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1.
Pilot Feasibility Stud ; 7(1): 88, 2021 Mar 26.
Artigo em Inglês | MEDLINE | ID: mdl-33771233

RESUMO

INTRODUCTION: 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 contamination, avoiding the dilution of intervention effectiveness that it may cause. However, cluster randomisation can result in selection bias and may not be feasible to deliver. We explored the extent of contamination in a qualitative study nested within a feasibility study of HENRY (Health, Exercise and Nutrition for the Really Young); a UK community-based child obesity prevention programme. We aimed to determine the nature and impact of contamination to inform a larger planned trial and other trials in community based public health settings. METHOD: We invited participants to take part in the nested qualitative study who were already involved in the HENRY feasibility study. Semi-structured interviews/focus groups were conducted with children's centre managers (n=7), children's centre staff (n=15), and parents (n=29). Data were transcribed and analysed using an integrative approach. First, deductively organised using a framework guided by the topic guide and then organised using inductive thematic analysis. RESULTS: Potential for contamination between treatment arms was recognised by all stakeholder groups. Staff within the intervention centres presented the greatest risk of contamination, predominantly because they were often asked to work in other children centre's (including control group centres). 'Sharing of best practice' by staff was reported to be a common and desirable phenomenon within community based settings. Parental sharing of HENRY messages was reported inconsistently; though some parents indicated a high degree of knowledge transfer within their immediate circles. CONCLUSIONS: The extent of contamination identified has influenced the design of a future effectiveness trial of HENRY which will be clustered at the centre level (with geographically distinct clusters). The common practice of knowledge sharing amongst community teams means that this clustering approach is also likely to be most suitable for other trials based within these settings. We provide recommendations (e.g. cluster randomisation, training intervention facilitators on implications of contamination) to help reduce the impact of contamination in public health intervention trials with or without clustering, whilst enabling transfer of knowledge where appropriate. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03333733 registered 6th November 2017.

2.
J Clin Oncol ; 39(3): 202-214, 2021 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-33332191

RESUMO

PURPOSE: High-grade nonmuscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease. Treatments include intravesical maintenance Bacillus Calmette-Guerin (mBCG) and radical cystectomy (RC). We wanted to understand whether a randomized trial comparing these options was possible. MATERIALS AND METHODS: We conducted a two-arm, prospective multicenter randomized study to determine the feasibility in Bacillus Calmette-Guerin-naive patients. Participants had new high-risk HRNMIBC suitable for both treatments. Random assignment was stratified by age, sex, center, stage, presence of carcinoma in situ, and prior low-risk bladder cancer. Qualitative work investigated how to maintain equipoise. The primary outcome was the number of patients screened, eligible, recruited, and randomly assigned. RESULTS: We screened 407 patients, approached 185, and obtained consent from 51 (27.6%) patients. Of these, one did not proceed and therefore 50 were randomly assigned (1:1). In the mBCG arm, 23/25 (92.0%) patients received mBCG, four had nonmuscle invasive bladder cancer (NMIBC) after induction, three had NMIBC at 4 months, and four received RC. At closure, two patients had metastatic BC. In the RC arm, 20 (80.0%) participants received cystectomy, including five (25.0%) with no tumor, 13 (65.0%) with HRNMIBC, and two (10.0%) with muscle invasion in their specimen. At follow-up, all patients in the RC arm were free of disease. Adverse events were mostly mild and equally distributed (15/23 [65.2%] patients with mBCG and 13/20 [65.0%] patients with RC). The quality of life (QOL) of both arms was broadly similar at 12 months. CONCLUSION: A randomized controlled trial comparing mBCG and RC will be challenging to recruit into. Around 10% of patients with high-risk HRNMIBC have a lethal disease and may be better treated by primary radical treatment. Conversely, many are suitable for bladder preservation and may maintain their prediagnosis QOL.

3.
Age Ageing ; 2020 Nov 06.
Artigo em Inglês | MEDLINE | ID: mdl-33156901

RESUMO

BACKGROUND: Providing cancer care and treatment for ageing populations with complicating comorbidities like dementia is a growing global challenge. This study aimed to examine the hospital-based cancer care and treatment challenges and support needs of people with dementia, and identify potential ways to address these. METHODS: A two-site ethnographic study in England involving semi-structured interviews, observations and accompanying conversations, and medical record review. Participants (N = 58) were people with dementia and comorbid cancer (n = 17), informal caregivers (n = 22) and hospital staff (n = 19). Ethnographically informed thematic analysis was conducted. RESULTS: There was an accumulated complexity of living with both illnesses simultaneously. People with dementia and families could feel confused and uninformed due to difficulties understanding, retaining and using cancer information, which impacted their informed treatment decision-making. Dementia increased the complexity and burden of travelling to and navigating unfamiliar hospital environments, frequent lengthy periods of waiting in hospital, and self-managing symptoms and side-effects at home. Oncology staff were often working without the full picture, due to variable documenting of dementia in medical records, dementia training was limited, and time and resource pressures impeded the highly individualised, flexible cancer care required by people with dementia. Supportive family carers were crucial in enabling people with dementia to access, navigate and undergo cancer treatment and care. CONCLUSIONS: Dementia complicates cancer care in a range of ways accumulating across the cancer pathway. Our findings suggest there are several strategies and interventions, which we list here, with potential to improve cancer care and treatment for people with dementia and their families.

