-
Article
Open AccessSupported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy (STAMINA): study protocol for a randomised controlled trial of the clinical and cost-effectiveness of the STAMINA lifestyle intervention compared with optimised usual care, including internal pilot and parallel process evaluation
UK national clinical guidance recommends that men with prostate cancer on androgen deprivation therapy are offered twice weekly supervised aerobic and resistance exercise to address iatrogenic harm caused by t...
-
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 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 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 AccessExplaining variable effects of an adaptable implementation package to promote evidence-based practice in primary care: a longitudinal process evaluation
Implementing evidence-based recommendations is challenging in UK primary care, especially given system pressures and multiple guideline recommendations competing for attention. Implementation packages that can...
-
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 AccessThe DANTE trial protocol: a randomised phase III trial to evaluate the Duration of ANti-PD-1 monoclonal antibody Treatment in patients with metastatic mElanoma
Immunotherapy is revolutionising the treatment of patients diagnosed with melanoma and other cancers. The first immune checkpoint inhibitor, ipilimumab (targeting cytotoxic T-lymphocyte-associated antigen 4 (C...
-
Article
Open AccessEmbedding supervised exercise training for men on androgen deprivation therapy into standard prostate cancer care: a feasibility and acceptability study (the STAMINA trial)
Lifestyle interventions involving exercise training offset the adverse effects of androgen deprivation therapy in men with prostate cancer. Yet provision of integrated exercise pathways in cancer care is spars...
-
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 AccessCluster randomised controlled feasibility study of HENRY: a community-based intervention aimed at reducing obesity rates in preschool children
Community-based obesity prevention interventions are often commissioned despite the limited evidence base. HENRY (Health, Exercise, Nutrition for the Really Young) is a programme delivered to parents of presch...
-
Article
Open AccessMeasuring commissioners’ willingness-to-pay for community based childhood obesity prevention programmes using a discrete choice experiment
In the UK, rates of childhood obesity remain high. Community based programmes for child obesity prevention are available to be commissioned by local authorities. However, there is a lack of evidence regarding ...
-
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 AccessUse of the confusion assessment method in multicentre delirium trials: training and standardisation
Delirium occurs commonly in older adults and is associated with adverse outcomes. Multicentre clinical trials evaluating interventions to prevent delirium are needed. The Confusion Assessment Method (CAM) is a...
-
Article
Open AccessCluster randomised controlled feasibility study of HENRY: a community-based intervention aimed at reducing obesity rates in preschool children
In the UK and beyond, public funding is used to commission interventions delivered in public health early years settings aimed at improving health and well-being and reducing inequalities in order to promote s...
-
Article
Open AccessEffectiveness of an implementation optimisation intervention aimed at increasing parent engagement in HENRY, a childhood obesity prevention programme - the Optimising Family Engagement in HENRY (OFTEN) trial: study protocol for a randomised controlled trial
Family-based interventions to prevent childhood obesity depend upon parents’ taking action to improve diet and other lifestyle behaviours in their families. Programmes that attract and retain high numbers of p...
-
Article
Open AccessAction to Support Practices Implement Research Evidence (ASPIRE): protocol for a cluster-randomised evaluation of adaptable implementation packages targeting ‘high impact’ clinical practice recommendations in general practice
There are recognised gaps between evidence and practice in general practice, a setting which provides particular challenges for implementation. We earlier screened clinical guideline recommendations to derive ...
-
Article
Open AccessSelf-Harm Intervention: Family Therapy (SHIFT), a study protocol for a randomised controlled trial of family therapy versus treatment as usual for young people seen after a second or subsequent episode of self-harm
Self-harm is common in the community with a lifetime prevalence of 13 %. It is associated with an elevated risk of overall mortality and suicide. People who harm themselves are high users of public services. E...
-
Article
Open AccessPrevention of delirium (POD) for older people in hospital: study protocol for a randomised controlled feasibility trial
Delirium is the most frequent complication among older people following hospitalisation. Delirium may be prevented in about one-third of patients using a multicomponent intervention. However, in the United Kin...
-
Article
Open AccessDelivering an Optimised Behavioural Intervention (OBI) to people with low back pain with high psychological risk; results and lessons learnt from a feasibility randomised controlled trial of Contextual Cognitive Behavioural Therapy (CCBT) vs. Physiotherapy
Low Back Pain (LBP) remains a common and costly problem. Psychological obstacles to recovery have been identified, but psychological and behavioural interventions have produced only moderate improvements. Revi...
