CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience.     

Evidence of improving quality of reporting of randomized controlled trials in subfertility

BACKGROUND: The quality of randomized controlled trials (RCTs) in subfertility and their suitability for inclusion in meta-analyses have been assessed in the past and found to be insufficient. Our aim was to assess whether this quality has improved over time, particularly since the publication of the Consolidated Standards of Reporting Trials (CONSORT) statement, and to assess what proportion of trials could be included in the meta-analyses of pregnancy outcomes such as those included in Cochrane Reviews. METHODS: A selection of subfertility trials published in 1990, 1996 and 2002 was collected from the Cochrane Menstrual Disorder and Subfertility Group (MDSG) database. Only trials published in English as full journal articles, claiming to be randomized and reporting on pregnancy outcomes, were included. RESULTS: One hundred and sixty-four trials met our inclusion criteria. Twenty-four (15%) were found not to be randomized, despite claims, and only 10 trials (6%) provided adequate details on the methods of randomization and allocation concealment. Of these, only three had sufficient details extractable to allow for an intention-to-treat analysis of the outcome 'live birth'. CONCLUSIONS: Although an improvement in some subfertility-specific issues was observed, the quality of reporting of RCTs still needs to improve to make them suitable for inclusion in meta-analyses such as those in the Cochrane Library.     

The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001

To comprehend the result of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this article incorporates new evidence and addresses some criticism of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Comment. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage or participants through an RCT. The revised flow diagram depicts information from 4 stages of a trial (enrollment, intervention allocation, follow-up and analysis). The diagram explicitly includes the number of participants, according to each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting or an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.     

Commentary: the Journal of Pediatric Psychology should adopt the CONSORT statement as a way of improving the evidence base in pediatric psychology

The CONSORT statement (www.consort-statement.org) was developedto improve standards of reporting of randomized clinical trials (RCTs) in medical journals. It currently includes 22 items usedby reviewers and editors to ensure consistent and full reportingof the results of an RCT. It also aids researchers in the planand execution of RCTs. The Journal of the American MedicalAssociation was one of the first journals to adopt the CONSORTitems as guidelines to ensure quality reporting of RCTs; since that time over 80 medical journals have adopted these standardsfor the reviewing and reporting of RCTs. Recent reviews ofthe quality of RCT reporting have demonstrated that the introductionof the     

Reporting infections in clinical trials of patients with haematological malignancies

BackgroundInfections are common among patients treated for haematological malignancies and are associated with significant morbidity and mortality. The completeness of reporting infectious complications in randomized controlled trials (RCTs) assessing treatments for haematological malignancies is unknown.ObjectivesWe aimed to evaluate the completeness of reporting infectious complications in RCTs assessing treatments for haematological malignancies.Data sourceA systematic literature search was performed in PubMed database.Study eligibility criteria and participantsAll primary published phase II/III RCTs between September 2016 and September 2018 evaluating treatments for haematological malignancies in adult patients were included.InterventionReporting infectious complications.MethodsA systematic review was conducted to evaluate the completeness of reporting. Study characteristics and data concerning reporting of infectious complications were collected by two independent reviewers. Quality of reporting was assessed using a modification of the CONSORT extension checklist for harms, including 15 items.ResultsOne-hundred and seven RCTs were included. Most trials (97; 91%) provided some report on infections. Approximately half reported on each of pneumonia, sepsis and neutropenic fever; 12 trials (11%) reported on fungal infections. Only nine trials (8%) listed infections by type of pathogen (i.e. bacterial, fungal or viral) and 48 (45%) by source/type of infection (i.e. pneumonia, urinary tract infection, etc.). Most trials did not address infections in their title, abstract, introduction or discussion. Median number of items of the CONSORT modification reported was 7 points, (interquartile range (IQR) 6–9) for all included trials, with lower median for 34 acute leukaemia trials (median 6, IQR 5–8).ConclusionsMost trials evaluating treatment for haematological malignancies provide some data relating to infectious complications. The reports are mostly incomplete and rarely provided in a structured presentation.     

CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions

Background

Web-based and mobile health interventions (also called “Internet interventions” or "eHealth/mHealth interventions") are tools or treatments, typically behaviorally based, that are operationalized and transformed for delivery via the Internet or mobile platforms. These include electronic tools for patients, informal caregivers, healthy consumers, and health care providers. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the suboptimal reporting of randomized controlled trials (RCTs). While the CONSORT statement can be applied to provide broad guidance on how eHealth and mHealth trials should be reported, RCTs of web-based interventions pose very specific issues and challenges, in particular related to reporting sufficient details of the intervention to allow replication and theory-building.

Objective

To develop a checklist, dubbed CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth), as an extension of the CONSORT statement that provides guidance for authors of eHealth and mHealth interventions.

Methods

A literature review was conducted, followed by a survey among eHealth experts and a workshop.

Results

A checklist instrument was constructed as an extension of the CONSORT statement. The instrument has been adopted by the Journal of Medical Internet Research (JMIR) and authors of eHealth RCTs are required to submit an electronic checklist explaining how they addressed each subitem.

Conclusions

CONSORT-EHEALTH has the potential to improve reporting and provides a basis for evaluating the validity and applicability of eHealth trials. Subitems describing how the intervention should be reported can also be used for non-RCT evaluation reports. As part of the development process, an evaluation component is essential; therefore, feedback from authors will be solicited, and a before-after study will evaluate whether reporting has been improved.     

中国儿科领域随机对照试验报告质量横断面调查

目的 评估CONSORT声明自1997年引入中国以来,中国儿科杂志发表RCT的报告质量是否得到提高。方法手工检索中国大陆被中国科学引文数据库（CSCD）收录的6种国内儿科杂志（《中华儿科杂志》、《中华小儿外科杂志》、《中国当代儿科杂志》、《中国实用儿科杂志》、《中国循证儿科杂志》和《临床儿科杂志》）,检索时间均为创刊至2010年12月。对照CONSORT声明的评价条目清单,设计标准的资料提取表格,评估纳入文献的报告质量,使用SPSS18．0软件进行统计分析。结果619篇RCT文献进入分析。1997至2010年与1997年前发表的RCT相比,其在文题、摘要、引言、受试者招募、基线资料和辅助分析等方面的报告质量有一定的改善（P〈0．05）,但在方法学的报告方面存在报告不充分或不准确的问题,如确定样本量的方法（0．6％vs1．1％）、随机序列产生的方法（3．2％vs7．6％）、分配隐藏（0vs1．1％）、盲法（0vs2．6％）等。进一步对稿约中要求CONSORT声明的《中国循证儿科杂志》发表的9篇RCT进行评估,其CONSORT条目符合率均高于其他儿科杂志,特别在方法学的报告方面,如确定样本量的方法、随机序列产生的方法、分配隐藏和盲法等。结论总体而言,CONSORT声明的引入并没有使中国儿科领域RCT的报告质量从根本上提高。在稿约中要求CONSORT声明的杂志可显著提高RCT的报告质量。     

Clinical trials in the Journal of Pediatric Psychology: applying the CONSORT statement

OBJECTIVE: To determine how well therapeutic randomized controlled trials (RCTs) in the Journal of Pediatric Psychology (JPP) met the CONSORT criteria as compared to pediatric trials in the Journal of Clinical and Consulting Psychology (JCCP), which served as a control. METHODS: Nine trials were found in JPP and 19 clinical trials were retrieved from JCCP. The modified Consort Checklist and Flow Chart was applied to each trial by two unblinded independent raters. RESULTS: The number of CONSORT items not reported between the two journals was strikingly similar. One half (11/22) of the CONSORT items were reported less than 25% of the time. Information provided on the flow of participants in the trials was similar across the two journals; however, JCCP more often reported on those assessed to be eligible overall, chi(2) = 5.241, p <.05. JPP reported on recruitment 33.3% of the time, while it was not reported at all in JCCP, chi(2) = 7.093, p <.05. CONCLUSIONS: Although many of the items in the CONSORT statement were not adhered to by the two psychological journals, most of the CONSORT items can clearly be applied to psychosocial trials.     

The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials

To comprehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis and interpretation. That goal can only be achieved through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement.The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results and Discussion. The revised checklist includes 22-items selected because empirical evidence indicates that not reporting the information is associated with biasedestimates of treatment effect or the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrolment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis.In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.     