4.
BMC Public Health ; 20(1): 1535, 2020 Oct 12.
Artigo em Inglês | MEDLINE | ID: mdl-33046078

RESUMO

BACKGROUND: 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 how programmes are commissioned and which attributes of programmes are valued most by commissioners. The aim of this study was to determine the factors that decision-makers prioritise when commissioning programmes that target childhood obesity prevention. METHODS: An online discrete choice experiment (DCE) was used to survey commissioners and decision makers in the UK to assess their willingness-to-pay for childhood obesity programmes. RESULTS: A total of 64 commissioners and other decision makers completed the DCE. The impact of programmes on behavioural outcomes was prioritised, with participants willing to pay an extra £16,600/year if average daily fruit and vegetable intake increased for each child by one additional portion. Participants also prioritised programmes that had greater number of parents fully completing them, and were willing to pay an extra £4810/year for every additional parent completing a programme. The number of parents enrolling in a programme (holding the number completing fixed) and hours of staff time required did not significantly influence choices. CONCLUSIONS: Emphasis on high programme completion rates and success increasing children's fruit and vegetable intake has potential to increase commissioning of community based obesity prevention programmes.

5.
Support Care Cancer ; 2020 Sep 21.
Artigo em Inglês | MEDLINE | ID: mdl-32955656

RESUMO

OBJECTIVES: The risks of developing 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 dementia face when navigating engagement with cancer treatment within secondary care. MATERIALS AND METHODS: An ethnographic study recruiting 17 people with cancer and dementia, 22 relatives and 19 oncology staff in two UK National Health Service Trusts. Observations (46 h) and informal conversations were conducted during oncology appointments involving people with dementia. Semi-structured interviews (n = 37) with people living with cancer and dementia, their relatives and staff working in various roles across oncology services were also carried out. Data were analysed using ethnographically informed thematic analysis. RESULTS: People with cancer and dementia experienced challenges across three areas of navigating cancer treatment and care: navigating through multiple services, appointments and layers of often complex information; repeatedly navigating transport to and from hospital; and navigating non-dementia-friendly hospital outpatient environments alongside the cognitive problems associated with dementia. CONCLUSIONS: Dementia impacts patients' abilities to navigate the many practical aspects of attending hospital for cancer treatment and care. This study indicates the importance of addressing ways to improve the experience of travelling to and from the hospital, alongside extending the ongoing efforts to develop 'dementia-friendly' hospital in-patient areas and practices, to outpatient departments. Such steps will serve to improve hospital-based cancer treatment and care and more broadly outpatient appointment experiences for people with dementia and their families.

6.
Pilot Feasibility Stud ; 6: 119, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32832098

RESUMO

Background: 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 interventions-and no clear NICE guidance or clinical consensus concerning aftercare. We examined the practicability of a definitive trial to evaluate problem-solving therapy (PST) to reduce repetition of self-harm; MIDSHIPS is a single-centre, parallel-group, individually randomised controlled feasibility trial comparing treatment-as-usual (TAU) alone to TAU plus up to six sessions of brief problem-solving therapy (PST) with adults who had recently attended hospital because of self-harm. Objectives were to adapt the intervention for a UK setting, train therapists, recruit and randomise patients, deliver PST under supervision, and establish comparative outcomes, assessed blindly. Methods: We adapted the problem-solving intervention from an earlier trial and trained a mental-health nurse to deliver it. Adult patients attending the general hospital for self-harm were recruited while undergoing psychosocial assessment by the mental health team, and 62 were randomly allocated (32 TAU, 30 PST). The primary outcome assessed repeat hospital attendance due to further self-harm 6 months post-randomisation. Secondary outcomes included participant-reported outcomes and service use at 3 and 6 months post-randomisation. Results: The recruitment period had to be extended and 710 patients screened in order to establish a trial sample of the planned size (N = 62). A quarter of participants allocated to PST did not undertake the therapy offered; those who received PST attended a median of three sessions. Secondary outcomes were established for 49 (79%) participants at 6 months; all participants' hospital records were retrieved. Repetition of self-harm leading to hospital presentation occurred in 19 of the 62 participants (30.6%, 95% CI 19.2%, 42.1%) within 6 months of randomisation. Promising differential rates of self-harm were observed with an event rate of 23.3% (95% CI 8.2%, 38.5%) in the PST arm; and 37.5% (95% CI 20.7%, 54.3%) in TAU. Economic findings were also encouraging, with a small QALY gain (0.0203) in the PST arm together with less reported use of the NHS in the PST arm (average £2120) than with TAU-only (£2878). Conclusions: The feasibility trial achieved its objectives despite considerable difficulties with recruitment-adapting the PST, training a therapist, recruiting patients who had recently self-harmed, delivering the therapy, and establishing primary and secondary outcomes. These data provide a robust platform for a definitive multicentre randomised controlled trial of brief problem-solving therapy after hospital attendance due to self-harm. Trial registration: Identification number and URL: ISRCTN54036115 http://www.isrctn.com/search?q=midships. Registered: 13 January 2012.

