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1.
Health Technol Assess ; 25(53): 1-52, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34505829

RESUMO

BACKGROUND: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. OBJECTIVES: To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. DESIGN: To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. SETTING: A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. RESULTS: To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. CONCLUSIONS: The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. LIMITATIONS: Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. FUTURE WORK: Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space. FUNDING: Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council-National Institute for Health Research Methodology Research programme.


Assuntos
Efeito Placebo , Humanos , Projetos de Pesquisa
3.
BMJ Open ; 11(4): e049093, 2021 04 29.
Artigo em Inglês | MEDLINE | ID: mdl-33926985

RESUMO

OBJECTIVES: Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist. METHODS: The development process involved five stages: (1) identification of the need for a reporting guideline and project launch; (2) conduct of a scoping review to identify possible modifications to CONSORT 2010 checklist items and possible new extension items; (3) a three-round modified Delphi study involving key stakeholders to gather feedback on the checklist; (4) a consensus meeting to finalise items to be included in the extension, followed by stakeholder piloting of the checklist; and (5) publication, dissemination and implementation of the final checklist. RESULTS: 27 items were initially developed and rated in Delphi round 1, 13 items were rated in round 2 and 11 items were rated in round 3. Response rates for the Delphi study were 92 of 125 (74%) invited participants in round 1, 77 of 92 (84%) round 1 completers in round 2 and 62 of 77 (81%) round 2 completers in round 3. Twenty-seven members of the project team representing a variety of stakeholder groups attended the in-person consensus meeting. The final checklist includes five new items and eight modified items. The extension Explanation & Elaboration document further clarifies aspects that are important to report. CONCLUSION: Uptake of CONSORT-ROUTINE and accompanying Explanation & Elaboration document will improve conduct of trials, as well as the transparency and completeness of reporting of trials conducted using cohorts and routinely collected data.


Assuntos
Projetos de Pesquisa , Dados de Saúde Coletados Rotineiramente , Lista de Checagem , Consenso , Técnica Delfos
4.
BMJ ; 369: m115, 2020 06 17.
Artigo em Inglês | MEDLINE | ID: mdl-32554564

RESUMO

Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised.This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process.The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist comprises seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text.The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits.


Assuntos
Lista de Checagem , Consenso , Editoração/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa/normas , Lista de Checagem/normas , Técnica Delfos , Guias como Assunto , Humanos , Publicações Periódicas como Assunto , Controle de Qualidade , Reprodutibilidade dos Testes
5.
Trials ; 21(1): 528, 2020 Jun 17.
Artigo em Inglês | MEDLINE | ID: mdl-32546273

RESUMO

Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised.This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process.The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist comprises seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text.The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits. In order to encourage its wide dissemination this article is freely accessible on the BMJ and Trials journal websites."To maximise the benefit to society, you need to not just do research but do it well" Douglas G Altman.


Assuntos
Lista de Checagem/normas , Consenso , Editoração/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa/normas , Técnica Delfos , Guias como Assunto , Humanos , Publicações Periódicas como Assunto , Controle de Qualidade , Reprodutibilidade dos Testes
7.
Lancet ; 395(10226): 828-838, 2020 03 07.
Artigo em Inglês | MEDLINE | ID: mdl-32145797

RESUMO

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial.


Assuntos
Placebos , Ensaios Clínicos Controlados Aleatórios como Assunto , Procedimentos Cirúrgicos Operatórios , Guias como Assunto , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa
8.
Emerg Med J ; 36(11): 645-651, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31591092

RESUMO

BACKGROUND: In England the demand for emergency care is increasing, while there is also a staffing shortage. This has implications for quality of care and patient safety. One solution may be to concentrate resources on fewer sites by closing or downgrading emergency departments (EDs). Our aim was to quantify the impact of such reorganisation on population mortality. METHODS: We undertook a controlled interrupted time series analysis to detect the impact of closing or downgrading five EDs, which occurred due to concerns regarding sustainability. We obtained mortality data from 2007 to 2014 using national databases. To establish ED resident catchment populations, estimated journey times by road were supplied by the Department for Transport. Other major changes in the emergency and urgent care system were determined by analysis of annual NHS Trust reports in each geographical area studied. Our main outcome measures were mortality and case fatality for a set of 16 serious emergency conditions. RESULTS: For residents in the areas affected by closure, journey time to the nearest ED increased (median change 9 min, range 0-25 min). We found no statistically reliable evidence of a change in overall mortality following reorganisation of ED care in any of the five areas or overall (+2.5% more deaths per month on average; 95% CI -5.2% to +10.2%; p=0.52). There was some evidence to suggest that, on average across the five areas, there was a small increase in case fatality, an indicator of the 'risk of death' (+2.3%, 95% CI +0.9% to+3.6%; p<0.001), but this may have arisen due to changes in hospital admissions. CONCLUSIONS: We found no evidence that reorganisation of emergency care was associated with a change in population mortality in the five areas studied. Further research should establish the economic consequences and impact on patient experience and neighbouring hospitals.


