Background: Most people with stroke in India have no access to organised

Recent reviews have demonstrated that the quality of stroke rehabilitation research has continued to improve over the last four decades but despite this progress, there are still many barriers in moving the field forward. Rigorous development, monitoring and complete reporting of interventions in stroke trials are essential in providing rehabilitation evidence that is robust, meaningful and implementable. An international partnership of stroke rehabilitation experts committed to develop consensus-based core recommendations with a remit of addressing the issues identified as limiting stroke rehabilitation research in the areas of developing, monitoring and reporting stroke rehabilitation interventions. Work exploring each of the three areas took place via multiple teleconferences and a two-day meeting in Philadelphia in May 2016. A total of 15 recommendations were made. To validate the need for the recommendations, the group reviewed all stroke rehabilitation trials published in 2015 (n ¼ 182 papers). Our review highlighted that the majority of publications did not clearly describe how interventions were developed or monitored during the trial. In particular, under-reporting of the theoretical rationale for the intervention and the components of the intervention call into question many interventions that have been evaluated for efficacy. More trials were found to have addressed the reporting of interventions recommendations than those related to development or monitoring. Nonetheless, the majority of reporting recommendations were still not adequately described. To progress the field of stroke rehabilitation research and to ensure stroke patients receive optimal evidence-based clinical care, we urge the research community to endorse and adopt our recommendations.

No abstract

Background and purpose: The aim of this pilot study was to determine the feasibility of a

IntroductionWe are undertaking a randomised controlled trial (fAmily led rehabiliTaTion aftEr stroke in INDia, ATTEND) evaluating training a family carer to enable maximal rehabilitation of patients with stroke-related disability; as a potentially affordable, culturally acceptable and effective intervention for use in India. A process evaluation is needed to understand how and why this complex intervention may be effective, and to capture important barriers and facilitators to its implementation. We describe the protocol for our process evaluation to encourage the development of in-process evaluation methodology and transparency in reporting.Methods and analysisThe realist and RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) frameworks informed the design. Mixed methods include semistructured interviews with health providers, patients and their carers, analysis of quantitative process data describing fidelity and dose of intervention, observations of trial set up and implementation, and the analysis of the cost data from the patients and their families perspective and programme budgets. These qualitative and quantitative data will be analysed iteratively prior to knowing the quantitative outcomes of the trial, and then triangulated with the results from the primary outcome evaluation.Ethics and disseminationThe process evaluation has received ethical approval for all sites in India. In low-income and middle-income countries, the available human capital can form an approach to reducing the evidence practice gap, compared with the high cost alternatives available in established market economies. This process evaluation will provide insights into how such a programme can be implemented in practice and brought to scale. Through local stakeholder engagement and dissemination of findings globally we hope to build on patient-centred, cost-effective and sustainable models of stroke rehabilitation.Trial registration numberCTRI/2013/04/003557.

BackgroundGlobally, most strokes occur in low- and middle-income countries, such as India, with many affected people having no or limited access to rehabilitation services. Western models of stroke rehabilitation are often unaffordable in many populations but evidence from systematic reviews of stroke unit care and early supported discharge rehabilitation trials suggest that some components might form the basis of affordable interventions in low-resource settings. We describe the background, history and design of the ATTEND trial, a complex intervention centred on family-led stroke rehabilitation in India.Methods/designThe ATTEND trial aims to test the hypothesis that a family-led caregiver-delivered home-based rehabilitation intervention, designed for the Indian context, will reduce the composite poor outcome of death or dependency at 6 months after stroke, in a multicentre, individually randomized controlled trial with blinded outcome assessment, involving 1200 patients across 14 hospital sites in India.DiscussionThe ATTEND trial is testing the effectiveness of a low-cost rehabilitation intervention that could be widely generalizable to other low- and middle-income countries.Trial registrationClinical Trials Registry-India CTRI/2013/04/003557. Australian New Zealand Clinical Trials Registry ACTRN12613000078752. Universal Trial Number U1111-1138-6707.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-1129-8) contains supplementary material, which is available to authorized users.

Background: Training family carers to provide evidence-based rehabilitation to stroke patients could address the recognized deficiency of access to stroke rehabilitation in low-resource settings. However, our randomized controlled trial in India (ATTEND) found that this model of care was not superior to usual care alone. Aims: This process evaluation aimed to better understand trial outcomes through assessing trial implementation and exploring patients', carers', and providers' perspectives. Methods: Our mixed methods study included process, healthcare use data and patient demographics from all sites; observations and semi-structured interviews with participants (22 patients, 22 carers, and 28 health providers) from six sampled sites. Results: Intervention fidelity and adherence to the trial protocol was high across the 14 sites; however, early supported discharge (an intervention component) was not implemented. Within both randomized groups, some form of rehabilitation was widely accessed. ATTEND stroke coordinators provided counseling and perceived that sustaining patients' motivation to continue with rehabilitation in the face of significant emotional and financial stress as a key challenge. The intervention was perceived as an acceptable community-based package with education as an important component in raising the poor awareness of stroke. Many participants viewed family-led rehabilitation as a necessary model of care for poor and rural populations who could not access rehabilitation. Conclusion: Difficulty in sustaining patient and carer motivation for rehabilitation without ongoing support, and greater than anticipated access to routine rehabilitation may explain the lack of benefit in the trial. Nonetheless, family-led rehabilitation was seen as a concept worthy of further development.

Introduction: Instrumental activities of daily living (IADLs) are complex daily tasks important for independent living. Many older adults experience difficulty with IADLs as their physical and/or cognitive function begins to decline. However, it is unknown in what order IADLs become difficult. Methods: Participants from the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) study who were free of IADL difficulty at baseline (N = 1,277) were followed up to 10 years until first reported IADL difficulty. A total of 19 IADL tasks were grouped into seven task categories. A discrete-time multiple-event process survival mixture model (MEPSUM) was used to generate hazard estimates of incident IADL difficulty in seven groups from ages 65 to 80. Hazard estimates were compared in the three intervention groups (memory, inductive reasoning, and speed of information processing) vs. the no-contact control group. Results: A total of 887 (69.5%) participants reported incident difficulty in at least one IADL task category. Compared to individuals who remained free of IADL difficulty, those who reported incident difficulty were more likely to be older, female, and have lower Short Form 36 general health scores. The IADL task categories to first become difficult were housework, managing health care, and phone use. There were no differences by intervention group in the hazard estimates of incident IADL difficulty. Conclusion: Managing health care and phone use are more cognitively demanding IADLs, and individuals who experience difficulty in these tasks first may be more likely to experience cognitive decline. Recognizing early difficulty in managing health care may allow for implementation of compensation strategies to minimize unintentional medication Feger et al. First IADL Difficulty in Elderly misuse, increased adverse medical events, and unnecessary hospitalization. Training of a specific cognitive domain may not influence ordering of IADL difficulty because IADL tasks require proficiency in, and integration of, multiple cognitive domains.