7.
Psychooncology ; 29(8): 1347-1354, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32567082

RESUMO

OBJECTIVE: Increasing numbers of people are expected to live with comorbid cancer and dementia. Cancer treatment decision-making for these individuals is complex, particularly for those lacking capacity, requiring support across the cancer care pathway. There is little research to inform practice in this area. This ethnographic study reports on the cancer decision-making experiences of people with cancer and dementia, their families, and healthcare staff. METHODS: Participant observations, informal conversations, semi-structured interviews, and medical note review, in two NHS trusts. Seventeen people with dementia and cancer, 22 relatives and 19 staff members participated. RESULTS: Decision-making raised complex ethical dilemmas and challenges and raised concerns for families and staff around whether correct decisions had been made. Whose decision it was and to what extent a person with dementia and cancer was able to make decisions was complex, requiring careful and ongoing consultation and close involvement of relatives. The potential impact dementia might have on treatment understanding and toleration required additional consideration by clinicians when evaluating treatment options. CONCLUSIONS: Cancer treatment decision-making for people with dementia is challenging, should be an ongoing process and has emotional impacts for the individual, relatives, and staff. Longer, flexible, and additional appointments may be required to support decision-making by people with cancer and dementia. Evidence-based decision-making guidance on how dementia impacts cancer prognosis, treatment adherence and efficacy is required.

8.
J Geriatr Oncol ; 11(7): 1125-1131, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32253158

RESUMO

OBJECTIVES: Despite cancer and dementia being conditions in which prevalence increases with age, there remains limited research on the cancer treatment and care needs of this population. Our study aimed to address this gap and this paper reports on the role of supportive networks in enabling people with dementia to access cancer treatment and care. MATERIALS AND METHODS: An ethnographic study involving seventeen people with cancer and dementia, 22 relatives and nineteen oncology staff. It comprised observations (46 h) of and informal conversations during oncology appointments attended by people with dementia and their relatives and semi-structured interviews (n = 37) with people living with cancer and dementia, their relatives and staff working in various roles across oncology services. Data were analysed using thematic analysis. RESULTS: Patients and oncology staff relied on and expected relatives to provide practical and emotional support around cancer treatment and care. Families varied in their ability to provide required support due to extent of the family network, practical issues, knowledge of the patient and their wishes, family conflict and the patient's willingness to accept help. Where no family network was available, support provision was complex and this could compromise access to cancer treatment. CONCLUSIONS: People with comorbid cancer and dementia rely heavily on a supportive family network to access treatment and care. Oncology services need to assess the supportive networks available to individual patients in developing cancer treatment plans. Urgent consideration needs to be given to how those with no family networks can be appropriately supported.

9.
Age Ageing ; 49(4): 648-655, 2020 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-32310260

RESUMO

BACKGROUND: delirium is a frequent complication of hospital admission for older people and can be reduced by multicomponent interventions, but implementation and delivery of such interventions is challenging. OBJECTIVE: to investigate fidelity to the prevention of delirium system of care within a multicentre, pragmatic, cluster randomised, controlled feasibility trial. SETTING: five care of older people and three orthopaedic trauma wards in eight hospitals in England and Wales. DATA COLLECTION: research nurse observations of ward practice; case note reviews and examination of documentation. ASSESSMENT: 10 health care professionals with experience in older people's care assessed the fidelity to 21 essential implementation components within four domains: intervention installation (five items; maximum score = 5); intervention delivery (12 items; maximum score = 48); intervention coverage (three items; maximum score = 16); and duration of delivery (one item; maximum score = 1). RESULTS: the mean score (range) for each domain was: installation 4.5 (3.5-5); delivery 32.6 (range 27.3-38.3); coverage 7.9 (range 4.2-10.1); and duration 0.38 (0-1). Of the 10 delirium risk factors, infection, nutrition, hypoxia and pain were the most and cognitive impairment, sensory impairment and multiple medications the least consistently addressed. Overall fidelity to the intervention was assessed as high (≥80%) in two wards, medium (51-79%) in five wards and low (≤50%) in one ward. CONCLUSION: the trial was designed as a pragmatic evaluation, and the findings of medium intervention fidelity are likely to be generalisable to delirium prevention in routine care and provide an important context to interpret the trial outcomes.

10.
Age Ageing ; 49(4): 640-647, 2020 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-32307515

RESUMO

OBJECTIVE: to provide a preliminary estimate of the effectiveness of the prevention of delirium (POD) system of care in reducing incident delirium in acute hospital wards and gather data for a future definitive randomised controlled trial. DESIGN: cluster randomised and controlled feasibility trial. SETTING: sixteen acute care of older people and orthopaedic trauma wards in eight hospitals in England and Wales. PARTICIPANTS: patients 65 years and over admitted to participating wards during the trial period. INTERVENTIONS: participating wards were randomly assigned to either the POD programme or usual care, determined by existing local policies and practices. The POD programme is a manualised multicomponent delirium prevention intervention that targets 10 risk factors for delirium. The intervention wards underwent a 6-month implementation period before trial recruitment commenced. Main outcome measure incidence of new-onset delirium measured using the Confusion Assessment Method (CAM) measured daily for up to 10 days post consent. RESULTS: out of 4449, 3274 patients admitted to the wards were eligible. In total, 714 patients consented (713 registered) to the trial, thirty-three participants (4.6%) withdrew. Adherence to the intervention was classified as at least medium for seven wards. Rates of new-onset delirium were lower than expected and did not differ between groups (24 (7.0%) of participants in the intervention group versus 33 (8.9%) in the control group; odds ratio (95% confidence interval) 0.68 (0.37-1.26); P = 0.2225). CONCLUSIONS: based on these findings, a definitive trial is achievable and would need to recruit 5220 patients in 26 two-ward hospital clusters. Trial registration: ISRCTN01187372. Registered 13 March 2014.

