A Systematic Review of Surgical Randomized Controlled Trials

Voineskos, Sophocles H.; Coroneos, Christopher J.; Ziolkowski, Natalia; Kaur, Manraj; Banfield, Laura; Meade, Maureen O.; Thoma, Achilleas; Chung, Kevin C.; Bhandari, Mohit

doi:10.1097/01.prs.0000475766.83901.5b

Cited by 33 publications

(13 citation statements)

References 38 publications

(47 reference statements)

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“…Studies were significantly more likely to have a high risk of bias domain if author conflicts of interest or industry funding were present. These findings are in line with other areas of the literature including orthopedic surgery, ophthalmology, and plastic surgery [14][15][16].…”

Section: Discussionsupporting

confidence: 90%

Assessment of Risk of Bias in Osteosarcoma and Ewing’s Sarcoma Randomized Controlled Trials: A Systematic Review

et al. 2021

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Aim: The aim of this study was to systematically assess the risk of bias in osteosarcoma and Ewing’s sarcoma (ES) randomized controlled trials (RCT) and to examine the relationships between bias and conflict of interest/industry sponsorship. Methods: An OVID-MEDLINE search was performed (1976–2019). Using the Cochrane Collaboration guidelines, two reviewers independently assessed the prevalence of risk of bias in different RCT design domains. The relationship between conflicts of interest and industry funding with the frequency of bias was examined. Results: 73 RCTs met inclusion criteria. Prevalence of low-risk bias domains was 47.3%, unclear-risk domains 47.8%, and 4.9% of the domains had a high-risk of bias. Domains with the highest risk of bias were blinding of participants/personnel and outcome assessors, followed by randomization and allocation concealment. Overtime, frequency of unclear-risk of bias domains decreased (χ2 = 5.32, p = 0.02), whilst low and high-risk domains increased (χ2 = 8.13, p = 0.004). Studies with conflicts of interest and industry sponsorships were 4.2 and 3.1 times more likely to have design domains with a high-risk of bias (p < 0.05). Conclusion: This study demonstrates that sources of potential bias are prevalent in both osteosarcoma and ES RCTs. Studies with financial conflicts of interest and industry sponsors were significantly more likely to have domains with a high-risk of bias. Improvements in reporting and adherence to proper methodology will reduce the risk of bias and improve the validity of the results of RCTs in osteosarcoma and ES.

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Section: Discussionsupporting

confidence: 90%

Assessment of Risk of Bias in Osteosarcoma and Ewing’s Sarcoma Randomized Controlled Trials: A Systematic Review

et al. 2021

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“…It has been reported that few RCTs in a certain surgical field have low RoB [ 4 , 5 ]. Gurusamy et al have reported that blinding is difficult in RCTs of surgical interventions, but that careful RCT design may reduce bias related to lack of blinding of surgeons and surgical staff.…”

Section: Introductionmentioning

confidence: 99%

Adequacy of risk of bias assessment in surgical vs non-surgical trials in Cochrane reviews: a methodological study

Barčot

Borić

Došenović

et al. 2020

BMC Med Res Methodol

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Background Bias in randomized controlled trials (RCTs) can lead to underestimation or overestimation of the true effects of interventions. Surgical RCTs may suffer from the risk of bias (RoB) that is avoidable in trials of other interventions, and vice versa. We aimed to compare the adequacy of RoB assessments in surgical versus non-surgical RCTs included in Cochrane reviews and to assess the most common differences in those RoB assessments. Due to specificities of surgical trials, i.e. difficulties associated with blinding of surgical interventions, we hypothesized that assessments of surgical trials may be more adequate, compared to RCTs of non-surgical interventions. Methods This was a methodological study, analyzing methods of published Cochrane systematic reviews. Data were extracted from RoB tables in Cochrane reviews (judgments and accompanying explanatory comment) for the following four RoB domains used in the 2011 Cochrane RoB tool: randomization, allocation concealment, blinding of participants and personnel, and blinding of outcome assessors. We defined adequate assessments as those that were in line with instructions from the Cochrane Handbook for Systematic Reviews of Interventions. The prevalence of adequate assessments was compared in surgical versus non-surgical trials. The most common differences in both groups of reviews were presented. Results In 729 analyzed Cochrane reviews, there were 10,537 included trials. The prevalence of adequate RoB judgments made by Cochrane authors ranged from 87.9, 95%CI (87.3 to 88.6%) for randomization to 70.7, 95%CI (69.8 to 71.5%) for blinding of participants and personnel. For all analyzed RoB domains, the prevalence of adequate RoB domains was higher in surgical trials than in non-surgical trials. For two RoB domains assessing blinding, this difference between surgical and non-surgical trials was statistically significant (P < 0.001), while the difference was not significant for the RoB domain regarding randomization (P = 0.124) and allocation concealment (P = 0.039, β < 0.8). Conclusions RoB judgments were more in line with instructions from the Cochrane Handbook when Cochrane reviews assessed surgical trials, compared to those that analyzed non-surgical interventions. However, further steps are warranted to scrutinize RoB assessment in trials of both surgical and non-surgical interventions.

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“…Randomization is the best research strategy to reduce bias in clinical research by virtue of its ability to distribute known and unknown confounding variables equally between treatment groups. 2-5 Since their introduction, RCTs have been increasing in quantity and quality, 6 with more than 40,000 RCTs currently being reported annually. 7…”

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confidence: 99%

The Importance of Pragmatic Study Design to the Scholarly Influence of Surgical Hip Fracture Randomized Controlled Trials

et al. 2023

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Background: Surgical randomized controlled trials (RCTs) have potential drawbacks, leading some to question their role in filling the information gap in orthopaedic surgery. Pragmatism in study design was introduced to increase the clinical applicability of study results. The purpose of this study was to examine how pragmatism affects the scholarly influence of surgical RCTs. Methods: A search for surgical hip fracture-related RCTs published between 1995 and 2015 was done. Journal impact factor, citation number, research question, significance and type of outcome, number of centers involved, and the Pragmatic-Explanatory Continuum Indicator Summary-2 level of pragmatism score were recorded for each study. Scholarly influence was estimated by a study's inclusion into orthopaedic literature or guidelines or through the study's average yearly citation rate. Results: One hundred sixty RCTs were included in the final analysis. A multivariate logistic regression identified large study sample size as the only predictor of an RCT being used in clinical guidance texts. Large sample size and multicenter RCTs were predictors of high yearly citation rates. The level of pragmatism in study design did not predict scholarly influence. Conclusions: Pragmatic design is not independently associated with increased scholarly influence; however, large study sample size was the most important study characteristic affecting scholarly influence.T he primary goal of clinical research is to effectively translate clinical evidence into practice. Randomized controlled trials (RCTs) together with RCT-based systematic reviews and meta-analyses are considered the highest level of evidence for therapeutic research. 1,2 Randomization is the best research strategy to reduce bias in clinical research by virtue of its ability to distribute known and unknown confounding

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A Systematic Review of Surgical Randomized Controlled Trials

Cited by 33 publications

References 38 publications

Assessment of Risk of Bias in Osteosarcoma and Ewing’s Sarcoma Randomized Controlled Trials: A Systematic Review

Assessment of Risk of Bias in Osteosarcoma and Ewing’s Sarcoma Randomized Controlled Trials: A Systematic Review

Adequacy of risk of bias assessment in surgical vs non-surgical trials in Cochrane reviews: a methodological study

The Importance of Pragmatic Study Design to the Scholarly Influence of Surgical Hip Fracture Randomized Controlled Trials

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