Search

ObjectiveThe objective of this review is to provide an overview of the justification reported for using unequal allocation ratios in randomized clinical trials (RCTs) testing a medical intervention.MethodsUsing the PICOS framework, we conducted a systematic search to find meta-studies within PubMed (a Medline database interface) that addressed the objective.ResultsThe developed search strategy generated 525 results, of which, three studies met criteria for inclusion. These studies found that 22-43% of RCTs provided a justification for the use of unequal allocation based on publication alone, and between 38.7 and 66% after seeking input from trial authors. The most common reason given for this design was to gather increased safety data according to two reviews and to gain experience with an intervention according to the third review.ConclusionReporting of justification for RCTs designed with unequal allocation appears to occur less than half the time in the included studies. The reasons given for designing clinical trials with unequal participants encompass many domains, including ethical considerations. As such, this design feature should be implemented with intentionality to maximize the ethical features of clinical trials for participants. Coupling lack of justification with lack of adjusting for sample size estimations depicts an overall landscape in which there is significant room for improvement in methodological transparency within this area of RCTs.

Aim: Heart failure (HF) is a major cause of morbidity and mortality in older adults. Randomized controlled trials (RCTs) inform HF policy and practice, but the accurate interpretation of results is contingent on clear and transparent reporting. The CONsolidated Standards Of Reporting Trials (CONSORT) statement serves as a guide to RCT reporting. We evaluated the quality of reporting in HF RCTs in high‐impact journals by assessing their adherence to CONSORT. Methods and results: We searched MEDLINE, EMBASE and CINAHL for HF RCTs published in high‐impact journals 2000–2020. We assessed the proportion of CONSORT criteria that individual HF RCTs adhered to, and used the Jonckheere–Terpstra test to examine temporal trends in adherence. Multivariable linear regression explored the association between trial characteristics and adherence to CONSORT. Primary analysis assessed adherence to CONSORT 2010 update. A sensitivity analysis assessed adherence to the original (1996) CONSORT criteria. Among 221 RCTs analysed, the mean (standard deviation [SD]) adherence was suboptimal overall (mean [SD] adherence 69.7 [11.5]%) (5513/7913 criteria), with a temporal increase in adherence over the 20‐year period (p < 0.001). Factors associated with adherence included publication after versus during/before 2010 (β = 10.17, 95% confidence interval [CI] 7.64–12.70; p < 0.001); two‐group parallel individual‐level randomization versus other (including multi‐group or cluster randomization) (β = 5.81, 95% CI 2.88–8.73; p < 0.001); and multicentre versus single‐centre trials (β = 7.26, 95% CI 3.25–11.27; p < 0.001). There was no difference in trial adherence to the updated CONSORT (2010) versus the original (1996) CONSORT criteria, and temporal trends in adherence to both sets of criteria were similar, likely due to overlap between the two sets of criteria. Trials with greater adherence to CONSORT were published in higher impact factor journals, with a positive correlation (r = 0.312; p < 0.001). Conclusion: The quality of reporting in HF RCTs, as measured by CONSORT adherence, has improved over time but remains suboptimal. [ABSTRACT FROM AUTHOR]