11.
PLoS Med ; 17(2): e1003045, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32109257

RESUMO

BACKGROUND: In primary care, multiple priorities and system pressures make closing the gap between evidence and practice challenging. Most implementation studies focus on single conditions, limiting generalisability. We compared an adaptable implementation package against an implementation control and assessed effects on adherence to four different evidence-based quality indicators. METHODS AND FINDINGS: We undertook two parallel, pragmatic cluster-randomised trials using balanced incomplete block designs in general practices in West Yorkshire, England. We used 'opt-out' recruitment, and we randomly assigned practices that did not opt out to an implementation package targeting either diabetes control or risky prescribing (Trial 1); or blood pressure (BP) control or anticoagulation in atrial fibrillation (AF) (Trial 2). Within trials, each arm acted as the implementation control comparison for the other targeted indicator. For example, practices assigned to the diabetes control package acted as the comparison for practices assigned to the risky prescribing package. The implementation package embedded behaviour change techniques within audit and feedback, educational outreach, and computerised support, with content tailored to each indicator. Respective patient-level primary endpoints at 11 months comprised the following: achievement of all recommended levels of haemoglobin A1c (HbA1c), BP, and cholesterol; risky prescribing levels; achievement of recommended BP; and anticoagulation prescribing. Between February and March 2015, we recruited 144 general practices collectively serving over 1 million patients. We stratified computer-generated randomisation by area, list size, and pre-intervention outcome achievement. In April 2015, we randomised 80 practices to Trial 1 (40 per arm) and 64 to Trial 2 (32 per arm). Practices and trial personnel were not blind to allocation. Two practices were lost to follow-up but provided some outcome data. We analysed the intention-to-treat (ITT) population, adjusted for potential confounders at patient level (sex, age) and practice level (list size, locality, pre-intervention achievement against primary outcomes, total quality scores, and levels of patient co-morbidity), and analysed cost-effectiveness. The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67-0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89-1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96-1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75-1.09, p = 0.214). No statistically significant effects were observed in any secondary outcome except for reduced co-prescription of aspirin and clopidogrel without gastro-protection in patients aged 65 and over (adjusted OR 0.62; 97.5% CI 0.39-0.99; p = 0.021). Main study limitations concern our inability to make any inferences about the relative effects of individual intervention components, given the multifaceted nature of the implementation package, and that the composite endpoint for diabetes control may have been too challenging to achieve. CONCLUSIONS: In this study, we observed that a multifaceted implementation package was clinically and cost-effective for targeting prescribing behaviours within the control of clinicians but not for more complex behaviours that also required patient engagement. TRIAL REGISTRATION: The study is registered with the ISRCTN registry (ISRCTN91989345).


Assuntos
Auditoria Clínica , Sistemas de Apoio a Decisões Clínicas , Medicina Baseada em Evidências/métodos , Feedback Formativo , Atenção Primária à Saúde/métodos , Adulto , Anti-Inflamatórios não Esteroides/efeitos adversos , Anticoagulantes/uso terapêutico , Anti-Hipertensivos/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Análise Custo-Benefício , Diabetes Mellitus/tratamento farmacológico , Interações Medicamentosas , Feminino , Hemoglobina A Glicada/metabolismo , Humanos , Hipertensão/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Ciência da Implementação , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/efeitos adversos , Anos de Vida Ajustados por Qualidade de Vida , Reino Unido , Adulto Jovem
12.
BMC Geriatr ; 19(1): 107, 2019 04 15.
Artigo em Inglês | MEDLINE | ID: mdl-30991945

RESUMO

BACKGROUND: 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 validated instrument for delirium detection. We hypothesised it would be possible for a large feasibility study to train a large number of research assistants, with varying experience levels, to conduct CAM assessments reliably in multiple hospital sites. METHODS: A standardised training programme was followed, incorporating structured training at a central location and at study sites. CAM practice sessions on both delirious and non-delirious patients by research assistants were conducted and, thereafter, there was ongoing inter-rater reliability assessment on the CAM between research assistant pairs at study sites. The setting was eight acute care hospitals in England and Wales. Participants were research assistants working on a multicentre feasibility study of delirium prevention. The measurement used was the Confusion Assessment Method. RESULTS: Thirty-seven research assistants were trained in CAM assessment and 33 returned training logs. The logs showed there was 100% overall agreement between research assistant pairs on 295 CAM assessments, of which 263 (89.2%) were negative for delirium and 32 (10.8%) were positive. In the course of the feasibility study, research assistants successfully completed 5065 (89.7%) of the 5645 expected CAM assessments, with minimal missing data. CONCLUSION: Using the training methods described in this study, it is possible to achieve high quality delirium assessments for large numbers of patients with little missing data across geographically dispersed sites in multicentre studies. The standardisation of multisite delirium assessments is an important contribution to research methodology, and provides a much-needed advance for the field. TRIAL REGISTRATION: ISRCT ISRCTN01187372 . Registered 13 March 2014.


