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1.
BMJ Open ; 14(3): e084509, 2024 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-38531561

RESUMO

INTRODUCTION: Chronic stable angina is common and disabling. Cardiac rehabilitation is routinely offered to people following myocardial infarction or revascularisation procedures and has the potential to help people with chronic stable angina. However, there is insufficient evidence of effectiveness and cost-effectiveness for its routine use in this patient group. The objectives of this study are to compare the effectiveness and cost-effectiveness of the 'Activate Your Heart' cardiac rehabilitation programme for people with chronic stable angina compared with usual care. METHODS AND ANALYSIS: ACTIVATE is a multicentre, parallel-group, two-arm, superiority, pragmatic randomised controlled trial, with recruitment from primary and secondary care centres in England and Wales and a target sample size of 518 (1:1 allocation; allocation sequence by minimisation programme with built-in random element). The study uses secure web-based allocation concealment. The two treatments will be optimal usual care (control) and optimal usual care plus the 'Activate Your Heart' web-based cardiac rehabilitation programme (intervention). Outcome assessment and statistical analysis will be performed blinded; participants will be unblinded. Outcomes will be measured at baseline and at 6 and 12 months' follow-up. Primary outcome will be the UK version of Seattle Angina Questionnaire (SAQ-UK), physical limitations domain at 12 months' follow-up. Secondary outcomes will be the remaining two domains of SAQ-UK, dyspnoea, anxiety and depression, health utility, self-efficacy, physical activity and the incremental shuttle walk test. All safety events will be recorded, and serious adverse events assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be cost-utility analysis from health service perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the cardiac rehabilitation programme. ETHICS AND DISSEMINATION: North of Scotland National Health Service Research Ethics Committee approval, reference 21/NS/0115. Participants will provide written informed consent. Results will be disseminated by peer-reviewed publication. TRIAL REGISTRATION NUMBER: ISRCTN10054455.


Assuntos
Angina Estável , Reabilitação Cardíaca , Humanos , Reabilitação Cardíaca/métodos , Análise Custo-Benefício , Medicina Estatal , Internet , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto
2.
BMJ Open ; 10(10): e039791, 2020 10 16.
Artigo em Inglês | MEDLINE | ID: mdl-33067298

RESUMO

INTRODUCTION: Proximal femoral (hip) fracture is common, serious and costly. Rehabilitation may improve functional recovery but evidence of effectiveness and cost-effectiveness are lacking. An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT). The objectives are to compare the effectiveness and cost-effectiveness of the enhanced rehabilitation programme following surgical repair of proximal femoral fracture in older people compared with usual care. METHODS AND ANALYSIS: Protocol for phase III, parallel-group, two-armed, superiority, pragmatic RCT with 1:1 allocation ratio; allocation sequence by minimisation programme with a built-in random element; secure web-based allocation concealment. The two treatments will be usual care (control) and usual care plus an enhanced rehabilitation programme (intervention). The enhanced rehabilitation will consist of a patient-held information workbook, goal setting diary and up to six additional therapy sessions. Outcome assessment and statistical analysis will be performed blind; patient and carer participants will be unblinded. Outcomes will be measured at baseline, 17 and 52 weeks' follow-up. Primary outcome at 52 weeks will be the Nottingham Extended Activities of Daily Living scale. Secondary outcomes will measure anxiety and depression, health utility, cognitive status, hip pain intensity, falls self-efficacy, fear of falling, grip strength and physical function. Carer strain, anxiety and depression will be measured in carers. All safety events will be recorded, and serious adverse events will be assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be a cost-utility analysis from a health service and personal social care perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the enhanced rehabilitation programme. ETHICS AND DISSEMINATION: National Health Service research ethics approval reference 18/NE/0300. Results will be disseminated by peer-reviewed publication. TRIAL REGISTRATION NUMBER: ISRCTN28376407; Pre-results registered on 23 November 2018.


Assuntos
Fraturas do Quadril , Acidentes por Quedas , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Análise Custo-Benefício , Fêmur , Fraturas do Quadril/cirurgia , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
3.
Int J Technol Assess Health Care ; 27(4): 376-83, 2011 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-22004780

RESUMO

OBJECTIVES: The aim of this study, in the context of disinvestment related health technology assessment, is to examine whether analysis of Web 2.0--commercial media output, blogs, and discussion forums--can provide an understanding of media framing, community perspectives, and the sociopolitical aspects of an entrenched technology. METHODS: Thematic analysis of relevant data from fifty-nine media articles, thirty-nine discussion forums, thirteen blogs, and three Facebook pages relating to our case study: public funding for assisted reproductive technology services. Mainstream media and community-based social media responses were compared. RESULTS: Media responses were narrow, primarily describing emotive individual narratives or the political nexus of interests. Community (including patient) responses were broader including discussion of opportunity cost and vested interests but mostly reflected the polar ends of the debate, diverging strongly for or against disinvestment from public funding. CONCLUSION: Web2.0 and media analysis offers an inexpensive method to capture media portrayal, divergent community responses both to that portrayal and independent of it, and insight into the sociopolitical aspects of an entrenched technology undergoing disinvestment debate.


Assuntos
Blogging , Meios de Comunicação de Massa , Opinião Pública , Mídias Sociais , Avaliação da Tecnologia Biomédica , Financiamento Governamental/organização & administração , Direitos Humanos , Humanos , Pais , Política , Técnicas de Reprodução Assistida/economia , Técnicas de Reprodução Assistida/psicologia , Fatores Socioeconômicos
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