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Abstract Background Compulsory submission of a checklist from the relevant reporting guideline is one of the most widespread journal requirements aiming to improve completeness of reporting. However, the current suboptimal levels of adherence to reporting guidelines observed in the literature may indicate that this journal policy is not having a significant effect. Findings We explored whether authors provided the appropriate CONSORT checklist extension for their study and whether there were inconsistencies between what authors claimed on the submitted checklist and what was actually reported in the published paper. We randomly selected 12 randomized trials from three journals that provide the originally submitted checklist and analyzed six core CONSORT items. Only one paper used the appropriate checklist extension and had no inconsistencies between what was claimed in the submitted checklist and what was reported in the published paper. Conclusion Journals should take further actions to take full advantage of the requirement for the submission of fulfilled CONSORT checklists, thus ensuring that these checklists reflect what is reported in the manuscript.

To evaluate reporting of items indicative of bias and weak study design. Literature survey. Papers published in Veterinary Anaesthesia and Analgesia. Reporting of randomization, blinding, sample size estimation and data exclusion were compared for papers published separated by a 10 year interval. A reporting rate of more than 95% was considered ideal. The availability of data supporting results in a publicly accessible repository was also assessed. Selected papers were randomized and identifiers removed for review, with data from 59 (57 in 2009, two in 2008) and 56 (52 in 2019, four in 2018) papers analyzed. Items were categorized for completeness of reporting using a previously published operationalized checklist. Two reviewers reviewed all papers independently. Full reporting of randomization increased over time from 13.6% to 85.7% [95% confidence interval (CI), 57.8–86.6%; p < 0.0001], as did sample size estimation (from 0% to 20%; 95% CI, 7.6–32.4%; p = 0.002). Reporting of blinding (49.2% and 50.0%; 95% CI, –18.3% to 20.0%; p = 1.0) and exclusions of samples/animals (39.0% and 50.0%; 95% CI, –8.8% to 30.8%; p = 0.3) did not change significantly. Data availability was low (2008/2009, zero papers; 2018/2019, two papers). None of the items studied exceeded the predetermined ideal reporting rate. These results indicate that reporting quality remains low, with a risk of bias. [ABSTRACT FROM AUTHOR]

Abstract Research is an essential part of surgical training, so a surgical trainee must publish to prosper. The most important piece of advice is to seek expert help before commencing the process of research and subsequent publication. Having a piece of research worthy of communication to peers is an essential prerequisite, but there are many different types of publication, and many different avenues for publication. Starting with a simple case report is often a good beginning. The higher profile the research, the more likely there are to be formal rules about its conduct and its publication (CONSORT, PRISMA, etc). Writing in scientific English requires economy of style and linguistic restraint. The author has evolved a method to make writing a scientific manuscript as painless as possible. It may be tempting to relax once the writing is complete but managing the paper through submission can also be challenging. Most journals will not accept a paper immediately but will require corrections suggested by independent referees after formal peer review. All dealings with journal Editors should be professional and courteous. [ABSTRACT FROM AUTHOR]

Abstract: Research is an essential part of surgical training, so a surgical trainee must publish to prosper. The most important piece of advice is to seek expert help before commencing the process of research and subsequent publication. Having a piece of research worthy of communication to peers is an essential prerequisite, but there are many different types of publication, and many different avenues for publication. Starting with a simple case report is often a good beginning; publication in high-profile, high-impact-factor journals requires high-quality research such as randomized trials or systematic reviews. The more high profile the research, the more likely there are to be formal rules about its conduct and its publication (CONSORT, PRISMA etc). Writing in scientific English requires economy of style and linguistic restraint; many readers will not have English as a first language. By convention, scientific articles are written in IMRAD style – introduction, methods, results and discussion. This author has evolved a method to make writing a scientific manuscript as painless as possible. It may be tempting to relax once the writing is complete, but managing the paper through submission can also be challenging. Most journals will not accept a paper immediately, but will require corrections suggested by independent referees after formal peer review. All dealings with journal editors should be professional and courteous. [Copyright &y& Elsevier]

Background and Objectives: Given the fact that randomized controlled clinical trials are more valid than other research methods to determine the therapeutic effects of treatment, proper design and accurate reporting is of particular importance. This study was conducted with the aim of evaluating the quality of writing the title and abstract of randomized clinical trials of Iranian medical universities journals in 2016 using the Consolidated Standards of Reporting Trials (CONSORT) checklist. Materials and Methods: In this descriptive study, information gathering through internet search was limited to Persian language journals affiliated to the medical universities of the country. Based on the CONSORT checklist, which contains 18 questions, all randomly controlled clinical trials, consisting of 262 papers published in these magazines in 2016, were reviewed. Statistical analysis was performed using descriptive statistics and Chi-square and Fisher’s exact tests. Results: Only 34 (13%) of the articles refered to “randomized” word in the title of the article. Regarding the proportion of cases observed in the articles, based on the gender of the author, only two "mentioning the place of data collection" (p=0.009) and "mentioning clinical trial registration number" (p=0.020) and based on the scientific rank two cases, namely, “mentioning the full details of the responsible author” (p=0.002) and "mentioning the randomized method" (p=0.039) were significantly different. Conclusion: The need to follow CONSORT criteria and eliminate the deficiencies mentioned for conducting these studies in the country seems necessary. Therefore, it is recommended to the authors to use the CONSORT clinical checklist while writing randomized controlled clinical trials. [ABSTRACT FROM AUTHOR]

