programs for meaningful impact. A field trial of
home-based neonatal care by Bang et al. (2005), found that interventions of home based
neonatal care such as the training of traditional birth attendants, group health education,
repeated home visits, and initiation of early and exclusive breast feeding reduced the NMR
from 62 to 25 over a period of two years Most of the decline was attributed to improved care
of low birth weight babies and improved care of sepsis [14].
Similarly, the Mitanin (meaning “a friend” in local dialect) program in Chhattisgarh
was an attempt to scale up the community health worker experience. The evaluation assessed
the Mitanin’s knowledge on treatment of diarrhea, fever, correct dose of chloroquine;
identified infant feeding messages; messages for neonate and children under-five; recognition
of grade II malnutrition, treatment of anemia; and refer high risk pregnancy case for delivery.
Results showed the utility of Mitanins in improving child health. For example, 70%
newborns were visited by Mitanin in first day or 1st week and 68.7 % of Mitanins had
provided advice on illness management in previous week [15]. India is diverse in traditions,
cultures, ethnicities, races, and languages. This diversity is reflected in child health care
practices found within communities throughout the nation. Therefore, in India, any health
care program that does not consider the influence of culture will be challenged to improve
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care. All public health strategies should also try to reduce the harm caused by some of the
prevailing practices by improving primary and secondary prevention practices.
India is the only country in the world to incorporate a neonatal component into IMCI,
creating IMNCI. The Integrated Management of Neonatal and Childhood Illnesses (IMNCI)
program will be introduced in at least 125 districts as part of the RCH II program. IMNCI
aims to reduce death, illness and disability; to promote improved growth and development
among children under-five years of age; and target acute respiratory infections (ARI),
diarrhea, measles, malaria and malnutrition, which are the five main causes of childhood
deaths. An important component for its success will be with active community involvement
and improving child care and health seeking practices at household level.
5. The Relationship between Child Survival and Equity
Inequity has moral and ethical connotations and is related to the allocation of
resources. It is the means by which inequalities are created [16]. IMNCI is part of GOI’s
efforts to address inequalities particularly for health of children under-five years. In India,
public health expenditure is 0.9% of the nation’s GDP while private health expenditure is
4.0% and 75% of health services in India are in private sector [28]. According to the World
Development Report (World Bank, 2004), countries that spend more in public health
resources have lower child mortality. But as illustrated by MCE increased public spending
are not enough and neither are interventions.
IMNCI efforts are intended to serve as a process to reduce child survival inequities
related to geography, caste, and gender in India; and in turn inequalities that contribute to
child morbidity and mortality rates. Income disparities often contribute to inequalities in
child health. According to UNICEF’s 2006 State of the World’s Children Report, income
disparities often contribute to disparities in the nutritional status of children [17]. This has a
profound effect on the health of children under-five years of age. It is currently estimated
that 53% of all child deaths can be attributed to being underweight [18]. Additionally, poor
children are more likely to experience negative health outcomes than rich children because
poverty increases their chances of undernutrition and other health risks, making them more
susceptible to disease [19]. Also contributing to increased susceptibility in poor children, is
poor water and sanitation such as access to a flush or pit toilet. The need to focus on
inequalities is also apparent in the finding that that poor children in India are three times more
likely to die compared to rich children as illustrated in Figure-2. While IMNCI will not aim
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to decrease income disparities, it will try to address the barriers of income disparities related
to child health.
Figure 2: Child Survival and Equity
Child survival inequalities in India are social as well as economic. For example,
women are disproportionately poor in India and have a hold a low social status compared to
men. Women’s position can be measured in terms of literacy, decision making, and social
access [20], all of which are an integral part of engaging in care seeking behaviors. There is
also a strong bias that exists in care taking and seeking practices for a female child, compared
with male children in India [19].
In India as a whole, child mortality between months 1 and 12 is 40 % higher for girls
than for boys [21]. There is great variance in female child mortality across India. For
example, while Haryana has the worst male to female child mortality than any country in the
world Tamil Nadu is only behind four other countries [22]. Yet, female infanticide, sex-
selective abortion, and neglect of female children are not uncommon. Therefore, addressing
gender disparities experienced by women and children in India will be necessary if the
country is committed to achieve MDGs Four & Five, respectively (reduce the under-five
mortality rate by two thirds between 1990 and 2015, and reduce the maternal mortality ratio
by three quarters between 1990 and 2015).
Children of women belonging to scheduled castes and scheduled tribes have higher
rates of infant and child mortality than children of women belonging to other backward
classes or “other” women. Children of “other” women have by far the lowest rates of infant
and child mortality. As expected, all indicators of infant and child mortality decline
substantially with increase in the household standard of living. There are 84.3 million
Source: State of the World’s Children. (2006) UNICEF. http://www.unicef.org/sowc06/index.php
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members of Scheduled Tribes (ST) in India, which is about 8.2% of the total population [23].
Members of this group as well as those of scheduled and backwards castes are often
geographically and socially isolated from the rest of the population. Throughout India health
inequalities and health disparities between hierarchical caste levels are common [24]. Such
inequalities often result from the social marginalization and discrimination; and social
disadvantages such as a lack of economic and educational opportunity. These social
inequalities experienced by scheduled castes or scheduled tribes serve as a barrier to health
care and in turn contribution to an increased likelihood of mortality for members of these
groups.
NFHS data from 1998-1999 illustrates that for children and adults up to age 45 there
is excess mortality among indigenous people when compared to non-indigenous [24].
Regarding infants under-one year of age the same was concluded, but the statistical
significance was less. However, mortality differences were more attributed to socioeconomic
status than indigenous status. Also another study utilizing NFHS data from 1998-1999 that
examining mortality risk rather than just mortality, found that the mortality risk for children
under-one year in the lowest quintile of the standard of living index used was 2.73 times
higher than infants in the highest quintile, but that results for gender and caste were not
statistically significant [25]. For children between 2 and 5 years of age, children from
scheduled tribes and backwards castes did not have a mortality risk different from children in
other castes, but children from scheduled castes did have a significantly higher mortality risk.
Nevertheless, when comparing odds ratios controlled for standard of living and caste, there is
a greater decrease in mortality risk for caste than for standard of living for infants and
children under-five years. As despite increased spending on health, disparities in morbidity
and mortality indicators will continue to persist if utilization of health primary health care
services is hindered by income and cultural factors. To achieve MDGs related to child health
and improved equity, key interventions like IMNCI will have to give attention to increasing
service utilization among the poor. One way of doing this would be to engage other health
care sectors such as NGOs and CBOs.
Both economic and gender inequalities are compounded by reduced financial or
geographic access to preventive and curative interventions at the primary level. According to
the Bellagio Study Group, 2/3 of child deaths worldwide could have been prevented if
effective and child survival interventions had reached children and mothers who needed them
[26]. Jones et al. (2003) have also shown that available low cost interventions could
potentially prevent 63% of the child deaths. As despite increased spending on health,
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disparities in morbidity and mortality indicators will continue to persist if utilization of health
at primary health care services is hindered by income and cultural factors. To achieve MDGs
related to child health and improved equity, key interventions such as IMNCI must be scaled
up with a strategy so that health care service utilization among the poor can increase.
According to Bangdiwala and colleagues (2006), the decision to seek care for
newborns and pregnant mothers is primarily made by husbands, particularly so in rural and
tribal areas [27]. Additional reasons for not seeking care included lack of transportation, lack
of money, lack of time, and rumors about the health system. Rural and tribal communities
often practice harmful newborn care practices such as withholding early breastfeeding, not
feeding colostrum, application of unhygienic things, immediate bathing after birth, etc.
In addition to decreasing disparities in health care service utilization due to social,
economic, and gender inequalities efforts to improve home-based care have proven
successful at improving child survival as well. An example of a successful scale up home-
based care efforts that draw on community resources was implemented by the Society for
Education, Action, and Research in Community Health (SEARCH) in Gadchiroli,
Maharastra, India. An evaluation of the efforts found that home based neonatal care efforts
reduced NMR from 62 to 25 in intervention areas, which was 70% more than in control areas.
Under NRHM, the Government of India is planning to promote access to improved
health care at the household level through a female link volunteer, called Accredited Social
Health Activist (ASHA), strengthen Sub-centers, Primary Health Centers (PHCs),
Community Health Centers (CHCs); and devise new health financing systems [28]. The
health worker, ASHA will serve a population of 1000. The Government of India aims to train
more than 4 lakh trained women as ASHAs/ community health workers (resident of the same
village/ hamlet for which they appointed as ASHA).
6. IMNCI Strategy in India
Implementation of Integrated Management of Neonatal and Childhood Illness, in the
districts is a component of the Child Health Strategy under the National Rural Health
Mission/ Reproductive and Child Health Programme Phase–II. The IMNCI strategy has been
developed by child health researchers, academicians, the Indian Academics of Pediatrics
(IAP) and National Neonatology Forum (NNF). According to Operational Guidelines
developed by the Indian Ministry of Health and Family Welfare, GOI, the IMNCI package
includes the following components [13]:
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I. Care of newborns and young infants (under-two months):
• Keeping the baby warm
• Initiation of breast feeding immediately after birth and counseling for exclusive
breastfeeding and non-use of prelacteal feeds
• Cord, skin and eye care
• Recognition of illness in newborn and management and/or referral
• Immunization
• Home visits in postnatal period
II. Care of infants (2 months to 5 years):
• Management of diarrhea, acute respiratory infections (pneumonia), malaria,
measles, acute ear infection, malnutrition and anemia
• Recognition of illnesses, risk conditions, and their management and referral
• Prevention and management of iron and vitamin A deficiency
• Counseling on feeding for all children below 2 years
• Counseling on feeding for malnourished children between 2-5 years
• Immunization
III. Home visits: Home visits made by ANMs, AWWs and ASHAs and link volunteers
are an integral part of this intervention which help mothers and families to understand
and provide essential newborn care at home
IV. Training: IMNCI involves two categories of skill based training. One for medical
officers and a second for front line functionaries including ANMs and AWWs. For
ASHA and link volunteers if any, a separate package focusing on home care of
Newborn and children is being prepared.
V. Improvements to the health systems: Essential elements include:
• Ensuring availability of essential drugs
• Improve referral to identified referral health facility.
• Referral mechanism to ensure that an identified sick infant or child can be swiftly
transferred to a higher level of care.
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• Functioning referral centres, especially where health care systems are weak, referral
institutions need to be reinforced or private/public partnership need to be
established.
• Ensuring availability of health workers/providers at all levels.
• Ensuring supervision and monitoring through follow up visits by trained
supervisors.
VI. Improvements of Family and Community Practices:
Counseling of families and creating awareness among communities on healthy behaviors
through IEC campaigns and counseling of caregivers and families as part of management of
the sick child.
VII. Collaboration/ Co-ordination with other departments, PRIs, Self Help Groups,
MSS etc.
7. IMNCI in the context of Public/ Private Health Framework of India
The government has built a vast infrastructure of public health services, and is
implementing health programs in the priority areas of reproductive and child health.
According to National Rural Health Mission (NRHM), India’s expenditure on public health is
amongst the lowest in the world, whereas its proportion of private spending on health is one
of the highest. The private sector health care is unregulated in India, which increases the cost
of health care and makes it unaffordable to the rural poor.
In India, the provision of public sector health care a responsibility shared by State,
Central and Local governments, although it is effectively a state responsibility in terms of
delivery. In total, public health expenditure is 0.9% of the nation’s GDP, while private health
expenditure is 4.0% [29]. The public sector has been organized largely to finance and deliver
curative care, as well as implement a number of centrally sponsored family welfare and
disease control programs. These programs are almost exclusively delivered through public
institutions.
As a result, India has amassed an enormous but under-funded public delivery
infrastructure and staff [27]. Public health management is affected by issues such as overly
centralized planning and control of resources, high levels of political interference over staff
postings; and the fragmentation of family welfare, nutrition, disease control programs and the
approaches for private sector to meet public policy objectives. Public sector management
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relies on inflexible input-based planning and expenditure controls that are centrally
determined, and do not adequately account for differences in needs or demands. It is
challenging to monitor quality of health care (both in public and private sector) and to
redefine standard of quality assurance and monitoring system.
In India, the private health sector refers to private, for-profit, medically trained
providers. Their range of practice varies from independent practice, small nursing homes
(inpatient facilities with usually less than 30 beds), to large corporate hospitals. There are
approximately 10,300 private hospitals in India, and about 225,000 private hospital beds [29].
The private sector also includes laboratory and diagnostic facilities, ambulance services, and
pharmacies. However, a much broader set of non-government actors is involved, that can be
categorized according to organizational type (profit or non-profit), size and scope of service
(solo practice, small nursing home, large specialized hospital), or system of care (Indian
systems of medicine- Auyervedic, Unani; or Western medicine- Allopathy). Many untrained
providers offer a combination of systems of medicine. It is estimated that there are
approximately 1.25 million informal providers practicing in India [29]. Because many are
not registered or work part time, this informality can be problematic when studying the health
system. However, indigenous, folk practitioners, and traditional providers constitute an
important part of the health system regarding infant and neonatal care because they are often
the first point of contact in rural areas [29].
Despite vast services provided by the public sector, there is an increasing use of
private sector health services in India. It is estimated that over 80% of the population uses
the private sector for outpatient curative services as a first line of treatment in both urban and
rural areas [29]. Nevertheless, the private sector in India has grown in an unregulated manner,
lacking in standards for quality of care and for pricing. The need to address issues related to
the growth of India’s private sector was acknowledged after the first formal national health
policy was adopted in 1983.
The recent National Population Policy 2000 also mentions the need to collaborate
with the private non-profit and for-profit sectors [30]. A variety of partnerships are pursued
under the existing programmes of the Ministry of Health, especially the RCH-II and
independently by the states with their own resources with non governmental partners. RCH-II
has developmental partners like UN agencies. Under this umbrella, States are trying contract
in, contract out, out sourcing, management of hospital facilities by NGOs, hiring staff, service
delivery, including family planning services, MTP, treatment of STI/ RTI, etc. NRHM
envisages to non-governmental sectors to provide high quality services in rural areas to meet
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the shortage of heath facilities there. Immunization, Polio eradication programs, the Janani
Suraksha Yojana has been involving private/ NGO facilities for delivery of promotive and
preventive service delivery. The non-governmental organizations are critical for the success
of NRHM. With the mother NGO (MNGO) programme scheme, 215 MNGOs covering 300
districts have already been involved. The mission aims at involving NGOs in capacity
building at all levels, monitoring and evaluation of health sector, delivery of heath services,
developing innovative approaches to health care delivery for marginalized sections or in
underserved areas and aspects, working together with community organizations and
Panchayati Raj institutions, and contributing to monitoring the right to health care and service
guarantees from the public health institutions.
8. Impact Model
This study hopes to generate evidence for policy makers and program mangers to
tailor child survival programs in India for improving skills of Health Provider’s related to the
management of childhood illness, health system logistics, more effective and equitable reach,
and community involvement in child survival activities. Child health programs in general and
IMNCI in specific aim to reduce under-five mortality, improve child health services with
particular focus on the care of neonates in the community and by the health system. The
study will take place in 16 districts of 8 Indian states covering different levels of health
infrastructure and governance, and cover diverse socio-cultural and geographic regions of the
country. This will allow results from the study to be generalized to all of India.
Taking into consideration the above factors an impact model (Figure-3) has been
developed which focuses on three important components of child health programs namely
Health Provider (Public/ Private), Health System and Community Perspective. It highlights
important issues influencing child health at various levels in the context of NRHM/ RCH and
equity. It also illustrates the interaction between communities, the public and private sector
and facilitating an enabling environment within the health system, as well as presents
assumptions of the implementation context. Thus this model shows inputs and outputs
mechanisms for achieving the objectives of the child survival programs in India including
IMNCI. Within the framework of this model some important and relevant indicators (input,
output, and outcome) could be derived which will eventually be helpful for evaluating
implementation of IMNCI and other child survival programs at all the three phases of this
study (baseline, concurrent and end line).
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The essential assumptions of the impact model are:
1. High quality training of health providers and strengthening of health systems on
their own will not be sufficient to improve effective coverage of program services.
2. Community participation and private sector involvement will further strengthen
health systems, service delivery and expand the pool of skilled health providers
rapidly.
3. Socio-cultural beliefs are significant influences and determinants of community
behavior in traditional societies and hence communication strategy must address
socio-cultural contexts as well.
4. Institutionalized mechanisms are required for:
(a) Monitoring of program activities by the community
(b) Involvement of private sector and regular assessment of their capacity to
contribute to public health activities for appropriate skill enhancement.
5. Effective coverage essentially includes the segments of the population that are at
highest risk for morbidity and mortality but are excluded from accessing and
benefiting from public health services for social, economic, and gender biases.
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Figure 3: Impact Model (IMNCI-IPEN STUDY)
Impact on Child Mortality/ Morbidity
Implementation of Child Survival Programs (IMNCI/ RCH) with focus on Newborns
Public Sector Private Sector
Community Component
Effective Coverage
Training and over sighting of Implementation
Partnership with Professional Bodies
IEC/ IP Communication/ Media
Family Community/ PRI/ NGO/CBO
Improved care of sick children 1. Early Recognition
of Danger Signs 2. Appropriate home
care/ care seeking
Strengthening Health System
Training
HealthFacility
Outreach sessions
Home visits by health workers
Enabling Environment
Depot Holder
Community Monitoring
Social Mobilization
Transport
Water & sanitation
1. Health Services 2. Infrastructure 3. Supplies/logistics 4. Manpower 5. Monitoring/supervis
ion/ coordination 6. Referral 7. Funds
Skills of health provider: 1. Counseling & Communication skills2. Clinical skills 3. Empowerment of family (Health Promotion, Case Management)
Service provisions (Consultation, Drug supply, Manpower, and Referral)
Needs Assessment o Gaps in skills/facility status/
Referral partnerships o Training stations
Contextual Issue o NRHM (RCH I/ RCH II) o Equity
Socio Cultural Beliefs
Improved Quality of Care for Sick children
Improved household practices of child care/preventive measures
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IMNCI Rollout in 2007 by MOHFW (GOI)
Program Saturation
Concurrent
Monitoring 2007-2008
(Phase II)
IMNCI Rollout in 2009-2010 by MOHFW (GOI)
RCH I Strategy
Concurrent Monitoring 2007-2008
(Phase II)
Baseline Survey 2006 -2007
By IPEN
(Phase I)
End line 2009-2010
By IPEN
(Phase III)
Intervention District (IMNCI in 2007)
Comparison District (Ongoing RCH-I/ IMNCI in 2010)
End line 2009-2010
By IPEN
(Phase III)
Estimate baseline child morbidity indicators and
sickness management practices
Document the implementation of
IMNCI and document health and non-health influences on process
Estimate end line child
morbidity indicators and sickness
management practices and compare with
baseline
Purpose
Baseline Survey 2006-2007
By IPEN
(Phase I)
9. Conceptual Framework of the Study Phases
The phased manner in which GOI is rolling out IMNCI is automatically creating
the intervention and comparison groups that will be used in this study. Some districts will
have IMNCI rolled out in 2007; while others have IMNCI programmed for 2009-2010.
This creates an opportunity for natural experiment allowing us to evaluate child health
services in two sets of districts using a baseline (Phase I) and end line (Phase III)
assessment. During the intervening period (Phase II), the processes of implementing the
various child survival programs will be documented with attempts to capture health and
non health events and/or interventions that are likely to confound outcomes of these
public health strategies. These include the introduction of new health programs, outbreaks
and epidemics, natural disasters, and major social developments. Data from Phase II of
study will help us explain possible reasons for changes in different child survival
indicators across study sites and between intervention and comparison districts with
greater certainty. The following framework (Figure 2) outlines how this study is
integrated with the rollout of IMNCI in India.
Figure 4: Conceptual Framework of IMNCI-IPEN Evaluation Study
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10. Expected Outcomes
The proposed evaluation study is designed to be an “action-oriented operational
research study” with built in mechanisms for constant feedback to decision makers and
program managers at various levels. The information collected from the baseline will be
shared with GOI for better implementation of child survival programs including IMNCI.
Particularly useful information will pertain to: skills of providers (including the health
workers) which need to be emphasized during training, feedback about the public health
infrastructure, role of the private sector and ways to strengthen public-private partnership,
as well as perceptions of program managers at district and state level. Equally important
are issues related to community perception and care seeking practices and equity as well
as access to public heath services.
The recommendations related to these areas will help redefine strategies for
implementing the child survival programs with special focus on the community
component for better utilization of services. The results will be shared with State and
Central program managers with follow up advocacy at all levels including district
officers. Efforts are being made to have a formal structure (a program managers group) to
share and engage policy makers and program managers so that findings can be translated
into action. We have requested Central and State governments to have meetings with
programme managers to share findings and take stock of implementation status.
11. IndiaCLEN Program Evaluation Network (IPEN)
11.1 Why IndiaCLEN and IPEN
IndiaCLEN consists of Clinical Epidemiology Units (CEUs) which are
functioning at eight medical colleges in India (New Delhi, Lucknow, Nagpur (2), Chennai
(2), Vellore and Thiruvananthapuram). CEU faculty members have been trained in
clinical epidemiology, health social sciences, biostatistics and health economics under the
global International Clinical Epidemiology Network (INCLEN) program. The main
objectives of the body include disseminating knowledge and skills related to clinical
epidemiology to other academic and non-academic medical institutions in the country and
participating in policy relevant research activities.
Since 1997, IndiaCLEN has expanded and is partnering with medical institutions
and NGOs beyond the CEUs and form IndiaCLEN Program Evaluation Network (IPEN).