Assuntos
Confusão/diagnóstico , Confusão/psicologia , Pessoal de Saúde/educação , Pessoal de Saúde/normas , Idoso , Idoso de 80 Anos ou mais , Confusão/epidemiologia , Delírio/diagnóstico , Delírio/epidemiologia , Delírio/psicologia , Inglaterra/epidemiologia , Estudos de Viabilidade , Feminino , Humanos , Masculino , Reprodutibilidade dos Testes , País de Gales/epidemiologia
13.
Pilot Feasibility Stud ; 4: 118, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29977593

RESUMO

Background: 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 school readiness. This is a key setting for obesity prevention programmes, which are often commissioned despite the limited evidence base. The HENRY (Health, Exercise, Nutrition for the Really Young) programme is an 8-week programme delivered to parents of preschool children, designed to support families to optimise healthy weight behaviours. Early evidence suggests that it may be effective, but a robust evaluation using a randomised controlled design has not been conducted. This study begins this process by evaluating the feasibility of conducting a multi-centre definitive trial to evaluate the effectiveness and cost-effectiveness of HENRY to prevent obesity in the early years. Methods: This is a multi-centre, open labelled, two group, prospective, cluster randomised, controlled, feasibility study aiming to recruit 120 parents from 12 children's centres, based in two local authority areas. Within each of the two local authorities, three centres will be randomised to HENRY and three will be randomised to a control arm of standard care (usual provision of services within children's centres). We will explore HENRY commissioning, provision and delivery and assess the feasibility of local authority, centre and parent recruitment, the processes and time required to train and certify staff to deliver the intervention, the potential sources (and associated risk) of contamination and the feasibility of the trial procedures. Research includes a process evaluation, feasibility of cost-effectiveness evaluation, with progression to the definitive trial judged against pre-defined criteria. Discussion: This feasibility study will support the decision to proceed to, and the design of, a future definitive trial, providing an evidence base of an approach to prevent childhood obesity, which has been deemed attractive to all stakeholders, including parents. Given the widespread adoption of the intervention, this has the potential to impact on public health in the UK and beyond. Trial registration: ClinicalTrials.gov Identifier NCT03333733 registered 6th November 2017Protocol date: 25th October 2017Protocol version: 4.0.

14.
Health Technol Assess ; 22(12): 1-222, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29532784

RESUMO

BACKGROUND: Self-harm in adolescents is common and repetition rates high. There is limited evidence of the effectiveness of interventions to reduce self-harm. OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of family therapy (FT) compared with treatment as usual (TAU). DESIGN: A pragmatic, multicentre, individually randomised controlled trial of FT compared with TAU. Participants and therapists were aware of treatment allocation; researchers were blind to allocation. SETTING: Child and Adolescent Mental Health Services (CAMHS) across three English regions. PARTICIPANTS: Young people aged 11-17 years who had self-harmed at least twice presenting to CAMHS following self-harm. INTERVENTIONS: Eight hundred and thirty-two participants were randomised to manualised FT delivered by trained and supervised family therapists (n = 415) or to usual care offered by local CAMHS following self-harm (n = 417). MAIN OUTCOME MEASURES: Rates of repetition of self-harm leading to hospital attendance 18 months after randomisation. RESULTS: Out of 832 young people, 212 (26.6%) experienced a primary outcome event: 118 out of 415 (28.4%) randomised to FT and 103 out of 417 (24.7%) randomised to TAU. There was no evidence of a statistically significant difference in repetition rates between groups (the hazard ratio for FT compared with TAU was 1.14, 95% confidence interval 0.87 to 1.49; p = 0.3349). FT was not found to be cost-effective when compared with TAU in the base case and most sensitivity analyses. FT was dominated (less effective and more expensive) in the complete case. However, when young people's and caregivers' quality-adjusted life-year gains were combined, FT incurred higher costs and resulted in better health outcomes than TAU within the National Institute for Health and Care Excellence cost-effectiveness range. Significant interactions with treatment, indicating moderation, were detected for the unemotional subscale on the young person-reported Inventory of Callous-Unemotional Traits (p = 0.0104) and the affective involvement subscale on the caregiver-reported McMaster Family Assessment Device (p = 0.0338). Caregivers and young people in the FT arm reported a range of significantly better outcomes on the Strengths and Difficulties Questionnaire. Self-reported suicidal ideation was significantly lower in the FT arm at 12 months but the same in both groups at 18 months. No significant unexpected adverse events or side effects were reported, with similar rates of expected adverse events across trial arms. CONCLUSIONS: For adolescents referred to CAMHS after self-harm, who have self-harmed at least once before, FT confers no benefits over TAU in reducing self-harm repetition rates. There is some evidence to support the effectiveness of FT in reducing self-harm when caregivers reported poor family functioning. When the young person themselves reported difficulty expressing emotion, FT did not seem as effective as TAU. There was no evidence that FT is cost-effective when only the health benefits to participants were considered but there was a suggestion that FT may be cost-effective if health benefits to caregivers are taken into account. FT had a significant, positive impact on general emotional and behavioural problems at 12 and 18 months. LIMITATIONS: There was significant loss to follow-up for secondary outcomes and health economic analyses; the primary outcome misses those who do not attend hospital following self-harm; and the numbers receiving formal FT in the TAU arm were higher than expected. FUTURE WORK: Evaluation of interventions targeted at subgroups of those who self-harm, longer-term follow-up and methods for evaluating health benefits for family groups rather than for individuals. TRIAL REGISTRATION: Current Controlled Trials ISRCTN59793150. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 12. See the NIHR Journals Library website for further project information.