A simplified search strategy for identifying randomised controlled trials for systematic reviews of health care interventions: a comparison with more exhaustive strategies

Background  

It is generally believed that exhaustive searches of bibliographic databases are needed for systematic reviews of health care interventions. The CENTRAL database of controlled trials (RCTs) has been built up by exhaustive searching. The CONSORT statement aims to encourage better reporting, and hence indexing, of RCTs. Our aim was to assess whether developments in the CENTRAL database, and the CONSORT statement, mean that a simplified RCT search strategy for identifying RCTs now suffices for systematic reviews of health care interventions.     

Guidelines for clinical trials using artificial intelligence – SPIRIT‐AI and CONSORT‐AI†

The rapidly growing use of artificial intelligence in pathology presents a challenge in terms of study reporting and methodology. The existing guidelines for the design (SPIRIT) and reporting (CONSORT) of clinical trials have been extended with the aim of ensuring production of the highest quality evidence in this field. We explore these new guidelines and their relevance and application to pathology as a specialty. © 2020 The Authors. The Journal of Pathology published by John Wiley & Sons, Ltd. on behalf of The Pathological Society of Great Britain and Ireland.     

Effects of psychotherapy for anxiety in children and adolescents: a meta-analytic review

This paper provides a comprehensive quantitative review of high quality randomized controlled trials of psychological therapies for anxiety disorders in children and young people. Using a systematic search for randomized controlled trials which included a control condition and reported data suitable for meta-analysis, 55 studies were included. Eligible studies were rated for methodological quality and outcome data were extracted and analyzed using standard methods. Trial quality was variable, many studies were underpowered and adverse effects were rarely assessed; however, quality ratings were higher for more recently published studies. Most trials evaluated cognitive behavior therapy or behavior therapy and most recruited both children and adolescents. Psychological therapy for anxiety in children and young people was moderately effective overall, but effect sizes were small to medium when psychological therapy was compared to an active control condition. The effect size for non-CBT interventions was not significant. Parental involvement in therapy was not associated with differential effectiveness. Treatment targeted at specific anxiety disorders, individual psychotherapy, and psychotherapy with older children and adolescents had effect sizes which were larger than effect sizes for treatments targeting a range of anxiety disorders, group psychotherapy, and psychotherapy with younger children. Few studies included an effective follow-up. Future studies should follow CONSORT reporting standards, be adequately powered, and assess follow-up. Research trials are unlikely to address all important clinical questions around treatment delivery. Thus, careful assessment and formulation will remain an essential part of successful psychological treatment for anxiety in children and young people.     

Gynaecologic surgery from uncertainty to science: evolution of randomized control trials

BACKGROUND: It is now accepted that both medical and surgical practice shouldbe based on reliable and sound clinical evidence. However, randomizedcontrol trials comparing surgical interventions have been associatedwith many problems. The aim of this review is to assess if therehas been progress made in establishing the evidence base forsurgical interventions in gynaecology. METHODS: Relevant reviews were identified from Cochrane Database of SystematicReviews (Issue , 2006) and data from individual randomized controltrials extracted. Chi-squared test was used to compare qualitypre- and post-Consolidated Standards of Reporting Trials (CONSORT)statement. Meta-regression analyses were performed to test thehypothesis that effect size decreased over time. Further multiplelinear regression analyses were used to test the hypothesisthat precision increased over time and finally a logistic regressionmodel was used to estimate whether treatment effects differedbetween trials with and without allocation concealment. RESULTS: Twenty-three relevant reviews were identified, including 94trials. The proportion of studies reporting allocation concealmentsignificantly increased after the introduction of the CONSORTstatement (P = 0.002). There was a trend towards improvementin precision over time. Similarly, there was a reduction insize of treatment effect over time (log of the ratio of oddsratios per year 0.96; 95% confidence interval 0.93–0.99,P = 0.04). CONCLUSIONS: Gynaecologic surgical practice appears to be benefiting fromimprovement in its research base in a subject where practitionersdo not participate readily in randomized evaluation.     

