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Shoulder Arthroplasty Trials Are Infrequently Registered: A Systematic Review of Trials.

ABSTRACT: With the intent of improving transparency in clinical research, the International Committee of Medical Journal Editors (ICMJE) established guidelines in 2005 regarding prospective clinical trial registration. This action worked to address bias related to selective outcome reporting in the medical literature. The objective of this study was to assess and characterize the quality of registration of clinical trials appearing in shoulder arthroplasty-related medical journals.All randomized trials involving human subjects, pertaining to shoulder arthroplasty, published between July 1, 2005 and December 31, 2015, and indexed in either PubMed or SportDISCUS were analyzed. We assessed the prevalence of registration, the timing of registration relative to patient enrollment periods, and the variable rates of orthopedic journal compliance with ICMJE and Food and Drug Administration clinical registration standards for our study.Of the 382 articles identified, 345 (90.3%) were excluded due to failure to meet inclusion criteria. From the remaining 37, only 12 (32.4%) studies were found to be registered in a trial registry. Ten (10/12, 83.3%) of these provided their registration information within the body of the article. None of the included studies from ICMJE-recognized journals were registered. From 34 included studies from non-ICMJE recognized journals, 12 (35.3%) were registered.The level of compliance with clinical trial registration guidelines in the decade since their release among shoulder arthroplasty trials in orthopedic journals is poor. Given the importance of the issue, the prevalence of the problem, and the fact that many other medical specialties have already made efforts to improve ICMJE compliance, further work on the part of orthopedic surgery journal authors and editors is needed to ensure the publication of unbiased results.UMIN000022487.

SUBMITTER: Sims MT

PROVIDER: S-EPMC5072652 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Shoulder Arthroplasty Trials Are Infrequently Registered: A Systematic Review of Trials.

Sims Matthew Thomas MT Sanchez Zachary Carter ZC Herrington James Murphy JM Hensel James Barrett JB Henning Nolan Michael NM Scheckel Caleb Josiah CJ Vassar Matt M

PloS one 20161020 10

<h4>Introduction</h4>With the intent of improving transparency in clinical research, the International Committee of Medical Journal Editors (ICMJE) established guidelines in 2005 regarding prospective clinical trial registration. This action worked to address bias related to selective outcome reporting in the medical literature. The objective of this study was to assess and characterize the quality of registration of clinical trials appearing in shoulder arthroplasty-related medical journals.<h4 ...[more]

PMID: 27764210

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Project description:BackgroundParkinson's disease (PD) is a neurodegenerative disorder associated with inferior clinical outcomes after surgical management of many orthopedic conditions. The purpose of this systematic review was to define the clinical, functional, and patient-reported outcomes of shoulder arthroplasty (SA) in patients with PD.MethodsFollowing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a systematic search was completed using the Ovid platform for searches in MEDLINE, EMBASE, Cochrane Central, and Cochrane Systematic Reviews, with additional searches in Web of Science and Scopus. Included studies were full-length, English-language, clinical investigations reporting on SA in patients with PD with at least one clinical outcome.ResultsSeven studies including 7126 patients (7134 SA) met inclusion criteria with a mean age of 72.6 (range, 69.5-75.8 years), 58.9% female, and the average follow-up duration was 65 months (range, 17-119 months). Anatomic total shoulder arthroplasty (aTSA) was the most reported implant surgery (n = 3455, 48.4%) followed by hemiarthroplasty (HA) (n = 2840, 39.8%), and reverse shoulder arthroplasty (RSA) (n = 839,1.8%). SA consistently improved pain. Forward elevation, abduction, and external rotation had a pooled mean increase of 36°, 20°, and 6°, respectively. Complications occurred at a pooled rate of 22.5%, with stiffness (7.1%), need for revision (5.3%), and instability (4.7%) as the most common complications reported. Reoperations inclusive of revisions occurred at a lower pooled rate of 5.6%, with aTSA (n = 201; 9.0%) having the highest rate, followed by HA (n = 158; 7.1%), and then RSA (n = 42; 1.9%).ConclusionsThe results of the present systematic review demonstrate that SA in patients with PD results in consistent pain relief. However, inferior improvements in clinical outcomes may be expected when compared with patients without PD, likely due to the neurodegenerative manifestations of this disorder. In addition, RSA had a lower reoperation rate than HA and aTSA in patients with PD.

