Development and Evaluation of a Framework for Identifying and Addressing Spin for Harms in Systematic Reviews of Interventions.

"Spin" refers to misleading reporting, interpretation, and extrapolation of findings in primary and secondary research (such as in systematic reviews). The study of spin primarily focuses on beneficial outcomes. The objectives of this research were threefold: first, to develop a framework for identifying spin associated with harms in systematic reviews of interventions; second, to apply the framework to a set of reviews, thereby pinpointing instances where spin may be present; and finally, to revise the spin examples, offering guidance on how spin can be rectified.The authors developed their framework through an iterative process that engaged an international group of researchers specializing in spin and reporting bias. The framework comprises 12 specific types of spin for harms, grouped by 7 categories across the 3 domains (reporting, interpretation, and extrapolation). The authors subsequently gathered instances of spin from a random sample of 100 systematic reviews of interventions. Of the 58 reviews that assessed harm and the 42 that did not, they found that 28 (48%) and 6 (14%), respectively, had at least 1 of the 12 types of spin for harms. Inappropriate extrapolation of the results and conclusions for harms to populations, interventions, outcomes, or settings not assessed in a review was the most common category of spin in 17 of 100 reviews.The authors revised the examples to remove spin, taking into consideration the context (for example, medical discipline, source population), findings for harms, and methodological limitations of the original reviews. They provide guidance for authors, peer reviewers, and editors in recognizing and rectifying or (preferably) avoiding spin, ultimately enhancing the clarity and accuracy of harms reporting in systematic review publications.

A cross-sectional analysis of reporting guideline and clinical trial registration policies in nephrology journals.

OBJECTIVE: To determine the extent to which nephrology journals recommend and require reporting guideline adherence and clinical trial registration. BACKGROUND: Despite a rising disease burden, research published on chronic kidney disease (CKD) and the field of nephrology has failed to keep pace and is limited. To improve the quality of research in the field of nephrology, reporting guidelines have been developed to minimize such deficits in research quality. However, the extent to which nephrology journals require and use reporting guidelines in addition to clinical trial registration is unknown. METHODS: Sixty-two Nephrology journals were selected through the 2021 Scopus CiteScore tool. Each journal's Instructions for Authors was assessed to determine endorsement of study design-specific reporting guidelines or clinical trial registration. Researchers used R (version 4.2.1) and RStudio to create data summaries of descriptive statistics for nephrology journal reporting guidelines. RESULTS: Clinical trial registration was required by 52% (32/62) of nephrology journals within our sample. The reporting guideline for clinical trials, CONSORT, was required by 17.74% (11/62) of journals. The EQUATOR Network was mentioned by 46.77% (29/62) of journals, while 9.67% (6/62) failed to mention the ICMJE. The reporting guideline for systematic review, PRISMA, was only required by 12.90% (8/62) of journals. When contacting journal editors, 9.67% (6/62) responded and 4.83% (3/62) provided clarifying information. CONCLUSIONS: Reporting guidelines and clinical trial registration are suboptimally required and recommended by nephrology journals. Their adoption may decrease bias and increase research quality. Thus, nephrology journals should consider a more complete endorsement of these safeguards.

Assessing Patient Risk, Benefit, and Outcomes in Drug Development: Insights From Afatinib Clinical Trials Across Diverse Cancer Indications.

