The Robustness of Trials That Guide Evidence-Based Orthopaedic Surgery

Checketts, Jake X.; Scott, Jared; Meyer, Chase; Horn, Jarryd; Jones, Jaclyn; Vassar, Matt

doi:10.2106/jbjs.17.01039

Cited by 57 publications

(45 citation statements)

References 82 publications

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“…Two investigators (SJ and HW) screened all studies for eligibility in an independent, blinded fashion which is consistent with our previous investigations 12–14. We used Rayyan, an online systematic review application, to screen PubMed records for eligibility with the blinding feature turned on.…”

Section: Methodsmentioning

confidence: 93%

Using the CONSORT statement to evaluate the completeness of reporting of addiction randomised trials: a cross-sectional review

et al. 2019

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ObjectivesEvaluate the completeness of reporting of addiction randomised controlled trials (RCTs) using the Consolidated Standards of Reporting Trials (CONSORT) statement.SettingNot applicable.ParticipantsRCTs identified using a PubMed search of 15 addiction journals and a 5-year cross-section.Outcome measuresCompleteness of reporting.ResultsOur analysis of 394 addiction RCTs found that the mean number of CONSORT items reported was 19.2 (SD 5.2), out of a possible 31. Twelve items were reported in <50% of RCTs; similarly, 12 items were reported in >75% of RCTs. Journal endorsement of CONSORT was found to improve the number of CONSORT items reported.ConclusionsPoor reporting quality may prohibit readers from critically appraising the methodological quality of addiction trials. We recommend journal endorsement of CONSORT since our study and those previous have shown that CONSORT endorsement improves the quality of reporting.

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Section: Methodsmentioning

confidence: 93%

Using the CONSORT statement to evaluate the completeness of reporting of addiction randomised trials: a cross-sectional review

et al. 2019

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“… Proportion of randomized controlled trials (RCTs) with a fragility index ≤3 and a fragility index ≤ loss to follow-up by different medical and surgical disciplines. 2 , 4 - 8 …”

Section: Is There An “Acceptable” Fragility Index?mentioning

confidence: 99%

How Fragile Are the Results of a Trial? The Fragility Index

Dettori

Norvell

2020

Global Spine Journal

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“…First, only 7/19 fracture types had been scrutinized in at least 2 trials with at least 100 patients totally. Second, few and underpowered studies for some fracture types might be part of the explanation for our findings [82], as a previous study found a mean overall study power (1-beta) among 117 trials of traumatic skeletal fractures of 25% [83]. Third, none of the included trials were associated with a low risk of bias for benefits, and only 2/44 (5%) trials were associated with a low risk of bias for SAEs, confirming a previous study summarizing orthopedic trials [82].…”

Section: Discussionmentioning

confidence: 91%

Surgical or non-surgical treatment of traumatic skeletal fractures in adults: systematic review and meta-analysis of benefits and harms

et al. 2020

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Background: A comprehensive overview of treatments of common fractures is missing, although it would be important for shared decision-making in clinical practice. The aim was to determine benefits and harms of surgical compared to non-surgical treatments for traumatic skeletal fractures. Methods: We searched Medline, Embase, CINAHL, Web of Science, and CENTRAL until November 2018, for randomized trials of surgical treatment in comparison with or in addition to non-surgical treatment of fractures in adults. For harms, only trials with patient enrollment in 2000 or later were included, while no time restriction was applied to benefits. Two reviewers independently assessed studies for inclusion, extracted data from full-text trials, and performed risk of bias assessment. Outcomes were self-reported pain, function, and quality of life, and serious adverse events (SAEs). Random effects model (Hedges' g) was used. Results: Out of 28375 records screened, we included 61 trials and performed meta-analysis on 12 fracture types in 11 sites: calcaneus, clavicula, femur, humerus, malleolus, metacarpus, metatarsus, radius, rib, scaphoideum, and thoraco-lumbar spine. Seven other fracture types only had one trial available. For distal radius fractures, the standardized mean difference (SMD) was 0.31 (95% CI 0.10 to 0.53, n = 378 participants) for function, favoring surgery, however, with greater risk of SAEs (RR = 3.10 (1.42 to 6.77), n = 436). For displaced intra-articular calcaneus fractures, SMD was 0.64 (0.13 to 1.16) for function (n = 244) and 0.19 (0.01 to 0.36) for quality of life (n = 506) favoring surgery. Surgery was associated with a smaller risk of SAE than non-surgical treatment for displaced midshaft clavicular fractures (RR = 0.62 (0.42 to 0.92), n = 1394). None of the other comparisons showed statistical significance differences and insufficient data existed for most of the common fracture types.

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The Robustness of Trials That Guide Evidence-Based Orthopaedic Surgery

Abstract: Our study found that trials that provided strong evidence for orthopaedic surgery guidelines were largely fragile, underpowered, and at risk of bias.

Cited by 57 publications

References 82 publications

Using the CONSORT statement to evaluate the completeness of reporting of addiction randomised trials: a cross-sectional review

Using the CONSORT statement to evaluate the completeness of reporting of addiction randomised trials: a cross-sectional review

How Fragile Are the Results of a Trial? The Fragility Index

Surgical or non-surgical treatment of traumatic skeletal fractures in adults: systematic review and meta-analysis of benefits and harms

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