Randomised pilot and feasibility trial of a group intervention for men who perpetrate intimate partner violence against women.

Background: There is a need for robust evidence on the effectiveness and cost-effectiveness of domestic abuse perpetrator programmes in reducing abusive behaviour and improving wellbeing for victim/survivors. While any randomised controlled trial can present difficulties in terms of recruitment and retention, conducting such a trial with domestic abuse perpetrators is particularly challenging. This paper reports the pilot and feasibility trial of a voluntary domestic abuse perpetrator group programme in the United Kingdom.

The effectiveness and cost-effectiveness of a group domestic abuse perpetrator programme: protocol for a randomised controlled trial.

Background: In contrast to evidence for interventions supporting victim/survivors of domestic violence and abuse (DVA), the effectiveness of perpetrator programmes for reduction of abuse is uncertain. This study aims to estimate the effectiveness and cost-effectiveness of a perpetrator programme for men.

Methods: Pragmatic two-group individually randomised controlled trial (RCT) with embedded process and economic evaluation.

BabyBreathe trial: protocol for a randomised controlled trial of a complex intervention to prevent postpartum return to smoking.

Introduction: Many people quit smoking during pregnancy, but postpartum smoking relapse is common. Maintaining smoking abstinence achieved during pregnancy is key to improving maternal and child health. There are no evidence-based interventions for preventing postpartum smoking relapse.

Cessation of smoking trial in the emergency department (CoSTED): protocol for a multicentre randomised controlled trial.

Introduction: Attendees of emergency departments (EDs) have a higher than expected prevalence of smoking. ED attendance may be a good opportunity to prompt positive behaviour change, even for smokers not currently motivated to quit. This study aims to determine whether an opportunist smoking cessation intervention delivered in the ED can help daily smokers attending the ED quit smoking and is cost-effective.

AiDAPT: automated insulin delivery amongst pregnant women with type 1 diabetes: a multicentre randomized controlled trial - study protocol.

Background: Pregnant women with type 1 diabetes strive for tight glucose targets (3.5-7.8 mmol/L) to minimise the risks of obstetric and neonatal complications.

A feasibility study to assess the design of a multicentre randomized controlled trial of the clinical and cost-effectiveness of a caregiving intervention for people following hip fracture surgery.

Aims: This study aims to assess the feasibility of conducting a pragmatic, multicentre randomized controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery.

Methods: This will be a mixed-methods feasibility RCT, recruiting 60 patients following hip fracture surgery and their informal caregivers. Patients will be randomized to usual NHS care, versus usual NHS care plus a caregiver-patient dyad training programme (HIP HELPER).

Can we achieve better recruitment by providing better information? Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets.

Background: The information given to people considering taking part in a trial needs to be easy to understand if those people are to become, and then remain, trial participants. However, there is a tension between providing comprehensive information and providing information that is comprehensible. User-testing is one method of developing better participant information, and there is evidence that user-tested information is better at informing participants about key issues relating to trials.

'It felt like there was always someone there for us': Supporting children affected by domestic violence and abuse who are identified by general practice.

One in five children in the UK are affected by domestic violence and abuse. However, primary care clinicians (GPs and nurses) struggle to effectively identify and support children and young people living in homes where it is present. The IRIS+ (Enhanced Identification and Referral to Improve Safety) training and advocacy support intervention aimed to improve how clinicians respond to children and young people affected by domestic violence and abuse.

Sharing reports about domestic violence and abuse with general practitioners: a qualitative interview study.

Background: Domestic violence and abuse (DVA) is common and damaging to health. UK national guidance advocates a multi-agency response to DVA, and domestic homicide reviews consistently recommend improved information-sharing between agencies. Identification of patients experiencing DVA in general practice may come from external information shared with the practice, such as police incident reports and multi-agency risk assessment conference (MARAC) reports.

Cost-effectiveness of a patient-centred approach to managing multimorbidity in primary care: a pragmatic cluster randomised controlled trial.

Objective: Patients with multiple chronic health conditions are often managed in a disjointed fashion in primary care, with annual review clinic appointments offered separately for each condition. This study aimed to determine the cost-effectiveness of the 3D intervention, which was developed to improve the system of care.

Design: Economic evaluation conducted alongside a pragmatic cluster-randomised trial.

Can implementation failure or intervention failure explain the result of the 3D multimorbidity trial in general practice: mixed-methods process evaluation.

Objectives: During a cluster randomised trial, (the 3D study) of an intervention enacting recommended care for people with multimorbidity, including continuity of care and comprehensive biennial reviews, we examined implementation fidelity to interpret the trial outcome and inform future implementation decisions.

