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Aims/Background Blended learning has been a commonly adopted teaching mode in the medical education community in recent years. Many studies have shown that the blended learning mode is superior to the traditional teaching mode. Nonetheless, pinpointing the specific advantages provided by blended teaching methods is challenging, since multiple elements influence their effectiveness. This study aimed to investigate the reliability of the conclusions of published randomised controlled trials (RCTs) on blended learning in medical education by assessing their quality, and to provide suggestions for future related studies. Methods Two investigators searched PUBMED and EMBASE, and assessed RCTs related to medical blended learning published from January 1, 2010 to December 31, 2021. The analysis of the overall quality of each report was based on the 2010 consolidated standard of reporting trials (CONSORT) Statement applying a 28-point overall quality score. We also conducted a multivariate assessment including year of publication, region of the trial, journal, impact factor, sample size, and the primary outcome. Results A total of 22 RCTs closely relevant to medical blended learning were eventually selected for study. The results demonstrated that half of the studies failed to explicitly describe at least 34% of the items in the 2010 CONSORT Statement. Medical blended learning is an emerging new teaching mode, with 95.45% of RCTs published since 2010. However, many issues that we consider crucial were not satisfactorily addressed in the selected RCTs. Conclusion Although the 2010 CONSORT Statement was published more than a decade ago, the quality of RCTs remains unsatisfactory. Some important items were inadequately reported in many RCTs such as sample size, blinding, and concealment. We encourage researchers who focus on the effects of blended learning in medical education to incorporate the guidelines in the 2010 CONSORT Statement when designing and conducting relevant research. Researchers, reviewers, and editors also need to work together to improve the quality of relevant RCTs in accordance with the requirements of the 2010 CONSORT Statement. [ABSTRACT FROM AUTHOR]

Background: This study aimed to assess the overall reporting quality of randomized controlled trials (RCTs) in Chinese herbal medicine (CHM) formulas for patients with diabetes, and to identify factors associated with better reporting quality. Methods: Four databases including PubMed, Embase, Cochrane Library and Web of Science were systematically searched from their inception to December 2022. The reporting quality was assessed based on the Consolidated Standards of Reporting Trials (CONSORT) statement and its CHM formula extension. The overall CONSORT and its CHM formula extension scores were calculated and expressed as proportions separately. We also analyzed the pre-specified study characteristics and performed exploratory regressions to determine their associations with the reporting quality. Results: Seventy-two RCTs were included. Overall reporting quality (mean adherence) were 53.56% and 45.71% on the CONSORT statement and its CHM formula extension, respectively. The strongest associations with reporting quality based on the CONSORT statement were multiple centers and larger author numbers. Compliance with the CHM formula extension, particularly regarding the disclosure of the targeted traditional Chinese medicine (TCM) pattern (s), was generally insufficient. Conclusion: The reporting quality of RCTs in CHM formulas for diabetes remains unsatisfactory, and the adherence to the CHM formula extension is even poorer. In order to ensure transparent and standardized reporting of RCTs, it is essential to advocate for or even mandate adherence of the CONSORT statement and its CHM formula extension when reporting trials in CHM formulas for diabetes by both authors and editors. [ABSTRACT FROM AUTHOR]

Background TCM manipulation is an important way for the treatment of cervical spondylosis. A large number of randomized controlled trials (RCTs) about TCM manipulation for cervical spondylosis have been published as relevant research develops. However, various levels of qualities of these RCTs may be non-beneficial to the promotion of TCM manipulation and the generation of high-quality clinical evidence. Objective To evaluate the quality of RCTs of TCM manipulation for cervical spondylosis. Methods We searched RCTs of TCM manipulation for cervical spondylosis in databases of CNKI, Wanfang Data, VIP, SinoMed, PubMed, Embase and Cochrane Library from inception to June 2021. RCTs enrollment and data extraction were performed by two researchers, separately. Quality assessment was conducted using the PEDro Rating Scale, The Cochrane Collaboration's tool for assessing risk of bias, and the CONSORT 2010 Statement and other six indicators (whether the RCT is multicenter, with ethical approval, informed consent, quality control for intervention, efficacy assessment criteria, and acknowledgement) . Results Finally, 81 RCTs were included, of which 28 were published from 2006 to 2014, annually averaged 3.11, other 53 were published from 2015 to 2021, annually averaged 7.57. By the PEDro Rating Scale, the quality of only 7 (8.6%) RCTs was rated as high-quality (≥7 points) . By the Cochrane Collaboration's tool for assessing risk of bias, the percentage of RCTs with high risk of bias was the least, followed by that of those with low risk of bias. Most of RCTs had unclear risk of bias due to reported incomplete information. By the CONSORT 2010 Statement, the rates of title, abstract, methods, results, discussion and other information reported by the included RCTs were insufficient. By other six indicators, the rate of RCTs with a multicenter design, ethical approval, quality control for intervention, and acknowledgement was low. Conclusion The quality of current RCTs about TCM manipulation for cervical spondylosis is generally low. The improvement recommendation for relevant researchers is writing RCTs about the TCM manipulation for cervical spondylosis standardly in accordance with the PEDro Rating Scale, the Cochrane Collaboration's tool for assessing risk of bias, and the CONSORT 2010 Statement.

Background/Aim: This study aimed to evaluate the methodological quality of randomized controlled trials (RCTs) that examine home-based rehabilitation (HBR) trials for knee osteoarthritis (KOA) using the Physiotherapy Evidence Database (PEDro) scale and the nine methodology-related items of the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement. Methods: Three electronic databases were scanned from baseline to October 10, 2021. Two reviewers independently evaluated the articles according to the two inclusion criteria: (1) in individuals diagnosed with KOA, at least one group received home-based rehabilitation as a study intervention and (2) at least one group received a comparison intervention or no intervention. The methodological quality of the included studies (n=22) was assessed using the PEDro scale and nine items of the CONSORT 2010 statement. Results: Among 1557 RCTs, 22 studies that fulfilled our criteria were included in the review. The mean PEDro scale score was 5.77 (1.54). This result reflects moderate methodological quality. Concealed allocation (6; 27.3%), blinding of subjects (4; 18.2%), and (0; 0.0%) of therapists associated with the methodological quality were not reported in most studies. An author's expertise in epidemiology and/or statistics was 0.78 points (95% confidence interval [CI] 0.11-1.44), the multicenter study 0.94 points (95% CI: 0.19-1.68), and a one-unit increase in the total score of the CONSORT statement led to an increase in methodological quality of 0.55 points (95% CI: 0.34-0.76). Conclusion: The methodological quality of most RCTs examining HBR in KOA that we included in our systematic review was moderate. The adherence of journals and authors to CONSORT checklists in reporting of studies may lead to an improvement in the methodological quality of future published studies. [ABSTRACT FROM AUTHOR]

