Research types ksr

Lecture delivered at MGACH&RC, Wardha

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
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



From the word “I can not” to . . .



Each and every episode we
encounter in the profession is
tackled with challenge – even -



Design the “challenge” to a project



Whether the Research is “CHOICE” or “CHANCE”


Deploy argument to
stop Struggle between
Types / Designs /
Phases


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



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.


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



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.


Ayurveda Clinical trial Registration

Clinical trial for Ayurveda drug
must be carried out under
conditions which ensure
adequate safety for the
subjects and registered in
www.ctri.in


What research is necessary?
• A research which
have evidence
• Which is –
– Feasible,
– Clear
– Significant
– Ethical


Level

Therapy

Prognosis

Diagnosis

Aetiology

I

Systematic
Review

Systematic
Review

Systematic
Review

Systematic
Review

II

RCT

Inception
cohort

Cross-sectional
(consecutive)

Prospective
cohort

III

NonRandomised
experimental

Untreated
control patients
in RCT

Cross-sectional
(nonconsecutive)

Retrospective
cohort

Comparative
with concurrent
control group

Retrospective
cohort

Diagnostic
case-control

Case-control
/ Ecological

Case series

Cohort patients
different
disease

Case series

Crosssectional

IV



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?


Nine Mistakes to Avoid
1. leading questions
2. questions that invite the social
desirability bias
3. double-barreled questions
4. long questions
5. negations
6. irrelevant questions
7. poorly worded response options
8. big words
9. ambiguous words & phrases


What makes a good question?

FINER criteria
Feasible
(answerable with a robust method)
Interesting
Novel
Ethical
Relevant



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?



More on PICO
Patients
• 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 treatment
Outcome
• frequency, risk, benefit, harm
• dichotomous or continuous
• type: mortality, morbidity, quality of life, etc.



Level Vs Quality of Evidence



Two sets of pyramidal explanation



Research questions
determine problem
(case reports/case-series, ecological/cross-sectional studies)

implement activities

find potential causes
(case-control/cohort studies)

(surveillance studies, meta-analyses)

design interventions
(randomized controlled trials)



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



Study designs

Population (P) Outcomes (O)
Interventions (I) or Exposures (E)
Centre for Evidence Based Medicine, Oxford, UK www.cebm.net



Case Report Series

Describe patients’ characteristics, and may generate ideas for future studies



Population

Randomized Controlled Trial
Meet
Inclusion
Criteria?

Sample

Baseline
Assessment

Follow-up
assessments

•Typical RCT randomises two (or more) groups of patients to different treatments



Cross-sectional study

Population

Group of interest
(e.g. smokers)

Compute prevalence
of stroke in smokers
Compare
groups

sample
Comparison Group
of interest
(e.g. non-smokers)

Compute prevalence
of stroke in non-smokers

Starting point

Present

•A cross-sectional study is a single “snapshot” in time
•We can only study current risk factors and diseases (prevalence)



Case-control study

Population of diseased
individuals

Sample of diseased
individuals

Sample of non-diseased
individuals

Population of non-diseased
individuals

Past

Exposure
History

Starting point

•Case-control studies examine the association of disease with past exposure (s)



Cohort study

Population of disease
free 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



Three Main Types:
Classifications of Research Studies
Observational Studies:
• Groups are studied & contrasts made between groups
• The observed data collected are analyzed
Analytic Studies:
• Also called Experimental
•
Study the impact of a certain therapy
•
Ultimately the investigator controls factor being studied
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


Phases of Clinical Trials
• Phase I: Small group [20-80] for 1st time to
evaluate safety, determine safe dosage
range & identify SE
• Phase II: Rx/tx given to larger group
[100-300] to confirm effectiveness,
monitor SE, & further evaluate safety



Phases of Clinical Trials (cont.)
• 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: 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.


Reporting statements
CONSORT for randomised controlled trials
STARD for diagnostic accuracy studies
STROBE for observational studies
PRISMA for systematic reviews of trials
MOOSE for meta-analyses of observational
studies
EQUATOR network

equator-network.org/resource-centre/library-of-health-research reporting/



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.



Pros and cons of the RCT
An 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 analysis
Disadvantages:
– expensive: time and money
– volunteer bias
– ethically problematic at times



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


Acknowledgements of Citations:
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,
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, tgroves@bmj.com
6. www.ayusoft.cdac.in/pshome/apps/en/src/Articles/Research/Researc
h_Methodology_and_Statistics_Evident_in_Ayurveda.htm

Dedicated to
Nitin R Choudary
Panchakarma
Massager who
disappeared in
Road mishap
On 18-01-2014


Research types ksr

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