Author: Kishor Patwardhan, Department of Kriya Sharir, Faculty of Ayurveda, IMS,BHU

1. Guidelines applicable for
reporting clinical studies in Ayurveda
Kishor Patwardhan
Faculty of Ayurveda, IMS, BHU, Varanasi

2. Three types of
research
questions
 Descriptive
 Associational
 Causal

3. Observational
Vs
Experimental
Observational study
 The investigators stand apart from the
events
 They only observe and record the events
Experimental or intervention study
 The investigators introduce an
intervention and then observe the events

4. Observational
studies
 A descriptive study is an observational
study that simply describes the
distribution of a characteristic
 An analytical study is an observational
study that describes associations and
analyses them for possible cause and
effect.

5. Cross-sectional
Vs longitudinal
 An observational study may be cross-
sectional or longitudinal
 In a cross-sectional study, measurements
are made on a single occasion
 In a longitudinal study, measurements
are made repeatedly over a period of
time

6. Retrospective
Vs prospective.
 A longitudinal observational study may
be retrospective or prospective.
 In a retrospective study, the
investigators study present and past
events.
 In a longitudinal prospective study, the
investigators follow subjects for future
events.

7. Case–control
studies
 Case–control studies are a type of observational-
analytical-retrospective studies over time
 A group of subjects with a specified outcome
(cases) and a group of subjects without that
outcome (controls) are identified
 Investigators then compare the extent to which
each subject was previously exposed to the
variable of interest, such as a risk factor, a
treatment or an intervention.
 Case–control studies can be efficient and
economical, but do not have the strength of
evidence of a prospective study.

8. Cohort Study
 In clinical and epidemiological research, a longitudinal
observational study is usually called a cohort study.
 One of the best examples of a prospective cohort study
was initiated by Austin Bradford Hill and Richard Doll
 40,000 British doctors were divided into four cohorts:
non-smokers, and light, moderate and heavy smokers.
 The study could demonstrate that the link between
smoking and ill-health was causal rather than
coincidental.
 The 20-year and 40-year results of this momentous study
illustrate the strength of evidence that can be obtained
from a properly conducted cohort study

9. Experimental
or intervention
studies
 The investigators test the effect of an intervention
on the events taking place in the study
 Giving a treatment to a patient or group of
patients and finding that the treatment works
gives only preliminary and non-definitive
information.
 We do not know what would have happened if no
treatment or a different treatment was given.
 For a more definitive answer, we need a “control”
group of patients who do not get the treatment
under study.

10. Randomization
 A controlled experimental study may be
randomized or non-randomized.
 In testing the outcome in a group of patients who
receive the treatment and another group who do
not, we are still not sure whether any difference
observed is because of the treatment or because
the characteristics of the patients in the two
groups were different.
 The best way to be sure is to randomize the
allocation of patients to either treatment or to no
treatment.

11. Randomized
controlled
trials
 Randomized controlled trials are intervention
studies characterized by the prospective
assignment of subjects, through a random method,
into an experimental group and a control group.
 In a clinical trial, the experimental group receives
the drug or treatment to be evaluated, while the
control group receives a placebo, no treatment, or
the standard of care.
 Both groups are followed for the outcome(s) of
interest.

12.  In a crossover study, half of the participants are
randomly assigned to start with the placebo and
then switch to active treatment, while the other
half does the opposite.
 A before-and-after study is a method of control in
which results from experimental subjects are
compared with outcomes from patients treated
before the new intervention was available. These
are called historic controls.

13.  A randomized controlled trial may be blinded if
participants in the trial are likely to change their
behaviour in a systematic way that may influence
the outcome of the study when they are aware of
which intervention they receive.
 Blinding can take place at a number of levels
(Participants, Physician, Assessing individuals,
Researchers.)
 A trial in which there is no attempt at blinding
may be called open or open label.

14. CONSORT Statement:
Background
 Randomized controlled trials, when appropriately
designed, conducted, and reported, represent the
gold standard in evaluating healthcare
interventions.
 Complete, clear, and transparent information on
methodology and findings is required.
 Unfortunately, authors of many reports neglect to
provide desired descriptions and hence, the
assessment of the trial becomes difficult

15.  Lack of adequate reporting led to the
development of the original CONSORT
(Consolidated Standards of Reporting Trials)
statement in 1996 and its revision in 2001.
 While those statements improved the reporting
quality for some randomized controlled trials,
many trial reports still remained inadequate.
 CONSORT 2010 is the latest update

16. 4 components
of CONSORT
 Statement
 Explanation and elaboration
 Checklist
 Flow Diagram