PURPOSE: In 2013, afatinib was approved for non-small-cell lung cancer with subsequent indication expansion. We investigated published afatinib clinical trials to assess risk and benefit profiles for the drug in its approved indication of non-small-cell lung cancer as well as in off-label uses. Previous literature demonstrates excessive patient burden and limited benefit as afatinib has spread into more indications. A trial analysis is needed to establish efficacy and risk. METHODS: In this investigation, we screened literature databases and clinical trial registries for trials of afatinib as monotherapy or in combination interventions for cancer treatment. We extracted participant demographics, adverse event characteristics, as well as clinical and surrogate endpoints for each trial. Studies were deemed positive, negative, or indeterminate based on their achieving of primary endpoints as well as their safety. RESULTS: Our search yielded 2444 articles; we excluded 2352 articles for a final inclusion of 92 trials of 8859 patients. Our sample had 49 (53%) positive trials, 27 (29%) negative trials, and 16 (17%) indeterminate trials. The most common off-label indications for afatinib were breast cancer and squamous cell carcinoma of head and neck. The median OS for all trials was 8.4 months, median PFS 3.4 months, and the total ORR was 29.6%. Our study found that trials performed in disease states beyond the initial indications were largely negative with little patient benefit. The adverse events within our trial sample appear to be in line with expectations for toxicity. IMPLICATIONS: These results are consistent with other studies that present similar findings, such as in Carlisle et al which indicate limited efficacy in nonapproved indications. Future trials should keep this potential evidence and patient burden in mind before initiation of those trials. This study contributes to the understanding of afatinib's risk-benefit profile across many clinical applications.

Assessing patient risk, benefit, and outcomes in drug development: A decade of ramucirumab clinical trials.

OBJECTIVE: This study aims to evaluate published clinical trials of ramucirumab to assess the risk/benefit profile and burden over time for patients. BACKGROUND: The burden of oncologic drug development on patients paired with increasing clinical trial failure rates emphasizes the need for reform of drug development. Identifying and addressing patterns of excess burden can guide policy, ensure evidence-based protections for trial participants, and improve medical decision-making. METHODS: On May 25, 2023 a literature search was performed on Pubmed/MEDLINE, Embase, Cochrane CENTRAL, and ClinicalTrials.gov for clinical trials using ramucirumab as monotherapy or in combination with other interventions for cancer treatment. Authors screened titles and abstracts for potential inclusion in a masked, duplicate fashion. Following data screening, data was extracted in a masked, duplicate fashion. Trials were classified as positive when meeting their primary endpoint and safety, negative or indeterminate. RESULTS: Ramucirumab was initially approved for gastric cancer but has since been tested in 20 cancers outside of its FDA approved indications. In our analysis of ramucirumab trials, there were a total of 10,936 participants and 10,303 adverse events reported. Gains in overall survival and progression-free survival for patients were 1.5 and 1.2 months, respectively. FDA-approved indications have reported more positive outcomes in comparison to off-label indications. CONCLUSION: We found that FDA-approved indications for ramucirumab had better efficacy outcomes than non-approved indications. However, a concerning number of adverse events were observed across all trials assessed. Participants in ramucirumab randomized controlled trials saw meager gains in overall survival when evaluated against a comparison group. Clinicians should carefully weigh the risks associated with ramucirumab therapy given its toxicity burden and poor survival gains.

Family medicine journals' endorsement of reporting guidelines and clinical trial registration: a cross-sectional analysis.

BACKGROUND: Family medicine, vital for patient care but underfunded, prompts an evaluation of how family medicine journals endorse, require, and advocate for reporting guidelines (RGs), clinical trial, and systematic review registration. AIM: Assess endorsement and requirement of RGs, and the stance on clinical trial and systematic review registration in family medicine journals, impacting research quality and transparency. DESIGN & SETTING: A cross-sectional analysis of 43 "Family Practice" journals, identified through the 2021 Scopus CiteScore. Editors-in-Chief were contacted to confirm article types. Data extracted from "instructions to authors" pages focused on RG recommendations, requirements, and trial registration. METHOD: To ensure confidentiality and prevent bias, authors independently extracted data on RG utilisation, adherence, and clinical trial registration provide a overview of research standards. RESULTS: Of 43 journals, the most recommended guidelines were CONSORT (69%), PRISMA (58%), and STROBE (60%). The most required were PRISMA (16%) and CONSORT (11%). Clinical trial registration was recommended or required by 67% of journals. Additionally, 40 out of the 43 (93%) journals cited at least one reporting guideline in their instructions to authors. CONCLUSION: Family medicine journals exhibit varied endorsement and requirement patterns for RGs and clinical trial registration. While guidelines like CONSORT, PRISMA, and STROBE are acknowledged, caution is needed in presuming a direct link to enhanced research quality. A nuanced approach, promoting diverse reporting guidelines and rigorous study registration, is essential for elevating transparency and advancing research standards in family medicine.