MAN v FAT Soccer is a sport-based weight-loss program for overweight and obese men that originated in the United Kingdom (i.e., as MAN v FAT Football) and appears to successfully engage men with weight loss. We sought to explore whether the program would work in an Australian context by (a) establishing a foundation for the implementation of the program on a larger scale and (b) determining how large-scale implementation is most feasible. We conducted a nonrandomized, single intervention group feasibility trial of MAN v FAT Soccer in Australia with 418 male participants with a body mass index greater than 27.50 kg/m2. Results indicate that the program is acceptable, with participants reporting positive perceptions of the various components of the program and a high proportion reporting intentions to recommend the program to others (95.9%). Furthermore, preliminary effectiveness results indicate positive changes in weight (4.6% reduction) and physical activity (88.5% increase) and improvements in psychological outcomes such as depression (17.6% decrease), stress (19.0% decrease), and body appreciation (19.1% increase). Our findings provide general support for the feasibility of MAN v FAT Soccer and the notion that leveraging competition and masculinity may help drive men's health behavior change. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the reporting quality of single‐patient (N‐of‐1) trials and protocols based on the CONSORT Extension for N‐of‐1 trials (CENT) statement and the standard protocol items: recommendations for interventional trials (SPIRIT) extension and elaboration for N‐of‐1 trials (SPENT) checklist to examine the factors that influenced reporting quality. Methods: Four electronic databases were searched to identify N‐of‐1 trials and protocols from 2015 to 2020. Quality was assessed by two reviewers. We calculated the overall scores based on binary responses in which "Yes" was scored as 1 (if the item was fully reported), and "No" was scored as 0 (if the item was not clearly reported or not definitely stated). Results: A total of 78 publications (55 N‐of‐1 trials and 23 protocols) were identified. The mean reporting score (SD) of the N‐of‐1 trials and protocols were 29.24 (0.89) and 29.61 (1.83), respectively. For the items related to outcomes, sample size, allocation concealment protocol, and informed consent materials, the reporting quality was low. Our results showed that the year of publication (t = ‐0.793, p = 0.872 for the trials and t = 1.352, p = 0.623 for the protocols) and the impact factor of the journal (t = 1.416, p = 0.619 for the trials and t = 0.359, p = 0.667 for the protocols) were not factors associated with better reporting quality. Conclusion: With the publication of the CENT 2015 statement and the SPENT 2019 checklist, authors should adhere to the relevant reporting guidelines and improve the reporting quality of N‐of‐1 trials and protocols. [ABSTRACT FROM AUTHOR]

The extension of the Consolidated Standards of Reporting Trials (CONSORT) statement provides guidelines for abstracts of randomized controlled trials (RCTs). This study was done to assess the reporting quality of abstracts of RCTs, on procedural sedation in children and identify factors associated with better quality. A PubMed search was conducted from inception of database till July 2017 to identify RCTs on procedural sedation in children. Search terms used were (procedural [All Fields] AND sedation [All Fields]) AND (“child” [MeSH Terms] OR “child” [All Fields] OR “children” [All Fields]) were included in the analysis, while primary RCTs, published in the English language unstructured abstracts, secondary analysis of primary RCTs and studies not exclusively on children we excluded. Our search strategy initially yielded 582 abstracts. Out of these, 535 abstracts were excluded. 47 articles were included in the final analysis. We extracted basic information and data on CONSORT items from abstracts. Each abstract was assessed using a 16-item composite abstract score (CAS) based on the CONSORT guidelines. This abstract quality was further explored by Method Score and by Result Score. Regression analysis was conducted to analyze factors associated with reporting quality. In majority of the abstracts, only objectives and conclusion were adequately reported. Inadequately reported items in >90% of abstracts included randomization, trial status, registration & funding. There was no significant difference in the CAS of abstracts (mean ± SD) published in & before 2008 (12.63 ± 4.0), to those published after 2009 (12.48 ± 4.23). Similarly, there was no significant difference in Result Score and Method Score of the abstracts. After the publication of 'CONSORT for abstracts' guideline, the quality of abstracts of RCTs on procedural sedation has shown suboptimal improvement. We suggest stricter adherence to guidelines by editors and reviewers. A checklist for adherence to CONSORT guidelines could be introduced during submission for the same.

