Rates of discontinuation and non-publication of upper and lower extremity fracture clinical trials.

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 RESULTS: Our final analysis included 142 RCTs, of which 57 (40.1%) were discontinued and 71 (50%) were unpublished.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.

Analysis of the Evidence Underpinning the American Academy of Orthopedic Surgeons Knee Osteoarthritis Clinical Practice Guidelines.

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.

Complication and revision rates after reverse total shoulder revision from hemiarthroplasty: a systematic review.

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.

An Analysis of the Evidence Underpinning the American Academy Orthopaedic Surgery Pediatrics Clinical Practice Guidelines.

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.

Evaluation of spin in the abstracts of systematic reviews and meta-analyses related to the treatment of proximal humerus fractures.

BACKGROUND: Research has shown that many physicians rely solely on abstracts to make clinical decisions. However, many abstracts have been shown to be misleading. The primary objective of this study was to identify the prevalence of spin - bias towards particular results - within the abstracts of systematic reviews and meta-analyses pertaining to the treatment of proximal humerus fractures, one of the most common osteoporotic fractures among elderly patients. METHODS: We systematically searched MEDLINE and Embase databases to identify systematic reviews and meta-analyses examining the treatment of proximal humerus fractures. Screening and data extraction occurred in a masked, duplicate fashion. The nine most severe types of spin that occur within abstracts were extracted along with study characteristics, including journal recommendations to adhere to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and year in which the review was performed, to identify potential associations. We subsequently explored the association between spin and the methodological quality of a systematic review using the revised A MeaSurement Tool to Assess systematic Reviews (AMSTAR 2) appraisal instrument. RESULTS: Our search retrieved 505 articles, of which 73 systematic reviews met inclusion criteria. We found that 34.2% (25/73) of the included systematic reviews contained spin. Spin type 3 (selective reporting of or overemphasis on efficacy outcomes or analysis favoring the beneficial effect of the experimental intervention) was the most common type identified (12/73, 16.4%). Three spin types were not identified in any of the abstracts. Spin was 3.2 (OR 3.2; 95% CI, 1.02-10.02) times more likely to be present in systematic reviews published in journals recommending adherence to PRISMA. Furthermore, the odds of an abstract containing spin was 1.25 (OR 1.25; 95% CI, 1.02-1.52) times more likely to be present in systematic reviews for each year after 2000. No other study characteristics were associated with spin. The methodological quality of 24 studies were rated as "critically low" (32.9%), 14 were "low" (19.2%), 28 were "moderate" (38.4%), and 7 were "high" (9.6%), but these findings were not associated with spin. CONCLUSION: Spin was present in systematic review abstracts regarding treatment of proximal humerus fractures. Measures such as education on the subject of spin and improved reporting standards should be implemented to increase awareness and reduce incidence of spin in abstracts. LEVEL OF EVIDENCE OF THE STUDY PERFORMED: Basic Science Study; Research Methodology.

Evaluation of Spin in the Abstracts of Systematic Reviews and Meta-analyses Covering Treatments for Achilles Tendon Ruptures.

BACKGROUND: Approximately 18 in every 100 000 people have experienced a ruptured Achilles tendon. Despite the prevalence of this condition, treatment options remain contested. HYPOTHESIS/PURPOSE: The objective of this study was to evaluate the use of spin-reporting practices that may exaggerate benefit or minimize harm-in abstracts of systematic reviews related to Achilles tendon repair. We also evaluated whether particular study characteristics were associated with spin. STUDY DESIGN: Cross-sectional. METHODS: We developed a search strategy for Ovid MEDLINE and Ovid Embase for systematic reviews focused on Achilles tendon treatment. Following title and abstract screening of these search returns, these reviews were evaluated for spin (according to a previously developed classification scheme) and received AMSTAR-2 (A Measurement Tool to Assess Systematic Reviews-2) appraisals by 2 investigators in a masked, duplicate manner. Study characteristics for each review were also extracted in duplicate. RESULTS: Our systematic search returned 251 articles of which 43 systematic reviews and meta-analyses were eligible for data extraction. We found that 65.1% of included studies contained spin (28/43). Spin type 3 was the most common type, occurring in 53.5% (23/43) of abstracts. Spin types 5, 6, 1, and 4 occurred in 16.3% (7/43), 9.3% (4/43), 7% (3/43), and 5.3% (1/43), respectively. Spin types 2, 7, 8, and 9 did not occur. AMSTAR-2 appraised 32.6% (14/43) of the studies as "moderate" quality, 32.6% (14/43) as "low" quality, and 34.9% (15/43) as "critically low" quality. No systematic reviews were rated as "high" quality. There was no significant association between the presence of spin and the following study characteristics: intervention type, article discussing Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) adherence, journal recommending PRISMA adherence, funding sources, journal 5-year impact factor, year the review was received for publication, or AMSTAR-2 critical appraisals. CONCLUSION: Spin was present in abstracts of systematic reviews and meta-analyses-covering Achilles tendon tear treatment. Steps should be taken to improve the reporting quality of abstracts on Achilles tendon treatment as well as other common orthopedic conditions. CLINICAL RELEVANCE: In order to avoid negative patient outcomes, articles should be free of spin within the abstract.