The methodology of randomized clinical trials is essential for the critical assessment and registration of therapeutic interventions. The CONSORT (Consolidated Standards of Reporting Trials) statement was developed to alleviate the problems arising from the inadequate reporting of randomized controlled trials. The present article reflects on the items that we believe should be included in the CONSORT checklist in the context of conducting and reporting trials in allergen-specific immunotherapy. Only randomized, blinded (in particular blinding of patients, health care providers, and outcome assessors), placebo-controlled Phase III studies in this article. Our analysis focuses on the definition of patients’ inclusion and exclusion criteria, allergen standardization, primary, secondary and exploratory outcomes, reporting of adverse events and analysis. [ABSTRACT FROM AUTHOR]

Purpose: Randomised controlled trials (RCTs) are considered the gold standard for evaluating the efficacy of an intervention. However, previous research has shown that RCTs in several surgical specialities are poorly reported, making it difficult to ascertain if various biases have been appropriately minimised. This systematic review assesses the reporting quality of surgical head and neck cancer RCTs. Methods: A literature search of PubMed and Embase was performed. Papers were included if they reported RCTs which assessed a surgical technique used to treat or diagnose head and neck cancer published during or after 2011. The CONSORT 2010 checklist was used to evaluate the reporting quality of these trials. Results: 41 papers were included. The mean CONSORT score was 16.5/25 (66% adherence) and the scores ranged from 7.5 (30%) to 25. The most common omissions were full trial protocol (found in 14.6%), participant recruitment method (22%) and effect size with a precision estimate for all outcome measures (29.3%). The full design and implementation of the randomisation methods were reported in 6 (14.6%). Papers published in journals which endorsed CONSORT had significantly higher scores (p = 0.02) and the journal impact factor was significantly correlated with CONSORT score (p = 0.01). Conclusion: We have identified several pieces of information that are underreported in surgical head and neck cancer RCTs. These omissions make understanding and comparing the methodologies and conclusions of RCTs more difficult. The endorsement of CONSORT by journals improved adherence, suggesting that wider adoption of the checklist may improve reporting. [ABSTRACT FROM AUTHOR]

To evaluate the quality of reporting in published randomized controlled trials (RTCs) in the field of fall injuries. The 188 RTCs published between 2001 and 2011, indexed in EMBASE and Medline databases were extracted through searching by appropriate keywords and EMTree classification terms. The evaluation trustworthiness was assured through parallel evaluations of two experts in epidemiology and biostatistics. About 40%-75% of papers had problems in reporting random allocation method, allocation concealment, random allocation implementation, blinding and similarity among groups, intention to treat and balancing benefits and harms. Moreover, at least 10% of papers inappropriately/not reported the design, protocol violations, sample size justification, subgroup/adjusted analyses, presenting flow diagram, drop outs, recruitment time, baseline data, suitable effect size on outcome, ancillary analyses, limitations and generalizability. Considering the shortcomings found and due to the importance of the RCTs for fall injury prevention programmes, their reporting quality should be improved. [ABSTRACT FROM AUTHOR]

Randomised controlled trials (RCTs) are the gold standard study design used to evaluate the safety and effectiveness of healthcare interventions. The reporting quality of RCTs is of fundamental importance for readers to appropriately analyse and understand the design and results of studies which are often labelled as practice changing papers. The aim of this article is to assess the reporting standards of a representative sample of randomised controlled trials (RCTs) published between 2019 and 2020 in four of the highest impact factor general medical journals. A systematic review of the electronic database Medline was conducted. Eligible RCTs included those published in the New England Journal of Medicine, Lancet, Journal of the American Medical Association, and British Medical Journal between January 1, 2019, and June 9, 2020. The study protocol was registered on medRxiv (https://doi.org/10.1101/2020.07.06.20147074). Of a total eligible sample of 497 studies, 50 full-text RCTs were reviewed against the CONSORT 2010 statement and relevant extensions where necessary. The mean adherence to the CONSORT checklist was 90% (SD 9%). There were specific items on the CONSORT checklist which had recurring suboptimal adherence, including in title (item 1a, 70% adherence), randomisation (items 9 and 10, 56% and 30% adherence) and outcomes and estimation (item 17b, 62% adherence). Amongst a sample of RCTs published in four of the highest impact factor general medical journals, there was good overall adherence to the CONSORT 2010 statement. However there remains significant room for improvement in areas such as description of allocation concealment and implementation of randomisation. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the reporting quality of randomized clinical trials (RCTs) in periodontology. Three leading periodontology journals, the Journal of Periodontology (JOP), the Journal of Clinical Periodontology (JOCP), and the Journal of Periodontal Research (JOPR), were selected for this investigation. The RCTs were identified by manually searching for human trial articles published in these three journals. Two authors independently conducted the literature search, and a pre-piloted extraction sheet was used to screen the potential RCTs. The CONSORT checklist guidelines were employed to calculate the score value. Intra-examiner reliability was assessed by scoring a random sample of 10% of the papers in a second round conducted by the first examiner three months after the initial data collection. A search of abstracts published over a five-year period yielded 176 articles that reported RCTs, accounting for 11.7% of all articles published in the three journals. The highest number of RCTs was published in 2020, and more than half of the included RCTs (51%) originated from Europe. Many of the analyzed RCTs inadequately reported almost half of the items on the CONSORT checklist. Furthermore, univariate analysis revealed significant associations between certain factors and the overall CONSORT score, such as publication in JOP (p = 0.048), publication year of 2019 (p = 0.041) and 2021 (p = 0.042), first author from North America (p = 0.016), and RCTs with more than six authors (p = 0.042). Clinical trial research in periodontics has made significant progress in the past five years. However, there is room for improvement in adhering to the CONSORT guidelines. [ABSTRACT FROM AUTHOR]

During the days August 22-24, 2013 has been held in Harbin (China) an International Consensus Conference aimed to improve the quality and the reporting of the randomized controlled trials (RCTs) in infertility and subfertility field. I, as Italian scientist with experience in clinical infertility trials, was invited to have a speech on the Italian experience in RCTs, with particular regard for the surgical trials. Considerations on this subject were particularly interesting to highlight pitfalls and triumphs of research in Italy. [ABSTRACT FROM AUTHOR]

