대한물리치료과학회지 (Journal of Korean Physical Therapy Science)

  • 제30권4호
  • /
  • Pages.82-91
  • /
  • 2023
  • /
  • 2733-6441(pISSN)
  • /
  • 2733-645X(eISSN)
대한물리치료과학회 (Korean Physical Therapy Science)
권호 표지
DOI QR코드

DOI QR Code

한국 물리치료 학술지에 무작위대조연구의 비뚤림 위험 평가: 2018~2022년 검토

TheAssessment of risk of bias in randomized controlled trials published in the Korean Journal of Physical Therapy: A 2018~2022 review

  • 임재현 (남부대학교 대학원 물리치료학과) ;
  • 박치복 (남부대학교 물리치료학과) ;
  • 김병근 (남부대학교 물리치료학과)
  • Jae Hyun Lim (Dept. of Physical Therapy, Graduate School of Nambu University) ;
  • Chi Bok Park (Dept. of Physical Therapy, Nambu University) ;
  • Byeong Geun Kim (Dept. of Physical Therapy, Nambu University)
  • 투고 : 2023.02.26
  • 심사 : 2023.05.23
  • 발행 : 2023.12.31
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

Background: Randomized controlled trials (RCTs) provide evidence on the effectiveness and safety of interventions and inform systematic reviews and guideline preparation for clinical application. However, methodological flaws can occur in many RCTs, and Cochrane's risk of bias version 2 (RoB2) can be used to evaluate RCTs' risk of bias (RoB). However, physical therapy RCTs in Korea did not confirm RoB. Therefore, the purpose of this study was to evaluate RoB using RoB2 in RCTs published in the Korean Physical Therapy Journal. Design: Review. Methods: The RCTs subject to evaluation were RCTs published in 11 physical therapy journals in Korea from 2018 to 2022. RoB2 evaluated a total of five domains: bias arising from the randomization process, bias due to deviations from intended interventions, bias due to missing outcome data, bias in measurement of the outcome, and bias in selection of the reported result. Results: A total of 616 RCTs were evaluated. As for bias arising from the randomization process, high risk was the highest at 555 (90.1%), followed by low risk at 41 (6.7%) and some concerns at 20 (3.2%). For bias due to deviations from intended interventions, the proportion of some concerns was the highest at 390 (63.3%), followed by high risk at 218 (35.4%) and low risk at 8 (1.3%). As for the bias due to missing outcome data, the rate of low risk was the highest at 399 (64.8%), followed by high risk at 159 (25.8%) and some concerns at 58 (9.4%). As for bias in measurement of the outcome, high risk was the highest at 294 (47.7%), followed by low risk at 224 (36.4%) and some concerns at 98 (15.9%). In the bias due to missing outcome data, the ratio of high risk was the highest at 610 (99%), followed by low risk at 4 (0.7%) and some concerns at 2 (0.3%). Conclusion: Most of the RoB evaluation results of RCTs published in the Korean Physical Therapy Journal were rated as high risk. Methodological quality of RCTs needs to be improved.

키워드

참고문헌

  1. 김형근, 하현근, 배영현. 물리치료 기술 개발 방향 정립을 위한 세부 연구 분야 우선순위 도출. 대한물리치료과학회지. 2022;29(1):15-29.
  2. 이윤재, 장보형, 고호연, 등. 한의학 관련 무작위배정비교임상연구의 비뚤림 위험 평가. 대한한방부인과학회지 2011;24(4):105-113. https://doi.org/10.15204/JKOBGY.2011.24.4.105
  3. Angelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Lancet 2004;364(9438):911-912. https://doi.org/10.1016/S0140-6736(04)17034-7
  4. Armijo-Olivo S, Saltaji H, da Costa BR, et al. What is the influence of randomisation sequence generation and allocation concealment on treatment effects of physical therapy trials? A meta-epidemiological study. BMJ Open 2015;5(9):e008562.
  5. Auleley GR, Giraudeau B, Baron G, et al. The methods for handling missing data in clinical trials influence sample size requirements. J Clin Epidemiol 2004;57(5):447-453. https://doi.org/10.1016/j.jclinepi.2003.09.012
  6. Bhide A, Shah PS, Acharya G. A simplified guide to randomized controlled trials. Acta Obstet Gynecol Scand 2018;97(4):380-387. https://doi.org/10.1111/aogs.13309
  7. Cho Y, Kim C, Kang B. Risk of bias assessment of randomised controlled trials referenced in the 2015 American Heart Association guidelines update for cardiopulmonary resuscitation and emergency cardiovascular care: a cross-sectional review. BMJ Open 2019;9(5):e023725.
  8. Dechartres A, Trinquart L, Atal I, et al. Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study. BMJ 2017;357:j2490.
  9. Endres S, Badura A. Shield kyphoplasty through a unipedicular approach compared to vertebroplasty and balloon kyphoplasty in osteoporotic thoracolumbar fracture: a prospective randomized study. Orthop Traumatol Surg Res 2012;98(3):334-340. https://doi.org/10.1016/j.otsr.2011.11.010
  10. Gardenier JS, Resnik DB. The misuse of statistics: concepts, tools, and a research agenda. Account Res 2002;9(2):65-74. https://doi.org/10.1080/08989620212968
  11. Hariton E, Locascio JJ. Randomised controlled trials - the gold standard for effectiveness research: Study design: randomised controlled trials. BJOG 2018;125(13):1716.
  12. Hrobjartsson A, Thomsen AS, Emanuelsson F, et al. Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors. BMJ 2012;344:e1119.
  13. Hrobjartsson A, Thomsen AS, Emanuelsson F, et al. Observer bias in randomized clinical trials with measurement scale outcomes: a systematic review of trials with both blinded and nonblinded assessors. CMAJ 2013;185(4):E201-E211. https://doi.org/10.1503/cmaj.120744
  14. Kahan BC, Rehal S, Cro S. Blinded Outcome Assessment Was Infrequently Used and Poorly Reported in Open Trials. PLoS One 2015;10(6):e0131926.
  15. Macleod MR, Michie S, Roberts I, et al. Biomedical research: increasing value, reducing waste. Lancet 2014;383(9912):101-104.
  16. Moseley AM, Rahman P, Wells GA, et al. Agreement between the Cochrane risk of bias tool and Physiotherapy Evidence Database (PEDro) scale: A meta-epidemiological study of randomized controlled trials of physical therapy interventions. PLoS One 2019;14(9):e0222770.
  17. Scott A, Rucklidge JJ, Mulder RT. Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration. PLos One 2015;10(8):e0133718.
  18. Simundic AM. Bias in research. Biochem Med (Zagreb) 2013;23(1):12-15. https://doi.org/10.11613/BM.2013.003
  19. Sterne JAC, Savovic J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 2019;366:l4898.
  20. 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 2021;19(4):e3001162.