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 Evaluation of Reporting Guidelines and Clinical Trial Registry Requirements Among Addiction Medicine Journals.

CONTEXT: Robust methodology and ethical reporting are paramount for quality scientific research, but recently, that quality in addiction research has been questioned. Avenues to improve such research quality include adherence to reporting guidelines and proper usage of clinical trial registries. Reporting guidelines and clinical trial registries have been shown to lead researchers to more ethical and transparent methodology. OBJECTIVES: To investigate the reporting guideline and clinical trial registration policies of addiction research journals and identify areas of improvement. METHODS: We used Google Scholar Metrics' h-5 index to identify the top 20 addiction research journals. We then examined the instructions for authors from each journal to identify whether they required, recommended, or made no mention of trial registration and reporting guidelines, including the Consolidated Standards of Reporting Trials (CONSORT), Meta-Analysis of Observational Studies in Epidemiology (MOOSE), Quality of Reporting of Meta-analyses (QUOROM), Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), Standards for Reporting Diagnostic Accuracy Studies (STARD), Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), Animal Research: Reporting of In Vivo Experiments (ARRIVE), Case Reports (CARE), Consolidated Health Economic Evaluation Reporting Standards (CHEERS), Standards for Reporting Qualitative Research (SRQR), Standards for Quality Improvement Reporting Excellence (SQUIRE), Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), Consolidated Criteria for Reporting Qualitative Research (COREQ), Transparent Reporting of a Multivariate Prediction Model for Individual Prognosis or Diagnosis (TRIPOD), Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P), and the International Committee of Medical Journal Editors (ICMJE) guidelines. We performed the same analysis regarding requirements for clinical trial registration. RESULTS: Of the 20 journals included in this study, 10 journals (50%) did not require adherence to any reporting guidelines. Trial registration followed a similar trend; 15 journals (75%) did not mention any form of trial or systematic review registration, and ClinicalTrials.gov was only recommended by only 1 journal (5%). CONCLUSIONS: Among top addiction medicine journals, required adherence to reporting guidelines and clinical trial registry policies remains substandard. A step toward fulfilling the National Institute on Drug Abuses' call for improvement in transparency and reproducibility within addiction research should include all journals adopting a strict reporting guideline and clinical trial registry adherence policy.

An Evaluation of the Presence of Spin in the Abstracts of Tonsillectomy Systematic Reviews.

OBJECTIVES/HYPOTHESIS: Spin-the practice of adding or omitting information intentionally or unintentionally to make the results of a study more favorable-may influence clinical decision making, especially when present in study abstracts. Here, we quantify and characterize the presence of spin in the abstracts of systematic reviews regarding tonsillectomy. METHODS: This study is an analysis of systematic review abstracts. Searches were conducted on September 23, 2019 on PubMed and Embase using the advanced search feature to retrieve systematic reviews regarding tonsillectomies. The nine most severe forms of spin were then evaluated. Spin was classified by two investigators in parallel, with each blinded to the classifications of the other. Study characteristics were also recorded in duplicate. Consensus meetings between investigators were held to resolve disagreements. RESULTS: In the 85 included systematic reviews, at least one form of spin was present in 44.7% (38/85) of abstracts. Journals with higher impact factors were less likely to contain spin in the abstracts of systematic reviews (point biserial correlation coefficient of -0.30). No statistically significant associations were found between the presence of spin and intervention type (P = .56) or adherence to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (P = .08); however, there was a significant association between spin and funding source (P = .03). CONCLUSIONS: Spin was common in the abstracts of our sample of tonsillectomy systematic reviews. Researchers, clinicians, and peer reviewers could benefit from learning to recognize spin in medical literature. Further research is needed into the effects of spin on clinical decision making. LEVEL OF EVIDENCE: NA Laryngoscope, 2020.

Evaluation of "Spin" in the Abstracts of Randomized Controlled Trial Reports in Cardiology.

