Transparent Reporting of Pediatric Clinical Trial Interventions: TIDieR-Children and Adolescents.

The CONSORT-SPI 2018 extension: a new guideline for reporting social and psychological intervention trials.

Assessment of the reporting quality of randomized controlled trials related to the pharmacotherapy of COVID-19 based on the CONSORT 2010 checklist: a systematic review

The Consolidated Standards for Reporting of Trials (CONSORT) statement was developed to help improve the quality of reports of randomized controlled trials (RCTs). To date, a paucity of data exists regarding whether it has achieved this goal. To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs. Comparative before-and-after evaluation in which reports of RCTs published in 1994 (pre-CONSORT) were compared with RCT reports from the same journals published in 1998 (post-CONSORT). We included 211 reports from BMJ, JAMA, and The Lancet (journals that adopted CONSORT) as well as The New England Journal of Medicine (a journal that did not adopt CONSORT and was used as a comparator). Number of CONSORT items included in a report, frequency of unclear reporting of allocation concealment, and overall trial quality score based on the Jadad scale, a 5-point quality assessment instrument. Compared with 1994, the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998, and this increase was statistically significant for the 3 adopter journals (pre-CONSORT, 23.4; mean change, 3.7; 95% confidence interval [CI], 2.1-5.3). The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals, and this change was statistically significant for adopters (pre-CONSORT, 61%; mean change, -22%; 95% CI, -38% to -6%). Similarly, 3 of the 4 journals showed an improvement in the quality score for reports of RCTs, and this increase was statistically significant for adopter journals overall (pre-CONSORT, 2.7; mean change, 0.4; 95% CI, 0.1-0.8). Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs.

In the era of evidence-based practice (EBP), randomized controlled trials (RCTs) may provide the best evidence of the efficacy of nursing interventions and yet the quality of Rct reporting in nursing literature has not been evaluated. The purposes of this study were to apply the Consolidated Standards of Reporting Trials (CONSORT) statement to published reports of nursing science, examine how adequately the published reports adhere to the statement, and examine the effect of the adoption of CONSORT on the quality of the Rct published reports. One hundred RCTs from 2002–2005 were identified from four nursing journals. Articles were randomly assigned to four reviewers and the quality of the published reports was evaluated using a modified CONSORT checklist. There was no difference between the four journals in the quality of the published reports of RCTs based on the modified CONSORT checklist employed (F = 1.27, P = 0.29). The quality of reporting of RCTs improved significantly in the only journal, Nursing Research, to adopt the CONSORT statement during the study period (t = -2.70, P = 0.01). Adoption of CONSORT is recommended as it may lead to an overall improvement in quality of reporting of RCTs in nursing journals. The profession may also wish to explore the use or development of standards similar to CONSORT but ones more appropriate for the types of research typical of that published by nurse scientists.

The Consolidated Standards for Reporting of Trials (CONSORT) statement was developed to improve the quality of randomized controlled trial (RCT) reports. We assessed the quality of current Japanese RCT reports by conducting a cross-sectional study to examine the extent to which they adhere to the CONSORT statement. Reports of RCTs conducted in Japan that were published in medical journals between January and March 2004 were sampled from MEDLINE. The proportion of adherence to each item in the CONSORT checklist was evaluated for each report. Additionally, information on ethics reporting and funding sources was collected. A total of 98 RCT reports from Japan were evaluated, and adherence to the CONSORT statement was found to be suboptimal. Only 6 of 29 items in the checklist were described in more than 80% of reports. Adherence to key methodological items of the CONSORT statement was as follows: 23% for sample size determination, 39% for random sequence generation, 17% for allocation concealment, 29% for blinding, 53% for numbers analyzed, and 6% for inclusion of a flow diagram. Adherence to additional items was 82% for ethics committee approval, 92% for receiving informed consent, and 20% for disclosing funding sources. Our study on adherence of recent RCT reports from Japan to the CONSORT statement reveals that there is a significant need for improvement. Further investigation on the quality of RCT reports and ways to improve reporting quality is required.

Recommendations for Reporting of Clinical Research Studies

ObjectiveEvaluating the reporting of safety data of medication in paediatric randomised controlled trials (RCTs) in 2017–2018 compared with our earlier study.DesignLiterature search with a systemic appraisal of adverse drug event...

A linguistic construction of a research gap in reports of randomised controlled trials: A systemic functional perspective

Establishing an institutional EAP teacher development scheme based on BALEAP's competency framework: A critical review of the competencies

Quality of reporting Randomized Controlled Trials (RCTs) in the nursing literature: Application of the Consolidated Standards of Reporting Trials (CONSORT)