Randomized controlled trials (RCT) are widely considered to be the gold standard for demonstrating intervention effects. Adequacy of reporting of participant compliance in RCTs affects the interpretation of study results. Our aims were two-fold: first, to assess the adequacy of reporting of participant compliance in RCTs investigating the effect of maternal nutritional supplements on infant outcomes; and second, to examine authors' adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines on participant flow. Papers reporting trials of nutritional supplementation during pregnancy, and published after revision of the CONSORT recommendations, were identified using a search of medical databases. Two researchers systematically reviewed the papers to assess the reporting of participant compliance according to specified criteria, and the presentation of participant flow data recommended in the CONSORT guidelines. The literature search identified 58 papers. Almost a third ( n = 18) did not describe how participant compliance was assessed. Nearly half of the papers ( n = 27) failed to report participant compliance numerically (absolute numbers or percentage) and differences in compliance data between treatment arms were not reported in 52% of papers ( n = 28). The majority (83%) gave no information on whether the study protocol included any researcher input aimed at maximizing compliance. In addition to inadequate reporting of compliance, two of the CONSORT requirements (eligibility criteria and numbers discontinuing the intervention) were inadequately reported in 69% and 60% of papers, respectively. We conclude that participant compliance in nutrition trials is frequently inadequately reported. ‘False negative’ results from RCTs with poor compliance could wrongly influence policy and inhibit further research concerned with nutritional supplementation for women of child-bearing age. We suggest that changes to the CONSORT guidelines may improve RCT reporting. [ABSTRACT FROM AUTHOR]

Objective: The description of controls is important in acupuncture clinical trials to interpret its effectiveness without fallacy. This paper aims to evaluate the reporting quality of acupuncture studies on the characteristics of sham needles. Study design and setting: Using a checklist developed from previously published reporting guidelines, the distribution of reported items and changes of reporting rates over time were investigated. Two-way ANOVA and linear regression were conducted. Results: Original articles of RCTs of any design involving sham needles as controls were eligible for assessment. 117 trials from three 2-year time periods between 2009 and 2018 were included. Seven items out of 25 were reported in more than 50% of the studies. While significant differences of reporting scores among categories were observed, there were no significant differences among time periods; no significant improvement was observed over time. Conclusions: Low reporting qualities of sham needles used in acupuncture studies may influence how researchers understand the effectiveness of acupuncture. This study evaluated previous publications from 2009 to 2018 and found that reporting qualities on sham needles did not improve over time. Further studies are required to validate the items used in this study to endorse better reporting of controls in acupuncture trials. [ABSTRACT FROM AUTHOR]

Objective: To promote better reporting quality regarding sham acupuncture in clinical trials for a precise appraisal of the adequacy of the sham acupuncture procedure. Methods: A three‐stage online Delphi survey was conducted to a group of experts. Items with higher than 80% consensus from the initial checklist were selected as the final candidates. Further discussion among the working group was convened to preclude potential redundancy among the items. Results: A total of 23 experts out of 35 (66%) responded to the Delphi process. The final checklist consists of 23 items in six categories: type of sham acupuncture, details of sham acupuncture manipulation, location of sham acupuncture, treatment regimen, practitioner, and protocol and settings. Conclusion: This paper presents the Acupuncture Controls gUideline for Reporting humAn Trials and Experiments (ACURATE) checklist, an extension of The Consolidated Standards for Reporting of Trials (CONSORT) and to be used along with STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) when sham acupuncture needles are used in the study. This checklist focuses on a clear depiction of sham needling procedures to enhance replicability and enable a precise appraisal. We encourage researchers to use ACURATE in trials and reviews involving sham acupuncture to assist reporting sham acupuncture procedures and the related components. [ABSTRACT FROM AUTHOR]

The multiphase optimization strategy (MOST) is an increasingly popular framework to prepare, optimize, and evaluate multicomponent behavioral health interventions. Within this framework, it is common to use a factorial trial to assemble an optimized multicomponent intervention by simultaneously testing several intervention components. With the possibility of a large number of conditions (unique combinations of components) and a goal to balance conditions on both sample size (for statistical efficiency) and baseline covariates (for internal validity), such trials face additional randomization challenges compared to the standard two-arm trial. The purpose of the current paper is to compare and contrast potential randomization methods for factorial trials in the context of MOST and to provide guidance for the reporting of those methods. We describe the principles, advantages, and disadvantages of several randomization methods in the context of factorial trials. We then provide examples to examine current practice in the MOST-related literature and provide recommendations for reporting of randomization. We identify two key randomization decisions for MOST-related factorial trials: (i) whether to randomize to components or conditions and (ii) whether to use restricted randomization techniques, such as stratification, permuted blocks, and minimization. We also provide a checklist to assist researchers in ensuring complete reporting of randomization methods used. As more investigators use factorial trials within the MOST framework for assembling optimized multicomponent behavioral interventions, appropriate implementation and rigorous reporting of randomization procedures will be essential for ensuring the efficiency and validity of the results. [ABSTRACT FROM AUTHOR]