CONTEXT: The misrepresentation and distortion of research findings, known as "spin," has been shown to affect clinical decision making. Spin has been found in randomized controlled trials (RCTs) published in various fields of medicine. OBJECTIVE: To evaluate the abstracts of RCTs found in the cardiology literature for spin. METHODS: The authors searched PubMed using a specific string of keywords to identify previously published articles documenting RCTs of cardiovascular treatments in humans. To be included, a cardiology trial had to randomize humans to an intervention, statistically compare 2 or more groups, and have a nonsignificant primary endpoint. Records were excluded if they did not meet these criteria. Data extraction was double-blinded and done using a pilot-tested Google Form. Items extracted from each trial included the title, journal, funding source, comparator arm, primary endpoint, statistical analysis of the primary endpoint, secondary endpoints, statistical analysis of secondary endpoints, and trial registration number (if reported). The 2 authors who screened records for inclusion were then asked whether spin was present in the abstract of the randomized trial. Spin in the title, abstract results, abstract conclusions, and selection of reported endpoints were considered. RESULTS: Of the 651 PubMed citations retrieved by our search string, 194 RCTs with a clearly defined primary endpoint were identified. Of these 194 RCTs, 66 trials contained nonsignificant primary endpoints and were evaluated for spin. Of these trials, spin was identified in 18 of the 66 abstracts (27.3%). CONCLUSIONS: Spin was present in our sample of cardiology RCTs. Spin may influence clinical decision making by creating false impressions of the true validity of a drug or intervention.

Evaluation of the Clarity and Completeness of Reporting in Orthopedic Clinical Practice Guidelines.

BACKGROUND: Clinical practice guidelines (CPGs) can positively affect the quality of patient care offered by physicians because they decrease variability in clinical practice and may help reduce unnecessary testing, promoting a more responsible use of resources. Building on existing framework for reporting guideline development, including the work of the Enhancing the Quality and Transparency of Health Research Network, the Reporting Items for Practice Guidelines in Healthcare (RIGHT) Working Group created a 2016 checklist of 35 items considered essential for high-quality reporting of CPGs. OBJECTIVES: To evaluate how many previously published CPGs in orthopedic surgery met the RIGHT criteria and assess how improvements can be made in future orthopedic CPGs based on any found deficiencies. METHODS: All 18 CPGs published before January 1, 2018, by the American Academy of Orthopedic Surgeons (AAOS) are publicly available on orthoguidelines.org. Two authors downloaded each file and both of those authors independently scored each CPG using piloted abstraction RIGHT checklist forms. RESULTS: Of the 35 RIGHT criteria outlined in 22 checklist items, 23 (65.7%) were met across all AAOS guidelines, 6 (17.1%) were not met by any of the AAOS guidelines, and 6 (17.2%) were met by some of the AAOS guidelines. CONCLUSION: Overall, the AAOS guidelines addressed many important recommendations within the RIGHT checklist. Assessing adherence to the RIGHT checklist can help ensure that future guidelines are more effectively communicated, hopefully assisting end users in efficient implementation and increasing the level of evidence-based patient care.

Evaluation of selective outcome reporting and trial registration practices among addiction clinical trials.

BACKGROUND AND AIMS: Selective outcome reporting occurs when trialists pre-specify primary and secondary outcomes during trial planning but alter the definitions in the published report. Here, we investigate selective outcome reporting in published addiction randomized controlled trials (RCTs) and evaluate whether particular funding sources are associated with an increased likelihood of selective outcome reporting. DESIGN: We conducted a cross-sectional study of published addiction clinical trials. A PubMed search was performed to identify RCTs in addiction journals from 2013 to 2017. Included studies used a randomized design to address one of the following topics: (1) drug, alcohol and tobacco addiction prevention, (2) stabilization following excessive use of a substance, (3) relapse prevention or (4) recovery maintenance. SETTING: Single-center, medical research institution. PARTICIPANTS: Our sample included 162 RCTs that were prospectively registered with a clearly defined primary outcome. MEASUREMENT: We extracted the following items from addiction RCTs: journal, funding source, trial registry number (if included), sample size, dates of subject enrollment, whether primary and secondary outcomes were denoted, all published outcomes, P-value for all outcomes and whether authors mentioned any deviations from the trial protocol as it related to RCT outcomes. FINDINGS: In total, 47 of 162 RCTs (29.0%) had at least one major discrepancy between the trial registry and published RCT. Overall, these 47 RCTs included 54 major discrepancies. The most common major discrepancy was demotion of a primary registered outcome (19/54, 35.2%). The majority of RCTs (132/162, 81.5%) were funded from public sources. Additionally, 166 RCTs were excluded from our sample because registration could not be confirmed. CONCLUSIONS: There is evidence suggestive of selective outcome reporting in addiction randomized controlled trials (RCTs). The most common major discrepancies pertained to the primary outcome.

An Evaluation of Publication Bias in High-Impact Orthopaedic Literature.