An Evaluation of Reporting Guidelines and Clinical Trial Registry Requirements Among Orthopaedic Surgery Journals.

BACKGROUND: The responsibility for ensuring that studies are adequately reported is primarily that of those conducting the study; however, journal policies may influence how thoroughly authors choose to report their research. The use of reporting guidelines and prospective trial registration are promising avenues for ensuring that published studies adhere to the highest methodological standards. The purpose of this study is to evaluate orthopaedic surgery journal policies regarding reporting guidelines and trial registration, and to evaluate the effects that these policies have on adherence to reporting. METHODS: We conducted a cross-sectional survey of journal policies and "Instructions for Authors" to determine the journals' policies and guidance regarding use of reporting guidelines and study registration. We also examined whether trials published in journals referencing CONSORT (Consolidated Standards of Reporting Trials) had higher rates of compliance with publishing a CONSORT flow diagram and whether journals with trial registration policies were more likely to contain registered trials than journals without these requirements. RESULTS: Of the 21 orthopaedic surgery journals, 6 (29%) did not mention a single guideline, and clinical trial registration was required by 11 (52%) orthopaedic surgery journals and recommended by 2 (10%). Of the 21 general medical journals, 3 (14%) did not mention a single guideline, and trial registration was required by 13 (62%) general medical journals and recommended by 5 (24%) others. Furthermore, journals that referenced CONSORT were more likely to publish trials with a CONSORT flow diagram. Journals with trial registration policies were more likely to publish registered trials. CONCLUSIONS: Reporting guidelines and trial registration are suboptimally required or recommended by orthopaedic surgery journals. These 2 mechanisms may improve methodology and quality, and should be considered for adoption by journal editors in orthopaedic surgery. CLINICAL RELEVANCE: Because orthopaedic surgeons rely on high-quality research to direct patient care, measures must be taken to ensure that published research is of the highest quality. The use of reporting guidelines and prospective clinical trial registration may improve the quality of orthopaedic research, thereby improving patient care.

Inconsistent selection of outcomes and measurement devices found in shoulder arthroplasty research: An analysis of studies on ClinicalTrials.gov.

INTRODUCTION: Recent evidence suggests a lack of standardization of shoulder arthroplasty outcomes. This issue is a limiting factor in systematic reviews. Core outcome set (COS) methodology could address this problem by delineating a minimum set of outcomes for measurement in all shoulder arthroplasty trials. METHODS: A ClinicalTrials.gov search yielded 114 results. Eligible trials were coded on the following characteristics: study status, study type, arthroplasty type, sample size, measured outcomes, outcome measurement device, specific metric of measurement, method of aggregation, outcome classification, and adverse events. RESULTS: Sixty-six trials underwent data abstraction and data synthesis. Following abstraction, 383 shoulder arthroplasty outcomes were organized into 11 outcome domains. The most commonly reported outcomes were shoulder outcome score (n = 58), pain (n = 33), and quality of life (n = 15). The most common measurement devices were the Constant-Murley Shoulder Outcome Score (n = 38) and American Shoulder and Elbow Surgeons Shoulder Score (n = 33). Temporal patterns of outcome use was also found. CONCLUSION: Our study suggests the need for greater standardization of outcomes and instruments. The lack of consistency across trials indicates that developing a core outcome set for shoulder arthroplasty trials would be worthwhile. Such standardization would allow for more effective comparison across studies in systematic reviews, while at the same time consider important outcomes that may be underrepresented otherwise. This review of outcomes provides an evidence-based foundation for the development of a COS for shoulder arthroplasty.

Clinical trial registry use in anaesthesiology systematic reviews: A cross-sectional study of systematic reviews published in anaesthesiology journals and the Cochrane Library.

