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To identify the similarities and differences in data-sharing policies for clinical trial data that are endorsed by biomedical journals, funding agencies, and other professional organizations. Additionally, to determine the beliefs, and opinions regarding data-sharing policies for clinical trials discussed in articles published in biomedical journals.Two searches were conducted, a bibliographic search for published articles that present beliefs, opinions, similarities, and differences regarding policies governing the sharing of clinical trial data. The second search analyzed the gray literature (non-peer-reviewed publications) to identify important data-sharing policies in selected biomedical journals, foundations, funding agencies, and other professional organizations.A total of 471 articles were included after database search and screening, with 45 from the bibliographic search and 426 from the gray literature search. A total of 424 data-sharing policies were included. Fourteen of the 45 published articles from the bibliographic search (31.1%) discussed only advantages specific to data-sharing policies, 27 (27/45; 60%) discussed both advantages and disadvantages, and 4 (4/45; 8.9%) discussed only disadvantages specific. A total of 216 journals (of 270; 80%) specified a data-sharing policy provided by the journal itself. One hundred industry data-sharing policies were included, and 32 (32%) referenced a data-sharing policy on their website. One hundred and thirty-six (42%) organizations (of 327) specified a data-sharing policy.We found many similarities listed as advantages to data-sharing and fewer disadvantages were discussed within the literature. Additionally, we found a wide variety of commonalities and differences-such as the lack of standardization between policies, and inadequately addressed details regarding the accessibility of research data-that exist in data-sharing policies endorsed by biomedical journals, funding agencies, and other professional organizations. Our study may not include information on all data sharing policies and our data is limited to the entities' descriptions of each policy.

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

Reproducibility is a core tenet of scientific research. A reproducible study is one where the results can be recreated by using the same methodology and materials as the original researchers. Unfortunately, reproducibility is not a standard to which the majority of research is currently adherent.Our cross-sectional survey evaluated 300 trials in the field of Obstetrics and Gynecology. Our primary objective was to identify nine indicators of reproducibility and transparency. These indicators include availability of data, analysis scripts, pre-registration information, study protocols, funding source, conflict of interest statements and whether or not the study was available via Open Access.Of the 300 trials in our sample, 208 contained empirical data that could be assessed for reproducibility. None of the trials in our sample provided a link to their protocols or provided a statement on availability of materials. None were replication studies. Just 10.58% provided a statement regarding their data availability, while only 5.82% provided a statement on preregistration. 25.85% failed to report the presence or absence of conflicts of interest and 54.08% did not state the origin of their funding.In the studies we examined, research in the field of Obstetrics and Gynecology is not consistently reproducible and frequently lacks conflict of interest disclosure. Consequences of this could be far-reaching and include increased research waste, widespread acceptance of misleading results and erroneous conclusions guiding clinical decision-making.

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.

Background The objective of this study was to evaluate the nature and extent of reproducible and transparent research practices in neurology publications. Methods The NLM catalog was used to identify MEDLINE-indexed neurology journals. A PubMed search of these journals was conducted to retrieve publications over a 5-year period from 2014 to 2018. A random sample of publications was extracted. Two authors conducted data extraction in a blinded, duplicate fashion using a pilot-tested Google form. This form prompted data extractors to determine whether publications provided access to items such as study materials, raw data, analysis scripts, and protocols. In addition, we determined if the publication was included in a replication study or systematic review, was preregistered, had a conflict of interest declaration, specified funding sources, and was open access. Results Our search identified 223,932 publications meeting the inclusion criteria, from which 400 were randomly sampled. Only 389 articles were accessible, yielding 271 publications with empirical data for analysis. Our results indicate that 9.4% provided access to materials, 9.2% provided access to raw data, 0.7% provided access to the analysis scripts, 0.7% linked the protocol, and 3.7% were preregistered. A third of sampled publications lacked funding or conflict of interest statements. No publications from our sample were included in replication studies, but a fifth were cited in a systematic review or meta-analysis. Conclusions Currently, published neurology research does not consistently provide information needed for reproducibility. The implications of poor research reporting can both affect patient care and increase research waste. Collaborative intervention by authors, peer reviewers, journals, and funding sources is needed to mitigate this problem.

The aim of this study was to assess the methodological quality and accuracy of reporting within systematic reviews (SRs) that provide evidence to form clinical practice guidelines (CPGs) in the management and treatment of breast cancer.The 5 included CPGs for breast cancer management among National Comprehensive Cancer Network and European Society for Medical Oncology were searched for all SRs and meta-analyses. The characteristics of each study along with their methodological reporting were extracted from each SR using the PRISMA (Preferred Reporting Instrument for Systematic Reviews and Meta-Analyses) and AMSTAR-2 (A Measurement Tool to Assess Systematic Reviews 2) tools. Our second objective was to compare SRs produced by Cochrane groups vs non-Cochrane.Our study included 5 CPGs for the management of breast cancer, containing 1341 total references with 69 being unique SRs we analyzed. PRISMA completeness percent had a mean 76.3% (n = 69), while AMSTAR-2 completeness score mean was 66.5% (n = 59). Cochrane SRs were found to adhere far better to PRISMA (0.91 vs. 0.74) and AMSTAR-2 (0.95 vs. 0.62) guidelines compared to the non-Cochrane SRs.The reporting quality of SRs that underpin CPGs in breast cancer management widely varies. We recommend that authors of SRs adopt a more uniform approach in assessing the quality of reporting within their studies. In addition, CPGs should use a more standardized method to seek out evidence to establish their recommendations. With improved reporting, clinicians may have increased confidence in CPGs and thus increased utilization of CPGs in clinical decision making.

