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BACKGROUND Randomized control trials (RCTs) serve as evidentiary support for recommendations underpinning clinical practice guidelines (CPGs) with the goal of optimizing patient care. A knowledge gap exists within scientific literature when evaluating the quality of RCTs used as evidence in the American Academy of Orthopaedic Surgery (AAOS) pediatric CPGs. We aim to evaluate the reporting quality and risk of bias in RCTs underlying AAOS Pediatric CPG recommendations. METHODS We located all AAOS Pediatric CPGs. We then extracted all RCTs from the CPG reference sections. All included RCTs were evaluated using the Consolidated Standards of Reporting Trials (CONSORT) checklist and Cochrane Collaboration risk of bias assessment tool (RoB 2.0). Descriptive statistics were recorded, and bivariate analysis was used to account for variance in CONSORT scores. A Mann-Whitney U test was completed to compare CONSORT studies published before and after 2010. RESULTS Three CPGs and 23 RCTs met inclusion criteria. Mean CONSORT adherence was 69.8% (21.6/31). The lowest adhered to CONSORT items were 10, 23, and 24, while items 2a, 13a, and 18 displayed the highest adherence. Ten RCTs (43.5%, 10/23) had "low" risk of bias, 5 RCTs (21.7%, 5/23) were of "some concerns," and 8 RCTs (34.8%, 8/23) received a "high" designation for risk of bias. There were no statistically significant associations in the bivariate regression analysis or Mann-Whitney U test. CONCLUSIONS Our results suggest that CONSORT adherence within RCTs used as evidence in AAOS Pediatric CPGs is substandard-relying on evidence that, in some cases, is >20 years old. Many of the RCTs cited as supporting evidence have a "high" risk of bias. Altogether, these CPGs may need to be updated or expanded to include more recent evidence relevant to pediatric orthopaedic surgery.

Background Research has shown that many physicians rely solely on abstracts to make clinical decisions. However, many abstracts have been shown to be misleading. The primary objective of this study was to identify the prevalence of spin—bias toward particular results—within the abstracts of systematic reviews and meta-analyses pertaining to the treatment of proximal humeral fractures, one of the most common osteoporotic fractures among elderly patients. Methods We systematically searched the MEDLINE and Embase databases to identify systematic reviews and meta-analyses examining the treatment of proximal humeral fractures. Screening and data extraction occurred in a masked, duplicate fashion. The 9 most severe types of spin that occur within abstracts were extracted, along with study characteristics, including journal recommendations to adhere to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines and year in which the review was performed, to identify potential associations. We subsequently explored the association between spin and the methodologic quality of a systematic review using the revised A Measurement Tool to Assess Systematic Reviews (AMSTAR 2) appraisal instrument. Results Our search retrieved 505 articles, among which 73 systematic reviews met the inclusion criteria. We found that 34.2% of the included systematic reviews (25 of 73) contained spin. Spin type 3 (“selective reporting of or overemphasis on efficacy outcomes or analysis favoring the beneficial effect of the experimental intervention”) was the most common type identified (12 of 73, 16.4%). Three spin types were not identified in any of the abstracts. Spin was 3.2 (odds ratio, 3.2; 95% confidence interval, 1.02-10.02) times more likely to be present in systematic reviews published in journals recommending adherence to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Furthermore, the odds of an abstract containing spin was 1.25 (odds ratio, 1.25; 95% confidence interval, 1.02-1.52) times more likely in systematic reviews for each year after 2000. No other study characteristics were associated with spin. The methodologic quality was rated as critically low in 24 studies (32.9%), low in 14 (19.2%), moderate in 28 (38.4%), and high in 7 (9.6%), but these findings were not associated with spin. Conclusion Spin was present in systematic review abstracts regarding the treatment of proximal humeral fractures. Measures such as education on the subject of spin and improved reporting standards should be implemented to increase awareness and reduce the incidence of spin in abstracts.

Purpose The purpose of this study is to determine the prevalence of spin in the abstracts of systematic reviews and meta-analyses on treatments for rotator cuff tears and whether various study and publishing journal characteristics were associated with the presence of spin. Methods A search strategy was developed for Ovid MEDLINE and Ovid Embase to retrieve systematic reviews focused on treatments for rotator cuff tears. For an article to be included, it must meet the following criteria: (1) the article must be a systematic review with or without a meta-analysis, (2) the article must pertain to the treatment of rotator cuff tears, (3) the article must only contain human subjects, and (4) the article must be accessible in English. Systematic reviews were analyzed for spin using a previously developed classification scheme in a masked, duplicate manner. Binary logistic regression was used to examine independent associations via unadjusted odds ratios and 95% confidence intervals between the presence of spin and study characteristics. Results Search queries returned 932 articles, of which 121 systematic reviews and meta-analyses were eligible. A total of 36.4% (44/121) of systematic reviews contained spin. Among the general characteristics evaluated, there were no correlations with spin. Conclusions Spin was present in more than one-third of systematic reviews and meta-analyses covering rotator cuff tear treatments. Spin was not associated with any general study or journal characteristics, which indicates that clinicians must be aware of the potential presence of spin in all such abstracts. Clinical Relevance Clinicians rely on systematic reviews and meta-analyses, especially abstracts of these articles, to provide succinct guidance on best practices in patient care. The presence of spin could adversely affect patient care; thus, steps should be taken to improve the reporting quality of abstracts on rotator cuff tear treatment.

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.

Objectives A cross-sectional analysis of orthopedic trauma randomized controlled trial (RCT) abstracts to assess the frequency and manifestations of spin, the misrepresentation or distortion of research findings, in orthopedic trauma clinical trials. Methods The top 5 orthopedic trauma journals were searched from January 1, 2012, to December 31, 2017. RCTs with nonsignificant endpoints (p > .05) were analyzed for spin in the abstract. The primary endpoint of our investigation was the frequency and type of spin. The secondary endpoint was to assess whether funding source was associated with the presence of spin. Due to the low reporting of funding sources no statistics were able to be computed for this outcome. Results Our PubMed search yielded 517 articles. Primary screening excluded 303 articles, and full text evaluation excluded an additional 161. Overall, 53 articles were included. Spin was identified in 35 of the 53 (66.0%) abstracts analyzed. Evidence of spin was found in 21 (39.6%) abstract results sections and 22 (41.5%) abstract conclusion sections. Of the 21 RCTs reporting a clinical trial registry, 3 (14.3%) had evidence of selective reporting bias. Conclusions Orthopedic trauma RCTs from highly ranked journals with nonsignificant endpoints published from 2012 to 2017 frequently have spin in their abstracts. Abstracts with evidence of spin may influence a reader's perception of new drugs or procedures. In orthopedic trauma, the implications of spin may affect the treatment of patients with orthopedic trauma, so efforts to mitigate spin in RCT abstracts must be prioritized.