Over a period of last 9 years, IndiaCLEN Program Evaluation Network has emerged as a
professional and cohesive network of 136 partner institutions (medical colleges/ NGOs/
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26
public health institutions). IPEN has successfully evaluated the Pulse Polio Immunization
Program for four consecutive cycles [1997-98, 1998-99, 1999-2000 and 2000-2001] and
was also involved in the evaluation of three rounds of Family Health Awareness
Campaign [1999, 2000, 2002] in the country. Additionally, this network has completed
the evaluation of Vitamin-A and Iron folic acid Supplementation Program(s) [2001-
2002]. Policy makers have incorporated several key recommendations made by this
network in the subsequent cycles of the respective programs, illustrating the relevance of
IPEN study findings. Most recently, a nation-wide Assessment of Injection Practices and
Routine Immunization had been conducted. Specifically, the results of this study
attracted wide attention and resulted in several policy level changes. Apart from
undertaking research activities, IPEN has tried to develop capacity of its network partners
to undertake policy and program relevant studies in their respective regions and states.
Members of the group have had the benefit of attending workshops on program
evaluation, qualitative research methods and continuous quality assurance.
11.2 Other Key Stakeholders and Partners
The study is being done in partnership with Ministry of Health and Family
Welfare, Government of India, State Health Departments, development partners
(UNICEF, World Bank, USAID); international partners (Johns Hopkins University,
Baltimore, USA; University of Rio de Janeiro, Brazil; Makerere University, Kampala,
Uganda; and London School of tropical Medicine and Hygiene, UK).
12. Description of Study Phases
12.1 Phase I: Baseline Survey (12 months)
Phase I of the study (2006-2007) will make a baseline assessment of various
parameters and dimensions related to child survival and health systems in both the
intervention and comparison districts. These would involve derivation of estimates for
childhood morbidity due to the diseases covered under IMNCI, mortality rate (neonate,
infant, and under-five), and analyses of causes of infant deaths.
Current practices and mechanisms involved in care of newborns and children at
the family/community, first facility and referral level will be identified. Client perspective
on existing child health services in terms of their availability, affordability and
acceptability will be studied in detail. In Phase I, information will be collected from
mothers, prescribers (operating in public and private sector), program managers,
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
27
community leaders, and NGOs/ CBOs regarding their perspectives on existing child
health services; the role of civil society in promoting, providing, utilizing and monitoring
child health services, health beliefs; and clinical practices using qualitative methods.
Skills of health workers; sickness management practices at the household, community,
and health facility levels; manpower and logistic support available at health facilities;
health and care seeking behaviors of families; and the mortality rate and morbidity
density of the study sample will be assessed using quantitative methods. FGD of mothers,
frontline workers (ANM’s, AWWs) and their supervisors will also be conducted. This
study will also assess equity and equality issues related to child health services.
The information collected from the baseline will be shared with GOI so that
implementation of child survival programs including IMNCI can be improved.
Particularly useful information will pertain to: skills of providers in areas that will be
emphasized during training, unique needs of the private sector and methods to fulfill
those, as well as perceptions of program managers at district and state level. Equally
important are issues related to community care seeking practices and equity as well as
access to public heath services. The recommendations related to these areas will help
redefine strategies for implementing the community component of child survival
programs. The results will be shared with State and Central program managers with
follow up advocacy at all levels including district level. Efforts are being made to have a
formal structure (a program managers group) to share and engage policy makers and
program managers so that findings can be translated into action.
12.2 Phase II: Concurrent Observation and Documentation of the Process of
Implementation of Child Health Programs in Study Districts (Intervention and
Comparison Districts)
It is important to emphasize that study investigators will not be involved in the
process of implementing IMNCI in any of the study areas so as to minimize bias. Phase II
will involve in-depth observation and documentation of the various facets of the
implementation process of child survival packages across 16 districts. It will be important
to document the process of implementing RCH-II/ IMNCI and ongoing RCH-I strategy,
regarding different training programs, methods used to ensure availability of essential
drugs, referral practices, counseling methods adopted for care givers for families,
implementation of home visits, and use of behavior change communication. This will
help identify barriers to implementing IMNCI and explain any changes observed between
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
28
baseline and end line assessments. In addition to process documentation, a separate study
on health economics will be undertaken in the second phase.
There will be two cycles of process evaluation: First in 2008 and Second in 2009.
The primary data will be collected by conducting sample survey in study districts.
Secondary data will be obtained from program managers. Based on information gathered
from primary and secondary data, (both qualitative and quantitative), saturation index for
IMNCI program in intervention districts will be determined before proceeding for end
line evaluation.
Major external events/ activities that are likely to effect health systems
specifically as they relate to child survival will be documented in all study districts during
this phase. What is observed and documented during the implementation process will be
discussed when the baseline is compared with the end line. In case of a natural disaster or
civil disturbance an additional baseline survey will be done in the affected area within a
span of 6 months. This will be done to document setbacks to the health system as a result
of the event and also serve as the comparison parameter for end line survey. It is assumed
that industrial and economic interventions are unlikely to have a major impact on the
implementation of child health programs within the study period. NGO/ CBO and other
civil society activities related to health in the area will be documented and lists will be
updated on yearly basis.
We have requested central and state governments to have meetings with
programme managers to share findings and take stock of implementation status. Some of
the major threats to Phase II will be: (1) different pace of implementation of IMNCI and
(2) variable quality of training and strengthening of health systems under IMNCI
program. The primary purpose of proposed regular interaction with program managers
will be to review IMNCI implementation process in intervention districts and identify
steps for minimizing above mentioned threats.
12.3 Phase III: End Line Survey
Phase III will estimate child morbidity indicators and sickness management
practices health system functioning, infrastructure, community care seeking practices,
morbidity and mortality pattern of under-five children in the study population after
IMNCI implementation. This information will be compared to that gathered during the
baseline assessment. Observations of Phase II (process monitoring) and documentation of
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
29
major events taking place between baseline and end line surveys will help explain
changes observed.
Keeping in mind the seasonal variation of childhood illnesses, the end line survey
will be done around the same time of the year as the baseline study. The sample sizes for
primary outcomes will be recalculated for this phase because of following reasons:
1. As part of secular changes, morbidity and mortality density is likely to decline
over the study period in all districts.
2. Mortality rates (neonatal/ infant/ under-five mortality rates) may decline at
different rates in intervention and comparison districts.
3. Sample size calculation will also take into account difference in mortality to be
measured between two sets of districts.
Intervention districts with IMNCI are not likely to be in the same phase of
saturation with IMNCI activities in 2009-2010. But as a principle, end line evaluation will
be undertaken only after about/ more than 70% of the rural communities have access to
IMNCI based strategy of child sickness care for at least 12 months. Therefore, the end
line evaluation is not expected to begin before early 2010. Indicators of IMNCI-program
saturation will be decided in consultation with International Advisory Board and State
Health Departments during Phase II of the study.
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Phase I: Baseline Assessment of Child Survival Activities in Selected Districts
13. Detailed Research Plan for Phase I
13.1 Study Universe and Design
IMNCI is a child survival strategy of RCH II under the National Rural Health
Mission (NRHM). Therefore, only rural populations will make up the sampling universe.
It is an “action-oriented operational research study” that utilizes quantitative and
qualitative research methods. Phase I will be a cross-sectional survey.
13.2 Objectives
Assess the current status of child survival indicators and process indicators for
existing program activities in Intervention (where IMNCI program will be implemented
in 2007) and Comparison (with ongoing RCH-I based child health strategy/ planned
IMNCI implementation in 2010) districts.
13.2.1 Primary Objectives
To determine:
1. Baseline mortality of children under-five years of age (neonatal, infant, and
under-five mortality).
2. Prevalence of fever, loose motion, cough and any other illness (morbidity
density) in the two weeks prior to day of field survey among children under-five
years of age.
3. Effective program coverage for specified disease condition (cough with fast
breathing) occurring in two weeks period prior to day of field survey as
determined by:
a. Proportion of ill under-five children approaching a care provider (any
public/ private health facility) outside the home during the sickness episode.
13.2.2 Secondary Objectives
1. To determine causes of under-five mortality (verbal autopsy) and pathway
analysis of events prior to death and recovery of sick under-five children.
2. To assess sickness management practices (location and type of care seeking and
sickness care) at the:
i. Household level
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
31
ii. Community level
iii. Health facility level (Out-patient)
3. To assess health behavior at the
i. Household level
ii. Community level
iii. Health facility level
4. To assess skills and care providing competencies of the health care providers
i. Doctors (Public and Private)
ii. Heath Workers (AWW/ ANM)
iii. Other community level non-conventional service providers, including ASHA
and TBA (wherever in place)
5. To assess health system support for
i. Manpower
ii. Logistics
iii. Referral mechanism
iv. Intersectoral coordination
v. Social mobilization
vi. Monitoring & supervision
6. To assess the perspectives of state level policy makers and program managers and
health providers at district and state level regarding child survival issues.
7. To assess the client and health provider perspective on existing child health
services in terms of their
i. Availability,
ii. Accessibility,
iii. Perceived Affordability,
iv. Appropriateness,
v. Quality of care and
vi. Socio-cultural acceptability.
8. To determine the role of civil society (NGOs, CBOs, Community leaders) in
promoting, providing, utilizing and monitoring child health services.
14. Identification of Study States and Districts
This study will be conducted in sixteen districts in eight states in India (two
districts per state) (Table-1 and Annexure-1). Two districts have been identified in each
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
32
state for the study; Intervention and Comparison districts (Annexure 2). These districts
have been identified in consultation with the Division of Child Health, Ministry of Health
and Family Welfare, Government of India, State Governments and UNICEF taking into
account IMNCI implementation plan and study phases. The total rural population of the
sixteen selected districts is approximately 1.7 crore (Census 2001) (Annexure 2). Table 1
summarizes the states and districts to be included in the study.
14.1 Selection of the Study States
14.1.1 Selection of the Study States
States selected for this study will represent for different levels of health system
governance and performance, health statistics, socio-cultural and geographic location.
Four Empowered Action Group (EAG) states (Uttar Pradesh, Madhya Pradesh,
Rajasthan, and Orissa) and three non-Empowered Action Group (non-EAG) states
(Karnataka, Haryana, Maharashtra) and one northeastern state (Meghalaya) will
participate in this study as shown in Table 1. Empowered Action Group states were
formed by the Ministry of Health and Family Welfare in 2001. The purpose of the groups
is to give attention to health and family welfare programs in states that are low on related
socio-demographic indices.
Selection Criteria for Study States are as Follows:
1. Recently formed EAG states not included;
2. Non-EAG states dispersed over all regions of the country;
3. States with good performance and low IMR (<40/1000 Live Births) were
excluded because of potentially less visible impact of IMCNI implementation;
4. Availability of functional IndiaCLEN Program Evaluation Network partner
institution in the state to participate in the study.
14.1.2 Selection of the Study Districts
GOI has planned to implement IMNCI program in 125 districts in a phased
manner, which creates a unique opportunity for a natural experiment. Districts where the
implementation of IMNCI occurs in the first stage (2007) will serve as Intervention
Districts for the present study. Districts where IMNCI implementation occurs later
(2009-2010) will be termed Comparison Districts.
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A pair of districts have been selected with matching demographic and health
indicators in order to minimize confounding by status of health systems and governance
variables.
Matching of the selected districts was done considering the following criteria:
1. Demographic profile: (a) Sex ratio; (b) Proportion of population (age 0-6 years);
(c) Scheduled caste (SC) and Scheduled tribe (ST) population (%); (d) Minority
population (%)
2. Literacy status: (a) Male; (b) Female
3. Population density
4. Health indicators: (a) Routine immunization; (b) Infant mortality rate (IMR).
As per the state planning for implementation of IMNCI program, districts have been
identified as Intervention and Comparison districts, which are listed in Table 1. The
detailed comparative demographic parameters of selected pair of districts in each state are
listed in Annexure-2
Table 1 - Intervention and Comparison Districts for Baseline Survey
State Status State Intervention Districts*
Comparison Districts**
Uttar Pradesh Kanauj Mathura Madhya Pradesh Morena Tikamgarh
Rajasthan Baran Chittorgarh
EAG States
Orissa Nayagarh Sonapur Maharashtra Amravati Parbhani Karnataka Gulbarga Gadag
Non-EAG States
Haryana Kaithal Mewat North-eastern State Meghalaya Ri-Bhoi Jaintia Hills
*Intervention districts: The districts for immediate implementation of IMNCI program (2007).
**Comparison districts: The districts with ongoing RCH I child health activities and IMNCI
program to be implemented in 2009-2010.
15. Development of Study Instruments
A team of program evaluation experts, pediatricians, social scientists,
epidemiologists, biostatisticians, and anthropologists at the central coordinating office
conducted several rounds of discussions and developed draft instruments keeping in mind
the key objectives of the study, points of interest for policy makers, program managers,
implementers and clients. Draft instruments are piloted in 12 locations in India for
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
34
validity, question framing, relevance, and sequencing before finalizing. The final version
of instruments are prepared with inputs from an International Advisory Board and Partner
Medical Colleges and Institutions, and then translated into local languages. Instrument
specific and general comments obtained during the pilot phase were also incorporated
into final instruments.
To ensure cultural sensitivity and appropriateness the following has been done:
• A multidisciplinary team from different parts of the country developed study
instruments
• Piloting has been done across the country to give attention to any issues of
cultural appropriateness
• Instruments will be translated into local languages
• Study implementation and administration of instruments will be done by local
[“Emic”] investigators.
16. Qualitative Component
16.1 Rationale
There are several aspects of health systems, program implementation and care
seeking behavior of clients that are context specific and currently not well understood.
To explore these, qualitative research methods will be used in the form of In-depth
Interviews and Focus Group Discussions (Annexures 3 and 4 respectively). In addition,
events prior to death and recovery will be child specific and therefore, will be explored in
an open ended manner.
16.2 Qualitative Sample Size
In-depth interviews and Focus Group Discussions will be conducted in each study
district and state involving family, community, health workers, care providers, program
and policy related stakeholders to derive a composite view about various influences on
program implementation, supervision and monitoring. Rapid Appraisal Procedures (RAP)
will be adopted to derive the reality by synthesizing multiple sources of information. The
technique will involve searching for opinions, motivations, behaviors and attitudes of key
stakeholders within their organizational and socio-cultural matrix. Stakeholders and their
location along with number to be interviewed per district are given in the table below
(Table 2).
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
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Table 2: Baseline Assessment of Child Survival Indicators: Qualitative Component
In-Depth Interviews Per District
Per State (For 2 districts)
Study (8 states)
State Level Officers
Health Secretary, DGHS, State RCH/ IMNCI Officer
- 3 24
District Level Officers District Magistrate 1 2 16 Chief Medical Officer 1 2 16 Medical Superintendent (District Hospital) 1 2 16 District RCH Officer 1 2 16 Rural Areas
Prescriber: Government 4 8 64 Prescriber: Private (Formal-2; Informal-2) 4 8 64 NGO’s/ CBO’s/ Community Leader 4 8 64 Focus Group Discussions ANMS and ICDS supervisors [@ 1 each in intervention district] and Health Supervisors and AWWs [@ 1 each in comparison district]
2 4 32
Mothers- Utilizers (who approached government health facility for the last illness episode of their under-5 child)
2 4 32
Mothers- Non-utilizers (who did not approach a government health facility for the last illness of their under-5 child)
2 4 32
Total 22 47 376
16.3 In-Depth Interviews
16.3.1 Participants
District Magistrates, Chief Medical Officers, NGO/ Community Leaders, and
prescribers will participate in in-depth interviews. Representatives from local NGO/
CBOs and Community Leaders who influence health issues in their communities will also
be interviewed. In addition three interviews will be conducted in every state with top
policy and decision makers.
16.3.2 Design
Purposive sampling will be done keeping in view the relevance and involvement
of the stakeholders to the district child health services. General instructions for
conducting interview are given in Annexure 3. The information collected will help
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
36
understand the process of child health program implementation, scope of program’s
coverage so as to ensure that target populations are reached, steps taken to address the
equity of services for all segments of the population, challenges faced, efforts taken to
overcome these barriers and suggestions to improve child health services in the area. The
information collected will complement the quantitative component of the study.
16.4 Focus Group Discussions (FGDs)
16.4.1 Participants
Mothers of under-five children, ANM, Health Supervisors, AWWs, ICDS
Supervisors will participate in focus group discussions.
16.4.2 Design
A total of 4 FGDs with mothers of under-five children will be conducted in each
district; 50% will consist of mothers who utilized public health facilities for the most
recent illness of their under-five children (utilizers), the rest will consist of mothers who
did not utilize public health facilities for the most recent illness. One FGD with each of
the following groups will be conducted in each state: ANMs and ICDS supervisors or
AWWs, and health supervisors. FGD’s will be conducted to assess health promotion and
sickness behavior, client and health provider perspective about existing child health
activities and problems related to them, and suggestions to improve these services. The
guidelines for conducting FGDs are provided in Annexure-4.
17. Verbal Autopsy (VA) and Tracking of Events Before Death/ Recovery from
Illness
Verbal Autopsy relies on the assumption that most causes of death have
distinct symptoms and signs that can be recognized, recalled, and reported by
household members or associates of the deceased to a trained field-worker. Further, it
is assumed that deaths characterized through verbal autopsy possess a distinct set of
features that can be distinguished from other underlying causes of death [31]. Thus,
diseases with very distinct symptoms and signs, such as tetanus, that are recognized by
the local population may be more suitable for verbal autopsy than systemic diseases,
such as malaria, which has signs and symptoms common to other illnesse. Factors that
influence the validity and reliability of verbal autopsy include the verbal autopsy
instrument (mortality classification, diagnostic procedures), the data collection
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procedures (recall period, interviewer's characteristics, respondent's characteristics),
and the underlying distribution of cause-specific mortality in a given population. The
diagnosis of childhood illness by maternal health interview surveys is widely used to
estimate the prevalence of childhood morbidity in developing countries.
Although there is variation in the sensitivity and specificity for specific
conditions, verbal autopsy help classify the broad patterns of child mortality in
populations that are not covered by adequate medical services.
17.1 Instruments
WHO’s verbal autopsy instrument and instrument developed by Population Health
Matrix (Johns Hopkins University and Harvard University, USA) for their Global
Challenge GC-13 project, have been the basis of the verbal autopsy instrument developed
for the current study. Questions for tracking of events prior to death have also been
incorporated into the instrument. Separate instruments have been designed and developed
for tracking of events prior to recovery from common childhood sickness (as covered
under IMNCI) and for events taking place in the first 10 days of life of neonates 10-18
days old.
17.2 Participants
Mothers of children below five years who have died or recovered from illness or
neonates (10-28 days old) will participate in verbal autopsy and tracking of events. If
mother/ caretaker are not available repeat attempt to interview the key person will be
made before leaving the cluster.
17.3 Data to be collected in Under-five Child Deaths for Qualitative Verbal Autopsy
All deaths in children below 5 years (occurred in previous one year from date of
survey) in a given cluster will be included in the sample for verbal autopsy and tracking
of events. When 160 households are screened (covering approximately 750-1000
population) approximately 20 live births are likely to be captured within a cluster. Death
rate of under-five children in study states/ districts is estimated to be 50-90/ 1000 live
births and at this rate, we are likely to get 1-2 deaths per cluster.
Senior Investigator will administer the Verbal Autopsy instrument in the cluster as
according to the guidelines provided (Annexure 6). He/she however will not be involved
in assigning causes of death. A physician review process will be used to assign the cause
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
38
of death. All the verbal autopsies will be independently reviewed by any two physicians
from a panel of trained physicians. These physicians will be members of the CCT. The
physicians will receive training on the cause of death assignment process. They will be
required to assign direct and underlying causes of death based on the International
Classification of Diseases version 10 (ICD-10). If two physicians agree on the direct and
underlying cause, that cause will be accepted. In the event of disagreement, the verbal
autopsy will be reviewed by the third physician on the panel. If his/her assigned cause of
death agrees with that of either of the other two physicians then that cause will be
accepted. If there is still disagreement, a “not determined” cause of death will be
assigned. The physicians will be allowed to assign “unspecified” as a cause of death if
they feel that there is not enough information to lead to a definite cause of death. If any
two physicians agree on “unspecified” as a cause of death then that will be assigned.
17.4 Tracking of Events
The objective of this part of the study is to determine sickness management and health
behavior practices at the household, community and health facility level regarding all
events occurring during illness. These will be identified during household screening of
the cluster. Tracking of events will be done by Senior Investigators as per the instructions
detailed in Annexure 7.
Senior Investigator will administer the instrument for tracking of events to the
mothers/ caregivers of following categories of children:
1. Morbidity–recovered and hospitalized (one per cluster): Child who was sick
anytime during last 3 months; sickness required hospitalization in a health facility
(public or private) for at least 24 hours, and is now asymptomatic for at least 72
hours.
2. Morbidity-recovered without hospitalization (one male and one female child per
cluster): Child who was sick anytime during last 2 weeks and is now
asymptomatic for at least 72 hours without the need for hospitalization.
3. Neonate (10-28 days) (one per cluster): First 10 days are critical for survival of
neonates. The purpose of tracking of events in neonates after they have completed
the critical period is to: (i) identify existing gaps/ inadequacies in the care to be
provided by pubic health system; (ii) explore family care seeking practices during
this period and (iii) health care facilities accessed by families during this critical
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39
period. [Neonates who die during first 10 days of life will be captured for tracking
events under verbal autopsy component].
17.5 Participants
Mothers/ caretakers will be asked details about the index child such as date of
birth. the pregnancy history of the mother including fetal losses and live births; details
about the birth of the child; what the newborn was fed and how it was cared for; and
details of the child’s sickness will be collected quantitatively. Details about interventions
at home and subsequent visits to health facilities will be collected qualitatively in
narrative form. All tracking processes will be done by Senior Investigators.
