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.

Assessing patient burden and benefit: A decade of cabozantinib clinical trials.

Drug development is complex and costly. Clinical trial participants take on risks, making it essential to maximize trial efficiency and maintain participant safety. Identifying periods of excessive burden during drug development can inform trial design, ensure patient benefit and prevent harm. This study aims to examine all published clinical trials for cabozantinib to assess patient benefit and burden over time. We conducted a retrospective cross-sectional review of interventional clinical trials of cabozantinib for solid cancer treatment. We searched PubMed/MEDLINE, Embase, Cochrane (CENTRAL) and ClinicalTrials.gov. We extracted adverse event rates, median progression-free survival (PFS), median overall survival and objective response rate (ORR) for each included trial. We calculated frequencies of trial characteristics, cumulative grade 3-5 adverse event rates and cumulative ORRs. Out of 1735 studies, 54 publications were included that involved 6372 participants and 21 cancers. Of the 54 studies in our sample, 31 (57.41%) were single-arm trials and 23 (42.60%) had negative results. Trials among and within various indications had conflicting results over time. Cumulative risk to participants increased over time, and clinical benefit decreased. The findings suggest that the risk profile of cabozantinib increased from 2011 to 2016 and has remained elevated but stable while benefit has decreased over time. The use of non-randomized and single-arm trials is concerning, and more methodologically rigorous trials are needed. The results of trials for different indications are inconsistent, and empirical administration may reduce the drug's efficacy.

Reporting of Harms in Randomized Controlled Trials Published in Urology Journals: An Updated Analysis.

PURPOSE: Harms are often overlooked, but important, outcomes of randomized controlled trial reporting. Our goal was to determine if harms reporting has improved in high-impact urology journals. MATERIALS AND METHODS: Randomized controlled trials published in The Journal of Urology®, Urology, European Urology, and BJU International in 2012 and 2020 were analyzed. Each randomized controlled trial was evaluated by 2 authors in a masked-duplicate fashion to evaluate for adherence to harms reporting guidelines recommended by the Consolidated Standards of Reporting Trials (CONSORT) group. RESULTS: One hundred and thirty-two published studies met inclusion criteria. Between 2012 and 2020, there was a statistically significant increase in the median number of harms criteria reported between 2012 and 2020 (5.3 vs 7.2; P = .01). Methods criteria demonstrating the greatest improvements included item #3 "which harms were assessed," item #4a "when harm information was collected," and item #4b "methods to attribute harm to intervention." Results sections with the most improvement in reporting include item #6 "reasons for patient withdrawal," item #8a "effect size for harms," and item #8b "stratified serious + minor harms." CONCLUSIONS: Reporting of adverse events in randomized trials published in several top urology journals has demonstrated marked improvement. Studies published in 2020 reported approximately 70% of CONSORT-Harms criteria-an increase of nearly 40% since 2004. While these improvements mark significant change, deficits remain present and should be addressed to provide clinicians with the most complete perspective possible.

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.

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.

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.

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.

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.

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.

Health inequities in human papillomavirus prevention, diagnostics and clinical care in the USA: a scoping review.

BACKGROUND: Human papillomavirus (HPV) represents the most common STI in the USA. HPV inequities in prevention, diagnostics and clinical care persist. We define inequities as systematic, avoidable and unfair differences in health outcomes. OBJECTIVES: The objectives of this scoping review are to chart existing data on HPV-related inequities, identify gaps in existing literature and guide future research to reduce these inequities. METHODS: We completed a scoping review following guidelines from the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses scoping reviews extension. We performed a literature search on PubMed and Ovid Embase in July 2022 for articles pertaining to HPV and evaluating populations within the USA. We included English language publications from 2018 to 2022 evaluating at least one health inequity outlined by the National Institutes of Health. General publication characteristics and health inequity data were charted in a masked, duplicate fashion using a pilot-tested Google Form. We analysed frequencies of health inequities and summarised main findings from included studies. RESULTS: Our final sample included 170 publications. The most common inequities examined were race/ethnicity (140 studies), sex or gender (97 studies), and income (69 studies). Many historically marginalised racial/ethnic groups had lower rates of HPV-related knowledge, vaccination and worse overall outcomes related to HPV. Compared with women, men had lower rates of HPV vaccination and provider recommendation, and higher rates of HPV-infection. Results regarding income were largely conflicting. CONCLUSION: Findings from our review demonstrate clear gaps in HPV-related inequity research. Vaccine completion, provider recommendation and intersectionality should continue to be evaluated to implement targeted interventions.

