English II Research Paper Putting together everything you’ve learned in school.
putting everything together drug resistance survey.ppt · To define responsibilities of all team...
Transcript of putting everything together drug resistance survey.ppt · To define responsibilities of all team...
Putting everything together:
drug resistance survey protocol
development, budget and checklist
Putting everything together:
drug resistance survey protocol
development, budget and checklist
Wayne van GemertWayne van GemertWHO Stop TB Department, Geneva
TB surveillance and surveys: a training workshop for consultants
Geneva - 24-27 May 2011
Why do we need a protocol?Why do we need a protocol?Why do we need a protocol?Why do we need a protocol?
� To solidify details in a single document that can be shared
and referred to
� To define responsibilities of all team members
� For approval of the study by the Ministry of Health
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 20112
� For approval of the study by the Ministry of Health
� For approval of the study by ethical bodies
� For fundraising purposes / to justify budget
Main elements of a protocolMain elements of a protocol
Introduction and background
Objectives
Sampling
Intake of patients and logistics
Laboratory methods
Trainings
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 20113
(see Annex 6)
Trainings
Survey monitoring plan
Data management and analysis
Ethical clearance
Human resources
Detailed budget
Elements of a survey protocolElements of a survey protocol
1. Introduction and background
� Country profile- population, relevant geographical/climatic
conditions, administrative divisions, anything relevant that
might affect the sampling frame of the survey
� Epidemiological situation of:
� TB, including smear positive case notifications by diagnostic
centre
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TB surveillance and surveys: a training workshop for consultants – 24-27 May 20114
centre
� MDR-TB, if anything known (past surveys, routine data)
� HIV (and TB/HIV)
� National TB control programme (NTP) information, including:
� Strategy
� Operational design
� Drug regimens used
Elements of a survey protocolElements of a survey protocol
1. Introduction and background (continued)
� Management of patients with MDR-TB
� Treatment outcome data: TB and MDR-TB cohort analysis
� TB laboratory network:
� Design
� Quality assurance system, including:
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 20115
� Internal quality assurance
� External quality assurance, including SRL link
� Health care providers not formally linked to the NTP
� Private sector
� Penitentiary services
� Other non-NTP public providers of TB care
Elements of a survey protocolElements of a survey protocol
2. Objectives of the survey (clearly in paragraph or list format)
– To determine the frequency of drug resistance patterns of first-
line anti-TB drugs among new smear-positive TB cases in the
[public] sector of [city/country name];
– To determine the frequency and drug resistance patterns of
first-line anti-TB drugs among previously treated smear-positive
TB cases in the [public] sector of [city/country name];
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 20116
TB cases in the [public] sector of [city/country name];
– To determine the frequency and drug resistance patterns of
second-line anti-TB drugs in strains with confirmed resistance to
isoniazid and rifampicin; and
– To determine the association between drug-resistant TB and
HIV status (And age? sex? Other risk factors: substance abuse,
history of incarceration, etc…?)
Elements of a survey protocolElements of a survey protocol
3. Survey sampling
� Sampling frame- geographic area and sectors (civilian, etc)
� Survey design:
� 100% sampling of diagnostic centres
• For how many months?
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 20117
� Cluster sampling
• How many and how large is a cluster?
• List of clusters at diagnostic centres
� Sample size and the statistical basis for its calculation
Elements of a survey protocolElements of a survey protocol
4. Intake of patients and logistics
� Intake period
� Rotate the intake by region to alleviate burden?
� Inclusion and exclusion criteria
� Include:
� Smear-positive patients
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TB surveillance and surveys: a training workshop for consultants – 24-27 May 20118
� Smear-positive patients
� Children?
� Exclude:
� Smear-negative
� Extrapulmonary patients
� Patients who have already started treatment
Elements of a survey protocolElements of a survey protocol
4. Intake of patients and logistics (continued)
� Sputum collection process
� How specimens will be managed at diagnostic centres /
intermediate labs / central lab / to SRL (?)