Assuntos
Serviço Hospitalar de Emergência/tendências , Fechamento de Instituições de Saúde/estatística & dados numéricos , Mortalidade/tendências , Serviço Hospitalar de Emergência/organização & administração , Inglaterra , Humanos , Análise de Séries Temporais Interrompida
9.
BMC Med ; 16(1): 210, 2018 11 16.
Artigo em Inglês | MEDLINE | ID: mdl-30442137

RESUMO

BACKGROUND: Adequate reporting of adaptive designs (ADs) maximises their potential benefits in the conduct of clinical trials. Transparent reporting can help address some obstacles and concerns relating to the use of ADs. Currently, there are deficiencies in the reporting of AD trials. To overcome this, we have developed a consensus-driven extension to the CONSORT statement for randomised trials using an AD. This paper describes the processes and methods used to develop this extension rather than detailed explanation of the guideline. METHODS: We developed the guideline in seven overlapping stages: 1) Building on prior research to inform the need for a guideline; 2) A scoping literature review to inform future stages; 3) Drafting the first checklist version involving an External Expert Panel; 4) A two-round Delphi process involving international, multidisciplinary, and cross-sector key stakeholders; 5) A consensus meeting to advise which reporting items to retain through voting, and to discuss the structure of what to include in the supporting explanation and elaboration (E&E) document; 6) Refining and finalising the checklist; and 7) Writing-up and dissemination of the E&E document. The CONSORT Executive Group oversaw the entire development process. RESULTS: Delphi survey response rates were 94/143 (66%), 114/156 (73%), and 79/143 (55%) in rounds 1, 2, and across both rounds, respectively. Twenty-seven delegates from Europe, the USA, and Asia attended the consensus meeting. The main checklist has seven new and nine modified items and six unchanged items with expanded E&E text to clarify further considerations for ADs. The abstract checklist has one new and one modified item together with an unchanged item with expanded E&E text. The E&E document will describe the scope of the guideline, the definition of an AD, and some types of ADs and trial adaptations and explain each reporting item in detail including case studies. CONCLUSIONS: We hope that making the development processes, methods, and all supporting information that aided decision-making transparent will enhance the acceptability and quick uptake of the guideline. This will also help other groups when developing similar CONSORT extensions. The guideline is applicable to all randomised trials with an AD and contains minimum reporting requirements.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa/normas , Ásia , Lista de Checagem , Consenso , Técnicas de Apoio para a Decisão , Europa (Continente) , Humanos
10.
PLoS One ; 13(2): e0192855, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29474392

RESUMO

BACKGROUND: The pressures of patient demand on emergency departments (EDs) continue to be reported worldwide, with an associated negative impact on ED crowding and waiting times. It has also been reported that a proportion of attendances to EDs in different international systems could be managed in settings such as primary care. This study used routine ED data to define, measure and profile non-urgent ED attendances that were suitable for management in alternative, non-emergency settings. METHODS: We undertook a retrospective analysis of three years of Hospital Episode and Statistics Accident Emergency (HES A&E) data for one large region in England, United Kingdom (April 1st 2011 to March 31st 2014). Data was collected on all adult (>16 years) ED attendances from each of the 19 EDs in the region. A validated process based definition of non-urgent attendance was refined for this study and applied to the data. Using summary statistics non-urgent attenders were examined by variables hypothesised to influence them as follows: age at arrival, time of day and day of week and mode of arrival. Odds ratios were calculated to compare non-urgent attenders between groups. RESULTS: There were 3,667,601 first time attendances to EDs, of which 554,564 were defined as non-urgent (15.1%). Non-urgent attendances were significantly more likely to present out of hours than in hours (OR = 1.19, 95% CI: 1.18 to 1.20, P<0.001). The odds of a non-urgent attendance were significantly higher for younger patients (aged 16-44) compared to those aged 45-64 (odds ratio: 1.42, 95% CI: 1.41 to 1.43, P<0.001) and the over 65's (odds ratio: 3.81, 95% CI: 3.78 to 3.85, P<0.001). Younger patients were significantly more likely to attend non-urgently out of hours compared to the 45-64's (OR = 1.24, 95% CI: 1.22 to 1.25, P<0.001) and the 65+'s (OR = 1.38, 95% CI: 1.35 to 1.40, P<0.001). 110,605/554,564 (19.9%) of the non-urgent attendances arrived by ambulance, increasing significantly out of hours versus in hours (OR = 2.12, 95% CI: 2.09 to 2.15, P<0.001). CONCLUSIONS: Younger adults are significantly more likely as older counterparts to use the ED to obtain healthcare that could be provided in a less urgent setting and also more likely to do this out of hours. Alternative services are required to manage non-urgent demand, currently being borne by the ED and the ambulance service, particularly in out of hours.