Trial Registry Searches in Plastic Surgery Systematic Reviews: A Meta-epidemiological Study.

INTRODUCTION: Clinical trial registry searches for unpublished clinical trial data are a means of mitigating publication bias within systematic reviews (SRs). The purpose of our study is to look at the rate of clinical trial registry searches conducted by SRs in the top five Plastic and Reconstructive Surgery journals. METHODS: We identified the top five plastic and reconstructive surgery journals using the Google h-5 index. We then searched Pubmed for SRs published in these journals and compared them to plastic surgery SRs published in the Cochrane Collaboration for SRs over the last 5 y. We included all SRs that were published within these top five journals and Cochrane between December 6, 2016 and December 6, 2021. We then conducted a secondary analysis on clinicaltrials.gov looking for unpublished clinical trials for 100 randomized SRs that did not conduct a clinical trial registry search. RESULTS: In SRs, 3.3% (17/512) from plastic surgery journals conducted trial registry searches. In comparison, 95.0% (38/40) of Cochrane Collaboration SRs conducted trial registry searches. Our secondary analysis found that 50% (50/100) of SRs could have included at least one unpublished clinical trial data set. CONCLUSIONS: We found that plastic surgery SRs rarely include searches for unpublished clinical trial data in clinical trial registries. To improve the data completeness of SRs in plastic surgery journals, we recommend journals alter their author guidelines to require a clinical trial registry search for unpublished literature.

Assessing the Reporting and Frequency of Harms in Systematic Reviews Focused on Minimally Invasive Hysterectomies: A Cross-sectional Analysis.

OBJECTIVE: To assess the quality of harms reporting in systematic reviews (SRs) regarding minimally invasive hysterectomies (MIHs). DATA SOURCES: We performed a cross-sectional analysis on SRs addressing MIHs to assess completeness of harms reporting. Hysterectomies are common gynecologic procedures and are associated with complications. Such adverse events can directly affect physician decision making and patient outcomes. Thus, it is important that SRs equally weigh the harms and benefits surrounding MIHs. METHODS OF STUDY SELECTION: On May 15, 2022, we searched MEDLINE (PubMed and Ovid), Embase, Epistemonikos, and the Cochrane Database of Systematic Reviews for SRs with or without a meta-analysis on MIH for any indication. Eligible studies underwent full-text screening, data extraction, harms reporting assessment, and A Measurement Tool to Assess Systematic Reviews-2 quality assessment in a masked, duplicate fashion. The corrected covered area was calculated to indicate any overlap between SR dyads. TABULATION, INTEGRATION, AND RESULTS: A total of 52 SRs met the inclusion criteria for data extraction. We found that >44 of included SRs (of 52; 84.6%) reported >50% of the harms items. Completeness of harms reporting was significantly associated with harms specification as a primary outcome (p <.05). The corrected covered area was 0.60%. CONCLUSION: The harms reporting was more complete than hypothesized, but still had deficiencies throughout, such as inconsistent use of severity scales to classify harms. Even though MIH harms reporting in sample SRs was more complete than other fields of medicine, it was still suboptimal overall and requires refinement.

Lowering the statistical significance threshold of randomized controlled trials in three major general anesthesiology journals.

