scholarly journals Dupuytren’s interventions surgery versus collagenase (DISC) trial: study protocol for a pragmatic, two-arm parallel-group, non-inferiority randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Joseph Dias ◽  
Catherine Arundel ◽  
Puvan Tharmanathan ◽  
Ada Keding ◽  
Charlie Welch ◽  
...  

Abstract Background Dupuytren’s contracture is a fibro-proliferative disease of the hands affecting over 2 million UK adults, particularly the white, male population. Surgery is the traditional treatment; however, recent studies have indicated that an alternative to surgery—collagenase clostridium histolyticum (collagenase)—is better than a placebo in the treatment of Dupuytren’s contracture. There is however no robust randomised controlled trial that provides a definitive answer on the clinical effectiveness of collagenase compared with limited fasciectomy surgery. Dupuytren’s intervention surgery vs collagenase trial (DISC) trial was therefore designed to fill this evidence gap. Methods/design The DISC trial is a multi-centre pragmatic two-arm parallel-group, randomised controlled trial. Participants will be assigned 1:1 to receive either collagenase injection or surgery (limited fasciectomy). We aim to recruit 710 adult participants with Dupuytren’s contracture. Potential participants will be identified in primary and secondary care, screened by a delegated clinician and if eligible and consenting, baseline data will be collected and randomisation completed. The primary outcome will be the self-reported patient evaluation measure assessed 1 year after treatment. Secondary outcome measures include the Unité Rhumatologique des Affections de la Main Scale, the Michigan Hand Questionnaire, EQ-5D-5L, resource use, further procedures, complications, recurrence, total active movement and extension deficit, and time to return to function. Given the limited evidence comparing recurrence rates following collagenase injection and limited fasciectomy, and the importance of a return to function as soon as possible for patients, the associated measures for each will be prioritised to allow treatment effectiveness in the context of these key elements to be assessed. An economic evaluation will assess the cost-effectiveness of treatments, and a qualitative sub-study will assess participants’ experiences and preferences of the treatments. Discussion The DISC trial is the first randomised controlled trial, to our knowledge, to investigate the clinical and cost-effectiveness of collagenase compared to limited fasciectomy surgery for patients with Dupuytren’s contracture. Trial registration Clinical.Trials.gov ISRCTN18254597. Registered on April 11, 2017.

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042365
Author(s):  
Jessica Leight ◽  
Negussie Deyessa ◽  
Vandana Sharma

ObjectivesExperience of intimate partner violence (IPV) is associated with adverse health and psychosocial outcomes for women. However, rigorous economic evaluations of interventions targeting IPV prevention are rare. This paper analyses the cost-effectiveness of Unite for a Better Life (UBL), a gender-transformative intervention designed to prevent IPV and HIV risk behaviours among men, women and couples.DesignWe use an economic evaluation nested within a large-scale cluster randomised controlled trial, analysing financial and economic costs tracked contemporaneously.SettingUBL was implemented in rural southern Ethiopia between 2013 and 2015.ParticipantsThe randomised controlled trial included 6770 households in 64 villages.InterventionsUBL is an intervention delivered within the context of the Ethiopian coffee ceremony, a culturally established forum for community discussion, and designed to assist participants to build skills for healthy, non-violent, equitable relationships.Primary and secondary outcome measuresThis paper reports on the unit cost and cost-effectiveness of the interventions implemented. Cost-effectiveness is measured as the cost per case of past-year physical and/or sexual IPV averted.ResultsThe estimated annualised cost of developing and implementing UBL was 2015 US$296 772, or approximately 2015 US$74 per individual directly participating in the intervention and 2015 US$5 per person annually for each community-level beneficiary (woman of reproductive age in intervention communities). The estimated cost per case of past-year physical and/or sexual IPV averted was 2015 US$2726 for the sample of direct beneficiaries, and 2015 US$194 for the sample of all community-level beneficiaries.ConclusionsUBL is an effective and cost-effective intervention for the prevention of IPV in a low and middle-income country setting. Further research should explore strategies to quantify the positive effects of the intervention across other domains.Trial registration numberNCT02311699 (ClinicalTrials.gov); AEARCTR-0000211 (AEA Registry)


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Meg Wiggins ◽  
Mary Sawtell ◽  
Octavia Wiseman ◽  
Christine McCourt ◽  
Sandra Eldridge ◽  
...  

