Transparency Matters: Assessing Harms Reporting Compliance in Randomized Controlled Trials Underpinning the AAOS Clinical Practice Guideline for Anterior Cruciate Ligament Injuries.

BACKGROUND: The American Academy of Orthopaedic Surgeons (AAOS) has developed a clinical practice guideline (CPG) for management of anterior cruciate ligament (ACL) injuries. Primary studies such as randomized controlled trials (RCTs) are cited as evidence for the guidelines. Given the influence that these trials have on patient care, adherence to standardized protocols for conducting and reporting RCTs is essential. PURPOSE: To evaluate the CONSORT (Consolidated Standards of Reporting Trials) Extension for Harms-related reporting of RCTs cited as supporting evidence for the AAOS CPG on the management of ACL tears. STUDY DESIGN: Cross-sectional study. METHODS: The reference section of the AAOS guideline for ACL tears was first screened for RCTs cited in the CPG. Next, each RCT was evaluated for adherence to the CONSORT Extension for Harms checklist. Both identification of RCTs and assessment of adherence were performed in a masked and duplicate process. Descriptive statistics were used to summarize adherence to CONSORT Extension for Harms items. A Pearson correlation test was conducted to assess the relationship between the year of publication and adherence to CONSORT harms reporting. RESULTS: The sample included 113 RCTs, of which 16 (14.2%) were published before the CONSORT Extension for Harms was implemented in 2004. Sample sizes ranged from 24 to 4564 participants, with a mean of 228. None of the included RCTs included all 18 items in the CONSORT Extension for Harms checklist. The mean number of checklist items reported was 4 (of 18; 22.2%). A moderate, positive, and statistically significant correlation was found between the RCT publication year and the adherence with reporting of the CONSORT Extension for Harms (t111 = 3.54; P < .001) (r = 0.32; 95% CI, 0.14-0.47). CONCLUSION: Harms were infrequently reported in RCTs cited as supporting evidence in the AAOS CPG for the management of ACL tears. One encouraging finding was the positive correlation between the year when RCTs were published and how well they adhered to reporting harms. Efforts to improve adverse event reporting are warranted, as RCTs are commonly used to make clinical decisions in orthopaedic surgery.

Assessing osteoporosis screening compliance in total joint surgery: a retrospective chart review.

CONTEXT: Osteoporosis is a prevalent concern, particularly among aging populations, leading to increased risk of fractures, including those related to hip and knee arthroplasty procedures. Screening for osteoporosis, especially with dual X-ray absorptiometry (DXA) scans, is crucial for early detection and management. OBJECTIVES: This study aimed to assess adherence to osteoporosis screening guidelines among patients aged 65 and older undergoing elective total hip arthroplasty (THA) or total knee arthroplasty (TKA) within a single health network. Factors influencing screening adherence were also explored. METHODS: A retrospective chart review of 2,160 patients undergoing elective THA or TKA between January 2019 and January 2023 was conducted. Demographic data, osteoporosis screening status, and occurrence of periprosthetic fractures were analyzed. Statistical analysis included descriptive statistics and chi-square tests. RESULTS: Only 24.1 % of eligible patients underwent a DXA scan prior to surgery. Females were more likely to undergo screening than males, and race was also associated with screening status. A total of 45 periprosthetic fractures were identified, with no significant correlation between osteoporosis status, DXA screening, and fracture occurrence. CONCLUSIONS: Adherence to osteoporosis screening guidelines among geriatric patients undergoing elective total joint arthroplasty remains low within the studied health network. Despite the lack of correlation between screening and fracture occurrence in this study, the importance of screening and potential optimization in high-risk patients is emphasized. Further research is needed to assess outcomes associated with different care pathways in bone health screening and management for elective geriatric total joint patients.

Salvage Treatment for a Periprosthetic Humeral Nonunion: A Case Report.

The patient, a 69-year-old female, presented one year after receiving a total elbow arthroplasty with a nonunion periprosthetic fracture of the humerus. Due to the patient's severe osteoarthritis of the ipsilateral shoulder and significant humeral deformity, a procedure linking the total elbow arthroplasty to the reverse shoulder implant via a cemented allograft-composite linkage sleeve was performed. Previous literature suggests upper extremity salvage surgery using large-scale allografts is successful in treating large tumor or infection-derived defects, though data is lacking as to whether this treatment is effective in periprosthetic fractures in patients with significant comorbidities. This patient's success in the postoperative year supports the use of allograft-composite reconstruction followed by linkage to a reverse shoulder implant as a salvage treatment for periprosthetic fractures under certain conditions, such as multiple adjacent implants, bone deformity, and severe osteoarthritis.