PURPOSE: The primary objective of our study was to determine how lowering a P value threshold from 0.05 to 0.005 would affect the statistical significance of previously published randomized controlled trials (RCTs) in major anesthesiology journals. METHODS: We searched the PubMed database for studies electronically published in 2020 within three major general anesthesiology journals as indexed by both Google Metrics and Scimago Journal & Country Rank. Studies included were RCTs published in 2020 in Anesthesiology, Anesthesia & Analgesia, and the British Journal of Anaesthesia; had a primary endpoint, and used a P value threshold to determine the effect of the intervention. We performed screening and data extraction in a masked duplicate fashion. RESULTS: Ninety-one RCTs met inclusion criteria. The most frequently studied type of intervention was drugs (44/91, 48%). From the 91 trials, 99 primary endpoints, and thus P values, were obtained. Fifty-eight (59%) endpoints had a P value < 0.05 and 41 (41%) had a P value ≥ 0.05. Of the 58 primary endpoints previously considered statistically significant, 21 (36%) P values would maintain statistical significance at P < 0.005, and 37 (64%) would be reclassified as "suggestive." CONCLUSIONS: Lowering a P value threshold of 0.05 to 0.005 would have altered one third of significance interpretations of RCTs in the surveyed anesthesiology literature. Thus, it is important for readers to consider post hoc probabilities when evaluating clinical trial results. Although the present study focused on the anesthesiology literature, we suggest that our results warrant further research within other fields of medicine to help avoid clinical misinterpretation of RCT findings and improve quality of care.

RéSUMé: OBJECTIF: L'objectif principal de notre étude était de déterminer comment l'abaissement d'un seuil de valeur P de 0,05 à 0,005 affecterait la signification statistique des études randomisées contrôlées (ERC) précédemment publiées dans certaines des principales revues d'anesthésiologie. MéTHODE: Nous avons réalisé des recherches dans la base de données PubMed pour trouver des études publiées électroniquement en 2020 dans trois des principales revues d'anesthésiologie générale et indexées par Google Metrics et Scimago Journal & Country Rank. Les études incluses étaient des ERC publiées en 2020 dans les revues Anesthesiology, Anesthesia & Analgesia, et le British Journal of Anaesthesia, qui avaient un critère d'évaluation principal et utilisaient un seuil de valeur P pour déterminer l'effet de l'intervention. Nous avons effectué la sélection et l'extraction des données de manière dupliquée masquée. RéSULTATS: Quatre-vingt-onze ERC remplissaient les critères d'inclusion. Le type d'intervention le plus fréquemment étudié était de nature médicamenteuse (44/91, 48 %). Sur les 91 études, 99 critères d'évaluation principaux, et donc valeurs P, ont été obtenus. Cinquante-huit (59 %) critères d'évaluation avaient une valeur P < 0,05 et 41 (41 %) avaient une valeur P ≥ 0,05. Sur les 58 critères d'évaluation principaux précédemment considérés comme statistiquement significatifs, 21 (36 %) valeurs P maintiendraient leur signification statistique à P < 0,005, et 37 (64 %) seraient reclassées comme étant « suggestives ¼. CONCLUSION: Le fait d'abaisser le seuil de valeur P de 0,05 à 0,005 aurait modifié un tiers des interprétations de signification des ERC dans la littérature anesthésiologique étudiée. Il est donc important que les lectrices et lecteurs tiennent compte des probabilités post hoc lors de l'évaluation des résultats d'études cliniques. Bien que la présente étude se soit concentrée sur la littérature en anesthésiologie, nous suggérons que nos résultats justifient des recherches supplémentaires dans d'autres domaines de la médecine afin d'éviter une mauvaise interprétation clinique des résultats des ERC et d'améliorer la qualité des soins.

Harms reporting by systematic reviews for functional endoscopic sinus surgery: a cross-sectional analysis.

OBJECTIVES: To evaluate the completeness of harms reporting in systematic reviews (SRs) pertaining to functional endoscopic sinus surgery (FESS). METHODS: Using a cross-sectional study design, we performed a comprehensive search using MEDLINE (PubMed and Ovid), EMBASE, Epistemonikos, and the Cochrane Database of Systematic Reviews databases for SRs regarding FESS on May 15th, 2022. Returns were screened and data were extracted in a masked, duplicate manner. Following established methodology, we extracted general study characteristics, harms items, and overall methodological quality for each SR in our sample. Corrected covered area (CCA) was calculated for SR dyads. For data analysis, using Stata 16.1 we performed a bivariate analysis between variables. RESULTS: Fifty-five SR's were included in our sample after excluding 375 studies that did not meet our inclusion criteria. Of the included SRs, 19 (19/55, 34.5%) did not report harms and 39 (39/55, 70.9%) reported half of the harms items or fewer. Our study found that 23 (23/55, 41.8%) of SRs demonstrated a method of harms data collection, 26 (26/55, 47.3%) of SRs had patients available for harms analysis in their results, and 25 (25/55, 45.5%) of SRs had a balanced discussion of harms and benefits of FESS. Fifty-two SRs were appraised as "critically low" quality using AMSTAR-2. A significant association was found between completeness of harms reporting (Mahady) and whether harms were listed as a primary outcome. No other associations were statistically significant. Two SR dyads had CCAs between 20% and 50% overlap and were compared for unique and shared harms. CONCLUSIONS: Our study demonstrates gaps in harms reporting regarding FESS in SRs. We recommend future studies implement guidelines such as the STROCCS guidelines or the harms extension of the PRISMA guidelines to improve harms reporting. Accurate harms reporting may advance patient safety and promote a more objective risk-benefit analysis for physicians and patients.

