Search

Results produced from randomized controlled trials (RCTs) help guide clinical decision making and health policy. Therefore, it is essential that RCT outcomes- including harms (eg, adverse events)-are adequately reported such that clinicians, patients, and policy makers are equipped with all necessary information to complete risk-benefit assessment of the RCT's intervention. Here, we evaluated the quality of reporting of harms (eg, adverse events) in RCTs cited as supporting evidence for recommendations in the American Academy of Orthopaedic Surgeons (AAOS) Management of Rotator Cuff Injuries clinical practice guidelines (CPGs) using the Consolidated Standards of Reporting Trials (CONSORT) Extension for Harms Checklist.To quantify adherence to CONSORT Extension for Harms items, each RCT was screened for pertinent information satisfying each checklist item. Screening of CPG reference sections for RCTs underpinning CPG recommendations, as well as data extraction from each of the included RCTs, was performed in a blind and duplicate manner. Descriptive statistics-including frequencies, percentages, and 95% confidence intervals-were used to summarize overall percent adherence to checklist items. A linear regression model assessed the relationship of CONSORT Harms reporting over time.Ninety-nine RCTs were included in our final sample. Fifty-seven RCTs (of 99; 57.6%) were conducted at a single center. Common funding sources included private (nonindustry) (17/99; 17.2%), private (industry) (8/99; 8.1%), and public (7/99; 7.1%) sources. Sample size for each trial most often consisted of50 participants (29/99; 29.3%) or 51-100 participants (50/99; 50.5%). The average number of CONSORT Extension for Harms items adequately reported across all included RCTs was 5.7 (of 18; 31.7%). None of the included trials reported all 18 items. Twenty-six RCTs (of 99; 26.3%) adequately reported ≥50% of eligible checklist items. Fifty-nine RCTs (of 99; 59.6%) adequately reported ≤33% of eligible checklist items. Items with ≥50% adherence included item 2, item 7a, and item 8a. Items with ≤20% adherence included item 3b, item 4d, and item 5. Results from our linear regression demonstrated a slight, yet nonsignificant, improvement in adherence to the Harms Extension over time (ROur results illustrate the poor state of harms reporting within RCTs cited as supporting evidence for the AAOS Management of Rotator Cuff Injuries CPG. Efforts to address these gaps in reporting are warranted, as complete knowledge of potential harms is critical to patients, clinicians, and health policy makers when determining best practice decisions in orthopedic surgery.

Context: Clinical practice guidelines (CPGs) are vital to establishing a standardized and evidence-based approach in medicine. These guidelines rely on the use of methodologically sound clinical trials, and the subsequent reporting of their methodology. Objective: To evaluate the completeness of randomized controlled trials (RCTs) underpinning CPGs published by the American Academy of Orthopedic Surgeons (AAOS) for management of osteoarthritis of the knee. Data Sources: We searched the most recent AAOS CPGs for surgical and nonsurgical management of osteoarthritis of the knee for RCTs. To estimate the necessary sample size, we performed a power analysis using OpenEpi 3.0 ( openepi.com ). Study Selection: Two authors independently screened the reference sections of the included CPGs. Included studies met the definition of an RCT, were retrievable in the English language, and were cited in at least one of the included CPGs. Study Design: Meta-Analysis Level of Evidence: Level 1a Data Extraction: We performed double-blind screening and extraction of RCTs included in the AAOS CPGs. We evaluated each RCT for adherence to the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist. A multiple regression analysis was conducted to assess CONSORT adherence against characteristics of included studies (ie, type of intervention, funding source, etc). Results: Our study included 179 RCTs. The overall adherence was 68.5% with significant differences between those published before and since the development of the 2010 CONSORT guidelines ( P = 0.02). We found that RCTs receiving funding from industry/private sources as well as studies that included a conflict of interest statement showed more completeness than RCTs that reported receiving no funding ( P < 0.01). Conclusion: We found suboptimal CONSORT adherence for RCTs cited in AAOS CGPs for management of osteoarthritis of the knee. Therefore, the CPGs are likely supported by outdated evidence and lack of high-quality reporting. It is important that evidence used to guide clinical decision making be of the highest quality in order to optimize patient outcomes. In order for clinicians to confer the greatest benefits to their patients, CPGs should provide the totality of evidence and emphasize emerging high-quality RCTs to ensure up-to-date, evidence-based clinical decision-making.