� How specimens/isolates will be transported
� Patient interview process Annex 9
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 20119
� Patient interview process
� Recording forms:
� Clinical information form
� Sputum shipment form
� Laboratory results form
Annex 9
Elements of a survey protocolElements of a survey protocol
5. Laboratory methods
� Use of microscopy, media preparation, culture and
identification
� Chosen methods for DST and diagnostic algorithm
� Established system of quality assurance
� Internal quality control of DST and other laboratory
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 201110
� Internal quality control of DST and other laboratory
processes
� External quality assurance, including proficiency testing in
advance, rechecking of samples, pre-survey onsite
assessments
� Biosafety measures
Elements of a survey protocolElements of a survey protocol
6. Trainings
� Training plan for all involved staff, including responsibilities, timing, location, topics, forms, etc.
� Separate training needs for: diagnostic centre coordinators, clinicians, laboratory staff
� Training topics:
• Enrolment of study subjects
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 201111
• Enrolment of study subjects
• Use and management of clinical information forms
• Determining previous anti-TB treatment
• Registration of specimens
• Management/transport of specimens at each level
• Laboratory techniques
• Registration of laboratory results and management of laboratory forms
Elements of a survey protocolElements of a survey protocol
7. Survey monitoring plan
� Supervisory trips of the coordination team to the diagnostic
centres a few weeks after start of enrolment
� Monitoring of procedures: patient enrolment and laboratory
� Troubleshooting
� Check registers to ensure that all eligible patients are being
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TB surveillance and surveys: a training workshop for consultants – 24-27 May 201112
� Check registers to ensure that all eligible patients are being
enrolled
� Re-interviewing of a subsample patients
� Organization of a midterm central meeting to discuss progress
and problems
Elements of a survey protocolElements of a survey protocol
8. Data management and analysis
� Development of a database
� Data collection plan
� Double entry
� Data monitoring
� Data analysis
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TB surveillance and surveys: a training workshop for consultants – 24-27 May 201113
� Data analysis
Elements of a survey protocolElements of a survey protocol
9. Ethical clearance
� Availability of treatment for patients
� If DR-TB treatment is not yet available, start preparations in
parallel
� Patient consent form
� Patient should be informed and not exploited
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TB surveillance and surveys: a training workshop for consultants – 24-27 May 201114
� Patient should be informed and not exploited
� Confidentiality of patient data
� Data collection, management, analysis, storage
� Ethical review panel
Elements of a survey protocolElements of a survey protocol
10. Human resources
� Identification of national coordination team members
� Should cover the main three operational levels
1.Programme management (Logistics, collection of patient clinical information, supervision)
2.Laboratory
3.Epidemiology / statistics (sampling, data management and analysis)
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TB surveillance and surveys: a training workshop for consultants – 24-27 May 201115
3.Epidemiology / statistics (sampling, data management and analysis)
� Team members usually consist of:
�Principal investigator
�NTP manager, or someone designated
�NRL manager, or someone designated
�Epidemiologist / Statistician
� Responsibilities of each coordination team member
Budgeting
Budgeting for a drug resistance surveyBudgeting for a drug resistance survey
A drug resistance survey budget:
� Should be detailed
� Should be created in advance
� Should identify the source of funds
� By line item, if coming from different funding sources
� Average survey costs: 100,000-150,000 USD
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TB surveillance and surveys: a training workshop for consultants – 24-27 May 201117
� Average survey costs: 100,000-150,000 USD