Background: In 1996, the CONSORT (CONsolidated Standards Of Reporting Trials) statement for the reporting of clinical trials was produced, based on empirical evidence regarding bias. Aims: This study assessed the quality of reporting of randomized controlled trials (RCTs) in the palliative care literature. Methods: Three specialist journals were hand searched for RCTs. A checklist was devised based on CONSORT recommendations. Two investigators independently assessed all the trials against this checklist. The trials were grouped into time cohorts of five years and quality comparisons made. Trials looking at pain were compared with those trials looking at other aspects of palliative care. Results: Ninety-three RCTs were identified. The number of trials has increased over time: nine in the first cohort, 37 in the second and 47 in the last cohort. The number of patients in the individual trials has also increased over time. Generally, the reporting quality was poor, particularly the areas of allocation concealment, randomization technique and intention to treat analysis, where there is empirical evidence, that it leads to trial bias. Although there were more pain papers than non-pain papers, the quality of reporting was only better for blinding and intention to treat analysis. Conclusion: The quality of reporting of RCTs in the palliative care literature is generally poor. However, there has been an increase in the number and the size of RCTs being carried out. This shows recognition of the importance of an evidence base in palliative care. However, in order to guide clinical decision making, future trials need to improve the quality of their reporting by adhering to the CONSORT statement. [ABSTRACT FROM AUTHOR]

This paper presents the Acupuncture Controls gUideline for Reporting humAn Trials and Experiments (ACURATE) checklist, an extension of The Consolidated Standards for Reporting of Trials (CONSORT), which is to be used with STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) when real and sham acupuncture needles are used in a study. This checklist focuses on a clear depiction of sham needling procedures to enhance replicability and enable a precise appraisal. We encourage researchers to use ACURATE in trials and reviews involving sham acupuncture to assist in the reporting of sham acupuncture procedures and related components. [ABSTRACT FROM AUTHOR]

Background A complete description of the intervention in a published trial report is necessary for readers to be able to use the intervention, yet the completeness of intervention descriptions in trials is very poor. Low awareness of the issue by authors, reviewers, and editors is part of the cause and providing specific instructions about intervention reporting to authors and encouraging full sharing of intervention materials is important. We assessed the extent to which: 1) journals' Instructions to Authors provide instructions about how interventions that have been evaluated in a randomised trial should be reported in the paper; and 2) journals offer the option of authors providing online supplementary materials. Methods We examined the web-based Instructions to Authors of 106 journals (the six leading general medical journals, 50 randomly selected journals from the National Library of Medicine's Core Clinical Journals, and 50 randomly selected journals from the remainder of the journal collection indexed by PubMed). To be eligible, each journal must have published at least one randomised trial involving human participants each year from 2008 to 2012. We extracted all information related to the reporting of interventions, reporting of randomised trials in general, and online supplementary materials. Results Of the 106 journals' Instructions to Authors, only 15 (14%) specifically mentioned the reporting of interventions and most of these provided non-specific advice such as 'describe essential features'. Just over half (62, 58%) of the journals mentioned the Consolidated Standards of Reporting Trials (CONSORT) statement in their author instructions. Seventyeight (74%) of the journals' instructions mentioned the option of providing supplementary content online as part of the paper; however, only four of these journals explicitly encouraged or mandated use of this option for providing intervention information or materials. Conclusions Most journals' Instructions to Authors do not provide any specific instructions regarding reporting of interventions or encourage authors to provide online supplementary materials to enhance intervention reporting. Journals can help to improve the problem of incomplete intervention reporting by providing specific instructions to authors and peer reviewers about intervention reporting and requiring full intervention descriptions to be provided. [ABSTRACT FROM AUTHOR]

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There is no assessment of the reporting quality of antifungal randomized, controlled trials (RCT), upon which guidelines for the treatment of invasive aspergillosis (IA) in patients with hematological malignancy are based. Trial reports were identified through Trip, Cochrane, Medline, and Embase database searches. Report quality was assessed using the 25-item CONSORT checklist and a rating scale of 1 (strongly disagree) to 4 (strongly agree). The primary endpoint was quality as assessed by mean group-scores among papers published at the time of the most recent IA treatment guidelines. Seven RCTs were identified for analysis. Overallmean group-score for all seven paperswas 2.44 (out of a total of four). There were significant differences between publications regarding overall reporting quality (P < .001) and specifically for the Methods and Results (P = .004 and P = .010, respectively), which best reflect data quality. The Cornely trial report achieved the highest mean group-score overall (3.15 ± 0.93; 95% CI, 2.82, 3.47), as well as for Methods (3.36) and Results (3.40). Mean group scores also showed that it was of significantly higher overall quality than the other six publications (P-value range; .012 to <.001), and of higher quality for Methods than five publications (P-value range; .013 to <.001). Incorporating this CONSORT analysis into the evidence-based grading systems in North American (IDSA), European (ECIL and ESCMID) IA guidelines could alter the value placed on these RCTs, thereby impacting on clinical recommendations. [ABSTRACT FROM AUTHOR]

Background: Surgical-assisted accelerated orthodontics (SAAO) has become very popular recently. Therefore, this study aimed to investigate the extent to which researchers adhere to Item 19 (harms) of the Consolidated Standards of Reporting Trials (CONSORT) in the published studies in the field of SAAO. In addition, the study evaluated the possible association between harm reporting and the human development index (HDI) of the recruited research sample country, CiteScore-based quartile (CSBQ) of the publishing journal, invasiveness of the surgical intervention (ISI), and the type of orthodontic tooth movement (TOTM). Moreover, it aimed to summarize the different possible harms and complications that maybe encountered in the course of SAAO. Materials and methods: Electronic searching of six databases was conducted for SAAO-related English RCTs published between January 2000 and April 2022. For the RCTs that did not report harms, information was sought by contacting the corresponding authors. Descriptive statistics of the evaluated variables were performed. The association between 'harm reporting' and the HDI of the research team, the BDRQ of the publication journal, the ISI, and the TOTM were investigated. Binary logistic regression was used, and the odds ratios (ORs) with 95% confidence interval (CIs) of the evaluated variables were obtained. Moreover, the risk of bias of the included RCTs was assessed using the RoB2 tool. Results: Among the 91 included RCTs, 54 RCTs (59.3%) did not adhere to reporting harm associated with the SAAO. The non-adherence was significantly associated with the ISI (OR 0.16; CI 0.03–0.73; p < 0.018) for invasive methods compared with minimally invasive ones). There was a significant positive correlation between harm reporting and both the CSBQ of the publishing journal and the HDI of the recruited research sample country (p = 0.001, p = 0.003, respectively). On the contrary, a non-significant association was found between harm reporting and the type of OTM (p = 0.695). The incidence of harms associated with SAAO was approximately 17.5%. Limitations: Assessment was restricted to English RCTs related to SAAO. Conclusion and implications: The adherence to reporting harms in the field of SAAO was deficient. Efforts should be made by authors, peer reviewers, and editors to improve compliance with the CONSORT guidelines regarding harms reporting. Additionally, there is a wide spectrum of harms that could be associated with SAAO that the practitioner should pay attention to and alert the patient to the possibility of their occurrence. [ABSTRACT FROM AUTHOR]

