Search

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.

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

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 ( t 111 = 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., Competing Interests: One or more of the authors has declared the following potential conflict of interest or source of funding: C.H. has received support for education from Pylant, consulting fees from Endeavor, and hospitality payments from Stryker. M.H. has received support for education from CDC Medical. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto.

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: No financial or other sources of support were provided during the development of this protocol. B.C. reports personal fees and nonfinancial support from Encore Medical, nonfinancial support from Medacta, outside the submitted work. M.V. reports grant funding from the National Institutes of Health, the US Office of Research Integrity, and Oklahoma Center for the Advancement of Science and Technology, all outside this work. M.H. receives research support through the National Institute of Justice and Health Resources and Services Administration, all outside of this work. All other authors have nothing to 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., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2024, Webber et al.)

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., Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2024.)

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., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. ICMJE forms for all authors are available online., (© The Author(s) 2023.)

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., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

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., (Copyright © 2022 Jacobs Institute of Women's Health, George Washington University. Published by Elsevier Inc. All rights reserved.)

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%; X 2  = 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., (© 2023. The Author(s).)

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)., (© 2023 the author(s), published by De Gruyter, Berlin/Boston.)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Esophageal motility disorders (EMD) can have significant effects on quality of life. Patient-reported outcomes (PROs) provide valuable insight into the patient's perspective on their treatment and are becoming increasingly used in randomized controlled trials (RCTs). Thus, our investigation aims to evaluate the completeness of reporting of PROs in RCTs pertaining to EMDs. We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for published RCTs focused on EMDs. Included RCTs were published between 2006 and 2020, reported a primary outcome related to an EMDs, and listed at least one PRO measure as a primary or secondary outcome. Investigators screened and extracted data in a masked, duplicate fashion. Data extraction was carried out using both the CONSORT-PRO adaptation and Cochrane Collaboration Risk of Bias 2.0 tool. We assessed overall mean percent completion of the CONSORT-PRO adaptation and a bivariate regression analysis was used to assess relationships between trial characteristics and completeness of reporting. The overall mean percent completion of the CONSORT-PRO checklist adaptation was 43.86% (SD = 17.03). RCTs with a primary PRO had a mean completeness of 47.73% (SD = 17.32) and RCTs with a secondary PRO was 35.36% (SD = 13.52). RCTs with a conflict of interest statement were 18.15% (SE = 6.5) more complete (t = 2.79, P = .009) than trials lacking a statement. No additional significant associations between trial characteristics and completeness of reporting were found. PRO reporting completeness in RCTs focused on EMDs was inadequate. We urge EMD researchers to prioritize complete PRO reporting to foster patient-centered research for future RCTs on EMDs., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., (© 2022 The Authors.)

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., (Copyright © 2022 Elsevier B.V. All rights reserved.)

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., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Context: Osteopathic medicine in the United States continues to produce a substantial number of physicians and medical educators. However, recently popularized misconceptions about osteopathic medical practice, education, and manual therapy suggest an unsettling prevalence of inaccurate beliefs held by the public. The public often searches the internet to find out information about osteopathic medicine, but the content of questions and the transparency of the resulting information is unknown., Objectives: We sought to explore frequently asked questions (FAQs) generated by Google to assess commonly searched questions about the osteopathic profession and to determine the level of information transparency associated with resulting sources., Methods: On June 16, 2021, we searched Google for three terms: "osteopathic medicine," "doctor of osteopathic medicine," and "DO," until a minimum of 100 FAQs and their answer links were extracted from each search. After excluding irrelevant FAQs, we used Rothwell's Classification of Questions to categorize the FAQs. We then used the Journal of the American Medical Association's Benchmark Criteria to assess information transparency for each corresponding answer source provided by Google. The answer sources were screened for the inappropriate use of "osteopathy" in place of "osteopathic medicine" and for "osteopath" in place of "DO," "Doctor of Osteopathic Medicine," or "Osteopathic Physician." We performed statistical tests to ascertain the differences in information transparency between osteopathic and nonosteopathic information sources., Results: Our Google search revealed 110 unique FAQs about osteopathic medicine. The majority of FAQs were classified as fact-based (82/110; 74.55%), nearly half of which (45.12%) were related to the medical practicing privileges of DOs. The FAQs were most commonly answered by academic institutions (44/110, 40.0%). Nearly half (49.09%) of the linked answer sources were deemed inadequate by JAMA benchmark criteria. Of the 110 linked answer sources, 19 (17.27%) misused either osteopathy, osteopath, or both to describe osteopathic physicians. Only 30 sources were linked to US-based osteopathic organizations. Osteopathic organizations were statistically less likely to meet high-transparency criteria than nonosteopathic organizations (p=0.002)., Conclusions: Our study shows that the US public may be unsure about the physician status of DOs, which may prevent securing the professional identity of osteopathic physicians in the eyes of the public. Osteopathic organizations should tailor awareness campaigns toward addressing the common misconceptions revealed by our study. Osteopathic organizations should use transparency criteria as a rubric when publishing information to enhance transparency., (© 2022 Nicholas B. Sajjadi et al., published by De Gruyter, Berlin/Boston.)

