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Types of research in ayurveda and contemporary are discussed by Dr KSR Prasad at Wardha, Maharastra on 21-01-2014

Types of research in ayurveda and contemporary are discussed by Dr KSR Prasad at Wardha, Maharastra on 21-01-2014

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Research types ksr Research types ksr Presentation Transcript

  • 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 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 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 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • Research Types in Ayurveda 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 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 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 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 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • Research Types in Ayurveda 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 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 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) Interesting Novel Ethical Relevant 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 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. 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 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) Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • Research Types in Ayurveda Trial Typology Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • Research Types in Ayurveda 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 Case Report Series Describe patients’ characteristics, and may generate ideas for future studies Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • Research Types in Ayurveda 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 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • Research Types in Ayurveda 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) Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • Research Types in Ayurveda 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) Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • Research Types in Ayurveda 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 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • Research Types in Ayurveda 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 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • Research Types in Ayurveda 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 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • Research Types in Ayurveda 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. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • Research Types in Ayurveda 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/ 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 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 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 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 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/