Purpose: To assess the quality of randomized controlled trials (RCTs) on varicocele published from 1979 to 2017. Materials and Methods: We searched for original RCT on varicocele published between 1979 and 2017. Jadad scale, van Tulder scale, and Cochrane Collaboration Risk of Bias Tool were used to analyze RCT quality over time. Effects on RCT quality including funding source, Institutional Review Board (IRB) approval, and intervention were assessed. Treatment parameters of varicocele were also analyzed. Results: Blinding and allocation concealment were described in 25.9% and 9.4% of RCT, respectively. Both tended to increase and a sharp dip in allocation concealment was observed in 2010–2017. Jadad scores increased steadily from 1979 to 2017 (1.28±0.59 to 2.19±1.10, p

Abstract Background Colorectal cancer (CRC) is currently one of the most frequently diagnosed cancers. Our aim was to evaluate transparency and selective reporting in interventional trials studying CRC. Methods First, we assessed indicators of transparency with completeness of reporting, according to the CONSORT statement, and data sharing. We evaluated a selection of reporting items for a sample of randomized controlled trials (RCTs) studying CRC with published full-text articles between 2021–03-22 and 2018–03-22. Selected items were issued from the previously published CONSORT based peer-review tool (COBPeer tool). Then, we evaluated selective reporting through retrospective registration and primary outcome(s) switching between registration and publication. Finally, we determined if primary outcome(s) switching favored significant outcomes. Results We evaluated 101 RCTs with published full-text articles between 2021–03-22 and 2018–03-22. Five trials (5%) reported all selected CONSORT items completely. Seventy-four (73%), 53 (52%) and 13 (13%) trials reported the primary outcome(s), the allocation concealment process and harms completely. Twenty-five (25%) trials were willing to share data. In our sample, 49 (49%) trials were retrospectively registered and 23 (23%) trials had primary outcome(s) switching. The influence of primary outcome(s) switching could be evaluated in 16 (16/23 = 70%) trials, with 6 (6/16 = 38%) trials showing a discrepancy that favored statistically significant results. Conclusions Our results highlight a lack of transparency as well as frequent selective reporting in interventional trials studying CRC.

Purpose: Temporomandibular disorders (TMDs) and their management are widely sought after by clinicians. They often refer to the reported randomized controlled trials (RCTs) in the literature. The Consolidated Standards of Reporting Trials (CONSORT) statement aims to improve the quality of published RCTs and is endorsed by healthcare journals. Despite the widespread acceptance of CONSORT, its use for reporting clinical trials in the journals remains suboptimal. The purpose of this study was to evaluate, to what extent RCTs related to TMDs have adhered to the CONSORT statement. Methodology: RCTs related to TMDs, published in PubMed from January 2017 to March 2021 were retrieved. Each article was assessed for its adherence to the CONSORT statement by four trained and calibrated investigators. Results: 88 articles were evaluated. Out of 37 items in the checklist, only 4 items demonstrated 100% adherence (item 2a, 2b, 5, 12a, and 16). The most under-reported items were 7a, 8b, 9, 10, 17a, 17b, 19, 23, and 24 (less than 50%). The mean percentage of adherence remained 71.2 ± 12.6. Only one study showed 100% adherence and three studies had less than 50% adherence. Considering adherence of abstract checklist, three items demonstrated 100% adherence (items 4, 5, and 6). Poor reporting was noted with items 8, 13, 15, and 16. The mean percentage of adherence to abstract reporting remained 68.60 ± 11.79. Conclusion: The present study indicates good adherence to CONSORT statement in reporting RCTs related to TMD management. Probably the mandatory instructions from the journals and increasing awareness among the researchers about CONSORT reporting might have done the trick.

Abstract Background With the improvement of therapeutic strategies from cytotoxic chemotherapy to immunotherapy, the possibility of achieving timely intervention for lung cancer has dramatically increased. This study aimed to systematically evaluate the reporting quality of randomized controlled trials (RCT) on immunotherapy in lung cancer. Methods The RCTs evaluating the efficacy of immunotherapy in lung cancer published up to 2021 were searched and collected from PUBMED and EMBASE by two investigators. The 2010 Consolidated Standards for Test Reports (CONSORT) statement‐based 28‐point overall quality score (OQS) and the 2001 CONSORT statement‐based 19‐point OQS was utilized for assessing the overall quality of each report. Results One hundred and fifty‐two related RCTs were retrieved in this study, including 81,931 patients. The average OQS in 2010 was 17.89 (range, 7.5–24.5). Overall, studies have sufficiently reported the eligibility criteria (143/152; 94.07%), described the scientific background (150/152; 98.7%) and discussed interventions (147/152; 96.7%). However, the RCTs did not consistently report the changes to trial after commencement (48/152; 31.6%), allocation, enrollment and assignment personnel (34/152; 22.4%), blinding (48/152; 31.6%), or randomization method (58/152; 38.2%). Conclusions The overall reporting quality of RCTs on immunotherapy in lung cancer was found to be unsatisfactory despite the fact that the CONSORT statement was issued more than a decade ago. Furthermore, there was virtual selectivity and heterogeneity in reporting some key issues in these trials. This is the first study to enlighten lung cancer researchers especially focusing on immunotherapy, and also to remind editors and peer reviewers to strengthen their due diligence.