The extension of the Consolidated Standards of Reporting Trials (CONSORT) statement provides guidelines for abstracts of randomized controlled trials (RCTs). This study was done to assess the reporting quality of abstracts of RCTs, on procedural sedation in children and identify factors associated with better quality. A PubMed search was conducted from inception of database till July 2017 to identify RCTs on procedural sedation in children. Search terms used were (procedural [All Fields] AND sedation [All Fields]) AND ("child" [MeSH Terms] OR "child" [All Fields] OR "children" [All Fields]) were included in the analysis, while primary RCTs, published in the English language unstructured abstracts, secondary analysis of primary RCTs and studies not exclusively on children we excluded. Our search strategy initially yielded 582 abstracts. Out of these, 535 abstracts were excluded. 47 articles were included in the final analysis. We extracted basic information and data on CONSORT items from abstracts. Each abstract was assessed using a 16-item composite abstract score (CAS) based on the CONSORT guidelines. This abstract quality was further explored by Method Score and by Result Score. Regression analysis was conducted to analyze factors associated with reporting quality. In majority of the abstracts, only objectives and conclusion were adequately reported. Inadequately reported items in >90% of abstracts included randomization, trial status, registration & funding. There was no significant difference in the CAS of abstracts (mean ± SD) published in & before 2008 (12.63 ± 4.0), to those published after 2009 (12.48 ± 4.23). Similarly, there was no significant difference in Result Score and Method Score of the abstracts. After the publication of 'CONSORT for abstracts' guideline, the quality of abstracts of RCTs on procedural sedation has shown suboptimal improvement. We suggest stricter adherence to guidelines by editors and reviewers. A checklist for adherence to CONSORT guidelines could be introduced during submission for the same. [ABSTRACT FROM AUTHOR]

ObjectivesTo evaluate the quality of reporting of single-patient (N-of-1) trials published in the medical literature based on the CONSORT Extension for N-of-1 Trials (CENT) statement and to examine factors that influence reporting quality in these trials.Study design and settingThrough a search of 10 electronic databases, we identified N-of-1 trials in clinical medicine published between January 1, 1985, and December 31, 2013. Two reviewers screened articles for eligibility and independently extracted data. Quality assessment was performed using the CENT statement. Discrepancies were resolved by consensus.ResultsWe identified 112 eligible N-of-1 trials published in 87 journals and involving a total of 2,278 patients. Overall, kappa agreement between the two evaluators for compliance with CENT criteria was 0.80 (95% confidence interval: 0.79, 0.82). Trials assessed pharmacology and therapeutics (87%), behavior (11%), or diagnosis (2%). Although 87% of articles described the trial design (including the planned number of subjects and length of treatment period), the median percentage of specific CENT elements reported in the Methods was 41% (range, 16-87%), and the median percentage in the Results was 38% (range, 32-93%). First authors were predominantly from North America (46%), Europe (29%), and Australia (17%). Quality of reporting was higher in articles published in journals with relatively high-impact factors (P = 0.004).ConclusionThe quality of reporting of published N-of-1 trials is variable and in need of improvement. Because the CENT guidelines were not published until near the end of the period of this review, these results represent a baseline from which improvement may be expected in the future.

The conduct and reporting of pilot studies is important to assess the feasibility of future randomized controlled trials (RCT). The Consolidated Standards of Reporting Trials (CONSORT) statement extension to pilot/feasibility studies addresses the reporting quality of the pilot studies (Summary Table 1). The aims of this systematic review are (1) to assess the reporting quality of pilot studies in pediatric urology and (2) to explore the factors that are associated with the reporting quality of these studies. A comprehensive search was conducted through MEDLINE® and EMBASE® to identify pilot RCTs from 2005 to 2018. Two reviewers independently performed title and abstract screening and full text review, with discrepancies resolved by consensus. CONSORT extension reported items were summarized and overall proportion of reported items for each article was estimated. A linear regression model was conducted to determine factors associated with higher reporting quality. Publication year, biostatistician/epidemiologist support, sample size justification and journal impact factor were collected. Of the 1463 titles duplicates were removed and 1347 were screened, 36 studies were included. Overall, 36 pilot studies reported about 8–9 of 17 items [51% (95% CI: 46 – 56%)]. The most reported items were contact details for the corresponding author (97%), title identification of study as randomised pilot or feasibility trial (95%), eligibility criteria and setting (81%), both interventions (78%), and specific objectives of the pilot trial (75%). Less fulfilled items were blinding (11%), registration of the trial (11%), randomization details (28%), detailing recruitment status in the pilot study (19%), trial design (31%), and source of funding for pilot trial (34%). Interpretation of the results of pilot trial and their implications for the future definitive trial was reported by 34% of the studies. Factors associated with higher reporting quality were the presence of biostatistician or epidemiologist (P = 0.004), and if the sample size for the pilot study was justified (P = 0.002). Overall reporting quality of pilot studies in pediatric urology literature from 2005-2018 was suboptimal. The quality of pilot RCTs included in the present review were lower than that observed in the orthopedic literature, however, it appears to be consistent with the trends regarding OQS in chronic kidney disease and allopathic medicine. While we endeavoured to maintain utmost rigidity of this systematic review, there are inherent limitations. The CONSORT 2010 extension for pilot RCTs was published in 2016. Clinical trials can take several years, many pilot studies published pre-2016 would not have had the guidance of the extension during designing phases. Not all pilot RCTs are published, so this could potentially reduce the generalizability of the findings from this review. Only studies in English, published in full peer-reviewed journals were included, and this review only addressed the reporting quality of pilot studies in pediatric urology. This review demonstrated that reporting quality of pilot studies in pediatric urology is currently suboptimal. Including biostatistician and/or epidemiologist, can ameliorate the quality of future pilot studies. Implementing CONSORT 2010 extension by journals as a prerequisite for submission of pilot or feasibility trials is recommended to improve the robustness and transparency of future pilot studies. [ABSTRACT FROM AUTHOR]

