Consolidated Standards Of Reporting Trials Extension Research Articles

REporting quality of PilOt randomised controlled trials in surgery (REPORTS): a methodological survey protocol

IntroductionThe aim of this methodological review is to evaluate the completeness of reporting of surgical pilot and feasibility randomised trials as per the Consolidated Standards of Reporting Trials (CONSORT) extension...

Low-quality of patient-reported outcome reporting in randomized clinical trials of major depressive disorder-a meta-epidemiological review.

Our goal was to review current peer-reviewed articles in which the BDI (Beck Depression Inventory), PHQ-9 (Patient Health Questionnaire), or QIDS-SR16 (16-Item Quick Inventory of Depressive Symptomatology) was used as the primary or secondary outcome measure and to evaluate the quality of PRO (Patient-Reported Outcome) reporting in RCTs (Randomized Controlled Trials) according to the 2013 PRO-specific CONSORT (Consolidated Standards of Reporting Trials) extension. We systematically searched in electronic databases. A study would be included if it included patients diagnosed with major depressive disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM) or International Classification of Diseases, version 10 (ICD-10) as participants, was a randomized controlled trial, included the BDI, PHQ-9, or QIDS-SR16 as the primary or secondary outcome measure, published between 1990 and 2013, and was in English. Two of the authors evaluated the quality of PRO reporting according to the 2013 CONSORT-PRO. Logistic regression were used to evaluate the association between reporting completeness and trial characteristics. A total of 116 studies were included. These studies were conducted in 25 countries. Sample sizes ranged from 12 to 750. The CONSORT-PRO was not cited in any one of the included studies. Among the 116 studies, 2 (1.72%) studies introduced the rationale for PRO assessment, 60 (51.72%) studies explicitly stated statistical approaches for dealing with missing data, 87 (75.00%) studies reported PRO outcome data at baseline and at subsequent time points. The mean score of reporting completeness was 66.24%. Significantly higher reporting completeness was found for RCTs published after 2013 (OR, 95%CI: 3.81, 1.32-10.99). Studies with a higher sample size were more completely reported than studies with a lower sample size (OR, 95%CI: 1.01, 1.00-1.02). The CONSORT-PRO guidance was rarely cited. The quality of PRO reporting in depression studies requires improvement. This result may be meaningful for the promotion of PRO reporting in RCTs.

Abstract 16310: Adherence of Randomized Controlled Trials in Heart Failure to Consort Reporting Standards

Introduction: Randomized control trials (RCTs) have changed care in Heart Failure (HF), but the reliability of results is contingent on trial validity and transparent reporting. The Consolidated Standards of Reporting Trials (CONSORT) checklist was developed in 1996 and subsequently updated to guide the design and reporting of RCTs, but the adherence of HF RCTs to CONSORT remains poorly understood. This study sought to evaluate the adherence of HF RCTs to the CONSORT 2010 update and to examine temporal trends in trial reporting in HF trials. Methods: We searched MEDLINE, EMBASE and CINAHL for HF RCTs in high-impact journals between 2000 and 2020. The primary outcome measure was RCT CONSORT statement or CONSORT extension reporting presented as mean CONSORT score. Descriptive statistics were calculated for CONSORT scores. We used the Jonckheere-Terpstra test to examine temporal trends and employed multivariable linear regression to evaluate the association between prespecified trial characteristics and the mean CONSORT score. Results: There were 221 RCTs, and mean CONSORT score was 69.7% (SD 11.5). Adherence to CONSORT reporting standards improved from 61.5% (SD 11.1) in 2000-2003 to 76.5% (SD 8.8) in 2016-2020 ( P <.001). Adherence was greater in two-group parallel individual-level RCTs (β =6.22 95% CI: 3.14, 9.30; P <.001) than in other trial types. Drug (β= -3.91, 95% CI: -7.32, -0.50; P <.001) and device/surgical (β= -2.82 (95% CI: -7.56, 1.93; P <.001) interventions were associated with lower adherence to CONSORT reporting standards than other interventions, while publication after 2010 was associated with greater adherence (β=10.96, 95% CI: 8.37, 13.55; P <.001). Funding source did not appear to have an association with adherence (β=1.51, 95% CI: -1.53, 4.55; P =.33). Conclusions: Among HF RCTs published in high-impact journals, adherence to CONSORT reporting standards has improved over time, but remains variable and suboptimal overall.

