Exploration and evaluation of reporting quality of randomised controlled trials on blended learning in medical education.

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.

The reporting quality of randomized controlled trials in Chinese herbal medicine (CHM) formulas for diabetes based on the consort statement and its extension for CHM formulas.

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.

[Evaluation of the report quality of Chinese and English randomized controlled trials of acupuncture based on CONSORT statement and STRICTA checklist].

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.

Evaluation of the report quality of Chinese and English randomized controlled trials of acupuncture based on CONSORT statement and STRICTA checklist / 中国针灸

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.

Study on the reporting quality of randomized controlled trials of flipped classroom in medical education.

With the deepening of medical education reform, the flipped classroom has become a commonly used teaching method. Many randomized controlled trials (RCTs) have shown that flipped classroom combined with problem-based learning improves many students' abilities. It remains unclear whether the design and reports of these RCTs comply with specifications. The aim of this study was to provide a systematic assessment of the quality of RCTs investigating the effectiveness of flipped classroom teaching in medical education. Two investigators searched PUBMED and EMBASE and analyzed 15 filtered RCTs addressing flipped classroom in medical education, published between January 1, 2016 and December 31, 2021. The overall reporting quality was assessed using the overall quality score (OQS) according to the 2010 CONSORT statement. The search revealed 15 RCTs closely related to flipped classrooms. After analysis, it appeared that least half of them made no mention of half of the OQS items in the CONSORT 2010 statement. Since the flipped classroom is an emerging teaching method, all the retrieved articles were published after 2016. Furthermore, a number of issues that we considered very important were not adequately addressed in the RCT reports. Although the CONSORT 2010 statement was issued 12 years ago, the quality and content of many RCTs are not satisfactory. Our findings suggest that authors need to make more effort to meet the CONSORT statement requirements.

Assessment of transparency and selective reporting of interventional trials studying colorectal cancer.

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.

Assessing the reporting quality of randomized controlled trials on COVID-19 vaccines: a systematic review.

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.

Evaluation of reporting quality of abstracts of randomized controlled trials regarding patients with COVID-19 using the CONSORT statement for abstracts.

OBJECTIVE: To evaluate the reporting quality of randomized controlled trial (RCT) abstracts regarding patients with coronavirus disease 2019 (COVID-19) and to analyze the factors influencing the quality. METHODS: The PubMed, Embase, Web of Science, and Cochrane Library databases were searched to collect RCTs on patients with COVID-19. The retrieval time was from inception to December 1, 2020. The CONSORT statement for abstracts was used to evaluate the reporting quality of RCT abstracts. RESULTS: A total of 53 RCT abstracts were included. The CONSORT statement for abstracts showed that the average reporting rate of all items was 50.2%. The items with a lower reporting quality were mainly the trial design and the details of randomization and blinding (<10%). The mean overall adherence score across all studies was 8.68 ± 2.69 (range 4-13.5). Multivariate linear regression analysis showed that the higher reporting scores were associated with higher journal impact factor (P < 0.01), international collaboration (P = 0.04), and structured abstract format (P < 0.01). CONCLUSIONS: Although many RCTs on patients with COVID-19 have been published in different journals, the overall quality of reporting in the included RCT abstracts was suboptimal, thus diminishing their potential usefulness, and this may mislead clinical decision-making. In order to improve the reporting quality, it is necessary to promote and actively apply the CONSORT statement for abstracts.

Quality Assessment and Relevant Clinical Impact of Randomized Controlled Trials of Varicocele: Next Step to Good-Quality Randomized Controlled Trial of Varicocele Treatment.

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<0.01). Van Tulder scores tended to increase from 1979 to 2017 (4.21±0.94 to 5.58±1.58, p<0.01). RCTs with funding statements had higher Jadad (Yes vs. No, 3.25±0.50 vs. 1.70±0.97; p<0.01) and van Tulder (Yes vs. No, 7.25±1.26 vs. 4.81±1.26; p<0.01) scores than unfunded RCTs. IRB approval and intervention were associated with better quality. CONCLUSIONS: The number of RCTs on varicocele increased from 1979 to 2017. Also, quality improved over time with increasing IRB approval, funding, and multicenter trial. Most RCTs on varicocele reported the use of surgical treatment. RCTs of surgical treatments have limitations to satisfy the condition of RCT to conduct, but their quality has improved over time.

Reporting quality of randomized, controlled trials evaluating immunotherapy in lung cancer.

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.

Quality of reporting of clinical trials in dogs and cats: An update.

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.