Objective: The objective of this review is to provide an overview of the justification reported for using unequal allocation ratios in randomized clinical trials (RCTs) testing a medical intervention., Methods: Using the PICOS framework, we conducted a systematic search to find meta-studies within PubMed (a Medline database interface) that addressed the objective., Results: The developed search strategy generated 525 results, of which, three studies met criteria for inclusion. These studies found that 22-43% of RCTs provided a justification for the use of unequal allocation based on publication alone, and between 38.7 and 66% after seeking input from trial authors. The most common reason given for this design was to gather increased safety data according to two reviews and to gain experience with an intervention according to the third review., Conclusion: Reporting of justification for RCTs designed with unequal allocation appears to occur less than half the time in the included studies. The reasons given for designing clinical trials with unequal participants encompass many domains, including ethical considerations. As such, this design feature should be implemented with intentionality to maximize the ethical features of clinical trials for participants. Coupling lack of justification with lack of adjusting for sample size estimations depicts an overall landscape in which there is significant room for improvement in methodological transparency within this area of RCTs., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: V.P. receives research funding from Arnold Ventures through a grant made to UCSF, and royalties for books and writing from Johns Hopkins Press, MedPage, and the Free Press. He declares consultancy roles with UnitedHealthcare and OptumRX; He hosts the podcasts, Plenary Session, VPZD, Sensible Medicine, writes the newsletters, Sensible Medicine, the Drug Development Letter and VP's Observations and Thoughts, and runs the YouTube channel Vinay Prasad MD MPH, which collectively earn revenue on the platforms: Patreon, YouTube and Substack. All other authors have no financial or non-financial conflicts of interest to report., (Copyright © 2024. Published by Elsevier Inc.)

Background: The numbers of articles reporting randomized controlled trials (RCTs) on viral hepatitis in China have been increasing, but there have been few systematic studies evaluating the reporting quality of RCTs in this field. This study was performed to assess the reporting quality of RCTs on the treatment of hepatitis B and C in China from 1991 to 2015. Methods: Articles published between January 1991 and December 2015 were identified via the PubMed, MEDLINE, and Embase databases using the key words “randomized clinical trials”, “treatment”, “therapy”, “hepatitis B”, “HBV”, “hepatitis C”, “HCV”, “China”, and “Chinese”. The reporting quality was assessed against the Consolidated Standards of Reporting Trials (CONSORT) checklist. Results: In total, 211 RCTs on the treatment of hepatitis B or C were included. The number of articles focusing on these RCTs increased rapidly over time, while the reporting quality improved steadily over time. Overall, compliance with the key components of the CONSORT checklist was low, with only 8.5%, 3.8%, and 11.4% of the articles fulfilling the reporting requirements of randomization, allocation concealment, and blinding, respectively. Conclusions: Both the number and the quality of RCT articles were found to have increased steadily over the last two decades. However, compliance with the key components of the CONSORT checklist still needs improvement. It is hoped that the results of this study will lead to improvements in the reporting quality of clinical trials on hepatitis B and C in China.

