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Erschienen in: Journal of Clinical Monitoring and Computing 1/2023

26.04.2022 | Original Research

Risk of bias for randomized controlled trials in Journal of Clinical Monitoring and Computing

verfasst von: Jeong Min Sung, Ji Yoon Kim, Bo Seok Kwon, Kyu Nam Kim, M.D., Ph.D.

Erschienen in: Journal of Clinical Monitoring and Computing | Ausgabe 1/2023

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Abstract

Purpose

Well-designed randomized controlled trials (RCTs) are considered to represent a high level of evidence and influence medical decision-making in evidence-based medicine. When biases occur in study design, processing, and reporting of RCTs, however, it is difficult to interpret results and judge the impact of interventions. Accordingly, we evaluate the quality of RCT reporting published in the Journal of Clinical Monitoring and Computing (JCMC) using three assessment tools.

Methods

Reporting quality of RCTs published in the JCMC was evaluated through December 31, 2020, using Jadad and van Tulder scales and the Cochrane Collaboration’s risk of bias tool (CCRBT). Stepwise regression analysis was performed to identify factors associated with reporting quality.

Results

Database searches confirmed 132 RCTs in 1,507 original articles. The numbers of RCTs meeting criteria for high reporting quality were 97 (73.5%) using the Jadad scale, 99 (75.0%) using the van Tulder scale, and 19 (14.4%) with the CCRBT. Jadad scores [median score (interquartile range) = 3.0 (2.0–5.0), coefficients (95% CI) = 0.08 (0.04, 0.11), p < 0.001], van Tulder scores [median score (interquartile range) = 7.0 (5.0–8.75), coefficients (95% CI) = 0.15 (0.11, 0.20), p < 0.001], and CCRBT assessment [coefficients (95% CI) = 0.04 (0.02, 0.06), p < 0.001] increased significantly with publication year. The median score (interquartile range) of the last 5 years were 4.0 (3.0–5.0) in Jadad scores, and 8.0 (6.0–9.0) in van Tulder scores. Only 33.3% and 37.1% of articles described detailed blinding and allocation methods, respectively.

Conclusions

Reporting quality increased over time, with consistently high reporting quality in recently published JCMC RCTs.
Literatur
4.
Zurück zum Zitat Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ (Clinical research ed). 2008;336(7644):601–5. doi:https://doi.org/10.1136/bmj.39465.451748.AD.CrossRef Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ (Clinical research ed). 2008;336(7644):601–5. doi:https://​doi.​org/​10.​1136/​bmj.​39465.​451748.​AD.CrossRef
7.
Zurück zum Zitat Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ (Clinical research ed). 2010;340:c869. doi:https://doi.org/10.1136/bmj.c869.CrossRef Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ (Clinical research ed). 2010;340:c869. doi:https://​doi.​org/​10.​1136/​bmj.​c869.CrossRef
8.
Zurück zum Zitat Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet (London England). 2001;357(9263):1191–4.CrossRef Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet (London England). 2001;357(9263):1191–4.CrossRef
13.
Zurück zum Zitat Higgins JPT, Green S. (2011) Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration. 2011. Higgins JPT, Green S. (2011) Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration. 2011.
19.
Zurück zum Zitat Cho HJ, Chung JH, Jo JK, Kang DH, Cho JM, Yoo TK, Lee SW. Assessments of the quality of randomized controlled trials published in International Journal of Urology from 1994 to 2011. Int J urology: official J Japanese Urol Association. 2013;20(12):1212–9. doi:https://doi.org/10.1111/iju.12150.CrossRef Cho HJ, Chung JH, Jo JK, Kang DH, Cho JM, Yoo TK, Lee SW. Assessments of the quality of randomized controlled trials published in International Journal of Urology from 1994 to 2011. Int J urology: official J Japanese Urol Association. 2013;20(12):1212–9. doi:https://​doi.​org/​10.​1111/​iju.​12150.CrossRef
23.
Zurück zum Zitat Bridoux V, Moutel G, Roman H, Kianifard B, Michot F, Herve C, Tuech JJ. Methodological and ethical quality of randomized controlled clinical trials in gastrointestinal surgery. J Gastrointest surgery: official J Soc Surg Aliment Tract. 2012;16(9):1758–67. doi:https://doi.org/10.1007/s11605-012-1952-0.CrossRef Bridoux V, Moutel G, Roman H, Kianifard B, Michot F, Herve C, Tuech JJ. Methodological and ethical quality of randomized controlled clinical trials in gastrointestinal surgery. J Gastrointest surgery: official J Soc Surg Aliment Tract. 2012;16(9):1758–67. doi:https://​doi.​org/​10.​1007/​s11605-012-1952-0.CrossRef
24.
Zurück zum Zitat Soares HP, Daniels S, Kumar A, Clarke M, Scott C, Swann S, Djulbegovic B. Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group. BMJ (Clinical research ed). 2004;328(7430):22–4. doi:https://doi.org/10.1136/bmj.328.7430.22.CrossRef Soares HP, Daniels S, Kumar A, Clarke M, Scott C, Swann S, Djulbegovic B. Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group. BMJ (Clinical research ed). 2004;328(7430):22–4. doi:https://​doi.​org/​10.​1136/​bmj.​328.​7430.​22.CrossRef
Metadaten
Titel
Risk of bias for randomized controlled trials in Journal of Clinical Monitoring and Computing
verfasst von
Jeong Min Sung
Ji Yoon Kim
Bo Seok Kwon
Kyu Nam Kim, M.D., Ph.D.
Publikationsdatum
26.04.2022
Verlag
Springer Netherlands
Erschienen in
Journal of Clinical Monitoring and Computing / Ausgabe 1/2023
Print ISSN: 1387-1307
Elektronische ISSN: 1573-2614
DOI
https://doi.org/10.1007/s10877-022-00864-8

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