Design: Mixed-methods process evaluation using cross-trial data and a sample of practices, clinicians, administrators and patients. Interviews, focus groups and review observations were analysed thematically and integrated with quantitative data about implementation.

Understanding usual care for patients with multimorbidity: baseline data from a cluster-randomised trial of the 3D intervention in primary care.

Objectives: Recent evidence has highlighted the high prevalence and impact of multimorbidity, but the evidence base for improving management is limited. We have tested a new complex intervention for multimorbidity (the 3D model). The paper describes the baseline characteristics of practices and patients in order to establish the external validity of trial participants.

Management of multimorbidity using a patient-centred care model: a pragmatic cluster-randomised trial of the 3D approach.

Background: The management of people with multiple chronic conditions challenges health-care systems designed around single conditions. There is international consensus that care for multimorbidity should be patient-centred, focus on quality of life, and promote self-management towards agreed goals. However, there is little evidence about the effectiveness of this approach.

Reporting and appraising the context, process and impact of PPI on contributors, researchers and the trial during a randomised controlled trial - the 3D study.

Plain English Summary: Including patient and public involvement (PPI) in health research is thought to improve research but it is hard to be clear exactly how it helps. This is because PPI takes many forms, is sometimes only token and is not always reported clearly. This makes it difficult to combine the evidence so that clear conclusions can be reached about the ingredients of successful PPI and what PPI achieves.

Development and validation of the Multimorbidity Treatment Burden Questionnaire (MTBQ).

Objective: To develop and validate a new scale to assess treatment burden (the effort of looking after one's health) for patients with multimorbidity.

Design: Mixed-methods.

Setting: UK primary care.

The Foundations Framework for Developing and Reporting New Models of Care for Multimorbidity.

Purpose: Multimorbidity challenges health systems globally. New models of care are urgently needed to better manage patients with multimorbidity; however, there is no agreed framework for designing and reporting models of care for multimorbidity and their evaluation.

Methods: Based on findings from a literature search to identify models of care for multimorbidity, we developed a framework to describe these models.

Making the journey with me: a qualitative study of experiences of a bespoke mental health smoking cessation intervention for service users with serious mental illness.

Background: Smoking is one of the major modifiable risk factors contributing to early mortality for people with serious mental illness. However, only a minority of service users access smoking cessation interventions and there are concerns about the appropriateness of generic stop-smoking services for this group. The SCIMITAR (Smoking Cessation Intervention for Severe Mental Ill-Health Trial) feasibility study explored the effectiveness of a bespoke smoking cessation intervention delivered by mental health workers.

Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial.

Objective:  To assess whether non-clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies.

Design:  Pragmatic, multicentre, randomised controlled trial.

Setting:  42 general practices in three areas of England.

Protocol for a process evaluation of a cluster randomised controlled trial to improve management of multimorbidity in general practice: the 3D study.

Introduction: As an increasing number of people are living with more than 1 long-term condition, identifying effective interventions for the management of multimorbidity in primary care has become a matter of urgency. Interventions are challenging to evaluate due to intervention complexity and the need for adaptability to different contexts. A process evaluation can provide extra information necessary for interpreting trial results and making decisions about whether the intervention is likely to be successful in a wider context.

Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention.

Background: Many countries are exploring the potential of telehealth interventions to manage the rising number of people with chronic disorders. However, evidence of the effectiveness of telehealth is ambiguous. Based on an evidence-based conceptual framework, we developed an integrated telehealth service (the Healthlines Service) for chronic disorders and assessed its effectiveness in patients with depression.

Improving the management of multimorbidity in general practice: protocol of a cluster randomised controlled trial (The 3D Study).

Introduction: An increasing number of people are living with multimorbidity. The evidence base for how best to manage these patients is weak. Current clinical guidelines generally focus on single conditions, which may not reflect the needs of patients with multimorbidity.

Bespoke smoking cessation for people with severe mental ill health (SCIMITAR): a pilot randomised controlled trial.

Background: People with severe mental ill health are three times more likely to smoke but typically do not access conventional smoking cessation services, contributing to widening health inequalities and reduced life expectancy. We aimed to pilot an intervention targeted at smokers with severe mental ill health and to test methods of recruitment, randomisation, and follow up before implementing a full trial.

Methods: The Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR) is a pilot randomised controlled trial of a smoking cessation strategy designed specifically for people with severe mental ill health, to be delivered by mental health nurses and consisting of behavioural support and drugs, compared with a conventional smoking cessation service (ie, usual care).