Assuntos
Psicoterapia/economia , Psicoterapia/métodos , Comportamento Autodestrutivo/terapia , Adolescente , Cuidadores/psicologia , Criança , Análise Custo-Benefício , Família/psicologia , Terapia Familiar/economia , Terapia Familiar/métodos , Feminino , Humanos , Masculino , Modelos Econométricos , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Projetos de Pesquisa , Medicina Estatal
15.
Lancet Psychiatry ; 5(3): 203-216, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29449180

RESUMO

BACKGROUND: Self-harm in adolescents is common and repetition occurs in a high proportion of these cases. Scarce evidence exists for effectiveness of interventions to reduce self-harm. METHODS: This pragmatic, multicentre, randomised, controlled trial of family therapy versus treatment as usual was done at 40 UK Child and Adolescent Mental Health Services (CAMHS) centres. We recruited young people aged 11-17 years who had self-harmed at least twice and presented to CAMHS after self-harm. Participants were randomly assigned (1:1) to receive manualised family therapy delivered by trained and supervised family therapists or treatment as usual by local CAMHS. Participants and therapists were aware of treatment allocation; researchers were masked. The primary outcome was hospital attendance for repetition of self-harm in the 18 months after group assignment. Primary and safety analyses were done in the intention-to-treat population. The trial is registered at the ISRCTN registry, number ISRCTN59793150. FINDINGS: Between Nov 23, 2009, and Dec 31, 2013, 3554 young people were screened and 832 eligible young people consented to participation and were randomly assigned to receive family therapy (n=415) or treatment as usual (n=417). Primary outcome data were available for 795 (96%) participants. Numbers of hospital attendances for repeat self-harm events were not significantly different between the groups (118 [28%] in the family therapy group vs 103 [25%] in the treatment as usual group; hazard ratio 1·14 [95% CI 0·87-1·49] p=0·33). Similar numbers of adverse events occurred in both groups (787 in the family therapy group vs 847 in the treatment as usual group). INTERPRETATION: For adolescents referred to CAMHS after self-harm, having self-harmed at least once before, our family therapy intervention conferred no benefits over treatment as usual in reducing subsequent hospital attendance for self-harm. Clinicians are therefore still unable to recommend a clear, evidence-based intervention to reduce repeated self-harm in adolescents. FUNDING: National Institute for Health Research Health Technology Assessment programme.


Assuntos
Terapia Familiar , Comportamento Autodestrutivo/terapia , Adolescente , Criança , Terapia Familiar/métodos , Feminino , Humanos , Masculino , Comportamento Autodestrutivo/psicologia , Inquéritos e Questionários , Resultado do Tratamento
16.
BMJ Open ; 7(8): e017913, 2017 Aug 11.
Artigo em Inglês | MEDLINE | ID: mdl-28801444

RESUMO

INTRODUCTION: High-risk non-muscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease that can be difficult to predict. While around 25% of cancers progress to invasion and metastases, the remaining majority of tumours remain within the bladder. It is uncertain whether patients with HRNMIBC are better treated with intravesical maintenance BCG (mBCG) immunotherapy or primary radical cystectomy (RC). A definitive randomised controlled trial (RCT) is needed to compare these two different treatments but may be difficult to recruit to and has not been attempted to date. Before undertaking such an RCT, it is important to understand whether such a comparison is possible and how best to achieve it. METHODS AND ANALYSIS: BRAVO is a multi-centre, parallel-group, mixed-methods, individually randomised, controlled, feasibility study for patients with HRNMIBC. Participants will be randomised to receive either mBCG immunotherapy or RC. The primary objective is to assess the feasibility and acceptability of performing the definitive phase III trial via estimation of eligibility and recruitment rates, assessing uptake of allocated treatment and compliance with mBCG, determining quality-of-life questionnaire completion rates and exploring reasons expressed by patients for declining recruitment into the study. We aim to recruit 60 participants from six centres in the UK. Surgical trials with disparate treatment options find recruitment challenging from both the patient and clinician perspective. By building on the experiences of other similar trials through implementing a comprehensive training package aimed at clinicians to address these challenges (qualitative substudy), we hope that we can demonstrate that a phase III trial is feasible. ETHICS AND DISSEMINATION: The study has ethical approval (16/YH/0268). Findings will be made available to patients, clinicians, the funders and the National Health Service through traditional publishing and social media. TRIAL REGISTRATION NUMBER: ISRCTN12509361; Pre results.