BACKGROUND: Publication bias within systematic reviews may result in incorrect conclusions leading to inappropriate clinical decisions and a decreased quality of patient care. Searching clinical trial registries for unpublished studies is one possible solution to minimise publication bias. OBJECTIVES: To examine rates of clinical trial registry searches in systematic reviews published in respected anaesthesiology journals and whether these searches found trials (or data) eligible for inclusion; to compare rates of registry searches between published reviews and similar reviews within the Cochrane Anaesthesia, Critical and Emergency Care Group; to conduct trial registry searches for a subset of reviews, determining whether eligible studies were overlooked; to investigate whether reporting of results in completed anaesthesia trials on ClinicalTrials.gov followed guidelines. DESIGN: A cross-sectional study of systematic reviews published in 10 anaesthesiology journals and the Cochrane Library. SETTING AND PARTICIPANTS: PubMed and the Cochrane Library were searched for systematic reviews or meta-analyses. MAIN OUTCOME MEASURES: The primary outcome was the number of systematic reviews that searched clinical trial registries for unpublished trials. Secondary outcomes included the number of registered trials in the ClinicalTrial.gov registry and the number of trials reporting trial results which were available on the ClinicalTrials.gov database and which should have been considered in a systematic review. RESULTS: The PubMed search yielded 507 records, and 415 remained after exclusions. Of these, 49 (11.8%) included a search of clinical trial registries. In total, 12 systematic reviews reported finding unpublished data but only five incorporated the data into their analyses. Of the Cochrane reviews, 58.9% (43/73) reported registry searches. Among a sample of 30 systematic reviews that omitted registry searches, we found many studies within the registries that were probably eligible to be included in the systematic reviews. For completed trials within the ClinicalTrials.gov database, only 15.4% reported results. CONCLUSION: The majority of systematic reviews in anaesthesiology did not include data from clinical trial registries. Exclusion of statistically nonsignificant data may lead to a biased interpretation of the data and hence inappropriate clinical interventions. TRIAL REGISTRATION: Registered in University hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN000021932).

Publication Bias and Nonreporting Found in Majority of Systematic Reviews and Meta-analyses in Anesthesiology Journals.

BACKGROUND: Systematic reviews and meta-analyses are used by clinicians to derive treatment guidelines and make resource allocation decisions in anesthesiology. One cause for concern with such reviews is the possibility that results from unpublished trials are not represented in the review findings or data synthesis. This problem, known as publication bias, results when studies reporting statistically nonsignificant findings are left unpublished and, therefore, not included in meta-analyses when estimating a pooled treatment effect. In turn, publication bias may lead to skewed results with overestimated effect sizes. The primary objective of this study is to determine the extent to which evaluations for publication bias are conducted by systematic reviewers in highly ranked anesthesiology journals and which practices reviewers use to mitigate publication bias. The secondary objective of this study is to conduct publication bias analyses on the meta-analyses that did not perform these assessments and examine the adjusted pooled effect estimates after accounting for publication bias. METHODS: This study considered meta-analyses and systematic reviews from 5 peer-reviewed anesthesia journals from 2007 through 2015. A PubMed search was conducted, and full-text systematic reviews that fit inclusion criteria were downloaded and coded independently by 2 authors. Coding was then validated, and disagreements were settled by consensus. In total, 207 systematic reviews were included for analysis. In addition, publication bias evaluation was performed for 25 systematic reviews that did not do so originally. We used Egger regression, Duval and Tweedie trim and fill, and funnel plots for these analyses. RESULTS: Fifty-five percent (n = 114) of the reviews discussed publication bias, and 43% (n = 89) of the reviews evaluated publication bias. Funnel plots and Egger regression were the most common methods for evaluating publication bias. Publication bias was reported in 34 reviews (16%). Thirty-six of the 45 (80.0%) publication bias analyses indicated the presence of publication bias by trim and fill analysis, whereas Egger regression indicated publication bias in 23 of 45 (51.1%) analyses. The mean absolute percent difference between adjusted and observed point estimates was 15.5%, the median was 6.2%, and the range was 0% to 85.5%. CONCLUSIONS: Many of these reviews reported following published guidelines such as PRISMA or MOOSE, yet only half appropriately addressed publication bias in their reviews. Compared with previous research, our study found fewer reviews assessing publication bias and greater likelihood of publication bias among reviews not performing these evaluations.