Background: In articles reporting randomized controlled trials, professional medical writing support is associated with increased adherence to Consolidated Standards of Reporting Trials (CONSORT). We set out to determine whether professional medical writing support was also associated with improved adherence to CONSORT for Abstracts. Methods: Using data from a previously published cross-sectional study of 463 articles reporting randomized controlled trials published between 2011 and 2014 in five top medical journals, we determined the association between professional medical writing support and CONSORT for Abstracts items using a Wilcoxon rank-sum test. Results: The mean proportion of adherence to CONSORT for Abstracts items reported was similar with and without professional medical writing support (64.3% vs 66.5%, respectively; p=0.30). Professional medical writing support was associated with lower adherence to reporting study setting (relative risk [RR]; 0.40; 95% confidence interval [CI], 0.23–0.70), and higher adherence to disclosing harms/side effects (RR 2.04; 95% CI, 1.37–3.03) and funding source (RR 1.75; 95% CI, 1.18–2.60). Conclusions: Although professional medical writing support was not associated with increased overall adherence to CONSORT for Abstracts, important aspects were improved with professional medical writing support, including reporting of adverse events and funding source. This study identifies areas to consider for improvement.

Background: In articles reporting randomized controlled trials, professional medical writing support is associated with increased adherence to Consolidated Standards of Reporting Trials (CONSORT). We set out to determine whether professional medical writing support was also associated with improved adherence to CONSORT for Abstracts. Methods: Using data from a previously published cross-sectional study of 463 articles reporting randomized controlled trials published between 2011 and 2014 in five top medical journals, we determined the association between professional medical writing support and CONSORT for Abstracts items using a Wilcoxon rank-sum test. Results: The mean proportion of adherence to CONSORT for Abstracts items reported was similar with and without professional medical writing support (64.3% vs 66.5%, respectively; p=0.30). Professional medical writing support was associated with lower adherence to reporting study setting (relative risk [RR]; 0.40; 95% confidence interval [CI], 0.23–0.70), and higher adherence to disclosing harms/side effects (RR 2.04; 95% CI, 1.37–3.03) and funding source (RR 1.75; 95% CI, 1.18–2.60). Conclusions: Although professional medical writing support was not associated with increased overall adherence to CONSORT for Abstracts, important aspects were improved with professional medical writing support, including reporting of adverse events and funding source. This study identifies areas to consider for improvement.

Background The numbers of articles reporting randomized controlled trials (RCTs) on viral hepatitis in China have been increasing, but there have been few systematic studies evaluating the reporting quality of RCTs in this field. This study was performed to assess the reporting quality of RCTs on the treatment of hepatitis B and C in China from 1991 to 2015. Methods Articles published between January 1991 and December 2015 were identified via the PubMed, MEDLINE, and Embase databases using the key words “randomized clinical trials”, “treatment”, “therapy”, “hepatitis B”, “HBV”, “hepatitis C”, “HCV”, “China”, and “Chinese”. The reporting quality was assessed against the Consolidated Standards of Reporting Trials (CONSORT) checklist. Results In total, 211 RCTs on the treatment of hepatitis B or C were included. The number of articles focusing on these RCTs increased rapidly over time, while the reporting quality improved steadily over time. Overall, compliance with the key components of the CONSORT checklist was low, with only 8.5%, 3.8%, and 11.4% of the articles fulfilling the reporting requirements of randomization, allocation concealment, and blinding, respectively. Conclusions Both the number and the quality of RCT articles were found to have increased steadily over the last two decades. However, compliance with the key components of the CONSORT checklist still needs improvement. It is hoped that the results of this study will lead to improvements in the reporting quality of clinical trials on hepatitis B and C in China. [ABSTRACT FROM AUTHOR]