Bayesian statistics in the design and analysis of cluster randomised controlled trials and their reporting quality: a methodological systematic review.

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.

Research transparency promotion by surgical journals publishing randomised controlled trials: a survey.

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.

Describing deprescribing trials better: an elaboration of the CONSORT statement.

OBJECTIVE: The objective of this study was to identify key features to be addressed in the reporting of deprescribing trials and to elaborate and explain CONSORT items in this regard. STUDY DESIGN AND SETTING: As a first step in a multistage process and based on a systematic review of deprescribing trials, we elaborated variation in design, intervention, and reporting of the included trials of the review. We identified items that were missed or insufficiently described, using the CONSORT and TIDieR checklists. The resulting list of items, which we considered relevant to be reported in deprescribing trials, were discussed in a single-round Delphi exercise and subsequently in a full-day face-to-face meeting with an international panel of 14 experts. We agreed on CONSORT items for further elaboration with regard to design and reporting of deprescribing trials. RESULTS: We identified seven CONSORT items on trial design, participants, intervention, outcomes, flowchart, and harms, where the investigators of deprescribing trials should take into consideration specific aspects, such as whether or not to use placebo or how to inform participants. CONCLUSION: This article presents an elaboration to the CONSORT statement for the reporting of deprescribing trials. It may also support investigators in motivated design choices.

[Influence of impact factor on reporting sample size calculations in publications on studies exemplified by AMD treatment : Cross-sectional investigation on the presence of sample size calculations in publications of RCTs on AMD treatment in journals with low and high impact factors]. / Einfluss des Impact-Faktors auf das Berichten einer Fallzahlplanung in Publikationen zu Studien am Beispiel der AMD-Therapie : Querschnittuntersuchung zum Vorliegen von Fallzahlplanungen in Publikationen von RCTs zur AMD-Therapie in Zeitschriften mit hohem und niedrigem Impact-Faktor.

BACKGROUND: For scientific and ethical reasons randomized controlled clinical trials (RCTs) should be based on a sample size calculation. The CONSORT statement, an established publication guideline for transparent study reporting, requires a sample size calculation in every study publication. OBJECTIVE: The availability of sample size calculations in RCT publications on treatment of age-related macular degeneration (AMD) was investigated. The primary hypothesis of this investigation compared the prevalence of reported sample size calculations between journals with higher (≥5) versus lower (<5) impact factors (IF). MATERIAL AND METHODS: It was examined whether information on sample size calculation was available in a series of 97 publications of RTCs on AMD treatment published between 2004 and 2014. RESULTS: Only 46 out of 97 (47%) study publications provided information on the reason for the number of patients enrolled. The comparison of publications from journals with an IF ≥ 5 (63%, 30) and from journals with an IF < 5 (40%, 67) showed a statistically significant difference of 23% in the frequencies of available sample size calculations (95% confidence interval, CI 2%; 44%). Of the publications published before 2010, 43% reported a sample size calculation versus 51% of the publications afterwards. CONCLUSION: Publications in journals with higher IF more frequently reported a sample size calculation. More than 50% of the publications did not report any sample size calculation. Authors and reviewers of publications should pay more attention to the explicit reporting of sample size calculations.

Accuracy in detecting inadequate research reporting by early career peer reviewers using an online CONSORT-based peer-review tool (COBPeer) versus the usual peer-review process: a cross-sectional diagnostic study.

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 < 0.001). Concerning secondary outcomes, the sensitivity of ECRs using COBPeer versus the usual peer-review process in detecting incompletely reported CONSORT items was 86% [95% CI 82-89] versus 20% [16-24] and in identifying a switch in primary outcome 61% [44-77] versus 11% [3-26]. The specificity of ECRs using COBPeer versus the usual process to detect incompletely reported CONSORT domains was 61% [57-65] versus 77% [74-81] and to identify a switch in primary outcome 77% [67-86] versus 98% [92-100]. CONCLUSIONS: Trained ECRs using the COBPeer tool were more likely to detect inadequate reporting in RCTs than the usual peer review processes used by journals. Implementing a two-step peer-review process could help improve the quality of reporting. TRIAL REGISTRATION: Clinical.Trials.gov NCT03119376 (Registered April, 18, 2017).

Randomized Controlled Trials on Intracerebral Hemorrhage: A Cross Sectional Retrospective Analysis of CONSORT Item Adherence.

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.

Quality of reporting of randomized controlled trials of herbal medicines conducted in metabolic disorders in Middle East countries: A systematic review.

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 ±â€¯SD score for 37 items of CONSORT checklist was 21.15 ±â€¯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.