Item Type of unit Cost/unit # units Total
Human resources
Principal investigator 0
Laboratory principal investigator 0
Information technology specialist 0
Laboratory technician(s) 0
Logistics staff (e.g. drivers, data entry,
secretarial) 0
0
Consumables
General (e.g. stationary, printing…)
0
Sputum containers 0
Reagents 0
Pure substances 0
Other ( ) 0
0
Equipment
Safety cabinet 0
Centrifuge 0
Computer 0
Other, including inspissator,
refrigerators ( ) 0
0
Meetings
Initial meeting, follow-up meeting 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Training
Training of personnel for intake 0
Subtotal
Subtotal
Subtotal
Subtotal
Annex 8
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 201118
Training of personnel for intake 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Collection and domestic transport of
specimens
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage)
0
Collection and international transport
of specimens to SRL*
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage) 0
0
SRL costs
Visit 0
Proficiency testing costs 0
ID and DST costs, including human
resources 0
0
Supervision
Per diem 0
Transportation of supervisor 0
0
0
Subtotal
Subtotal
Subtotal
Subtotal
TOTAL
Subtotal
Item Type of unit Cost/unit # units Total
Human resources
Principal investigator 0
Laboratory principal investigator 0
Information technology specialist 0
Laboratory technician(s) 0
Logistics staff (e.g. drivers, data entry,
secretarial) 0
0
Consumables
General (e.g. stationary, printing…)
0
Sputum containers 0
Reagents 0
Pure substances 0
Other ( ) 0
0
Equipment
Safety cabinet 0
Centrifuge 0
Computer 0
Other, including inspissator,
refrigerators ( ) 0
0
Meetings
Initial meeting, follow-up meeting 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Training
Training of personnel for intake 0
Subtotal
Subtotal
Subtotal
Subtotal
Note:
•Lines depend on the team
•A survey is added work
•Incentives motivate staff = a better product
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 201119
Training of personnel for intake 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Collection and domestic transport of
specimens
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage)
0
Collection and international transport
of specimens to SRL*
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage) 0
0
SRL costs
Visit 0
Proficiency testing costs 0
ID and DST costs, including human
resources 0
0
Supervision
Per diem 0
Transportation of supervisor 0
0
0
Subtotal
Subtotal
Subtotal
Subtotal
TOTAL
Subtotal
= a better product
•Contract external people if needed
Item Type of unit Cost/unit # units Total
Human resources
Principal investigator 0
Laboratory principal investigator 0
Information technology specialist 0
Laboratory technician(s) 0
Logistics staff (e.g. drivers, data entry,
secretarial) 0
0
Consumables
General (e.g. stationary, printing…)
0
Sputum containers 0
Reagents 0
Pure substances 0
Other ( ) 0
0
Equipment
Safety cabinet 0
Centrifuge 0
Computer 0
Other, including inspissator,
refrigerators ( ) 0
0
Meetings
Initial meeting, follow-up meeting 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Training
Training of personnel for intake 0
Subtotal
Subtotal
Subtotal
Subtotal
Note:
•Some items may need to be purchased centrally and distributed to diagnostic centres to ensure quality
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 201120
Training of personnel for intake 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Collection and domestic transport of
specimens
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage)
0
Collection and international transport
of specimens to SRL*
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage) 0
0
SRL costs
Visit 0
Proficiency testing costs 0
ID and DST costs, including human
resources 0
0
Supervision
Per diem 0
Transportation of supervisor 0
0
0
Subtotal
Subtotal
Subtotal
Subtotal
TOTAL
Subtotal
ensure quality
Item Type of unit Cost/unit # units Total
Human resources
Principal investigator 0
Laboratory principal investigator 0
Information technology specialist 0
Laboratory technician(s) 0
Logistics staff (e.g. drivers, data entry,
secretarial) 0
0
Consumables
General (e.g. stationary, printing…)
0
Sputum containers 0
Reagents 0
Pure substances 0
Other ( ) 0
0
Equipment
Safety cabinet 0
Centrifuge 0
Computer 0
Other, including inspissator,