We report a randomised controlled trial evaluation of an intensive one-to-one numeracy programme –Numbers Count– which formed part of the previous government's numeracy policy intervention –Every Child Counts.We rigorously designed and conducted the trial to CONSORT guidelines. We used a pragmatic waiting list design to evaluate the intervention in real life settings in diverse geographical areas across England, to increase the ecological validity of the results. Children were randomly allocatedwithinschools to either the intervention (Numbers Countin addition to normal classroom practice) or the control group (normal classroom practice alone). The primary outcome assessment was the Progress in Maths (PIM) 6 test from GL Assessment. Independent administration ensured that outcome ascertainment was undertaken blind to group allocation. The secondary outcome measure was the Sandwell test, which was not undertaken and marked blind to group allocation. At post-test the effect size (standardised mean difference between intervention and control group) on the PIM6 was d = 0.33 95% confidence intervals [0.12, 0.53], indicating strong evidence of a difference between the two groups. The effect size for the secondary outcome (Sandwell test) was d = 1.11 95% CI [0.91, 1.31]. Our results demonstrate a statistically significant effect ofNumbers Counton our primary, independently marked, mathematics test. Like many trials, our study had both strengths and limitations. We feel, however, due to oura prioridecision to report these in an explicit manner, as advocated by the CONSORT guidelines, that we could maximise rigour (e.g., by using blinded independent testing) and report potential problems (e.g., attrition rates). We have demonstrated that it is feasible to conduct an educational trial using the rigorous methodological techniques required by the CONSORT statement. [ABSTRACT FROM AUTHOR]

Abstract: Blinding in randomized controlled trials (RCTs) is a strategy that is widely endorsed as a method of reducing the biases that can result from people''s awareness of study participants’ treatment group status. Blinding of participants and interventionists is often impossible in nursing RCTs, but data analysts can almost always be blinded. Yet, such blinding seldom occurs, perhaps because of misperceptions about the objectivity of statistical analysis. Data analysts make many semi-subjective decisions about such issues as handling missing data, transforming variables, undertaking subgroup analysis, and selecting covariates. These decisions ideally should be made without the analyst''s knowledge of how treatment groups are coded. Strategies for achieving blinding among data analysts are discussed. [Copyright &y& Elsevier]

The article discusses a study which investigated the extent to which nurse researchers use blinding as a bias-reduction strategy. The study included 199 randomized controlled trials (RCTs) that were published in 16 nursing journals from 2007 to 2009. It found that blinding for data analysts and data collectors were used in 33 percent of the RCTs. Study authors note that blinding should be pursued in RCTs.

Background/Aim: Hujoel & Moulton previously questioned the reported quality of split-mouth studies. Since then, there has been little enquiry into the methodology of this study design. The aim was to conduct a systematic review of the reported methodology of clinical studies using a split-mouth design published in dental journals over a 1-year period (2004). Material and Methods: An extension of the CONSORT guidelines for cluster-randomized designs was used to evaluate quality. We evaluated the methods used and quality of reporting split-mouth studies. Results: Thirty-four studies were eligible for this review. The results showed that many papers lack essential qualities of good reporting, e.g. five of 34 papers gave the rationale for choosing a split-mouth design, 19 of 34 (56%) used appropriate analytical statistical methods and only one of 34 presented an appropriate sample size calculation. Of the five studies that used survival analysis, none of them used a paired approach. Conclusions: Despite some progress in statistical analysis, if the reporting of studies represents the actual methodology of the trial, this review has identified important aspects of split-mouth study design and analysis that would benefit from development. [ABSTRACT FROM AUTHOR]

