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Research Types in Ayurveda
Research is a search for Knowledge, at the appraisal, as less as people understand they
reciprocate appreciation pretended projection as more as they understood.
-
Dr KSR Prasad
Lecture delivered at MGACH&RC, Wardha
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Research is balancing Science, Economy, Safety,Quality &Efficacy for attaining new knowledge
Research Types in Ayurveda
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
From the word “I can not”
to . . .
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Each and every episode we encounter in the profession is tackled with challenge –
even -
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Design the “challenge”
to a project
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Whether the Research is “CHOICE” or “CHANCE”
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Deploy argument to stop Struggle between Types / Designs / Phases
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Research Methodology and Statistics Evident in Ayurveda Treatises –
Dr. Asmita
Wele
•
Basic level research is defined as a process to find the truth -
operational level
steps involved to find the truth are ––
Clinical research
–
Drug research–
Literary research
–
Epidemiological–
Fundamental
www.ayusoft.cdac.in/pshome/apps/en/src/Articles/Research/Research_Methodology_and_Statistics_Evident_in_Ayurveda.htm
Mile stones of Initiation for regulation •
Drugs & Cosmetics Act 1940 and the Rules. National policy on traditional medicine in India updated 1964,1970, 1982
•
In 1959, the Govt. of India amended the Drugs and Cosmetics Act to include drugs which are derived from traditional Indian medicine.
•
The Indian Medicine Central Council Act, 1970•
CCRAS, established for research in 1978 by GOI, coordinates and promotes research in the fields of Ayurveda medicine
•
In 1993, the guidelines for the safety and efficacy of herbal medicines developed by an expert committee
•
AYUSH regulation-2005
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
WHO initiatives•
Since 1991, WHO –
–
Guidelines for the assessment of herbal medicines; –
Research guidelines for evaluating the safety
–
Efficacy of herbal medicines; and –
Guidelines for clinical research on acupuncture.
•
In 1997, WHO in support of ––
National Center of Complementary and Alternative Medicine, National Institutes of Health, Bethesda, MD, USA, a WHO informal discussion developed –
•
draft guidelines for methodology on research and evaluation of traditional medicine.
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Assessment of Ayur-medicine in clinical research 1.
Evaluate traditional medicine in its own theoretical framework (Tridosha, Sapta dhatu, Dasa vidha Pariksya etc)
2.
Evaluate traditional medicine in the theoretical framework of conventional medicine (e.g. mechanistic studies);
3.
Compare the efficacy of Ayurveda with different systems of traditional medicine and/or conventional medicine;
4.
Compare the efficacy of different practices within Ayurveda.
5.
Ayurveda drugs: Single herb / mineral / animal product / Poly herbal / Folk medicine
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Clinical trial -
Regulation•
Central Drugs Standard control Organization issued GCP for clinical research in India.
1.No Phase I study is required.2.Neither would any toxicity study be needed for phase
II trial unless there are reports suggesting toxicity or when the herbal preparation is to be used for more than 3 months.
3.Treated as a new substance or new chemical entity (NCE) and the same type of acute, sub-acute and chronic toxicity data will have to be generated as required by the regulatory authority before it is cleared for clinical evaluation.
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Clinical trial for Ayurveda drug must be carried out under conditions which ensure adequate safety for the
subjects and registered in www.ctri.in
Ayurveda Clinical trial Registration
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
What research is necessary?•
A research which have evidence
•
Which is ––
Feasible,
–
Clear–
Significant
–
Ethical
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Level Therapy Prognosis Diagnosis Aetiology
I Systematic Review
Systematic Review
Systematic Review
Systematic Review
II RCT Inception cohort
Cross-sectional(consecutive)
Prospective cohort
III Non-
Randomised experimental
Untreated control patients in RCT
Cross-sectional (non-
consecutive)
Retrospective cohort
Comparative with concurrent control group
Retrospective cohort
Diagnostic case-control
Case-control / Ecological
IV Case series Cohort patients different disease
Case series Cross-
sectional
Questions to ask at Research •
What is study about?
•
What are the goals?•
Study sponsor?
•
Participant input into protocols? •
Inclusion criteria?
•
Benefits & risks•
Is there an incentive? (positive motivational influence / payment)
•
How protected from harm?•
What is required: # study visit & what occurs?
•
What happens after study is over?•
How results will be disseminated?
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Nine Mistakes to Avoid1. leading questions2. questions that invite the social
desirability bias3. double-barreled questions4. long questions5. negations6. irrelevant questions7. poorly worded response options8. big words9. ambiguous words & phrases
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
What makes a good question? FINER
criteria
Feasible (answerable with a robust method)
InterestingNovelEthicalRelevant
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Exactly what are you planning to do?
PICO
P
-
who are the patients or what’s the problem?I
-
what is the intervention or exposure?
C
–
what is the comparison group?O
-
what is the outcome or endpoint?
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
More on PICOPatients•
disease or condition•
stage, severity•
demographic characteristics (age, gender, etc.)Intervention•
type of intervention or exposure•
dose, duration, timing, route, etc.Comparison•
risk or treatment•
placebo or other active treatmentOutcome•
frequency, risk, benefit, harm•
dichotomous or continuous•
type: mortality, morbidity, quality of life, etc.