Reporting of Complications in Rhinoplasty Randomized Controlled Trials: An Analysis Using the CONSORT Extension for Harms Checklist.

OBJECTIVE: This study aimed to assess the completeness of adverse event (AE) reporting in randomized control trials (RCTs) focused on rhinoplasty, using the Consolidated Standards for Reporting (CONSORT) Extension for Harms checklist. STUDY DESIGN: A cross-sectional design was employed to review RCTs related to rhinoplasty published between January 1, 2005, and January 28, 2022. SETTING: The study analyzed clinical trials on rhinoplasty retrieved from PubMed. METHODS: We performed a comprehension search on PubMed, blind and duplicate screening, and data extraction. Adherence to the 18 recommendations of the CONSORT Extension for Harms was evaluated, with 1 point assigned for each adhered item. Percent adherence was calculated based on the 18 points, taking into account the multiple subcategories within some recommendations. Descriptive statistics were used to summarize adherence-including frequencies, percentages, and 95% confidence intervals. RESULTS: Our search returned 240 articles, of which 56 met inclusion criteria. No RCTs adhered to all 18 CONSORT Extension for Harms items. Twenty-six (26/56, 46.4%) adhered to ≥50% of the items, and 30 (30/56, 53.6%) adhered to ≥33.3% of the items. Seven (7/56, 12.5%) RCTs adhered to no items. Across all RCTs, the average number of CONSORT-Harms items adhered to was 7.2 (7.2/18, 40.0%). The most adhered to item was item 10. Discussion balanced with regard to efficacy and AEs (80.4%, [70.0-90.8]). CONCLUSION: This study highlights the inadequacy of AE reporting in rhinoplasty RCTs according to CONSORT-Harms guidelines. Urgent efforts are required to bridge this reporting gap and enhance transparency in surgical research, ultimately safeguarding patient well-being.

Understanding Public Perception of Naloxone: A Study of FAQs and Answer Source Credibility.

PURPOSE: The most commonly used intervention for opioid overdoses is naloxone. With naloxone soon to be sold over-the-counter in the United States, the goal of this paper is to categorize frequently asked questions (FAQs) and answers about naloxone using internet sources in a cross-sectional fashion. METHODS: Terms "narcan" and "naloxone" were searched on a clean Google Chrome browser using the "People also asked" tab to find FAQs and their answer sources. We classified questions and sources and assessed each website's quality and credibility grading with JAMA benchmark criteria. The Kruskal-Wallis H test was used to determine variance of mean JAMA score by source type and Post-Hoc Dunn's test with Bonferroni corrected alpha of 0.005 used to compare source types. RESULTS: Of the 305 unique questions, 202 (66.2%) were classified as facts, 78 (25.6%) were policy, and 25 (8.2%) were value. Of the 144 unique answer sources, the two most common included 55 (38.2%) which were government entities and 47 (32.6%) which were commercial entities. Ninety-two (of 144, 63.9%) sources met three or more JAMA benchmark criteria. Statistical analysis showed a significant difference between the JAMA benchmark scores by source type H(4) = 12.75, p = 0.0126 and between the mean rank of academic and government sources (p = 0.0036). CONCLUSION: We identified FAQs and their citations about naloxone, highlighting potential lack of understanding and knowledge of this important intervention. We recommend updating websites to accurately reflect current and useful information for those that may require naloxone.