18. Qualitative Data Management and Analysis
Efforts will be made to record all the in-depth interviews with district level
program officers, NGO’s, rural prescribers, and FGDs to the extent possible on audiotape.
In all situations, responses will be written in interview schedules verbatim (local
language). The content of interviews will be supplemented later by the tape recorded
versions, and there after translated into English. An ‘insider's view (emic)’ will be
obtained by ensuring that investigators are familiar with the local dialect and vernacular.
However verbal autopsy and tracking of events instruments will be conducted by
Senior Investigators during cluster survey. These interviews will not be tape recorded.
A team of investigators from IPEN (including CCT members) will analyze the
qualitative data. Steps for analyzing qualitative data will be: free listing of narrative
responses; domain formation; code application; and data summarization. Data will be
analyzed separately for each state and then combined to assess similarities and differences
in the perceptions of stakeholders across the study sites. Based on the experience of the
investigators from previous qualitative studies in traditional and developing societies,
data will be analyzed and interpreted by trained social scientists and anthropologists from
diverse cultural backgrounds. Responses will be entered into a computerized data base by
question and stakeholder category under the supervision of the CCO. Data will then be
analyzed in concordance with research questions. Domains are evolved on the basis of
responses that convey homogenous perceptions. Efforts will be made to retain common
domains on common issues throughout the stakeholder categories for meaningful
comparisons.
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19. Qualitative Research Teams at Regional Center
One Principal Investigator (preferably with social science background) along with
the Regional Coordinator and two Research Assistants will constitute a team at each
regional center/ state for qualitative component and organize interviews at district level.
In all 8 states, there will be 8 such teams (32 persons). They will be responsible for
conducting:
1. Interviews of program managers/ stakeholders/ prescribers.
2. Focus group discussions with mothers of under-five children and ANMs/ AWWs/
ICDS Health Supervisors.
The Verbal Autopsy and Tracking of Events associated with death and recovery
from childhood morbidity will be done by Senior Investigators of the field teams
(Annexure 6 and Annexure 7 respectively).
20. Quantitative Component Design
The study will be restricted to rural populations of the selected districts. Cluster
survey design using probability proportionate to size (PPS) technique will be adopted.
Using this method, the likelihood of a community being selected is in relation to the size
of its population (i.e., larger villages are more likely to be selected than smaller ones).
Census data of 2001 (Registrar General of India) will be utilized for selecting clusters
after adjusting for population growth rate.
20.1 Mortality Survey
20.1.1 Mortality Survey Sample Size Calculation
Of the indicators being measured by the cluster survey, child mortality is the
rarest. Therefore the cluster survey sample size was calculated based on U5MR (80-
100/1000 live births), IMR (60-80/1000 live births), and NMR (30-50/1000 live births)
which were obtained from the NFHS-2 survey. Basing the sample size on NMR will
create a sample size large enough to capture all events that are more common than
neonatal mortality. To estimate the prevalence of NMR (4%), in the study universe (rural
part of a district) with an admissible error of +/- 1%, at a 95% confidence level,
approximately 1500 live births which occurred over the past one year will have to be
surveyed. This will allow IMR, NMR, and under-5 mortality to be detected with a margin
of error between +/- 1% and +/- 1.5%.
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However, in order to identify and survey 1500 live births, between 45,000 and
75,000 individuals total will have to be interviewed assuming a crude birth rate of 20-
35/1000. This will result in screening between 12,500 (with 6 people per household) to
15,000 (with 5 persons per household) household in each district. Taking into account
crude birth rates and rural household size in the study districts, a total of 12800
households will be recruited in every district at the rate of 160 households per cluster. A
design effect of one (1) was considered while determining the sample size, despite cluster
survey methodology, due to feasibility issues. However, design effect will be
reconsidered in Phase III when the sample size will be calculated taking into account
design effect observed during phase I and for expected changes in mortality resulting
from program implementation in intervention and comparison districts.
Table 3: Sample Size of Live Births for Estimating NMR, IMR and U5MR
Sl. no. Indicator Estimated
prevalenceAdmissible
error
Sample size (at 95% confidence level)
Estimated Sample Size
1 Neonatal Mortality Rate (NMR)
4% ± 1%
1454
2 Infant Mortality Rate (IMR)
7% ± 1.3%
1478
3 Under-five Mortality Rate (U5MR)
9% ±1.5% 1498
≈1500 live births [This translates into approximately 45,000- 75,000 population residing in a sampling universe with a birth rate of 20-35/ 1000 population]
20.1.2 Mortality Survey Sampling Strategy
The unit of survey in the study will be the household. Household is defined as a
group of people sharing a common kitchen. In each household, the number of people
residing in the household, their ages, and sex will be obtained. Pregnancy history from
2000-2006 will be obtained form every woman of reproductive age (15-49 years old).
More than one woman of reproductive age may be present in a household. Mortality
information of under-five children will also be collected. As already indicated in previous
section, 160 households will be screened in every cluster giving us a total of 12800
households in every district. At the rate of 5.3 to 5.5 persons per household, a population
of 67,800 to 70,400 will be screened to obtain the desired number of live births and
associated under-five mortality.
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42
20.2 Morbidity Survey
ARI, malaria, and diarrhea are morbidities that IMNCI is focusing on and will be
used as assessment measures for this evaluation. Cough, fever, and loose motion are
indicator symptoms for the morbidities ARI, malaria, and diarrhea respectively. Multiple
studies were consulted to arrive at a prevalence estimate for ARI, malaria, and diarrhea
before the sample size was calculated. According to NFHS II (1998-1999), in India the
prevalence of cough with fast breathing was 19.3%, fever was 29.5%, and loose motions
was 19.2%.
However, according to NFHS-II data for the eight states participating in the study,
the lowest prevalence of ARI was 7.9%, fever was 23.7%, and diarrhea was 13.9%.
UNICEF and MOHFW-GOI conducted a Multi Indicator Cluster Survey (MICS) in 2000
which surveyed all under-five children. This study found the lowest prevalence of the
indicator conditions in the eight states chosen for this study to be 18.8% for ARI, 21.3%
for fever, and 14.5% for diarrhea. Table 4 summarizes the prevalence rates of the child
morbidity indicators from different surveys (NFHS-II and MICS) and figures used to
calculate sample size.
Table 4: Prevalence of Cough, Fever and Diarrhea as Indicators of Child Morbidity in India
NFHS II -1998-99*
(0-3 years) MICS- 2000 (0- 5 years)
Level
Cough with fast respiration
Fever Diarrhea Cough Fever Diarrhea
All India ( % prevalence)
19.3 29.5 19.2 29.1 29.8 23.1
Least prevalence among any of the study states ( % prevalence)
7.9 23.7 13.9 18.8 21.3 14.5
( % prevalence)** ≈8 ≈24 ≈14 ≈19 ≈21 ≈15
* Morbidity density over previous two weeks (% of specified age child population having the symptoms) ** The figures used for sample size calculation.
Since there was a wide variation in the prevalence of ARI reported in NFHS II
and MICS studies an average was taken and a prevalence of 13.5% was used to calculate
the sample size with 20% admissible error. A design effect of 1.5 was used to calculate
the final sample size required to estimate density of three indicator morbidities.
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Approximately 923 under-five children will need to be surveyed to estimate morbidity
density (Table 5).
Table 5: Sample Size for Estimating Morbidity Density (Per District)
Sl.no.
Indicator illness
Source Prevalence (Refer Table 4)
Admissible error (±20%)
Sample size (at 95% Confidence level)
Sample size
Design effect
Estimated sample size per district
NFHS II 14 ± 2.8 590 1 Diarrhea MICS 15 ± 3 544 NFHS II 8 ± 1.6 2 ARI/
Cough with fast respiration
MICS 19 ± 3.8
615*
NFHS II 24 ± 4.8 304 3 Fever MICS 21 ± 4.2 361
615
1.5
923 Say 960
* Calculated for an average prevalence of 13.5%
20.3 Sample Size to Estimate Under-five Accessing Government Health Facility for one
of the Indicator Illnesses (Cough with Fast Breathing).
Of the three indicator illnesses being studied in this evaluation, ARI has the lowest
prevalence rate in India. Therefore, the sample size for estimating the number of under-
five children accessing government health facilities for all the indicator illnesses was
calculated based on the ARI prevalence rate of 13.5%. Regarding use of health facilities,
(according to NFHS-II) 64% of children in India with ARI are taken to a health
facility/provider (either government or private). Therefore of the 13.5% of children
experiencing ARI, 9% are likely to be taken to a health facility/ provider (either
government or private), requiring a sample size of 621 with an admissible error of 25%.
This study also seeks to estimate the number of ARI children taken to government
health facilities. Assuming that out of the 13.5% of children experiencing ARI who are
taken to a health facility/provider (9%), 50% (4.5%) were taken to a government facility,
a sample size of 1072 with a 25% admissible error at 95% confidence level will be
needed. However, considering a design effect of 1.5, a total sample of 1600 under-five
children will be required in each district (20 per cluster) to estimate the number of
children accessing government health facilities when they are experiencing the indicator
illness (cough and fast breathing) with adequate power.
According to various surveys, approximately 50% of the under 5 population are
likely to be having one or more indicator symptoms at any time, but even if 1/5 of the
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sick children access a health facility/ provider, sample of 1600 under-five children per
district will be able to estimate the behavior with a confidence level of 95% and 20%
admissible error.
20.4 Sample Size for Quantitative Survey
Table 6 summarizes the estimated sample size for the quantitative survey to be
undertaken in this study.
Table 6: Sample Size for Quantitative Survey
Level
Cluster No. of Households Surveyed (@ 160/ Cluster)
Expected Live Births* (@ app. 20/cluster)
Expected Mortality (@1-2/ cluster)
No. of under-5 children to be screened for morbidity density and being taken to health facility/ provider for ARI (@ 20/cluster)
District 80 12,800 1,600 80-160 1600 State (2 districts)
160 25,600 3,200 160-320 3200
National (8 states)
1,280 204,800 25,600 1,280- 2560
25600
* Live births will be considered from the 12 months period prior to survey
21. Field Operation
21.1 Identification of the cluster
The data from census 2001 will be arranged in three columns: the first column
lists the names of the villages [i.e. the community], second column indicates the total
population of the communities and third column contains the cumulative population
which is obtained by adding the rural population of all the communities preceding it on
the list. The list is arranged in order given in the national census data. The sampling
interval is obtained by dividing the total population of the rural part of the district by the
number of clusters desired. A random number between 1 and the sampling interval is
chosen as the population number for starting cluster and the sampling interval is added
sequentially to the random number until the desired numbers of clusters are chosen. The
villages whose cumulative population includes these numbers are chosen for the cluster
survey. The selected clusters are plotted on a map of the respective district, and a logical
sequence (route map) for the fieldwork is developed for each of the survey teams.
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21.2 Cluster Survey Team
In every district there will be eight cluster survey teams, each team will survey 10
clusters; thereby covering 80 clusters in the districts. Each survey team will consist of six
members: two Senior Investigators (SI), two Doctors/ Medical Officers (MO)/ Interns and
two Research Assistants (RA); preferably one male and one female (Table 7). All centers
are encouraged to co-opt one social scientist/ anthropologist of the institution as one of
the Senior Investigators into the team. Senior Investigators will mostly be faculty
members from partner institutions. Research Assistants with social science or social work
background will be preferred. It is estimated that each survey team would be able to cover
one cluster in 2 days. Thus senior faculty members along with the whole research team
will be in the field to undertake data collection which will be of highest quality.
Table 7: Composition of Survey Teams (Cluster Survey)
2 Senior Investigators (SI), 2 Medical Officers (MO), 2 Research Assistants (RA) per team
No. of Persons (@ 6 Per Team)
Level No. of Teams
SI MO RA Total
District 8 16 16 16 48
Total per state (2 Districts)
16 32 32 32 96
Total in 8 states (16 Districts)
128 256 256 256 768
Each member of the research team will have specified responsibilities to
accomplish the cluster activities. Senior Investigators will be responsible for the quality
of data collected by the Doctors and Research Assistants. Table 8 provides list of
responsibilities proposed for every team member.
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Table 8: Responsibility of Team Members during Cluster Survey
Sl. no.
Members Responsibility Work load for Each Cluster
1. First Senior Investigator
1. Observation of prescriber-client interaction (specific skill observation). 2. Generic Observation of Health Facility. 3. Scrutinize and complete all instruments/ Quality Assurance along with other SI.
1. Investigator will visit one public or private health facility for every two clusters covered by his/her team per cluster. 2. At each health facility visited, observe doctor examining 3 children (< 5 year old). 3. Health facility assessment for logistics, manpower, and patient care facilities. 4. All instruments to be verified for quality and ICR sheets to be completed.
2. Second Senior Investigator
1. Conduct Verbal Autopsy 2. Tracking of Events (deaths/ recovered illness/ newborn) 3. Observation of skills of ANM/ AWW and ASHA/ TBA/ TH 4. Scrutinize and complete instruments/ quality assurance along with other SI.
1. All deaths among < 5 year old (in last one year) [approx. 1-2 per cluster] 2. Two recovered non-hospitalized sick children, (one male and one female) and one recovered hospitalized sick child per cluster. 3. One neonate per cluster 4. Observe skill of two health providers (ANM/ AWW/ and ASHA/ TBA/ TH) in each cluster 5. All instruments to be verified for quality and ICR sheets to be completed.
3. Doctors/ MO (2)
1. Household Screening of 160 households 2. Inform 2nd Senior Investigator about all deaths, one child with hospitalized-recovered morbidity and newborn for tracking of events.
1. Screening of 160 households. This will translate into approx. 1000 population with 20 live births in past one year. 2. Report the following to the Senior Investigator from every cluster: a) All deaths of under-five children in last
one years b) Neonate (10-28 days) (1) c) Hospitalized-recovered morbidity (1)
4. Research Assistants (2)
1. Household Survey of 20 households with under-five children to find out morbidity density and health and care seeking behavior. 2. Inform 2nd SI about 2 children with non-hospitalized recovered morbidity for tracking of events and two sick children for skill observation of the paramedical workers. 3. Join Doctors for household screening after completing household survey.
1. 20 households per cluster (10 males+ 10 female children under-5 year old) 2. Report the following to the Senior Investigator from every cluster: a) non-hospitalized recovered morbidity (2) b) Sick under-five children for skill assessment of paramedical workers (ANM/ AWW and ASHA/TBA/TH) (2) 3. Screening households as mentioned above with Doctors.
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21.3 Activities within Cluster
Activities within a cluster are carried out according to a pre-defined and consistent
strategy. Broadly each cluster will be divided into four quadrants to sample every
segment of population. In each quadrant, the team will decide about the first household
through a random process using the last two digits on the currency notes available with
Research Assistants/ Doctors. Thereafter the team will move clockwise and anticlockwise
in the alternate quadrants respectively. Flow diagram of field operations is given as
Annexure 8. An account of all the households visited will be kept by maintaining the log
sheet (Annexure 10 and Annexure 13). This will provide count of locked houses, refusals
and other incomplete information.
21.4. Household Screening
The purpose of household screening is to:
1. Obtain basic demographic information about members of the household.
2. Identify all women of reproductive age (15-49 years) and record their pregnancy
history for last five years. It will be asked in a retrospective manner from the
most recent outcome of pregnancy till the last outcome of year 2000. A
truncated instrument will be used for this purpose. A local seasonal calendar will
be used to assign the approximate date in case the exact date of pregnancy
outcome is not known. A pregnancy without an outcome will be considered as a
non-event.
3. Record all maternal deaths that occurred in last one year (2006) and their
pregnancy outcomes.
4. Record the death of children under-five that occurred in the past one year
5. Identify neonates (10-28 days old).
6. Identify children who were hospitalized and recovered.
7. Obtain information about equity indicators regarding gender, education status of
mother and head of household, occupation, and religion and caste. A Standard of
Living Index (NFHS II) has been incorporated into this instrument as well.
21.4.1 Design: Household Screening
The study will recruit 160 households in each cluster. Thus a population of
approximately 70,000 residing in 12,800 households will be screened. It is estimated that
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considering crude birth rates (≈ 20-35/ 1000 population/ year); almost 1500-1600 live
births will be detected in every district during survey in rural areas.
Household screening will be done by both the Doctors and Research Assistants in
the cluster survey team. The screening will be done till 160 households are captured in the
given cluster. If there are more than one ever married female (15-49 years) in the given
household, then a separate instrument will be filled for each female. Research Assistants
will join the Doctor for screening after completing household survey to complete
household screening. A local seasonal calendar (Annexure 32) will be used to assign
approximate date while taking the pregnancy history, if exact dates are not known.
Therefore, dates on the instrument will be assigned by the interviewer. Detailed
instructions for household screening are provided in Annexure 9.
21.5 Household Survey
This component will capture morbidity density in the study population (children <
5 year old with or without indicator symptoms on the day of survey and during two weeks
prior to day of survey). In addition, household practices with respect to health and
sickness care seeking behavior will also be determined. In every cluster 20 under-five
children (10 females and 10 males) will be identified. Only one under-five child per
household will be selected by using the random number table (Annexure 31). Research
Assistants will conduct the household survey. The process and instructions for household
survey are given in Annexure 12.
For morbidity tracking:
During the household survey, the survey team will identify one neonate (between
10-28 days of age) for tracking of events and two (one female and one male) under-five
children, who were sick anytime during the last two weeks prior to the survey but
recovered without hospitalization and asymptomatic for at least 72 hours prior to the
survey for tracking of events. Senior Investigator will be informed by the Doctor/ RA
about these children by handing over the completed referral slips for the same (Annexure
11 and Annexure 14).
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22. Generic Health Facility Observation
22.1 Types of Health Facilities Included in the Study
In a district, a total of 40 rural health facilities will be selected for generic
observation; 20 government and 20 private health facilities. For every two clusters
surveyed, one health facility either government or private health facility will be identified.
Private health facilities will be identified in pairs of clusters that have cluster number
divisible by four. In remaining pairs, government health facilities will be recruited. Senior
Investigators will accomplish this task.
22.2 Selecting Health Facilities for Observation
Government Health Facilities
Government Health Facility (PHC / CHC which are not attached /linked to local
medical college) present within or located nearest to the selected cluster, will be selected
for generic and prescriber skill observation. These health facilities must have OPD
facility where newborns and children are seen and with a sanctioned position of medical
officer.
Private Health Facilities
Private Health Facility (formal / Informal Practitioner), located in (or nearest to)
within or near the selected cluster where the childcare OPD is available will be selected.
(If more than one private health facility exists in the cluster, one, where more children are
managed will be selected).
The general instructions for generic observation of the health facility are provided
in Annexure 15.
22.3 Justification of Private Sector Assessment
• Majority of community even in rural areas utilizes the services of private
providers. Hence, knowledge about their skills will be critical to the overall
improvement in child survival. It will serve as a guide to their needs
assessments and involvement in NRHM.
• NRHM envisages public-private partnership
22.4 Data to Be Collected
Observations will be made for infrastructure/ available manpower, supplies,
logistics, and referral services.
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23. Skill Observations
23.1 Skill Observations of Prescribers
23.1.1 Participants
One doctor (prescriber), delivering child health services, will be selected for
assessment of clinical skills from each of the selected health facility (government/
private) (refer to Section Para 22: Generic Health Facility Observation; Page no. 48).
23.1.2 Design
Out of 80 clusters in a district, we propose to observe the skills of health care
provider from 40 health facilities. Out of these, 50% health care providers will be from
government and rest will be from the private sector. Prescribers will be directly observed
by one of the Senior Investigators for management of five children (0-59 months) in the
OPD. The present intervention places emphasis on evaluating the process of assessing the
sick child. No cross validation of the process and key parameters inferred by health
provider will be done during the skill observation of the prescriber.
23.1.2.1 Selection Criteria for Prescriber
a. Between a pair of two clusters one health facility is to be chosen. This health
facility will be alternately either government or non-government. Cluster pairs
containing cluster number divisible by four (4) will be considered for non-
governmental/ private prescriber.
b. The person in-charge of health facility to be contacted to facilitate filling up this
schedule
c. Government health facility: Designated for the cluster or the one which is
geographically nearest is to be selected.
d. Private health facility/ NGO: One where cluster residents take their sick
children; if more than one private health facilities are present, choose the one
where more under-five children are seen.
e. The doctor managing the children under-five years will be considered for skill
assessment.
f. Child brought for follow up visit should not be included.
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23.1.3 Data Collection
Skills related to history taking and general physical examination related to
indicator symptoms other common and important sicknesses, feeding, immunization,
home care assessment, counseling of caretaker, prescription and referral (if applicable) of
sick child will be directly observed and documented. Three live cases and three
hypothetical case scenarios will be used for skill assessment of prescriber. Prescription
audit will be carried out as a component of skill observation for diagnosis and
classification for severity of illness. Guidelines for skill observations are found in
Annexure 16.
23.2 Skill Observation of Paramedical Workers
23.2.1 Participants
ANMs/ AWWs and ASHAs/ other Non-conventional community health providers
(TBAs/ Traditional Healers) will be assessed for management of common childhood
illnesses for two groups of patients: neonotes (10-28 days) and children between 2-59
months old.
23.2.2 Design
Skills of one ANM or AWW per cluster (ANM from odd and AWW from even
numbered cluster) will be assessed for management of common childhood illnesses by
Senior Investigator and/or Doctor of the team. Management of three live under-five
children (including a neonate if available) and three hypothetical case scenarios will be
observed for each health worker (ANM/ AWW). During the time of survey the district
authorities will be requested to coordinate availability of ANM/ AWW in the respective
clusters.