Assuntos
Adjuvantes Imunológicos/uso terapêutico , Antineoplásicos/uso terapêutico , Cistectomia , Imunoterapia , Neoplasias da Bexiga Urinária/terapia , Bexiga Urinária/patologia , Adjuvantes Imunológicos/administração & dosagem , Administração Intravesical , Adolescente , Adulto , Idoso , Antineoplásicos/administração & dosagem , Progressão da Doença , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Projetos de Pesquisa , Bexiga Urinária/efeitos dos fármacos , Bexiga Urinária/cirurgia , Neoplasias da Bexiga Urinária/tratamento farmacológico , Neoplasias da Bexiga Urinária/cirurgia
17.
Trials ; 18(1): 40, 2017 01 24.
Artigo em Inglês | MEDLINE | ID: mdl-28115006

RESUMO

BACKGROUND: 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 parents provide an enhanced opportunity to improve public health and are also likely to be more cost-effective than those that do not. We have developed a theory-informed optimisation intervention to promote parent engagement within an existing childhood obesity prevention group programme, HENRY (Health Exercise Nutrition for the Really Young). Here, we describe a proposal to evaluate the effectiveness of this optimisation intervention in regard to the engagement of parents and cost-effectiveness. METHODS/DESIGN: The Optimising Family Engagement in HENRY (OFTEN) trial is a cluster randomised controlled trial being conducted across 24 local authorities (approximately 144 children's centres) which currently deliver HENRY programmes. The primary outcome will be parental enrolment and attendance at the HENRY programme, assessed using routinely collected process data. Cost-effectiveness will be presented in terms of primary outcomes using acceptability curves and through eliciting the willingness to pay for the optimisation from HENRY commissioners. Secondary outcomes include the longitudinal impact of the optimisation, parent-reported infant intake of fruits and vegetables (as a proxy to compliance) and other parent-reported family habits and lifestyle. DISCUSSION: This innovative trial will provide evidence on the implementation of a theory-informed optimisation intervention to promote parent engagement in HENRY, a community-based childhood obesity prevention programme. The findings will be generalisable to other interventions delivered to parents in other community-based environments. This research meets the expressed needs of commissioners, children's centres and parents to optimise the potential impact that HENRY has on obesity prevention. A subsequent cluster randomised controlled pilot trial is planned to determine the practicality of undertaking a definitive trial to robustly evaluate the effectiveness and cost-effectiveness of the optimised intervention on childhood obesity prevention. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02675699 . Registered on 4 February 2016.


Assuntos
Serviços de Saúde Comunitária , Terapia Familiar/métodos , Pais/psicologia , Obesidade Pediátrica/prevenção & controle , Serviços Preventivos de Saúde/métodos , Serviços de Saúde Comunitária/economia , Análise Custo-Benefício , Dieta Saudável , Exercício Físico , Terapia Familiar/economia , Hábitos , Custos de Cuidados de Saúde , Humanos , Obesidade Pediátrica/diagnóstico , Obesidade Pediátrica/economia , Obesidade Pediátrica/psicologia , Serviços Preventivos de Saúde/economia , Projetos de Pesquisa , Fatores de Risco , Comportamento de Redução do Risco , Fatores de Tempo , Resultado do Tratamento , Reino Unido
18.
Age Ageing ; 45(5): 652-61, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-27207749

RESUMO

BACKGROUND AND OBJECTIVES: delirium is a distressing but potentially preventable condition common in older people in long-term care. It is associated with increased morbidity, mortality, functional decline, hospitalization and significant healthcare costs. Multicomponent interventions, addressing delirium risk factors, have been shown to reduce delirium by one-third in hospitals. It is not known whether this approach is also effective in long-term care. In previous work, we designed a bespoke delirium prevention intervention, called 'Stop Delirium!' In preparation for a definitive trial of Stop Delirium, we sought to address key aspects of trial design for the particular circumstances of care homes. DESIGN: a cluster randomized feasibility study with an embedded process evaluation. SETTING AND PARTICIPANTS: residents of 14 care homes for older people in one metropolitan district in the UK. INTERVENTION: Stop Delirium!: a 16-month-enhanced educational package to support care home staff to address key delirium risk factors. Control homes received usual care. MEASUREMENTS: we collected data to determine the following: recruitment and attrition; delirium rates and variability between homes; feasibility of measuring delirium, resource use, quality of life, hospital admissions and falls; and intervention implementation and adherence. RESULTS: two-thirds (215) of eligible care home residents were recruited. One-month delirium prevalence was 4.0% in intervention and 7.1% in control homes. Proposed outcome measurements were feasible, although our approach appeared to underestimate delirium. Health economic evaluation was feasible using routinely collected data. CONCLUSION: a definitive trial of delirium prevention in long-term care is needed but will require some further design modifications and pilot work.