Context: Traditionally, the Accreditation Council for Graduate Medical Education (ACGME) requires residency programs to implement research and other scholarly activities into their training curriculum. Encouraging residents to publish during residency is believed to promote research throughout their careers; however, no study has attempted to quantify research productivity among orthopedic surgery residents before, during, and after residency., Objectives: To determine whether publishing in peer-reviewed journals during orthopedic residencies was an indicator of continued academic achievement after graduation., Methods: This study was observational in nature and employed a cross-sectional design. We examined whether research outcomes during orthopedic residency was associated with academic advancement or continued research involvement after residency. We identified 201 orthopedic residency programs on the Doximity website and randomly selected 50 to include in our sample. Of these programs, graduate rosters for 31 programs were located and subsequently included. Of the 341 graduates identified, we recorded the number of peer-reviewed publications, H-indices, fellowships, and whether the graduate pursued a career in private practice or academia., Results: Orthopedic residency graduates from 31 programs published a total of 1923 peer-reviewed manuscripts. On average, residents had a total of 5.6 publications and an h-index of 3.2. Residents entering academia and pursuing fellowships had a significantly higher total number of publications, higher number of first-author publications, and greater H-indices compared to those who did not enter academia or pursue a fellowship., Conclusions: Increased research productivity was associated with continued academic pursuits and an increased likelihood of pursuing fellowship training after residency., (© 2022 Marvin Carr et al., published by De Gruyter, Berlin/Boston.)

Objective: With approximately 15 million individuals in the United States meeting criteria for Alcohol Use Disorder (AUD), advancing effective medication-assisted treatment options is crucial. This advancement stems from the publication of clinical trial (CT) results. The primary objective of this study was to assess the rates of discontinuation and non-publication of results in CTs focused on the pharmacologic treatment of AUD and to assess associated factors. Design : A cross-sectional study was completed after acquiring trials focused on AUD within the ClinicalTrials.gov database. Inclusion criteria for CTs were the use of a pharmaceutical intervention with an outcome measure of alcohol intake or craving, conducted between October 2008 through September 2018. The primary outcome measures were the frequency of trial discontinuation and non-publication. Discontinuation was assessed as the listed status on ClinicalTrials.gov. Publications were identified through verification of listings on ClinicalTrials.gov, or via searches of PubMed, Embase, and Google Scholar. If publications were not found, correspondence to trial contacts were sent. Data analysis occurred on December 5th, 2020. Results: Of 235 trials returned from the search, 87 met inclusion criteria. Our study found that 12.6% (11) of CTs involving pharmaceutical treatments for AUD were prematurely terminated, and 39.1% (34) had no published results. Recruitment and lower cutoff of targeted age groups were significantly associated with discontinuation and non-publication, respectively. Conclusions: Scientific evidence advances faster when all results are known-furthering the progress of positive studies, while avoiding duplicative efforts to test the same hypotheses with the same methods, thereby reducing scientific waste. Given the number of unpublished AUD trials, potentially useful information regarding treatment for individuals with AUD may be inaccessible to clinicians while also adding to the abundance of research waste.Key points Question: What are the rates of discontinuation or non-publication of clinical trials for pharmacological treatments for AUD and associated factors? Findings: Among 87 trials, 11 (12.6%) were prematurely terminated and 34 (39.1%) did not reach publication, with trials that included participants 21 years and older more likely to reach publication than those with younger participants. Meaning: Low publication rates of CTs for pharmacological treatments of AUD may (1) stunt the advancement of AUD research, (2) decrease the value in funding AUD research from government entities, and (3) needlessly expose participants to potentially harmful interventions.