Assessment of Rehabilitation Journal Requirements for the Use of Reporting Guidelines and Clinical Trial Registration.

OBJECTIVE: To assess reporting guideline and clinical trial registration requirements in rehabilitation journals. DESIGN: We examined rehabilitation journals with 5-year impact factors exceeding 1.00 from the 2021 Scopus CiteScore tool, alongside the 28 journals included in the 2014 rehabilitation and disability quality improvement initiative. Journals outside the traditional rehabilitation scope were excluded. SETTING: A publicly-funded academic health center in the United States. PARTICIPANTS AND INTERVENTIONS: N/A. MAIN OUTCOME MEASURE(S): The proportion of journals requiring/recommending reporting guideline use and clinical trial registration. RESULTS: Over 90% (57/63) of journals required/recommended clinical trial reporting guidelines, while 68% (39/57) specified guideline requirements for systematic review/meta-analysis protocols. The 2014 collaborative initiative journals demonstrated higher rates of requiring/recommending reporting guidelines for clinical trials (24/26; 92.3%), systematic reviews/meta-analyses (23/26; 88.5%), observational studies in epidemiology (22/25; 88%), and diagnostic accuracy studies (20/24; 83.3%). Conversely, the 2021 Scopus CiteScore journals displayed higher rates for the remaining study designs. Overall, 52/63 (82.5%) journals required/recommended trial registration. Trial registration policies were comparable, with a slight advantage favoring the 2021 Scopus CiteScore journals. CONCLUSION: Rehabilitation journals variably promoted reporting guideline use and clinical trial registration. Common study designs like clinical trials, observational studies in epidemiology, and diagnostic accuracy studies demonstrated robust requirement/recommendation rates, while less common designs like economic evaluations and animal research had suboptimal rates. Journals can enhance reporting guideline use and trial registration by directing authors to the EQUATOR Network, requiring adherence to registration and reporting standards, and clarifying language in author instructions.

Assessing Patient Risk, Benefit, and Outcomes in Drug Development: A Decade of Lenvatinib Clinical Trials: A Systematic Review.

IMPORTANCE: Chemotherapy agents are typically initially tested in their most promising indications; however, following initial US FDA approval, new clinical trials are often initiated in less promising indications where patients experience a worse burden-benefit ratio. The current literature on the burden-benefit profile of lenvatinib in non-FDA-approved indications is lacking. OBJECTIVE: This study aimed to evaluate published clinical trials of lenvatinib in order to determine the burden-benefit profile for patients over time. EVIDENCE REVIEW: On 25 May 2023, we searched the Pubmed/MEDLINE, Embase, Cochrane CENTRAL, and ClinicalTrials.gov databases for clinical trials of lenvatinib used to treat solid cancers. Eligible articles were clinical trials, containing adult participants, published in English, and involving solid tumors. Screening and data collection took place in a masked, duplicate fashion. For each eligible study, we collected adverse event data, trial characteristics, progression-free survival (PFS), overall survival (OS), and objective response rate (ORR). Trials were classified as positive when meeting their primary endpoint and safety, negative (not meeting either criteria), or indeterminate (lacking prespecified primary endpoint). FINDINGS: Expansion of clinical trial testing beyond lenvatinib's initial FDA indication demonstrated a consistent rise in cumulative adverse events, along with a decline in drug efficacy. Lenvatinib was tested in 16 cancer indications, receiving FDA approval in 4. A total of 5390 Grade 3-5 adverse events were experienced across 6225 clinical trial participants. Expanded indication testing further demonstrated widely variable ORR (11-69%), OS (6.2-32 months), and PFS (3.6-15.7 months) across all indications. After initial FDA approval, clinical trial results in expanded indications were less likely to meet their primary endpoints, particularly among non-randomized clinical trials. CONCLUSION AND RELEVANCE: Our paper evaluated the effectiveness of lenvatinib for its FDA-approved indications; however, expansion of clinical trials into novel indications was characterized by diminished efficacy, while patients experienced a high burden of adverse events consistent with lenvatinib's established safety profile. Furthermore, clinical trials testing in novel indications was marked by repeated phase I and II clinical trials along with a failure to progress to phase III clinical trials. Future clinical trials using lenvatinib as an intervention should carefully evaluate the potential benefits and burden patients may experience.