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.

Transparent and Reproducible Research Practices in the Surgical Literature.

INTRODUCTION: Previous studies have established a baseline of minimal reproducibility in the social science and biomedical literature. Clinical research is especially deficient in factors of reproducibility. Surgical journals contain fewer clinical trials than non-surgical areas of medicine, suggesting that it should be easier to reproduce the outcomes of surgical literature. METHODS: In this study, we evaluated a broad range of indicators related to transparency and reproducibility in a random sample of 387 articles published in Surgery journals between 2014 and 2018. RESULTS: A small minority of our sample made available their materials (5.3%, 95% C.I. 2.4%-8.2%), protocols (1.2%, 0-2.5%), data (2.5%, 0.7%-4.2%), or analysis scripts (0.04%). Four studies were adequately pre-registered. No studies were explicit replications of previous literature. Most studies (58%), declined to provide a funding statement, while conflicts of interest were declared in a small fraction (9.3%). Most have not been cited by systematic reviews (83%) or meta-analyses (87%), and most were only accessible to paying subscribers (59%). CONCLUSIONS: The transparency of the surgical literature could improve with adherence to baseline standards of reproducibility.

An Evaluation of Evidence Underpinning Management Recommendations in Tobacco Use Disorder Clinical Practice Guidelines.

INTRODUCTION: Clinical practice guidelines(CPGs) are important tools for medical decision-making. Given the high prevalence and financial burden associated with tobacco use disorder(TUD), it is critical that recommendations within CPGs are based on robust evidence. Systematic reviews(SRs) are considered the highest level of evidence, thus, we evaluated the quality of SRs underpinning CPG recommendations for TUD. METHODS: We used PubMed to search for CPGs relating to TUD published between January 1, 2010 and May 21, 2021. SRs were extracted from CPG references and evaluated using Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA) and A MeaSurement Tool to Assess Systematic Reviews(AMSTAR-2) tools. We then compared SRs conducted by the Cochrane Collaboration with non-Cochrane SRs using a Mann-Whitney U test and determined associations between PRISMA and AMSTAR-2 extracted characteristics using multiple regression. RESULTS: Our search generated 10 CPGs with 98 SRs extracted. Mean PRISMA completion was 74.7%(SD = 16.7) and mean AMSTAR-2 completion was 53.8%(SD = 22.0) across all guidelines. Cochrane SRs were more complete than non-Cochrane studies in the PRISMA and AMSTAR-2 assessments. The regression model showed a statistically significant association between PRISMA completion and AMSTAR-2 rating, with those classified as "low" or "moderate" quality having higher PRISMA completion than those with "critically low" ratings. CONCLUSION: We found substandard adherence to PRISMA and AMSTAR-2 checklists across SRs cited in TUD CPGs. A lack of recent SRs in CPGs could lead to outdated recommendations. Therefore, frequent guideline updates with recently published evidence may ensure more accurate clinical recommendations and improve patient care. IMPLICATIONS: Systematic reviews used to underpin clinical practice guideline recommendations influence treatment decisions and, ultimately, patient outcomes. We found that many systematic reviews underpinning tobacco use disorder guideline recommendations were out of date and unsatisfactory in reporting and quality. Thus, including newer systematic reviews containing more recently conducted trials and better reporting could alter recommendations and improve the rate of successful tobacco cessation attempts.

An analysis of harms reporting in systematic reviews regarding ketorolac for management of perioperative pain.