세계 유수의 의학관련 연구 저널의 편집자들은 제출된 원고의 질을 관리하기 위하여 연구진행의 가이드라인 역할을 할 수 있는 보고 지침을 개발하여 평가에 적용하고 있다. 따라서 본 연구는 RCTs를 위한 보고 지침인 CONSORT의 2010년 개정판 내용과 특징을 소개함으로써 치위생 연구의 계획 및 수행에 도움을 주고 더 나아가 EBP의 활성화에 기여하고자 하였다. CONSORT는 시험 보고의 질을 향상시킬 수 있도록 논문 저자들에게 보고 지침을 제공한다. 이 보고 지침은 RCTs 보고서에 반드시 포함되어야 할 필수 항목인 25개의 체크 리스트와 연구 과정의 도식화를 위한 순서도를 제시한다. 저자들은 연구 설계 시점부터 CONSORT의 각 항목을 참고함으로써 연구의 질을 향상시킬 수 있다. 따라서 우리 치위생계에서도 이러한 보고지침을 준수함으로써 치위생 연구의 타당성을 높이고, 이러한 연구 결과를 질 높은 근거 기반적 치위생 실무로 접목시켜 발전시킬 수 있을 것으로 생각된다. Recently, there are lots methodologies to improve the quality of research in medical and public health fields. One of them is to checking a process of research with a reporting guideline before reporting paper. Especially, reporting guideline for randomized controlled trials (RCTs) is the consolidated standards of reporting trials (CONSORT). Therefore, this review describes the latest version of the CONSORT statement, CONSORT 2010, including intent, background, and contents of this. The CONSORT statement comprises a checklist of essential items that should be included in reports of RCTs and a diagram for documenting the flow of participants through a trial. This report guideline aims at providing guidance to authors about how to improve the reporting of their trials. As consulting the CONSORT, authors could be strictly reported about research methods and results. From this review, we expect to elevate the quality of such research about dental hygiene and to establish the foundation for evidence-based dental hygiene.

ObjectivesThis study aims to assess the completeness of reporting of randomised controlled trials (RCTs) of acupuncture in the Korean literature.DesignSystematic review.MethodsWe searched 12 Korean databases and 7 Korean journals to...

To evaluate the methodological qualities of clinical therapeutic research papers published in Chinese Journal of Pediatrics and find out the weaknesses and defects in the literature of clinical therapeutic research in China. The clinical therapeutic research articles from Chinese Journal of Pediatrics, which were published in the years 1999, 2000, 2001, 2009, 2010 and 2011, were analyzed manually, after dividing into randomized controlled trials (RCT) and non-randomized controlled trials. The methodological quality of RCT articles were evaluated by Consolidated Standards for Reporting of Trials (CONSORT) and Jadad scale, while non-RCT reports were assessed by specific evaluation standard criteria and analytical table. And the group A (1999 - 2001) and group B (2009 - 2011) of the quality documents were compared and analyzed. Seventeen RCTs were included. Based on the items in the CONSORT statement, the reporting quality of sample size determination, demographic baseline, random principle, blinding, lost to follow-up were all lower than 50%. Fourteen (82.4%) in the 17 RCTs mentioned 'eligibility criteria for participants', 11 (64.7%) RCTs mentioned 'details of the interventions', 15 (88.2%) RCTs mentioned 'adverse effects'. Compared with RCT reports in the year of 1999, 2000 and 2001, the methodological qualities of those in 2009, 2010 and 2011 were not improved. In the 17 RCTs, the total score achieved based on the Jadad scale, only 11.8% (2 out of 17) were high-quality trials (≥ 3 points). Analysis of the 28 non-RCTs, which were included and assessed by evaluation criteria and evaluation table, also showed some disadvantages on some key items. The methodological quality of clinical therapeutic research reports should be consistent with the standards of international evaluation, pediatric clinicians should improve know ledge in clinical epidemiology, clinical trial methodology, and improve the quality of research reports.

The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the reporting quality of randomized controlled trials (RCTs). Our primary aim was to assess to what extent reports of RCTs in solid organ transplantation adhere to the 2010 CONSORT statement. Secondly, we investigated the relationship between CONSORT adherence, methodological quality and some other factors. We included 290 RCTs that were published between 2007 and 2009. We examined to what extent trial reports complied with 30 items of the CONSORT statement. Methodological quality was evaluated using the Jadad scale plus allocation concealment and whether data analysis was by randomized group (intention to treat). On average, trial reports addressed 47% of the CONSORT items. Forty-three per cent of RCTs was considered to be of good quality according to Jadad scale, and the items allocation concealment and data analysis were satisfied in approximately one-third of trials. Good quality RCTs reported on more CONSORT items than poor quality trials. The methodological quality and adherence to the CONSORT statement of RCTs published in journals that endorse the CONSORT statement was superior to those in journals without CONSORT endorsement. Overall compliance with the CONSORT statement and the methodological quality of RCTs in organ transplantation remains unsatisfactory.

To assess the changes in compliance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines for randomized controlled trials (RCTs) in four orthodontic journals. To assess whether reporting of randomization, concealment, and blinding has improved. Electronic hand searching was undertaken to identify orthodontic RCTs published in four orthodontic journals from January 2016 to June 2017 (T1) and from January 2019 to June 2020 (T2). The journals were the American Journal of Orthodontics and Dentofacial Orthopaedics (AJO-DO), Angle Orthodontist (AO), European Journal of Orthodontics (EJO), and Journal of Orthodontics (JO). Each item on the CONSORT checklist was scored as either reported, not reported, or not applicable for each paper reporting an RCT. The study included 69 papers reporting an RCT published in T1 and 64 RCTs published in T2. The median CONSORT score in T1 was 48.7% (interquartile range [IQR] 27.6%, 68.6%) and 67% in T2 (IQR 43.9%, 79.5%). This increase was statistically significant (P = 0.001) and largely attributable to improved reporting in AO (P = 0.016) and EJO (P = 0.023). Reporting did not change significantly in AJO-DO (P = 0.13) or in JO (P = 1.0). Reporting of random allocation sequence generation (OR 2.09; 95% CI 1.01, 4.29) and concealment of allocation (OR 2.27%, 95% CI 1.12, 4.57) were significantly higher in T2 compared with T1. Reporting of blinding did not change significantly. Overall reporting of CONSORT items in reports of orthodontic RCTs published in the AJO-DO, AO, EJO, and JO, improved significantly from 2016-17 to 2019-20. This could be improved further by authors, journal referees, and editors adhering to the guidelines.