Abstract Background Comprehensive reporting of clinical trials is essential to allow the trial reader to evaluate the methodological rigor of the trial and interpret the results. Since publication of the updated Consolidated Standards of Reporting Trials (CONSORT) guidelines for reporting of parallel clinical trials in humans, extensions for reporting of abstracts and crossover trials have been published. Objectives To describe the types of trials using dogs and cats published from 2015 to 2020 and to evaluate the quality of reporting of a sample of recently published parallel and crossover trials. Animals None. Methods A comprehensive search was conducted to identify parallel or crossover design clinical trials using dogs and cats published from January 1, 2015 onwards. Quality of reporting was evaluated on a subset of trials published during 2019. The reporting of items recommended in the CONSORT reporting guidelines for abstracts, parallel trials, and crossover trials was evaluated independently by 2 reviewers using standardized forms created for this study. Disagreements among reviewers were resolved by consensus. Results were tabulated descriptively. Results The frequency of reporting of trial features varied from low to high. There remain deficiencies in the quality of reporting of key methodological features and information needed to evaluate and interpret trial results. Conclusions and Clinical Importance There is still a need for authors, peer‐reviewers, and editors to follow reporting guidelines such as CONSORT to maximize the value of clinical trials and to increase confidence in the validity of the trial results.

Abstract Background In a cluster randomised controlled trial (CRCT), randomisation units are “clusters” such as schools or GP practices. This has methodological implications for study design and statistical analysis, since clustering often leads to correlation between observations which, if not accounted for, can lead to spurious conclusions of efficacy/effectiveness. Bayesian methodology offers a flexible, intuitive framework to deal with such issues, but its use within CRCT design and analysis appears limited. This review aims to explore and quantify the use of Bayesian methodology in the design and analysis of CRCTs, and appraise the quality of reporting against CONSORT guidelines. Methods We sought to identify all reported/published CRCTs that incorporated Bayesian methodology and papers reporting development of new Bayesian methodology in this context, without restriction on publication date or location. We searched Medline and Embase and the Cochrane Central Register of Controlled Trials (CENTRAL). Reporting quality metrics according to the CONSORT extension for CRCTs were collected, as well as demographic data, type and nature of Bayesian methodology used, journal endorsement of CONSORT guidelines, and statistician involvement. Results Twenty-seven publications were included, six from an additional hand search. Eleven (40.7%) were reports of CRCT results: seven (25.9%) were primary results papers and four (14.8%) reported secondary results. Thirteen papers (48.1%) reported Bayesian methodological developments, the remaining three (11.1%) compared different methods. Four (57.1%) of the primary results papers described the method of sample size calculation; none clearly accounted for clustering. Six (85.7%) clearly accounted for clustering in the analysis. All results papers reported use of Bayesian methods in the analysis but none in the design or sample size calculation. Conclusions The popularity of the CRCT design has increased rapidly in the last twenty years but this has not been mirrored by an uptake of Bayesian methodology in this context. Of studies using Bayesian methodology, there were some differences in reporting quality compared to CRCTs in general, but this study provided insufficient data to draw firm conclusions. There is an opportunity to further develop Bayesian methodology for the design and analysis of CRCTs in order to expand the accessibility, availability, and, ultimately, use of this approach.

Background: Colorectal cancer (CRC) is currently one of the most frequently diagnosed cancers. Our aim was to evaluate transparency and selective reporting in interventional trials studying CRC.Methods: First, we assessed indicators of transparency with completeness of reporting, according to the CONSORT statement, and data sharing. We evaluated a selection of reporting items for a sample of randomized controlled trials (RCTs) studying CRC with published full-text articles between 2021-03-22 and 2018-03-22. Selected items were issued from the previously published CONSORT based peer-review tool (COBPeer tool). Then, we evaluated selective reporting through retrospective registration and primary outcome(s) switching between registration and publication. Finally, we determined if primary outcome(s) switching favored significant outcomes.Results: We evaluated 101 RCTs with published full-text articles between 2021-03-22 and 2018-03-22. Five trials (5%) reported all selected CONSORT items completely. Seventy-four (73%), 53 (52%) and 13 (13%) trials reported the primary outcome(s), the allocation concealment process and harms completely. Twenty-five (25%) trials were willing to share data. In our sample, 49 (49%) trials were retrospectively registered and 23 (23%) trials had primary outcome(s) switching. The influence of primary outcome(s) switching could be evaluated in 16 (16/23 = 70%) trials, with 6 (6/16 = 38%) trials showing a discrepancy that favored statistically significant results.Conclusions: Our results highlight a lack of transparency as well as frequent selective reporting in interventional trials studying CRC. [ABSTRACT FROM AUTHOR]

Abstract Objective To describe surgical journals’ position statements on data-sharing policies (primary objective) and to describe key features of their research transparency promotion. Methods Only “SURGICAL” journals with an impact factor higher than 2 (Web of Science) were eligible for the study. They were included, if there were explicit instructions for clinical trial publication in the official instructions for authors (OIA) or if they had published randomised controlled trial (RCT) between 1 January 2016 and 31 December 2018. The primary outcome was the existence of a data-sharing policy included in the instructions for authors. Data-sharing policies were grouped into 3 categories, inclusion of data-sharing policy mandatory, optional, or not available. Details on research transparency promotion were also collected, namely the existence of a “prospective registration of clinical trials requirement policy”, a conflict of interests (COIs) disclosure requirement, and a specific reference to reporting guidelines, such as CONSORT for RCT. Results Among the 87 surgical journals identified, 82 were included in the study: 67 (82%) had explicit instructions for RCT and the remaining 15 (18%) had published at least one RCT. The median impact factor was 2.98 [IQR = 2.48–3.77], and in 2016 and 2017, the journals published a median of 11.5 RCT [IQR = 5–20.75]. The OIA of four journals (5%) stated that the inclusion of a data-sharing statement was mandatory, optional in 45% (n = 37), and not included in 50% (n = 41). No association was found between journal characteristics and the existence of data-sharing policies (mandatory or optional). A “prospective registration of clinical trials requirement” was associated with International Committee of Medical Journal Editors (ICMJE) allusion or affiliation and higher impact factors. Journals with specific RCT instructions in their OIA and journals referenced on the ICMJE website more frequently mandated the use of CONSORT guidelines. Conclusion Research transparency promotion is still limited in surgical journals. Standardisation of journal requirements according to ICMJE guidelines could be a first step forward for research transparency promotion in surgery.

