-
Article
Open AccessEarly vocational rehabilitation and psychological support for trauma patients to improve return to work (the ROWTATE trial): study protocol for an individually randomised controlled multicentre pragmatic trial
Moderately severe or major trauma (injury severity score (ISS) > 8) is common, often resulting in physical and psychological problems and leading to difficulties in returning to work. Vocational rehabilitation...
-
Article
Open AccessLong-term cost-utility analysis of family therapy vs. treatment as usual for young people seen after self-harm
The joint evidence of the cost and the effectiveness of family-based therapies is modest.
-
Article
Open AccessUsing healthcare systems data for outcomes in clinical trials: issues to consider at the design stage
Healthcare system data (HSD) are increasingly used in clinical trials, augmenting or replacing traditional methods of collecting outcome data. This study, PRIMORANT, set out to identify, in the UK context, iss...
-
Article
Open AccessPeRsOnaliSed care Planning for oldER people with frailty (PROSPER): protocol for a randomised controlled trial
Frailty is common in older age and is characterised by loss of biological reserves across multiple organ systems. These changes associated with frailty mean older people can be vulnerable to sudden, dramatic c...
-
Article
Open Access‘Smart’ BLE wearables for digital contact tracing in care homes during the COVID-19 pandemic—a process evaluation of the CONTACT feasibility study
Rapid and mass transmission of the SARS-CoV-2 virus amongst vulnerable people led to devastating effects from COVID-19 in care homes. The CONTACT intervention introduced Bluetooth Low Energy ‘smart’ wearable d...
-
Article
Open AccessA cluster randomised controlled trial, process and economic evaluation of quality improvement collaboratives aligned to a national audit to improve the care for people with diabetes (EQUIPD): study protocol
People with type 1 diabetes and raised glucose levels are at greater risk of retinopathy, nephropathy, neuropathy, cardiovascular disease, sexual health problems and foot disease. The UK National Institute for...
-
Article
Open AccessAn intervention to support stroke survivors and their carers in the longer term: results of a cluster randomised controlled feasibility trial (LoTS2Care)
To address the limited provision of longer-term stroke care, we conducted a programme of research (LoTS2Care) to develop and test an intervention to form part of a replicable longer-term care strategy. New Sta...
-
Article
Open AccessCharacteristics and general practice resource use of people with comorbid cancer and dementia in England: a retrospective cross-sectional study
Cancer and dementia are common in older people and management of the conditions as comorbidities can be challenging, yet little is known about the size or characteristics of this group. We aimed to estimate th...
-
Article
Open AccessDevelo** an implementation fidelity checklist for a vocational rehabilitation intervention
Despite growing numbers of studies reporting the efficacy of complex interventions and their implementation, many studies fail to report information on implementation fidelity or describe how fidelity measures us...
-
Article
Open AccessImplementing personalised care planning for older people with frailty: a process evaluation of the PROSPER feasibility trial
Personalised Care Planning (PCP) is a collaborative approach used in the management of chronic conditions. Core components of PCP are shared decision making to achieve joint goal setting and action planning by...
-
Article
Open AccessAmitriptyline at low-dose and titrated for irritable bowel syndrome as second-line treatment (The ATLANTIS trial): protocol for a randomised double-blind placebo-controlled trial in primary care
Irritable bowel syndrome (IBS) is a common functional bowel disorder that has a considerable impact on patient quality of life and substantial societal and health care resource costs. Current treatments are of...
-
Article
Open AccessAcceptance and Commitment Therapy to support medication decision-making and quality of life in women with breast cancer: protocol for a pilot randomised controlled trial
Adherence to adjuvant endocrine therapy is affected by medication side-effects and associated distress. Previous interventions focused on educating women to enhance adherence have proved minimally effective. W...
-
Article
Open AccessA cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial
Poor and variable implementation of childhood obesity prevention programmes reduces their population impact and sustainability. We drew upon ethnographic work to develop a multi-level, theory-based implementat...
-
Article
Open AccessNavigating cancer treatment and care when living with comorbid dementia: an ethnographic study
The risks of develo** cancer and dementia increase as we age; however, this comorbidity remains relatively under-researched. This study reports on the challenges that people affected by comorbid cancer and d...
-
Article
Open AccessContamination within trials of community-based public health interventions: lessons from the HENRY feasibility study
Contamination occurs when participants allocated to trial control arms receive elements of the active intervention. Randomisation at cluster level, rather than individual level, may reduce or eliminate contami...
-
Article
Open AccessEstablishing a primary care audit and feedback implementation laboratory: a consensus study
There is a significant variation among individual primary care providers in prescribing of potentially problematic, low-value medicines which cause avoidable patient harm. Audit and feedback is generally effec...
-
Article
Open AccessAn individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial
Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising incidence of stroke among younger people, the UK economic forecast, and clinical drivers highlight the need for stroke survivor...
-
Article
Open AccessProblem-solving therapy rather than treatment as usual for adults after self-harm: a pragmatic, feasibility, randomised controlled trial (the MIDSHIPS trial)
Non-fatal self-harm is one of the commonest reasons for adults’ emergency hospital attendance. Although strongly associated with fatal and non-fatal repetition, there is weak evidence about effective intervent...
-
Article
Open AccessStudy protocol for a cluster randomised controlled feasibility trial evaluating personalised care planning for older people with frailty: PROSPER V2 27/11/18
Frailty is characterised by increased vulnerability to falls, disability, hospitalisation and care home admission. However, it is relatively reversible in the early stages. Older people living with frailty oft...
-
Article
Open AccessTreatment of irritable bowel syndrome with diarrhoea using titrated ondansetron (TRITON): study protocol for a randomised controlled trial
Irritable bowel syndrome with diarrhoea (IBS-D) affects up to 4% of the general population. Symptoms include frequent, loose, or watery stools with associated urgency, resulting in marked reduction of quality ...