NRHM is planning to have ASHA as a link person and depot holder for the
community. Therefore, their skills will be assessed during the study as and when they are
in position on the ground. Management of one live under-five child (it may be a neonate
if available) and three hypothetical case scenarios will be observed for each health worker
for every cluster one ASHA or non-conventional health worker will be selected for skill
observation. At all places ASHA will be the preferred over others for observation when
available.
Research Assistants will identify sick children (0-59 months; including a neonate
if available) during Household Survey and refer to Senior Investigator for the skill
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assessment of paramedical health providers. The three hypothetical case scenarios will be
same for all the prescribers and paramedical health workers, targeting at assessment of
common childhood illnesses and neonatal problems. During the survey of 80 clusters in a
district, we propose to observe the skills of 40 ANM and 40 AWW and 80 ASHA or other
non-conventional health workers (TBA/ Traditional Healer).
23.2.3 Data Collection
Broad framework of skill assessment for paramedical workers will be similar to
that used for prescribers. Three live cases (sick under-five children identified by RAs
during household survey) and three hypothetical case scenarios (same as prescribers) will
be used for the skill assessment of ANMs/ AWWs. For ASHA/ non-conventional health
workers (TBA/ Traditional Healer) one live case (sick under-five children identified by
RAs during household survey) will be used for the skill assessment.
24. Data Management
24.1 Unique Serial Number
Every interview schedule will be given a unique serial number. From a unique
serial number the state, district, cluster number and category of stakeholder can be
identified. The unique ID number is comprised of seven digits; first digit represents the
state/ region (1 to 8), second digit represents the district (1-Intervention district and 2-
Comparison district), third and fourth digits represent the cluster number (01 to 80) for
ever district, last three digits represent the interview/ schedule number (001 to 277).
Instrument Code Cluster Code
State Code District Code
Each instrument will have a Unique ID number and it will be specific for the state,
district, cluster and the nature of instrument. Same instrument designated for different
clusters will have the same last three digits of Unique ID, but different first four digits.
From a Unique ID, the type of instrument, and its data source including the cluster,
district, state and stakeholder/ nature of data can be identified. It will also help in linking
of data from the same household. The format of Unique IDs assigned to the states,
districts and instruments is given in Annexure 34.
1 1 0 1 2 4 0
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24.2 Data Management and Transmission for Quantitative Intervention
Collected data will be checked for completeness and quality at the cluster level by
the Senior Investigators. ICR (Intelligent Character Reading) sheets will be filled for
every quantitative instrument for rapid scanning and database formation. Guidelines for
filling ICR sheets are given in Annexure 17. The completed instruments along with filled
ICR sheets will be submitted to the Regional Coordinator. The Regional Coordinator will
dispatch all the completed instruments and ICR sheets from 80 clusters at one time to
CCO-Delhi for further data processing and analysis.
24.3 Data Analysis and Reporting
Data will be collated and organized at the CCO, Delhi. A multidisciplinary team
guided by the CCT will perform the data analysis and write the reports. A list of
indicators (Annexure 18) has been prepared which will be consulted during analysis
25. Summary of Activities
The following Table 9 provides the proposed magnitude of activities to be
undertaken under this baseline phase of this study.
Table 9: Summary of Cluster Level Activities
Mortality & Morbidity Component Sl.No
Activity Per Cluster
Per District (80 Clusters)
Per State (2 Districts)
Total (8 States)
1. Household Screening for live births and under-five deaths
160 12800 25600 204800
2. Verbal Autopsy and Tracking of Events (children deaths <5 years) (all deaths)
2 (approx.)
160 320 2560
3. Tracking of Event for newborn (10-28 days)
1 80 160 1280
4. Tracking of Events for sickness- recovered non-hospitalized children
2 160 320 2560
5. Tracking of Events for sickness- recovered hospitalized child
1 80 160 1280
6. Household Survey (20 per cluster: 10 males and 10 females each)
20 1600 3200 25600
Observations
7. Health facilities: (Equal number 40 80 640
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of public and private) (One Generic Observation of the facility every alternate cluster)
0.5 (1 per 2 clusters)
8. Prescriber Skill Observation: (equal number of public and private) (three under-five live cases and three hypothetical cases per prescriber)
0.5 (1 per 2 clusters)
40 80 640
10. ANM/ AWW: (three under-five live cases and three hypothetical cases per ANM/ AWW)
1 80 160 1280
11. ASHA/ TBA/ TH (one under-five live case per worker)
1 80 160 1280
26. Ethical Considerations
• Approval has been obtained from ethics committees of AIIMS, New Delhi. The
present study is a program evaluation of a government program and hence doesn’t
require consent from individual participants. However, consent will be obtained
while undertaking verbal autopsy.
• While prescriber is managing cases under-five years, investigator will just observe
the process for assessing the skills and will not validate process for correctness.
However, while observing the skills, if there is an irrational/ wrong practice having
life threatening implications, the investigator will intervene. He or she will then
discontinue the observation in this health facility/ with the provider and move to the
next health facility/ health provider for completing the remaining observations. All
such observations will be recorded and reported in analysis.
27. Independence of IPEN during the Study
IPEN considers program evaluation a partnership exercise. Policy and program
managers at Central and State levels are key allies for translating our research to action.
We work with Ministry of Health & Family Welfare to evolve research questions and
feasibility of doing study on the ground. Thereafter investigator selection, study design,
instruments development, data collection and processing; analysis and report writings are
completely independent and external processes in which government representatives are
not invited at any step. IPEN is also not involved in the implementation of programs that
it is evaluating.
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The study team is a partnership between medical colleges (government and
private) and NGO’s in health. At all levels, IPEN team maintains its status of an external
evaluator and expresses and communicates the findings of the study in that capacity.
28. Sharing Data for Policy Making and Programme Refinement
Information collected at baseline will be shared with policy makers and program
managers/ providers so that implementation of IMNCI can be improved/ refined.
Particularly useful information will pertain to system processes; current provider skills
and areas requiring specific emphasis during training, unique needs of the private sector
and perceptions of district level program providers to improve implementation of IMNCI
in their area. The results will be shared with State and Central program officers through
face to face meetings with follow up advocacy at all levels including district officers.
Efforts are being made to have a formal structure (a program managers group) where
policy makers and program managers can translate findings into action. District
dissemination and feedback workshops for local program officers and those in the private
sector will be organized in middle of 2007.
29. Project Administration
This study is a large collaborative study involving about 140 partners from about
60 partner institutions in 8 states.
In this study the capabilities of the network will:
• Maintain high level of motivation and commitment to the project activities,
• Maintain highest level of quality assurance
• Foster camaraderie among all partners
29.1 Composition of the Central Coordination Team
The Central Coordinating Team (CCT) is a multidisciplinary team composed of
15-20 investigators co-opted from various medical colleges and professional institute. It is
comprised of program evaluation experts, epidemiologists, pediatricians/ neonatologists,
public health specialists, social scientists, anthropologists, and biostatisticians. The
Central Coordinating Team has guided in all the previous IPEN studies. The CCT
operates from the Central Coordinating Office (CCO) and functions as a team of
investigators who drive the whole project. The CCT holds several meetings to arrive at a
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draft protocol for the study and to discuss other operational details. The CCT facilitate
development of operational manual, study instruments, undertake quality assurance visits
to the study sites, supervise and conduct focus group discussions and provide inputs at the
time of project report writing. Additional investigators from partner institutions have been
inducted into CCT and are termed as Extended CCT members.
29.2 Central Coordinating Office – CCO, Delhi
Central Coordinating Office (CCO) of the study is located at International Clinical
Epidemiology Network office, New Delhi. The CCT and IPEN office will provide
technical and quality assurance support for the study. CCO will manage the network
activities and will be responsible for coordinating with all partner medical colleges,
monitoring progress of the network, screening the data to ensure quality, processing and
analyzing the data. Queries from partner medical colleges are entertained at all times and
responded by CCO using the fastest mode of communication.
29.3 Regional Centers
The study will be conducted in 16 districts located in eight states. One institution
will be nominated as a regional center in each study state. The regional center will
coordinate identification of research teams, training of the research team members, data
collection and quality assurance activities of both districts in the respective state.
29.4 Partner Institutions
There will be 5 to 8 partner medical colleges involved in each state. Each partner
medical college will be responsible for forming of 2-3 survey teams. These network
partners are medical colleges or NGO’s or Institutions working in the field of health.
Table 10 shows participating medical colleges and partners.
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Table 10: List of Regions and Corresponding Partner Institutions
S.No. State Partner Medical Colleges
S.N Medical College, Agra Medical College, Kanpur J.N Medical College, Aligarh KGMC, Lucknow
1 Uttar Pradesh
Santosh Medical College, Gaziabad
G.R Medical College, Gwalior Government Medical College, Jabalpur
Mahatma Gandhi Medical College, Bhopal
Gramin Sewa Sanstha
2 Madhya Pradesh
M.G.M Medical College, Indore Nidan Samaj Sevi Sammiti RNT Medical College, Udaipur Dhar Santha ,Barmer PRAYAS, Chittorgarh SMS Medical College, JaipurSeva Mandir, Udaipur National Institute of Medical
Sciences, Jaipur
3 Rajasthan
MGNIMS, Jaipur MKCG Medical College, Berhampur
S.C B medical College, Cuttak
4 Orissa
VSS Medical College, Sambalpur
Hi-Tech Medical College, Bhubaneshwar
Seva Mandir, Udaipur Grant Medical College, Mumbai
Family Welfare Training & Research Centre, Mumbai
Government Medical College, Nanded
Dhar Santha ,Barmer B.J Medical College, Pune Topiwala National Medical College, Mumbai
Government Medical College, Latur
5 Maharastra
Public Health Institute, Nagpur Khaja Bandanawaz Institute of Medical Sciences, Gulbarga
B.M Patil Medical College, Bijapur
6 Karnataka
M R Medical College, Gulbarga S.N Medical College, Bagalkot
Government Medical College, Srinagar
St. Stephen’s Hospital, New Delhi
Haryana
Government Medical College, Amritsar
Maulana Azad Medical College, New Delhi
7
Dayanand Medical College, Ludhiana
Pt. B.D. Sharma PGIMS, Rohtak
NEHIGRIHMS, Shillong PGIMER, Kolkata Assam Medical College, Dibrugarh
Gauhati Medical College, Guwahati
SNEHA, Dibrugarh NESPYM, Guwahati
8 Meghalaya
PRAYAS, Dibrugarh
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30. Network Monitoring
30.1 Regional Coordinator
A Regional Coordinator will be identified at each regional center to coordinate
activities in his/her state and streamline research activities. The regional coordinator will
be in constant touch with CCO, Delhi. Soon after the regional workshop, list of research
team members (Annexure 19), the plan of cluster/ field activities (Annexure 20) will be
sent to CCO. Thereafter regional center and CCO will remain in constant touch to
monitor progress of fieldwork and data collection. Regional coordinator will update CCO,
Delhi every alternate day (on every Monday, Wednesday and Friday) regarding the
progress of the fieldwork accomplished by their research teams and communicate
problems faced by any team (Annexure 25).
The responsibilities of Regional Coordinator
1. Identify partners in his/her state to develop network that will accomplish the
study in two designated districts. This state network becomes part of national
team i.e. IPEN.
2. Encourage and ensure that state partners participate in national protocol
finalization workshop.
3. To conduct and organize two, four-day district level orientation workshops in
two-selected districts separately in coordination with the PMCs to understand
the objectives and methodology including hands on training for all team
members to conduct the interviews and health facility observation. Hands on
training will not be done in those areas which are to be taken as study clusters.
4. Help/ guide the PMCs to prepare a route map for every team to cover ten
clusters per team.
5. Coordinate movements of all teams, solving problems and facilitating local
arrangements.
6. Identify triggers of a problem and taking pre-emptive actions.
7. Monitor movements of teams on the field and facilitate quality assurance visit by
CCT member.
8. Facilitate smooth data collection and data transmission to CCO.
9. To conduct the state/ district levels interviews and conduct FGD’s.
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
59
10. To disburse funds for the field travel. Funds will be transferred to regional
coordinator office from CCO. The final audited accounts will be submitted back
to CCO for reconciliation by regional coordinators.
30.2 Monitoring Network Progress
All field teams from partner medical colleges will prepare an activity plan to
accomplish the targeted number of clusters within the given time frame (Annexure 20).
This will be closely monitored thrice weekly using activity log sheets. The network
progress regarding activities accomplished during the week will be monitored at CCO.
Whenever a team defaults in sending the activity log sheets, contact will be made through
telephone/ fax/ e-mail to remind them and ensure data collection or to know if there is a
problem. Such phone calls will also be entered in monitoring sheets. (Samples of various
monitoring sheets are given as Annexure 21-25).
30.3 Network Communication
Network communication is critical for the success of the study. Its significance
would be emphasized during all contacts and correspondence with regional centers and
partner institutions. A network directory containing office and residential addresses along
with the telephone and fax numbers of Senior Investigators will be compiled and
circulated to every member of the network with the explicit request of establishing
contact with their regional coordinating centre or CCO in case of need at any time. The
motto of the network communication will be to use “the fastest mode of communication”.
Decisions will be made quickly and no matter would be kept pending for more than 24
hours at the Central Coordinating Office. All network letters and completed study
instruments will be mailed through speed post/ courier, ensuring quick and safe delivery.
The network communication and dynamics is presented in Annexure 29.
31. Quality Assurance
Quality assurance measures will be incorporated into the study implementation
design at several levels.
Level 1: Program Managers Meeting
One day program manager meeting will be organized for seeking partnership
from the respective state government and to facilitate the activities of the project.
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
60
Level 2: International Advisory Board
A one-day meeting consisting of members of International Advisory Board
will be held before the National Protocol Finalization Workshop to share
experiences from other parts of the world and get technical inputs for the present
study. Subsequently International Advisory Board will provide technical and quality
assurance inputs at all stages of program implementation and later during analysis
and report writing.
Level 3: National Protocol Finalization Workshop at Delhi
A three-day workshop will be held for all the investigators including CCT
members, and partners from Ministry of Health & Family Welfare, Government of
India, donor agencies and other stakeholders. Objectives of the national workshop
will be to finalize the study protocol including the study instruments. Modalities of
data collection and transmission would also be finalized.
Level 4: Regional Orientation Workshops
Two separate four-day regional workshops will be conducted for Senior
Investigators and research teams from partner institutions in the region. Data
collection techniques and all the study instruments are discussed in detail at these
workshops. Participation of CCT members ensures that there are no distortions or
dilutions in communicating the study protocol to the research teams across the
network. All participants will have hands on experience to conduct interviews and
observation of health facilities in the near by village under the close supervision of
regional coordinator and CCT member.
Level 5: Quality Check at Cluster Levels
Everyday at the end of data collection, the Senior Investigators will
scrutinize the schedules filled by MOs and RAs for completeness and appropriate
coding of the answers in ICR sheets. If satisfied, they will sign the schedule or else
the researcher will be asked to do an extra interview to replace it.
Level 6: Field Visit by CCT Members during Data Collection
In every district, two CCT members will visit 8 clusters (@ 1 cluster per
team) during the cluster survey to ensure quality and consistency of data collection.
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
61
The objective of these visits is to identify problems of methodology and logistics in
the field and find solutions in consultation with Regions Coordinators and CCO.
The CCT members will cross check authenticity of data that has actually been
collected and quality of interviews being conducted by researchers through direct
observation. CCTs will provide the feedback about overall cluster activities,
interview techniques, quality (correctness and completeness) of data collected, and
quality of transcription of data by the team members (Annexure 27 & 28).
Level 7: Quality check at Regional Centers
At each regional centre, all qualitative study instruments completed by
Senior Investigator and RAs would be checked for correctness and completeness
before transmission to CCO, Delhi.
Level 8: Quality Check at CCO
A team of Research Assistants will cross check ICR sheets and match
these with data in the instruments. The ICR sheets will be scanned only after these
steps have been accomplished. Qualitative data will be analyzed by trained
anthropologists and social scientists with participation from CCT members.
32. Limitations and Challenges
The potential limitations of rapid appraisal procedures (RAP) are both intrinsic to
the methodology and extrinsic for the purpose of generalization. The problems are
primarily related to:
(i) Accuracy of the information
(ii) Respondents responses may not be generalizable
(iii) Cultural appropriateness
(iv) Subjectivity of the investigators leading to a bias in the interviews and
subsequent interpretation of data.
Several quality assurance mechanisms have been put in place starting from stage
of project conceptualization till data analysis and report preparation to overcome and or
minimize these biases.
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
62
32.1 Challenges for Phase II and Phase III of Study
A major external threat to the study is speed, consistency and quality of
implementation of IMNCI for intervention districts across different states. If the program
is not implemented completely and/or dilution in the quality of these components of
IMNCI, the changes observed in intervention districts will not be truly reflective of
effectiveness of IMNCI as a child survival package.
To overcome this challenge, the study team is making an effort to set up an
institutional arrangement with State and Central program managers to discuss the above
issues. The purpose will be to encourage state program implementation machinery to
facilitate, complete and consistent implementation of IMNCI in the respective districts
within the time frame decided in the state implementation places.
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
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33. Timeline of IMNCI-IPEN Study Phase I (2006-2007)
Activity JUL 06 AUG 06 SEPT 06 OCT 06 NOV 06 DEC 06 JAN 07 FEB 07 MAR 07 Weeks 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4
1. Development of study instruments and operational manual
2. Field testing 3. Finalization of Study
Instruments
4. Meeting of State Health Secretaries and Program Officers
5. Identification of Regional coordinator and PMC
6. Preparation of National
Level Workshop
7. International Advisory Board Meeting
8. National Workshop 9. Second Advisory Board
Meeting
10. Finalization of project proposal and Instruments
11. District Level Workshop 12.Data Collection 13.Data Analysis
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
64
References
1. Jones G, Schultink W, Babille M. Child Survival in India. Indian J Pediatr. 2006; 73:479-487 2. Mudur G. (2003). Neonatal deaths hamper India's infant mortality targets. British Medical Journal.
32. from bmj.bmjjournals.com/cgi/content/full/327/7426/1249. 3 Jones, G., Stekette, R.W., Black, R.E., Bhutta, Z.A., Morris, S., Bellagio Child Survival Study
Group. (2003). How Many Child Deaths Can We Prevent This Year? Lancet Child Survival Series. 361. 11-17.
4. World Health Organization. Towards Better Child Health and Development: Components of IMCI:
Website: www.searo.who.int/EN/Section13/Section37/Section2017/Section2038_10202.htm. Accessed: December 2006.
5. Tanzania IMCI Mulit-Country Evaluation Health Facility Survey Group. (2004). The effect of
Integrated Management of Childhood Illness on Observed Quality of Care of Under-fives in rural Tanzania. Health Policy and Planning, 19, 1-10.
6. Schellenberg JRA, Taghreed, A., Mshinda, H., Masanja, H., Kabadi, G., Mukasa O, et al. (2004).
Effectiveness and cost of facility-based Integrated Management of Childhood Illness (IMCI) in Tanzania. Lancet, 364, 1583-1594.
7. World Health Organization. Multi-Country Evaluation: Tanzania Web Site: www.who.int/imci-
mce/Sites/tanzania.htm. Accessed October 2006. 8. Huicho, L., Davila, M., Gonzales,F., Drasbek, C., Victoria, C., Bryce, J. Policy contributions and
key messages from the Multi-Country Evaluation of IMCI : Peru Fact Sheet from Global Forum for Health research, Ministerial Summit on Health Research.
9. Makerere University Institute of Public Health, Johns Hopkins University, WHO (Dept. of Child
and Adolescent Health and Development). Policy contributions and key messages from the Multi-Country Evaluation of IMCI: Uganda Fact Sheet from Global Forum for Health research, Ministerial Summit on Health Research.
10. Amaral, J, Gouws, E., Bryce, J., Leite, A., Alves da Cuna, A., and Victoria, C. (2004). Effect of
Integrated Management of Childhood Illness (IMCI) on health worker performance in Northeast-Brazil. Cad. Saude Publica, 20, 109-118.
11. El Arifeen, S., Blum, L., Hopue, D., Chowdhury, E., Khan, R., Black, R., Victoria, C., Bryce, J.
(2004). Integrated Management of Childhood Illness (IMCI) in Bangladesh: early findings from a cluster-randomised study. Lancet, 364, 1595-1602.
12. Baqui, AH et al. (2006). Rates, timing and causes of neonatal deaths in rural India: implications
for neonatal health programmes. Bull World Health Organ, 84,706-713.
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
65
13. National Rural Health Mission: Government of India. (2006). Operational Guidelines for
Implementation of Integrated Management of Neonatal and Childhood Illness (IMNCI). 14. Bang, A., Reddy, H., Deshmukh, M., Baitule, S. and Bang, R. (2005). Neonatal and Infant
Mortality in the Ten Years (1993 to 2003) of the Gadchiroli Field Trial: Effect of Home-Based Neonatal Care. Journal of Perinatology, 25, S92–S107.
15. Policy Reform Options Database. Outcome Evaluation of the Mitanin Porgramme: A critical
Assessment of the Nation’s Largest Ongoing Community Health Programme. Retrieved November 13, 2006, from www.prod-india.com/files/PROD49.
16. USAID. (2005). Mainstreaming Gender: A Start-Up Resource Kit. 17. UNICEF. (2005). State of the World’s Children. New York. Retrieved October 2006, from
www.unicef.org/sowc06/. 18. Black R., Morris, S., Bryce, J. (2003). Where and why are 10 million children dying every year?
Lancet, 361, 2226-2234. 19. Victora, C.G., Wagstaff, A., Schellenberg, J.A., Gwatkin, D., Claeson, M., and Habicht, J. (2003).