Context “Spin” is a form of bias that involves highlighting study results in a way that presents the conclusions about benefit or efficacy beyond the scope of the data. Spin in the abstract of published studies has the potential to affect patient care, making investigations about its presence and prevalence important for readers. Objectives To evaluate the most severe types of spin in the abstracts of systematic reviews and metaanalyses focused on percutaneous coronary intervention. Methods Using a cross sectional study design, the authors searched MEDLINE and Embase with the terms “percutaneous coronary intervention,” “percutaneous coronary revascularization,” “PCI,” “systematic review,” “meta analysis,” and “meta-analysis.” To be considered for this study, the article must have (1) focused on PCI; (2) had either a systematic review or metaanalysis study design; (3) been conducted on human subjects; and (4) been available in English. Reviews were excluded if these criteria were not met. Each included article was assessed for the nine most severe types of spin as defined in a previously published article, as well as other study characteristics (type of intervention being compared, date the review was received, adherence of systematic review and/or meta-analysis to Preferred Reporting for Systematic Reviews or Metanalyses (PRISMA) guidelines, requirement of PRISMA guidelines by the publishing journal, the publishing journal’s five-year impact factor, and sources of funding). Results Our database search retrieved 7,038 records; 2,190 duplicates were removed. Initial title and abstract screening led to the exclusion of 4,367 records, and an additional 281 records were excluded during full text screening. An arbitrary limit of 200 articles was applied for this analysis; five additional articles were excluded for ineligible study design, so 195 were included in our final analysis. Spin was present in the abstracts of 43 studies from that pool (22.1%). Spin type 3—selective reporting of or overemphasis on efficacy outcomes or analysis favoring the beneficial effect of the experimental intervention—occurred most frequently (29; 14.8%). The presence of spin was not associated with any of the extracted study characteristics. Conclusions Our data showed that spin occurred in more than one in every five systematic reviews or metaanalyses of PCI. Spin has the potential to distort a reader’s ability to translate the true findings of a study; therefore, efforts are needed to prevent spin from appearing in article summaries.

Context Considering the substantial increase in research funding in the field of urology, minimizing research waste should be a top priority. Systematic reviews (SRs) compile available evidence regarding a clinical question into a single critical resource. If properly utilized, SRs can help minimize redundant studies, focus attention to unsubstantiated treatments, and reduce research waste. Objectives To appraise the use of SRs as justification for conducting randomized controlled trials (RCTs) published in high impact urology journals, and to report the ways SRs were incorporated into RCT manuscripts published in the top four urology journals by h5 index. Methods On December 13, 2019, a PubMed search was conducted for RCTs published in the top four urology journals according to the Google Scholar h5-index: European Urology, BJU International, The Journal of Urology, and Urology. For an article to be eligible for inclusion in this study, it must have been a full length RCT, published between November 30, 2014, and November 30, 2019 in one of the identified journals, reported only human subjects, and been accessible in English. The following data points were extracted independently by select investigators from each included RCT: manuscript title, year of publication, journal title, type of intervention (drug, medical device, procedure, other), funding source (government, hospital/university, industry, mixed) type of trial (parallel groups, crossover, cluster), and total number of participants reported in each RCT. The included RCTs were searched for reference to an SR, which was then recorded as “yes – verbatim,” “yes – inferred,” or “not used as justification” and the location in the manuscript where the SR was cited was recorded. Results Of the 566 articles retrieved, 276 were included. Overall, 150 (54.3%) RCTs cited an SR as either verbatim (108; 39.1%) or inferred (42; 15.2%) trial justification, while 126 (45.7%) did not use an SR for RCT justification. Of those 126, 107 (84.9%) RCTs did not cite an SR to any extent. A significant association was noted between verbatim justification and type of intervention (x 2=20.23, p=0.017), with 18 of 31 (58.1%) “other” interventions (i.e. psychosocial intervention, exercise programs, and online therapy) having an SR cited as verbatim justification. Only 39 of 118 (33.1%) pharmaceutical trials referenced an SR as verbatim justification. Of 403 systematic review citations, 205 (50.8%) appeared in the Discussion section, while 15 (3.7%) were in the Methods section. Conclusions We found that RCTs published in four high impact urology journals inconsistently referenced an SR as justification and 39.1% of our entire sample did not reference an SR at all. These findings indicate that a divide exists between the instruction and implementation of evidence based medicine in the field of urology concerning RCTs published in the top four journals. Educating clinicians and researchers on the use of SR as justification for RCTs in urology may reduce research waste and increase the quality of RCTs in the field.

Background: With 14.4 million U.S. adults diagnosed with alcohol use disorder (AUD) annually, effective treatments for combatting this condition are essential. Clinicians are often guided by systematic reviews and meta-analyses - considered the gold standard of research. Spin, a biased way of reporting results, may lead to misinterpretation of research findings, resulting in suboptimal patient care.Objective: Our primary objective was to investigate the presence of spin in the abstracts of systematic reviews of AUD treatments.Methods: After systematically searching MEDLINE and Embase for systematic reviews of AUD treatments, abstracts were evaluated for the nine most severe types of spin. Additional article characteristics were concurrently extracted and study quality was evaluated. Descriptive statistics of spin were calculated and associations between spin and study characteristics were determined through Fisher's exact and logistic regression.Results: Among 79 included systematic reviews, 44 instances of spin were identified spanning 43% of our sample (34/79). Of the nine forms of spin, eight were found with a majority of instances being "selective reporting of or overemphasis on efficacy outcomes" (13/44, 29.5% of cases). The majority of articles were rated as critically low quality (51/79, 64.6%). No association was found between the presence of spin and extracted study characteristics.Conclusions: Spin was found in more than 40% of systematic review abstracts that evaluated pharmacotherapies in the treatment of AUD. Coupled with the finding that the majority of systematic reviews on the subject were of low quality, increased awareness of spin among physicians may be warranted.

Purpose Outcomes of randomized controlled trials (RCTs) have been shown to influence clinical decision making. Thus, the quality and reliability of these outcomes are essential for both patients and medical care providers. To date, no study has assessed the quality of intervention reporting of RCTs in orthopaedics. The aim of this study was to evaluate the quality of intervention reporting of published RCTs in the field of orthopaedics using the Template for Intervention Description and Replication (TIDieR) checklist. Methods In this cross-sectional analysis, we applied the TIDieR checklist to assess the quality of intervention reporting in orthopaedic RCTs. Additionally, we evaluated the TIDieR checklist’s influence on intervention reporting by comparing overall adherence to checklist items in trials published before the TIDieR checklist’s release versus trials published after its release. Finally, we assessed whether certain factors were associated with the quality of intervention reporting. Results From a random sample of 300 publications in orthopaedic journals, 175 parallel-arm and cluster RCTs were identified. The overall rate of adherence to TIDieR items was 58.4%. Only 31.4% of orthopaedic RCTs adhered to at least 6 of the 12 TIDieR checklist items, whereas 0% adhered to all 12 items. We found no significant improvement in the quality of intervention reporting in studies published after the TIDieR checklist’s release compared with studies published before its release (P = .97). Additionally, preregistered trials were associated with more complete intervention reporting. Conclusions Our results suggest suboptimal reporting of orthopaedic RCT interventions. In addition, the TIDieR checklist’s intended effect—to better the quality of RCT intervention reporting—appears to have fallen short of its goal. Clinical Relevance Because outcomes of RCTs are used to guide clinical decision making, it is essential that orthopaedic surgeons and clinical practice guideline panels are equipped with high-quality published research. Increasing the accuracy of intervention reporting may lead to more accurate clinical application. Thus, adoption of more stringent reporting of trial interventions by researchers, authors, and journal editors may improve the quality of orthopaedic research, as well as improve patient outcomes.