Restoring Functionality: Humeroradial Total Elbow Revision for Salvaging Total Elbow Arthroplasty Failure and Ulnar Bone Loss.

As the number of total elbow arthroplasty (TEA) continues to increase worldwide, one might predict the number of revision TEA would rise as well. The most common indications for revision TEA include (a) loosening, (b) infection, and (c) periprosthetic fracture. Although the rate of revision TEA procedures continues to rise due to the infrequency in which they are performed compared to other arthroplasty surgeries, no gold standard algorithm or procedure for managing severe ulnar bone loss in revision TEA has been determined. Various surgical techniques and strategies including allograft-prosthesis composite, custom long prosthesis with or without allograft, and resection arthroplasty have all been employed in attempting to address severe ulnar bone loss in revision TEA. Though the reported outcomes are mixed at best between each treatment strategy with similar complication rates. Another option is implanting the ulnar component into the radius. In those patients with severe ulnar bone loss, a humeroradial TEA revision can provide stability, restore range of motion, and provide pain relief.

Wide-Awake Local Anesthesia for a Proximal Humerus Fracture: A Case Report.

Introduction: Over the past two decades, wide-awake local anesthesia no-tourniquet (WALANT) surgery has gained substantial popularity, challenging conventional assumptions regarding the safety of epinephrine. This report investigates the unprecedented expansion of the wide-awake local anesthesia technique beyond hand surgeries. It meticulously documents its successful application in a peri-implant proximal humerus fracture, presenting a fresh perspective on its safety and viability for managing intricate orthopedic injuries. Case Report: The subject of this study is a 61-year-old HIV-positive male with a history of recurrent falls, seeking treatment for a peri-implant proximal humerus fracture. Electing the wide-awake local anesthesia option due to financial constraints, the patient underwent a successful surgery. The technique employed involved precise administration of local anesthetic, facilitating fracture reduction, and plate replacement. Notably, the emphasis was placed on active patient participation during intraoperative assessment. Conclusion: This report extends the recognized utility of WALANT surgery beyond hand surgeries, demonstrating its versatility and potential transformative impact on health-care delivery. The study underscores the pivotal role played by wide-awake local anesthesia surgery in addressing challenges related to health-care accessibility. It presents a promising avenue for future orthopedic interventions and positions itself as a safe and viable option for patients in underserved areas globally.

Genetic drift and purifying selection shape within-host influenza A virus populations during natural swine infections.

Patterns of within-host influenza A virus (IAV) diversity and evolution have been described in natural human infections, but these patterns remain poorly characterized in non-human hosts. Elucidating these dynamics is important to better understand IAV biology and the evolutionary processes that govern spillover into humans. Here, we sampled an IAV outbreak in pigs during a week-long county fair to characterize viral diversity and evolution in this important reservoir host. Nasal wipes were collected on a daily basis from all pigs present at the fair, yielding up to 421 samples per day. Subtyping of PCR-positive samples revealed the co-circulation of H1N1 and H3N2 subtype swine IAVs. PCR-positive samples with robust Ct values were deep-sequenced, yielding 506 sequenced samples from a total of 253 pigs. Based on higher-depth re-sequenced data from a subset of these initially sequenced samples (260 samples from 168 pigs), we characterized patterns of within-host IAV genetic diversity and evolution. We find that IAV genetic diversity in single-subtype infected pigs is low, with the majority of intrahost Single Nucleotide Variants (iSNVs) present at frequencies of <10%. The ratio of the number of nonsynonymous to the number of synonymous iSNVs is significantly lower than under the neutral expectation, indicating that purifying selection shapes patterns of within-host viral diversity in swine. The dynamic turnover of iSNVs and their pronounced frequency changes further indicate that genetic drift also plays an important role in shaping IAV populations within pigs. Taken together, our results highlight similarities in patterns of IAV genetic diversity and evolution between humans and swine, including the role of stochastic processes in shaping within-host IAV dynamics.

Genetic drift and purifying selection shape within-host influenza A virus populations during natural swine infections.