This systematic review evaluated the reporting quality of COVID-19 vaccine randomized controlled trials (RCTs). Relevant RCTs published between July 20, 2020 and June 11, 2021 were identified in the PubMed database by two independent reviewers. Study quality was evaluated with the 2010 AND 2001 Consolidated Standards of Reporting Trials (CONSORT) adherence scores. A total of 22 RCTs were included. The median CONSORT adherence score according to the 2010 criteria was 21 (range, 12–25), thus indicating that 75% of the items in more than half of the RCTs had clear reports. Univariate analysis showed that CONSORT adherence scores were not predicted by category; analysis of variance also showed no significant difference between groups. Our results indicated that the overall quality of COVID-19 vaccine RCTs was very good. Current evidence indicates that a variety of COVID-19 vaccines are effective. No RCTs have reported serious adverse effects such as mortality.

Objective: To evaluate the reporting quality of randomized controlled trials (RCTs) of acupuncture for depression., Methods: Systematic searches were performed in PubMed, the Cochrane Library, EMbase, CNKI, Wanfang, SinoMed and VIP Database for RCTs of acupuncture in treatment of depression. The search time was from the establishment of database to December 1, 2023, and the language restriction was Chinese and English. The reporting quality of RCTs of acupuncture for depression was evaluated using the CONSORT statement, the international standardization for trial reporting, STRICTA, the international standard for clinical trial interventions of acupuncture, and SHARE, the guideline and checklist for reporting sham acupuncture controls., Results: According to the CONSORT statement items, the items with the reporting rate less than 50% was accounted for 54.05% of all of the items for Chinese articles, and there were 8 and 1 items with a reporting rate of 0% and 100%, respectively. For the English articles, the items with the reporting rate less than 50% was accounted for 35.14% of all of the items, and there were 3 and 7 items with a reporting rate of 0% and 100%, respectively. The reporting rate of 15 items in Chinese and English articles was greater than 50%, e.g. structured abstract, background and purpose. Based on STRICTA criteria, the reporting rate of either Chinese or English articles was relatively high. The items for Chinese articles with the reporting rate less than 50% was accounted for 23.53% of all of the items, and there were 1 and 4 items with a reporting rate of 0% and 100%, respectively. For English articles, the items with the reporting rate less than 50% was accounted for 11.76% of all of the items, and there was 1 item with a reporting rate of either 0% or 100%. In compliance with SHARE checklist, the reporting rate was low for either Chinese or English articles. The items with the reporting rate less than 50% was accounted for 57.89% of all of the items for Chinese articles, and there were 2 and 0 items with a reporting rate of 0% and 100%, respectively. For English articles, the items with the reporting rate less than 50% was accounted for 52.63% of all of the items, and there was 1 item with a reporting rate of 0% and 100%, respectively., Conclusion: The overall reporting quality of RCTs of acupuncture for depression is low currently. It is urgent to enhance the reporting of the details on sham acupuncture control especially. It is suggested that RCTs should be reported strictly in compliance with the CONSORT statement, STRICTA criteria, and SHARE checklist in the future.

Background: With the improvement of therapeutic strategies from cytotoxic chemotherapy to immunotherapy, the possibility of achieving timely intervention for lung cancer has dramatically increased. This study aimed to systematically evaluate the reporting quality of randomized controlled trials (RCT) on immunotherapy in lung cancer. Methods: The RCTs evaluating the efficacy of immunotherapy in lung cancer published up to 2021 were searched and collected from PUBMED and EMBASE by two investigators. The 2010 Consolidated Standards for Test Reports (CONSORT) statement‐based 28‐point overall quality score (OQS) and the 2001 CONSORT statement‐based 19‐point OQS was utilized for assessing the overall quality of each report. Results: One hundred and fifty‐two related RCTs were retrieved in this study, including 81,931 patients. The average OQS in 2010 was 17.89 (range, 7.5–24.5). Overall, studies have sufficiently reported the eligibility criteria (143/152; 94.07%), described the scientific background (150/152; 98.7%) and discussed interventions (147/152; 96.7%). However, the RCTs did not consistently report the changes to trial after commencement (48/152; 31.6%), allocation, enrollment and assignment personnel (34/152; 22.4%), blinding (48/152; 31.6%), or randomization method (58/152; 38.2%). Conclusions: The overall reporting quality of RCTs on immunotherapy in lung cancer was found to be unsatisfactory despite the fact that the CONSORT statement was issued more than a decade ago. Furthermore, there was virtual selectivity and heterogeneity in reporting some key issues in these trials. This is the first study to enlighten lung cancer researchers especially focusing on immunotherapy, and also to remind editors and peer reviewers to strengthen their due diligence. [ABSTRACT FROM AUTHOR]

Background: Comprehensive reporting of clinical trials is essential to allow the trial reader to evaluate the methodological rigor of the trial and interpret the results. Since publication of the updated Consolidated Standards of Reporting Trials (CONSORT) guidelines for reporting of parallel clinical trials in humans, extensions for reporting of abstracts and crossover trials have been published. Objectives: To describe the types of trials using dogs and cats published from 2015 to 2020 and to evaluate the quality of reporting of a sample of recently published parallel and crossover trials. Animals: None. Methods: A comprehensive search was conducted to identify parallel or crossover design clinical trials using dogs and cats published from January 1, 2015 onwards. Quality of reporting was evaluated on a subset of trials published during 2019. The reporting of items recommended in the CONSORT reporting guidelines for abstracts, parallel trials, and crossover trials was evaluated independently by 2 reviewers using standardized forms created for this study. Disagreements among reviewers were resolved by consensus. Results were tabulated descriptively. Results: The frequency of reporting of trial features varied from low to high. There remain deficiencies in the quality of reporting of key methodological features and information needed to evaluate and interpret trial results. Conclusions and Clinical Importance: There is still a need for authors, peer‐reviewers, and editors to follow reporting guidelines such as CONSORT to maximize the value of clinical trials and to increase confidence in the validity of the trial results. [ABSTRACT FROM AUTHOR]