Purpose To determine how changing the P value threshold of statistical significance from .05 to .005 could affect the statistical significance of findings in previously published orthopaedic sports medicine randomized controlled trials (RCTs). Methods The authors searched PubMed from January 1, 2016, to December 31, 2017, for RCTs published in the American Journal of Sports Medicine, Arthroscopy, and Knee Surgery, Sports Traumatology, Arthroscopy. Data were extracted blinded and in duplicate fashion by 2 of us. The authors then extracted P value data for primary end points, since RCTs are most often powered for these end points. Discrepancies were resolved by consensus. Google Forms were used for data extraction and STATA 15.1 for the data analysis. Results In total, 275 primary end points were identified from 132 trials. Analysis of primary end points found 45.8% (126/275) had a P value less than .05 and were classified as statistically significant under the current threshold, whereas 54.2% (149/275) had a P value greater than .05 and were not classified as suggestive. Of those end points that were previously considered statistically significant, 38.9% (49/126) were less than .005, whereas 61.1% (77/126) were between .005 and .05 and thereby would be reclassified as suggestive rather than statistically significant under the proposed threshold. Overall, when analyzing the 275 primary end points, we found only 49 (17.8%) of the end points were less than .005 and would hold statistical significance with the proposed threshold. Conclusions The results suggest that if the threshold of statistical significance were to change to .005, the significance of orthopaedic sports medicine RCTs would be heavily altered. The authors also acknowledge the many issues research faces in regard to P value reliability and therefore interpretation of study results. Because P values from RCTs can often influence the ways physicians choose interventions, it is important to implement methodology that decreases incidence of bias and misrepresentation of these results. However, the authors also understand that lowering the P value could increase the needed sample size and by consequence increase study costs as well, while not directly correlating to clinical significance. Thus, the authors recommend that this proposed threshold should be further evaluated and cautiously interpreted. Clinical Relevance If the statistical significance threshold is changed, clinical practice guideline recommendations also may be affected.

Objective: Scholastic activity through research involvement is a fundamental aspect of a physician’s training and may have a significant influence on future academic success. Here, we explore publication rates before, during, and after otolaryngology residency training and whether publication efforts correlate with future academic achievement. Methods: This cross-sectional analysis included a random sample of 50 otolaryngology residency programs. From these programs, we assembled a list of residents graduating from the years in 2013, 2014, and 2015. Using SCOPUS, PubMed, and Google Scholar, we compiled the publications for each graduate, and data were extracted in an independent, double-blinded fashion. Results: We included 32 otolaryngology residency programs representing 249 residents in this analysis. Graduates published a mean of 1.3 (SD = 2.7) articles before residency, 3.5 (SD = 4.3) during residency, and 5.3 (SD = 9.3) after residency. Residents who pursued a fellowship had more total publications ( t247 = −6.1, P 247 = −5.4, P 247 = −8.2, P 247 = −7.9, P Conclusion: Research productivity correlated with a number of characteristics such as future fellowship training, the pursuit of an academic career, and overall h-index in this study.

Objectives: To identify, quantify, and characterize the presence of spin—specific strategies leading to misrepresentation of study results—in the abstracts of systematic reviews and meta-analyses of Ménière’s disease treatment. Methods: Using a cross-sectional design, we searched MEDLINE and Embase on May 28, 2020, for systematic reviews and meta-analyses focused on Ménière’s disease treatment. Returned searches were screened, and data were extracted in a masked, duplicate fashion. Results: Our sample included 36 systematic reviews and meta-analyses. Of the 36 included studies, 22 (61.1%) abstracts contained spin while 14 (38.9%) did not. The most common spin types were selective reporting of benefit (10/36, 27.8%) or harm (8/36, 22.2%). Other types of spin occurred when findings were extrapolated to the global improvement of the disease (5/36, 13.9%), beneficial effects were reported with high risk of bias in primary studies (3/36, 8.3%), and when beneficial effects were extrapolated to an entire class of interventions (1/36, 2.8%). No instances of other spin types occurred. Abstracts containing spin were substantively associated with studies of critically low methodological quality compared with studies with low and moderate quality. No studies had a methodological rating of high quality. No associations were observed between spin and intervention types, journal recommendation of adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses, or funding. We found a negative correlation ( r = −.31) between abstract word limit and presence of spin. Conclusions: Our study highlights that spin in the abstracts of systematic reviews of Ménière’s disease is common, and it further enhances the discussion surrounding spin in abstracts of scientific research. Spin in an abstract does not discredit a study’s findings; however, its occurrence should be eliminated.

Purpose We investigated meetings of the Dermatologic and Ophthalmic Drug Advisory Committee (DODAC) and the Ophthalmic Devices Panel (ODP) of the Food and Drug Administration (FDA) to determine whether a relationship exists between receipt of industry payments by speakers of the Open Public Hearing (OPH) portion and the nature of their recommendations regarding treatment approval. Design Cross-sectional study. Methods We reviewed publicly available transcripts of all DODAC and ODP meetings from February 2009 to December 2019. For each meeting, information about each public speaker including presence of conflict of interest (COI) and whether their testimony regarding the drug or device was positive, negative, or neutral toward treatment approval was extracted in a blinded fashion using a pilot-tested Google Form. Results Of the 86 speakers, 66 (76.7%) included a COI disclosure statement and 41 (47.7%) disclosed a COI. Regarding classification of the speakers' testimonies, 70 (81.4%) of 86 were positive, 9 (10.5%) of 86 were negative, and 7 (8.1%) of 86 were neutral. Each one of the 41 speakers with a COI gave a positive testimony. Speakers who disclosed a COI were significantly more likely to give a positive testimony than speakers who did not (P Conclusion We recommend the DODAC and ODP require full disclosure of COI information and introduce stricter policies to manage COIs, allowing the committee to fully understand the context of the public speakers' comments, including the possible influence of COI on these comments.

Prcis In our sample of systematic reviews focusing on treatments for glaucoma, reviews conducted by authors with a conflict of interest were more likely to reach favorable conclusions compared with reviews without conflicted authors. Purpose Previous studies have demonstrated that authors' conflict of interest can influence outcomes of systematic reviews. Therefore, we aimed to determine whether the presence of 1 of more conflicts was associated with more favorable results and conclusions in systematic reviews of glaucoma interventions. Materials and methods MEDLINE and Embase were searched for systematic reviews of glaucoma treatments published between September 1, 2016 and June 2, 2020. Author conflicts of interest were located using multiple databases (eg, CMS Open Payments Database, Dollars for Profs, Google Patents, the United States Patent and Trademark Office USPTO) and previously published disclosure statements. Study sponsorship was determined using each review's funding disclosure statement. Results Our study included 26 systematic reviews conducted by 108 authors. Of these reviews, 9 (35%) were conducted by at least 1 author with an undisclosed conflict of interest. Of those 9, 3 (33%) reported results favoring the treatment group, and 5 (56%) reported conclusions favoring the treatment group. Of the 17 systematic reviews with no conflicted authors, 1 (6%) reported results favoring the treatment group, and 2 (12%) reported conclusions favoring the treatment group. The Fisher exact tests demonstrated that these differences held a statistically significant association between author conflicts and the favorability of the reviews' conclusions toward the treatment group (P=0.04). Conclusions We found that systematic reviews conducted by 1 or more authors with conflicts of interest were more likely than those with no conflicted authors to draw favorable conclusions about the investigated intervention.