Patterns of within-host influenza A virus (IAV) diversity and evolution have been described in natural human infections, but these patterns remain poorly characterized in non-human hosts. Elucidating these dynamics is important to better understand IAV biology and the evolutionary processes that govern spillover into humans. Here, we sampled an IAV outbreak in pigs during a week-long county fair to characterize viral diversity and evolution in this important reservoir host. Nasal wipes were collected on a daily basis from all pigs present at the fair, yielding up to 421 samples per day. Subtyping of PCR-positive samples revealed the co-circulation of H1N1 and H3N2 subtype IAVs. PCR-positive samples with robust Ct values were deep-sequenced, yielding 506 sequenced samples from a total of 253 pigs. Based on higher-depth re-sequenced data from a subset of these initially sequenced samples (260 samples from 168 pigs), we characterized patterns of within-host IAV genetic diversity and evolution. We find that IAV genetic diversity in single-subtype infected pigs is low, with the majority of intra-host single nucleotide variants (iSNVs) present at frequencies of <10%. The ratio of the number of nonsynonymous to the number of synonymous iSNVs is significantly lower than under the neutral expectation, indicating that purifying selection shapes patterns of within-host viral diversity in swine. The dynamic turnover of iSNVs and their pronounced frequency changes further indicate that genetic drift also plays an important role in shaping IAV populations within pigs. Taken together, our results highlight similarities in patterns of IAV genetic diversity and evolution between humans and swine, including the role of stochastic processes in shaping within-host IAV dynamics.

Insights Into Patients Questions Over Bunion Treatments: A Google Study.

Background: Approximately 1 in 4 adults will develop hallux valgus (HV). Up to 80% of adult Internet users reference online sources for health-related information. Overall, with the high prevalence of HV combined with the numerous treatment options, we believe patients are likely turning to Internet search engines for questions relevant to HV. Using Google's people also ask (PAA) or frequently asked questions (FAQs) feature, we sought to classify these questions, categorize the sources, as well as assess their levels of quality and transparency. Methods: On October 9, 2022, we searched Google using these 4 phrases: "hallux valgus treatment," "hallux valgus surgery," "bunion treatment," and "bunion surgery." The FAQs were classified in accordance with the Rothwell Classification schema and each source was categorized. Lastly, transparency and quality of the sources' information were evaluated with the Journal of the American Medical Association's (JAMA) Benchmark tool and Brief DISCERN, respectively. Results: Once duplicates and FAQs unrelated to HV were removed, our search returned 299 unique FAQs. The most common question in our sample was related to the evaluation of treatment options (79/299, 26.4%). The most common source type was medical practices (158/299, 52.8%). Nearly two-thirds of the answer sources (184/299; 61.5%) were lacking in transparency. One-way analysis of variance revealed a significant difference in mean Brief DISCERN scores among the 5 source types, F(4) = 54.49 (P < .001), with medical practices averaging the worst score (12.1/30). Conclusion: Patients seeking online information concerning treatment options for HV search for questions pertaining to the evaluation of treatment options. The source type encountered most by patients is medical practices; these were found to have both poor transparency and poor quality. Publishing basic information such as the date of publication, authors or reviewers, and references would greatly improve the transparency and quality of online information regarding HV treatment. Level of Evidence: Level V, mechanism-based reasoning.

Genomic Surveillance for SARS-CoV-2 Variants: Circulation of Omicron Lineages - United States, January 2022-May 2023.

CDC has used national genomic surveillance since December 2020 to monitor SARS-CoV-2 variants that have emerged throughout the COVID-19 pandemic, including the Omicron variant. This report summarizes U.S. trends in variant proportions from national genomic surveillance during January 2022-May 2023. During this period, the Omicron variant remained predominant, with various descendant lineages reaching national predominance (>50% prevalence). During the first half of 2022, BA.1.1 reached predominance by the week ending January 8, 2022, followed by BA.2 (March 26), BA.2.12.1 (May 14), and BA.5 (July 2); the predominance of each variant coincided with surges in COVID-19 cases. The latter half of 2022 was characterized by the circulation of sublineages of BA.2, BA.4, and BA.5 (e.g., BQ.1 and BQ.1.1), some of which independently acquired similar spike protein substitutions associated with immune evasion. By the end of January 2023, XBB.1.5 became predominant. As of May 13, 2023, the most common circulating lineages were XBB.1.5 (61.5%), XBB.1.9.1 (10.0%), and XBB.1.16 (9.4%); XBB.1.16 and XBB.1.16.1 (2.4%), containing the K478R substitution, and XBB.2.3 (3.2%), containing the P521S substitution, had the fastest doubling times at that point. Analytic methods for estimating variant proportions have been updated as the availability of sequencing specimens has declined. The continued evolution of Omicron lineages highlights the importance of genomic surveillance to monitor emerging variants and help guide vaccine development and use of therapeutics.