微创经皮与传统开放椎弓根螺钉置入固定胸腰椎骨折的文献荟萃

BACKGROUND: Open reduction pedicle screw fixation for thoracolumbar fracture could obtain satisfactory effects, and has been extensively used. However, it has potential risk during and after repair. Minimally invasive percutaneous pedicle screw technique minimizes the trauma and complications of soft tissue. It remains poorly understood which is better minimally invasive percutaneous or conventional open pedicle screw fixation for the repair of thoracolumbar fracture. OBJECTIVE: To perform quality evaluation and meta-analysis on curative effect and postoperative complications of minimally invasive percutaneous and conventional open pedicle screw fixation in the treatment of thoracolumbar fractures. METHODS: A detailed search of several electronic databases, including Cochrane Library, PubMed, WanFang, CNKI, VIP and CBM, was undertaken. Simultaneously, Chinese Journal of Orthopaedics, Chinese Journal of Orthopaedic Trauma, and Chinese Journal of Trauma were checked by hand to identify controlled trials regarding minimally invasive percutaneous and conventional open pedicle screw fixation in the treatment of thoracolumbar fractures published from inception to 2015, and the references of the included studies were checked. According to inclusion and exclusion criteria, references were screened, data were extracted and quality was evaluated by four investigators independently. Meta-analysis was conducted using RevMan 5.2 software. The quality of references of the included controlled trials was assessed with CONSORT statement and some surgery clinical evaluation indexes. RESULTS AND CONCLUSION: We included 28 studies, including 25 randomized controlled trials/quasi-randomized controlled trials and 3 retrospective comparative studies, with 1 285 patients. Meta-analysis results demonstrated that compared with the conventional open pedicle screw, minimally invasive percutaneous pedicle screw fixation could significantly reduce operation time, blood loss, hospital stays, postoperative complication rate and height loss (P < 0.05). No significant difference in postoperative pain grade was detected between them (P > 0.05). These results indicate that minimally invasive percutaneous pedicle screw fixation for thoracolumbar fracture was safe and reliable, had small trauma, less blood loss, rapid recovery, short hospital stay, and less postoperative complications. Nevertheless, methods and results of most studies are not detailed enough. We suggested reporting randomized controlled trials according to related standards in order to improve the report quality and authenticity of randomized controlled trials.       

Cross-sectional study of the quality of randomized control trials on problem-based learning in medical education

Problem-based learning (PBL) is increasingly being used in medical education globally, but its effectiveness in teaching remains controversial. A randomized controlled trial (RCT) is the method of choice for evaluating its effectiveness. The quality of an RCT has a significant effect on this evaluation, but to date we have not seen an assessment of the quality of RCTs for PBL. Two researchers searched MEDLINE and EMBASE for RCTs addressing PBL in medical education. The overall quality of each report was measured on a 28-point overall quality score (OQS) based on the 2010 revised Comprehensive Standards for Reporting and Testing (CONSORT) Statement. Furthermore, to study the key factors affecting OQS more effectively, a linear regression model of those factors was established using SPSS. After literature screening, 30 RCTs were eventually included and analyzed. The median OQS was 15 (range, 7–20), which meant that half of the items in the revised 2010 CONSORT statement were poorly reported in at least 40% of the RCTs analyzed. The regression model showed that the year of publication of RCTs and the impact factors of the journals in which they were published were the main factors affecting OQS. The overall quality of reporting of RCTs on PBL teaching in medical education was not satisfactory. Some RCTs were subjectively selective in reporting certain items, leading to heterogeneity in quality. It is expected that statisticians will develop new standards more suitable for evaluating RCTs related to teaching research and that editors and peer reviewers will be required to review the relevant RCTs more strictly.     

Electronic search strategies to identify reports of cluster randomized trials in MEDLINE: low precision will improve with adherence to reporting standards

Background  

Cluster randomized trials (CRTs) present unique methodological and ethical challenges. Researchers conducting systematic reviews of CRTs (e.g., addressing methodological or ethical issues) require efficient electronic search strategies (filters or hedges) to identify trials in electronic databases such as MEDLINE. According to the CONSORT statement extension to CRTs, the clustered design should be clearly identified in titles or abstracts; however, variability in terminology may make electronic identification challenging. Our objectives were to (a) evaluate sensitivity ("recall") and precision of a well-known electronic search strategy ("randomized controlled trial" as publication type) with respect to identifying CRTs, (b) evaluate the feasibility of new search strategies targeted specifically at CRTs, and (c) determine whether CRTs are appropriately identified in titles or abstracts of reports and whether there has been improvement over time.