Applying an equity lens to child health and mortality: more of the same is not enough. Lancet, 362, 24-32.
20. The World Bank Group. (1996). Summary of: Improving Women’s Health in India. Retrieved
October 2006, from http://www.worldbank.org/html/extdr/hnp/population/iwhindia.htm. 21. Desai, S., Rastogi, S., and Vanneman, R. (2005). Gender Differences in Child Survival in India:
What do we know? Retrieved January 15, 2007, from iussp2005.princeton.edu/download.aspx?submissionId=51398.
22. Filmer, D., King, E.M., Pritchett, L. (1998). Gender Disparity in South Asia: Comparisons
Between and Within Countries. Retrieved January 16, 2007, from www.worldbank.org/html/dec/Publications/ Workpapers/WPS1800series/wps1867/. (World Bank policy research working paper No 1867.)
23. India Ministry of Tribal Affairs. (2004). The National Tribal Policy (draft). New Delhi: India
Ministry of Tribal Affairs. Available: http://tribal.nic.in/finalContent.pdf. Accessed: December 2006.
24. Subramanian, S., Smith, G.D., and Subramanyam, M. (October 2006). Indigenous Health and
Socioeconomic Status in India. PLoS Medicine. 3: e421, from 10.1371/journal.pmed.0030421. 25. Subramanian, S., Nandy, S., Irving, M., Gordon, D., Lambert, H., Smith, G. (May 2006). The
Mortality Divide in India: The Differential Contributions of Gender, Caste, and Standard of Living Across the Life Course. American Journal of Public Health, 96, 818-825.
26. The Bellagio Study Group on Child Survival. (2003). Knowledge into action for child survival.
Lancet, 362, 33-38.
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
66
27. Bangdiwala, S. Niswade, A., Ughade, S., and Zodpey, S. (2006). Integrating Results from
Formative Phase Studies for Informing the Design of Intervention Studies on Neonatal Health in India. World Health and Population.
28. National Rural Health Mission. (2005). National Rural Health Mission: Mission Document (2005-
2012). New Delhi: Retrieved in September 2006, from www.mohfw.nic.in/NRHM/ 20Mission/ 20Document.pdf.
29. The World Bank: South Asia Region, Health Nutrition, Population Sector Unit: India. (2001).
India: Raising the Sights: Better Health Systems for India’s Poor Overview. Retrieved September 2006 from lnweb18.worldbank.org/sar/sa.nsf/Attachments/ovr/$File/hOvr.pdf
30. population commission.nic.in/npp.htm. Accessed December 2006. 31. Anker M, Black R, Coldham C, Kalter H, Quigley M, et al. (1999) A standard verbal autopsy for
investigating causes of death in infants and children. Geneva (Switzerland): World Health Organization. Report Number WHO/CDS/CRS/ISR/99.4.
Operational Manual IPEN-IMNCI Study Phase I (2006-2007)
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ANNEXURE- 1 Integrated Management of Neonatal and Childhood Illness:
Baseline Assessment of Childhood Morbidity and Mortality in Selected Districts in India (IMNCI-IPEN Study 2006-2007)
Selected Study States and Districts for IMNCI-IPEN Study
Amravati
Parbhani
Gulbarga
Kaithal
Mewat
Mathura
Kannauj
Chittorgarh
Morena
Baran
Gadag
Sonpur
Nayagarh
Jaintia Hills
Ri-bhoi
Comparison Districts
Intervention Districts
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Integrated Management of Neonatal and Childhood Illness: Baseline Assessment of Childhood Morbidity and Mortality in Selected Districts in India
(IMNCI-IPEN Study 2006-2007)
Profile of Intervention and Comparison Study Districts Haryana 1 HARYANA
KAITHAL Intervention
MEWAT* Comparison
Total Total Rural Total Rural Demographic Profile (2001) %(#) %(#) %(#) %(#) %(#)
Total Population 100
(21144564) 4.4
(946131) 80.6
(762649) 5.5
(1178000) 93
(1095540)
Male Population 53.7
(11363953) 53.9
(510513) 53.9
(411628) 53
(624340) 52.2
(580636)
Female Population 46.2
(9780611) 46
(435618) 46
(351021) 47
(553660) 47
(514904) Sex Ratio 861 853 853 Population (0-6 yrs) 15.7 15.3 15.5 28.3 Male (0-6 yrs) 54.9 55.8 55.6 Female (0-6 yrs) 45 44.1 44.3 SC Population 19.3 21.5 22.7 5.5 ST Population 0 0 Minority population 10% Total Literacy Population 57.1 49.9 47 23 Male Literate 61.8 62.8 64 84 Female Literate 38.1 37.1 35.9 15.9 Population Density/ sq.km 478 408 Health Facility Profile HF/Lac HF/Lac Community health centres 5 0.6 4 0.3 Primary health centres 17 2.2 17 1.5 Primary health subcentres 143 16.7 109 9.9 Health Indicators Routine Immunization (2005) 69.5 45.7 57.5 Infant Mortality Rate (2001-IIPS) 62 69 65**
* Mewat is a newly created district (2005) and hence most statistics are not available. ** IMR is for Gurgaon district from which Mewat has been carved out. Karnataka 2 KARNATAKA GULBARGA
Intervention GADAG
Comparison Total Total Rural Total Rural Demographic Profile (2001) % (#) %(#) %(#) %(#) %(#) Total Population 100
(52850562) 5.9
(3130922) 72.7
(2278301) 1.8
(971835) 64.7
(629652) Male Population 50.8
(26898918) 50.8
(1592789) 50.5
(1152343) 50.7
(493533) 50.7
(319629) Female Population 49.1
(25951644) 49.1
(1538133) 49.4
(1125958) 49.2
(478302) 49.2
(310023) Sex Ratio 966 977 969 970 Population (0-6 yrs) 13.5 17.1 17.7 14.1 14.5 Male (0-6 yrs) 51.3 51.6 51.4 51.2 51.2 Female (0-6 yrs) 48.6 48.3 48.5 48.7 48.7 SC Population 16.2 22.9 24.9 14.1 16.1 ST Population 6.5 4.9 5.9 5.5 7.28 Minority Population 16% 2400% 15 Total Literate Population 57.5 41.4 34.7 56.7 52.5 Male Literate Population 58 62.6 65.4 60.8 62.9 Female Literate Population 41.9 37.3 34.5 39.1 37 Population Density 275.56 193 209 Health Facility Profile HF/1 Lac HF/ 1Lac Community health centres 19 0.8 6 0.9 Primary health centres 102 4.4 29 4.6 Primary health subcentres
507 22.2 183 29 Health Indicators Routine Immunization (2005) 90.9 50.2 49.4 IMR (2001- IIPS) 58 60 59
ANNEXURE 2
Source: Census 2001
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69
Profile of Intervention and Comparison Study Districts Madhya Pradesh
Maharastra 4 MAHARASHTRA
AMRAVATI Intervention
PARBHANI Comparison
Total Total Rural Total Rural Demographic Profile (2001) % (#) % (#) % (#) % (#) % (#)
Total Population 100
(96878627) 2.6
(2607160) 65.4
(1707581) 1.5
(1527715) 68.2
(1042529)
Male Population 52
(50400596) 51.6
(1345614) 51.5
(880387) 51
(780191) 50.8
(529729)
Female Population 47.9
(46478031) 48.3
(1261546) 48.4
(827194) 48.9
(747524) 49.1
(512800) Sex Ratio 922 938 940 958 968 Population (0-6 yrs) 14.1 13.7 14.3 16.5 16.9 Male (0-6 yrs) 52.2 7 51.3 52 51.8 Female (0-6 yrs) 47.7 48.4 48.6 47.9 48.1 SC Population 10.2 17.1 18.6 9.9 10.4 ST Population 8.8 13.6 18.8 2.3 2.5 Minority population 28% 27% Total Literacy Population 66 71.2 67.7 55.1 51 Male Literate 58.1 55.6 56.5 61.3 63.4 Female Literate 41.8 44.3 43.4 38.6 36.5 Population Density/ sq.km 315 213 229 Health Facility Profile HF/1 lac HF/lac Community health centres 18 1 10 0.9 Primary health centres 56 3.3 31 2.9 Primary health subcentres 320 18.7 231 22.1 Health Indicators Routine Immunization (2005) 78.7 82.4 80.8 Infant Mortality Rate (2001-IIPS) 50 51
3 MADHYA PRADESH
MORENA Intervention
TIKAMGARH Comparison
Total Total Rural Total Rural Demographic Profile (2001) % (#) % (#) % (#) % (#) % (#) Total Population 100
(60348023) 2.6
(1592714) 78.4
(1249409) 1.9
(1202998) 82.3
(990265) Male Population 52.1
(31443652) 54.8
(874089) 55
(687664) 53
(637913) 53.1
(525864) Female Population 47.8
(28904371) 45.1
(718625) 44
(561745) 46.9
(565085) 46.8
(464401) Sex Ratio 919 822 817 886 883 Population (0-6 yrs) 17.8 18.7 19.3 19 19.4 Male (0-6 yrs) 51.7 54.4 54.3 52.2 52.2 Female (0-6 yrs) 48.2 45.5 45.6 47.7 47.7 SC Population 15.1 21 21.2 24.2 25 ST Population 20.2 0.8 0.9 4.3 4.7 Minority Population 9 4 4 Total Literate Population 52.3 52.6 49.7 45 42.5 Male Literate Population 62.2 67.8 69.7 65.5 67 Female Literate Population 37.7 32.1 30.2 34.4 32.9 Population density/sq km 195.78 318.00 Health Facility Profile HF/1 Lac HF/1 Lac Community health centres 5 0.4 4 0.4 Primary health centres 18 1.4 18 1.8 Primary health subcentres
196 15.6 158 15.9 Health Indicators Routine Immunization (2005) 51.4 26.8 34 IMR (2001-IIPS) 86 118 142
ANNEXURE 2
Source: Census 2001
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70
Profile of Intervention and Comparison Study Districts Meghalaya 5 MEGHALAYA RI-BHOI
Intervention JAINTIA HILLS
Comparison Total Total Rural Total Rural
Demographic Profile (2001) % (#) % (#) % (#) % (#) % (#)
Total Population 100
(2318822) 8.3
(192790) 93.1
(179610) 12.8
(299108) 91.6
(274051)
Total Male Population 50.7
(1176087) 51.5
(99319) 51.5
(92563) 50.1
(149891) 50.2
(137629)
Total Female Population 49.2
(1142735) 48
(934714) 48.4
(87047) 49.8
(149217) 49.7
(136422) Sex-ratio 972 941 940 996 991 0- 6 Population 20.1 22 22.1 22.5 23 0-6 Male Population 50.6 50.7 50.6 50.1 50 0-6 Female Population 49.3 49.2 49.3 49.8 49.9 SC Population 0.48 0.1 0.1 0.15 0.15 ST Population 85.9 87 87.2 95.9 96.4 Minority Population 87 85 96 Literate population 49.9 51.2 50.6 40.1 37 Male Literate Population 53 54.1 54.2 48.3 48.1 Female Literate Population 46.9 45.8 45.7 51.6 51.8 Population Density (Per sq. km) 103.38 81 77 Health Facility Profile HF/lac HF/Lac Community health centres 3 1.6 5 1.8 Primary health centres 8 4.4 16 5.8 Primary health subcentres 26 14.4 70 25.5 Health Indicators Rotine Immunization (2005) 48.8 43 47.2 IMR (2001-IIPS) 61/1000 47.52
Orissa 6 ORISSA NAYAGARH
Intervenmtion SONAPUR
Comparison Total Total Rural Total Rural
Demographic Profile (2001) % (#) %(#) %(#) %(#) %(#) Total Population 100
(36804660) 2.3
(864516) 95.7
(827450) 1.4
(541835) 92.6
(501767) Male Population 50.7
(18660570) 51.6
(446177) 51.5
(426794) 50.8
(275601) 50.7
(254805) Female Population 49.2
(18144090) 48.3
(418339) 48.4
(400656) 49.1
(266234) 49.2
(246962) Sex Ratio 972 938 939 966 969 Population (0-6 yrs) 14.5 13 13.1 14.2 14.4 Male (0-6 yrs) 51.2 52.5 52.4 7.2 7.3 Female (0-6 yrs) 48.7 47.4 47.5 7 7 SC Population 16.5 14 13.8 23.6 23.5 ST Population 22.1 5.8 6 9.7 10.2 Minority Population 6 1 1 Literate Population 53.8 61.2 60.6 53.8 52.7 Male Literate Population 60.4 60.3 60.5 63.9 64.3 Female Literate Population 39.5 39.6 39.4 36 35.6 Population Density 236.37 222 231.00 Health Facility Profile HF/ 1 Lac HF/1 Lac Community health centres 4 0.48 3 0.5 Primary health centres 8 0.9 6 1.1 Primary health subcentres
150 18.12 75 14.9 Health Indicators Routine Immunization (2005) 70.4 62.3 65.2 IMR (2001-IIPS) 87 55 62
ANNEXURE 2
Source: Census 2001
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Profile of Intervention and Comparison Study Districts
Rajasthan
7 RAJASTHAN BARAN
Intervention CHITTORGARH
Comparison Total Total Rural Total Rural
Demographic Profile (2001) % (#) %(#) %(#) %(#) %(#)
Total Population 100
(56507188) 1.8
(1021653) 83.1
(849638) 3.1
(1803524) 83.3
(1514255)
Total Male Population 52.1
(29420011) 52.3
(535137) 52.2
(445205) 50.9
(918063) 50.6
(767555)
Total Female Population 47.9
(27087177) 47.6
(486516) 47.6
(404433) 49
(885461) 49.3
(746700) Sex-ratio 921 909 908 964 973 0-6 Population 18.8 18.5 18.8 17.2 17.6 0-6 Male Population 52.3 52.1 52 51.8 51.6 0-6 Female Population 47.6 47.8 47.9 48.1 48.3 SC Population 17.1 17.7 17.4 13.9 14 ST Population 12.5 21.2 24.8 21.5 24.9 Minority Population 11% 7% 8% Literate population 49 48.4 45.9 44.7 40.2 Male Literate Population 65.1 66.7 68.3 66.8 69.6 Female Literate Population 34.8 33.2 31.6 33.1 30.3 Population Density (Per sq. km) 165.11 146 166 Health Facility Profile HF/1 Lac HF/! Lac Community health centres 8 0.9 12 0.7 Primary health centres 32 3.7 54 3.5 Primary health subcentres 201 23.6 391 25.8 Health Indicators Routine Immunization (2005) 38.8 30% 23.30% IMR (2001-IIPS) 79 77 92
Uttar Pradesh 8 UTTAR
PRADESH KANNAUJ
Intervention MATHURA
Comparison Total Total Rural Total Rural
Demographic Profile (2001) % (#) %(#) %(#) %(#) %(#)
Total Population 100 (166197921)
0.8 (1388923)
83.2 (1156951)
1.2 (2074516)
71.7 (1487493)
Male Population 52.6
(87565369) 53.5
(744170) 53.7
(621751) 54.3
(1127512) 54.4
(809946)
Female Population 47.3
(78632552) 46.4
(644753) 46.2
(535200) 45.6
(947004) 45.5
(677547) Sex ratio 866 861 840 837 Population (0-6 yrs) 19 18.7 19 19.5 20.9 Male (0-6 yrs) 52.2 52.3 52.2 53.4 53.3 Female (0-6 yrs) 47.7 47.6 47.7 46.5 46.6 SC Population 21.1 18.4 19.7 19.5 21.9 ST Population 0.06 0.003 0 0.01 0.009 Minority population 19% 16% 9% Total Literacy Population 27 50.2 49.3 49.5 45.5 Male Literate 64.5 63.3 64.4 67.9 71.5 Female Literate 35.4 36.6 35.5 32 28.4 Population Density/ sq.km 689.82 695 586 Health Facility Profile HF/Lac HF/Lac Community health centres 2 0.17 5 0.3 Primary health centres 35 3 31 2.08 Primary health subcentres 180 15.5 207 13.9 Health indicators Routine Immunization (2005) 37.90% 21.8 21.7 Infant Mortality Rate (2001- IIPS) 79 81 83
ANNEXURE 2
Source: Census 2001
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(IMNCI-IPEN Study 2006-2007)
General Instructions for Interviewing
The Interview is primarily a product of the interaction between the interviewer and the
respondent. Competence in interviewing is acquired only after careful study of instruments and
practice of interviewing. However, there are some accepted, general guide posts which may help
the beginner to avoid mistakes and establish effective working relationships with the respondents
to accomplish what he/she sets out to do.
Remember the following rules while conducting an interview:
1. Study the questionnaire carefully until you are familiar with all the questions.
2. Before you leave for interviewing, please check that you have the required schedules
guidelines/ references and stationary needed for conducting the interview(s).
3. Before starting interviewing, make sure that you are interviewing the right (correct) person
and have the right schedule with you.
4. Seek privacy.
5. The initial step in conducting an interview is to establish a relationship of confidence through
pleasant association/ conversation.
6. You should try to help the interviewees to feel at ease and ready to talk. The best way to do
this is to be at ease yourself.
7. For many people, being interviewed is a new idea. Help your respondent feel that his/her
ideas are important, that you are interested in hearing them and in discussing with him/her as
an equal. Let him/her know that he/she is the only one who can give this important piece of
information. This could be accomplished by telling her about the objectives of the study and
how these findings will help the government or whosoever you represent in reorganizing the
current policies and plans.
8. Confidentiality is necessary both for purpose of scientific integrity and to assure respondents
that the information they were sharing would not be turned over to anyone else.
9. Create an atmosphere of trust and equality so that people can explain and explore their
feeling and behaviors.
10. If another colleague or some family member interrupts the interview, do not make a face.
Very politely explain the objectives of the study and try to get cooperation and relax.
ANNEXURE 3
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11. If the respondent is uncooperative, do not get upset or show your anger. Talk very politely
and calmly to him/her. Explain the importance of the study. Remember, a smile always helps.
Also remember that you cannot and should not force anyone to respond.
12. Always use the brief introductory approach written into the questions which should include
an identification of who you are, why have you come, who do you represent, what will be done
with the information gained and promise confidentiality.
13. Listening is another important skill to be learned and practice. Always watch for additional
information or new leads in the casual remarks of the respondent as in their attitude, “body
language” (posture, expressions, etc).
14. Must be willing to listen with an open mind.
15. Ask questions just as they are written. Deviations from the prepared questions may serve to
promote the respondent into giving you answer (s)he thinks you may want to hear. In case the
question is not comprehended easily use relevant prologue.
16. Ask only one question at a time.
17. Ask questions in the order that they appear.
18. Adhere to the subject. If the respondent is not talking straight to the point, make a suggestion
or ask a question which will lead back to the general subject of the interview.
19. Be frank and straight forward rather than shrewd or clever. Do not talk down to the
respondent.
20. If a question is not easily understood, repeat it. Sometimes wrong or inaccurate information is
given because the question is not understood. If necessary use local terms to explain/clarify.
21. Get the full meaning of each statement. Make sure you understand each answer carefully
before recording it.
22. Generally, the first reaction to a question is the important or true one. Do not record any
changes in an answer to a past question if you already have gone into other items.
23. Do not record a ‘do not know’ answer too quickly. Sometimes the respondent might say, ‘I
do not know’ while stalling for time or arrange his/her thoughts. The words ‘do not know’
could be an introduction to a meaningful comment, so give the respondent a little time to think.
24. Record comments or remarks just as they are given. Use abbreviations that are
understandable, so in checking over the interview you can fill in the content of the answer.
25. Do not let the silence grow, the respondent might become distracted, bored, resentful, or may
even change his/her mind. Keep eye contact with the respondent.
26. Spend a few minutes checking the answers before you leave the respondent. Remember you
cannot supplement an answer after you leave.
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27. Do thank and extend your appreciation to the interviewee when the interview is completed.
Focus Group Discussions (FGDs)
Reassure that none of the answers will put the interviewee or his/her community at
any disadvantage.
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Integrated Management of Neonatal and Childhood Illness: Baseline Assessment of Childhood Morbidity and Mortality in Selected Districts in India
(IMNCI-IPEN Study 2006-2007)
Instructions for Focus Group Discussions (FGDs)
• FGDs are conducted by Senior Investigators in the presence of CCT members
• The purpose is to explore the perceptions of participants in areas relevant to study objectives.
FGDs can generate new domains/ issues and re-confirm/ triangulate issues raised and
expressed during in-depth interviews with key informants.
• FGDs are a group situation in which participants talk with each other under the guidance of
a facilitator. Each participant is stimulated by comments of the others and in turn stimulates
them.
• Participants (6-10) from similar backgrounds are assembled in a comfortable and neutral
environment.
• Discussion is facilitated (not led) by the Facilitator (Senior Investigator/ CCT member)
• A flexible unstructured topic guide is used to conduct FGDs.
• Facilitator has to encourage discussion and expression of thoughts from all participants.
• Nobody is allowed to dominate or hijack the discussion; similarly quiet participants are
prodded to speak and express their perceptions.
• Warm-up period is necessary to create a warm, friendly environment to build rapport and
gain confidence of participants.
• Sociogram has to be drawn by CCT member (or Senior Investigator) to reflect on the group
participation and intensity of discussion or major themes (topics).
• Many times the most useful comments or perceptions are expressed as we are in the process
of winding off the FGD. Hence keep the tape recorder on and keep eyes and ears open till the
last participant has left the venue.
• FGD can last for 1-2 hours but with interested participants and useful discussion; it can
continue beyond the scheduled time.
• Detailed guideline for Focus Group Discussions are available as separate booklet with
Senior Investigators.
