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VOLUME 12 , ISSUE 2 ( April-June, 2023 ) > List of Articles

REVIEW ARTICLE

Critical Appraisal of Randomized Controlled Trials: An Overview

Harish M Maheshwarappa, Snehali Majumder

Keywords : Critical Appraisal, Narrative Review, Randomized Control Trials

Citation Information : Maheshwarappa H M, Majumder S. Critical Appraisal of Randomized Controlled Trials: An Overview. Indian J Respir Care 2023; 12 (2):163-168.

DOI: 10.5005/jp-journals-11010-1040

License: CC BY-NC-SA 4.0

Published Online: 30-06-2023

Copyright Statement:  Copyright © 2023; The Author(s).


Abstract

Randomized Control Trials (RCTs) are the major source of information on the efficacy and safety of new and repurposed therapeutic agents and treatments. Therefore, it becomes essential that RCTs are of good quality and free of any biases. In the ever-evolving field of healthcare, making the correct clinical decision is important. Critical appraisal of new medical findings is therefore of utmost importance since clinical judgments are made based on the evidence provided by the publications and trial reports. In this review, we analyze the process of critically appraising RCTs using various researcher-developed guidelines and The Critical Appraisal Skills Programme (CASP) checklist for RCTs.

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  1. Young JM, Solomon MJ. How to critically appraise an article. Nat Clin Pract Gastroenterol Hepatol 2009;6(2):82–91. DOI: 10.1038/ncpgasthep1331
  2. Kudhail K, Thompson J, Mathews V, et al. Randomized controlled trials in patients with covid-19: a systematic review and critical appraisal. Int J Infect 2022;122:72–80. DOI: 10.1016/j.ijid.2022.05.034
  3. Vinkers CH, Lamberink HJ, Tijdink JK, et al. The methodological quality of 176,620 randomized controlled trials published between 1966 and 2018 reveals a positive trend but also an urgent need for improvement. PLoS Biol 2001;19(4):e3001162. DOI: 10.1371/journal.pbio.3001162
  4. Hariton E, Locascio JJ. Randomised controlled trials - the gold standard for effectiveness research: study design: randomised controlled trials. BJOG 2018;125(13):1716. DOI: 10.1111/1471-0528.15199
  5. Randomized Controlled. Trials (RCTs). https://www.unicef-irc.org/KM/IE/impact_7.php
  6. Sackett DL. Evidence-based medicine. Semin Perinatol 1997;21(1):3–5. DOI: 10.1097/00007632-199805150-00001
  7. Guyatt GH, Sackett DL, Cook DJ. Users’ guides to the medical literature. II. How to use an article about therapy or prevention. A. Are the results of the study valid? Evidence-based medicine working group. JAMA 1993;270(21):2598–2601. DOI: 10.1001/jama.270.21.2598
  8. Wang B, Wang H, Tu XM, et al. Comparisons of superiority, non-inferiority, and equivalence trials. Shanghai Arch Psychiatry 2017;29(6):385–388. DOI: 10.11919/j.issn.1002-0829.217163
  9. Kendall JM. Designing a research project: randomised controlled trials and their principles. Emerg Med J 2003;20(2):164–168. DOI: 10.1136/emj.20.2.164
  10. Lai YA, Chen X, Kunasekaran M, et al. Global epidemiology of vaccine-derived poliovirus 2016-2021: a descriptive analysis and retrospective case-control study. EClinicalMedicine 2022;50:101508. DOI: 10.1016/j.eclinm.2022.101508
  11. Chow S. JS and HW. Sample Size Calculations in Clinical ResearchChow, S., JShao and H. Wang; 2003.
  12. Riva JJ, Malik KM, Burnie SJ, et al. What is your research question? An introduction to the picot format for clinicians. J Can Chiropr Assoc 2012;56(3):167–171.