OBJECTIVE We investigated the randomized controlled trials (RCTs) related to acute respiratory distress syndrome (ARDS) to assess the presentation and frequency of misrepresented research findings, also known as spin. METHODS We searched PubMed (MEDLINE) for studies published from January 1, 2011 to December 31, 2019. We included randomized controlled trials with an ARDS intervention and a nonsignificant primary endpoint. Trial screening and data extraction was performed on all studies independently and in duplicate. The primary endpoint was to investigate the frequency and manifestation of spin in RCT abstracts. Our secondary endpoint was to investigate associations between funding source and spin. RESULTS Our PubMed search returned 766 articles with 37 meeting inclusion criteria. Spin was present in 14 (14/37, 37.8%; 95% CI 22.5%-55.2%) abstracts. The most common manifestations of spin were claiming benefit based on a significant secondary endpoint (6/14, 42.9%), followed by the use of 'trend' statements, such as 'trend toward significance' (2/14, 14.3%; 95% CI 1.8%-42.8%). The most common spin in abstract conclusions was in the form of claiming benefit due to a significant secondary endpoint (3/4, 75%; 95% CI 19.4%-99.4%). Our secondary endpoint did not identify a significant difference in the prevalence of spin in publicly funded (5/19, 26.3%; 95% CI 9.1%-51.2%) compared to privately funded (4/12, 33.3%; 95% CI 9.9%-65.1%) studies (p>.05). CONCLUSIONS RCTs of ARDS interventions with nonsignificant primary endpoints often included spin in the abstract. Spin in the abstract may influence clinician appraisal and interpretation of diagnostic or treatment modalities.

Objective Randomized controlled trials (RCTs) play a crucial role in the research and advancement of medical treatment. A cross-sectional study design was utilized to analyze the completeness of intervention reporting using the Template for Intervention Description and Replication (TIDieR) checklist and to evaluate factors associated with intervention reporting. A comparison of the completeness of intervention reporting before and after the publication of TIDieR was sought. Methods PubMed was searched for RCTs in the top 10 obesity journals per the Google h5-index. After excluding non-RCTs, 300 articles were randomly sampled. After assessing each publication for eligibility, two authors (SLR and DT) extracted data related to intervention reporting from records in an independent, masked fashion. Data were then verified and analyzed. Results The analysis revealed that the quality of intervention reporting is quite variable. Overall, no statistically significant difference in the quality of intervention reporting before and after the release of TIDieR guidelines was found. In general, obesity research has good intervention reporting in areas such as the mode of delivery, material lists for intervention, and procedure lists. However, four main areas in which obesity researchers can improve reporting quality were determined. These include providing the expertise and background of intervention providers and providing statements regarding the assessment of fidelity of the intervention. Conclusions Urgent intervention is warranted to improve the quality of research reporting in obesity research, which is a fundamental component of obesity management. This will likely require a unified approach from researchers, journals, and funding sources.

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

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

Aims Perhaps the most important step when designing and conducting randomized controlled trials (RCTs) in addiction is to put methodological safeguards in place to minimize the likelihood for bias to affect trial outcomes. In this study, we applied the revised Cochrane risk of bias tool (ROB 2) to RCTs of drug, alcohol or tobacco interventions. Methods We searched for trials published in 15 addiction medicine journals over a 7-year period. Our primary endpoint is the risk of bias of included studies. We conducted a sensitivity analysis of publicly funded trials. Results Overall, included RCTs were most often at high risk of bias per our judgments (244/487, 50.1%). However, significant proportions of included RCTs were at low risk of bias (123/487, 25.3%) or some concerns for bias (120/497, 24.6%). RCTs with behavioral modification interventions (19/44, 43.2%) and alcohol interventions (80/150, 53.3%) had the highest proportion of high-risk judgments. In a sensitivity analysis of publicly funded RCTs), 195/386 (50.5%) were at high risk of bias. Conclusions Approximately half of included drug, alcohol or tobacco RCTs in our sample were judged to be at high risk of bias with the most common reason being a lack of proper blinding or proper description of blinding. Key action items to reduce bias in future addiction RCTs include adequate randomization, blinding and inclusion of a trial registry number and protocol.

Thunberg's increased media attention coupled with her diagnosis-Asperger Syndrome (AS)-may foster help-seeking behaviors among those with similar psychiatric disorders. Using Google Trends data, we compared values of AS from the week of the UN Climate Summit through the end of the year compared to an ARIMA model predicting search interest had Thunberg not been in the media. The search trend for AS at peak was 254.07% higher than predicted and was on average 10.61 points above the projected model during this time. As the primary goal of AS intervention focuses on improving quality of life and preventing common comorbidities such as depression and anxiety, capitalizing on increased public interest in AS and help-seeking behaviors is imperative.

Objective The extent of intervention reporting in emergency medicine journals remains unclear. The primary objective is to assess overall completion of the Template for Intervention Description and Replication (TIDieR) checklist described in emergency medicine randomized clinical trials (RCTs). The secondary outcomes were to (1) compare reporting before and after TIDieR publication; (2) evaluate factors associated with intervention reporting. Methods Our cross-sectional study used Google Scholar's metrics to identify seven emergency medicine journals; of which, we randomly sampled 300 articles. Using two PubMed searches, we extracted 150 RCTs before and after publications of TIDieR. Two investigators independently extracted data. The primary analysis to measure overall completion included descriptive statistics for each checklist item. Our secondary analysis used an interrupted time series analysis and generalized estimating equations to determine the effect of TIDieR publication on intervention reporting. Results Our initial search yielded 635 articles; from which, we randomly sampled 300 articles. We excluded 67 articles, leaving 233 for analysis. The mean number of TIDieR items reported was 5.4 (standard deviation = 1.18). Of the 233 trials, 42.9% provided information about materials, 67% provided intervention procedures, and 99.1% provided intervention delivery. The least reported items were intervention modifications (2.6%), intervention adherence assessment methods (3.4%), and intervention adherence assessment outcomes (2.2%). Conclusions The completeness of intervention reporting is suboptimal in emergency medicine journals, necessitating improvement. The current state of adherence could be improved through the combined efforts of journal editors, major editorial organizations, and authors.

Background Randomized controlled trials (RCTs) play an integral role in childhood cancer research. Several efforts to improve the quality of reporting of clinical trials have been published in recent years, including the TIDieR checklist. Many reviews have since used TIDieR to evaluate how well RCTs are being reported, but no such study has yet been done in childhood cancer. The aim of this study is to evaluate adherence of RCTs involving acute lymphocytic leukemia (ALL) to the TIDieR checklist. Methods The PubMed database was used to screen for RCTs involving ALL published since 2015. Of 1546 articles identified, 46 met study criteria and were then evaluated against the TIDieR 12-point checklist to measure the degree of adherence. Results Of the 46 articles included, 9 (19.6%) met full TIDieR criteria. Seven of the 9 reported non-pharmacological interventions, and the remaining 2 reported pharmacological interventions. The average article properly reported 8.98/12 checklist items. Item 5 (intervention provider) was the most poorly reported item, properly reported in only 34.8% of articles. Conclusion We conclude that overall TIDieR adherence is low and needs to be adhered to more fully in order to improve research in ALL as well as in all childhood cancers.