Assessing the degree to which randomized controlled trials align with the core outcome set for osteoarthritis of knee and hip: A cross-sectional analysis.

OBJECTIVE: To assess the degree of core outcome set alignment and identify issues with alignment to the 2019 COS among clinical trial registrations focused on knee and/or hip osteoarthritis (OA). METHODS: Our search was performed on registered knee and hip OA randomized controlled trials (RCTs) available on ClinicalTrials.gov and WHO International Clinical Trials Registry Platform. The screening process considered trials registered between 8/2014 and 6/2023. We extracted data on general trial characteristics and the five trial endpoints detailed in the COS (pain, physical function, quality of life, patient global assessment, and adverse events), in a masked and duplicate manner. The frequencies of COS alignment were assessed over time prior to and after COS publication. RESULTS: Of the 10,718 RCTs screened, 481 met inclusion criteria. Most were phase 3 (368/481, 76.51%) and heavily university-funded (184/481, 38.25%). Despite the 2019 COS, no marked enhancement in overall alignment was noted. The outcome 'Pain' exhibited the highest degree of COS alignment (455/481, 94.59%), whereas 'adverse events' lagged behind (89/481, 18.50%). Additionally, trial factors such as 'Continent', 'Funding Type', and 'Recruitment Status' displayed no significant influence on COS alignment. CONCLUSIONS: Despite the acknowledged advantages of using COS in RCTs and the availability of an updated COS, the alignment to these outcomes remains notably low. Significant efforts are needed to encourage broader adoption in future studies on knee and hip OA, with the aim of improving research quality and patient care.

Gender disparities in neuropsychological assessment research in drug abuse populations: A systematic review.

Objective: To systematically review the literature on the neurocognitive effects of drug use to determine if there are significant gender differences. Methods: In April 2023, we conducted a broad search in MEDLINE (via PubMed), PsycINFO, and Embase for original research studies that used objective neuropsychological assessment to evaluate neurocognition in persons with drug use. Data extraction was performed in a masked, duplicate fashion. Results: Our initial search returned 22,430 records, of which 273 articles were included in our analysis. We found significant underrepresentation of women as participants in the studies. Twenty-one percent of studies had exclusively male participants; when women were included, they averaged only 23% of the sample. Only 49 studies sufficiently documented an analysis of their results by gender; due to the heterogeneity in study characteristics, no conclusions about cognitive differences between women and men could be made. Conclusions: Women are significantly underrepresented in the research on cognition in drug use. Increased efforts to include more women participants and consistent analysis and reporting of data for potential gender differences will be required to close this gap in knowledge, which may lead to improved substance abuse treatment approaches for women.

Inadequate harms reporting among randomized controlled trials cited as supporting evidence in the AAOS management of hip fractures in older adults clinical practice guideline recommendations.