refrigerators ( ) 0
0
Meetings
Initial meeting, follow-up meeting 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Training
Training of personnel for intake 0
Subtotal
Subtotal
Subtotal
Subtotal
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 201121
Training of personnel for intake 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Collection and domestic transport of
specimens
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage)
0
Collection and international transport
of specimens to SRL*
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage) 0
0
SRL costs
Visit 0
Proficiency testing costs 0
ID and DST costs, including human
resources 0
0
Supervision
Per diem 0
Transportation of supervisor 0
0
0
Subtotal
Subtotal
Subtotal
Subtotal
TOTAL
Subtotal
Item Type of unit Cost/unit # units Total
Human resources
Principal investigator 0
Laboratory principal investigator 0
Information technology specialist 0
Laboratory technician(s) 0
Logistics staff (e.g. drivers, data entry,
secretarial) 0
0
Consumables
General (e.g. stationary, printing…)
0
Sputum containers 0
Reagents 0
Pure substances 0
Other ( ) 0
0
Equipment
Safety cabinet 0
Centrifuge 0
Computer 0
Other, including inspissator,
refrigerators ( ) 0
0
Meetings
Initial meeting, follow-up meeting 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Training
Training of personnel for intake 0
Subtotal
Subtotal
Subtotal
Subtotal
Note:
•Ideally three central meetings of representatives from each participating centre-before, during, and after
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 201122
Training of personnel for intake 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Collection and domestic transport of
specimens
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage)
0
Collection and international transport
of specimens to SRL*
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage) 0
0
SRL costs
Visit 0
Proficiency testing costs 0
ID and DST costs, including human
resources 0
0
Supervision
Per diem 0
Transportation of supervisor 0
0
0
Subtotal
Subtotal
Subtotal
Subtotal
TOTAL
Subtotal
before, during, and after
•Coordinating team should meet biweekly/monthly
Item Type of unit Cost/unit # units Total
Human resources
Principal investigator 0
Laboratory principal investigator 0
Information technology specialist 0
Laboratory technician(s) 0
Logistics staff (e.g. drivers, data entry,
secretarial) 0
0
Consumables
General (e.g. stationary, printing…)
0
Sputum containers 0
Reagents 0
Pure substances 0
Other ( ) 0
0
Equipment
Safety cabinet 0
Centrifuge 0
Computer 0
Other, including inspissator,
refrigerators ( ) 0
0
Meetings
Initial meeting, follow-up meeting 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Training
Training of personnel for intake 0
Subtotal
Subtotal
Subtotal
Subtotal
Note:
•Trainings can be centralized, regionalized, or at each diagnostic
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 201123
Training of personnel for intake 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Collection and domestic transport of
specimens
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage)
0
Collection and international transport
of specimens to SRL*
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage) 0
0
SRL costs
Visit 0
Proficiency testing costs 0
ID and DST costs, including human
resources 0
0
Supervision
Per diem 0
Transportation of supervisor 0
0
0
Subtotal
Subtotal
Subtotal
Subtotal
TOTAL
Subtotal
or at each diagnostic centre
Item Type of unit Cost/unit # units Total
Human resources
Principal investigator 0
Laboratory principal investigator 0
Information technology specialist 0
Laboratory technician(s) 0
Logistics staff (e.g. drivers, data entry,
secretarial) 0
0
Consumables
General (e.g. stationary, printing…)
0
Sputum containers 0
Reagents 0
Pure substances 0
Other ( ) 0
0
Equipment
Safety cabinet 0
Centrifuge 0
Computer 0
Other, including inspissator,
refrigerators ( ) 0
0
Meetings
Initial meeting, follow-up meeting 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Training
Training of personnel for intake 0
Subtotal
Subtotal
Subtotal
Subtotal
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 201124
Training of personnel for intake 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Collection and domestic transport of
specimens