Assuntos
Delírio/prevenção & controle , Instituição de Longa Permanência para Idosos , Acidentes por Quedas/prevenção & controle , Acidentes por Quedas/estatística & dados numéricos , Idoso , Estudos de Viabilidade , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Pessoal de Saúde/educação , Instituição de Longa Permanência para Idosos/economia , Instituição de Longa Permanência para Idosos/organização & administração , Hospitalização/estatística & dados numéricos , Humanos , Assistência de Longa Duração/economia , Assistência de Longa Duração/métodos , Masculino , Qualidade de Vida , Fatores de Risco
19.
Implement Sci ; 11: 25, 2016 Feb 29.
Artigo em Inglês | MEDLINE | ID: mdl-26923369

RESUMO

BACKGROUND: 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 a set of 'high impact' indicators based upon criteria including potential for significant patient benefit, scope for improved practice and amenability to measurement using routinely collected data. We aim to evaluate the effectiveness and cost-effectiveness of a multifaceted, adaptable intervention package to implement four targeted, high impact recommendations in general practice. METHODS/DESIGN: The research programme Action to Support Practice Implement Research Evidence (ASPIRE) includes a pair of pragmatic cluster-randomised trials which use a balanced incomplete block design. Clusters are general practices in West Yorkshire, United Kingdom (UK), recruited using an 'opt-out' recruitment process. The intervention package adapted to each recommendation includes combinations of audit and feedback, educational outreach visits and computerised prompts with embedded behaviour change techniques selected on the basis of identified needs and barriers to change. In trial 1, practices are randomised to adapted interventions targeting either diabetes control or risky prescribing and those in trial 2 to adapted interventions targeting either blood pressure control in patients at risk of cardiovascular events or anticoagulation in atrial fibrillation. The respective primary endpoints comprise achievement of all recommended target levels of haemoglobin A1c (HbA1c), blood pressure and cholesterol in patients with type 2 diabetes, a composite indicator of risky prescribing, achievement of recommended blood pressure targets for specific patient groups and anticoagulation prescribing in patients with atrial fibrillation. We are also randomising practices to a fifth, non-intervention control group to further assess Hawthorne effects. Outcomes will be assessed using routinely collected data extracted 1 year after randomisation. Economic modelling will estimate intervention cost-effectiveness. A process evaluation involving eight non-trial practices will examine intervention delivery, mechanisms of action and unintended consequences. DISCUSSION: ASPIRE will provide 'real-world' evidence about the effects, cost-effectiveness and delivery of adapted intervention packages targeting high impact recommendations. By implementing our adaptable intervention package across four distinct clinical topics, and using 'opt-out' recruitment, our findings will provide evidence of wider generalisability. TRIAL REGISTRATION: ISRCTN91989345.


Assuntos
Pesquisa Biomédica/organização & administração , Medicina Baseada em Evidências , Medicina Geral , Avaliação de Programas e Projetos de Saúde/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto , Fibrilação Atrial/tratamento farmacológico , Biomarcadores , Análise por Conglomerados , Diabetes Mellitus/tratamento farmacológico , Humanos , Hipertensão/tratamento farmacológico , Padrões de Prática Médica , Atenção Primária à Saúde
20.
Trials ; 16: 501, 2015 Nov 04.
Artigo em Inglês | MEDLINE | ID: mdl-26537599

RESUMO

BACKGROUND: 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. Estimates of the 1-year risk of repetition vary between 5 and 15 % per year. Currently, limited evidence exists on the effectiveness of clinical interventions for young people who engage in self-harm. Recent reviews have failed to demonstrate any effect on reducing repetition of self-harm among adolescents receiving a range of treatment approaches. Family factors are particularly important risk factors associated with fatal and non-fatal self-harm among children and adolescents. Family therapy focuses on the relationships, roles and communication patterns between family members, but there have been relatively few studies of specifically family-focused interventions with this population. The Self-Harm Intervention: Family Therapy (SHIFT) Trial was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (grant no. 07/33/01) following a commissioned call for this research. METHODS/DESIGN: SHIFT is a pragmatic, phase III, multicentre, individually randomised, controlled trial comparing Family Therapy (FT) with treatment as usual (TAU) for adolescents aged 11 to 17 who have engaged in at least two episodes of self-harm. Both therapeutic interventions were delivered within the National Health Service (NHS) Child and Adolescent Mental Health Services (CAMHS) in England. Participants and therapists were, of necessity, aware of treatment allocation, but the researchers were blind to the allocations to allow unbiased collection of follow-up data. Primary outcome data (repetition of self-harm leading to hospital attendance 18 months post-randomisation) were collected from the Health and Social Care Information Centre (HSCIC), augmented by directed searches of medical records at Acute Trusts. Secondary outcome data (including suicidal intent, depression, hopelessness and health economics) were collected at 12 and 18 months post-randomisation via researcher-participant interviews and by post at 3 and 6 months. DISCUSSION: SHIFT will provide a well-powered evaluation of the clinical and cost effectiveness of Family Therapy for young people who have self-harmed on more than one occasion. The study will be reported in 2016, and the results will inform clinical practice thereafter. TRIAL REGISTRATION: ISRCTN59793150 . 26 January 2009.


Assuntos
Comportamento do Adolescente , Comportamento Infantil , Terapia Familiar/métodos , Comportamento Autodestrutivo/terapia , Adolescente , Fatores Etários , Criança , Protocolos Clínicos , Análise Custo-Benefício , Inglaterra , Terapia Familiar/economia , Feminino , Custos de Cuidados de Saúde , Humanos , Masculino , Valor Preditivo dos Testes , Escalas de Graduação Psiquiátrica , Recidiva , Projetos de Pesquisa , Comportamento Autodestrutivo/diagnóstico , Comportamento Autodestrutivo/economia , Comportamento Autodestrutivo/fisiopatologia , Fatores de Tempo , Resultado do Tratamento
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