Assessment of Reporting of Patient-Reported Outcomes in Randomized Controlled Trials for Interventions of Post-Traumatic Stress Disorder.

BACKGROUND: Post-traumatic stress disorder (PTSD) has debilitating effects on quality of life. Patient-reported outcomes (PROs) assess changes in quality of life and serve as subjective measurements of patient experience. The aim of this study is to assess the completeness of PRO reporting within randomized controlled trials with interventions pertaining to PTSD. METHODS: This cross-sectional, meta-epidemiological study assessed the completeness of PRO reporting in RCTs investigating PTSD interventions. We searched multiple databases for published RCTs of PTSD interventions that used PROs as a primary or secondary outcome. We assessed PRO completeness using the PRO adaptation of the Consolidated Standards of Reporting Trial (CONSORT). We used a bivariate regression model to determine the association between trial characteristics and the completeness of reporting. RESULTS: After an initial screening of 5906 articles, our final sample of RCTs for inclusion was 43. The mean completeness of reporting of PROs was 58.4% (SD = 14.50). We found no significant associations between trial characteristics and completeness of the CONSORT-PRO adaptation. CONCLUSION: Reporting of PROs was often incomplete among RCTs focused on PTSD. We believe that adherence to CONSORT-PRO will improve both PRO reporting and implementation into clinical practice to improve assessment of quality of life.

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.

Evaluating the underreporting of patient-reported outcomes in carpal tunnel syndrome randomized controlled trials.

CONTEXT: In recent years, patient-centered healthcare has become a primary concern for researchers and healthcare professionals. When included in randomized controlled trials (RCTs), patient-reported outcome (PRO) measures serve a critical role in supplementing efficacy outcomes with a patient perspective. OBJECTIVES: The goals of this study are to evaluate the reporting completeness of PROs within literature concerning carpal tunnel syndrome (CTS) utilizing the Consolidated Standards of Reporting Trials Patient-Reported Outcomes (CONSORT-PRO) extension. METHODS: We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) for published RCTs relating to CTS with at least one PRO measure from 2006 to 2020. Two investigators screened all RCTs for inclusion utilizing Rayyan (https://rayyan.qcri.org/), a systematic review screening platform. In an independent, masked fashion, investigators then evaluated all RCTs utilizing the CONSORT-PRO adaptation and Cochrane Collaboration Risk of Bias (RoB) 2.0 tool. Bivariate regression analyses were utilized to assess relationships between trial characteristics and completeness of reporting. RESULTS: Our search returned 374 publications, yet only 31 unique RCTs met the inclusion criteria. The mean overall percent of adherence for CONSORT-PRO was 41%. Our secondary outcome-assessing study characteristics-indicated significantly higher completeness of reporting in the absence of a conflict of interest statement (p<0.05), 'some concerns' for bias (p<0.005), and when journals required the use of the CONSORT statement (p<0.005). The RoB assessment determined overall suspicion for bias among included RCTs, with 35% (n=11/31) being labeled as 'high,' 58% (n=18/31) as 'some concerns,' and 7% (n=2/31) as 'low.' CONCLUSIONS: Our study indicated that the completeness of CONSORT-PRO reporting was deficient within CTS trials. Because of the importance placed on PROs in clinical practice, we recommend adherence to CONSORT-PRO prior to publication of RCTs to increase the understanding of various interventions on patients' quality of life (QoL).

Evaluating The Reporting of Patient-Reported Outcomes in Surgical Management of Stress Urinary Incontinence in Women: An Analysis of Randomized Controlled Trials.

