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Additional file 1. Data extraction form.

Additional file 8. BOTS Risk Assessment Tool (BRAT).

Additional file 2. Online survey.

Additional file 4. Additional analyses.

Additional file 7. BOTS guidance.

Additional file 6. BOTS stakeholder group membership.

Additional file 5. BOTS stakeholder survey responses.

The aim of this systematic review is to explore the views and experiences of healthcare service providers regarding the delivery of non-pharmacological treatments for people with dementia living in the community.

Background There is an urgent clinical need for evidence based psychosocial interventions for people with mild dementia. We aimed to determine clinical and cost-effectiveness of Journeying through Dementia (JtD), an intervention designed to promote wellbeing and independence in people with mild dementia. Methods We conducted a phase 3, two-arm parallel group, superiority, individually randomised controlled trial. Thirteen NHS sites across England recruited community-dwelling people with mild dementia and Mini-Mental State Examination score of ≥18. Centralised randomisation (1:1) was conducted for participants to receive JtD plus usual care or usual care (control), stratified by site. The JtD Intervention comprised 12 group and four one-to-one sessions, delivered in the community at each site. The primary endpoint was Dementia Related Quality of Life (DEMQOL), eight-months postrandomisation. Only outcome assessors were blinded. Analysis was by intention-to-treat. Costeffectiveness analysis reported cost per quality adjusted life year (QALY) from a UK NHS and social care perspective. Findings In total 480 people were randomised to intervention (241) or control (239) arms. Intervention adherence was very good. Mean DEMQOL scores at eight months were intervention arm 93·3 (SD 13·0, n=191) and control 91·9 (SD 14·6, n=197). Difference in means was 0·9 (95% CI -1·2 to 3·0) after adjustment for covariates, lower than that identified as clinically meaningful. Incremental cost per QALY ranged from £88K to -£205K, indicating that JtD was not cost-effective. Unrelated serious adverse events were experienced by 17% (40/241) of intervention and 15% (35/239) of control participants. Interpretation In common with other recently reported studies the JtD intervention was not provenly effective. However, this complex trial successfully recruited and retained people with dementia without necessarily involving carers, and people with dementia they were actively involved as participants and study advisors throughout. Further research into methods of measuring small, meaningful changes in this population is needed. Questions remain regarding how services can match the complex, diverse and individual needs of people with mild dementia, and how interventions to meet such needs can be delivered at scale.

Additional file 1. Participant information sheet.

Additional file 4. The consolidated criteria for reporting qualitative research (COREQ).

Additional file 2. Informed consent form.

Additional file 3. Topic guide.

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.

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