Purpose To our knowledge, no study has quantified the rate of discontinuation and nonpublication of randomized controlled trials (RCTs) regarding upper and lower extremity fractures. Methods We searched ClinicalTrials.gov on September 9th, 2020, for phase 3 and 4 RCTs pertaining to upper and lower extremity fractures. Trial completion status was determined using records available on ClinicalTrials.gov. Publication status was determined using records on ClinicalTrials.gov and by searching PubMed (MEDLINE), Embase, and Google Scholar. We queried corresponding authors on trial status if a peer-reviewed publication was not identified. Results Our final analysis included 142 RCTs, of which 57 (40.1%) were discontinued and 71 (50%) were unpublished. Thirty-six (of 57, 63.2%) discontinued trials failed to provide a reason for discontinuation, the most commonly identified reason for discontinuation was due to inadequate recruitment (13/21, 61.9%). Completed trials were more likely to reach publication (59/85; 69.4%; X2 = 32.92; P ≤ 0.001) than discontinued trials. Trials with more than 80 participants were less likely not to reach publication (AOR: 0.12; 95% CI 0.15–0.66). Conclusion Our analysis of 142 upper and lower extremity fracture RCTs demonstrated one-half failed to reach publication and two-fifths were discontinued prior to trial completion. These findings indicate the need for increased guidance in developing, completing, and publishing RCTs in upper and lower extremity fractures. Discontinuation and nonpublication of orthopaedic RCTs hinder the public’s access to collected data and negate the valued contribution from study participants. Discontinuation and non-publication of clinical trials may subject participants to potentially harmful interventions, limit the advancement of clinical research, and contribute to research waste. Level of Evidence: III.

BACKGROUND Randomized control trials (RCTs) serve as evidentiary support for recommendations underpinning clinical practice guidelines (CPGs) with the goal of optimizing patient care. A knowledge gap exists within scientific literature when evaluating the quality of RCTs used as evidence in the American Academy of Orthopaedic Surgery (AAOS) pediatric CPGs. We aim to evaluate the reporting quality and risk of bias in RCTs underlying AAOS Pediatric CPG recommendations. METHODS We located all AAOS Pediatric CPGs. We then extracted all RCTs from the CPG reference sections. All included RCTs were evaluated using the Consolidated Standards of Reporting Trials (CONSORT) checklist and Cochrane Collaboration risk of bias assessment tool (RoB 2.0). Descriptive statistics were recorded, and bivariate analysis was used to account for variance in CONSORT scores. A Mann-Whitney U test was completed to compare CONSORT studies published before and after 2010. RESULTS Three CPGs and 23 RCTs met inclusion criteria. Mean CONSORT adherence was 69.8% (21.6/31). The lowest adhered to CONSORT items were 10, 23, and 24, while items 2a, 13a, and 18 displayed the highest adherence. Ten RCTs (43.5%, 10/23) had "low" risk of bias, 5 RCTs (21.7%, 5/23) were of "some concerns," and 8 RCTs (34.8%, 8/23) received a "high" designation for risk of bias. There were no statistically significant associations in the bivariate regression analysis or Mann-Whitney U test. CONCLUSIONS Our results suggest that CONSORT adherence within RCTs used as evidence in AAOS Pediatric CPGs is substandard-relying on evidence that, in some cases, is >20 years old. Many of the RCTs cited as supporting evidence have a "high" risk of bias. Altogether, these CPGs may need to be updated or expanded to include more recent evidence relevant to pediatric orthopaedic surgery.