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.

Author(s): Johnson, Bradley S.; Rauh, Shelby; Tritz, Daniel; Schiesel, Michael; Vassar, Matt | Abstract: Introduction: We aimed to assess the reproducibility of empirical research by determining the availability of components required for replication of a study, including materials, raw data, analysis scripts, protocols, and preregistration.Methods: We used the National Library of Medicine catalog to identify MEDLINE-indexed emergency medicine (EM) journals. Thirty journals met the inclusion criteria. From January 1, 2014–n December 31, 2018, 300 publications were randomly sampled using a PubMed search. Additionally, we included four high-impact general medicine journals, which added 106 publications. Two investigators were blinded for independent extraction. Extracted data included statements regarding the availability of materials, data, analysis scripts, protocols, and registration.Results: After the search, we found 25,473 articles, from which we randomly selected 300. Of the 300, only 287 articles met the inclusion criteria. Additionally, we added 106 publications from high- impact journals of which 77 met the inclusion criteria. Together, 364 publications were included, of which 212 articles contained empirical data to analyze. Of the eligible empirical articles, 2.49%, (95% confidence interval [CI], 0.33% to 4.64%] provided a material statement, 9.91% (95% CI, 5.88% to 13.93%) provided a data statement, 0 provided access to analysis scripts, 25.94% (95% CI, 20.04% to 31.84%) linked the protocol, and 39.15% (95% CI, 32.58% to 45.72%) were preregistered.Conclusion: Studies in EM lack indicators required for reproducibility. The majority of studies fail to report factors needed to reproduce research to ensure credibility. Thus, an intervention is required and can be achieved through the collaboration of researchers, peer reviewers, funding agencies, and journals.

Take Home MessageMany components of transparency and reproducibility are lacking in urology publications, making study replication, at best, difficult.IntroductionReproducibility is essential for the integrity of scientific research. Reproducibility is measured by the ability of investigators to replicate the outcomes of an original publication by using the same materials and procedures.MethodsWe sampled 300 publications in the field of urology for assessment of multiple indicators of reproducibility, including material availability, raw data availability, analysis script availability, pre-registration information, links to protocols, and whether the publication was freely available to the public. Publications were also assessed for statements about conflicts of interest and funding sources.ResultsOf the 300 sample publications, 171 contained empirical data and could be analyzed for reproducibility. Of the analyzed articles, 0.58% (1/171) provided links to protocols, and none of the studies provided analysis scripts. Additionally, 95.91% (164/171) did not provide accessible raw data, 97.53% (158/162) did not provide accessible materials, and 95.32% (163/171) did not state they were pre-registered.ConclusionCurrent urology research does not consistently provide the components needed to reproduce original studies. Collaborative efforts from investigators and journal editors are needed to improve research quality, while minimizing waste and patient risk.

BACKGROUND Reproducibility is the backbone to ensuring reliable and transparent research. However, evidence reveals reproducibility may be lacking within emergency medicine. Reproducibility is defined by the replication of a study design and obtaining similar findings. Studies that share research components such as raw data, protocols, and analysis scripts increase the overall reproducibility by aiding study replication. Due to the evidence reproducibility in emergency medicine research may be lacking, investigation of the sharing of these research components is warranted. OBJECTIVE We aimed to assess the reproducibility of empirical research by determining the availability of components required for replication of a study, including materials, raw data, analysis scripts, protocols, and preregistration. METHODS The National Library of Medicine catalog was used to identify English language and MEDLINE-indexed emergency medicine journals. From 30 journals that met the inclusion criteria, 300 publications from January 1, 2014, to December 31, 2018, were randomly sampled using a refined PubMed search. Two investigators were trained for data extraction and analysis and were blinded for independent extraction of data. Extracted data included statements regarding the availability of materials, data, analysis scripts, protocols, and registration. RESULTS After search criteria were set, 25,473 articles were found, from which we randomly selected a sample of 300. Of the 300 articles, only 290 articles were accessible, and of these, 178 articles contained empirical data to analyze. Of the empirical articles eligible for each type of statement, 3.94% (95% confidence interval [95% CI] 1.74% to 6.14%) provided a materials statement, 9.42% (95% CI 6.11% to 12.73%) provided a data statement, 0.72% (95% CI 0% to 1.68%) provided access to the analysis scripts, 2.17% (95% CI 0.52% to 3.82%) linked the protocol, and 7.25% (95% CI 4.31% to 10.18%) were preregistered. CONCLUSIONS Emergency medicine studies are lacking indicators required for reproducibility. The vast majority of studies fail to report factors needed to reproduce research to ensure credibility, which requires an intervention that can be achieved through the collaboration of researchers, peer reviewers, funding agencies, and journals.