Copyright of Kufa Journal for Nursing Sciences is the property of Republic of Iraq Ministry of Higher Education & Scientific Research (MOHESR) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Abstract Background The peer review process has been questioned as it may fail to allow the publication of high-quality articles. This study aimed to evaluate the accuracy in identifying inadequate reporting in RCT reports by early career researchers (ECRs) using an online CONSORT-based peer-review tool (COBPeer) versus the usual peer-review process. Methods We performed a cross-sectional diagnostic study of 119 manuscripts, from BMC series medical journals, BMJ, BMJ Open, and Annals of Emergency Medicine reporting the results of two-arm parallel-group RCTs. One hundred and nineteen ECRs who had never reviewed an RCT manuscript were recruited from December 2017 to January 2018. Each ECR assessed one manuscript. To assess accuracy in identifying inadequate reporting, we used two tests: (1) ECRs assessing a manuscript using the COBPeer tool (after completing an online training module) and (2) the usual peer-review process. The reference standard was the assessment of the manuscript by two systematic reviewers. Inadequate reporting was defined as incomplete reporting or a switch in primary outcome and considered nine domains: the eight most important CONSORT domains and a switch in primary outcome(s). The primary outcome was the mean number of domains accurately classified (scale from 0 to 9). Results The mean (SD) number of domains (0 to 9) accurately classified per manuscript was 6.39 (1.49) for ECRs using COBPeer versus 5.03 (1.84) for the journal’s usual peer-review process, with a mean difference [95% CI] of 1.36 [0.88–1.84] (p

Background: In a cluster randomised controlled trial (CRCT), randomisation units are "clusters" such as schools or GP practices. This has methodological implications for study design and statistical analysis, since clustering often leads to correlation between observations which, if not accounted for, can lead to spurious conclusions of efficacy/effectiveness. Bayesian methodology offers a flexible, intuitive framework to deal with such issues, but its use within CRCT design and analysis appears limited. This review aims to explore and quantify the use of Bayesian methodology in the design and analysis of CRCTs, and appraise the quality of reporting against CONSORT guidelines. Methods: We sought to identify all reported/published CRCTs that incorporated Bayesian methodology and papers reporting development of new Bayesian methodology in this context, without restriction on publication date or location. We searched Medline and Embase and the Cochrane Central Register of Controlled Trials (CENTRAL). Reporting quality metrics according to the CONSORT extension for CRCTs were collected, as well as demographic data, type and nature of Bayesian methodology used, journal endorsement of CONSORT guidelines, and statistician involvement. Results: Twenty-seven publications were included, six from an additional hand search. Eleven (40.7%) were reports of CRCT results: seven (25.9%) were primary results papers and four (14.8%) reported secondary results. Thirteen papers (48.1%) reported Bayesian methodological developments, the remaining three (11.1%) compared different methods. Four (57.1%) of the primary results papers described the method of sample size calculation; none clearly accounted for clustering. Six (85.7%) clearly accounted for clustering in the analysis. All results papers reported use of Bayesian methods in the analysis but none in the design or sample size calculation. Conclusions: The popularity of the CRCT design has increased rapidly in the last twenty years but this has not been mirrored by an uptake of Bayesian methodology in this context. Of studies using Bayesian methodology, there were some differences in reporting quality compared to CRCTs in general, but this study provided insufficient data to draw firm conclusions. There is an opportunity to further develop Bayesian methodology for the design and analysis of CRCTs in order to expand the accessibility, availability, and, ultimately, use of this approach. [ABSTRACT FROM AUTHOR]

A new system for foods with functional claims (FFC) was implemented in April 2015. The efficacy of FFC must now be proven by systematic review or randomized clinical trials (RCTs). The aim of this study was to establish the scientific reporting quality of RCTs on the efficacy of FFC and to identify areas that require improvement. The reporting quality of 33 RCT papers on 31 FFC that were received between April 1, 2015 and December 31, 2016 were analyzed by two experts with regard to consistency with the 29 Consolidated Standards of Reporting Trials (CONSORT) items. RCTs on FFC reported 13.8 (47.6%) of the CONSORT items, which is similar to those on FOSHU. There were 7 least reported items, including study design. Determining the reporting quality of FFC studies is an important way of identifying items that require improvement in future papers.

Copyright of Der Ophthalmologe is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a new class of medicines approved recently for the treatment of type 2 diabetes. To improve the quality of randomized clinical trial (RCT) reports, the Consolidated Standards of Reporting Trials (CONSORT) statement for methodological features was created. For achieving our objective in this study, we assessed the quality of methodological reporting of RCTs of SGLT2 inhibitors according to the 2010 CONSORT statement. We reviewed and analyzed the methodology of SGLT2 inhibitors RCTs that were approved by the Food & Drug Administration (FDA). Of the 27 trials, participants, eligibility criteria, and additional analyses were reported in 100% of the trials. In addition, trial design, interventions, and statistical methods were reported in 96.3% of the trials. Outcomes were reported in 93.6% of the trials. Settings were reported in 85.2% of the trials. Blinding and sample size were reported in 66.7 and 59.3% of the trials, respectively. Sequence allocation and the type of randomization were reported in 63 and 74.1% of the trials, respectively. Besides those, a few methodological items were inadequate in the trials. Allocation concealment was inadequate in most of the trials. It was reported only in 11.1% of the trials. The majority of RCTs have high percentage adherence for more than half of the methodological items of the 2010 CONSORT statement.

Object: Intracranial hemorrhage (ICH) is the second most common cause of stroke but still there is little consolidated knowledge about the optimal treatment strategies (e.g., the benefit of surgical evacuation). We evaluated the current randomized controlled trials (RCTs) on primary ICH (01.2013–03.2017) according to their fulfillment of the CONSORT statement's criteria (published in 2010) –as a marker of transparency and quality of study planning and realization.Methods: A Pubmed and a Cochrane database (including clinicaltrials.gov) search was carried out (01.2014–3.2017, respectively 01.2013–12.2013). Abstracts were screened for inclusion. Eligible full text manuscripts were assessed for the implementation of the CONSORT criteria. Citation frequencies and impact factors of the journals were related to ratio of CONSORT criteria fulfillment. Further, the risk of bias according to the Risk of bias tool 2 (RoB 2) was assessed.Results: Overall 3097 abstracts were screened for inclusion; 39 studies were suitable for final analysis. A mean fulfillment ratio of 51% (±28%) was found. A high correlation between impact factor and adherence to CONSORT criteria was shown (r = 0.7664; p < 0.0001). Citation frequency per year was related to ratio of CONSORT item fulfillment (r = 0.6747; p < 0.0001) and to the impact factor of the publishing journal (r = 0.7310; p < 0.0001). Of note, the items 10 (randomization: implementation) and 21 (generalizability) showed particularly high rates of non-fulfillment (87 and 85%). The majority of studies (95%) complied with item 2b (specific objectives or hypotheses), but strikingly objectives were mostly described vaguely. Other essential criteria such as sample size determination, definition of outcome parameters, and participant flow were only fulfilled weakly (51, 54, and 39%).Conclusions: Over 20 years after its inception there is still weak adherence to the CONSORT statement. As a consequence, conclusions are hampered by inadequate planning and/or reporting. Particularly with respect to pathologies as ICH lacking clear, evidence-based guidelines adherence to the CONSORT statement might improve research quality in order to define valuable treatment strategies.