Assuntos
Serviço Hospitalar de Emergência/estatística & dados numéricos , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Inglaterra , Humanos , Pessoa de Meia-Idade , Razão de Chances , Estudos Retrospectivos , Fatores de Tempo , Transporte de Pacientes/estatística & dados numéricos , Adulto Jovem
11.
Trials ; 18(1): 308, 2017 07 06.
Artigo em Inglês | MEDLINE | ID: mdl-28683809

RESUMO

BACKGROUND: Trials which test the effectiveness of interventions compared with the status quo frequently encounter challenges. The cohort multiple randomised controlled trial (cmRCT) design is an innovative approach to the design and conduct of pragmatic trials which seeks to address some of these challenges. MAIN TEXT: In this article, we report our experiences with the first completed randomised controlled trial (RCT) using the cmRCT design. This trial-the Depression in South Yorkshire (DEPSY) trial-involved comparison of treatment as usual (TAU) with TAU plus the offer of an intervention for people with self-reported long-term moderate to severe depression. In the trial, we used an existing large population-based cohort: the Yorkshire Health Study. We discuss our experiences with recruitment, attrition, crossover, data analysis, generalisability of results, and cost. The main challenges in using the cmRCT design were the high crossover to the control group and the lower questionnaire response rate among patients who refused the offer of treatment. However, the design did help facilitate efficient and complete recruitment of the trial population as well as analysable data that were generalisable to the population of interest. Attrition rates were also smaller than those reported in other depression trials. CONCLUSION: This first completed full trial using the cmRCT design testing an intervention for self-reported depression was associated with a number of important benefits. Further research is required to compare the acceptability and cost effectiveness of standard pragmatic RCT design with the cmRCT design. TRIAL REGISTRATION: ISRCTN registry: ISRCTN02484593 . Registered on 7 Jan 2013.


Assuntos
Depressão/terapia , Projetos de Pesquisa , Protocolos Clínicos , Análise Custo-Benefício , Estudos Cross-Over , Depressão/diagnóstico , Depressão/economia , Depressão/psicologia , Inglaterra , Custos de Cuidados de Saúde , Humanos , Análise de Intenção de Tratamento , Pacientes Desistentes do Tratamento , Seleção de Pacientes , Índice de Gravidade de Doença , Resultado do Tratamento
12.
Trials ; 18(1): 299, 2017 06 30.
Artigo em Inglês | MEDLINE | ID: mdl-28666463

RESUMO

BACKGROUND: Despite controversy regarding homeopathy, some patients consult homeopaths for depression. Evidence is required to determine whether this is an effective, acceptable and safe intervention for these patients. METHODS: A pragmatic trial using the "cohort multiple randomised controlled trial" design was used to test the effectiveness of adjunctive treatment by homeopaths compared to usual care alone, over a period of 12 months in patients with self-reported depression. One third of patients were randomly selected for an offer of treatment provided by a homeopath. The primary outcome measure was the Patient Health Questionnaire (PHQ-9) at 6 months. Secondary outcomes included depression scores at 12 months; and the Generalised Anxiety Disorder (GAD-7) outcome at 6 and 12 months. RESULTS: The trial over-recruited by 17% with a total of 566 patients. Forty percent took up the offer and received treatment. An intention-to-treat analysis of the offer group at 6 months reported a 1.4-point lower mean depression score than the no offer group (95% CI 0.2, 2.5, p = 0.019), with a small standardized treatment effect size (d = 0.30). Using instrumental variables analysis, a moderate treatment effect size in favour of those treated was found (d = 0.57) with a between group difference of 2.6 points (95% CI 0.5, 4.7, p = 0.018). Results were maintained at 12 months. Secondary analyses showed similar results. Similar results were found for anxiety (GAD-7). No evidence suggested any important risk involved with the intervention. CONCLUSION: This trial provides preliminary support for both the acceptability and the effectiveness of treatment by a homeopath for patients with self-reported depression. Our results provide support for further pragmatic research to provide more precise estimates of treatment effect. TRIAL REGISTRATION: ISRCTN registry, ISRCTN02484593 . Registered on 7 January 2013.