A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials

Interventional trials that evaluate treatment effects using surrogate endpoints have become increasingly common. This paper describes four linked empirical studies and the development of a framework for defining, interpreting and reporting surrogate endpoints in trials. As part of developing the CONSORT (Consolidated Standards of Reporting Trials) and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) extensions for randomised trials reporting surrogate endpoints, we undertook a scoping review, e-Delphi study, consensus meeting, and a web survey to examine current definitions and stakeholder (including clinicians, trial investigators, patients and public partners, journal editors, and health technology experts) interpretations of surrogate endpoints as primary outcome measures in trials. Current surrogate endpoint definitional frameworks are inconsistent and unclear. Surrogate endpoints are used in trials as a substitute of the treatment effects of an intervention on the target outcome(s) of ultimate interest, events measuring how patients feel, function, or survive. Traditionally the consideration of surrogate endpoints in trials has focused on biomarkers (e.g., HDL cholesterol, blood pressure, tumour response), especially in the medical product regulatory setting. Nevertheless, the concept of surrogacy in trials is potentially broader. Intermediate outcomes that include a measure of function or symptoms (e.g., angina frequency, exercise tolerance) can also be used as substitute for target outcomes (e.g., all-cause mortality)-thereby acting as surrogate endpoints. However, we found a lack of consensus among stakeholders on accepting and interpreting intermediate outcomes in trials as surrogate endpoints or target outcomes. In our assessment, patients and health technology assessment experts appeared more likely to consider intermediate outcomes to be surrogate endpoints than clinicians and regulators. There is an urgent need for better understanding and reporting on the use of surrogate endpoints, especially in the setting of interventional trials. We provide a framework for the definition of surrogate endpoints (biomarkers and intermediate outcomes) and target outcomes in trials to improve future reporting and aid stakeholders' interpretation and use of trial surrogate endpoint evidence. SPIRIT-SURROGATE/CONSORT-SURROGATE project is Medical Research Council Better Research Better Health (MR/V038400/1) funded.

STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM): Extending the CONSORT statement.

Massage is a common therapy of nonpharmacological treatments, particularly in Tuina (Chinese massage) as its most common style, detailed guidance in reporting the intervention is warranted for its evaluation and replication. Based on the CONSORT (Consolidated Standards of Reporting Trials), we aimed to develop an Extension for Tuina/Massage, namely "The STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM)." A group of professional clinicians, trialists, methodologists, developers of reporting guidelines, epidemiologists, statisticians, and editors has developed this STRICTOTM checklist through a standard methodology process recommended by the EQUATOR (Enhancing the QUAlity and Transparency of Health Research) Network, including prospective registration, literature review, draft of the initial items, three rounds of the Delphi survey, consensus meeting, pilot test, and finalization of the guideline. A checklist of seven items (namely Tuina/Massage rationale, details of Tuina/Massage, intervention regimen, other components of the intervention, Tuina/Massage provider background, control or comparator interventions, and precaution measures), and 16 subitems were developed. Explanations and examples (E&E) for each item are also provided. The working group hopes that the STRICTOTM, in conjunction with both the CONSORT statement and extension for nonpharmacologic treatment, can improve the reporting quality and transparency of Tuina/Massage clinical research.