Background: This study aimed to assess the overall reporting quality of randomized controlled trials (RCTs) in Chinese herbal medicine (CHM) formulas for patients with diabetes, and to identify factors associated with better reporting quality. Methods: Four databases including PubMed, Embase, Cochrane Library and Web of Science were systematically searched from their inception to December 2022. The reporting quality was assessed based on the Consolidated Standards of Reporting Trials (CONSORT) statement and its CHM formula extension. The overall CONSORT and its CHM formula extension scores were calculated and expressed as proportions separately. We also analyzed the pre-specified study characteristics and performed exploratory regressions to determine their associations with the reporting quality. Results: Seventy-two RCTs were included. Overall reporting quality (mean adherence) were 53.56% and 45.71% on the CONSORT statement and its CHM formula extension, respectively. The strongest associations with reporting quality based on the CONSORT statement were multiple centers and larger author numbers. Compliance with the CHM formula extension, particularly regarding the disclosure of the targeted traditional Chinese medicine (TCM) pattern (s), was generally insufficient. Conclusion: The reporting quality of RCTs in CHM formulas for diabetes remains unsatisfactory, and the adherence to the CHM formula extension is even poorer. In order to ensure transparent and standardized reporting of RCTs, it is essential to advocate for or even mandate adherence of the CONSORT statement and its CHM formula extension when reporting trials in CHM formulas for diabetes by both authors and editors., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Liu, Hu, Zhou, Zhang, Kang, Wen, Yuan, Li, Zhao, Zhang and Yang.)

Objective: To review and evaluate the quality of the randomized controlled trials of exercise for the treatment of cervical radiculopathy with the present internationally recognized CONSORT statement, which provides reference and basis for the improvement of clinical research on exercise for intervening cervical radiculopathy in the future. Methods: A computer-based search of large domestic databases, including CNKI, Wanfang database and VIP database screened out literature that meet the requirements and used CONSORT statement for quality assessment. Results: According to the prescribed inclusion and exclusion criteria, 30 articles were retrieved in accordance with the standard. No literature was referred to the randomized controlled trial, 2 documents clearly defined the type of test design, 1 documents carried out the calculation of sample size, 13 documents clearly randomly assigned, 1 literature implemented the blind method, in the 7 literature, baseline information was shown in tabular form, and no reference was made to trial registration, trial protocol and funding. Conclusion: There are some aspects of randomized controlled trials on exercise for the treatment of cervical radiculopathy. However, there are some aspects that need to be improved. In the future randomized controlled trial report, the CONSORT statement should be highly valued and carefully considered to improve the accuracy and credibility of the research. [ABSTRACT FROM AUTHOR]

Given the questionable quality of reporting of randomized controlled trials (RCTs) of herbal interventions, especially in developing countries, this study aims to evaluate the quality of reporting of RCTs of the top 10 herbs prescribed in Thailand and published in Thai healthcare journals. A systematic search was conducted within five databases: PubMed, Cochrane Library, Thai Journal Online, Thai Index Medicus, and Online Public Access Catalog of Khon Kaen University for Thai and English herbal medicine intervention RCTs published in Thai healthcare journals. Reporting quality of RCTs was assessed by using adapted CONSORT Herbal Intervention and CONSORT 2010 comprised of 52 items. Of 1351 potential studies, 16 RCTs met the eligibility criteria. For the quality of reporting by each item of 16 included studies, 27 of 52 items were reported in at least 50 % of RCTs which data on participants, physical characteristics of the herbal product, similarity of interventions, baseline data, numbers analyzed, ancillary analyses, and generalizability were reported in all included RCTs when applicable. However, 20 items had less than 50 % reported in included RCTs. There were no included RCTs reported information on the participant flow diagram, registration, and protocol. The quality of reporting of Thai herbal invention RCTs published in Thai healthcare journals was suboptimal. Improvement in the reporting quality of Thai herbal RCTs was needed to provide a high level of evidence. Relevant Thai healthcare journals should encourage Thai herbal medicine RCT authors to follow the CONSORT statement and herbal medicine intervention extensions. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: Randomized controlled trials (RCTs) provide the best quality clinical evidence. The aim of this study was to assess the quality of RCTs published by the International Urogynecology Journal (IUJ) in 2007-2016.Methods: RCTs in original articles were extracted from PubMed and IUJ homepage. Change in RCT quality over time was assessed with Jadad and van Tulder scales and Cochrane Collaboration’s risk of bias tool (CCRBT). Jadad scores of 3-5 or van Tulder scores of >5 indicated high-quality RCTs. The effect on RCT quality of including funding source and institutional review board (IRB) approval statements and describing the intervention was assessed. In addition, changes in RCT topics over time were assessed.Results: Annual RCT frequencies did not change significantly (6.7-15.7%): 36.1% and 25.7% described blinding and allocation concealment, respectively. Both tended to increase between 2013 and 2016, particularly 2013 and 2014. Funding statement inclusion (39.1% overall) and intervention description (78.2% overall) tended to increase steadily. IRB statement inclusion (60.4% overall) increased significantly (p < 0.01). Jadad scores and van Tulder rose significantly until 2014 (p < 0.01). Frequencies of high-quality RCTs tended to rise. CCRBT indicated that RCTs with a low risk of bias tended to increase until 2014. However, from 2015, Jadad scores, van Tulder, and CCRBT the low risk tended to decreased. RCTs with funding and IRB approval statements had higher Jadad and van Tulder scores than unfunded RCTs (p < 0.01 and p < 0.01, respectively). Intervention description did not associate with better quality.Conclusions: RCT quality improved over time, but a dip in quality was observed in 2015-2016 because of decreased blinding and allocation concealment. [ABSTRACT FROM AUTHOR]