Background:Quality of reporting (QR) in industry-funded research is a concern of the scientific community. Greater scrutiny of industry-sponsored research reporting has been suggested, although differences in QR by sponsorship type have not been evaluated in weight loss interventions.Objective:To evaluate the association of funding source and QR of long-term obesity randomized clinical trials (RCT).Methods:We analysed papers that reported long-term weight loss trials. Articles were obtained through searches of Medline, HealthStar, and the Cochrane Controlled Trials Register between the years 1966 and 2003. QR scores were determined for each study based upon expanded criteria from the Consolidated Standards for Reporting Trials (CONSORT) checklist for a maximum score of 44 points. Studies were coded by category of industry support (0=no industry support, 1=industry support, 2=in kind contribution from industry and 3=duality of interest reported). Individual CONSORT reporting criteria were tabulated by funding type. An independent samples t-test compared the differences in QR scores by funding source and the Wilcox–Mann–Whitney test and generalised estimating equations (GEE) were used for sensitivity analyses.Results:Of the 63 RCTs evaluated, 67% were industry-supported trials. Industry funding was associated with higher QR score in long-term weight loss trials compared with nonindustry-funded studies (mean QR (s.d.): industry=27.9 (4.1), nonindustry=23.4 (4.1); P<0.0005). The Wilcox–Mann–Whitney test confirmed this result (P<0.0005). Controlling for the year of publication and whether the paper was published before the CONSORT statement was released in the GEE regression analysis, the direction and magnitude of effect were similar and statistically significant (P=0.035). Of the individual criteria that prior research has associated with biases, industry funding was associated with greater reporting of intent-to-treat analysis (P=0.0158), but was not different from nonindustry studies in reporting of treatment allocation and blinding.Conclusion:Our findings suggest that the efforts to improve reporting quality be directed to all obesity RCTs, irrespective of funding source.International Journal of Obesity (2008) 32, 1531–1536; doi:10.1038/ijo.2008.137; published online 19 August 2008 [ABSTRACT FROM AUTHOR]

Background: Discrepancies between pre-specified and reported outcomes are an important and prevalent source of bias in clinical trials. COMPare (Centre for Evidence-Based Medicine Outcome Monitoring Project) monitored all trials in five leading journals for correct outcome reporting, submitted correction letters on all misreported trials in real time, and then monitored responses from editors and trialists. From the trialists' responses, we aimed to answer two related questions. First, what can trialists' responses to corrections on their own misreported trials tell us about trialists' knowledge of correct outcome reporting? Second, what can a cohort of responses to a standardised correction letter tell us about how researchers respond to systematic critical post-publication peer review?Methods: All correspondence from trialists, published by journals in response to a correction letter from COMPare, was filed and indexed. We analysed the letters qualitatively and identified key themes in researchers' errors about correct outcome reporting, and approaches taken by researchers when their work was criticised.Results: Trialists frequently expressed views that contradicted the CONSORT (Consolidated Standards of Reporting Trials) guidelines or made inaccurate statements about correct outcome reporting. Common themes were: stating that pre-specification after trial commencement is acceptable; incorrect statements about registries; incorrect statements around the handling of multiple time points; and failure to recognise the need to report changes to pre-specified outcomes in the trial report. We identified additional themes in the approaches taken by researchers when responding to critical correspondence, including the following: ad hominem criticism; arguing that trialists should be trusted, rather than follow guidelines for trial reporting; appealing to the existence of a novel category of outcomes whose results need not necessarily be reported; incorrect statements by researchers about their own paper; and statements undermining transparency infrastructure, such as trial registers.Conclusions: Researchers commonly make incorrect statements about correct trial reporting. There are recurring themes in researchers' responses when their work is criticised, some of which fall short of the scientific ideal. Research on methodological shortcomings is now common, typically in the form of retrospective cohort studies describing the overall prevalence of a problem. We argue that prospective cohort studies which additionally issue correction letters in real time on each individual flawed study-and then follow-up responses from trialists and journals-are more impactful, more informative for those consuming the studies critiqued, more informative on the causes of shortcomings in research, and a better use of research resources. [ABSTRACT FROM AUTHOR]