BACKGROUND: Owing to the frequent perioperative use of ketorolac tromethamine and its ability to minimise postoperative opioid requirements, it is important to continually reassess harms associated with its use. Our primary objective was to investigate the extent of harms reporting in systematic reviews (SRs) on ketorolac for perioperative pain. METHODS: In May 2022, we conducted a search of major databases, MEDLINE (PubMed and Ovid), Embase, Epistemonikos, and the Cochrane Database of Systematic Reviews to identify eligible SRs on ketorolac for perioperative pain. Screening and data extraction were performed in masked, duplicate fashion. A MeaSurement Tool to Assess systematic Reviews-2 (AMSTAR-2) was used to appraise the methodological quality of included SRs. Corrected covered area (CCA) was calculated to determine overlap of primary studies between SR dyads. RESULTS: A total of 28 SRs evaluating 630 primary studies met the inclusion criteria. Seven SRs (7/28, 25%) reported no harms and 17 SRs (17/28, 60.7%) reported ≤50% of harms items. A significant association was found between completeness of harms reporting and whether harms were specified as a primary outcome (P<0.001). No other associations were statistically significant. Regarding methodological quality, 22 SRs were appraised as 'critically low' (22/28, 78.6%), 5 as 'low' (5/28, 17.9%), and 1 as 'high' (1/28, 3.6%). One SR dyad had a CCA >50% but neither reported harms. CONCLUSIONS: The extent of harms reporting in systematic reviews was inadequate. Given the importance that systematic reviews have on guiding perioperative decision-making, it is essential to improve the completeness of harms reporting.

Conflicts of Interest Among Authors of Systematic Reviews Regarding the Management of Chronic Non-Cancer Pain with Opioids Analgesics.

OBJECTIVE: We sought to determine whether author conflict of interest (disclosed or undisclosed) or industry sponsorship influenced the favorability of reporting of systematic reviews and meta-analyses investigating the use of opioid analgesics for the management of chronic non-cancer pain. METHODS: Our search included the MEDLINE (Ovid) and Embase (Ovid) databases. Study sponsorship was determined using the funding statement provided in each systematic review. Author COI information was extracted from the COI disclosure statement. This information was cross-referenced with information available on the CMS Open Payments Database, Dollars for Profs, Google Patents, the United States Patent and Trademark Office (USPTO), and previously published COI disclosures. RESULTS: Eight systematic reviews authored by 83 authors were included. Of these authors, 19 (23.0%) were found to have a COI, of which the majority (17/19; 89.5%) had at least one undisclosed COI. Despite nearly one-quarter of authors having a COI, we found no association between the presence of a COI and the favorability of results (P = 0.64) or conclusions (P = 0.07). CONCLUSIONS: COI are common and frequently undisclosed among systematic review authors investigating opioid analgesics for the management of chronic non-cancer pain. Despite a high prevalence of COI, we did not find that these author-industry relationships had a significant influence on the favorability of results and conclusions; however, our findings should be considered a lower bound estimate of the true influence author COI have on outcomes of pain medicine systematic reviews secondary to the low sample size included in the present study.

Electronic cigarettes and public health awareness: a cross-sectional analysis of Google search inquiries.

The number of American adults who use electronic nicotine delivery systems (ENDS) increased by 3 million people in 2018, up 38.3% from 8.1 to 11.2 million. Search data for ENDS were analyzed against relevant traits including state longitude, tobacco tax rate and national tobacco program funding. Searches increased 88% (95% CI, 70-100) over the last 5 years and peaked on 8 September 2019, after the CDC issued a warning about the link between ENDS and high-profile lung damage cases. Searches aimed at buying ENDS subsequently dropped 25% (95% CI, 20.1-29.6), while health-related ENDS searches spiked to their all-time high, increasing 22% (95% CI, -6 to 55) compared with the first half of 2019. ENDS searches are now more concentrated than 5 years ago, reversing the trend of the early 2010s, likely because certain states have passed laws to curb the use of ENDS. The public prefers searching for 'vaping' over 'e-cigarette' in a phenomenon similar to 'high fructose corn syrup' versus 'sugar'. Consequently, public policy discussions and public education campaigns need to use 'vaping' terms, and more states should enact policies that are strongly associated with lower ENDS usage, many of which we identify.