Introduction: Based on WHO recommendation for considering herbal medicine as an inexpensive appropriate method to treat metabolic disorders, conducting randomized controlled trials (RCTs) is increasing worldwide. Since poor quality RCTs can lead to wrong conclusion, we assessed the quality of reporting of herbal medicines' RCTs conducted in Middle East in a systematic review study.Materials& Methods: All herbal medicines' RCTs in metabolic disorders (diabetes mellitus, metabolic syndrome, hyperlipidemia, obesity and osteoporosis) conducted in Middle East countries and published before January 2017 were included. To obtain all related studies PubMed, Scopus, Web of Science, Cochran library, and Embase web databases were searched. Exclusion criteria were animal studies, non-herbal medicines' RCTs, RCTs conducted in Type 1 diabetes, in children or pregnant women. We used Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist for reporting study selection processes as well as Consolidated Standards of Reporting Trials (CONSORT) statement for assessment of quality of reporting.Results: Out of 5319 identified studies, 215 RCTs were included. The proportion of published RCTs in the topic increased significantly over the time (P < 0.001). The total mean ± SD score for 37 items of CONSORT checklist was 21.15 ± 4.27. Most of RCTs (60%) were not reported randomization in the title. Some important items were incompletely reported including trial registration (42.3%), sample size estimation (38.1%), randomization method (35.3%), generation of allocation (27.9%), and concealment of allocation (13.5%).Conclusions: Our findings indicate that the quality of reporting of herbal medicines' RCTs in metabolic disorders has improved over time in Middle East, but remains suboptimal. [ABSTRACT FROM AUTHOR]

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Abstract: Objectives: We conducted a systematic review and meta‐analysis of literature to determine if the publication of the Consolidated Standards of Reporting Trials (CONSORT) abstract guideline in 2008 was followed by change in reporting quality of randomized controlled trial (RCT) abstracts. Study design and settings: Evaluations were included if they compared reporting quality of RCT abstracts before and after the publication of CONSORT–abstract guideline. The literature search was performed (January 2008 to April 2017) in Medline (Ovid), EMbase, CINAHL plus and Cochrane methodologies register. We assessed study validity with a special validity tool, adapted from a previous Cochrane review. Results: Initial search identified 4142 articles, of which total 10 evaluations including 5184 abstracts were included. Total 22 outcomes related to individual items of CONSORT–abstract guideline were assessed, and 14 showed significant effect sizes favoring CONSORT–abstract guideline. Despite significant effect size, the overall post‐CONSORT reporting (PCR) was suboptimal for ten items: title (RR = 1.40, 95% CI 1.23 to 1.59, PCR = 53.4%), participants (RR = 1.58, 95% CI 1.11 to 2.26, PCR = 24.5%), primary outcome (RR = 1.12, 95% CI 1.02 to 1.23, PCR = 65%), blinding (RR = 2.13, 95% CI 1.20 to 3.76, PCR = 13.9%), trial status (RR = 1.81, 95% 1.39 to 2.35, PCR = 10.6%), numbers analyzed (RR = 1.51, 95% CI 1.15 to 1.98, PCR = 26.5%), outcome (RR = 1.40, 95% 1.05 to 1.86, PCR = 21.9%), effect size and precision (RR = 1.59, 95% CI 1.15 to 2.19, PCR = 58.9%), harms (RR = 1.24, 95% CI 1.04 to 1.48, PCR = 41.8%), trial registration (RR = 2.02, 95% CI 1.63 to 2.50, PCR = 33.8%). Three items with favorable effect size in addition had wide CIs: randomization (RR = –4.28, 95% CI 1.56 to 11.75, PCR = –3.3%), allocation concealment (RR = –19.89, 95% CI 1.54 to 256.69, PCR = –5.7%), and funding (RR = –22.61, 95% CI 8.13 to 62.67, PCR = –11.32%). Conclusion: The change in reporting quality of RCT abstracts is far from satisfactory, as evidenced by suboptimal post‐CONSORT rates and wide CIs of effect sizes for majority of improved items. Mere publication of CONSORT–abstract guideline, without strict endorsement has failed to translate into good quality abstracts. [ABSTRACT FROM AUTHOR]

A new system for foods with functional claims (FFC) was implemented in April 2015. The efficacy of FFC must now be proven by systematic review or randomized clinical trials (RCTs). The aim of this study was to establish the scientific reporting quality of RCTs on the efficacy of FFC and to identify areas that require improvement. The reporting quality of 33 RCT papers on 31 FFC that were received between April 1, 2015 and December 31, 2016 were analyzed by two experts with regard to consistency with the 29 Consolidated Standards of Reporting Trials (CONSORT) items. RCTs on FFC reported 13.8 (47.6%) of the CONSORT items, which is similar to those on FOSHU. There were 7 least reported items, including study design. Determining the reporting quality of FFC studies is an important way of identifying items that require improvement in future papers. [ABSTRACT FROM AUTHOR]

Abstract: Background: The randomized controlled trial (RCT) is the gold standard to objectively assess the effect of treatments. To help improve the quality of RCTs, experts established a list of recommendations, the CONsolidated Standards of Reporting Trials (CONSORT) Statement. In this study, we evaluated the implementation of the CONSORT Statement in the field of high‐grade gliomas in adult patients and looked for criteria associated with higher quality of RCTs. Materials and Methods: We searched all high‐grade gliomas RCTs published in PubMed between January 1990 and December 2016. The quality of these RCTs was assessed by completing a modified CONSORT Score (CS). Results: Ninety‐six published RCTs were identified. The median CS was 19.5 on a scale of 0–33. Items were not equally reported. Items regarding the method of randomization or the blinding were reported in less than 25% of RCTs. However, the CS has constantly improved over the years. Before the implementation of the CONSORT Statement in 1996, the median CS was 13, whereas it was 17 for the period 1996–2004 and 22 after 2005. A higher CS was observed when RCTs were published in a journal with an impact factor above 10 (p < .001) or after 2010 (p = .001), when the primary outcome was clearly defined (p < .001) and for RCTs that enrolled more than 200 patients (p = .004). Conclusion: Although there has been a steady improvement in the CS over the years in the field of high‐grade gliomas, a major effort must be made in the reporting methods for randomization and blinding. Implications for Practice: This study showed that the quality of reporting of randomized control trials (RCTs) concerning the treatment of high‐grade gliomas is poor. Factors associated with a better quality of reports were identified and should be incorporated into the design of future RCTs. When clinicians read the results of RCTs, they should be aware of the possible inadequate reporting from these trials and take it into account for the management of their patients. This study identifies how RCTs can be improved in their reporting but also in their design, in order to advance care for patients with high‐grade gliomas in the future. [ABSTRACT FROM AUTHOR]