A cross-sectional study of the endorsement proportion of reporting guidelines in 1039 Chinese medical journals

BackgroundReporting quality is a critical issue in health sciences. Adopting the reporting guidelines has been approved to be an effective way of enhancing the reporting quality and transparency of clinical research. In 2012, we found that only 7 (7/1221, 0.6%) journals adopted the Consolidated Standards of Reporting Trials (CONSORT) statement in China. The aim of the study was to know the implementation status of CONSORT and other reporting guidelines about clinical studies in China.MethodsA cross-sectional bibliometric study was conducted. Eight medical databases were systematically searched, and 1039 medical journals published in mainland China, Hong Kong, Macau, and Taiwan were included. The basic characteristics, including subject, language, publication place, journal-indexed databases, and journal impact factors were extracted. The endorsement of reporting guidelines was assessed by a modified 5-level evaluation tool, namely i) positive active, ii) positive weak, iii) passive moderate, iv) passive weak and v) none.ResultsAmong included journals, 24.1% endorsed CONSORT, and 0.8% endorsed CONSORT extensions. For STROBE (STrengthening the Reporting of Observational Studies in Epidemiology), PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses), STARD (An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies), CARE (CAse REport guidelines), the endorsement proportion were 17.2, 16.6, 16.4, and 14.8% respectively. The endorsement proportion for SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials), TRIPOD (Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis), AGREE (Appraisal of Guidelines, Research, and Evaluation), and RIGHT (Reporting Items for Practice Guidelines in Healthcare) were below 0.7%.ConclusionsOur results showed that the implementation of reporting guidelines was low. We suggest the following initiatives including i) enhancing the level of journal endorsement for reporting guidelines; ii) strengthening the collaboration among authors, reviewers, editors, and other stakeholders; iii) providing training courses for stakeholders; iv) establishing bases for reporting guidelines network in China; v) adopting the endorsement of reporting guidelines in the policies of the China Periodicals Association (CPA); vi) promoting Chinese medical journals into the international evaluation system and publish in English.

The quality of reporting of randomized controlled trials of HuatuoZaizao pill for stroke.

Background: HuatuoZaizao pill (HZP), a Chinese patent medicine, is often used in the treatment of stroke. However, there is still a lack of enough evidence to recommend the routine use of HZP for stroke. This study is aimed at evaluating the quality of reporting of randomized controlled trials (RCTs) on HZP for stroke. Methods: RCTs on HuatuoZaizao pill for stroke were evaluated by using Consolidated Standards of Reporting Trials (CONSORT) guidelines and CONSORT extension criteria on reporting herbal interventions (CONSORT-CHM) guidelines. Microsoft Excel 2007 and SPSS20.0 was used for statistics analyses. Results: Seventeen studies involving 1801 stroke patients were identified. CONSORT-CHM has expanded 24.3% (9/37) items in CONSORT and added a small item. The average scores of CONSORT evaluation is 14.6, while the average scores of the CONSORT-CHM evaluation is 11.6. The central items in CONSORT as eligibility criterion, sample size calculation, primary outcome, method of randomization sequence generation, allocation concealment, implementation of randomization, description of blinding, and detailed statistical methods were reported in 77%, 6%, 100%, 47%, 6%, 6%, 6%, and 94% of trials, respectively. In terms of the CONSORT-CHM, none of the articles reported in detail the dosage form, origin, formula basis and so on of HZP, and only half of studies reported the outcome indicators related to Traditional Chinese Medicine syndromes. Conclusion: The overall report quality of RCT related to HZP is low. HZP still needs to report higher quality RCTs to prove its effectiveness and safety.

Harms-related data are poorly reported among randomized controlled trials underpinning the American Academy of Orthopaedic Surgeons clinical practice guideline recommendations for rotator cuff injuries.