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage)
0
Collection and international transport
of specimens to SRL*
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage) 0
0
SRL costs
Visit 0
Proficiency testing costs 0
ID and DST costs, including human
resources 0
0
Supervision
Per diem 0
Transportation of supervisor 0
0
0
Subtotal
Subtotal
Subtotal
Subtotal
TOTAL
Subtotal
Item Type of unit Cost/unit # units Total
Human resources
Principal investigator 0
Laboratory principal investigator 0
Information technology specialist 0
Laboratory technician(s) 0
Logistics staff (e.g. drivers, data entry,
secretarial) 0
0
Consumables
General (e.g. stationary, printing…)
0
Sputum containers 0
Reagents 0
Pure substances 0
Other ( ) 0
0
Equipment
Safety cabinet 0
Centrifuge 0
Computer 0
Other, including inspissator,
refrigerators ( ) 0
0
Meetings
Initial meeting, follow-up meeting 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Training
Training of personnel for intake 0
Subtotal
Subtotal
Subtotal
Subtotal
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 201125
Training of personnel for intake 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Collection and domestic transport of
specimens
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage)
0
Collection and international transport
of specimens to SRL*
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage) 0
0
SRL costs
Visit 0
Proficiency testing costs 0
ID and DST costs, including human
resources 0
0
Supervision
Per diem 0
Transportation of supervisor 0
0
0
Subtotal
Subtotal
Subtotal
Subtotal
TOTAL
Subtotal
Item Type of unit Cost/unit # units Total
Human resources
Principal investigator 0
Laboratory principal investigator 0
Information technology specialist 0
Laboratory technician(s) 0
Logistics staff (e.g. drivers, data entry,
secretarial) 0
0
Consumables
General (e.g. stationary, printing…)
0
Sputum containers 0
Reagents 0
Pure substances 0
Other ( ) 0
0
Equipment
Safety cabinet 0
Centrifuge 0
Computer 0
Other, including inspissator,
refrigerators ( ) 0
0
Meetings
Initial meeting, follow-up meeting 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Training
Training of personnel for intake 0
Subtotal
Subtotal
Subtotal
Subtotal
Note:
•Discuss with the partner SRL in advance what are their needs
•Pre-survey visit, post-
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 201126
Training of personnel for intake 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Collection and domestic transport of
specimens
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage)
0
Collection and international transport
of specimens to SRL*
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage) 0
0
SRL costs
Visit 0
Proficiency testing costs 0
ID and DST costs, including human
resources 0
0
Supervision
Per diem 0
Transportation of supervisor 0
0
0
Subtotal
Subtotal
Subtotal
Subtotal
TOTAL
Subtotal
•Pre-survey visit, post-survey visit to discuss findings, visit during the survey if problems are found
Item Type of unit Cost/unit # units Total
Human resources
Principal investigator 0
Laboratory principal investigator 0
Information technology specialist 0
Laboratory technician(s) 0
Logistics staff (e.g. drivers, data entry,
secretarial) 0
0
Consumables
General (e.g. stationary, printing…)
0
Sputum containers 0
Reagents 0
Pure substances 0
Other ( ) 0
0
Equipment
Safety cabinet 0
Centrifuge 0
Computer 0
Other, including inspissator,
refrigerators ( ) 0
0
Meetings
Initial meeting, follow-up meeting 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Training
Training of personnel for intake 0
Subtotal
Subtotal
Subtotal
Subtotal
Putting everything together: drug resistance survey protocol development, budget and checklist
TB surveillance and surveys: a training workshop for consultants – 24-27 May 201127
Training of personnel for intake 0
Per diem 0
Transportation of attendees 0
Meeting room costs 0
0
Collection and domestic transport of
specimens
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage)
0
Collection and international transport
of specimens to SRL*
Transport containers, packaging 0
Transport costs (fuel, air/bus,
postage) 0
0
SRL costs
Visit 0
Proficiency testing costs 0
ID and DST costs, including human
resources 0
0
Supervision
Per diem 0
Transportation of supervisor 0
0
0
Subtotal
Subtotal
Subtotal
Subtotal
TOTAL
Subtotal
Thanks!