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ESM 1.

Additional file 1

Background: Recruitment to randomised controlled trials (RCTs) can be challenging, with most trials not reaching recruitment targets. Randomised feasibility studies can be set up prior to a main trial to identify and overcome recruitment obstacles. This paper reports on an intervention – the QuinteT Recruitment Intervention (QRI) - to optimise recruitment within a randomised feasibility study of surgical treatments for patients with Dupuytren’s contracture (the HAND-1 study).Methods: The QRI was introduced in 2-phases: phase 1 sought to understand the recruitment challenges by interviewing trial staff, scrutinising screening logs and analysing audio recorded patient consultations; in phase 2 a tailored plan of action consisting of recruiter feedback and training was delivered to address the identified challenges.Results: Two key recruitment obstacles emerged: 1) issues with the recruitment pathway, in particular methods to identify potentially eligible patients and; 2) equipoise of recruiters and patients. These were addressed by liaising with centres to share good practice and refine their pathway, and by providing bespoke feedback and training on consent discussions to individual recruiters and centres whilst recruitment was ongoing. The HAND-1 study subsequently achieved its recruitment target.Conclusions: Transferable lessons learnt from the QRI in the feasibility study will be implemented in the definitive RCT, enabling a ‘head start’ in the tackling of wider issues around screening methods and consent discussions in the set up/early recruitment study phases, with ongoing QRI addressing specific issues with new centres and recruiters. Findings from this study are likely to be relevant to other surgical and similar trials that are anticipated to encounter issues around patient and recruiter equipoise of treatments and variation in recruitment pathways across centres. The study also highlights the value of feasibility studies in fine-tuning design and conduct issues for definitive RCTs. Embedding a QRI in an RCT, at feasibility or main stage, offers an opportunity for a detailed and nuanced understanding of key recruitment challenges and the chance to address them in ‘real-time’ as recruitment proceeds.

Background: Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) in adolescents is common and disabling. Teenagers in the United Kingdom (UK) are more likely to recover if they access specialist care, but most do not have access to a local specialist CFS/ME service. Delivering treatment remotely via the internet could improve access to treatment.Objective: This study aimed to assess (1) the feasibility of recruitment and retention into a trial of internet-delivered specialist treatment for adolescents with CFS/ME and (2) the acceptability of trial processes and 2 web-based treatments (to inform continuation to full trial).Methods: This study was an internal pilot for the initial 12 months of a full randomized controlled trial (RCT), with integrated qualitative methods (analysis of recruitment consultations and participant and clinician interviews). Recruitment and treatment were delivered remotely from a specialist pediatric CFS/ME treatment service within a hospital in South West UK. Adolescents (aged 11-17 years) from across the United Kingdom with a diagnosis of CFS/ME and no access to local specialist treatment were referred by their general practitioner to the treatment center. Eligibility assessment and recruitment were conducted via remote methods (telephone and on the web), and participants were randomized (via a computer-automated system) to 1 of 2 web-based treatments. The trial intervention was Fatigue in Teenagers on the InterNET in the National Health Service, a web-based modular CFS/ME-specific cognitive behavioral therapy program (designed to be used by young people and their parents/caregivers) supported by individualized clinical psychologist e-consultations (regular, scheduled therapeutic message exchanges between participants and therapist within the platform). The comparator was Skype-delivered activity management with a CFS/ME clinician (mainly a physiotherapist/occupational therapist). Both treatments were intended to last for up to 6 months. The primary outcomes were (1) the number of participants recruited (per out-of-area referrals received between November 1, 2016, to October 31, 2017) and the proportion providing 6-month outcome data (web-based self-report questionnaire assessing functioning) and (2) the qualitative outcomes indicating acceptability of trial processes and treatments.Results: A total of 89 out of 150 (59% of potentially eligible referrals) young people and their parents/caregivers were recruited, with 75 out of 89 (84%) providing 6-month outcome data. Overall, web-based treatment was acceptable; however, participants and clinicians described both the advantages and disadvantages of remote methods. No serious adverse events were reported.Conclusions: Recruiting young people (and their parents/caregivers) into an RCT of web-based treatment via remote methods is feasible and acceptable. Delivering specialist treatment at home via the internet is feasible and acceptable, although some families prefer to travel across the UK for face-to-face treatment.Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 18020851; http://www.isrctn.com/ISRCTN18020851.

Additional file 2. Screening log (Phase 1 and 2).

Additional file 3. Data Extraction Form.

Supplemental material, Appendix_1_online_supp for Mapping to Quality of Life and Capability Measures in Cataract Surgery Patients: From Cat-PROM5 to EQ-5D-3L, EQ-5D-5L, and ICECAP-O Using Mixture Modelling by Padraig Dixon, William Hollingworth and John Sparrow in MDM Policy & Practice

Additional file 4 Papers included in the systematic review (n = 85).

Additional file 1. Supplementary material 1. Identifying procedures for ankle fractures.

Additional file 1. Search strategy for Ovid Medline (1946 to present) (search 1 to 21 ref Doble et al 2017).

Additional file 2. Supplementary material 2. Fracture management during unplanned readmissions.

Additional file 1. Hand-1 Quintet Recruitment Intervention (QRI) Staff Interview Topic Guide.