BACKGROUND: Recommendations within clinical practice guidelines (CPGs) are heavily influenced by results from randomized controlled trials (RCTs). Therefore, it is imperative that all RCT outcomes are reported thoroughly to ensure CPGs are created using accurate information. Here, we evaluate the quality of harms reporting using the CONSORT Extension for Harms in RCTs underpinning recommendations in the American Academy of Orthopedic Surgeons (AAOS) Management of Hip Fractures in Older Adults CPG. METHODS: Each RCT cited as evidence for recommendations in the AAOS Management of Hip Fractures in Older Adults CPG was evaluated using the CONSORT Extension for Harms to determine the quality of harms reporting. Descriptive statistics (frequencies, percentages, 95 % confidence intervals) were used to summarize adherence to CONSORT Harms items. A linear regression model was used to evaluate the CONSORT Harms influence on the quality of reporting over time. RESULTS: Among the 156 RCTs identified, there were a total of 31,848 participants. Most RCTs were conducted at a single center (137; 87.8 %) and in a single-blind manner (130; 83.3 %). Fifty-four (34.6 %) RCTs did not provide funding statements. Trials adequately reported an average of 6.65 out of 18 CONSORT Extension for Harms items (37.0 %). One RCT adequately reported all items, while five reported zero items. Forty-seven RCTs (30.1 %) reported ≥ 50 % of items and 73 (46.8 %) reported ≤ 33.3 % of items. The linear regression model demonstrated no significant increase in mean adherence over time (adjusted R2 = -0.006; p = 0.563). CONCLUSION: Our results highlight inadequate harms reporting among RCTs in the AAOS Management of Hip Fractures in Older Patients CPG. While the CONSORT Harms Extension was intended to enhance reporting, the linear regression model did not demonstrate significant improvements over time.

Assessing uptake of the core outcome set in clinical trials for immune thrombocytopenia: A cross-sectional analysis.

INTRODUCTION: Clinical trials (CTs) guide clinical practice, but inconsistent outcome reporting presents challenges. To increase comparability, a core outcome set (COS) was created for primary Immune thrombocytopenia (ITP) in 2009 to standardize outcome measurements. We aimed to evaluate uptake of the primary ITP COS in CT registries. MATERIALS & METHODS: Our cross-sectional analysis employed a search string on ClinicalTrials.gov and ICTRP for phase III/IV CTs in June 2023. Inclusion criteria consisted of subjects with primary ITP, study was registered five years before COS publication to June 26, 2023, and assessed effectiveness of interventions. Two investigators extracted data in a masked, duplicate manner. Interrupted time series analysis, ANOVAs, and correlation analyses were conducted to assess the main outcome of COS uptake pre/post COS publication. RESULTS: The search identified 131 eligible trials for data extraction. Altogether, 38.2 % (50/131) followed IWG platelet response guidelines. An alternative platelet count measurement was 50,000 × 109 L, with 46.56 % (61/131) of trials reporting it. The most measured outcome was adverse events (106/131, 80.9 %). Remaining secondary outcomes were measured in <50 % of studies. After COS publication, there was a statistically non-significant 0.03 % (p = 0.50, CI 95 % = [-0.06, 0.13]) 0.03 % (p = 0.50, CI 95 % = [-0.06, 0.13]) increase in the monthly trend of COS-defined outcomes. CONCLUSION: We found a non-significant increase in uptake of the ITP COS since its publication and highlighted the lack of standardization among endpoints within ITP clinical trials. Our analysis highlights the need for heightened awareness and a COS update that acknowledges the variability in clinical trials.

Assessing the uptake of the type 1 diabetes core outcome set in randomized controlled trials: A Cross-Sectional study.

AIMS: This study analyzed uptake of the core outcome set (COS) for type 1 diabetes (T1D) and trends in its use before and after its development in December 2017. METHODS: On June 26, 2023, ClinicalTrials.gov was systematically searched for T1D randomized controlled trials. The Core Outcome Measures in Effectiveness Trials (COMET) database provided a COS of eight key outcomes for analysis. Included trials were analyzed for COS uptake before and after its release in December 2017 in a masked, duplicate fashion by independent reviewers. We also calculated the proportion of trials that measured the complete COS and assessed the most frequently reported COS outcomes. RESULTS: Of 3,792 originally screened articles, 144 RCTs were included in the final sample. Following COS publication, its use steadily decreased. Within the COS, HbA1c and severe hypoglycemia were most frequently implemented as endpoints; other recommended outcomes were rarely used in the published trials. CONCLUSION: Despite the 2017 T1D COS publication, use has decreased over time. This inconsistency negatively influences evidence-based practices and care. Educating researchers on COS and promoting uptake is crucial. Wider COS adoption in T1D trials could enhance clinical research overall. Further study of barriers and facilitators influencing uptake is essential to support consistent use and reporting.