Background: Research has shown that recruitment to trials is a process that stretches from identifying potentially eligible patients, through eligibility assessment, to obtaining informed consent. The length and complexity of this pathway means that many patients do not have the opportunity to consider participation. This article presents the development of a simple framework to document, understand and improve the process of trial recruitment.Methods: Eight RCTs integrated a QuinteT Recruitment Intervention (QRI) into the main trial, feasibility or pilot study. Part of the QRI required mapping the patient recruitment pathway using trial-specific screening and recruitment logs. A content analysis compared the logs to identify aspects of the recruitment pathway and process that were useful in monitoring and improving recruitment. Findings were synthesised to develop an optimised simple framework that can be used in a wide range of RCTs.Results: The eight trials recorded basic information about patients screened for trial participation and randomisation outcome. Three trials systematically recorded reasons why an individual was not enrolled in the trial, and further details why they were not eligible or approached, or declined randomisation. A framework to facilitate clearer recording of the recruitment process and reasons for non-participation was developed: SEAR - Screening, to identify potentially eligible trial participants; Eligibility, assessed against the trial protocol inclusion/exclusion criteria; Approach, the provision of oral and written information and invitation to participate in the trial, and Randomised or not, with the outcome of randomisation or treatment received.Conclusions: The SEAR framework encourages the collection of information to identify recruitment obstacles and facilitate improvements to the recruitment process. SEAR can be adapted to monitor recruitment to most RCTs, but is likely to add most value in trials where recruitment problems are anticipated or evident. Further work to test it more widely is recommended. [ABSTRACT FROM AUTHOR]

Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a new class of medicines approved recently for the treatment of type 2 diabetes. To improve the quality of randomized clinical trial (RCT) reports, the Consolidated Standards of Reporting Trials (CONSORT) statement for methodological features was created. For achieving our objective in this study, we assessed the quality of methodological reporting of RCTs of SGLT2 inhibitors according to the 2010 CONSORT statement. We reviewed and analyzed the methodology of SGLT2 inhibitors RCTs that were approved by the Food & Drug Administration (FDA). Of the 27 trials, participants, eligibility criteria, and additional analyses were reported in 100% of the trials. In addition, trial design, interventions, and statistical methods were reported in 96.3% of the trials. Outcomes were reported in 93.6% of the trials. Settings were reported in 85.2% of the trials. Blinding and sample size were reported in 66.7 and 59.3% of the trials, respectively. Sequence allocation and the type of randomization were reported in 63 and 74.1% of the trials, respectively. Besides those, a few methodological items were inadequate in the trials. Allocation concealment was inadequate in most of the trials. It was reported only in 11.1% of the trials. The majority of RCTs have high percentage adherence for more than half of the methodological items of the 2010 CONSORT statement. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the report quality of Chinese and English randomized controlled trials (RCTs) of acupuncture based on the CONSORT statement and STRICTA checklist., Methods: The Chinese and English RCTs of acupuncture published from January 1, 2015 to December 31, 2019 were searched in 7 databases including PubMed. The report quality of the included RCTs was evaluated with the CONSORT 2010 statement and STRICTA checklist., Results: A total of 506 Chinese RCTs and 76 English RCTs were included. According to the CONSORT statement, in Chinese RCTs, the items with report rate less than 50% accounted for 78.38% of all items, and the report rate of 25 items, such as background and reason, study design, outcome index, and sample size, was less than 10%. In English RCTs, the items with report rate less than 50% accounted for 35.14% of all items, and 5 items had a report rate of less than 10%. The difference of the report rate of 15 items, such as background, reason and study design, was more than 50% between Chinese and English RCTs. The report rate of all items of STRICTA checklist was relatively high in both Chinese and English RCTs. In Chinese RCTs, the items with report rate less than 50% accounted for 29.41% of all items, which included acupuncture rationale and depth of insertion. In English RCTs, only two items had a report rate less than 50%, which were acupuncture rationale, setting and context of treatment. The report rate of five items, including needle retention time, frequency and duration of treatment sessions, details of other interventions administered to the acupuncture group, setting and context of treatment, and precise description of the control or comparator in Chinese RCTs, were higher than in English RCTs., Conclusion: The report quality of Chinese acupuncture RCT needs to be improved urgently, and corresponding measures should be taken to further standardize the writing and reporting of acupuncture clinical research.

Background: Randomized controlled trials (RCT) provide the strongest evidence to justify interventions in patients. However, trials with inadequate methods are associated with bias and exaggerated treatment effects. A search of the literature was conducted to review RCTs in testicular cancer (TC) to assess demographic and trial reporting quality patterns over time.Methods: MEDLINE and CENTRAL were queried for TC RCTs from 1989 to 2014. Demographic information was abstracted and reporting quality score was evaluated using the Consolidated Standards of Reporting Trials criteria. Linear regression was used to assess the trend in reporting quality over time.Results: A total of 39 RCTs were identified, of which 25 were published from 1989 to 2001 and 14 were published from 2002 to 2014. Most (59%) of the RCTs involved chemotherapy as the intervention, had a medical oncologist as the first author (87%), and took place in Europe (59%). RCTs published between 2002 and 2014 had longer enrollment periods (mean = 6.1 [2.7] vs. 3.7 [1.5] years, P = 0.007), whereas the number of patients randomized, median follow-up, or time from manuscript submission to acceptance were not significantly different between the periods. For each increasing year of publication, there was a significant improvement of 1.34% points (95% CI: 0.86-1.83, P<0.0001) in the Consolidated Standards of Reporting Trials score.Conclusions: Fewer RCTs in TC were published in the recent 13-year period. Although the quality of trial reporting improved compared with the preceding 13-year period, deficiencies remain. Urologists can play an important role in trial design, recruitment, and execution, and ensuring trial methodology and reporting quality is prioritized. [ABSTRACT FROM AUTHOR]