Recommendations For Interventional Trials Statement Research Articles

Emergency cerclage using double-level versus single-level suture in the management of cervical insufficiency (Cervical Occlusion double-level Stitch Application, COSA): study protocol for a multicentre, non-blinded, randomised controlled trial

IntroductionCervical insufficiency accounts for 15% of recurrent pregnancy losses between 16 and 28 weeks of gestation. The aim of the study is to verify the effectiveness of emergency double-level cerclage...

Phase III, two arm, multi-centre, open label, parallel-group randomised designed clinical investigation of the use of a personalised early warning decision support system to predict and prevent acute exacerbations of chronic obstructive pulmonary disease: ‘Predict & Prevent AECOPD’ – study protocol

IntroductionWith 65 million cases globally, chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death and imposes a heavy burden on patients’ lives and healthcare resources worldwide. Around...

LIMPER trials: immediate mobilisation versus 2-week cast immobilisation after distal radius fracture treated with volar locking plate – a study protocol for a prospective, randomised, controlled trial

IntroductionOpen reduction and internal fixation with volar locking plate has become the most common fixation method in the treatment of unstable distal radius fracture (DRF). There is, however, no consensus...

Cardiopulmonary and muscular effects of different doses of high-intensity physical training in substance use disorder patients: study protocol for a block allocated controlled endurance and strength training trial in an inpatient setting

IntroductionPatients with substance use disorder (SUD) have high prevalence of lifestyle-related comorbidities. Physical exercise is known to yield substantial prophylactic impact on disease and premature mortality, and there seems to...

Melatonin supplementation for the treatment of infantile spasms: protocol for a randomised placebo-controlled triple-blind trial

IntroductionInfantile spasms (IS) is a type of severe epileptic encephalopathy that occurs in infancy and early childhood. IS is characterised clinically by epileptic spasms, often accompanied by sleep disorder and...

Standardizing definitions and reporting guidelines for the infertility core outcome set: an international consensus development study† ‡.

STUDY QUESTIONCan consensus definitions for the core outcome set for infertility be identified in order to recommend a standardized approach to reporting?SUMMARY ANSWERConsensus definitions for individual core outcomes, contextual statements and a standardized reporting table have been developed.WHAT IS KNOWN ALREADYDifferent definitions exist for individual core outcomes for infertility. This variation increases the opportunities for researchers to engage with selective outcome reporting, which undermines secondary research and compromises clinical practice guideline development.STUDY DESIGN, SIZE, DURATIONPotential definitions were identified by a systematic review of definition development initiatives and clinical practice guidelines and by reviewing Cochrane Gynaecology and Fertility Group guidelines. These definitions were discussed in a face-to-face consensus development meeting, which agreed consensus definitions. A standardized approach to reporting was also developed as part of the process.PARTICIPANTS/MATERIALS, SETTING, METHODSHealthcare professionals, researchers and people with fertility problems were brought together in an open and transparent process using formal consensus development methods.MAIN RESULTS AND THE ROLE OF CHANCEForty-four potential definitions were inventoried across four definition development initiatives, including the Harbin Consensus Conference Workshop Group and International Committee for Monitoring Assisted Reproductive Technologies, 12 clinical practice guidelines and Cochrane Gynaecology and Fertility Group guidelines. Twenty-seven participants, from 11 countries, contributed to the consensus development meeting. Consensus definitions were successfully developed for all core outcomes. Specific recommendations were made to improve reporting.LIMITATIONS, REASONS FOR CAUTIONWe used consensus development methods, which have inherent limitations. There was limited representation from low- and middle-income countries.WIDER IMPLICATIONS OF THE FINDINGSA minimum data set should assist researchers in populating protocols, case report forms and other data collection tools. The generic reporting table should provide clear guidance to researchers and improve the reporting of their results within journal publications and conference presentations. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials statement, and over 80 specialty journals have committed to implementing this core outcome set.STUDY FUNDING/COMPETING INTEREST(S)This research was funded by the Catalyst Fund, Royal Society of New Zealand, Auckland Medical Research Fund and Maurice and Phyllis Paykel Trust. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility Group. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. R.S.L. reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. B.W.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. C.N. reports being the Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and a financial interest in NexHand. E.H.Y.N. reports research sponsorship from Merck. A.S. reports consultancy fees from Guerbet. J.W. reports being a statistical editor for the Cochrane Gynaecology and Fertility Group. A.V. reports that he is a Statistical Editor of the Cochrane Gynaecology & Fertility Review Group and of the journal Reproduction. His employing institution has received payment from Human Fertilisation and Embryology Authority for his advice on review of research evidence to inform their ‘traffic light’ system for infertility treatment ‘add-ons’. N.L.V. reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the work presented. All authors have completed the disclosure form.TRIAL REGISTRATION NUMBERCore Outcome Measures in Effectiveness Trials Initiative: 1023.

Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER)

IntroductionHealthcare systems around the world are looking for solutions to the growing problem of mental disorders. RECOVER is the synonym for an evidence-based, stepped and cross-sectoral coordinated care service model...

Adequate reporting of the sample size calculation in surgical randomized controlled trials

BackgroundThe sample size calculation for a randomized controlled trial should assure that a statistically significant and clinically relevant difference can be detected with a high probability. To be certain that readers of a randomized controlled trial can critically judge whether the assumptions for the sample size calculation were realistic, a number of specific subitems should be reported. MethodsIn this minireview, the frequency of adequate reporting of specific sub-items of the sample size was assessed from surgical randomized controlled trials that were published in the 5 leading general surgical journals in 2017. Subitems from the Consolidated Standards for Reporting Trials and from the Standard Protocol Items: Recommendations for Interventional Trials Statement were considered. ResultsA total of 85 relevant randomized controlled trials were identified over PubMed. The overall adequate reporting of the sample size according to the Consolidated Standards for Reporting Trials was 53% (45 of 85). When considering additional subitems from the Standard Protocol Items: Recommendations for Interventional Trials Statement which are not explicitly requested by the Consolidated Standards for Reporting Trials Statement, the adherence decreased to 12% (10 of 85). ConclusionThe adherence in reporting potentially important subitems of the sample size from the Consolidated Standards for Reporting Trials Statement was moderate among surgical randomized controlled trials. It is crucial that surgeons who plan and conduct randomized controlled trials be aware of these subitems.