Objective: To evaluate communication of clinical research in the written media for completeness and accuracy.Design: Observational assessment.Setting: United States.Participants: Not applicable.Interventions: Content of media articles discussing randomized controlled trials was assessed by three reviewers on the basis of the Consolidated Standards of Reporting Trials (CONSORT) criteria modified for the mass media. Reports from October 1 through December 31, 2002, published in the top two U.S. daily newspapers (USA Today and Wall Street Journal), weekly news magazines (Time and Newsweek), and daily news Web sources (CNN.com and MSNBC.com) and the corresponding published RCTs were analyzed.Main Outcome Measures: Total score and score in 10 specific content areas, leading to classification of coverage as poor, fair, or excellent.Results: A total of 60 media reports discussing results of 25 RCTs appeared in these media during the study period. All reports were categorized as fair, and no content area was rated excellent. Several content areas received poor rankings in all and/or most media, including reporting of adverse effects, outcomes data, and statistical tests used. Media reports written by newswire services were rated more highly than were those prepared by nonnewswire services, but only 1 of 10 criteria had statistically significant differences.Conclusion: Mass media reports of RCTs are often incomplete. This type of reporting may misinform the lay public and may lead to questions about the applicability of the results to individual patients. [ABSTRACT FROM AUTHOR]

Background: Most retractions of obstetrics and gynecology manuscripts are because of scientific misconduct. It would be preferable to prevent randomized controlled trials with scientific misconduct from ever appearing in the peer-reviewed scientific literature, rather than to have to retract them later., Objective: This study aimed to evaluate the policies of obstetrics and gynecology and top medical journals in their author guidelines and electronic submission systems regarding prospective randomized controlled trial registration, ethics committee approval, research protocols, Consolidated Standards of Reporting Trial guidelines, and data sharing and to detect the most common quality criteria requested for randomized controlled trials in these journals., Study Design: Author guidelines were identified via online Google searches from the websites of selected peer-reviewed medical journals. Journals in obstetrics and gynecology were selected from the list of journals with impact factors based on the Journal Citation Report released by Clarivate Analytics on June 29, 2020, focusing on those publishing original clinical research in obstetrics, in particular randomized controlled trials. In addition, 4 of the top impact factor peer-reviewed general medical journals publishing randomized controlled trials were included. The requirements for selected quality criteria for randomized controlled trials analyzed in the author guidelines for each journal were details of 5 general issues: prospective randomized controlled trial registration (4 subcategories), ethics committee approval (4 subcategories), research protocol (3 subcategories), Consolidated Standards of Reporting Trials guidelines (3 subcategories), and data sharing (3 subcategories). To evaluate the requirements within the electronic submission system, a mock submission of a randomized controlled trial was also done for each journal, and the same criteria were assessed on the online software for submission. The primary outcome was the overall percentage for each of the quality criteria that were listed as required within the author guidelines or required in the submission system among all journals. Planned subgroup analyses were top general medicine vs obstetrics and gynecology journals and top 4 obstetrics and gynecology vs other obstetrics and gynecology journals., Results: Most studied peer-reviewed journals listed in their author guidelines 7 specific criteria for submission of randomized controlled trials: prospective registration and registration number, statement of ethical approval with name of approving committee and statement of informed consent, statement of adherence to Consolidated Standards of Reporting Trials guidelines, and data sharing statement. For most journals, the submission software did not require these or any other criteria for submission. There were minimal differences in criteria listed for top medical journals vs other obstetrics and gynecology journals and among top vs other obstetrics and gynecology journals., Conclusion: Prospective registration and registration number, statement of ethical approval with name of approving committee and statement of informed consent, statement of adherence to Consolidated Standards of Reporting Trials guidelines, and data sharing statement are the randomized controlled trial quality criteria requested by leading medical and obstetrics and gynecology journals. These obstetrics and gynecology journals agree to make, as much as possible, these criteria uniform and mandatory in author guidelines and also through improved submission software., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background : In articles reporting randomized controlled trials, professional medical writing support is associated with increased adherence to Consolidated Standards of Reporting Trials (CONSORT). We set out to determine whether professional medical writing support was also associated with improved adherence to CONSORT for Abstracts. Methods : Using data from a previously published cross-sectional study of 463 articles reporting randomized controlled trials published between 2011 and 2014 in five top medical journals, we determined the association between professional medical writing support and CONSORT for Abstracts items using a Wilcoxon rank-sum test. Results : The mean proportion of adherence to CONSORT for Abstracts items reported was similar with and without professional medical writing support (64.3% vs 66.5%, respectively; p=0.30). Professional medical writing support was associated with lower adherence to reporting study setting (relative risk [RR]; 0.40; 95% confidence interval [CI], 0.23-0.70), and higher adherence to disclosing harms/side effects (RR 2.04; 95% CI, 1.37-3.03) and funding source (RR 1.75; 95% CI, 1.18-2.60). Conclusions : Although professional medical writing support was not associated with increased overall adherence to CONSORT for Abstracts, important aspects were improved with professional medical writing support, including reporting of adverse events and funding source. This study identifies areas to consider for improvement., Competing Interests: Competing interests: Mills I is an employee of PAREXEL International. Sheard C, Hays M, and Douglas K have no disclosures to report. Gattrell WT is an employee of Ipsen Biopharma. Winchester CC is an employee and Director of Oxford PharmaGenesis Ltd, and a Director and shareholder of Oxford PharmaGenesis Holdings Ltd.