Background: The coronavirus pandemic has led to the creation of clinical guidelines by a large number of professional medical communities. However, the quality and methodology of development of Russian clinical guidelines has been little studied. The continued relevance of studying the use of DOACs (Direct oral anticoagulants) in patients with COVID-19 was the basis for conducting this study. Aim: The objective of this study was to assess DOAC consumption and expenditure in the Russian Federation during the COVID-19 pandemic and to analyze whether it was supported by the domestic evidence base for the use of DOACs in COVID-19 patients through identifying all publicly available Russian-produced CPGs (Clinical practice guidelines) for the treatment of COVID-19 and assessing their quality as the source of recommendations for the use of oral anticoagulants for the prevention of thrombotic complications in COVID-19 patients. We searched Russian databases for CPGs, published between 2020 and 2023. We identified seven relevant documents that met our inclusion criteria. Three authors analyzed Russian clinical guidelines using an AGREE II questionnaire. We calculated DOAC DDD (defined daily dose) consumption according to Russian clinical guidelines and DDD consumption in patients with COVID-19 for the period 2020–2022. Results: Seven clinical CPGs were analyzed with the AGREE II tool. It was revealed that experts gave the highest scores for the sections on scope and purpose (from 62.98% to 100%), and clarity of presentation (from 96.30% to 100%). The lowest scores were given for the sections on stakeholder involvement (33.33% to 64.81%), rigour of development (from 0% to 49.31%), applicability (from 23.61% to 50%), and editorial independence (from 0% to 50%). When comparing the total score, it was found that two clinical guidelines received the highest scores—ROPNIZ (Livzan), and ROPNIZ (Drapkina). The minimum score was registered with the NIIOZMM (Khripun) clinical guideline. No guideline received a total score of more than 70%. According to clinical recommendations, the consumption of apixaban and rivaroxaban is 15 DDD (30-day course of therapy), or 22.5 DDD (45-day course of therapy). Consumption of apixaban in the Russian Federation in 2020 and 2021 corresponds to the indicators presented in clinical recommendations (in 2020—26.59 DDD per patient with COVID-19; in 2021—15.75 DDD per patient with COVID-19), and in 2022—10.67 DDD, which is below the recommended values. In 2020, consumption of rivaroxaban in the Russian Federation was 26.59 which corresponds to data from clinical recommendations; in 2021, consumption decreased to 7.87 DDD; in 2022 it decreased to 5.48 DDD, which is 2.74 times less than recommended. Conclusions: Analysis of seven clinical recommendations revealed that such sections of clinical recommendations as scope, purpose, and clarity of presentation had the highest degree of assessment in accordance with AGREE II. The lowest scores were given for the sections on stakeholder involvement, rigour of development, applicability, and editorial independence. When comparing the total score, it was found that two clinical guidelines received the highest scores—the Russian Society for the Prevention of Non-communicable Diseases (Livzan), and the Russian Society for the Prevention of Non-communicable Diseases (Drapkina). The minimum score was registered with the Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare Department clinical guideline. No guideline received a total score of more than 70%. During the pandemic, the highest DDD consumption of DOACs was in 2020, which exceeded the DOACs' recommended DDD by Russian clinical guidelines. DOAC consumption had decreased by 2022. There was a decrease in the consumption of rivaroxaban, with an increase in apixaban's share in the structure of DOAC consumption during the coronavirus pandemic. Obtained data indicate that in 2021 the apixaban consumption in the Russian Federation corresponded to the recommended DDD in the national guidelines, which indicates the most correct use of apixaban according to Russian GPGs. [ABSTRACT FROM AUTHOR]

Background: Complete and transparent reporting of clinical trial protocols and reports ensures that these documents are useful to all stakeholders, that bias is minimized, and that the research is not wasted. However, current studies repeatedly conclude that pediatric trial protocols and reports are not appropriately reported. Guidelines like SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) may improve reporting, but do not offer guidance on issues unique to pediatric trials. This paper reports two systematic reviews conducted to build the evidence base for the development of pediatric reporting guideline extensions: 1) SPIRIT-Children (SPIRIT-C) for pediatric trial protocols, and 2) CONSORT-Children (CONSORT-C) for pediatric trial reports.Method: MEDLINE, the Cochrane Methodology Register, and reference lists of included studies were searched. Publications of any type were eligible if they included explicit recommendations or empirical evidence for the reporting of potential items in a pediatric protocol (SPIRIT-C systematic review) or trial report (CONSORT-C systematic review). Study characteristics, recommendations and evidence for pediatric extension items were extracted. Recurrent themes in the recommendations and evidence were identified and synthesized. All steps were conducted by two reviewers.Results: For the SPIRIT-C and CONSORT-C systematic reviews 366 and 429 publications were included, respectively. Recommendations were identified for 48 of 50 original reporting items and sub-items from SPIRIT, 15 of 20 potential SPIRIT-C reporting items, all 37 original CONSORT items and sub-items, and 16 of 22 potential CONSORT-C reporting items. The following overarching themes of evidence to support or refute the utility of reporting items were identified: transparency; reproducibility; interpretability; usefulness; internal validity; external validity; reporting bias; publication bias; accountability; scientific soundness; and research ethics.Conclusion: These systematic reviews are the first to systematically gather evidence and recommendations for the reporting of specific items in pediatric protocols and trials. They provide useful and translatable evidence on which to build pediatric extensions to the SPIRIT and CONSORT reporting guidelines. The resulting SPIRIT-C and CONSORT-C will provide guidance to the authors of pediatric protocols and reports, respectively, helping to alleviate concerns of inappropriate and inconsistent reporting, and reduce research waste. [ABSTRACT FROM AUTHOR]

Background The primary goals in conducting clinical trials of treatments for alcohol use disorders ( AUDs) are to identify efficacious treatments and determine which treatments are most efficacious for which patients. Accurate reporting of study design features and results is imperative to enable readers of research reports to evaluate to what extent a study has achieved these goals. Guidance on quality of clinical trial reporting has evolved substantially over the past 2 decades, primarily through the publication and widespread adoption of the Consolidated Standards of Reporting Trials statement. However, there is room to improve the adoption of those standards in reporting the design and findings of treatment trials for AUD. Methods This paper provides a narrative review of guidance on reporting quality in AUD treatment trials. Results Despite improvements in the reporting of results of treatment trials for AUD over the past 2 decades, many published reports provide insufficient information on design or methods. Conclusions The reporting of alcohol treatment trial design, analysis, and results requires improvement in 4 primary areas: (i) trial registration, (ii) procedures for recruitment and retention, (iii) procedures for randomization and intervention design considerations, and (iv) statistical methods used to assess treatment efficacy. Improvements in these areas and the adoption of reporting standards by authors, reviewers, and editors are critical to an accurate assessment of the reliability and validity of treatment effects. Continued developments in this area are needed to move AUD treatment research forward via systematic reviews and meta-analyses that maximize the utility of completed studies. [ABSTRACT FROM AUTHOR]