Background Given the central role of radiology in patient care, it is important that radiological research is grounded in reproducible science. It is unclear whether there is a lack of reproducibility or transparency in radiologic research. Purpose To analyze published radiology literature for the presence or lack of key indicators of reproducibility. Methods This cross-sectional retrospective study was performed by conducting a search of the National Library of Medicine (NLM) for publications contained within journals in the field of radiology. Our inclusion criteria were being MEDLINE indexed, written in English, and published from January 1, 2014, to December 31, 2018. We randomly sampled 300 publications for this study. A pilot-tested Google form was used to record information from the publications regarding indicators of reproducibility. Following peer-review, we extracted data from an additional 200 publications in an attempt to reproduce our initial results. The additional 200 publications were selected from the list of initially randomized publications. Results Our initial search returned 295,543 records, from which 300 were randomly selected for analysis. Of these 300 records, 294 met inclusion criteria and 6 did not. Among the empirical publications, 5.6% (11/195, [3.0–8.3]) contained a data availability statement, 0.51% (1/195) provided clear documented raw data, 12.0% (23/191, [8.4–15.7]) provided a materials availability statement, 0% provided analysis scripts, 4.1% (8/195, [1.9–6.3]) provided a pre-registration statement, 2.1% (4/195, [0.4–3.7]) provided a protocol statement, and 3.6% (7/195, [1.5–5.7]) were pre-registered. The validation study of the 5 key indicators of reproducibility—availability of data, materials, protocols, analysis scripts, and pre-registration—resulted in 2 indicators (availability of protocols and analysis scripts) being reproduced, as they fell within the 95% confidence intervals for the proportions from the original sample. However, materials’ availability and pre-registration proportions from the validation sample were lower than what was found in the original sample. Conclusion Our findings demonstrate key indicators of reproducibility are missing in the field of radiology. Thus, the ability to reproduce studies contained in radiology publications may be problematic and may have potential clinical implications.

Study objective We aim to investigate spin in emergency medicine abstracts, using a sample of randomized controlled trials from high-impact-factor journals with statistically nonsignificant primary endpoints. Methods This study investigated spin in abstracts of emergency medicine randomized controlled trials from emergency medicine literature, with studies from 2013 to 2017 from the top 5 emergency medicine journals and general medical journals. Investigators screened records for inclusion and extracted data for spin. We considered evidence of spin if trial authors focused on statistically significant results, interpreted statistically nonsignificant results as equivalent or noninferior, used favorable rhetoric in the interpretation of nonsignificant results, or claimed benefit of an intervention despite statistically nonsignificant results. Results Of 772 abstracts screened, 114 randomized controlled trials reported statistically nonsignificant primary endpoints. Spin was found in 50 of 114 abstracts (44.3%). Industry-funded trials were more likely to have evidence of spin in the abstract (unadjusted odds ratio 3.4; 95% confidence interval 1.1 to 11.9). In the abstracts' results, evidence of spin was most often due to authors' emphasizing a statistically significant subgroup analysis (n=9). In the abstracts' conclusions, spin was most often due to authors' claiming they accomplished an objective that was not a prespecified endpoint (n=14). Conclusion Spin was prevalent in the selected randomized controlled trial, emergency medicine abstracts. Authors most commonly incorporated spin into their reports by focusing on statistically significant results for secondary outcomes or subgroup analyses when the primary outcome was statistically nonsignificant. Spin was more common in studies that had some component of industry funding.

Objective To determine the extent to which systematic reviews published in surgery journals reported a clinical trial registry search as part of their search strategy and whether systematic reviews that omitted such searches would have located additional trials for inclusion. Background Systematic reviews are used by clinicians to guide clinical decision making. When conducting systematic reviews, the comprehensive search strategy is particularly critical to identify all studies—whether published or not—for producing an overall summary effect. Inclusion of only published studies may lead to overestimated and inaccurate summary effects; thus, it is important to consider unpublished studies. Here, we investigate the extent of clinical trial registry searches performed in surgical systematic reviews because trial registries may be the most viable approach to locate unpublished trial data. Methods We retrieved systematic reviews from the top surgery journals and the Cochrane Collaboration. Each was reviewed to determine which bibliographic databases were used and which, if any, trial registries were searched. Results Of 996 total systematic reviews, 252 (25.3%) reported having included a clinical trial registry search, with systematic reviews published in journals reporting searches of unpublished research at a rate of 6.4% (47/737). Reviews published by the Cochrane Collaboration included searches of unpublished research 79.2% of the time (205/259). Conclusions Many systematic reviews published in surgery journals include only published research, which may contribute to publication bias. We recommend that authors maximize available information by using unpublished trial data found in clinical trial registries.

A multidisciplinary international cohort of 72 expert statisticians and researchers recently proposed lowering the p value threshold from 0.05 to 0.005 to mitigate distortion of trial results and decrease bias. We hereby explored how a change to the p value threshold may alter the statistical significance of primary endpoints in gastroenterology (GE) randomized control trials (RCTs). We analyzed RCTs published in the 20 highest ranked GE and medicine journals. For each trial, we extracted the p values for the corresponding primary endpoints. We retrieved 233 RCTs, of which 159 were included in the final analysis yielding 202 primary endpoints. Of these endpoints, 60% had a p value less than 0.05 and when a threshold of less than 0.005 was applied, approximately 50% retained significance. We endorse a lower p value threshold as an actionable, provisional measure for improving statistical inference in GE RCTs until more long-term solutions become available.

BACKGROUND/OBJECTIVE: Given the drastic increase in publication output in recent years, minimizing research waste should be a top priority. There are established areas of concern regarding research waste within ophthalmology along with a lack of systematic review usage to inform trial design in other areas of medicine. Given these concerns, the aim of this study is to evaluate the use of systematic reviews as justification for conducting randomized controlled trials (RCT) in top ophthalmology and optometry journals. METHODS: We searched PubMed on December 5, 2018 for RCTs published in one of the top five Google Scholar h-5 index journals within Ophthalmology and Optometry. We used a pilot-tested Google Form and searched each RCT for systematic reviews. Each systematic review was then given the designation of “verbatim”, “inferred”, or “not used as justification for conducting the RCT” based on the context the systematic review was used. RESULTS: Our analysis yielded 152 included phase III RCTs. We found 22.4% (34 of 152) of phase III ophthalmology clinical trials cited a systematic review as justification for conducting the trial. A total of 102 systematic reviews were cited in the 152 RCTs. Fifty-seven of the one hundred fifty-two (37.5%) RCTs cited a systematic review somewhere in the manuscript. CONCLUSION: Less than one-quarter of phase III RCTs cited systematic reviews as justification for conducting the RCT. We believe placing a higher priority on justifying RCTs with systematic reviews would go a long way to minimizing research waste within ophthalmology.