BACKGROUND: Statistical analysis of systematic reviews allows the results of previous studies to be combined and synthesized to assess the overall health effect of the intervention in question. Systematic reviews can also be used to guide the creation of clinical practice guidelines and are considered to have a high level of evidence. Thus, it is important that their methodological quality is of the highest standard. Publication bias presents 2 problems: (1) studies with significant results may be overrepresented in systematic reviews and meta-analyses ("false positives") and (2) studies without significant results may not be included in systematic reviews and meta-analyses ("false negatives") because each study, on its own, was underpowered, meaning that some treatment options that may have clinical benefit will not be adopted. METHODS: We performed a study to evaluate the techniques used by authors to report and evaluate publication bias in the top 10 orthopaedic journals as well as 3 orthopaedic-related Cochrane groups. Two authors independently screened the titles and abstracts to identify systematic reviews and meta-analyses. We assessed publication bias in the systematic reviews that did not assess publication bias themselves. RESULTS: Our final sample included 694 systematic reviews or meta-analyses that met our inclusion criteria. Our review included 502 studies (72%) that focused on clinical outcomes, with the majority of the remaining studies focused on predictive and prognostic accuracy (20%) or diagnostic accuracy (5%). Publication bias was discussed in 295 (42.5%) of the included studies and was assessed in 135 (19.5%). Of the studies that assessed publication bias, 31.9% demonstrated evidence of publication bias. Only 43% and 22% of studies that involved use of the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines discussed and assessed publication bias, respectively. CONCLUSIONS: Publication bias is infrequently discussed and assessed in the high-impact orthopaedic literature. Furthermore, nearly one-third of the studies that assessed for publication bias demonstrated evidence of publication bias. In addition to these shortcomings, fewer than half of these studies involved use of the PRISMA guidelines and yet only one-fourth of the studies assessed for publication bias. CLINICAL RELEVANCE: By understanding the degree to which publication bias is discussed and presented in high-impact orthopaedic literature, changes can be made by journals and researchers alike to improve the overall quality of research produced and reported.

Evaluation of spin in the abstracts of otolaryngology randomized controlled trials.

OBJECTIVE: Spin, the misrepresentation and distortion of research findings, has been shown to affect clinical decision making. Spin has been found in randomized controlled trials (RCTs) published in various fields of medicine, but no study has tested for the presence of spin in otolaryngology RCTs. The purpose of this study is to evaluate the abstracts of RCTs found in the otolaryngology literature for spin. METHODS: In this cross-sectional analysis, we analyzed the abstracts of RCTs for spin using a pilot-tested form. Double data extraction was performed by two blinded authors, and discrepancies were resolved using mutual discussion. RESULTS: Out of the 534 PubMed citations retrieved by our search string, 162 parallel-group RCTs with clearly defined primary and secondary endpoints were identified. Further analysis identified 47 trials with nonsignificant primary outcomes, which were then evaluated for spin. Spin was identified in 33 of the 47 (70%) abstracts. Spin was found in the results sections of 25 (53%) of the included abstracts and was found in the conclusion section of 27 (57%) of the abstracts. Spin was not present in the titles of any of the included studies. CONCLUSION: Spin was common in our sample of otolaryngology RCTs. Spin may potentially create false impressions about the true validity of a drug or intervention. Further research needs to test for potential clinical implications of spin in the otolaryngology literature. LEVEL OF EVIDENCE: NA. Laryngoscope, 2018.

An analysis of the literature addressing tonsillectomy knowledge gaps.

IMPORTANCE: The ability of clinical practice guidelines to improve patient outcomes depends on the quality of evidence that they are built upon. Research into tonsillectomy in children is lacking, and the gaps in evidence were identified by guideline authors. OBJECTIVE: The objective of this study is to evaluate the extent that new research is addressing the gaps identified in the AAO-HNS Tonsillectomy in Children Guideline. DESIGN: For each recommendation in the AAO-HNS guideline Tonsillectomy In Children, we created PICO (Participants, Intervention, Comparator, Outcome) questions and search strings. PubMed was searched to locate studies undertaken after the final literature search performed by the AAO-HNS work group. These studies were then extracted and analyzed. SETTING: This study is relevant to all invested in focusing otolaryngological research on questions which currently lack strong evidence. PARTICIPANTS: Trials in tonsillectomy that started after the development of the AAO-HNS clinical practice guidelines. MAIN OUTCOME MEASURES: The main outcome measures of this study is the extent to which tonsillectomy research is addressing the evidence gaps listed in the clinical practice guideline. RESULTS: Of the 2519 studies included in our sample, 276 (11%) were relevant to the 18 recommendations made within the Tonsillectomy in Pediatric Patients clinical practice guideline. All but one of the recommendations was met by at least one study. CONCLUSIONS: and Relevance: Our findings indicate that knowledge gaps within the guideline at publication may have since been addressed and a guideline update may thus be warranted. LEVEL OF EVIDENCE: NA.