Botulinum toxin use has become the most commonly performed aesthetic procedure among individuals of all age groups, encompassing both women and men. Randomized controlled trials (RCTs) provide the highest level of evidence and quality reporting of their abstracts plays a significant role for health professionals, influencing their decision-making in patient management. Therefore, our study aimed to assess the reporting quality of published RCT abstracts for botulinum toxin aesthetic use in the head area. The CONSORT-A checklist with 17 items was used to assess the quality of reporting. All available RCT abstracts (N = 191) found by searching the Medline database that were published up until June 2023 were included in this study. The average reporting rate was 52.9%. General items were inadequately reported (30.9%), with few abstracts describing the trial design. The methods section was better reported (62.0%), with interventions, objectives, and outcomes properly reported in over 97.5% abstracts. The results section (56.9%) demonstrated good reporting of randomized participant numbers but limited reporting of primary outcomes and harms. None of the abstracts reported funding sources or randomization information. To enhance the transparency and reliability of RCT results, abstracts should adhere more rigorously to the CONSORT-A guidelines. Improved reporting in abstracts can facilitate evidence-based decision-making in everyday practice of medical professionals in the field of aesthetic medicine. [ABSTRACT FROM AUTHOR]

Background: Reporting the scoring details of continuous outcome measures in randomized trials allows readers to interpret the size of any effect of the intervention. This study aimed to determine, in a sample of randomized trials: 1) the completeness of reporting of scoring details for continuous outcome measures, and 2) whether trial authors comment on the clinical significance of statistically significant trial results. Methods: A descriptive analysis of randomized trials of non-pharmacological interventions published during 2009 in the six leading general medical journals (n = 138), and which used at least one continuous outcome measure (n = 85). From each trial report, two authors independently extracted the following information about each continuous outcome measure: the reporting of its scoring details, presentation of its results, and the reporting and justification of the clinical significance of the results. Results: Across the 84 trials, we identified 336 continuous outcome measures. A total of 146 (44%) were published measures, 12 (4%) were adapted from published measures, 5 (1%) were developed for the trial, and 173 (51%) were ‘conventional measures’ for which scoring details are not necessary (such as weight). For 57 (35%) of the 163 non-conventional outcome measures no scoring details or reference to the outcome measure were provided in the trial report. Of the 159 outcome measures with a statistically significant result, clinical significance was not mentioned for 81 (51%) and was reported without any elaboration or justification for 39 (25%) of them. Conclusions: Scoring details of continuous outcome measures used in this sample of randomized trials of non-pharmacological interventions were incompletely reported, which hampers interpretation of a trial’s results. Complete reporting of scoring details is important when considering the clinical significance of the results. When deciding about an intervention, having this information may help clinicians in their conversations with patients about the possible benefits and harms, and their size, of the intervention. [ABSTRACT FROM AUTHOR]

Clinical research reports serve as the presentation of scientific research findings and directly reflect the quality of the research. This article describes the writing of different types of clinical research reports， such as observational studies and randomized controlled trial studies， with a particular focus on randomized controlled trials. Each scientific research design has its reporting focus， and the writing of scientific research papers has uniform requirements and a specific writing format. Mastering the proper format of drafting research reports is of practical value and significant importance for conduction high-quality clinical research.

Abstract: Background: Despite being the gold-standard for investigations, randomised controlled trials can deliver biassed results if methodology is flawed. The CONSORT statements are intended to guide the reporting of trials. We assessed the reporting quality of anti-arrhythmic drug trials over the last decade. Methods: Medline and Embase databases were searched for anti-arrhythmic drug trials between 2002 and 2011. Results were searched by two authors and relevant papers selected. Papers were scored according to the 2001 and 2010 CONSORT statements by two reviewers and compared against surrogate markers of paper quality. Results: 694 papers were retrieved. 59 papers met the inclusion criteria. The mean CONSORT 2010 score was 15.4 out of 25 (SD 3.05). The least reported items related to abstract content (0%), randomization (6.8%), and protocol referencing (8.5%). There was a significant correlation between the CONSORT 2010 score and the annual and 5-year impact factors of the publishing journal (R=0.44 and R=0.45 respectively; p<0.001 for both). No significant correlation was found between the year of publication or number of authors, and 2010 CONSORT score. Conclusions: Although several papers gained high scores, no paper successfully met all criteria laid out in either the CONSORT 2001 or 2010 statements. Correlation between CONSORT 2010 score and impact factor lends support to this as a marker for paper quality. The lack of reporting clarity found, indicates that application of the CONSORT guidelines remains incomplete within the cardiology literature. Further work is needed collectively by trial groups, funding agencies, authors, and journals to improve reporting. [Copyright &y& Elsevier]