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Level Vs Quality of Evidence
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Two sets of pyramidal explanation
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Research questionsdetermine problem
(case reports/case-series, ecological/cross-sectional studies)
design interventions(randomized controlled trials)
find potential causes(case-control/cohort studies)implement activities
(surveillance studies, meta-analyses)
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Trial Typology
Are you going to observe or experiment?Observational –
cross sectional, case series, case-control studies,cohort studies•
identify participants•
observe and record characteristics•
look for associations
Experimental –
before and after studies, comparative trials(controlled or head to head), randomised trials (ditto)•
identify participants•
place in common context•
intervene•
observe/evaluate effects of intervention
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Study designs
Population (P) Outcomes (O) Interventions (I) or Exposures (E) Centre for Evidence Based Medicine, Oxford, UK www.cebm.net
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Describe patients’
characteristics, and may generate ideas for future studies
Case Report Series
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Randomized Controlled TrialPopulation
Sample
BaselineAssessment
Meet InclusionCriteria?
Follow-upassessments
•Typical RCT randomises two (or more) groups of patients to different treatments
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Population
sample
Group of interest(e.g. smokers)
Comparison Groupof interest
(e.g. non-smokers)
Compute prevalenceof stroke in smokers
Compute prevalenceof stroke in non-smokers
Comparegroups
Present
Starting point
•A cross-sectional study is a single “snapshot”
in time•We can only study current risk factors and diseases (prevalence)
Cross-sectional study
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Population of diseased individuals
Sample of diseased individuals
ExposureHistory Starting pointPast
•Case-control studies examine the association of disease with past exposure (s)
Population of non-diseased individuals
Sample of non-diseased individuals
Case-control study
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Population of diseasefree individuals
Sample
Starting point Future
• Selected group of disease-free people who are classified according to a specific exposure.•Observed over time to see who develops the disease or outcomes (s) of interest.•Can measure incidence (new cases of disease) and thus risk
Cohort study
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Three Main Types: Classifications of Research Studies
Observational Studies:Observational Studies:•
Groups are studied & contrasts made between groups•
The observed data collected are analyzedAnalytic Studies:Analytic Studies:•
Also called Experimental•
Study the impact of a certain therapy•
Ultimately the investigator controls factor being studiedClinical Trial:Clinical Trial:•
Considered the “true”
experimental study•
“Gold Standard”
of clinical research•
Often a prospective study that compares the effect and value of an intervention against a control in human subjects
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Phases of Clinical Trials••
Phase I:Phase I:
Small group [20-80] for 1st time to
evaluate safety, determine safe dosage range & identify SE
••
Phase II:Phase II:
Rx/tx given to larger group [100-300] to confirm effectiveness, monitor SE, & further evaluate safety
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Phases of Clinical Trials (cont.)••
Phase III:Phase III:
Rx/tx
given to even larger group
[1,000-3,000] to fulfill all of Phase II objectives & compare it to other commonly used txs
& collect data that will allow it to
be used safely••
Phase IV:Phase IV:
Done after rx/tx
has been
marketed -
studies continue to test rx/tx
to collect data about effects in various populations & SE from long term use.
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Reporting statementsCONSORT for randomised controlled trials STARD for diagnostic accuracy studies STROBE for observational studies PRISMA for systematic reviews of trialsMOOSE for meta-analyses of observational
studies EQUATOR network
equator-network.org/resource-centre/library-of-health-research reporting/
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Level of significance
•
Relies on α
error or type I error. The maximum level of α
has been arbitrarily
set to 5% or 0.05. •
Alpha error can be minimized to 0.01 or even 0.001 but this consequently increases the sample size. –
Thus, sample size is inversely related to the level of α
error.
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Pros and cons of the RCTAn experimental comparison study where participants are
allocated to Treatment / intervention or control / placebo groups using a random mechanism is RCT; Best for studying the effect of an intervention.
Advantages: –
unbiased distribution of confounders –
blinding more likely –
randomisation facilitates statistical analysisDisadvantages: –
expensive: time and money–
volunteer bias –
ethically problematic at times
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Summary •
Research is a Choice
but not Chance•
Innovation, Creativity, Attitude
and utilizing opportunities
makes researcher to reach goal •
Ayurveda did scientific research in the past•
Good research require to follow FINER & PICO•
Type of research adaptation based on the Research question
•
Research quality depends upon the level and Evidence•
Fundamentally types are –
Observational, Analytical & Clinical
•
Research phases 1 to 4
represent the connection with the concerns
•
All researches should have proper registration
and reporting
•
Submitting proper analysis
of non fabricated with good level of significance
is the responsibility of researcher
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Research Types in Ayurveda
1. Dr. Rasha Salama, Conducting Research, PhD. Community Medicine
2. Sara Back, NP, Understanding Clinical Trials, Bronx-Lebanon Hospital Center
3. Dr Rafael Perera, Study design and Levels of Evidence, Director of Research Methods, Center for Evidence based Medicine, oxford University
4. Dr Ashok Kumar Panda, Regulation of Clinical trial in Ayurveda, Regulation of Clinical trial in Ayurveda, Officer In charge, Ayurveda Regional Research Institute, Gangtok,Sikkim, An Unit of Central Council for Research in Ayurveda, Department Of AYUSH, Government of India
5. Dr Trish Groves, Different types of clinical evidence and study design Deputy editor, BMJ, [email protected]
6. www.ayusoft.cdac.in/pshome/apps/en/src/Articles/Research/Researc h_Methodology_and_Statistics_Evident_in_Ayurveda.htm
Acknowledgements of Citations:
Dedicated to Nitin
R ChoudaryPanchakarma
Massager who disappeared in
Road mishapOn 18-01-2014