ANNEXURE 4
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Integrated Management of Neonatal and Childhood Illness: Baseline Assessment of Childhood Morbidity and Mortality in Selected Districts in India
(IMNCI-IPEN Study 2006-2007)
Common Instructions to Fill-up Cluster Survey Instruments
1. The respondent information will be treated as confidential and the identity of either the respondent or health facility will be revealed to any one outside the research team.
2. Don’t prompt any answer. Don’t assume any answer. 3. Use only pencil to fill questionnaires. 4. Ask questions to mother/ immediate care provider of the child (Houseold Survey); specific
women in the reproductive age group (15-49 years) (Household Screening); doctor in-charge of the health facility (Generic Observations).
5. After filling the instruments, scan for completeness. 6. After completion of cluster work, the Senior Investigator will fill up the ICR sheets. 7. No answer box should be left blank unless required so due to Skip-pattern.
ANNEXURE 28
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Integrated Management of Neonatal and Childhood Illness: Baseline Assessment of Childhood Morbidity and Mortality in Selected Districts in India
(IMNCI-IPEN Study 2006-2007)
Instructions for Conducting Verbal Autopsy Objective of Verbal Autopsy: Assigning cause of death and documenting events before death by
interviewing relatives of the deceased who are present at the time of death. The Senior
Investigator will conduct verbal autopsy. Coding and assigning the cause of death will be done by
trained CCT members. The CCT members will be trained in ICD-10 coding systems before
undertaking this exercise.
Instructions to Interviewer:
The Senior Investigator will speak to the mother or to another adult caretaker who was
present during the illnesses that lead to death. If this is not possible in the first contact, arrange
a time to revisit the household when the mother or caretaker will be home on same day/ next day.
Note: Written consent should be taken before proceeding further with the verbal autopsy.
Selection of clients for verbal autopsy:
All deaths in children below 5 years (occurred in previous one year from date of survey) in the
screened households of the cluster will be included in the sample for verbal autopsy. The
information about dead children will be passed on by research team (Doctors/ RAs) to Senior
Investigator.
Points to remember for conducting the Verbal Autopsy:
1. Verbal autopsy interview can be very sensitive; so it is important that you are aware of
this and are sensitive to the mental and emotional state of family members you are
interviewing. Be courteous and calm if the respondent breaks down and help her/him to
recover. If necessary re-schedule the interview at a later time.
2. If more than one person is trying to respond to the questions or you cannot talk to the
mother of the child, tell them that it is important for the information to be confidential and
suggest moving to a different location, request that bystanders to come back later, or
reschedule a time to interview the main respondent.
3. Please remember that “verbal autopsy” instrument is a mixture of “closed-ended”
(quantitative) and “open-ended” (qualitative) questions.
ANNEXURE 6
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4. Read all questions exactly as they are written, and slowly and clearly so that the
respondent understands the question and does not feel rushed.
5. There are 13 sections in the instruments. Follow the instructions and skip patterns
carefully.
6. Be aware that some “close-ended’ questions allow for more than one answer.
7. If date of death is not known you can calculate the year by subtracting age from the year
of death.
8. If date of birth is not known ask the respondent if she remembers any social, religious, or
calendar event that could be related to the year the deceased was born.
9. If the respondent says that they do not know the answer or they begin to look
uncomfortable you can try probing for an answer by reframing the question.
10. If the participant becomes angry or says that they no longer want to participate, explain to
them the importance of their participation in the overall context of saving children. Re-
emphasize that all of their responses are confidential and that individual names will not be
known to anyone outside of the project. If this does not work, ask the participant if they
would like to take a break or reschedule a time to finish the interview.
11. No answer box should be left blank; if answer to a particular question is not possible/not
applicable, enter “Not Applicable”.
Linking the “Neonate”/ “Child” with the Household and Mothers Details:
Quote the unique ID of Mother’s Screening Instrument at the pre-designated place in
the Verbal Autopsy Instrument.
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Integrated Management of Neonatal and Childhood Illness: Baseline Assessment of Childhood Morbidity and Mortality in Selected Districts in India
(IMNCI-IPEN Study 2006-2007)
Instructions for Conducting Tracking of Events Objective of Tracking of Events: To find out the pathway of events before recovery from sickness of children under-five years and their social, economic and contextual determinants. All tracking process will be accomplished by Senior Investigators. The purpose is to record relevant health and non-health events prior to outcome of interest (recovery from illness). Selection of Clients for “Tracking of Events” Tracking will be done for three types of subjects:
1. Morbidity- recovered with hospitalization (1 per cluster): Identified by Doctors during household screening and referred to Senior Investigators.
2. Neonate (10-28 days) (1 per cluster): Identified by Doctors during household
screening and referred to Senior Investigators.
3. Morbidity –recovered without hospitalization (1 male and 1 female child under- five per cluster): Identified during household survey by Research Assistants and referred to Senior Investigator.
Points to remember for conducting the “Tracking of Events” 1. Broad guidelines given in Annexure 3 (General Instructions for Interviewing) are to be
followed. 2. Please remember that “Tracking” instruments are mixture of quantitative and qualitative
type of questions (close-ended and open-ended questions respectively). 3. For “close-ended” questions, answers/ options are already provided and you have to
mark the responses as told by respondents in the appropriate box(es). 4. Read all questions exactly as they are written, and slowly and clearly so that respondent
understands the question and does not feel rushed. 5. For “open-ended” questions, please record the answers verbatim. Allow the respondent
(mother/ care provider) adequate time to reflect, and synthesize his/her answers. Answers in “monosyllables” are discouraged.
6. Be aware that some “close-ended” questions allow for more than one answer.
ANNEXURE 7
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7. There are 6 (six) sections in the tracking instruments. Follow the instructions and skip patterns carefully.
8. Ensure that events are recorded as per the location. As the child is taken from one health
facility to another, the events and related activities and reasons are to be recorded under the health facility where these happened.
9. Similarly ensure events happening at home are recorded under home care. 10. “Reasons” and “problems” are the key issues that should be carefully listened to and
recorded appropriately. 11. If the respondent says that they do not know the answer or they begin to look
uncomfortable you can try probing for an answer by reframing the question. 12. No answer box should be left blank. If answer to a particular question is not possible/ not
applicable, enter “Not applicable”. Linking the “Neonate”/ “Child” with the Household and Mother’s details:
Quote the unique ID of the Household Screening Instrument at the pre-designated place in
the Tracking of Events Instrument.
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Summary of Field Operations
RESEARCH ASSISTANTS Administer the Household Survey instrument Once the first household is completed, the one close to the first will be selected as the next household. This will be repeated until 20 children (10 male or 10
female) are included in the survey; 5in each quadrant. In two quadrants (i.e. one half cluster) only female children to be recruited; in the remaining two quadrants (other half cluster) only male children to be included.
Recovered morbidity without hospitalization in children under 5 years (One male and one female in each half of the cluster). Children under-five with illness in previous two weeks before survey, who recovered without hospitalization and are asymptomatic for previous 3 days will be included. These are referred to SI-1 for tracking of events.
SENIOR INVESTIGATOR- 1 (SI-1) Receive and sort the children referred by the Doctor, and select to administer the following instruments:
o Verbal Autopsy o Tracking of Events: Morbidity (hospitalized & non-hospitalized) o Tracking of Events: Neonate o Skill Observation: ANM (odd clusters)/ AWW (even clusters) o Skill Observation: ASHA or TBA or TH (one per cluster)
Scrutinize ALL the instruments at the end of the day and assess for quality and send the completed instruments to regional coordinator Fill up ICR Sheets Sick children referred to SI-1 for tracking will be used for skill assessment of health workers
• At the end of day, scrutinize ALL the instruments and assess for quality & completeness.
• Fill up ICR Sheets.
• Skill Observation of Prescriber managing cases under-five (from the health facility where generic health facility observation done)
• In depth interview of Prescriber • Generic Health Facility Observation
Identification of either government or private health facility in every alternate cluster (20 government and 20 private health facilities/
district)
Duties of Senior Investigator 2 (SI-2)
ANNEXURE 8
DOCTOR: Administer the Household Screening Instruments; 40 households in each quadrant or a total of 160 households in each cluster. Refer appropriate cases to the SI-1 for the following: o All deaths of children under-five years in previous one year. (for verbal autopsy) o Households for Neonate aged 10- 28 days on the date of survey (for tracking). o Recovered morbidity in children under-5 who were hospitalized in previous 3
months. Only one such case (preferably female) will be included in the survey in each cluster.(for tracking)
Divide the cluster into four quadrants. Divide the rest of teams into two pairs. One team will cover two quadrants of the cluster (i.e. half cluster)
3rd & 4th quadrant: Doctor # 2 and Research Assistant # 2
Identify the first house in each quadrant by using last two digits of the currency note from SI-1. This house will be the beginning of both: Household Screening & Household Survey
First two quadrants: Doctor # 1 and Research Assistant # 1
After entering the cluster the team prepares a village map with the help of local volunteers. They will then identify a central point where a Senior Investigator will be available.
Fill the appropriate referral sheet and refer to SI-1.
Senior Investigator-1 (SI-1) will be stationed at a central point of the cluster and Senior Investigator -2 will go to Health facility
Integrated Management of Neonatal and Childhood Illness: Baseline Assessment of Childhood Morbidity and Mortality in Selected Districts in India (IMNCI-IPEN Study 2006-2007)
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Integrated Management of Neonatal and Childhood Illness: Baseline Assessment of Childhood Morbidity and Mortality in Selected Districts in India
(IMNCI-IPEN Study 2006-2007)
Instructions for Household Screening
The study will recruit 160 households in each cluster. Thus we will screen a population of
approximately 65,000-70,000 population residing in 12,800 household spread in 80 clusters.
Considering crude birth rates (≈ 20-35/ 1000 population/ year), almost 1500-1700 live births would
have occurred during the previous one year in the screened population in every district.
• Household screening will be done by both the Doctors and Research Assistants in the cluster
survey team.
• The screening will be done till 160 households are captured in the given cluster.
• The cluster is divided into four quadrants.
• The research team (Doctor/ Research Assistants) will recruit 40 households from each
quadrant starting with a randomly chosen house.
• Last two digits of currency notes available with research team will determine the first house in
each quadrant.
• If there are more than one ever married female (15-49 years) in the given household, then a
separate instrument will be filled for each female.
• Research Assistants will join the Doctor for screening after completing household survey to
complete household screening.
Objective of Household Screening is to collect information regarding
• Details of individuals residing in household with age and sex.
• Every ever married woman of reproductive age (15-49 yrs) and their pregnancy history of
last 6 years with details of pregnancy including fetal and child outcomes as on the day of
survey.
• Maternal deaths of 2006 and their pregnancy outcomes
• Under-five children
• Deaths of under-five children in the index household.
THIS IS THE PREREQUISITE FOR ALL
OTHER ACTIVITIES IN THE FIELD
ANNEXURE 9
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• Socioeconomic and equity status of the household
During the screening process cases will be identified for
o Verbal autopsy (Death of under-five children in 2006)
o Tracking of events for Neonate (10-28 days old)
o Tracking of events for recovered hospitalized morbidity (under-five children)
These identified cases will be referred to Senior Investigator for appropriate action (Annexure 11)
Screening households for verbal autopsy
Each team will inquire about any death of child under-five years in previous one year, and total
number of children below 5 years with their age and sex in every household. Truncated pregnancy
history will be obtained from all ever married women in reproductive age group (15-49 years). This
strategy will be adopted to identify child deaths to minimize bias in estimating mortality indices.
Verbal Autopsy instrument will be administered for deaths occurring in 2006.
Screening for tracking of events for neonate
Any neonate between age of 10 -28 days as on date of survey will be identified and accordingly the
Senior investigator will be informed for tracking. Purpose of selecting this age group is for capturing
home visits made by health functionaries for early neonatal care and other health/sickness, care
seeking practices of the family during first 10 days of life, which is the most critical period of
neonate’s life. (Neonates with age less than 10 days will have incomplete information- and hence not
included for this part of the study).
Screening for recovered morbidity in children under-five years who were hospitalized
Field teams will also identify one child under-five years of age who was sick and hospitalized for
least 24 hours and recovered in 3 months prior to date of survey. Only one such case (preferably
female) will be included in the survey from each cluster for tracking events prior to recovery. If such a
child is not present in 160 households screened in a cluster, teams will not pursue further.
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Important note:
1. Instruments are to be filled up ONLY for those households where respondents are available
and agree to participate in the survey.
2. Do not fill up the instrument if the household is locked or if the person refuses.
3. It is necessary to mention details on refusal/ locked houses in the log sheet (Annexure 9).
4. If there is more than one eligible woman (15-49 years) in a household, fill up separate
instruments for each eligible woman (15-49 years).
5. Unique ID of the first instrument filled for a household is critical. This will be called “Unique
ID of First Female”.
6. All subsequent women interviewed from the same household have a “pre-designated” location
to record “Unique ID of First Female” for linking baseline demographic information about the
household.
7. Baseline demographic, social, economic, and equity related questions are asked ONLY from
“First Female”. Therefore unique ID of first Female will serve as link for subsequent females
from same household and also for other instruments such as: Household Survey, Verbal
Autopsy and Tracking of events.
8. For subsequent respondents from the same households, Section A is skipped. Only
“Pregnancy-related” questions. (Section B or C).
9. Table of Indian Calendar months and its corresponding English calendar and months is
provided. If the woman gives dates and month of their deliveries according to Indian calendar,
convert it to the nearest date and month of the English calendar. In case only Indian month is
mentioned, first-day of the nearest English month is to be entered.
10. Quantity of agricultural land (Q-25): Use the state specific conversion table to estimate
approximate ACRES of land (Annexure 33).
PLEASE DO NOT FILL UP THE INSTRUMENT IF HOUSEHOLD IS LOCKED
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Integrated Management of Neonatal and Childhood Illnesses: Baseline Assessment of Childhood Morbidity and Mortality in Selected Districts in India
(IMNCI IPEN Study 2006-2007)
Log Sheet for Household Screening (Refusals/ Locked houses only) State: _____________ District: ______________ Team No: _________________ Village: _____________ Cluster No: Date: _________________
SN. Name of Head of Household
Reason for Refusal/ Non-Participation*
Revisited or Not
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
* Reasons for Refusal 01. Locked Household/ No responsible adult respondent available 02. Individuals available but busy with household work/ function at home or family 03. Refuse to be interviewed 04. All or any women/ woman of the reproductive age group (15-49years) not available [THIS HOUSEHOLD MUST BE REVISITED] 05. Any other Reason. Please specify.
Name: _____________________________ Signature of Research Assistant: _________________
ANNEXURE 10
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Name ___________________________ Signature of Doctor/RA_______________
Integrated Management of Neonatal and Childhood Illnesses: Baseline Assessment of Childhood Morbidity and Mortality in Selected Districts
(IMNCI IPEN Study 2006-2007)
Household Screening Referral Sheet
Team No. Name of Senior Investigator: _________________________________________ Unique ID of mother from Household Screening
This household has one or more of the following for further workup: (Tick if present)
1. All Under-five child deaths during 2006 and 2007 (till the date of interview):
Name of child ___________________
Name of child ___________________
2. Neonate (10-28 days old)
Name of child ___________________
Name of the mother__________________
3. Child under-5 years who was sick and required hospitalization
during last 3 months and now recovered (for at least 72 hours/ 3 days prior
to date of interview)
Name of child ____________________
Name of the mother ____________________
District
Tehsil
Village
Cluster No.
Name of head of the household: Address:
Please give this slip to your Senior Investigator for tracking of events
ANNEXURE 11
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Integrated Management of Neonatal and Childhood Illness: Baseline Assessment of Childhood Morbidity and Mortality in Selected Districts in India
(IMNCI-IPEN Study 2006-2007)
Instructions for Household Survey
Objectives of Household Survey: To estimate the morbidity density and to capture care seeking
practices for under-five children in last two weeks.
Instructions
• This will be conducted by the Research Assistants (RA).
• Household survey will be done only in those households where household screening has been
done.
• Selection of household and index child:
- The cluster will be divided into four quadrants. RA will recruit 5 children from each
quadrant. A total of 10 male and 10 female children will be covered in each half of the
cluster thus including 20 children from each cluster.
- A household having at least one under-five child should be considered for Household-
Survey. - The child could be sick or well.
- If more than one child of less than five years is present in the given household, an index
child would be selected randomly by using random number table (provided in Annexure
31) amongst all under-five children.
- In case of twins/ multiple births recruit only one of them through random process.
• Two Recovered (non-hospitalized) children under-five years (one male & one female for each
cluster) will be identified during household survey. Referral sheet should be filled and sent to
Senior Investigator for “Event Tracking”.
Use local terms where necessary when describing symptoms for measles, tetanus, pneumonia, fast
breathing and other childhood illnesses.
Use local seasonal calendar, provided with the cluster packets.
Screening for recovered morbidity in children under-five years who were non-hospitalized
Each team will identify first male and first female child of less than five years (in this half of cluster)
who have recovered of morbidity in their respective area (i.e. 1 male and 1 female in each half of the
quadrants of the cluster). These are children under-five year who had any illness in the previous two
weeks before survey, and now recovered without hospitalization and are asymptomatic for at least 3
ANNEXURE 12
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days (72 hours) prior to day of survey from any illness. This component is for tracking of events prior
to recovery. Event tracking will be done by Senior Investigator.
• It is necessary to mention details on refusal/ locked houses in the log sheet (Annexure 13).
• Plan for revisit for household survey, if the mother/ primary care taker is not available.
• Maintain the household survey monitoring sheet and the children identified and referred for
tracking of events/ skill assessment of health workers (Annexure 14).
Household survey has to be preceded by Household Screening. Make use of local terms for measles/ tetanus/ pneumonia/ fast breathing, etc.
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(IMNCI IPEN Study 2006-2007)
Household Survey Log Sheet (Refusals/ locked houses only)
State: _____________ District: ____________ Village: ____________ Cluster No. Cluster Half: (1. Male 2. Female) Team No: Date: _____________
SN. Name of Head of Household Reason for Refusal/ Non-Participation*
Revisited or Not
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
* Reasons for Refusal 01. Locked Household/ No responsible adult respondent available 02. No one in eligible age group available at home 03. Individuals available but busy with household work/ function at home 04. Refuse to be interviewed 05. Mother/ Primary care provider not available [THIS HOUSEHOLD MUST BE REVISITED] 06. Any other Reason. Please specify
Name: ______________________________________ Signature of Research Assistant: ___________________
ANNEXURE 13
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Integrated Management of Neonatal and Childhood Illnesses: Baseline Assessment of Childhood Morbidity and Mortality in Selected Districts
(IMNCI IPEN Study 2006-2007)
Household Survey Referral Sheet
Team No. Name of Senior Investigator: _______________________________________
District:
Tehsil
Village
Cluster No.
Name of head of the household:
Address:
Please give this slip to your Senior Investigator for tracking of events and skill observation
Recovered non-hospitalized morbidity: First child under-five years who was sick in last two weeks and recovered without hospitalization and presently asymptomatic for last three days. Is the child referred for tracking? Please tick inside the box Name of the child: _____________________ Household Survey Unique ID:
Referral for sick child Child is sick on day of survey Is the child referred for skill observation? Please tick inside the box Name of the child: _______________________ Household Survey Unique ID:
Name: ______________________________________ Signature of Research Assistant: ________________
ANNEXURE 14
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(IMNCI-IPEN Study 2006-2007)
Guidelines for Generic Observation at Health Facility
Objectives of Generic Observation: To undertake baseline assessment of the selected health facility
for infrastructure, manpower and supply status.
Selection Criteria
• In a district, a total of 40 rural health facilities will be selected (20 government and 20 private)
• Between two clusters either one government or private health facility will be recruited. Private
health facilities will be identified in pairs of clusters that have cluster number divisible by 4. In the
remaining pairs of clusters government health facilities will be recruited. For example; from
cluster pair 5-6 select government health facility; and from 15-16 clusters select a private health
facility.
• If more than two health facilities of same category are found in the cluster; then select the health
facility where the under-five children case load is more.
• Select the Government health facility designated for the cluster or the one which is geographically
nearest will to be selected. The government facility could be a CHC or PHC but not attached to
medical college.
• Private health facility: Choose the most popular private health facility for under-five children for
the cluster.
• Timing of the observation would be according to the OPD timing (this information could be
obtained from the cluster community prior to the visit).
• The person In-charge of health facility to be contacted to facilitate filling up this schedule.
• Type of Health Facility can be anyone of the following
1. Government: Allopathic (Hospital /CHC /PHC) 2. Government: Indian System of Medicine (Homeopathic /Ayurvedic /Unani /Siddha) 3. Private: Formal Allopathic (Hospital /Nursing Home /Clinic) 4. Private:ormal Indian System of Medicine
(Homeopathic /Ayurvedic / Unani /Siddha) 5. Private: Informal Traditional Healer /Informally trained prescriber (Unqualified/ RMP/ Jhola Doctor/ Jhar Phookwala/ Jadu-Tonawala) 6. NGO: Allopathic/ Homeopathic /Ayurvedic /Unani /Siddha
ANNEXURE 15
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Integrated Management of Neonatal and Childhood Illness: Baseline Assessment of Childhood Morbidity and Mortality in Selected Districts in India
(IMNCI-IPEN Study 2006-2007)
Guidelines for Skill Observation
Objective: To assess the quality of care provided by prescribers and non-traditional health
providers to under-five children.
(a) Skill Observation of prescriber
After selecting the facility (as mentioned for Generic Observation), prescriber will be selected for skill
observation from the selected health facility.
• Prescriber will be the person (irrespective of his training, education status) managing the
children under-five years.