Abstract: Objective: The Consolidated Standards for Reporting of Trials (CONSORT) statement has already proved to be an efficient standard for reporting quality of randomized controlled trials (RCTs). However, most of the Chinese medical journals have not endorsed the CONSORT statement. The current situation about the reporting quality of RCTs in Chinese medical journals is still unclear. The purpose of the study was to evaluate the reporting quality of RCTs on papers published in 5 leading Chinese medical journals. Methods: We evaluated 232 original RCT papers using a reporting quality scale based on CONSORT statement from 2001 to 2006 in 5 Chinese medical journals (Journal type 1) without adoption of CONSORT and Chinese Journal of Evidence-based Medicine (Journal type 2) which adopted CONSORT in 2004. We measured the inclusion of 26 items for the reporting quality scale and 6 core items of each RCT report, gave score to each item and calculated the total score obtained in each report and the proportion of reports including individual items. The reporting quality of RCT trials from 2001 to 2003 (pre-adoption period) was compared with that from 2004 to 2006 (post-adoption period). Results: The average reporting quality of RCTs was moderate (mean score, 15.18), and the mean score of the 6 core items was low (mean score, 1.09) in 5 leading journals. The difference in the total score and the score of the 6 core items between pre-adoption period (2001–2003) and post-adoption period (2004—2006) was statistically significant (P=0.003; P=0.000). Interaction between journal type and period was not significant (F=0.76; P=0.383). We concluded that the change tendency of reporting quality between Journal type 1 and 2 was not different. But as to the core items of sequence concealment and intention-to-treat analysis, the increases were greater for Journal type 2 when evaluated against Journal type 1 (P=0.038; P=0.016). Conclusion: The reporting quality of RCT trials in 5 leading Chinese medical journals is improving. However, the lack of important items in RCT trials remains a serious problem. We recommend the endorsement of the Consolidated Standards for Reporting of Trials statement in Chinese medical journals and the continuing education on evidence-based medicine in China. [Copyright &y& Elsevier]

Objective Methodological criteria that characterise ethically sound community-based studies are often described in overviews but are rarely documented in clinical studies. Research investigating the health of Aboriginal Australians is often small-scale, descriptive and largely driven by non-Indigenous people. The ‘community-controlled’ model of research relating to Aboriginal peoples health is a form of ‘participatory’ research that shifts the balance of control towards those being researched. This paper describes the methodological issues and principles that underpin community-controlled health research; their practical application; and encourages their adoption in research involving Indigenous populations.Design Descriptive report of the methods used to conduct the landmark Aboriginal community-controlled multi-centre double-blind randomised controlled clinical ear trial investigating ototopical treatments for chronic suppurative otitis media.Results The characteristics of the community-controlled research model are illustrated under the headings of: setting the research agenda; research project planning and approval; conduct of research; and analysis, dissemination and application of findings.Conclusion The 22 methodological elements which defined the community-controlled design of the ear trial may assist community groups, external research bodies and funding agencies to improve the acceptability, quality and scope of research involving Indigenous peoples. Aboriginal community-controlled organisations are well placed to lead research, which can be interventional and of a high scientific standard without compromising the values and principles of those being researched. With over 120 Aboriginal community-controlled health services (ACCHSs) across Australia, the potential exists for these services to engage in multi-centre research to realise solutions to health problems faced by Indigenous Australians. [ABSTRACT FROM AUTHOR]

This project aims to: (1) assess the completeness of information in flow diagrams of published early phase dose-finding (EPDF) trials based on CONSORT recommendations, and if additional features on dose (de-)escalation were presented; (2) propose new flow diagrams presenting how doses were (de-)escalated throughout the trial. Flow diagrams were extracted from a random sample of 259 EPDF trials, published from 2011 to 2020 indexed in PubMed. Diagrams were scored out of 15 following CONSORT recommendations with an additional score for presence of (de-)escalation. New templates were proposed for features that were deficient and presented to 39 methodologists and 11 clinical trialists in October and December 2022. 98 (38%) papers included a flow diagram. Flow diagrams were most deficient in the reporting of reasons for lost to follow up (2%) and reasons for not receiving allocated intervention (14%). Few (39%) presented sequential dose-decision stages. Of voting methodologists, 33/38 (87%) agreed or strongly agreed that for participants recruited in cohorts, presenting the (de-)escalation steps in the flow diagram is a useful feature, also expressed by the trial investigators. Most workshop attendees (35/39, 90%) preferred a larger dose to be displayed higher up within the flow diagram than a smaller dose. Most published trials do not provide a flow diagram, and for those that do, essential information is often omitted. EPDF flow diagrams capturing information on participant flow in the trial's journey, encapsulated within one figure, are highly recommended to promote transparency and interpretability of trial results. [ABSTRACT FROM AUTHOR]

Background and aims: Compulsive buying-shopping disorder (CBSD) is mentioned as an example of other specified impulse control disorders in the ICD-11 coding tool, highlighting its clinical relevance and need for treatment. The aim of the present work was to provide a systematic update on treatment studies for CBSD, with a particular focus on online CBSD. Method: The preregistered systematic review (PROSPERO, CRD42021257379) was performed in accordance with the PRISMA 2020 statement. A literature search was conducted using the PubMed, Scopus, Web of Science and PsycInfo databases. Original research published between January 2000 and December 2022 was included. Risk of reporting bias was evaluated with the CONSORT guideline for randomized controlled trials. Effect sizes for primary CBSD outcomes were calculated. Results: Thirteen studies were included (psychotherapy: 2 open, 4 waitlist control design; medication: 2 open, 3 placebo-controlled, 2 open-label phase followed by a double-blind discontinuation phase; participants treatment/control 349/149). None of the studies addressed online CBSD. Psychotherapy studies suggest that group cognitive-behavioral therapy is effective in reducing CBSD symptoms. Pharmacological studies with selective serotonin re-uptake inhibitors or topiramate did not indicate superiority over placebo. Predictors of treatment outcome were rarely examined, mechanisms of change were not studied at all. Risk of reporting bias was high in most studies. Discussion: Poor methodological and low quality of reporting of included studies reduce the reliability of conclusions. There is a lack of studies targeting online CBSD. More high-quality treatment research is needed with more emphasis on the CBSD subtype and mechanisms of change. [ABSTRACT FROM AUTHOR]