Aims. To examine frontline staff acceptance of telehealth and identify barriers to and enablers of successful adoption of remote monitoring for patients with Chronic Obstructive Pulmonary Disease and Chronic Heart Failure. Background. The use of telehealth in the UK has not developed at the pace and scale anticipated by policy. Many existing studies report frontline staff acceptance as a key barrier, however data are limited and there is little evidence of the adoption of telehealth in routine practice. Design. Case studies of four community health services in England that use telehealth to monitor patients with Chronic Obstructive Pulmonary Disease and Chronic Heart Failure. Methods. Thematic analysis of qualitative interviews with 84 nursing and other frontline staff; and 21 managers and key stakeholders; data collected May 2012-June 2013. Findings. Staff attitudes ranged from resistance to enthusiasm, with varied opinions about the motives for investing in telehealth and the potential impact on nursing roles. Having reliable and flexible technology and dedicated resources for telehealth work were identified as essential in helping to overcome early barriers to acceptance, along with appropriate staff training and a partnership approach to implementation. Early successes were also important, encouraging staff to use telehealth and facilitating clinical learning and increased adoption. Conclusions. The mainstreaming of telehealth hinges on clinical 'buy-in'. Where barriers to successful implementation exist, clinicians can lose faith in using technology to perform tasks traditionally delivered in person. Addressing barriers is therefore crucial if clinicians are to adopt telehealth into routine practice.

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.

Users generally describe home telehealth in positive terms; however, patients still value face-to-face contact with health care professionals. The positive aspects of home telehealth, such as better access to health care and providing peace of mind, could be communicated to prospective users to improve uptake. Similarly, sustained use of telehealth is likely to be ensured if occasional visits from health care professionals are maintained.

BackgroundAdoption of telehealth has been slower than anticipated, and little is known about the service improvements that help to embed telehealth into routine practice or the role of frontline staff in improving adoption. This paper reports on participatory action research carried out in four community health settings using telehealth for patients with Chronic Obstructive Pulmonary Disease and Chronic Heart Failure.MethodsTo inform the action research, in-depth case studies of each telehealth service were conducted (May 2012–June 2013). Each service was then supported by researchers through two cycles of action research to implement changes to increase adoption of telehealth, completed over a seven month period (July 2013–April 2014). The action research was studied via observation of multi-stakeholder workshops, analysis of implementation plans, and focus groups.ResultsAction research participants included 57 staff and one patient, with between eight and 20 participants per site. The case study findings were identified as a key source of information for planning change, with sites addressing common challenges identified through this work. For example, refining referral criteria; standardizing how and when patients are monitored; improving data sharing; and establishing evaluation processes. Sites also focused on raising awareness of telehealth to increase adoption in other clinical teams and to help secure future financial investment for telehealth, which was required because of short-term funding arrangements. Specific solutions varied due to local infrastructures, resources, and opinion, as well as previous service developments. Local telehealth champions played an important role in engaging multiple stakeholders in the study.ConclusionsAction research enabled services to make planned changes to telehealth and share learning across multiple stakeholders about how and when to use telehealth. However, adoption was impeded by continual changes affecting telehealth and wider service provision, which also hindered implementation efforts and affected motivation of staff to engage with the action research, particularly where local decision-makers were not engaged in the study. Wider technological barriers also limited the potential for change, as did uncertainties about goals for telehealth investment, thereby making it difficult to identify outcomes for demonstrating the added value over existing practice.

BackgroundAdequate 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.MethodsWe developed the guideline in seven overlapping stages:Building on prior research to inform the need for a guideline;A scoping literature review to inform future stages;Drafting the first checklist version involving an External Expert Panel;A two-round Delphi process involving international, multidisciplinary, and cross-sector key stakeholders;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;Refining and finalising the checklist; andWriting-up and dissemination of the E&E document.The CONSORT Executive Group oversaw the entire development process.ResultsDelphi 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.ConclusionsWe 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.Electronic supplementary materialThe online version of this article (10.1186/s12916-018-1196-2) contains supplementary material, which is available to authorized users.