Results produced from randomized controlled trials (RCTs) help guide clinical decision making and health policy. Therefore, it is essential that RCT outcomes- including harms (eg, adverse events)-are adequately reported such that clinicians, patients, and policy makers are equipped with all necessary information to complete risk-benefit assessment of the RCT's intervention. Here, we evaluated the quality of reporting of harms (eg, adverse events) in RCTs cited as supporting evidence for recommendations in the American Academy of Orthopaedic Surgeons (AAOS) Management of Rotator Cuff Injuries clinical practice guidelines (CPGs) using the Consolidated Standards of Reporting Trials (CONSORT) Extension for Harms Checklist. To quantify adherence to CONSORT Extension for Harms items, each RCT was screened for pertinent information satisfying each checklist item. Screening of CPG reference sections for RCTs underpinning CPG recommendations, as well as data extraction from each of the included RCTs, was performed in a blind and duplicate manner. Descriptive statistics-including frequencies, percentages, and 95% confidence intervals-were used to summarize overall percent adherence to checklist items. A linear regression model assessed the relationship of CONSORT Harms reporting over time. Ninety-nine RCTs were included in our final sample. Fifty-seven RCTs (of 99; 57.6%) were conducted at a single center. Common funding sources included private (nonindustry) (17/99; 17.2%), private (industry) (8/99; 8.1%), and public (7/99; 7.1%) sources. Sample size for each trial most often consisted of <50 participants (29/99; 29.3%) or 51-100 participants (50/99; 50.5%). The average number of CONSORT Extension for Harms items adequately reported across all included RCTs was 5.7 (of 18; 31.7%). None of the included trials reported all 18 items. Twenty-six RCTs (of 99; 26.3%) adequately reported ≥50% of eligible checklist items. Fifty-nine RCTs (of 99; 59.6%) adequately reported ≤33% of eligible checklist items. Items with ≥50% adherence included item 2, item 7a, and item 8a. Items with ≤20% adherence included item 3b, item 4d, and item 5. Results from our linear regression demonstrated a slight, yet nonsignificant, improvement in adherence to the Harms Extension over time (R2=0.009; P=.407). Our results illustrate the poor state of harms reporting within RCTs cited as supporting evidence for the AAOS Management of Rotator Cuff Injuries CPG. Efforts to address these gaps in reporting are warranted, as complete knowledge of potential harms is critical to patients, clinicians, and health policy makers when determining best practice decisions in orthopedic surgery.

Scoping and targeted reviews to support development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: protocol

IntroductionUsing a surrogate endpoint as a substitute for a primary patient-relevant outcome enables randomised controlled trials (RCTs) to be conducted more efficiently, that is, with shorter time, smaller sample size...

Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE

IntroductionRandomised controlled trials (RCTs) may use surrogate endpoints as substitutes and predictors of patient-relevant/participant-relevant final outcomes (eg, survival, health-related quality of life). Translation of effects measured on a surrogate endpoint...

Inadequate Reporting of Complications in Randomized Controlled Trials Cited as Supporting Evidence Underpinning AAOS CPG Recommendations for Hip and Knee Osteoarthritis: Application of the CONSORT Harms Checklist

BackgroundRandomized controlled trials (RCTs) have been shown to influence clinical decision-making and health policy. Therefore, it is essential that trial outcomes—including harms—are completely reported. MethodsWe included all RCTs cited as supporting evidence for the American Academy of Orthopaedic Surgeons Surgical Management of Osteoarthritis of the Knee, Osteoarthritis of the Knee, and Osteoarthritis of theHip Clinical Practice Guideline recommendations. Manuscripts were analyzed for compliance with the Consolidated Standards of Reporting Trials (CONSORT) Extension for Harms items. We determined the Extension for Harms' influence on harms reporting by comparing RCTs published before and after the extension’s release. ResultsOne hundred and seventy-three RCTs were included, of which 81 (47%) adequately reported ≥50% of the checklist and 75 (43%) reported ≤33% of the checklist items. The mean number of checklist items reported was 8 items (of 18; 45%). Our interrupted time-series analysis suggests the implementation of the CONSORT Extension for Harms did not have a statistically significant effect on the completeness of harms reporting (P = .35; 95% Confidence interval = −0.0041 to 0.0014). ConclusionHarms-related data are poorly reported within RCTs cited as supporting evidence for the American Academy of Orthopaedic Surgeons management for hip and knee OA Clinical Practice Guideline. Our time series analysis illustrates the failure of the CONSORT Extension for Harms on improving the reporting of harms-related data. Future efforts to improve the quality of harms reporting is crucial for patients, clinicians, and policy makers to perform thorough risk-benefit appraisals as RCT results directly influence clinical decision-making in orthopaedic surgery.