Assuntos
Depressão/terapia , Homeopatia/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Protocolos Clínicos , Depressão/diagnóstico , Depressão/psicologia , Inglaterra , Feminino , Homeopatia/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Questionário de Saúde do Paciente , Dados Preliminares , Escalas de Graduação Psiquiátrica , Projetos de Pesquisa , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
13.
Health Technol Assess ; 21(13): 1-218, 2017 03.
Artigo em Inglês | MEDLINE | ID: mdl-28397649

RESUMO

BACKGROUND: Emergency calls are frequently made to ambulance services for older people who have fallen, but ambulance crews often leave patients at the scene without any ongoing care. We evaluated a new clinical protocol which allowed paramedics to assess older people who had fallen and, if appropriate, refer them to community-based falls services. OBJECTIVES: To compare outcomes, processes and costs of care between intervention and control groups; and to understand factors which facilitate or hinder use. DESIGN: Cluster randomised controlled trial. PARTICIPANTS: Participating paramedics at three ambulance services in England and Wales were based at stations randomised to intervention or control arms. Participants were aged 65 years and over, attended by a study paramedic for a fall-related emergency service call, and resident in the trial catchment areas. INTERVENTIONS: Intervention paramedics received a clinical protocol with referral pathway, training and support to change practice. Control paramedics continued practice as normal. OUTCOMES: The primary outcome comprised subsequent emergency health-care contacts (emergency admissions, emergency department attendances, emergency service calls) or death at 1 month and 6 months. Secondary outcomes included pathway of care, ambulance service operational indicators, self-reported outcomes and costs of care. Those assessing outcomes remained blinded to group allocation. RESULTS: Across sites, 3073 eligible patients attended by 105 paramedics from 14 ambulance stations were randomly allocated to the intervention group, and 2841 eligible patients attended by 110 paramedics from 11 stations were randomly allocated to the control group. After excluding dissenting and unmatched patients, 2391 intervention group patients and 2264 control group patients were included in primary outcome analyses. We did not find an effect on our overall primary outcome at 1 month or 6 months. However, further emergency service calls were reduced at both 1 month and 6 months; a smaller proportion of patients had made further emergency service calls at 1 month (18.5% vs. 21.8%) and the rate per patient-day at risk at 6 months was lower in the intervention group (0.013 vs. 0.017). Rate of conveyance to emergency department at index incident was similar between groups. Eight per cent of trial eligible patients in the intervention arm were referred to falls services by attending paramedics, compared with 1% in the control arm. The proportion of patients left at scene without further care was lower in the intervention group than in the control group (22.6% vs. 30.3%). We found no differences in duration of episode of care or job cycle. No adverse events were reported. Mean cost of the intervention was £17.30 per patient. There were no significant differences in mean resource utilisation, utilities at 1 month or 6 months or quality-adjusted life-years. In total, 58 patients, 25 paramedics and 31 stakeholders participated in focus groups or interviews. Patients were very satisfied with assessments carried out by paramedics. Paramedics reported that the intervention had increased their confidence to leave patients at home, but barriers to referral included patients' social situations and autonomy. CONCLUSIONS: Findings indicate that this new pathway may be introduced by ambulance services at modest cost, without risk of harm and with some reductions in further emergency calls. However, we did not find evidence of improved health outcomes or reductions in overall NHS emergency workload. Further research is necessary to understand issues in implementation, the costs and benefits of e-trials and the performance of the modified Falls Efficacy Scale. TRIAL REGISTRATION: Current Controlled Trials ISRCTN60481756 and PROSPERO CRD42013006418. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 13. See the NIHR Journals Library website for further project information.