Background The fragility index (FI) is calculated by iteratively changing one outcome “event” to a “non-event” within a trial until the associated p-value exceeds 0.05. Purpose To investigate the FI and fragility quotient (FQ) of trial endpoints referenced in the ACCF/AHA/SCAI guidelines in the management of ST-elevation myocardial infarctions. Secondarily, we assess the post-hoc power and risk of bias for these specific outcomes and whether differences exist between adequately and inadequately powered studies on fragility measures. Basic procedures All citations referenced in the guideline were screened for inclusion criteria. The FI and FQ for all included trials were then calculated. The Cochrane ‘risk of bias’ Tool 2.0 was used to evaluate the likelihood and sources of bias in the included trials. Main findings Forty-two randomized controlled trials were included for assessment. The median FI was 10 with a FQ of 0.0055. Seven trials were at a high risk of bias, all due to bias in the randomization process. Fifteen trials were found to be underpowered. Adequately powered studies had higher FIs and FQs compared to underpowered studies. Principal conclusions Our findings support the use of FI and FQ analyses with power analyses in future methodology of randomized control trials. With understanding and reporting of FI and FQ, evidence of studies can be readily available and quickly eliminate some readers' concern for possible study limitations.

The exaggerated language used in news articles to describe the benefits of cannabis for conditions without FDA indications may mislead the public and healthcare providers. Thus, this study's objective was to investigate the use of exaggerated language in news articles focused on cannabis and cannabis-derived products. Using a cross-sectional study design, we searched Google News from March 3, 2020, and September 3, 2019 for 11 prespecified superlative terms along with the search terms "cannabis," "cannabidiol," "pot," "marijuana," "weed," and "CBD." Articles were evaluated for these exaggerative terms describing cannabis and cannabis-derived products along with additional news article characteristics. Screening and data extraction occurred in a masked, duplicate fashion. We identified 612 superlative terms in 374 different news articles focused on cannabis and cannabis-derived products from 262 news outlets. Only 26 (of 374, 7.0%) news articles provided clinical data. In total, superlative terms were used to describe cannabis and cannabis-derived products for the treatment of 91 medical conditions, of which only 2 are FDA approved. The most common psychiatric disorder indicated was anxiety disorder appearing in 88 news articles. Superlatives in news articles covering the treatment of psychiatric illnesses with cannabis and cannabis-derived products are common.

INTRODUCTION AND OBJECTIVE:Publication bias in the form of discontinued or unpublished trials may warp our understanding of urologic oncology. This is due to trials dictating clinical practice are ...

Introduction The objective of this study was to assess for spin - a form of reporting that overemphasizes benefits or downplay harms - within abstracts of systematic reviews and meta-analyses related to the clinical practice of emergency medicine (EM). Methods PubMed was searched for systematic reviews and meta-analyses published since 2015 in either EM or general medical journals that examined an aspect of emergency medical care. In a duplicate, masked fashion, article titles and abstracts were screened to determine eligibility based on predetermined inclusion criteria. The included full-text studies were read and evaluated for spin using a previously determined search strategy. Two authors further evaluated study quality using the AMSTAR-2 tool. Results Our PubMed search identified 478 systematic reviews and meta-analyses, of which a random sample of 200 was selected for data extraction. Spin within the abstract of the manuscript was identified in 34.5% (69/200) of the included reviews. We identified seven of the nine spin types, with two types being most common: (1) conclusion claiming a benefit despite high risk of bias among studies reviewed (19.5% of abstracts), and (2) conclusion claiming a benefit despite reporting bias (14.5%). No significant associations were found between the presence of spin and any of the evaluated study characteristics, the AMSTAR-2 appraisal, or the journal of publication. Conclusion Spin is commonly present in abstracts of EM systematic reviews. The reporting quality for EM systematic reviews requires improvement. Measures should be taken to improve the overall review process and way information is conveyed through abstracts.

Aims Currently, there is a growing body of research demonstrating that spin - the misinterpretation and distortion of a study's findings - is common in different fields of medicine. To our knowledge, no study has investigated its presence in systematic reviews focused on diabetic therapies. Methods We performed a cross-sectional study by searching MEDLINE and Embase for systematic reviews focused on pharmacologic treatments for type 2 diabetes mellitus. Our search retrieved 26,490 records, from which 199 studies were extracted in a masked, duplicate fashion. Each study was evaluated for the nine most severe types of spin and other study design parameters. Spin was presented as frequencies and odds ratios to identify associations between study characteristics. Results Spin was identified in the abstracts of 15 systematic reviews (15/199, 7.5%). Spin type 5 was the most common type identified (7/199, 3.5%). Spin types 1, 2, 4, and 8 were not identified. In the last 5 years (2016-2021), 7 systematic reviews contained spin within their abstract. There was no association between spins presence and any extracted study characteristic . Conclusions Our findings show that spin infrequently occurs in abstracts of systematic reviews focused on pharmacologic therapies for type 2 diabetes mellitus. However, any amount of spin can lead to the distortion of a reader's interpretation of the study's findings. Thus, we provide recommendations with rationale to prevent spin in future systematic reviews.

Purpose: Detrimental effects of using non–patient-centered language (nPCL) have been reported for diabetes, mental illness, and obesity, and both the American Medical Association (AMA) and International Committee of Medical Journal Editors (ICMJE) recommend using patient-centered language in medical literature. Heart failure is a common yet stigmatized disease, and nPCL may further propagate stigma. This study analyzed current use of nPCL in journals focused on heart failure research and also examined whether the journals steer authors to adhere to AMA or ICMJE guidelines regarding nPCL. Methods: Following systematic search of PubMed for heart failure-related articles published from May 1, 2018, to April 30, 2020, cross-sectional analysis was performed. Each selected article was inspected for an array of nPCL terms and frequency of nPCL usage. Chi-squared tests and multivariable logistic regressions were used to assess relationships between study characteristics and nPCL use. Results: Of the 195 articles fully analyzed, 108 (55.4%) contained a nPCL term, the most frequently used being “heart failure patient” (78.7%), “burden” (23.1%), and “suffer” (15.7%). Use of nPCL was disproportionately more common in original research articles (63.5%) and less common in case reports (18.2%). Articles that did not detail any treatment or intervention used the most nPCL (71.1%). No statistically significant association was found between a journal’s impact factor and its adherence to AMA or ICMJE recommendations. Conclusions: nPCL is widely used in publications reporting on heart failure. We encourage authors and journals to reduce nPCL to help decrease the stigma patients with this disease often encounter.

Objective This study assesses the quality and completeness of systematic reviews (SRs) included by the National Comprehensive Cancer Network (NCCN) cancer screening clinical practice guidelines (CPGs). Methods We evaluated SRs according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and AMSTAR-2 (A Measurement Tool to Assess systematic Reviews). Results Seven NCCN CPGs were included with 109 SRs. The mean PRISMA percent completeness of included SRs was 71 % (range 0.1–1.0). The mean AMSTAR-2 percent completeness was 56 % (range 0.05−0.99). Of the 70 SRs assessed via AMSTAR-2, 42 (60 %) received a “critically low” rating, 11 (15.7 %) received “low” ratings, and 17 (24.3 %) received “moderate”. None of the SRs received a “high” rating. Conclusion Lack of adherence to AMSTAR-2 and PRISMA reporting standards among the SRs included is prevalent. We suggest improved reporting of SR inclusion criteria and evaluation to bolster the reporting quality of SRs underpinning CPG recommendations.