BACKGROUND: Stress urinary incontinence (SUI) significantly reduces women's quality of life (QoL). Use of patient-reported outcomes (PROs) is increasing in randomized controlled trials (RCTs), thus standardization is important to ensure reporting completeness. We aim to evaluate completeness of reporting of RCTs for surgical management of SUI in women based on an adaptation of the Consolidated Standards of Reporting Trials statement with PRO extension (CONSORT-PRO). STUDY DESIGN: A literature search was conducted and all RCTs meeting inclusion criteria were evaluated using the CONSORT-PRO adapted checklist and the Cochrane Collaboration risk of bias assessment tool (RoB). We calculated a completion percentage score for each trial's adherence to the CONSORT-PRO adapted checklist and used bivariate regression analysis to examine associations between trial characteristics and completion percentage scores. RESULTS: Forty-three RCTs underwent data extraction and analysis. Mean completion percentage of the CONSORT-PRO was 50.53% (SD = 15.63). A total of 38 (of 43; 88.37%) RCTs received an RoB 2.0 rating of "some concern." RCTs with follow-up longer than 3 months had statistically significantly higher CONSORT-PRO completion: 3-6 months (p = .049), 6-12 months (p = .009), more than 12 months (p = .021). Compared with studies without a conflict of interest statement, studies reporting a conflict of interest (p < .001) or reporting no conflict of interest (p = .048) had higher reporting completeness. CONCLUSIONS: Our results suggest many RCTs addressing surgical management of SUI in women have poor adherence to CONSORT-PRO reporting guidelines. Improving reporting completeness through adherence to the CONSORT-PRO checklist can better inform clinical decision making and improve QoL.

Reporting of patient-reported outcomes in trials on alcohol use disorder: a meta-epidemiological study.

OBJECTIVES: Currently, limited research exists to assess the extent of patient-reported outcome (PRO) reporting among randomised controlled trials (RCTs) evaluating alcohol use disorder (AUD). We sought to investigate the completeness of reporting of PROs using the Consolidated Standards of Reporting Trials-PRO (CONSORT-PRO) extension in AUD RCTs. DESIGN SETTING: Meta-epidemiological study. METHODS: We searched MEDLINE, Embase and the Cochrane Central Register of Controlled Trials (CENTRAL) on 29 June 2021 for published RCTs focused on AUD. Following these searches, title and abstract screening, and full-text screening were performed by two investigators. To be included, a study must have employed a randomised trial design, published in English, focused on treatment of AUD and included at least one PRO. Trials meeting inclusion criteria were evaluated for completeness of reporting using the CONSORT-PRO extension adaptation. These trials were also evaluated for risk of bias (RoB) using the Cochrane RoB V.2.0 tool. Additionally, an exploratory analysis of each RCT's therapeutic area was extracted using the Mapi Research Trust's ePROVIDE platform. Screening and data collection were all performed in masked, duplicate fashion. MAIN OUTCOME MEASURES: PRO completeness of reporting, identification of factors associated with completeness of reporting and PRO measures used in RCTs to evaluate patients with AUD. RESULTS: Nineteen RCTs were evaluated in our analysis. Our primary outcome, the mean completion score for CONSORT-PRO, was 40.8%. Our secondary outcome-the identification of factors associated with completeness of reporting-found that trials published after 2014 (ie, 1 year after the publication of the CONSORT-PRO extension) were 15.0% more complete than trials published before 2014. We found no additional associations with better reporting. CONCLUSIONS: We found that the completeness of PRO reporting in RCTs involving AUD was deficient. Complete reporting of PROs is instrumental in understanding the effects of interventions, encourages patient participation in their treatment and may increase clinician confidence in the value of PROs. High quality treatment strategies for AUD require properly reported PROs.

Examining the Public's Most Frequently Asked Questions About Carpal Tunnel Syndrome and Appraising Online Information About Treatment.