Assuntos
Acidentes por Quedas/prevenção & controle , Pessoal Técnico de Saúde/organização & administração , Protocolos Clínicos , Encaminhamento e Consulta/organização & administração , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Pessoal Técnico de Saúde/economia , Pessoal Técnico de Saúde/normas , Ambulâncias , Análise Custo-Benefício , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Nível de Saúde , Humanos , Masculino , Saúde Mental , Satisfação do Paciente , Qualidade de Vida , Encaminhamento e Consulta/economia , Autoeficácia , Fatores Sexuais , Medicina Estatal/economia , Reino Unido
14.
Ann Emerg Med ; 70(4): 495-505.e28, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28302422

RESUMO

STUDY OBJECTIVE: We aim to determine clinical and cost-effectiveness of a paramedic protocol for the care of older people who fall. METHODS: We undertook a cluster randomized trial in 3 UK ambulance services between March 2011 and June 2012. We included patients aged 65 years or older after an emergency call for a fall, attended by paramedics based at trial stations. Intervention paramedics could refer the patient to a community-based falls service instead of transporting the patient to the emergency department. Control paramedics provided care as usual. The primary outcome was subsequent emergency contacts or death. RESULTS: One hundred five paramedics based at 14 intervention stations attended 3,073 eligible patients; 110 paramedics based at 11 control stations attended 2,841 eligible patients. We analyzed primary outcomes for 2,391 intervention and 2,264 control patients. One third of patients made further emergency contacts or died within 1 month, and two thirds within 6 months, with no difference between groups. Subsequent 999 call rates within 6 months were lower in the intervention arm (0.0125 versus 0.0172; adjusted difference -0.0045; 95% confidence interval -0.0073 to -0.0017). Intervention paramedics referred 8% of patients (204/2,420) to falls services and left fewer patients at the scene without any ongoing care. Intervention patients reported higher satisfaction with interpersonal aspects of care. There were no other differences between groups. Mean intervention cost was $23 per patient, with no difference in overall resource use between groups at 1 or 6 months. CONCLUSION: A clinical protocol for paramedics reduced emergency ambulance calls for patients attended for a fall safely and at modest cost.


Assuntos
Acidentes por Quedas , Auxiliares de Emergência , Avaliação Geriátrica/estatística & dados numéricos , Encaminhamento e Consulta/estatística & dados numéricos , Idoso de 80 Anos ou mais , Protocolos Clínicos , Análise por Conglomerados , Redes Comunitárias , Análise Custo-Benefício , Serviços Médicos de Emergência , Feminino , Humanos , Masculino , Reino Unido
16.
BMJ ; 353: i2647, 2016 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-27252245

RESUMO

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. PARTICIPANTS:  Between 3 December 2012 and 23 July 2013 we recruited 641 adults aged 40 to 74 years with a 10 year cardiovascular disease risk of 20% or more, no previous cardiovascular event, at least one modifiable risk factor (systolic blood pressure ≥140 mm Hg, body mass index ≥30, current smoker), and access to a telephone, the internet, and email. Participants were individually allocated to intervention (n=325) or control (n=316) groups using automated randomisation stratified by site, minimised by practice and baseline risk score. INTERVENTIONS:  Intervention was the Healthlines service (alongside usual care), comprising regular telephone calls from trained lay health advisors following scripts generated by interactive software. Advisors facilitated self management by supporting participants to use online resources to reduce risk factors, and sought to optimise drug use, improve treatment adherence, and encourage healthier lifestyles. The control group comprised usual care alone. MAIN OUTCOME MEASURES:  The primary outcome was the proportion of participants responding to treatment, defined as maintaining or reducing their cardiovascular risk after 12 months. Outcomes were collected six and 12 months after randomisation and analysed masked. Participants were not masked. RESULTS:  50% (148/295) of participants in the intervention group responded to treatment compared with 43% (124/291) in the control group (adjusted odds ratio 1.3, 95% confidence interval 1.0 to 1.9; number needed to treat=13); a difference possibly due to chance (P=0.08). The intervention was associated with reductions in blood pressure (difference in mean systolic -2.7 mm Hg (95% confidence interval -4.7 to -0.6 mm Hg), mean diastolic -2.8 (-4.0 to -1.6 mm Hg); weight -1.0 kg (-1.8 to -0.3 kg), and body mass index -0.4 ( -0.6 to -0.1) but not cholesterol -0.1 (-0.2 to 0.0), smoking status (adjusted odds ratio 0.4, 0.2 to 1.0), or overall cardiovascular risk as a continuous measure (-0.4, -1.2 to 0.3)). The intervention was associated with improvements in diet, physical activity, drug adherence, and satisfaction with access to care, treatment received, and care coordination. One serious related adverse event occurred, when a participant was admitted to hospital with low blood pressure. CONCLUSIONS:  This evidence based telehealth approach was associated with small clinical benefits for a minority of people with high cardiovascular risk, and there was no overall improvement in average risk. The Healthlines service was, however, associated with improvements in some risk behaviours, and in perceptions of support and access to care.Trial registration Current Controlled Trials ISRCTN 27508731.