Introduction and aims: The high prevalence and economic burden of alcohol use disorder (AUD) requires methodologically sound research to guide treatment decisions. Systematic reviews (SR) are fundamental to clinical decision making as they collate results of all studies for a given topic and provide summaries of the clinical evidence. Bias resulting from industry relationships can compromise the validity of SRs. Thus, we investigated financial conflicts of interests (FCOI) within SRs involving the pharmacologic treatment of AUD. Design and Methods: We conducted a systematic search of PubMed, Embase, and the Cochrane Database to retrieve SRs published between September 2016 and December 2019. Screening and data extraction were performed in duplicate, blinded fashion-collecting characteristics of the reviews including the authors' FCOI statements. The results and discussion sections were rated as favorable or unfavorable toward the treatment drug. A stepwise method was used to identify undisclosed FCOIs for all SR authors. Results: Nineteen (of 51) authors representing 7 (of 12) SRs were found to have FCOI. Among reviews with conflicted authors, 3 of 7 (42.9%) results sections were favorable toward the treatment drug, whereas 6 of 7 (85.7%) conclusions were rated as favorable. Discussion and Conclusions: More than one-third of SR authors and nearly two-thirds of studies were found to have FCOIs. Our investigation shows that financial ties are frequent among SR authors on AUD pharmacotherapies and that discussion sections often favored the drug for which the sponsor provided payments.

Background Cardiac assessment in noncardiac surgery clinical practice guidelines should be supported by the highest-quality evidence such as that offered by systematic reviews. Currently, the methodological and reporting quality of these studies remains unknown. Methods We used PubMed to search for all clinical practice guidelines related to perioperative cardiovascular patients undergoing noncardiac surgery from 2010 to 2021. The included clinical practice guidelines were analysed for all systematic reviews and meta-analyses. The primary objective of this study was to determine reporting and methodological quality using the PRISMA (Preferred Reporting Instrument for Systematic Reviews and Meta-Analyses) and AMSTAR-2 (A Measurement Tool to Assess Systematic Reviews-2) instruments. Our secondary objective was to compare systematic reviews conducted by the Cochrane Collaboration with non-Cochrane studies. Results Three clinical practice guidelines were included in our study. Within these, 78 systematic reviews were included. PRISMA completion ranged from 34.8% to 100.0% with a mean of 76.9%. AMSTAR-2 completion ranged from 15.6% to 96.9% with a mean of 58.0%. Fifty-four systematic reviews underpinned a clinical practice guidelines recommendation, of which 25 were rated ‘critically low' by AMSTAR-2 appraisal. Cochrane systematic reviews typically performed better than non-Cochrane studies, but were a minority of the included studies (10/78). Conclusion We found deficiencies in several key areas regarding the methodological and reporting qualities of systematic reviews included in cardiac assessment in noncardiac surgery clinical practice guidelines. As these clinical practice guidelines are instrumental to clinical decision-making and patient care in cardiac assessment in noncardiac surgery, we advocate for improved reporting quality among systematic reviews cited as supportive evidence for these recommendations.

Objectives Randomized controlled trial (RCT) discontinuation and nonpublication are potential mechanisms of waste in resources and lead to decreased advancement of medical science and compromised ethical issues in all specialties. However, the prevalence of discontinued or unpublished RCTs regarding common pediatric otolaryngology disorders and interventions remains unclear. Study design Cross-sectional analysis. Methods Retrospective analysis of common pediatric otolaryngology RCTs registered in ClinicalTrials.gov up until November 2, 2018. Data were collected from the registry, and publication status was identified. If a reason for trial discontinuation or nonpublication was not identified through a systematic search, corresponding trialists were contacted through email. Results After exclusion, 260 RCTs were included for analysis. Analysis found 198 (76%) RCTs were completed, and 62 (24%) trials were discontinued. The most commonly reported reasons for RCT discontinuation were program termination by sponsor or management (7/24; 29.2%), lack of participant enrollment, difficulty recruiting, or slow accrual (7/24; 29.2%). A total of 192 (192/260; 73.8%) published RCTs and 68 (68/260; 26.2%) unpublished RCTs were identified. Twenty-six (26/62; 42%) of the discontinued RCTs reached publication, while 36 (58%) remained unpublished. Regarding the completed RCTs, 166 of 198 (83.8%) completed trials reached publication, while 32 (32/198; 16.2%) remained unpublished after trial completion. Conclusions Approximately 1 in 4 of included RCTs were discontinued or did not reach publication. Findings suggest further guidance is needed for RCTs regarding common pediatric otolaryngology disorders and interventions. Level of evidence NA.

Non-publication and premature discontinuation for clinical trials pose an ethical dilemma for trial participants, patients, clinicians, and researchers, as well as the general public as these studies receive significant public funding that may be further contributing to research waste. Here, we investigate the rate of trial discontinuation and non-publication among CRC trials using ClinicalTrials.gov. We performed an advanced search on ClinicalTrials.gov pertaining to the treatment of CRC using the keyword colorectal cancer. For each clinical trial, links to the publication provided by ClinicalTrials.gov were searched and verified to be correct. If a publication was unable to be found using the methods above, we attempted to contact the lead investigator via email for the reason for non-publication. Of the 123 (123/428, 28.7%) discontinued trials, a reason for discontinuation was provided for 57 (57/123, 46.3%) trials. Of the 305 (305/428, 71.3%) completed trials, 244 (244/305, 80.0%) had a verifiable publication, while 61 (61/305, 20.0%) did not publish their findings or were unable to be located. We found that more than one-quarter of trials were prematurely ended, and almost one-third of completed trials did not publish their findings. Subjecting trial participants to potentially harmful treatments and interventions that fail to complete or publish study findings have the potential to undermine the patient-provider relationship, as well as public confidence in government-sponsored clinical trials.

We used the Template for Intervention Description and Replication (TIDieR) to find evidence that intervention reporting in urology randomized controlled trials is suboptimal. Action to improve intervention reporting is warranted and we advise extending TIDieR into Consolidated Standards for Reporting Trials guidelines.

Highlights • Randomized Controlled Trials in plastic surgery are uncommon and complicated. • Plastic surgery articles have been shown to have poor compliance to CONSORT, with intervention reporting being the poorest. • The TIDieR checklist, when applied, improves intervention reporting and reproducibility., Background Randomized controlled trials (RCTs) are critical in developing new therapeutic approaches. Historically, in plastic surgery, RCTs are uncommon as they make up less than 2% of all publications. However there has recently been an increase in RCTs appearing in plastic surgery but the quality of these articles has yet to be assessed. We aim to determine the completeness of intervention reporting in plastic surgery RCTs using the TIDieR checklist. Methods A search of Pubmed for RCTs published in the top 10 plastic surgery journals as determined by the Google h5-index will be performed by two investigators. All identified articles will be isolated and a random selection of 300 articles will be screened for inclusion in the study by two different investigators. All types of RCTs will be included in this study. Articles will be excluded if they are nonrandomized, observational, follow-up studies, or secondary analyses. Full exclusion criteria can be found within this protocol. Extracted data includes all 12 points of the TIDieR checklist, journal, intervention type, sample size, and funding source. A complete list of what data will be extracted is listed within this protocol. All data extraction will be performed by two independent investigators. All work will be verified by the two investigators and any discrepancies will be resolved via consensus between investigators or with third party adjudication. Dissemination We plan to publish this review in a peer-reviewed journal. We may also present this review at local and/or national conferences.

