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Quantitative & qualitative analysis of RCT from India

Quantitative & qualitative analysis of RCT from India . Introduction: .

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Quantitative & qualitative analysis of RCT from India

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  1. Quantitative & qualitative analysis of RCT from India

  2. Introduction: • To consolidate and sustain the growth of the profession in the developing countries, it is essential to demonstrate that PT interventions are of high quality and cost effective Community is unique- cultural, social, customs.* • Randomized controlled trials and systematic reviews of randomized controlled trials are considered the best sources of evidence about the effects of interventions. * Robertson VJ. A quantitative analysis of research in Physical Therapy. Phys Ther. 1995; 75:315327.

  3. Objective: • The aim of the study is to locate the number of randomized controlled trial published from India and to analyze its quality.

  4. Methods: • Inclusion criteria: -all the studies in the Medline database from the time period 2000-May’13 -PT author • Exclusion criteria: -studies not relevant to PT (MEDLINE inclusion are based on considerations of both scientific policy and scientific quality. http://www.nlm.nih.gov/pubs/factsheets/jsel.html)

  5. keyterms used are “India”,”Indian” and “Physiotherapy”

  6. Parameters for Analysis: Quantitative Qualitative • Symptomatic/Asymptomatic • Clinical condition • Area of focus • Author’s affiliation • Year • Region • Core journal publications. • PEDro & CONSORT items • ‘a priori’ sample size calculation • Outcomes based on ICF domains • Explanation of the intervention • CONSORT flowchart • Reporting of ‘adverse effects’ • Statement of Primary & secondary outcome measures. • RCT in title • Funding

  7. RESULTS:

  8. Quantitative: Year trend

  9. Salient finding:

  10. PEDro:

  11. PEDro.. • Median & mode of PEDro score-5(out of 10) • Allocation concealment: 28.3% • Baseline : 73.9% • Assessor blinded : 19.6%

  12. Yearly Mean score Of PEDro:

  13. Domains: • ICF domains • Impairment -95% • Activity -32% • Participation -24%

  14. Sample size calculation: (hit or miss) • Sample size- 26.8% • Type 1 & 2 error(alpha & beta). • False positive & False negative. • Ref:Latif et al;Sample size calculation in physical medicine and rehabilitation: a systematic review of reporting, characteristics, and results in randomized controlled trials.Arch Phys Med Rehabil. 2011 Feb;92(2):306-15. doi: 10.1016/j.apmr.2010.10.003.

  15. Explanation of Intervention: • Explanation of intervention- 78% Explained Not-Explained source:Ajimsha et al source:Pattanshetty et al Arch Phys Med RehabilVol 93,April 2012 Ind journal of Med sci;2011 . If trial reports do not have a sufficient description of interventions, other researchers cannot build on the findings, and clinicians and patients cannot reliably implement useful interventions. Ref:BMJ 2013;347:f3755

  16. CONSORT flowchart(patient flow):

  17. Other quantitative findings: • Trial registry:11.6% • Reports of adverse effects:36.4% • Statement of Primary outcome measures:37.2% • RCT in title: 40% • Funding of study: 20%

  18. Discussion & Conclusion: • The trend of slope is UPWARDS. • Most of the study participants are SYMPTOMATIC(81%). • Needs to be focused on area such as knee OA, cardiovascular diseases, stroke, and others. • Future clinical trials from all regions especially eastern and western regions might increase context specific studies.

  19. Discussion(contd)… • Average!? PEDro of 5 implies the average quality of study published. Future studies need to focus on improving the quality of study design. • Patient centric outcome measures need to be considered. • A comprehensive explanation about the intervention is essential for applicability in the clinical setting. • Trial registry insist to follow the CONSORT guidelines thus enabling to report the trial effectively in a more applicable way.

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