Assuntos
Doenças Cardiovasculares/prevenção & controle , Atenção Primária à Saúde/métodos , Comportamento de Redução do Risco , Telemedicina/métodos , Adulto , Idoso , Pressão Sanguínea , Doenças Cardiovasculares/diagnóstico , Inglaterra/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Pesquisa Qualitativa , Projetos de Pesquisa , Fatores de Risco , Design de Software , Telemedicina/economia
17.
Lancet Psychiatry ; 3(6): 515-25, 2016 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-27132075

RESUMO

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. We aimed to compare the Healthlines Depression Service plus usual care with usual care alone. METHODS: This study was a pragmatic, multicentre, randomised controlled trial with participants recruited from 43 general practices in three areas of England. To be eligible, participants needed to have access to the internet and email, a Patient Health Questionnaire 9 (PHQ-9) score of at least 10, and a confirmed diagnosis of depression. Participants were individually assigned (1:1) to either the Healthlines Depression Service plus usual care or usual care alone. Random assignment was done by use of a web-based automated randomisation system, stratified by site and minimised by practice and PHQ-9 score. Participants were aware of their allocation, but outcomes were analysed masked. The Healthlines Service consisted of regular telephone calls from non-clinical, trained health advisers who followed standardised scripts generated by interactive software. After an initial assessment and goal-setting telephone call, the advisers called each participant on six occasions over 4 months, and then made up to three more calls at intervals of roughly 2 months to provide reinforcement and to detect relapse. Advisers supported participants in the use of online resources (including computerised cognitive behavioural therapy) and sought to encourage healthier lifestyles, optimise medication, and improve treatment adherence. The primary outcome was the proportion of participants responding to the intervention (defined as PHQ-9 <10 and reduction in PHQ-9 of ≥5 points) at 4 months after randomisation. The primary analysis was based on the intention-to-treat principle without imputation and all serious adverse events were investigated. This trial is registered with Current Controlled Trials, number ISRCTN 14172341. FINDINGS: Between July 24, 2012, and July 31, 2013, we recruited 609 participants, randomly assigning 307 to the Healthlines Service plus usual care and 302 to usual care. Primary outcome data were available for 525 (86%) participants. At 4 months, 68 (27%) of 255 individuals in the intervention group had a treatment response compared with 50 (19%) of 270 individuals in the usual care group (adjusted odds ratio 1·7, 95% CI 1·1-2·5, p=0·019). Compared with usual care alone, intervention participants reported improvements in anxiety, better access to support and advice, greater satisfaction with the support they received, and improvements in self-management and health literacy. During the trial, 70 adverse events were reported by participants, one of which was related to the intervention (increased anxiety from discussing depression) and was not serious. INTERPRETATION: This telehealth service based on non-clinically trained health advisers supporting patients in use of internet resources was both acceptable and effective compared with usual care. Our results provide support for the development and assessment of similar interventions in other chronic disorders to expand care provision. FUNDING: National Institute for Health Research (NIHR).