BACKGROUND: Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy. Patients often search online for health information regarding common musculoskeletal complaints. Thus, the purpose of this study was to use language processing information from Google to assess the content of CTS frequently asked questions (FAQs) searched online and the transparency and quality of online CTS information. METHODS: On March 11, 2021, we searched Google for 3 terms "carpal tunnel syndrome treatment," "carpal tunnel syndrome surgical treatment," and "carpal tunnel syndrome non-surgical treatment" until a minimum of 100 FAQs and their answer links were extracted from each search. We used Rothwell classification to categorize the FAQs. The Journal of the American Medical Association's benchmark criteria were used to assess information transparency. Information quality was assessed using the Brief DISCERN tool. RESULTS: Our Google search returned 124 unique FAQs. Fifty-six (45.2%) were value based and most were related to the evaluation of treatment options (45/56, 80.4%). The most common source type was medical practices (26.6%). Nearly half of the answer sources (45.9%) were found to be lacking in transparency. One-way analysis of variance revealed a significant difference in mean Brief DISCERN scores among the 5 source types, F(4, 119) = 5.93, P = .0002, with medical practices averaging the worst score (13.73/30). CONCLUSIONS: Patients are most commonly searching Google to gain information regarding CTS treatment options. Online sources such as medical practices should use widely accepted rubrics for ensuring transparency and quality prior to publishing CTS information.

Correlation analysis of financial conflicts of interest and favourability of results or conclusions in addiction medicine systematic reviews and meta-analysis.

OBJECTIVE: To quantify conflicts of interest, assess the accuracy of authors self-reporting them, and examine the association between conflicts of interest and favourability of results and discussions in addiction medicine systematic reviews. DESIGN: A search was performed on Medline (Ovid) from January 2016 to 25 April 2020 to locate systematic reviews and meta-analyses focused on treatments of addiction disorders using a systematic search strategy. Data were extracted from each systematic review, including conflict of interest statements, authorship characteristics and the favourability of the results/conclusion sections. A search algorithm was used to identify any undisclosed conflicts of interest on the Open Payments Database (Dollars for Docs), Dollars for Profs, Google Patents/United States Patent and Trade Office, and prior conflict of interest statements in other published works from these authors. RESULTS: The search identified 127 systematic reviews, representing 665 unique authors. Of the 127 studies, 81 reported no authors with conflicts of interest, 28 with 1 or more conflict, and 18 had no conflict of interest statement. Additional non-disclosed conflicts of interest were found for 34 authors. There were 69 reviews that had at least one author with a conflict of interest. Of the 69 reviews, 14 (20.3%) reported favourable results and 26 (37.7%) reported favourable discussion/conclusions with no statistically significant association. A subanalysis was performed on publications with only US authors (51) with 35 (68.9%) having at least 1 conflict of interest. US authored studies that had a conflict of interest favoured the results (p = <0.001) and discussion/conclusion (p = 0.018) more often. CONCLUSION: Although multiple undisclosed financial conflicts of interest were found, there was no correlation with the favourability of the results or discussion/conclusions across all addiction medicine systematic reviews. Further research needs to be done on US-based publications and encourage disclosure systems worldwide to provide more accurate reporting.

Reporting of Patient-Reported Outcome Measures in Randomized Controlled Trials on Shoulder Rotator Cuff Injuries Is Suboptimal and Requires Standardization.

Purpose: To evaluate the completeness of patient-reported outcomes (PROs) reporting using Consolidated Standards of Reporting Trials Patient-Reported Outcome (CONSORT-PRO) in randomized controlled trials (RCTs) involving rotator cuff injuries. Methods: We performed a comprehensive search of MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for published RCTs focused on rotator cuff injuries that included at least one PRO measure. We included RCTs published from 2006 to 2020. Investigators extracted data from RCTs using the CONSORT-PRO and evaluated each RCT using the Cochrane Risk of Bias 2.0 tool. Our primary objective was to evaluate the mean completion percentage of CONSORT-PRO. Our secondary objective used bivariate regression analyses to explore the relationship between trial characteristics and completeness of reporting. Results: The initial search returned 467 results, with 33 published RCTs meeting the prespecified inclusion criteria. The mean CONSORT-PRO completeness across all included RCTs was 49.7% (standard deviation 15.43). An increase in sample size was associated with an increase in mean completeness of reporting (t = 2.31; P = .028). The Risk of Bias assessment found 29 (of 33, 87.88%) RCTs had "some concerns" for bias. We did not find any additional significant associations between completeness of reporting and trial characteristics. Conclusions: Randomized controlled trials involving rotator cuff injuries frequently use PRO measures as primary outcomes. Reporting of these PRO measures is suboptimal and may benefit from rigorous standardization. Clinical Relevance: PRO measures are increasingly incorporated as primary or secondary outcomes of RCTs. Appropriate reporting and use of state-of-the-art PRO measures may improve the dissemination of clinical knowledge from RCTs to guide treatment and determine intervention effectiveness. With increased adoption of Patient-Reported Outcome Measure Information System and adherence to CONSORT-PRO, orthopaedic literature may improve PRO reporting to optimize the interpretability of PROs and facilitate patient-centered care.