Background There is currently insufficient evidence for the clinical effectiveness and cost-effectiveness of psychological therapies for post-stroke depression. Objective To evaluate the feasibility of undertaking a definitive trial to evaluate the clinical effectiveness and cost-effectiveness of behavioural activation (BA) compared with usual stroke care for treating post-stroke depression. Design Parallel-group, feasibility, multicentre, randomised controlled trial with nested qualitative research and a health economic evaluation. Setting Acute and community stroke services in three sites in England. Participants Community-dwelling adults 3 months to 5 years post stroke who are depressed, as determined by the Patient Health Questionnaire-9 (PHQ-9) or the Visual Analogue Mood Scales ‘Sad’ item. Exclusions: patients who are blind and/or deaf, have dementia, are unable to communicate in English, do not have mental capacity to consent, are receiving treatment for depression at the time of stroke onset or are currently receiving psychological intervention. Randomisation and blinding Participants were randomised (1 : 1 ratio) to BA or usual stroke care. Randomisation was conducted using a computer-generated list with random permuted blocks of varying sizes, stratified by site. Participants and therapists were aware of the allocation, but outcome assessors were blind. Interventions The intervention arm received up to 15 sessions of BA over 4 months. BA aims to improve mood by increasing people’s level of enjoyable or valued activities. The control arm received usual care only. Main outcome measures Primary feasibility outcomes concerned feasibility of recruitment to the main trial, acceptability of research procedures and measures, appropriateness of baseline and outcome measures, retention of participants and potential value of conducting the definitive trial. Secondary feasibility outcomes concerned the delivery of the intervention. The primary clinical outcome 6 months post randomisation was the PHQ-9. Secondary clinical outcomes were Stroke Aphasic Depression Questionnaire – Hospital version, Nottingham Leisure Questionnaire, Nottingham Extended Activities of Daily Living, Carer Strain Index, EuroQol-5 Dimensions, five-level version and health-care resource use questionnaire. Results Forty-eight participants were recruited in 27 centre-months of recruitment, at a recruitment rate of 1.8 participants per centre per month. The 25 participants randomised to receive BA attended a mean of 8.5 therapy sessions [standard deviation (SD) 4.4 therapy sessions]; 23 participants were allocated to usual care. Outcome assessments were completed by 39 (81%) participants (BA, n = 18; usual care, n = 21). Mean PHQ-9 scores at 6-month follow-up were 10.1 points (SD 6.9 points) and 14.4 points (SD 5.1 points) in the BA and control groups, respectively, a difference of –3.8 (95% confidence interval –6.9 to –0.6) after adjusting for baseline PHQ-9 score and centre, representing a reduction in depression in the BA arm. Therapy was delivered as intended. BA was acceptable to participants, carers and therapists. Value-of-information analysis indicates that the benefits of conducting a definitive trial would be likely to outweigh the costs. It is estimated that a sample size of between 580 and 623 participants would be needed for a definitive trial. Limitations Target recruitment was not achieved, although we identified methods to improve recruitment. Conclusions The Behavioural Activation Therapy for Depression after Stroke trial was feasible with regard to the majority of outcomes. The outstanding issue is whether or not a sufficient number of participants could be recruited within a reasonable time frame for a definitive trial. Future work is required to identify whether or not there are sufficient sites that are able to deliver the services required for a definitive trial. Trial registration Current Controlled Trials ISRCTN12715175. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 47. See the NIHR Journals Library website for further project information.

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

Background Knowledge mobilisation is a term used in healthcare research to describe the process of generating, sharing and using evidence. ‘Co’approaches, such as co-production, co-design and co-creation, have been proposed as a way of overcoming the knowledge to practice gap. There is a need to understand why researchers choose to adopt these approaches, how they achieve knowledge mobilisation in the management of health conditions, and the extent to which knowledge mobilisation is accomplished. Methods Studies that explicitly used the terms co-production, co-design or co-creation to mobilise knowledge in the management of health conditions were included. Web of Science, EMBASE via OvidSP, MEDLINE via OvidSP and CINHAL via EBSCO databases were searched up to April 2021. Quality assessment was carried out using the Joanna Briggs Institute qualitative quality assessment checklist. Pluye and Hong’s seven steps for mixed studies reviews were followed. Data were synthesised using thematic synthesis. Results Twenty four international studies were included. These were qualitative studies, case studies and study protocols. Key aspects of ‘co’approaches were bringing people together as active and equal partners, valuing all types of knowledge, using creative approaches to understand and solve problems, and using iterative prototyping techniques. Authors articulated mechanisms of action that included developing a shared understanding, identifying and meeting needs, giving everyone a voice and sense of ownership, and creating trust and confidence. They believed these mechanisms could produce interventions that were relevant and acceptable to stakeholders, more useable and more likely to be implemented in healthcare. Varied activities were used to promote these mechanisms such as interviews and creative workshops. There appeared to be a lack of robust evaluation of the interventions produced so little evidence in this review that ‘co’approaches improved the management of health conditions. Conclusion Those using ‘co’approaches believed that they could achieve knowledge mobilisation through a number of mechanisms, but there was no evidence that these led to improved health. The framework of key aspects and mechanisms of ‘co’approaches developed here may help researchers to meet the principles of these approaches. There is a need for robust evaluation to identify whether ‘co’approaches produce improved health outcomes. Trial Registration PROSPERO CRD42020187463.