17. http://www.consort-statement.org/

18. Explanation and Elaboration

19. Checklist

21. Reporting of Multi-Arm Parallel-Group
Randomized Trials: Extension of the CONSORT
2010 Statement
Reporting of stepped wedge cluster
randomised trials: extension of the CONSORT
2010 statement with explanation and
elaboration
Reporting randomised trials of social and
psychological interventions: the CONSORT-SPI
2018 Extension
CONSORT 2010 statement: extension checklist
for reporting within person randomised trials
CONSORT Extension for Chinese Herbal
Medicine Formulas 2017: Recommendations,
Explanation, and Elaboration
CONSORT 2010 statement: extension to
randomised pilot and feasibility trials
The CONSORT Statement: Application within
and adaptations for orthodontic trials
CONSORT extension for reporting N-of-1 trials
(CENT) 2015 Statement
Better reporting of harms in randomized
trials: an extension of the CONSORT Statement
Reporting of patient-reported outcomes in
randomized trials: the CONSORT PRO extension
Improving the reporting of pragmatic trials: an
extension of the CONSORT statement
CONSORT for reporting randomised trials in
journal and conference abstracts
CONSORT Statement for Randomized Trials of
Nonpharmacologic Treatments: A 2017 Update
and a CONSORT Extension for
Nonpharmacologic Trial Abstracts

22. Checklist for the preparation and review of pain
clinical trial publications: a pain-specific
supplement to CONSORT
Improving the reporting of clinical trials of
infertility treatments (IMPRINT): modifying the
CONSORT statement
Reporting Guidelines for Health Care
Simulation Research: Extensions to the
CONSORT and STROBE Statements
CONSORT-EHEALTH: improving and standardizing
evaluation reports of Web-based and mobile
health interventions
Reporting randomized, controlled trials of herbal
interventions: an elaborated CONSORT Statement
Consort 2010 statement: extension to cluster
randomised trials
Reporting of noninferiority and equivalence
randomized trials: extension of the CONSORT 2010
statement
Revised STandards for Reporting Interventions in
Clinical Trials of Acupuncture (STRICTA):
extending the CONSORT statement
CONSORT-Equity 2017 extension and elaboration for
better reporting of health equity in randomised
trials

25. Guidelines for reporting
observational studies
 The Strengthening the Reporting of Observational
Studies in Epidemiology (STROBE) Statement
 The STROBE Statement is a checklist of items that
should be addressed in articles reporting on the 3
main study designs of analytical epidemiology:
 Cohort studies
 Case-control studies
 Cross-sectional studies

26. STROBE statement

27. STROBE Checklist

28. STROBE-Extensions
CONSISE statement on the reporting of Sero-
epidemiologic Studies for influenza (ROSES-I
statement): an extension of the STROBE statement
Strengthening the Reporting of Observational
Studies in Epidemiology for Newborn Infection
(STROBE-NI): an extension of the STROBE statement
for neonatal infection research
Strengthening the Reporting of Observational
Studies in Epidemiology—Nutritional Epidemiology
(STROBE-nut): An Extension of the STROBE
Statement
STROBE-AMS: recommendations to optimise
reporting of epidemiological studies on
antimicrobial resistance and informing
improvement in antimicrobial stewardship
The REporting of studies Conducted using
Observational Routinely-collected health Data
(RECORD) Statement
Strengthening the Reporting of Observational
Studies in Epidemiology for Respondent-Driven
Sampling Studies: ‘STROBE-RDS’ Statement.
Strengthening the reporting of molecular
epidemiology for infectious diseases (STROME-
ID): an extension of the STROBE statement
Draft STROBE checklist for conference abstracts
STrengthening the Reporting of OBservational
studies in Epidemiology – Molecular Epidemiology
(STROBE-ME): An extension of the STROBE
statement

29. STrengthening the REporting of Genetic
Association Studies (STREGA): An Extension
of the STROBE Statement.
Reporting Guidelines for Health Care
Simulation Research: Extensions to the
CONSORT and STROBE Statements
Launch of a checklist for reporting
longitudinal observational drug studies in
rheumatology: a EULAR extension of
STROBE guidelines based on experience
from biologics registries

30. CARE Guidelines
 Case Reports
 Case Series

31. CARE Checklist

33. CARE Extensions
 Adaptation of the CARE Guidelines for
Therapeutic Massage and Bodywork
Publications: Efforts To Improve the Impact
of Case Reports
 The SCARE 2018 Statement: Updating
Consensus Surgical CAse REport (SCARE)
Guidelines
 Homeopathic clinical case reports:
Development of a supplement (HOM-CASE)
to the CARE clinical case reporting guideline

38. Thanks!