Background Thus, the purpose of the present study was to (1) characterize common postoperative complications and (2) quantify the rates of revision in patients undergoing hemiarthroplasty to reverse total shoulder arthroplasty revisional surgery. We hypothesize that hardware loosenings will be the most common complication to occur in the sample, with the humeral component being the most common loosening. Methods This systematic review adhered to PRISMA reporting guideline. For our inclusion criteria, we included any study that contained intraoperative and/or postoperative complication data, and revision rates on patients who had undergone revision reverse total shoulder arthroplasty due to a failed hemiarthroplasty. Complications include neurologic injury, deep surgical site infections, hardware loosening/prosthetic instability, and postoperative fractures (acromion, glenoid, and humeral fractures). Results The study contained 22 studies that assessed complications from shoulders that had revision reverse total shoulder arthroplasty from a hemiarthroplasty, with a total sample of 925 shoulders. We found that the most common complication to occur was hardware loosenings (5.3%), and of the hardware loosenings, humeral loosenings (3.8%) were the most common. The revision rate was found to be 10.7%. Conclusion This systematic review found that revision reverse total shoulder arthroplasty for failed hemiarthroplasty has a high overall complication and reintervention rates, specifically for hardware loosening and revision rates.

Purpose Outcomes of randomized controlled trials (RCTs) have been shown to influence clinical decision making. Thus, the quality and reliability of these outcomes are essential for both patients and medical care providers. To date, no study has assessed the quality of intervention reporting of RCTs in orthopaedics. The aim of this study was to evaluate the quality of intervention reporting of published RCTs in the field of orthopaedics using the Template for Intervention Description and Replication (TIDieR) checklist. Methods In this cross-sectional analysis, we applied the TIDieR checklist to assess the quality of intervention reporting in orthopaedic RCTs. Additionally, we evaluated the TIDieR checklist’s influence on intervention reporting by comparing overall adherence to checklist items in trials published before the TIDieR checklist’s release versus trials published after its release. Finally, we assessed whether certain factors were associated with the quality of intervention reporting. Results From a random sample of 300 publications in orthopaedic journals, 175 parallel-arm and cluster RCTs were identified. The overall rate of adherence to TIDieR items was 58.4%. Only 31.4% of orthopaedic RCTs adhered to at least 6 of the 12 TIDieR checklist items, whereas 0% adhered to all 12 items. We found no significant improvement in the quality of intervention reporting in studies published after the TIDieR checklist’s release compared with studies published before its release (P = .97). Additionally, preregistered trials were associated with more complete intervention reporting. Conclusions Our results suggest suboptimal reporting of orthopaedic RCT interventions. In addition, the TIDieR checklist’s intended effect—to better the quality of RCT intervention reporting—appears to have fallen short of its goal. Clinical Relevance Because outcomes of RCTs are used to guide clinical decision making, it is essential that orthopaedic surgeons and clinical practice guideline panels are equipped with high-quality published research. Increasing the accuracy of intervention reporting may lead to more accurate clinical application. Thus, adoption of more stringent reporting of trial interventions by researchers, authors, and journal editors may improve the quality of orthopaedic research, as well as improve patient outcomes.

Purpose To determine how changing the P value threshold of statistical significance from .05 to .005 could affect the statistical significance of findings in previously published orthopaedic sports medicine randomized controlled trials (RCTs). Methods The authors searched PubMed from January 1, 2016, to December 31, 2017, for RCTs published in the American Journal of Sports Medicine, Arthroscopy, and Knee Surgery, Sports Traumatology, Arthroscopy. Data were extracted blinded and in duplicate fashion by 2 of us. The authors then extracted P value data for primary end points, since RCTs are most often powered for these end points. Discrepancies were resolved by consensus. Google Forms were used for data extraction and STATA 15.1 for the data analysis. Results In total, 275 primary end points were identified from 132 trials. Analysis of primary end points found 45.8% (126/275) had a P value less than .05 and were classified as statistically significant under the current threshold, whereas 54.2% (149/275) had a P value greater than .05 and were not classified as suggestive. Of those end points that were previously considered statistically significant, 38.9% (49/126) were less than .005, whereas 61.1% (77/126) were between .005 and .05 and thereby would be reclassified as suggestive rather than statistically significant under the proposed threshold. Overall, when analyzing the 275 primary end points, we found only 49 (17.8%) of the end points were less than .005 and would hold statistical significance with the proposed threshold. Conclusions The results suggest that if the threshold of statistical significance were to change to .005, the significance of orthopaedic sports medicine RCTs would be heavily altered. The authors also acknowledge the many issues research faces in regard to P value reliability and therefore interpretation of study results. Because P values from RCTs can often influence the ways physicians choose interventions, it is important to implement methodology that decreases incidence of bias and misrepresentation of these results. However, the authors also understand that lowering the P value could increase the needed sample size and by consequence increase study costs as well, while not directly correlating to clinical significance. Thus, the authors recommend that this proposed threshold should be further evaluated and cautiously interpreted. Clinical Relevance If the statistical significance threshold is changed, clinical practice guideline recommendations also may be affected.

