Type-II Error Rates (Beta Errors) of Randomized Trials in Orthopaedic Trauma

Lochner, Heather V.; Bhandari, Mohit; Tornetta, Paul

doi:10.2106/00004623-200111000-00005

Cited by 110 publications

(70 citation statements)

References 8 publications

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“…Thus, confounding may still pose a major threat to the validity of findings despite best efforts and should be included in the analysis of results. Given the problematic nature of sample sizes in surgical and orthopaedic research, this post hoc quality control becomes even more important [5,8,9]. This can be done either by stratification of the data by suspected variables or by multivariate analysis, usually using regression models.…”

Section: Discussionmentioning

confidence: 99%

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Management of Confounding in Controlled Orthopaedic Trials

Vavken

Culen

Dorotka

2008

Clinical Orthopaedics &Amp; Related Research

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Confounding occurs when the effect of an exposure on an outcome is distorted by a confounding factor and will lead to spurious effect estimates in clinical studies. Although confounding can be minimized at the design stage, residual confounding may remain. An argument therefore can be made for controlling for confounding during data analysis in all studies. We asked whether confounding is considered in controlled trials in orthopaedic research and hypothesized the likelihood of doing so is affected by participation of a scientifically trained individual and associated with the magnitude of the impact factor. We performed a cross-sectional study of all controlled trials published in 2006 in eight orthopaedic journals with a high impact factor. In 126 controlled studies, 20 (15.9%; 95% confidence interval, 9.5%-22.3%) studies discussed confounding without adjusting in the analysis. Thirty-eight (30.2%; 95% confidence interval, 22.2%-38.2%) controlled for confounding, although we suspect the true proportion might be somewhat higher. Participation of a methodologically trained researcher was associated with (odds ratio, 3.85) controlling for confounding, although there was no association between impact factor and controlling for confounding. The question remains to what extent the validity of published findings is affected by failure to control for confounding.

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Section: Discussionmentioning

confidence: 99%

“…Numerous articles and reviews explore the basics of research methodology to provide a sound understanding of proper design and conduct of studies [1,2,5,7,8,11,15]. Associations found in trials, however, may derive from four sources: chance, bias, confounding, or a true effect.…”

Section: Introductionmentioning

confidence: 99%

Management of Confounding in Controlled Orthopaedic Trials

Vavken

Culen

Dorotka

2008

Clinical Orthopaedics &Amp; Related Research

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“…A power calculation indicated a total of less than 20 subjects was required to detect a target difference of less than 50% wear compared with published results of noncross-linked polyethylene (a = 0.05, b = 0.9). A post hoc power calculation [33,52] with 2-year results showed a b value greater than 90% for vertical, 2-D, and 3-D wear. Changes in clinical outcomes scores assessed preoperatively and at 1 year followup were compared using the Wilcoxon's matched pairs signedranks test.…”

Section: Methodsmentioning

confidence: 99%

Second-generation Highly Cross-linked X3™ Polyethylene Wear: A Preliminary Radiostereometric Analysis Study

Campbell

Field

Callary

2010

Clinical Orthopaedics &Amp; Related Research

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Background First-generation highly cross-linked polyethylene liners have reduced the incidence of wear particleinduced osteolysis. However, failed acetabular liners have shown evidence of surface cracking, mechanical failure, and oxidative damage. This has led to the development of second-generation highly cross-linked polyethylene, which has improved wear and mechanical properties and resistance to oxidation in vitro. Owing to its recent introduction, there are no publications describing its clinical performance. Questions/purposes We assessed early clinical wear of a second-generation highly cross-linked polyethylene liner and compared its clinical performance with the published results of hip simulator tests and with first-generation highly cross-linked polyethylene annealed liners. Patients and Methods Twenty-one patients were enrolled in a prospective cohort study. Clinical outcome and femoral head penetration were measured for 19 patients at 6 months and 1 and 2 years postoperatively. Results The median proximal head penetration was 0.009 mm and 0.024 mm at 1 and 2 years, respectively. The median two-dimensional (2-D) head penetration was 0.083 mm and 0.060 mm at 1 and 2 years, respectively. The median proximal wear rate between 1 and 2 years was 0.015 mm/year. Conclusions The wear rate calculated was similar to the in vitro wear rate reported for this material; however, it was less than the detection threshold for this technique. Although longer followup is required for wear to reach a clinically quantifiable level, this low level of wear is encouraging for the future clinical performance of this material.

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“…In the orthopedic literature, evidence often needs to be obtained from randomized controlled trials with small sample sizes (Lochner et al 2001). Metaanalyses provide a useful tool to give doctors upto-date knowledge in order to help them in clinical decision making .…”

mentioning

confidence: 99%

Hamstring tendon autograft better than bone patellartendon bone autograft in ACL reconstruction A cumulative meta-analysis and clinically relevant sensitivity analysis applied to a previously published analysis

2007

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Background Current debate on treatment options for anterior cruciate ligament (ACL) reconstruction complicate the choice between hamstring and bone patellartendon bone autografts. We hypothesized a priori that cumulative meta-analysis (a form of sensitivity analysis) might show that the evidence for reduction of morbidity by hamstring grafts could have been reached at an earlier time. Furthermore, we hypothesized a priori that modern state-of-the-art hamstring graft fixation technique would give similar results regarding stability as bone-patellar tendon-bone autografts.Methods We performed a cumulative meta-analysis and sensitivity analysis based on femoral graft fixation techniques to compare hamstring autograft and bonepatellar tendon-bone autografts in ACL reconstruction derived from a previously published meta-analysis.Results Cumulatively, that hamstring autograft reduces anterior knee pain had already reached statistical significance in 2001 (relative risk 0.49 (95%CI: 0.32-0.76; p = 0.001, I2 = 0%)). The modern endobutton hamstring graft fixation technique (2 studies) yielded similar stability in the Lachman test as bone-patellar tendon-bone grafts, with a relative risk of 1.1 (95%CI: 0.82-1.5; p = 0.6, I2 = 0%). Exclusion of the endobutton group explains the increased laxity in the hamstring graft group.Interpretation Cumulative meta-analysis strengthens the evidence for reduced morbidity using hamstring tendon autograft for anterior cruciate ligament reconstruction. Sensitivity analysis focusing on state-of-the-

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Type-II Error Rates (Beta Errors) of Randomized Trials in Orthopaedic Trauma

Cited by 110 publications

References 8 publications

Management of Confounding in Controlled Orthopaedic Trials

Management of Confounding in Controlled Orthopaedic Trials

Second-generation Highly Cross-linked X3™ Polyethylene Wear: A Preliminary Radiostereometric Analysis Study

Hamstring tendon autograft better than bone patellartendon bone autograft in ACL reconstruction A cumulative meta-analysis and clinically relevant sensitivity analysis applied to a previously published analysis

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