• If more than one doctor/ prescriber is present/ available, identify the doctor/ prescriber
managing children under-five years. This could be found out by asking the personnel at health
facility or village mukhiya/ community leader after entering in the cluster.
• For skill observation/ assessment of each prescriber, there will be a total of six cases (three live
cases from the OPD and three hypothetical cases as mentioned in the instrument).
(b) Skill Observation of ANM/AWW
• Skill of one ANM/AWW is to be assessed per cluster.
• From odd numbered clusters, select ANMs and AWWs from even numbered clusters. (For
example; ANM from cluster numbers 1,3,5,7,9, etc. and AWW from 2,4,6,8, etc.)
• For skill observation/ assessment of ANM/ AWW, there will be a total of six cases (three live
cases identified during household survey for tracking of morbidity and three hypothetical cases
as mentioned in the instrument).
(c) ASHA/Other non-conventional Community Health Worker
• From every cluster one ASHA or other non-conventional Community Health Worker (TBA or
Traditional Healer) will be selected from skill observation. At all places, ASHA will be
preferred over others for observation when available. One case referred for tracking of
morbidity will be used for skill assessment.
ANNEXURE 16
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(d) General instruction for skill observation
1. You will be assessing the skill of the health provider.
2. Please do not probe or ask any questions or guide during the observation.
3. For case scenarios, don’t guide them for response (history/ examination/ communication).
Record whatever they respond and note the responses in appropriate boxes.
4. Mark “X” in the boxes against the items if the doctor is observed doing it. If not, leave them
blank.
5. Cases for skill observation
Category of health
provider
Live cases for assessment per
Prescriber/ HW *
Hypothetical Case
studies per Prescriber/
HW
Prescriber 3 3
ANM/ AWW 3 3
ASHA**/ TBA/ TH 1 0
* Preference will be given to neonate if available. ** Preference will be given to ASHA over TBA/ TH.
6. Sick children brought/ identified for the first time for care are to be included for skill
observation.
7. Children brought for follow up visit should not be included.
8. Case studies: Read out the case study slowly in the language of health provider. Clarify and
repeat if asked for by the respondent.
For “case study” skill assessment- Ask the respondent:
(i) What questions, will the health provider ask the care taker (Direct Questioning)?
(ii) How will the health provider proceed further for:
Examination
Feeding History
Immunization
What prescription will be given?
What instructions will he/she give to care provider?
Referral advice
(iii) The health providers should be allowed to respond spontaneously. Do not prompt
responses.
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(e) Specific Instruction for skill observation
1. Process of eliciting wakefulness
If the child is not awake, in order to confirm the unconsciousness/ lethargic condition, observe
if health provider does either of the following to awaken the child:
i. Pinch the skin
ii. Tapping on the feet
2. Examination of the ears/ eyes
The process is done if the doctor/ provider uses torch for examination of both the ears/eyes.
3. Examination for skin rash/ pustules
The doctor/ provider remove the clothes/ bares the part (abdomen, chest, back buttocks) to
looks for the rash.
4. Process of measuring axillary temperature
• Doctor/ provider use a thermometer.
• Keep the thermometer high in the axilla
• Record temperature
5. Measure temperature by hand
• Feels the infant’s abdomen or axilla with the dorsal side of hand.
6. Process of measurement of respiratory rate
• Abdomen and chest is exposed.
• Doctor/ provider has watch with second’s hand or the examination room has a wall clock
with minute hand.
• Movement of respiration is watched at least for one minute (the respiratory rate is counted
with reference to the watch).
7. Process of examination of umbilical cord
• Doctor/ provider holds umbilicus and checks it for discharge.
9. Process of doing skin pinch for assessing dehydration
• Doctor/ provider locates the area between the umbilicus and the side of the abdomen
• Firmly pick ups skin and tissue between two fingers (preferably thumb and index finger)
• Pinches the skin for approximately 10 seconds, releases & observes.
10. Process of observing severe wasting
• Severe wasting is defined as loss of fat and muscle mass of the shoulders, arms, buttocks,
and legs, with ribcage easily seen, and indicates presence of marasmus.
• Doctor/ provider removes child’s clothes.
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• Looks for severe wasting of the muscles over shoulders, arms, buttocks, legs and ribcage.
(The face of such a child may still be normal and abdomen may be large or distended).
11. Determination of the weight-for-age for under-five children
• Doctor/ provider ensures child’s age in weeks.
• Weighs the child if he has not already been weighed.
• The child should wear light clothing when he/she is weighed (asks the mother to help
remove any shoes or sweater).
• Uses the weight-for-age chart to determine the same & marks weight on it.
11. Feeding assessment
• Doctor/ health provider asks for the frequency of feeding appropriate for age (breast feeding
for neonates and infants and especially about night feeding).
• Doctor/ health provider asks for additional/ complementary feeding other than breastfeeds
including the tme of starting, frequency, consistency.
• Doctor/ provider advises about the appropriate frequency and amount of feeds for the age.
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Integrated Management of Neonatal and Childhood Illness: Baseline Assessment of Childhood Morbidity and Mortality in Selected Districts in India
(IMNCI-IPEN Study 2006-2007)
Guideline for Filling ICR Sheets
Purpose of ICR Sheets
ICR sheets represent the summarized data format of the quantitative instruments to be used for
some of the information collected during the community survey. The sheets will be scanned for
reading the characters to be transformed into a data format for analysis. To have a high quality data
analysis, it is must to have the ICR sheets correctly filed up.
ICR Sheets will be used for Household Screening, Household Survey, Skill Observations, Generic
Health Facility Observations and Verbal Autopsy.
1. In the evening, after filling all the schedules in the cluster, please open the packet containing
the ICR sheets.
2. The ICR sheets have unique serial numbers matching with the schedules of the cluster and
are arranged in a sequence.
3. Take the filled schedules one by one, open the ICR Sheet the matching unique serial number
and place the cross marks (X) and numbers in the appropriate boxes. The [X] mark should
not extend beyond the boundary of the square box for accurate scanning.
4. Do NOT use tick marks.
5. To be filled and signed by the Senior Investigators only.
6. Only pencils are to be used for marking.
7. Only appropriate boxes are too be marked. Leave all other boxes blank.
8. Do not separate the ICR sheets from the folder.
9. Do not fold or stain the ICR sheets.
In case of incorrect entry erase the (X) mark/ number completely with the eraser and then
mark appropriately
X
ANNEXURE 17
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Integrated Management of Neonatal and Childhood Illness: Baseline Assessment of Childhood Morbidity and Mortality in Selected Districts in India (IMNCI-IPEN Study 2006-2007)
INDICATORS
Indicator Numerator Denominator
IMPACT INDICATORS
Mortality
1 U-5 Mortality Rate Number of under-five children who died in the last one year Total number of live births in last one year
2 Still births/ Late fetal death rate Number of babies born dead after 28 weeks of gestation in last one year
Total number of births (live births+ late fetal deaths) in last one year
3 Infant Mortality Rate Number of deaths in the first 12 months of life in the last one year Total number of live births in last one year
4 Neonatal Mortality Rate Number of deaths in the first 28 completed days (0-27 days) of life in the last one year Total number of live births in last one year
5 Perinatal Mortality Rate Sum of late fetal deaths and death to live birth babies within first 7 days (0-6 days) of life in the last one year
Total number of births (live births+ late fetal deaths) in last one year
6 Sex specific (male/ female) Mortality Rate Number of under-five male/ female children who died in the last one year Total number of male/female live births in last one year
7 U-5 Cause specific Mortality Rate Number of deaths attributed to a specific cause in children aged 0-59 months during the last one year
Total number of children aged 0-59 months in the last one year
Morbidity
8
Prevalence (Period)of 1. Cough 2. Fever 3. Diarrhea
1. Number of children aged 0-59 months who had cough and/or fast breathing due to a problem in the chest at any time in the two weeks prior or at the time of survey
2. Number of children aged 0-59 months who had fever at any time in the two weeks prior or at the time of survey
3. Number of children aged 0-59 months who had diarrhea at any time in the two weeks or at the time of survey
Total Number of children aged 0-59 months surveyed
9 Prevalence (Point) of sickness Prevalence of any illness in children aged 0-59 months at the time of the survey Total Number of children aged 0-59 months surveyed
10 Proportion of pregnant women who had Number of pregnant women who had institutional delivery in Total number of pregnant women in last one year
ANNEXURE 18
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institutional delivery in last one year. last one year.
11 Proportion of pregnant women delivering at home in last one year Number of pregnant women delivering at home in last one year. Total number of pregnant women in last one year.
12 Proportion of deliveries taking place in government facilities in last one year
Number of deliveries taking place in government facilities in last one year in a given population
Total number of pregnant women in last one year in a same population
13 Proportion of deliveries taking place in private facility in last one year
Number of deliveries taking place in private facility in last one year in a given population
Total number of pregnant women in last one year in a same population
14 Proportion of pregnant women aware of Janani Suraksha Yojana
Number of pregnant women aware of Janani Suraksha Yojana in 2005-06
Total number of pregnant women in last two years in a same population
15 Proportion of pregnant women availing any facility under Janani Suraksha Yojana
Number of pregnant women availing any facility under Janani Suraksha Yojana in 2005-06
Total number of pregnant women in last two years in a same population
16 Proportion of women died in last two years during pregnancy or within 42 days/6 weeks after delivery
Number of women died in last two years during pregnancy or within 42 days/6 weeks after delivery
Total no. of pregnancy women in the same population in last one year
17 Proportion of literate ever married women (15-49 yrs) Number of literate ever married women (15-49 yrs) Total number of ever married females (15-49 yrs)
18 Proportion of ever married (15-49 yrs) female working f or a cash income
Number of ever married female (15-49 yrs) working f or a cash income Total number of ever married females (15-49 yrs)
19 Proportion of ever married female (15-49 yrs) member of any SHG or Mahila Mandal
Number of ever married female member of any SHG or Mahila Mandal Total number of ever married females (15-49 yrs)
20 Proportion of child under-5 years sick in last three months, required hospitalization and now recovered
Number of child under-5 years sick in last three months, required hospitalization and now recovered Total number of under-five children
21 Proportion of mothers (primary caretakers) of under-five child going out to work for at least 6 hours a day
Number of mothers (primary caretaker ) of under-five child going out to work for at least 6 hours a day in a given population
Total number of mothers (primary care taker ) in the that population
PROXIMAL INDICATORS
Improved Care of Sick Child
22 Percentage of children aged 0-59 months with cough taken to an appropriate health provider
Number of children aged 0-59 months with cough taken to a health provider Total number of children aged 0-59 months with cough
23 Percentage of children aged 0-59 months Number of children aged 0-59 months with fever taken to a Total number of children aged 0-59 months with fever
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with fever taken to an appropriate health provider
health provider
24 Percentage of children aged 0-59 months with diarrhea taken to an appropriate health provider
Number of children aged 0-59 months with diarrhea taken to a health provider
Total number of children aged 0-59 months with diarrhea
25 Proportion of children aged 0-59 months who were taken to any health facility during sickness but died subsequently
Number of children aged 0-59 months who were taken to any health facility during sickness but died subsequently
Total number of children aged 0-59 months whose verbal autopsy was conducted
26 Proportion of sick children aged 0-59 months who were taken to any health facility during sickness
Number of sick children aged 0-59 months who were taken to any health facility during sickness
Total number of sick children aged 0-59 months surveyed for household survey
27 Proportion of neonates aged 10 – 28 days who were taken to any health facility during sickness
Number of neonates aged 10 – 28 days who were taken to any health facility during sickness
Total number of sick neonates aged 10-28 days who were tracked for neonate
28 Proportion of sick children aged 0-59 months whose caretaker practice ANY form of home based care during sickness
Number of sick children aged 0-59 months whose caretaker practice ANY form of home based care during sickness
Total number of sick children aged 0-59 months surveyed for household survey
29
Proportion of sick children aged 0-59 months whose caretaker practice ANY form of home based care during sickness and who died subsequently
Number of sick children aged 0-59 months whose caretaker practice ANY form of home based care during sickness and who died subsequently
Total number of sick children aged 0-59 months whose verbal autopsy was conducted
30
Proportion of sick neonates aged 10-28 days whose caretaker practice ANY form of home based care during sickness and who died subsequently
Number of sick neonates aged 10-28 days whose caretaker practice ANY form of home based care during sickness and who died subsequently
Total number of sick neonates aged 10-28 days who were tracked for neonate
31
Proportion of children aged 0-59 months who died & whose caretaker knew at least 2 signs for seeking care immediately (child not able to drink/breastfeed, child becomes sicker despite home care)
Number of children aged 0-59 months who died & whose caretaker knew at least 2 signs for seeking care immediately
Total number of children aged 0-28 days whose verbal autopsy was conducted
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32
Proportion of neonates (aged 10-28 days) whose caretaker knew at least 2 signs for seeking care immediately (child not able to drink/breastfeed, child becomes sicker despite home care)
Number of neonates (aged 10-28 days) whose caretaker knew at least 2 signs for seeking care immediately
Total number of neonates aged 10-28 days who were tracked for neonate
Improved Quality of Care of Sick Child
33
Proportion of sick children Checked for ALL ten danger signs (0 to less than 2 months) convulsions, fast breathing, severe chest indrawing, nasal flaring, grunting, bulged fontanelle, 10 or more skin pustules, axillary temp. >37.5 C, lethargic, movements less than normal)
Number of sick children aged 0 to less than 2 months seen who are checked for ALL ten general danger signs
Number of sick children 0 to less than 2 months observed for management
34 Proportion of sick children Checked for ALL three general danger signs (2-59 months) [convulsions, vomiting, lethargy]
Number of sick children aged 2 to 59 months seen who are checked for all three general danger signs
Number of sick children 2 to 59 months observed for management
35
Proportion of sick children (aged 2-59 months) seen who were assessed for the presence of cough (chest in-drawing, nasal flaring, grunting), diarrhea (loose motions, blood in stools, pinching skin on the abdomen) and fever (temperature by hand, temperature by thermometer)
Number of sick children (aged 2-59 months) seen who were assessed for the presence of cough, diarrhea and fever
Number of sick children aged 2-59 months observed for management
36
Proportion of sick children aged 2-59 months seen who were weighed and whose weights were checked against a recommended growth chart
Number of sick children aged 2-59 months seen who were weighed and whose weights were checked against a recommended growth chart
Number of sick children aged 2-59 months observed for management
37
Proportion of sick children whose mother/ caretaker was explained care practices (home care, signs for when to return, follow-up, how and when to administer drugs and exclusive breastfeeding)
Number of sick children whose caretaker was explained care practices.
Number of sick children under-five years observed for management
38 Proportion of sick children whose mother/ Number of sick children whose caretakers are advised to give Number of sick children under-five years observed for
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caretakers are advised to give extra fluid and continue feeding
extra fluid and continue feeding management
39 Proportion of mother/ caretaker who were explained care practices (IFA tablets, nutritional advice & child spacing)
Number of mother/caretaker who were explained care practices Number of sick children under-five years observed for management
40
Proportion of sick children aged 0 to less than 2 months referred (explained ANY of the following: the site of referral, feeding during transport, keeping baby warm and referral slip given)
Number of sick children aged 0 to less than 2 months referred Number of sick children 0 to less than 2 months observed for management
41
Proportion of sick children (0 to less than 2 months) referred after being explained ALL of the following: the site of referral, feeding during transport, keeping baby warm and referral slip given
Number of sick children (0 to less than 2 months) referred after being explained ALL of the following: the site of referral, feeding during transport, keeping baby warm and referral slip given
Number of sick children 0 to less than 2 months observed for management
42
Proportion of sick children (2-59 months) referred (explained ANY of the following: the site of referral, feeding during transport, keeping baby warm and referral slip given)
Number of sick children (2-59 months) referred Number of sick children 2 to 59 months observed for management
43
Proportion of sick children (2-59 months) referred after being explained ALL of the following: the site of referral, feeding during transport, keeping baby warm and referral slip given)
Number of sick children (2-59 months) referred after being explained ALL of the following: the site of referral, feeding during transport, keeping baby warm and referral slip given)
Number of sick children 2 to 59 months observed for management
44 Proportion of Prescribers who Supervise the field staff Number of government doctors who supervise the field staff Total number of Prescribers interviewed
45
Proportion of caretaker whose understanding was assessed before leaving the Health facility (for periodicity & quantity of drugs and when to return)
Number of caretaker whose understanding was assessed before leaving the Health facility
Number of sick children under-five years observed for management
46 Proportion of prescribers who have been trained in ANY child care program
Number of prescribers who have been trained in ANY child care program Total number of Prescribers interviewed
47 Proportion of prescribers who have been ever trained in IMNCI program
Number of Prescribers who have been ever trained in IMNCI program Total Number of Prescribers interviewed
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Enabling Environment (Government/ Private)
48 Proportion of health facilities who have adequate* manpower (in government health facilities, facility specific)
Number of health facilities who have adequate* manpower present
Total number of health facilities observed
49
Proportion of government health facilities who have ALL essential drugs & vaccines present
Antibiotics (oral & injectable) Antipyretics Antimalarial Vaccines Miscellaneous
Number of government health facilities who have ALL essential drugs and vaccines present
Total number of health facilities observed
50
Proportion of health facilities who have ALL three aspects of Infrastructure complete
Patient Care facilities Water and Sanitation Electricity
Number of health facilities who have ALL three aspects of infrastructure complete Total number of health facilities observed
51
Proportion of health facilities who have a functional government vehicle present & they have used it at least once to transport patients in the last one month
Number of health facilities who have a functional government vehicle present & they have used it at least once to transport patients in the last one month
Total number of health facilities observed
52
Proportion of health facilities who have ALL essential equipments functional (in government health facilities, facility and state specific)
Number of health facilities who have ALL essential equipments functional (specific to their health facility) Total number of health facilities observed
53
Proportion of health facilities who have ALL essential supplies/logistics present (in government health facilities, facility and state specific)
Number of health facilities who have ALL essential supplies/logistics present (specific to their health facility) Total number of health facilities observed
54 Proportion of health facilities who have an on-call doctor available in the non-working hours
Number of health facilities who have an on-call doctor available in the non-working hours Total number of health facilities observed
55 Proportion of districts where there were instances of stock outs Number of districts where there were instances of stock outs Total number of CMO/DHO’s interviewed
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Household Practices
56 Proportion of households with access to an improved source of drinking water
Number of households with access to an improved source of drinking water Total number of households surveyed
57 Proportion of households using an improved toilet facilities Number of household members using an improved toilet facility Total number of ho2usehold members in households
surveyed that have a toilet at home
58 Proportion of households storing drinking water safely
Number of households storing drinking water safely i.e cover the container, use narrow neck containers or store water in cisterns or roof tanks
Total number of households surveyed that store drinking water
59 Proportion of households where the caretaker of the youngest child under-five reported appropriate hand washing behavior
Number of households where the caretaker of the youngest child under-five years reported using soap for washing hands within the past 24 hours at two or more critical times (after defecation and one of the following four: after changing a young child, before preparing food, before eating and before feeding the child)
Total number of households with children under-five years surveyed
60 Proportion of neonates aged 10-28 whose caretaker practices ANY form of prevention of hypothermia
Number of children aged 10-28 days who were tracked and whose mother practice ANY form of prevention of hypothermia
Total number of children aged 10-28 days who were tracked for neonate
61 Proportion of children aged 0-28 who died AND whose caretaker practices ANY form of prevention of hypothermia
Number of children aged 0-28 who died AND whose caretaker practices ANY form of prevention of hypothermia
Total number of children aged 0-28 days whose verbal autopsy was conducted
DISTAL OUTCOME INDICATORS
Effective Coverage – Services
62 Proportion of live births whose mother received ANY antenatal contact during pregnancy
Number of live births whose mother received ANY antenatal contact during pregnancy in the last one year Total number of live births in the last one year
63 Proportion of live births whose mother received ANY tetanus toxoid (TT) during pregnancy in the last one year
Number of live births whose mother received ANY tetanus toxoid (TT) during pregnancy in the last one year
Total number of live births in the last one year
64
Proportion of children aged 0 to 28 days who died, whose caretakers were aware/ or were told of 2 or more danger signs during pregnancy
Number of children aged 0-28 days who died, whose caretakers were aware/or were told of 2 or more danger signs during pregnancy
Total number of children aged 0-28 days whose verbal autopsy was conducted
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65 Proportion of children aged 10-28 days whose caretakers were aware/or were told of 2 or more danger signs during pregnancy
Number of children aged 10-28 days whose caretakers were aware/or were told of 2 or more danger signs during pregnancy
Total number of children aged 10-28 days who were tracked for neonate
66
Proportion of live births whose mother’s delivery in the 1 year prior to the survey was attended by a skilled health personnel in the last one year
Number of live births whose mother’s delivery in the 1 year prior to the survey was attended by skilled health personnel in the last one year
Total number of live births in the last one year
67 Proportion of live births whose mother’s delivery in the 1 year prior to the survey occurred at a health facility
Number of live births whose mother’s delivery in the 1 year prior to the survey occurred at a health facility Total number of live births in the last one year
68 Proportion of children aged 0-28 days who died who were visited by a health worker within first 10 days of birth
Number of children aged 0-28 days who died and who were visited by a health worker within first 10 days of birth
Total number of children aged 0-28 days whose verbal autopsy was conducted
69 Proportion of children aged 10-28 days who were visited by a health worker within first 10 days of birth
Number of children aged 10-28 days who were tracked who were visited by a health worker within first 10 days of birth
Total number of children aged 10-28 days who were tracked for neonate
70 Exclusive breastfeeding rate Infants less than 4 months (<120 days) of age who were exclusively breastfed in the last 24 hours Infants less than 4 months (<120 days) of age
71 Continued breastfeeding rate Children 12-15 months of age who were breastfed in the last 24 hours Children 12-15 months of age
72 Proportion of infants 6-9 months of age who received complementary foods in addition to breast milk in the last 24 hours
Number of infants 6-9 months of age who received complementary foods in addition to breast milk in the last 24 hours
Total number of infants aged 6-9 months of age who were tracked for morbidity
73 Proportion of infants less than 12 months of age who were put to the breast within one hour of delivery
Number of infants less than 12 months of age who were put to the breast within one hour of delivery
Total number of infants less than 12 months of age who were tracked for morbidity
74 Proportion of children 9-59 months who were immunized with measles vaccine before age 12 months
Number of children aged 9-59 months who were immunized with measles vaccine before age 12 months Total number of children aged 9-59 months surveyed
75 Proportion of children 0-59 months who were immunized with BCG vaccine before age 12 months
Number of children aged 0-59 months who were immunized with BCG before 12 months of age Total number of children 0-59 months surveyed
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Integrated Management of Neonatal and Childhood Illness: Baseline Assessment of Childhood Morbidity & Mortality in Selected Districts in India
(IMNCI-IPEN Study 2006-2007)
Cluster Survey Team Composition
District .........................State…………………. Regional Coordinator............................