Randomized controlled trials (RCTs) have been shown to influence clinical decision-making and health policy. Therefore, it is essential that trial outcomes-including harms-are completely reported.We included all RCTs cited as supporting evidence for the American Academy of Orthopaedic Surgeons Surgical Management of Osteoarthritis of the Knee, Osteoarthritis of the Knee, and Osteoarthritis of theHip Clinical Practice Guideline recommendations. Manuscripts were analyzed for compliance with the Consolidated Standards of Reporting Trials (CONSORT) Extension for Harms items. We determined the Extension for Harms' influence on harms reporting by comparing RCTs published before and after the extension's release.One hundred and seventy-three RCTs were included, of which 81 (47%) adequately reported ≥50% of the checklist and 75 (43%) reported ≤33% of the checklist items. The mean number of checklist items reported was 8 items (of 18; 45%). Our interrupted time-series analysis suggests the implementation of the CONSORT Extension for Harms did not have a statistically significant effect on the completeness of harms reporting (P = .35; 95% Confidence interval = -0.0041 to 0.0014).Harms-related data are poorly reported within RCTs cited as supporting evidence for the American Academy of Orthopaedic Surgeons management for hip and knee OA Clinical Practice Guideline. Our time series analysis illustrates the failure of the CONSORT Extension for Harms on improving the reporting of harms-related data. Future efforts to improve the quality of harms reporting is crucial for patients, clinicians, and policy makers to perform thorough risk-benefit appraisals as RCT results directly influence clinical decision-making in orthopaedic surgery.

Background Results from systematic reviews and meta-analyses, which have the highest level of evidence (Level I), often drive clinical decision-making and health policy. Often, unpublished trial data are omitted from systematic reviews, raising concerns about the extent of the reliability and validity of results that have been drawn from systematic reviews. We aimed to determine the extent to which systematic review authors include searches of clinical trial registries for unpublished data when conducting systematic reviews in orthopaedic surgery. Methods Systematic reviews and/or meta-analyses were gathered from the top 5 orthopaedic surgery journals based on the h5-index from Google Scholar Metrics. Systematic reviews that had been published in the Cochrane Database of Systematic Reviews, which requires the inclusion of a clinical trial registry search, served as controls. For the primary outcome, each systematic review from the top 5 orthopaedic journals was screened to determine whether the authors of each study searched for unpublished data in clinical trial registries. We then compared the rate of registry searches with those in the control group. For the secondary analysis, a search of ClinicalTrials.gov was performed for unpublished trial data for 100 randomized systematic reviews. Results All 38 of the Cochrane systematic reviews (100%) included clinical trial registry searches, while the top 5 orthopaedic journals had only 31 of 480 studies (6.5%) that looked at clinical trial registries. The secondary analysis yielded 59 of 100 systematic review articles (59.0%) that could have included unpublished clinical trial data from ≥1 studies to their sample. Conclusions Systematic reviews that have been published in the top orthopaedic surgery journals seldom included a search for unpublished clinical trial data. Clinical relevance The exclusion of clinical trial registry searches potentially contributes to publication bias within the orthopaedic literature. Moving forward, systematic review authors should include clinical trial registry searches for unpublished clinical trial data to provide the most accurate representation of the available evidence for systematic reviews and meta-analyses.