Abstract Background Group antenatal care has been successfully implemented around the world with suggestions of improved outcomes, including for disadvantaged groups, but it has not been formally tested in the UK in the context of the NHS. To address this the REACH Pregnancy Circles intervention was developed and a randomised controlled trial (RCT), based on a pilot study, is in progress. Methods The RCT is a pragmatic, two-arm, individually randomised, parallel group RCT designed to test clinical and cost-effectiveness of REACH Pregnancy Circles compared with standard care. Recruitment will be through NHS services. The sample size is 1732 (866 randomised to the intervention and 866 to standard care). The primary outcome measure is a ‘healthy baby’ composite measured at 1 month postnatal using routine maternity data. Secondary outcome measures will be assessed using participant questionnaires completed at recruitment (baseline), 35 weeks gestation (follow-up 1) and 3 months postnatal (follow-up 2). An integrated process evaluation, to include exploration of fidelity, will be conducted using mixed methods. Analyses will be on an intention to treat as allocated basis. The primary analysis will compare the number of babies born “healthy” in the control and intervention arms and provide an odds ratio. A cost-effectiveness analysis will compare the incremental cost per Quality Adjusted Life Years and per additional ‘healthy and positive birth’ of the intervention with standard care. Qualitative data will be analysed thematically. Discussion This multi-site randomised trial in England is planned to be the largest trial of group antenatal care in the world to date; as well as the first rigorous test within the NHS of this maternity service change. It has a recruitment focus on ethnically, culturally and linguistically diverse and disadvantaged participants, including non-English speakers. Trial registration Trial registration; ISRCTN, ISRCTN91977441. Registered 11 February 2019 - retrospectively registered. The current protocol is Version 4; 28/01/2020.


BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e029044 ◽  
Author(s):  
Daniel Hayes ◽  
Anna Moore ◽  
Emily Stapley ◽  
Neil Humphrey ◽  
Rosie Mansfield ◽  
...  

IntroductionThe prevalence of emotional difficulties in young people is increasing. This upward trend is largely accounted for by escalating symptoms of anxiety and depression. As part of a public health response, there is increasing emphasis on universal prevention programmes delivered in school settings. This protocol describes a three-arm, parallel group cluster randomised controlled trial, investigating the effectiveness and cost-effectiveness of two interventions, alongside a process and implementation evaluation, to improve mental health and well-being of Year 9 pupils in English secondary schools.MethodA three-arm, parallel group cluster randomised controlled trial comparing two different interventions, the Youth Aware of Mental Health (YAM) or the Mental Health and High School Curriculum Guide (The Guide), to Usual Provision. Overall, 144 secondary schools in England will be recruited, involving 8600 Year 9 pupils. The primary outcome for YAM is depressive symptoms, and for The Guide it is intended help-seeking. These will be measured at baseline, 3–6 months and 9–12 months after the intervention commenced. Secondary outcomes measured concurrently include changes to: positive well-being, behavioural difficulties, support from school staff, stigma-related knowledge, attitudes and behaviours, and mental health first aid. An economic evaluation will assess the cost-effectiveness of the interventions, and a process and implementation evaluation (including a qualitative research component) will explore several aspects of implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, feasibility, utility), and their moderating effects on the outcomes of interest, and perceived impact.Ethics and disseminationThis trial has been approved by the University College London Research Ethics Committee. Findings will be published in a report to the Department for Education, in peer-reviewed journals and at conferences.Trial registration numberISRCTN17631228.ProtocolV1 3 January 2019. Substantial changes to the protocol will be communicated to the trials manager to relevant parties (eg, ISRCTN).


BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029207 ◽  
Author(s):  
Jessica Wright ◽  
Alexis Foster ◽  
Cindy Cooper ◽  
Kirsty Sprange ◽  
Stephen Walters ◽  
...  

IntroductionServices are being encouraged to provide postdiagnostic treatment to those with dementia but the availability of evidence-based interventions following diagnosis has not kept pace with increase in demand. To address this need, the Journeying through Dementia (JtD) intervention was created. A randomised controlled trial (RCT), based on a pilot study, is in progress.Methods and analysisThe RCT is a pragmatic, two-arm, parallel group trial designed to test the clinical and cost-effectiveness of JtD compared with usual care. Recruitment will be through NHS services, third sector organisations and Join Dementia Research. The sample size is 486 randomised (243 to usual care and 243 to the intervention usual care). Participants can choose to ask a friend or relative (supporter) to become involved in the study. The primary outcome measure for participants is Dementia-Related Quality of Life (DEMQOL), collected at baseline and at 8 months’ postrandomisation. Secondary outcome measures will be collected from participants and supporters at those visits. Participants will also be followed up at 12 months’ postrandomisation with a reduced set of measures. A process evaluation will be conducted through qualitative and fidelity substudies. Analyses will compare the two arms of the trial on an intention to treat as allocated basis. The primary analyses will compare the mean DEMQOL scores of the participants at 8 months between the two study arms. A cost-effectiveness analysis will consider the incremental cost per Quality Adjusted Life Years of the intervention compared with usual care. Qualitative and fidelity substudies will be analysed through framework analysis and fidelity assessment tools respectively.Ethics and disseminationREC and HRA approval were obtained. A Data Monitoring and Ethics Committee has been constituted. Dissemination will be via publications, conferences and social media. Intervention materials will be made open access.Trial registration numberISRCTN17993825.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jesus Montero-Marin ◽  
◽  
Elizabeth Nuthall ◽  
Sarah Byford ◽  
Catherine Crane ◽  
...  

Abstract Background MYRIAD (My Resilience in Adolescence) is a superiority, parallel group, cluster randomised controlled trial designed to examine the effectiveness and cost-effectiveness of a mindfulness training (MT) programme, compared with normal social and emotional learning (SEL) school provision to enhance mental health, social-emotional-behavioural functioning and well-being in adolescence. The original trial protocol was published in Trials (accessible at 10.1186/s13063-017-1917-4). This included recruitment in two cohorts, enabling the learning from the smaller first cohort to be incorporated in the second cohort. Here we describe final amendments to the study protocol and discuss their underlying rationale. Methods Four major changes were introduced into the study protocol: (1) there were changes in eligibility criteria, including a clearer operational definition to assess the degree of SEL implementation in schools, and also new criteria to avoid experimental contamination; (2) the number of schools and pupils that had to be recruited was increased based on what we learned in the first cohort; (3) some changes were made to the secondary outcome measures to improve their validity and ability to measure constructs of interest and to reduce the burden on school staff; and (4) the current Coronavirus Disease 2019 (SARS-CoV-2 or COVID-19) pandemic both influences and makes it difficult to interpret the 2-year follow-up primary endpoint results, so we changed our primary endpoint to 1-year follow-up. Discussion These changes to the study protocol were approved by the Trial Management Group, Trial Steering Committee and Data and Ethics Monitoring Committees and improved the enrolment of participants and quality of measures. Furthermore, the change in the primary endpoint will give a more reliable answer to our primary question because it was collected prior to the COVID-19 pandemic in both cohort 1 and cohort 2. Nevertheless, the longer 2-year follow-up data will still be acquired, although this time-point will be now framed as a second major investigation to answer some new important questions presented by the combination of the pandemic and our study design. Trial registration International Standard Randomised Controlled Trials ISRCTN86619085. Registered on 3 June 2016.


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