Assuntos
Prestação Integrada de Cuidados de Saúde , Depressão/terapia , Serviços de Saúde Mental/organização & administração , Telemedicina/organização & administração , Adulto , Inglaterra , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
18.
J Health Serv Res Policy ; 21(1): 51-60, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25990712

RESUMO

OBJECTIVES: To assess the clinical effectiveness, in acute ischaemic stroke patients, of bypassing non-specialist centres in preference for a specialist stroke centre to receive the time-critical intervention of thrombolysis. METHODS: Systematic review and meta-analysis using: MEDLINE; MEDLINE In-Process; EMBASE; CINAHL; Cochrane Library including Cochrane Database of Systematic Reviews, Cochrane CENTRAL Controlled Trials Register, DARE, NHS EED and HTA databases. Studies were included if they compared acute ischaemic stroke patients directly triaged to a specialist centre versus those initially triaged to a non-specialist centre with some or all later transferred to a specialist centre. Studies were excluded if they compared patients ever treated in a specialist centre versus those never treated in such a centre, since the aim was to assess the optimum initial triage route rather than the optimum location for overall management. The assumption being, based on previous research, that management in a specialist centre leads to better patient outcomes. RESULTS: Fourteen studies investigating 2790 patients were identified. Studies comparing commencement of thrombolysis in non-specialist centres versus the specialist centres (n=1394) showed no significant difference in unadjusted mortality (OR = 0.89; 95% CI = 0.61-1.30) or morbidity (favourable modified Rankin Score, n = 899) (OR = 1.16; 95% CI = 0.85-1.59) among thrombolysed patients. In studies where thrombolysis could only be administered in a specialist centre, data for patients arriving within the therapeutic window (n = 140) revealed significantly higher mortality for those initially admitted to a non-specialist centre compared to directly admitted to a specialist centre (OR = 6.62; 95% CI = 2.60-16.82); morbidity data also favoured direct admission to a specialist centre, although not consistently. CONCLUSIONS: For ischaemic stroke patients, the location of initial thrombolysis treatment does not affect outcomes. However, if thrombolysis is only available at a specialist centre, outcomes are considerably better for those patients admitted directly. However, these conclusions are based on poor quality data with small sample populations, significant heterogeneity and subject to confounding.

19.
J Health Serv Res Policy ; 21(1): 5-14, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26248621

RESUMO

OBJECTIVE: To identify factors affecting variation in avoidable emergency admissions that are not usually identified in statistical regression. METHODS: As part of an ethnographic residual analysis, we compared six emergency and urgent care systems in England, interviewing 82 commissioners and providers of key emergency and urgent care services. RESULTS: There was variation between the six cases in how interviewees described three parts of their emergency and urgent care systems. First, interviewees' descriptions revealed variation in the availability of services before patients decided to attend emergency departments. Poor availability of general practice out of hours services in some of the cases reportedly made attendance at emergency departments the easier option for patients. Second, there was variation in how interviewees described patients being dealt with during their emergency department visit in terms of availability of senior review by specialists and in coding practices when patients were at risk of breaching the NHS's 4-hour waiting time target. Third, there was variability in services described as facilitating discharge home from emergency departments. In some cases, emergency department staff described dealing with multiple agencies in multiple localities outside the hospital, making admission the easier option. In other cases, proactive multidisciplinary rapid assessment teams were described as available to avoid admissions. Perceptions of resources available out of hours and the extent of integration between different health services, and between health and social services, also differed by case. CONCLUSIONS: This comparative case study approach identified further factors that may affect avoidable emergency admissions. Initiatives to improve GP out of hours services, make coding more accurately reflect patient experience, increase senior review in emergency departments, offer proactive multidisciplinary admission avoidance teams, improve the availability of out of hours care in the wider emergency and urgent care system, and increase service integration may reduce avoidable admissions. Evaluation of such initiatives would be necessary before wide-scale adoption.

20.
Trials ; 16: 392, 2015 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-26337522

RESUMO

Until recently, insufficient attention has been paid to the fact that surgical interventions are complex. This complexity has several implications, including the way in which surgical interventions are described and delivered in trials. In order for surgeons to adopt trial findings, interventions need to be described in sufficient detail to enable accurate replication; however, it may be permissible to allow some aspects to be delivered according to local practice. Accumulating work in this area has identified the need for general guidance on the design of surgical interventions in trial protocols and reports. Key issues to consider when designing surgical interventions include the identification of each surgical intervention and their components, who will deliver the interventions, and where and how the interventions will be standardised and monitored during the trial. The trial design (pragmatic and explanatory), comparator and stage of innovation may also influence the extent of detail required. Thoughtful consideration of surgical interventions in this way may help with the interpretation of trial results and the adoption of successful interventions into clinical practice.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa , Procedimentos Cirúrgicos Operatórios , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa/normas , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Procedimentos Cirúrgicos Operatórios/normas , Resultado do Tratamento
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