  13. FINER: a research framework | Elsevier Author Services Blog. https://scientific-publishing.webshop.elsevier.com/research-process/finer-research-framework/
  14. Fandino W. Formulating a good research question: pearls and pitfalls. Indian J Anaesth 2019;63(8):611–616. DOI: 10.4103/ija.IJA_198_19
  15. Edgar ABowling, A. 1997. Measuring health; a review of quality of life measurement scales (2nd Ed.). Vol 1. 4TH (2001). Oxford University Press; 1998. doi:10.1023/A:1009999222296
  16. Suresh K, Chandrashekara S. Sample size estimation and power analysis for clinical research studies. J Hum Reprod Sci 2012;5(1):7–13. DOI: 10.4103/0974-1208.97779
  17. Serdar CC, Cihan M, Yücel D, et al. Sample size, power and effect size revisited: simplified and practical approaches in pre-clinical, clinical and laboratory studies. Biochem Med 2021;31(1):10502. DOI: 10.11613/BM.2021.010502
  18. Sessler DI, Myles PS. Novel clinical trial designs to improve the efficiency of research. Anesthesiology 2020;132(1):69–81. DOI 10.1097/ALN.0000000000002989
  19. Banjot K. No integration in India's disease data collection systems: Niti Aayog.
  20. Egger M, von Elm E, Altman DG, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ 2007;335(7624):806–808. DOI: 10.1097/EDE.0b013e3181577511
  21. Moorjani P, Thangaraj K, Patterson N, et al. Genetic evidence for recent population mixture in India. Am J Hum Genet 2013;93(3):422–438. DOI: 10.1016/j.ajhg.2013.07.006
  22. Das AK. Randomised clinical trials in surgery: a look at the ethical and practical issues. Indian J Surg 2011;73(4):245–250. DOI: 10.1007/s12262-011-0307-5
  23. Merriam-Webster.com. http://www.merriam-webster.com/dictionary/bias.
  24. Pannucci CJ, Wilkins EG. Identifying and avoiding bias in research. Plast Reconstr Surg 2010;126(2):619–625. DOI: 10.1097/PRS.0b013e3181de24bc
  25. Schulz KF, Chalmers I, Hayes RJ, et al. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273(5):408–412. DOI: 10.1001/jama.273.5.408
  26. Gerhard T. Bias: considerations for research practice. Am J Health Syst Pharm 2008;65(22):2159–2168. DOI: 10.2146/ajhp070369
  27. Dettori JR. Loss to follow-up. Evid Based Spine Care J 2011;2(1):7–10. DOI: 10.1055/s-0030-1267080
  28. Warschburger P, Kröller K. Loss to follow-up in a randomized controlled trial study for pediatric weight management (EPOC). BMC Pediatr 2016;16(1):184. DOI: 10.1186/s12887-016-0727-2
  29. Haynes RB, Sackett DL, Richardson WS, et al. Evidence-based medicine: how to practice & teach EBM. Can Med Assoc. 2005;157(6):788.
  30. Bamat NA, Ekhaguere OA, Zhang L, et al. Protocol adherence rates in superiority and noninferiority randomized clinical trials published in high impact medical journals. Clin Trials 2020;17(5):552–559. DOI: 10.1177/1740774520941428
  31. Deichmann RE, Krousel-Wood M, Breault J. Bioethics in practice: considerations for stopping a clinical trial early. Ochsner J 2016;16(3):197–198.
  32. Lièvre M, Ménard J, Bruckert E, et al. Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility. BMJ 2001;322(7286):603–605. DOI: 10.1136/bmj.322.7286.603
  33. Fine LJ, Beddhu S, Cheung AK, et al. Final report of a trial of intensive versus standard blood-pressure control. N Engl J Med 2021;384(20):1921–1930. DOI: 10.1056/NEJMoa1901281
  34. Karanicolas PJ, Farrokhyar F, Bhandari M. Practical tips for surgical research: blinding: who, what, when, why, how? Can J Surg 2010;53(5):345–348.