Team Members Name Team 1 Team 2
Sr. Investigator
Sr. Investigator
Doctor
Doctor
Research Assistant
Research Assistant
Team 3 Team 4 Sr. Investigator
Sr. Investigator
Doctor
Doctor
Research Assistant
Research Assistant
Team 5 Team 6 Sr. Investigator
Sr. Investigator
Doctor
Doctor
Research Assistant
Research Assistant
Team 7 Team 8 Team Sr. Investigator
Sr. Investigator
Doctor
Doctor
Research Assistant
Research Assistant
ANNEXURE 19
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Integrated Management of Neonatal and Childhood Illness: Baseline Assessment of Childhood Morbidity & Mortality in Selected Districts in India (IMNCI-IPEN Study 2006-2007)
Plan for Cluster Survey Activity
(To be filled up During Regional Workshop)
State……………………. District……………………………….. Date of Workshop…………………to ………………
Team no 1 Team no 2 Team no 3 Team no 4
Sl. no
Cluster no Date planned
Sl. no
Cluster no Date planned
Sl. no
Cluster no Date planned
Sl. no
Cluster no Date planned
1 1 1 1 2 2 2 2 3 3 3 3 4 4 4 4 5 5 5 5 6 6 6 6 7 7 7 7 8 8 8 8 9 9 9 9 10 10 10 10
Team no 5 Team no 6 Team no 7 Team no 8
Sl. no
Cluster no Date planned
Sl. no
Cluster no Date planned
Sl. no
Cluster no Date planned
Sl. no
Cluster no Date planned
1 1 1 1 2 2 2 2 3 3 3 3 4 4 4 4 5 5 5 5 6 6 6 6 7 7 7 7 8 8 8 8
9 9 9 9 10 10 10 10
ANNEXURE 20
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Integrated Management of Neonatal and Childhood Illness: Baseline Assessment of Childhood Morbidity & Mortality in Selected Districts in India
(IMNCI-IPEN Study 2006-2007)
Monitoring Sheet of Cluster Schedules Received at Regional Coordinator’s Office
STATE: ___________________ DISTRICT: ___________________ Signatures
Cluster Team
no
1 2 3 4 5 6 7 8 9 10 Cluster Boxes
delivered
Cluster Boxes
received Cluster
no Team
1 Date
SI
RC
SI
RC Cluster
no Team
2 Date
SI
RC
SI
RC Cluster
no Team
3 Date
SI
RC
SI
RC Cluster
no Team
4 Date
SI
RC
SI
RC Cluster
no Team
5 Date
SI
RC
SI
RC Cluster
no Team
6 Date
SI
RC
SI
RC Cluster
no Team
7 Date
SI
RC
SI
RC Cluster
no Team
8 Date
SI
RC
SI
RC Cluster
no Team
9 Date
SI
RC
SI
RC Cluster
no Team
10 Date
SI
RC
SI
RC Cluster
no Team
11 Date
SI
RC
SI
RC Cluster
no Team
12 Date
SI
RC
SI
RC
ANNEXURE 21
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(IMNCI-IPEN Study 2006-2007)
Regional Telephone Monitoring Sheets (To be maintained at the Regional Center)
Please note: 1. To be maintained for each team. 2. Each team is expected to telephone every day to the Regional Coordinator giving update of the activities.
STATE: ___________________ DISTRICT: ___________________
Cluster
Team no
1 2 3 4 5 6 7 8 9 10
Cluster no Date started
Team 1
Date completed Cluster no
Date started Team
2 Date completed
Cluster no Date started
Team 3
Date completed Cluster no
Date started Team
4 Date completed
Cluster no Date started
Team 5
Date completed Cluster no
Date started Team
6 Date completed
Cluster no Date started
Team 7
Date completed Cluster no
Date started Team
8 Date completed
Cluster no Date started
Team
Date completed Cluster no
Date started Team
Date completed
ANNEXURE 22
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Plan and Progress of Team Activity at a Glance
State……………………. District………………………………..
Team 1
Team 2 Team 3 Team 4
Sl. no
Cluster no
Date planned
Date done
Date handed
over RC
Sl. no
Cluster no
Date planned
Date done
Date handed
over RC
Sl .no
Cluster no
Date planned
Date done
Date handed
over RC
Sl .no
Cluster no
Date planned
Date done
Date handed
over RC
1 2 3 4 5 6 7 8 9 10
Team 5
Team 6 Team 7 Team 8
Sl. no
Cluster no
Date planned
Date done
Date handed
over RC
Sl. no
Cluster no
Date planned
Date done
Date handed
over RC
Sl .no
Cluster no
Date planned
Date done
Date handed
over RC
Sl. no
Cluster no
Date planned
Date done
Date handed
over RC
1 2 3 4 5 6 7 8 9 10
ANNEXURE 23
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Regional Network Progress at a Glance Fax 011-26960373/ 26589325
State: ………………… District………………….. Cluster Survey Date of Start...................... Date of Completion........................... Cluster
no Team
no Date
planned Date done
Date received by RC
Cluster no
Team no
Date planned
Date done
Date received by RC
Cluster no
Team no
Date planned
Date done
Date received by RC
1 28 55 2 29 56 3 30 57 4 31 58 5 32 59 6 33 60 7 34 61 8 35 62 9 36 63 10 37 64 11 38 65 12 39 66 13 40 67 14 41 68 15 42 69 16 43 70 17 44 71 18 45 72 19 46 73 20 47 74 21 48 75 22 49 76 23 50 77 24 51 78 25 52 79 26 53 80 27 54
This sheet to be updated and faxed to CCO every Monday, Wednesday and Friday till the survey is over.
ANNEXURE 24
Signature……………… (Regional Coordinator)
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CCO Monitoring Sheet
Daily Network Progress
(Faxes Received from Regional Coordinators)
Cluster Survey Start Date…………… Date completed……………….. Week no……… (Date: from………….to …………..)
State Number of Clusters Completed Districts Mon Wed Fri Total This Week Cumulative Date
Kaithal Haryana Mewat Gulbarga Karnataka Gadag Morena Madhya
Pradesh Tikamgarh Amrawati Maharastra Parbhani Ri-Bhoi Meghalaya Jaintia Hills Nayagarh Orissa Sonapur Baran Rajasthan Chittorgarh Kannauj Uttar
Pradesh Mathura
Annexure 25
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CCO Data Processing Activities at a Glance
State…………………… District………………………………………….
Cluster No.
Date Received
Screened Scanned ICR
Cluster No.
Date Received
Screened Scanned ICR
Cluster No.
Date Received
Screened Scanned ICR
Cluster No.
Date Received
Screened Scanned ICR
01
21 41 61
02 22 42 62
03 23 43 63
04
24 44 64
05
25 45 65
06
26 46 66
07
27 47 67
08
28 48 68
09
29 49 69
10
30 50 70
11
31 51 71
12
32 52 72
13
33 53 73
14
34 54 74
15
35 55 75
16
36 56 76
17
37 57 77
18 38 58 78
19 39 59 79
20 40 60 80
ANNEXURE 26
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(IMNCI-IPEN Study 2006-2007)
CCT Visits for Quality Assurance Qualitative Component
Name of CCT Member: ………………………………….
Date of Visit:
From: …….../………./2007 To:………./…………/2007
Region:.................................................................... District:.......................................................... Locations Visited……………………….. . ………………………………………
………………………… ……………………………………….
Quality Assurance Checklist Guide
(A) Check list for In-depth Interviews
1. Interview conducted in private place and creates atmosphere of trust and equality. 2. Interviewer introduces him/herself and states the purpose of the study. 3. Interviewer places emphasis on confidentiality. 4. Interviewer established relationship with interviewee. 5. Helps interviewee feel that their ideas are important. 6. Interviewer reads questions as written and in their entirety. 7. Interviewer probes when necessary and does not prompt answers. 8. Answers are recorded in respondent’s language verbatim. 9. Interviewer allows the respondent time to synthesize her/his answer and doesn’t rush. . 10. Interviewer checks answers before leaving the respondent. 11. Interview tape recorded. 12. Completeness of data. 13. Time constrain if any.
(B) Quality Checklist for: Focus Group Discussions
1. Facilitator introduces him/herself and states the purpose of the study 2. FGD conducted in a private place and facilitator creates an atmosphere of trust and equality 3. Facilitator establishes relationship with participants 4. Facilitator encourages discussion from all participants 5. Facilitator probes when necessary and does not prompt answers 6. FGD tape recorded 7. Time constraints if any
(C) Quality Checklist for Transcription
1. Research Assistants read through the answer already written for a question 2. Carefully listens to the tape recorded version of the same question 3. Supplements the missing answers with a different color pen in verbatim language 4. The above process is followed for every question of the instrument
ANNEXURE 27
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114
CCT Visits for Quality Assurance Qualitative Component
Qualitative Data Collection
(Please give your perception about all team members who are involved in data collection individually)
1. Interview Techniques:
2. Quality of data:
a) Completeness
b) Correctness (Crosscheck from respondents if required)
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CCT Visits for Quality Assurance Qualitative Component
Qualitative Data Collection
3. Transcription of data:
4. Suggestions and Actions taken:
Signature …………………………
Name of CCT Member…………………………
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(IMNCI-IPEN Study 2006-2007)
CCT Visits for Quality Assurance (Cluster Survey) Quantitative Component
Name of CCT Member: ..................................
Region: ............................................. District: .........................................
Cluster Number Cluster Location ………………….. Block ……………………………… Village …………………………….
Date of Visit From: …….../………./2007 To:………./…………/2007
Quality Assurance Checklist Guide (A) Check list for In-depth Interviews (Household screening and Household Survey)
1. Interview conducted in private place and creates atmosphere of trust and equality. 2. Interviewer introduces him/herself and states the purpose of the study. 3. Interviewer places emphasis on confidentiality. 4. Interviewer established relationship with interviewee. 5. Helps interviewee feel that their ideas are important. 6. Interviewer reads questions as written and in their entirety. 7. Interviewer probes when necessary and does not prompt answers. 8. Answers are recorded in respondent’s language verbatim. 9. Interviewer allows the respondent time to synthesize her/his answer and doesn’t rush. . 10. Interviewer checks answers before leaving the respondent. 11. Unique IDs of index female/mother of index child are written correctly and carefully at appropriate places in
different instruments 12. Subjects/households identified for referral to Senior Investigator for further workup. 13. Completeness of data. 14. Time constraint if any.
(B) Skill Observations (Prescriber/ANM/AWW or ASHA)
1. Observer is in close proximity of location where provider-patient are interacting. 2. Ger conversant with instrument well; health providers may do the steps in sequence other than that
provided in the instrument. 3. Observer should be able to synchronize the steps taken by health provider and record on the instruments. 4. Observer is a silent observer and doesn’t prompt health provider for miss up steps. 5. Does not assume but record what actually has been done by health provider. 6. Skill assessment is observing the process. Even if the health provider does it wrongly but performs the
step, please mark the step as done. (C) Generic Observations at the Health Facility
1. Observer has to make an objective assessment of health facilities for a) infrastructure b) available logistics/ supplies a) manpower assessment
d) patient care related facilities. 2. Observation process involves
a) direct observation b) cross checking the registers and records c) asking medical officer-in-charge
These have been specified with appropriate questions. 3. Do not assume and record all your findings objectively.
If the medical officer in-charge refuses or is reluctant to share information; record accordingly.
ANNEXURE
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CCT Visits for Quality Assurance (Cluster Survey)
Quantitative Component
QUALITY CHECK OF DATA COLLECTED IN THE CLUSTER
Quality Check of Data Collected in the Cluster
Total Scrutinized
Remarks
1. Household Screening (at least 25 instruments )*
2. Household Survey (at least 5 instruments)*
3. Generic Observations at Health Facility
4.Observation of Skill- Prescriber/ ANM/ AWW
5. Observation of Skill- ASHA/ Other Non-Conventional Community Health Provider
6. Verbal Autopsy (Under-five Deaths)
8. Tracking of Events- Morbidity- Sick Child (1- 59 Months)
9. Tracking of Events- Neonate (10-28 Days)
* Representing data collected by different team members
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CCT Visits for Quality Assurance (Cluster Survey) Quantitative Component
Quantitative Data Collection
(Please give your perception about all team members who are involved in data collection individually)
1. Interview Techniques/ Observation Process:
2. Quality of data:
a) Completeness
b) Correctness (Crosscheck from respondents if required)
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CCT Visits for Quality Assurance (Cluster Survey) Quantitative Component
Quantitative Data Collection
3. Suggestions and Actions Taken:
Signature …………………………………………………. Name of CCT member ………….. ……………………….
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CCO
CCT Members
Feed back about districts
District workshop And Quality check
Regional Coordinator
Team Members (Senior Investigator- 2,
Doctor- 2, Research Assosicate-2)
District workshop/ Route maps Data transfer/ Funds/ Coordination
Once the cluster-level task is completed by the team, send the filled schedules to Regional Centers.
Intimate
Fax/ E-mail every Mon, Wed, Fri:- - clusters completed - packets received at regional office
Phone daily: Progress of interviews, any problems
Phone daily: Progress of interviews, schedules dispatched, travel plans, any problems
Partner Medical Institutions
ANNEXURE 29 Integrated Management of Neonatal and Childhood Illness:
Baseline Assessment of Childhood Morbidity & Mortality in Selected Districts in India (IMNCI-IPEN Study 2006-2007)
Network Dynamics (Cluster Survey)
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Network Directory Update Format
(To be updated During Regional Workshop)
State: ………………….. District: ………………………………….. Team Names Designation Official
Address Official
Telephone and Fax
no.
Residential Address
Residential telephone and
Fax no.
Mobile no. E-mail Signature
Senior Investigator 1
Senior Investigator 2
Doctor 1
Doctor 2
Research Assistant 1
Research Assistant 2
ANNEXURE 30
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122
IIInnnttteeegggrrraaattteeeddd MMMaaannnaaagggeeemmmeeennnttt ooofff NNNeeeooonnnaaatttaaalll aaannnddd CCChhhiiillldddhhhooooooddd IIIllllllnnneeessssss::: BBBaaassseeellliiinnneee AAAsssssseeessssssmmmeeennnttt ooofff CCChhhiiillldddhhhooooooddd MMMooorrrbbbiiidddiiitttyyy &&& MMMooorrrtttaaallliiitttyyy iiinnn SSSeeellleeecccttteeeddd DDDiiissstttrrriiiccctttsss iiinnn IIInnndddiiiaaa
(IMNCI-IPEN Study 2006-2007)
Guidelines to Select Index Child for Household Survey
1. Please list all children (either MALE or FEMALE- whichever is applicable in your case) less than five
years of age living in the household in descending order (eldest to youngest).
2. Assign a serial number to each child
3. If there is ONLY ONE child of eligible age and sex in the household,
No need to refer the random number table, recruit the child for household survey.
4. If there is more than one child, use random number table (below) for selecting the index child.
5. Process of selecting the index child:
a. Refer to column according to “SEX” category and “Quadrant” allocated to you.
b. Refer to first number of the appropriate column of the random number table. If the first number in this
column is less than or equal to the total number of listed children in the household, select the child
with the corresponding serial number as “Index child”.
c. If this number exceeds the total number of children in a given household, move down to the next number
in the same column till you find the number less than or equal to the total number of children listed in
the household. Select the child with the corresponding serial number as “index child”.
d. As you move down the column for selecting the index child, keep striking out the numbers which were
used/ not used for selecting index child.
e. Continue the process to select “index child” from subsequent households till desired number of
households are completed.
[Example: You are working in 1st quadrant
“Female” half of the cluster. Household list
of female children under-five years in the
first house has three girls. You will omit (X
strike out) number 4 in the quadrant
1(female) column and move down. It is
number 1. This number is equal or less than
3 children in the household. Therefore select
the child with serial number 1 (Eldest girl)
listed in the household and recruit for
survey. Strike out this number also as you
proceed to the next household for identifying
index child in the same manner.]
Random Number Table Male Female
Quadrant 1 Quadrant 2 Quadrant 1 Quadrant 2 5 1 4 2 2 5 1 5 3 3 3 4 1 2 2 1 4 4 5 3 2 2 2 4 1 4 3 1 5 3 4 5 3 1 5 3 4 5 1 2 3 3 3 4 1 5 2 5 5 4 1 3 2 1 4 2 4 2 5 1
ANNEXURE 31
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Integrated Management of Neonatal and Childhood Illness: Baseline Assessment of Childhood Mortality and Morbidity in SSSeeellleeecccttteeeddd DDDiiissstttrrriiiccctttsss iiinnn IIInnndddiiiaaa
(IMNCI-IPEN Study 2006-2007)
Calendar and List of Festivals
Hindu Lunar Calendar: Months
Chaitra
(citra-naksatra)
March - April Vaisakha
(visakha-naksatra)
April - May
Jyaistha
(jyestha-naksatra)
May - June Asadha
(purvasadha-naksatra)
June - July
Sravana)
(sravana-naksatra)
July - August Bhadrapada
(purva-bhadrapada-naksatra)
August - September
Asvina
(asvini-naksatra)
September - October Karttika
(krttika-naksatra)
October - November
Margasirsa/
Agrahayana
(mrgasirsa-naksatra)
November - December Pausa
(pusya-naksatra)
December - January
Magha (magha-
naksatra)
January - February Phalguna (phalguna-
naksatra)
February - March
Ritu (Season)
Grisma
(Summer)
May to July Varsa
(Rainy)
July to September
Sarad
(Autumn)
September to
November
Hemanta
(Winter)
November to January
Sisira
(Cool)
January to March Vasanta
(Spring)
March to May
ANNEXURE 32
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Integrated Management of Neonatal and Childhood Illness: Baseline Assessment of Childhood Mortality and Morbidity in SSSeeellleeecccttteeeddd DDDiiissstttrrriiiccctttsss iiinnn IIInnndddiiiaaa
(IMNCI-IPEN Study 2006-2007)
Land Measure Conversion Table
State Conversion State Conversion
Uttar Predesh 1 Acre = 4 Bigha
1 Bigha= 20 Biswa
1 Biswa = 60 Sq. yards
Madhya Pradesh 1 Acres= 3.5 Bighas
1 acre = 100 decimal
Haryana 1 Acre = 1 Killa
1 Killa = 8 Kanal
1 Kanal= 20 marla
Rajasthan 1 Acre = 2.5 Bighas
1 Bigha = 20 Biswa
1 Biswa ≈ 100 Sq. Yards
Maharasra 1 Acre = 2.5 Bighas
= 40 Guntha
=60 Kotta
= 8 Kanal
= 4 Rood
Orissa 1 Acre = 1 Mana
1Mana = 25 Guntha
1 Acre = 100 Decimal
Karnataka 1 Acre = 40 Guntha Meghalaya 1 Acre= 43560 sq. feet
1 Hectare= 2.5 acres
1 Acre = 4840 sq yards
1 Acre= 43560 sq. feet
ANNEXURE 33
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(IMNCI-IPEN Study 2006-2007)
Unique ID Scheme for Instruments used for the Baseline Survey
State Code District Code
Name of State
Code Name of State
Code Name of District
Code (Intervention)
Name of District
Code (Comparison)
Kaithal 1 Mewat 2 Haryana 1 Meghalaya 5 Gulbarga 1 Gadag 2 Morena 1 Tikamgarh 2 Karnataka 2 Orissa 6 Amrawati 1 Parbhani 2 Ri-Bhoi 1 Jaintia Hills 2 Madhya
Pradesh 3 Rajasthan 7
Nayagarh 1 Sonapur 2 Baran 1 Chittorgarh 2 Maharastra 4 Uttar
Pradesh 8
Kanauj 1 Mathura 2 Cluster Code:
01 to 80 for Each District
Instrument Code
Name of Instrument Code Name of Instrument Code
Household Screening (n=160+80)
001 to 240 Household Survey (n=20+4)
241 to 264
Skill Observation: ASHA/ TBA/ TH (n=1)
265 Skill Observation: ANM/ AWW (n=1)
266
Skill Observation: Prescriber (n=1)
267 Generic Health Facility Observation (n=1)
268
Verbal Autopsy (n=3)
269 to 271 Tracking of Events Recovered Hospitalized under-five Child (n=1)
272
Tracking of Events Non-hospitalized Child (Male/ Female/ Extra) (n=2+1)
273 to 275 Tracking of Events (Neonate/ Extra) (n=1+1)
276 to 277
Cluster code
Instrument code
ANNEXURE 34
1 1 0 4 0 4 0
State code
District code