Introduction A recent proposal suggests changing the threshold for statistical significance from a P value of .05 to .005 to minimize bias and increase reproducibility of future studies. P values less than .05 but greater than .005 would be reclassified as “suggestive”, whereas P values less than .005 would be considered significant. The present study explores how lowering the P value threshold would affect the interpretation of previously published orthopaedic trauma randomized controlled trials (RCTs) and whether outcomes from these trials would maintain statistical significance under the proposed P value threshold. Methods All RCTs published between January 01, 2016 and January 31, 2018 in the Journal of Orthopaedic Trauma, Injury, and Archives of Orthopaedic and Trauma Surgery were screened by at least 2 authors. Data from included trials were extracted in blinded and duplicate fashion. All P values for primary endpoints were included from each study. Results We identified 124 primary endpoints from 48 trials: 39.5% (49/124) of endpoints had a P value less than .05 and 60.5% (75/124) had a P value greater than .05. Overall, 51.0% (25/49) of statistically significant primary endpoints were less than .005, while 49.0% (24/49) would be reclassified as suggestive. Conclusion Based on our results, adopting a lower threshold of significance would heavily alter the significance of orthopaedic trauma RCTs and should be further evaluated and cautiously considered when viewing the effect such a proposal on orthopaedic practice.

ImportanceClear and comprehensive descriptions of clinical trial interventions are necessary to translate new results into clinical practice. The TIDieR checklist was developed to be a minimum set of key items considered essential to high-quality reporting of clinical trial interventions.ObjectiveTo determine the quality of reporting of recent Food and Drug Administration (FDA)-approved oncology interventions.DesignCross-sectional investigation.Setting/Participants/InterventionRecent, FDA-approved haematology/oncology anticancer interventions.Main outcome measureQuality of reporting.ResultsAcross all included trials (n=96), a median of 8–9 (out of 12) TIDieR items were reported. Seven TIDieR items had >90% adherence, including individual-level and study-level modifications of drugs and dosing schedules. Three items were less often reported: intervention provider, including training and expertise (7/192, 3.6%); trial institution infrastructure (0/192, 0.0%); and how intervention compliance was assessed (59/192, 30.7%). Publication of a protocol improved intervention reporting (pConclusionsIn this analysis of clinical trials of recent, FDA-approved anticancer interventions, we found good adherence to the TIDieR checklist. These studies were homogeneous in their structure and included information; some TIDieR items were always or never/rarely reported. Clinical trial effect sizes may not translate to real-world practice for a number of reasons. Thus, to aid the translation of trial effect sizes to real-world practice, we recommend authors adhere to the TIDieR checklist and describe the infrastructure of trial centres and describe who provided the intervention, along with their expertise.

AIM The fragility index is calculated by changing one outcome event to a nonevent within a trial until the associated P value exceeds 0.05. In this study, we assessed the robustness, risk of bias (RoB), and power of randomized controlled trials that underlie recommendations set forth by the American College of Gastroenterology (ACG) on managing dyspepsia and Helicobacter pylori infections. METHODS All citations referenced in the guidelines were screened for inclusion criteria. The fragility indexes for eligible trials were then calculated. The likelihood and sources of bias in the included trials were evaluated by the Cochrane 'RoB' Tool 2.0. RESULTS The median fragility index for the 52 trials was three events. Five studies (9.6%) resulted in a fragility index of 0 when statistical analysis was applied. For the 52 trials, 12 (23.1%) were at a low RoB, 15 (28.8%) had some concerns, and 25 (48.1%) were at a high RoB. High RoB was most commonly due to bias of selection in the reported result (15.5%). CONCLUSION A median of three events was needed to nullify statistical significance in 52 trials that underpin guideline recommendations on the management of dyspepsia and H. pylori infections. In addition, concerns for RoB were found for these trials.

Study objective Randomized controlled trials govern evidence-based clinical practice, and it is therefore critical that their results be robust. We aim to investigate the fragility of randomized controlled trials in emergency medicine by determining how often significance would be nullified with small changes in outcomes using the fragility index. Methods We conducted a methodological systematic review of randomized controlled trials in emergency medicine published in the top 10 general medicine journals and the top 10 emergency medicine journals. Inclusion criteria required that trials be emergency medicine studies structured with a 2-arm or 2-by-2 factorial design and report at least 1 statistically significant dichotomous outcome. Results A total of 180 trials met inclusion criteria. The median fragility index across all trials in emergency medicine was 4 (interquartile range [IQR] 2 to 10) and the median sample size was 140 (IQR 69.5 to 286). For trials from general medicine journals (n=32), the median fragility index was 9 (IQR 4 to 16.5) and the median sample size was 415.5 (IQR 219.5 to 901); for trials from emergency medicine journals (n=148), the median fragility index was 4 (IQR 1 to 9) and the median sample size was 119 (IQR 60 to 227.25). One third of all trials (62/180) had a loss to follow-up that was greater than or equal to the fragility index. There was a modest correlation between fragility index and total number of events ( r =0.36; 95% confidence interval [CI] 0.23 to 0.48) and a weak correlation between fragility index and total sample size ( r =0.26; 95% CI 0.12 to 0.39). There was no correlation between fragility index and either P value ( r =–0.14; 95% CI –0.28 to –0.006) or Science Citation Index ( r =0.07; 95% CI –0.08 to 0.22). Conclusion The statistical significance of the results of randomized controlled trials in emergency medicine was often contingent on a small number of events. Until frequentist interpretation of clinical trials is replaced with Bayesian analysis, the fragility index may have utility as a tool to aid clinicians in assessing the robustness of randomized controlled trials in emergency medicine when considered in conjunction with the fragility quotient and other reported metrics.

Background Spin is a specific type of reporting bias that misrepresents data and results within randomized controlled trials (RCTs). Because spin may provide a surgeon with an inaccurate representation of trial results, thus misconstruing the surgeons' interpretation thereof and possibly negatively affecting patient care, it is important that spin is identified within publications. The primary goal of our study was to determine the prevalence of spin found within the abstracts of lower extremity joint trials. Methods Using Google Scholar’s H-5 index, we selected the top 20 journals in the orthopedic surgery category. We then conducted a PubMed search on July 2nd, 2018 using the advanced search feature, encompassing all RCTs published in these journals from January 1, 2016 to January 1, 2017. Spin was evaluated using a standardized protocol, using a previously published protocol on the Open Science Network. Results Our final sample consisted of 46 trials published in 9 of the top 20 orthopedic surgery journals. Spin was found in 27 (58.7%) of the 46 abstracts. Evidence of spin in the abstract results was found in 19 (41.3%) of the 46 articles, and spin in abstract conclusions was found in 15 (32.6%) of the 46 articles. Conclusions Our study found that a significant number of lower extremity joint RCTs contain one or more form of spin in either their abstract results, conclusions, or both. In addition, our investigation revealed that a sizable portion of these lower extremity orthopedic joint RCTs are not registered or do not report their registration, and funding sources are also underreported.