Objectives: To evaluate the quality of reporting of single-patient (N-of-1) trials published in the medical literature based on the CONSORT Extension for N-of-1 Trials (CENT) statement and to examine factors that influence reporting quality in these trials., Study Design and Setting: Through a search of 10 electronic databases, we identified N-of-1 trials in clinical medicine published between January 1, 1985, and December 31, 2013. Two reviewers screened articles for eligibility and independently extracted data. Quality assessment was performed using the CENT statement. Discrepancies were resolved by consensus., Results: We identified 112 eligible N-of-1 trials published in 87 journals and involving a total of 2,278 patients. Overall, kappa agreement between the two evaluators for compliance with CENT criteria was 0.80 (95% confidence interval: 0.79, 0.82). Trials assessed pharmacology and therapeutics (87%), behavior (11%), or diagnosis (2%). Although 87% of articles described the trial design (including the planned number of subjects and length of treatment period), the median percentage of specific CENT elements reported in the Methods was 41% (range, 16-87%), and the median percentage in the Results was 38% (range, 32-93%). First authors were predominantly from North America (46%), Europe (29%), and Australia (17%). Quality of reporting was higher in articles published in journals with relatively high-impact factors (P = 0.004)., Conclusion: The quality of reporting of published N-of-1 trials is variable and in need of improvement. Because the CENT guidelines were not published until near the end of the period of this review, these results represent a baseline from which improvement may be expected in the future., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Abstract: Background: Public interest in herbal medicines has generated an increasing number of trials evaluating their efficacy. Trials with poor methodologic quality have exaggerated estimates of treatment effect, and incomplete reporting of trials causes difficulties in assessing trial methodologic quality. The objective of this project was to examine the quality of reporting of randomized controlled intervention trials of herbal medicine. Methods: MEDLINE (1966 to September 2003) was searched for randomized controlled trials of 10 herbal medicines. Two individuals (J. G. and J. D.) independently assessed trials using the Consolidated Standard of Reporting Trials checklist. Disagreements were resolved by consensus. The mean number of checklist items reported across all and for individual herbal medicines was calculated. The influence of decade of publication and species of herbal medicine tested was explored using an analysis of variance. Results: A total of 206 randomized controlled trials of herbal medicine were included. Interrater reliability on reporting quality assessment was high. A total of 45% of items were reported across all trials. The quality of reporting improved across decades from the 1970s to the 2000s. Individual herbal species differed in the total number of items reported, with echinacea, ginkgo, St. John’s wort, and kava trials reporting the most items. Conclusions: Important methodologic components of randomized controlled trials of herbal medicines are incompletely reported including allocation concealment, method used to generate the allocation sequence, and whether an intention-to-treat analysis was used. Also, key information unique to these trials may be missing, such as percentage of active constituents and type or form of the herbal medicine preparation. We suggest trialists consult a recent extension of the Consolidated Standard of Reporting Trials statement specific to herbal medicine trials when designing and reporting randomized controlled intervention trials of herbal medicines. [Copyright &y& Elsevier]

Presents a letter to the editor regarding the comparison of immunodulatory treatments for multiple sclerosis.