  35. Schulz KF, Grimes DA. Blinding in randomised trials: hiding who got what. Lancet 2002;359(9307):696–700. DOI: 10.1016/S0140-6736(02)07816-9
  36. Noseworthy JH, Ebers GC, Vandervoort MK, et al. The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial. Neurology 1994;44(1):16–20. DOI: 10.1212/wnl.44.1.16
  37. Kennedy-Martin T, Curtis S, Faries D, et al. A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results. Trials 2015;16:495. DOI: 10.1186/s13063-015-1023-4
  38. Spieth PM, Kubasch AS, Penzlin AI, et al. Randomized controlled trials - a matter of design. Neuropsychiatr Dis Treat 2016;12:1341–1349. DOI: 10.2147/NDT.S101938
  39. Clinical. ClinicalTrials.gov Final Rule (42 CFR Part 11) Information.
  40. Sedgwick P. External and internal validity in clinical trials. BMJ 2012;344:e1004. DOI: 10.1136/bmj.e1004
  41. Ghooi RB. The nuremberg code-a critique. Perspect Clin Res 2011;2(2):72–76. DOI: 10.4103/2229-3485.80371
  42. World Medical Association. World medical association declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organ 2001;79(4):373–374. DOI: 10.1007/bf03178503
  43. Mathur R, Swaminathan S. National ethical guidelines for biomedical & health research involving human participants, 2017: a commentary. Indian J Med Res 2018;148(3):279–283. DOI: 10.20529/IJME.2018.065
  44. Yao B, Zhu L, Jiang Q, et al. Safety monitoring in clinical trials. Pharmaceutics 2013;5(1):94–106. DOI: 10.3390/pharmaceutics5010094
  45. Feehan AK, Garcia-Diaz J. Investigator responsibilities in clinical research. Ochsner J 2020;20(1):44–49. DOI: 10.31486/toj.19.0085
  46. The Critical Appraisal Skills Programme. https://casp-uk.net/casp-tools-checklists
  47. Skelly AC, Dettori JR, Brodt ED. Assessing bias: the importance of considering confounding. Evid Based Spine Care J 2012;3(1):9–12. DOI: 10.1055/s-0031-1298595
  48. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996;276(8):637–639. DOI: 10.1001/jama.276.8.637
  49. Díaz I, Colantuoni E, Rosenblum M. Enhanced precision in the analysis of randomized trials with ordinal outcomes. Biometrics 2016;72(2):422–431. DOI: 10.1111/biom.12450
  50. Herbert RD. How to estimate treatment effects from reports of clinical trials. II: dichotomous outcomes. Aust J Physiother 2000;46(4):309–313. DOI: 10.1016/s0004-9514(14)60292-0
  51. Herbert RD. How to estimate treatment effects from reports of clinical trials. I: continuous outcomes. Aust J Physiother. 2000;46(3):229–235. DOI: 10.1016/S0004-9514(14)60334-2
  52. Gardner MJ, Altman DG. Statistics with confidence - confidence Intervals and Statistical Guidelines. Br Med J 1989:20–33.
  53. Benkeser D, Díaz I, Luedtke A, et al. Improving precision and power in randomized trials for COVID-19 treatments using covariate adjustment, for binary, ordinal, and time-to-event outcomes. Biometrics 2021;77(4):1467–1481. DOI: 10.1111/biom.13377
  54. Palmer S, Byford S, Raftery J. Economics notes: types of economic evaluation. BMJ 1999;318(7194):1349. DOI: 10.1136/bmj.318.7194.1349
  55. Balarajan Y, Selvaraj S, Subramanian SV. Health care and equity in India. Lancet 2011;377(9764):505–515. DOI: 10.1016/S0140-6736(10)61894-6
  56. Østengaard L, Lundh A, Tjørnhøj-Thomsen T, et al. Influence and management of conflicts of interest in randomised clinical trials: qualitative interview study. BMJ 2020;371:m3764. DOI: 10.1136/bmj.m3764
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