Quality of reporting for pilot randomized controlled trials in the pediatric urology literature–A systematic review

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

Assessment of the reporting quality of randomised controlled trials of massage

ObjectiveTo assess the reporting quality of randomised controlled trials (RCTs) of massage, particularly whether necessary elements related to massage interventions were adequately reported.MethodsA total of 8 electronic databases were systematically searched for massage RCTs published in English and Chinese from the date of their inception to June 22, 2020. Quality assessment was performed using three instruments, namely the CONSORT (Consolidated Standards of Reporting Trials) 2010 Checklist (37 items), the CONSORT Extension for NPT (Nonpharmacologic Treatments) 2017 checklist (18 items), and a self-designed massage-specific checklist (16 items) which included massage rationale, intervention and control group details. Descriptive statistics were additionally used to analyse the baseline characteristics of included trials.ResultsA total of 2,447 massage RCTs were identified, of which most (96.8%) were distributed in China. For the completeness of CONSORT, NPT Extension, and massage-specific checklists, the average reporting percentages were 50%, 10% and 45%, respectively. Of 68 assessed items in total (exclusion of 3 repeated items on intervention), 42 were poorly presented, including 18 CONSORT items, 15 NPT items, and 9 massage-specific items. Although the overall quality of reporting showed slightly improvement in articles published after 2010, the international (English) journals presented a higher score of the CONSORT and NPT items, while the Chinese journals were associated with the increased score of massage-specific items.ConclusionThe quality of reporting of published massage RCTs is variable and in need of improvement. Reporting guideline “CONSORT extension for massage” should be developed.

A Cross-sectional literature survey showed the reporting quality of multicenter randomized controlled trials should be improved

ObjectiveTo assess the reporting quality of randomized controlled trials (RCTs) with multicenter design, particularly whether necessary information related to multicenter characteristics was adequately reported. Study Design and SettingThrough a search of 4 international electronic databases, we identified multicenter RCTs published in English from 1975 to 2019. Reporting quality was assessed by the CONSORT (Consolidated Standards of Reporting Trials) checklist (37 items) and by a self-designed multicenter-specific checklist (27 items covering multicenter design, implement and analysis). The scores of trials published in three time periods (1975-1995; 1996-2009; and 2010-2019) were also compared. ResultsA total of 2,844 multicenter RCTs were included. For the CONSORT checklist, the mean (standard deviation) reporting score was 24.1 (5.5), 12 items were assessed as excellent (>90%), 12 items as good (50%-90%), and 13 items as poor (<50%). For the multicenter checklist, the reporting score was 3.9 (2.2), only 3 items were excellent or good, and the remaining 24 items were poor. Time period comparison showed that reporting quality improved over time, especially after the CONSORT 2010 issued. ConclusionAlthough CONSORT appears to have enhanced the reporting quality of multicenter RCTs, further improvement is needed. A “CONSORT extension for multicenter trials” should be developed.

Adherence to the CONSORT statement and extension for nonpharmacological treatments in randomized controlled trials of bariatric surgery: A systematic survey.