A scoping review of health inequities in alcohol use disorder.

Background: Alcohol Use Disorder (AUD) poses a significant health burden on individuals. The burden occurs more frequently in the medically underserved, as well as racial and sexual minority populations. Ameliorating health inequities is vital to improving patient-centered care.Objectives: The objective of this scoping review is to chart the existing evidence on health inequities related to AUD and identify existing knowledge gaps to guide future equity-centered research.Methods: We performed a literature search using the Ovid (Embase) and MEDLINE (PubMed) databases for articles on AUD that were published in the 5-year period spanning from 2017 to 2021 and written in English. The frequencies of each health inequity examined were analyzed, and findings from each included study were summarized.Results: Our sample consisted of 55 studies for analysis. The most common inequity examined was by race/ethnicity followed by sex or gender. The least reported inequities examined were rural under-resourced areas and occupational status. Our findings indicate that significant research gaps exist in education, rural under-resourced populations, and LGBTQ+ communities with AUD.Conclusions: This scoping review highlights the gaps in research on inequities in AUD. To bridge the current gaps, we recommend research on the following: 1) triage screening tools and the use of telemedicine for rural, under-resourced populations; 2) interventions to increase treatment engagement and retention for women; and 3) community-based participatory methodologies for the LGBTQ+ communities.

Data-Sharing Across Otolaryngology: Comparing Journal Policies and Their Adherence to the FAIR Principles.

OBJECTIVE: Data-sharing plays an essential role in advancing scientific understanding. Here, we aim to identify the commonalities and differences in data-sharing policies endorsed by otolaryngology journals and to assess their adherence to the FAIR (findable, accessible, interoperable, reusable) principles. METHODS: Data-sharing policies were searched for among 111 otolaryngology journals, as listed by Scimago Journal & Country Rank. Policy extraction of the top biomedical journals as ranked by Google Scholar metrics were used as a comparison. The FAIR principles for scientific data management and stewardship were used for the extraction framework. This occurred in a blind, masked, and independent fashion. RESULTS: Of the 111 ranked otolaryngology journals, 100 met inclusion criteria. Of those 100 journals, 79 provided data-sharing policies. There was a clear lack of standardization across policies, along with specific gaps in accessibility and reusability which need to be addressed. Seventy-two policies (of 79; 91%) designated that metadata should have globally unique and persistent identifiers. Seventy-one (of 79; 90%) policies specified that metadata should clearly include the identifier of the data they describe. Fifty-six policies (of 79; 71%) outlined that metadata should be richly described with a plurality of accurate and relevant attributes. CONCLUSION: Otolaryngology journals have varying data-sharing policies, and adherence to the FAIR principles appears to be moderate. This calls for increased data transparency, allowing for results to be reproduced, confirmed, and debated.

Delayed discovery: the COVID-19 pandemic's influence on osteoarthritis clinical trials.

CONTEXT: The COVID-19 pandemic disrupted clinical research in many medical and surgical fields, resulting in research waste and loss of treatment for patients. Although other areas have been explored, the extent of the pandemic's influence on osteoarthritis (OA) trials is currently unknown. OBJECTIVES: This study aims to explore the reasons for termination of clinical trials investigating OA during the COVID-19 pandemic. METHODS: We searched ClinicalTrials.gov for OA trials and characterized their reason for discontinuation, noting where trialists directly cited the COVID-19 pandemic as the reason for trial discontinuation. We also coded other common reasons for trial discontinuation. Descriptive and inferential statistics were performed to determine the difference in enrollment, funding source, trial phase, allocation, and intervention type between the trials terminated early due to pandemic and nonpandemic reasons. RESULTS: Out of 135 clinical trials, 119 were included and 27 (22.7 %) of them reported the COVID-19 pandemic as a primary reason for discontinuation, which was the overall most common reason for OA trial discontinuation during the study period. We found statistically significant differences for trials discontinued due to pandemic vs. non-pandemic-related reasons, with trials having sites outside the United States, randomized allocation, and drug or device intervention type being most affected. However, there was no statistically significant difference between groups regarding trial phase, funding source, or enrollment. CONCLUSIONS: This study highlights the impact of the COVID-19 pandemic on the clinical trials related to OA. We found that many trials reported discontinuation directly due to the pandemic, which may lead to the loss or delay of novel treatments for OA. To avoid such discontinuation in the future, alternative methods for conducting OA-related clinical trials should be explored and implemented.