SARS-CoV-2 Delta-Omicron Recombinant Viruses, United States.

To detect new and changing SARS-CoV-2 variants, we investigated candidate Delta-Omicron recombinant genomes from Centers for Disease Control and Prevention national genomic surveillance. Laboratory and bioinformatic investigations identified and validated 9 genetically related SARS-CoV-2 viruses with a hybrid Delta-Omicron spike protein.

Incomplete reporting of patient-reported outcomes in multiple sclerosis: A meta-epidemiological study of randomized controlled trials.

BACKGROUND: Multiple Sclerosis significantly affects quality of life, which is often measured by patient-reported outcomes. The incorporation of patient-reported outcomes within clinical trials supplements the efficacy of outcomes in order to provide a patient's perspective for clinicians. Our objective was to evaluate current literature for completeness of reporting of PROs in randomized controlled trials (RCTs) for the management of MS. METHODS: We used MEDLINE, Embase, and Cochrane Central Register of Controlled Trials to search for RCT publications investigating the management of MS. After duplicate screening via Rayyan, RCTs fitting our inclusion criteria were abstracted employing the Consolidated Standards of Reporting Trials - Patient-Reported Outcome (CONSORT-PRO) adaptation and the Cochrane Collaboration Risk of Bias (RoB) 2.0 tool. Mean percent completion of an adaptation of CONSORT-PRO was calculated to address completeness of reporting. In addition, bivariate regression models were used to evaluate relationships between trial characteristics and completeness of reporting. RESULTS: Our search returned 3,966 results and 92 RCTs were included for data abstraction and analysis. We found an overall completion of 48.68% (SD=19.03). Sixty-five (of 92; 70.65%) of the RCTs were evaluated as having 'high' RoB. There were significant associations between completeness of reporting and the following: mention of CONSORT within published RCTs (t=2.55, p=.013), length of PRO follow-up (t=2.9, p=.005; t=2.14, p=.035), and sample size (t=3.12, p=.002). No other significant associations were found. CONCLUSION: Our study found incomplete adherence to the CONSORT-PRO adaptation among RCTs pertaining to MS. Of the most underreported items, the failure to report a hypothesis and define an approach to missing data threaten the validity of the evidence acquired from RCTs. Furthermore, PROs provide an opportunity to supplement trial outcomes with the patient's perspective. Thus, trialists of future RCTs may improve PRO reporting with increased adherence to the CONSORT-PRO adaptation.

The evaluation of reporting of patient-reported outcomes in MDD: A meta-epidemiological study of clinical trials.

Major depressive disorder (MDD) is a multifaceted disease that profoundly affects quality of life. Patient reported outcomes (PROs) are used in randomized controlled trials (RCTs) to better understand patient perspectives on interventions. Therefore, we sought to assess the completeness of reporting PROs in RCTs addressing MDD. We identified RCTs evaluating MDD containing a PRO measure published between 2016 and 2020 from MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials. Inclusion of studies was performed in duplicate. The completion of reporting of RCTs was assessed using the Consolidated Standards of Reporting Trials (CONSORT-PRO) adaptation. Bivariate regression analyses were used to evaluate reporting completeness and trial characteristics. A total of 49 RCTs were included in our analysis, with a mean CONSORT-PRO completion score of 56.7% (SD = 17.3).Our findings show a significant association with completeness of reporting and the following: secondary PRO trials were less completely reported as compared to primary PRO trials (t = -3.19, p = .003); studies with a follow-up period between six months and year were more completely reported as compared to three months or less (6 months to a year, t = 2.34, p = .024); and increased trial sample size was associated with more completeness of reporting (t = 3.17, p = .003). As compared to brain stimulation, the intervention types classified as combination, other, and psychotherapy had greater completeness of reporting (combination, t = 2.35, p = .024; other, t = 3.13, p = .003; psychotherapy, t = 3.41, p = .001). There were no other significant findings. Our study found the completeness of PRO reporting to be inconsistent in RCTs regarding MDD. Moreover, we advocate for the need to establish a core outcome set relevant to the management of adults diagnosed with MDD and facilitate training on the application of PRO data.