Reporting is critical for establishing the value of randomized controlled trials (RCTs). This study evaluated the adherence of bariatric surgery RCT reporting to the CONsolidated Standards Of Reporting Trials (CONSORT) statement 2010 and its 2017 extension for non-pharmacologic treatments (NPT extension). We identified all RCTs comparing bariatric surgery with conservational therapy or alternative bariatric surgery up to June 30, 2020. Reporting quality was assessed using criteria developed from the CONSORT statement and the NPT extension and scored as a percentage. The factors associated with reporting quality were explored by univariate and multivariate analysis. In total, 102 RCTs of bariatric surgery were included. The median scores according to the CONSORT statement and NPT extension were 63.3 and 26.8 of a maximum possible 100, respectively. Two-thirds of NPT extension items were reported in less than 25% of the RCTs. The median score improved over time for the CONSORT statement but not the NPT extension. A higher CONSORT score was associated with publication in core clinical journals, protocol registration, and funding. No factors associated with the NPT extension score were identified. Substantial efforts are warranted from authors, journals, registration platforms, and funders to overcome the flaws in the reporting of bariatric surgery RCTs.

Guidelines for reporting randomized controlled trials in paediatric dentistry based on the CONSORT statement.

The significance of randomized controlled trials (RCT) depends on how thoroughly the results were reported. Reporting of RCTs should be accurate and transparent and encompasses design, implementation, analysis, and results of the trial. The Consolidated Standards of Reporting Trials (CONSORT) statement and its extension were developed to guide the researchers to report clinical trials in a systematic manner. Despite this recommendation, the overall reporting quality of RCTs still remains suboptimal. To describe the relevance and importance of CONSORT reporting guidelines and explain the items using examples derived from randomized trials published in Paediatric Dentistry. This is a narrative review that illustrates the importance of reporting items in the CONSORT guidelines from relevant sources. RCTs published in the International Journal of Paediatric Dentistry between 2017 and 2020 were identified from PubMed and Scopus databases and through handsearching. An explanation has been provided for each of the 37 items in the 2010 CONSORT checklist and 17 items in the CONSORT extension for reporting abstracts. This explanation and elaboration document would enable investigators to report trials in Paediatric Dentistry with accuracy and transparency as well as for reviewers and editors in evaluating the suitability of RCTs for publication.

The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised.This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process.The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist comprises seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text.The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits. In order to encourage its wide dissemination this article is freely accessible on the BMJ and Trials journal websites.“To maximise the benefit to society, you need to not just do research but do it well” Douglas G Altman

Australian Indigenous model of mental healthcare based on transdiagnostic cognitive–behavioural therapy co-designed with the Indigenous community: protocol for a randomised controlled trial – CORRIGENDUM

Background A four- to seven-fold increase in the prevalence of current mood, anxiety, substance use and any mental disorders in Indigenous adults compared with non-Indigenous Australians has been reported. A lifetime prevalence of major depressive disorder was 23.9%. High rates of comorbid mental disorders indicated a transdiagnostic approach to treatment might be most appropri- ate. The effectiveness of psychological treatment for Indigenous Australians and adjunct Indigenous spiritual and cultural healing has not previously been evaluated in controlled clinical trials. Aims This project aims to develop, deliver and evaluate the effectiveness of an Indigenous model of mental healthcare (IMMHC). Trial registration: ANZCTR Registration Number: ACTRN12618001746224 and World Health Organization Universal Trial Number: U1111-1222-5849. Method The IMMHC will be based on transdiagnostic cognitive–behav- iour therapy co-designed with the Indigenous community to ensure it is socially and culturally appropriate for Indigenous Australians. The IMMHC will be evaluated in a randomised con- trolled trial with 110 Indigenous adults diagnosed with a current diagnosis of depression. The primary outcome will be the severity of depression symptoms as determined by changes in Beck Depression Inventory-II score at 6 months post-interven- tion. Secondary outcomes include anxiety, substance use disorder and quality of life. Outcomes will be assessed at base- line, 6 months post-intervention and 12 months post- intervention. Results The study design adheres to the Consolidated Standards of Reporting Trials (CONSORT) statement recommendations and CONSORT extensions for pilot trials. We followed the Standard Protocol Items for Randomised Trials statement recommenda- tions in writing the trial protocol. Conclusions This study will likely benefit participants, as well as collaborating Aboriginal Medical Services and health organisations. The transdiagnostic IMMHC has the potential to have a substantial impact on health services delivery in the Indigenous health sector.