Project description:BackgroundLateralized reverse shoulder arthroplasty (RSA) has emerged as an attempt to improve on some of the drawbacks of conventional RSA, such as glenoid notching and decrease in ROM. Although this new design is being used in clinical practice, the evidence is mostly limited to case series and has not been systematically reviewed.Questions/purposes(1) How much did patient-reported outcome measures (PROMs) and ROM improve among patients who receive a lateralized RSA implant? (2) What proportion of shoulders experience complications, revision surgery, or scapular notching?MethodsThe PubMed and EMBASE databases were searched from database inception to January 31, 2020. We included clinical studies that reported the PROMs and/or ROM of patients with insufficient rotator cuffs undergoing RSA with a lateralized implant. All other types of studies and those including patients with fractures, instability or escape, infection, rheumatologic disease, neurologic disease, or revision surgeries as an indication for RSA were excluded. PROMs and ROM were collected and are reported as mean values and ranges. Complications, revision surgery, and scapular notching are presented as proportions. The percentage of the mean change relative to the minimum clinically important difference (MCID) was calculated using the anchor-based value for each outcome. The Methodological Index for Non-randomized Studies (MINORS) was used to assess study quality. The initial search yielded 678 studies; 61 full-text articles were analyzed according to our eligibility criteria. After a detailed analysis, we included nine studies that evaluated 1670 patients (68% of whom [1130] were women) with a mean age of 71.8 ± 0.6 years. The mean follow-up period was 41.1 ± 5.6 months. The mean MINORS score was 12 ± 4.ResultsActive ROM improved for forward flexion (mean change 47° to 82°; MCID 12°), abduction (mean change 43° to 80°; MCID 7°), external rotation (mean change 8° to 39°; MCID 3°), and internal rotation (mean change -2 to 1 points). PROM scores also improved, including the American Shoulder and Elbow Surgeons score (mean change 20 to 50; MCID 20.9 points), Constant score (mean change 28 to 40; MCID 5.7 points), Simple Shoulder Test score (mean change 3 to 7; MCID 2.4 points), and VAS score (mean change -1.8 to -4.9; MCID -1.6 points). The proportion of shoulders with complications ranged from 0% (0 of 44) to 21% (30 of 140), and the proportion of shoulders with scapular notching ranged from 0% (0 of 76) to 29% (41 of 140). The proportion of patients undergoing revision ranged from 0% (0 of 44) to 13% (10 of 76) at short-term follow-up.ConclusionLateralized RSA is a reasonable alternative to medialized implants for patients with rotator cuff insufficiency because it might reduce the likelihood of scapular notching without apparently compromising PROMs or ROM. More studies are required to determine whether there is a direct correlation between the amount of lateralization and PROMs or ROM.

Project description:BackgroundSince the outbreak of coronavirus disease 2019 (COVID-19), many researchers in China have performed related clinical research. However, systematic reviews of the registered clinical trials are still lacking. Therefore, we conducted a systematic review of clinical trials for COVID-19 to summarize their characteristics.MethodsThis study is based on the PRISMA recommendations in the Cochrane handbook. The Chinese Clinical Registration Center and the ClinicalTrials.gov databases were searched to identify registered clinical trials related to COVID-19. The retrieval inception date was February 9, 2020. Two researchers independently selected the literature based on the inclusion and exclusion criteria, extracted data, and evaluated the risk of bias.ResultsA total of 75 registered clinical trials (63 interventional studies and 12 observational studies) for COVID-19 were identified. The majority of clinical trials were sponsored by Chinese hospitals. Only 11 trials have begun to recruit patients, and none of the registered clinical trials have been completed; 34 trials were early clinical exploratory trials or in the pre-experiment stage, 13 trials were phase III, and four trials were phase IV. The intervention methods included traditional Chinese medicine in 26 trials, Western medicine in 30 trials, and integrated traditional Chinese medicine and Western medicine in 19 trials. The subjects were primarily non-critical adult patients (≥ 18 years old). The median sample size of the trials was 100 (IQR: 60-200), and the median length of the trial periods was 179 d (IQR: 94-366 d). The main outcomes were clinical observation and examinations. Overall, the methodological quality of both the interventional trials and observational studies was low.ConclusionsIntensive clinical trials on the treatment of COVID-19 using traditional Chinese medicine and Western medicine are ongoing or will be performed in China. However, based on the uncertain methodological quality, small sample size, and long trial duration, we will not be able to obtain reliable, high-quality clinical evidence regarding the treatment of COVID-19 in the near future. Improving the quality of study design, prioritizing promising drugs, and using different designs and statistical methods are worth advocating and recommending for clinical trials of COVID-19 in the future.

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Shoulder Arthroplasty Trials Are Infrequently Registered: A Systematic Review of Trials.

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Shoulder Arthroplasty Trials Are Infrequently Registered: A Systematic Review of Trials.

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