Endorsement of reporting guidelines and clinical trial registration across Scopus-indexed rheumatology journals: a cross-sectional analysis.

The purpose of this study was to investigate the instructions for authors of rheumatology journals and analyze their endorsement of reporting guidelines and clinical trial registration. Sixty rheumatology journals were selected by a research librarian and an investigator through the 2021 Scopus CiteScore tool. The instructions for authors' subsection of each journal was assessed to determine endorsement of study design-specific reporting guidelines or clinical trial registration. Descriptive statistics were calculated using R (version 4.2.1) and RStudio. Of the 58 journals analyzed, 34 (34/58; 59%) mentioned the EQUATOR Network: an online compendium of best practice reporting guidelines. The most commonly mentioned reporting guidelines were CONSORT with 44 journals (44/58; 75%), and PRISMA with 35 journals (35/58; 60%). The least mentioned guidelines were QUOROM with 56 journals not mentioning the guideline (56/58; 97%), and SRQR with 53 journals not mentioning the guideline (53/57, 93%). Clinical trial registration was required by 38 journals (38/58; 66%) and recommended by 8 journals (8/58; 14%). Our study found that endorsement of reporting guidelines and clinical trial registration within rheumatology journals was suboptimal with great room for improvement. Endorsement of reporting guidelines have shown to not only mitigate bias, but also improve research methodologies. Therefore, we recommend rheumatology journals broadly expand their endorsement of reporting guidelines and clinical trial registration to improve the quality of evidence they publish.

Taking a chance on outcome standardisation: A cross-sectional analysis assessing the uptake of the prevention of preterm birth core outcome set in randomised controlled trials.

OBJECTIVE: Analyse uptake of the core outcome set (COS) within preterm birth (PTB) clinical trials. DESIGN: On 26 June 2023, we conducted a systematic search of phase III/IV trial registry entries regarding PTB interventions via ClinicalTrials.gov and the International Clinical Trial Registry Platform. These trials were analysed for the outcomes measured. SETTING: N/A. SAMPLE: After searching the two databases, 5257 randomised controlled trials (RCTs) were screened, resulting in 92 RCTs for analysis. METHODS: Inclusion criteria were the following: subjects were patients receiving an intervention for PTB, study enrolment began within 5 years prior to publication of PTB COS to 26 June 2023, and evaluated the efficacy of interventions. Authors screened and extracted data in masked, duplicate fashion, then performed an interrupted time series analysis, analysis of variance and correlation analysis. MAIN OUTCOME MEASURES: We extracted outcomes measured by each clinical trial in our sample. Trials were analysed for the percentage of adopted outcomes from PTB COS. RESULTS: After COS publication, there was no significant change in percentage of COS outcomes measured. The most measured outcome was 'offspring mortality' (54.34%, 50/92) and the least measured outcome was 'late neonatal neurodevelopment morbidity' (3.26%, 3/92). Additionally, 22.83% (21/92) of trials measured zero outcomes related to the PTB COS. CONCLUSION: Our results demonstrated no significant change in outcome measurement before or after PTB COS publication. We recommend focusing on both the measurement of outcomes and the assessments that are used.