Australian Indigenous model of mental healthcare based on transdiagnostic cognitive-behavioural therapy co-designed with the Indigenous community: protocol for a randomised controlled trial.

A four- to seven-fold increase in the prevalence of current mood, anxiety, substance use and any mental disorders in Indigenous adults compared with non-Indigenous Australians has been reported. A lifetime prevalence of major depressive disorder was 23.9%. High rates of comorbid mental disorders indicated a transdiagnostic approach to treatment might be most appropriate. The effectiveness of psychological treatment for Indigenous Australians and adjunct Indigenous spiritual and cultural healing has not previously been evaluated in controlled clinical trials. This project aims to develop, deliver and evaluate the effectiveness of an Indigenous model of mental healthcare (IMMHC). Trial registration: ANZCTR Registration Number: ACTRN12618001746224 and World Health Organization Universal Trial Number: U1111-1222-5849. The IMMHC will be based on transdiagnostic cognitive-behaviour therapy co-designed with the Indigenous community to ensure it is socially and culturally appropriate for Indigenous Australians. The IMMHC will be evaluated in a randomised controlled trial with 110 Indigenous adults diagnosed with a current diagnosis of depression. The primary outcome will be the severity of depression symptoms as determined by changes in Beck Depression Inventory-II score at 6 months post-intervention. Secondary outcomes include anxiety, substance use disorder and quality of life. Outcomes will be assessed at baseline, 6 months post-intervention and 12 months post-intervention. The study design adheres to the Consolidated Standards of Reporting Trials (CONSORT) statement recommendations and CONSORT extensions for pilot trials. We followed the Standard Protocol Items for Randomised Trials statement recommendations in writing the trial protocol. This study will likely benefit participants, as well as collaborating Aboriginal Medical Services and health organisations. The transdiagnostic IMMHC has the potential to have a substantial impact on health services delivery in the Indigenous health sector.

Toward Better Reporting Standards of Patients' Characteristics in Rehabilitation Trials: Applying a New Conceptual Framework to Current Standards.

The reporting of clinical studies in rehabilitation has been criticized in several aspects, including the reporting of patient characteristics. This article aims to contribute to the improvement of the reporting of patient characteristics in rehabilitation trials. Specifically, we want to determine the type of information that should be reported in rehabilitation trials that is specific to rehabilitation patients and how this information is captured by current reporting standards. In the first step, we made a conceptual analysis of characteristics of rehabilitation patients by addressing the specifics of the field of medical rehabilitation, including the definition of rehabilitation and a description of its beneficiaries. In the second step, we compared this reference framework to the current reporting standards, especially the Consolidated Standards of Reporting Trials (CONSORT) statement and its extensions, as well as standards for the reporting of clinical guidelines (agree, right). Patients included in rehabilitation interventions should be distinguished by specific information. From a clinical perspective, patients dealt with in rehabilitation comprise broader diagnostic groups compared with other clinical settings. Information on comorbidities should be added in the description of the patients. In addition, a description of baseline characteristics of patients should always include functioning characteristics of the patients, including information on relevant context factors, ie, environmental and personal factors. The CONSORT statement aims to provide patient characteristic to enable transferability of results to users. It is represented in terms of selection (inclusion/exclusion) criteria and the description of the resulting samples. Extensions of the CONSORT statement specified that information on socioeconomic variables should be added, and the selection of patient characteristics to be reported at baseline should be based on the selection of outcome variables. In addition, all relevant prognostic variables should be reported. Only one CONSORT extension asks explicitly to include comorbid conditions. The reporting standards on guidelines demand a more comprehensive characterization of patients, specific to the rehabilitation area. Present reporting standards can only partly address relevant issues pertinent to medical rehabilitation. The present analysis provides a conceptual and empirical framework for the development of reporting standards on patient characteristics in rehabilitation trials.