Implementation studies are often poorly reported and indexed, reducing their potential to inform initiatives to improve healthcare services. The Standards for Reporting Implementation Studies (StaRI) initiative aimed to develop guidelines for transparent and accurate reporting of implementation studies. Informed by the findings of a systematic review and a consensus-building e-Delphi exercise, an international working group of implementation science experts discussed and agreed the StaRI Checklist comprising 27 items. It prompts researchers to describe both the implementation strategy (techniques used to promote implementation of an underused evidence-based intervention) and the effectiveness of the intervention that was being implemented. An accompanying Explanation and Elaboration document (published in BMJ Open, doi:10.1136/bmjopen-2016-013318) details each of the items, explains the rationale, and provides examples of good reporting practice. Adoption of StaRI will improve the reporting of implementation studies, potentially facilitating translation of research into practice and improving the health of individuals and populations.
Background Informal care givers support disabled stroke patients at home but receive little training for the caregiving role. Objective To evaluate the effectiveness of training care givers in reducing burden of stroke in patients and their care givers. Design A single, blind, randomised controlled trial. Setting Stroke rehabilitation unit. Subjects 300 stroke patients and their care givers. Interventions Training care givers in basic nursing and facilitation of personal care techniques. Main outcome measures Cost to health and social services, caregiving burden, patients' and care givers' functional status (Barthel index, Frenchay activities index), psychological state (hospital anxiety and depression score), quality of life (EuroQol visual analogue scale) and patients' institutionalisation or mortality at one year. Results Patients were comparable for age (median 76 years; interquartile range 70-82 years), sex (53% men), and severity of stroke (median Barthel index 8; interquartile range 4-12). The costs of care over one year for patients whose care givers had received training were significantly lower (£10 133 v £13 794 ($18 087 v $24 619; €15 204 v €20 697); P = 0.001). Trained care givers experienced less caregiving burden (care giver burden score 32 v 41; P = 0.0001), anxiety (anxiety score 3 v 4; P = 0.0001) or depression (depression score 2 v 3; P = 0.0001) and had a higher quality of life (EuroQol score 80 v 70; P = 0.001). Patients' mortality, institutionalisation, and disability were not influenced by caregiver training. However, patients reported less anxiety (3 v 4.5; P < 0.0001) and depression (3 v 4; P < 0.0001) and better quality of life (65 v 60; P = 0.009) in the caregiver training group. Conclusion Training care givers during patients' rehabilitation reduced costs and caregiver burden while improving psychosocial outcomes in care givers and patients at one year.
Objective. Chronic knee pain is a major cause of disability and health care expenditure, but there are concerns about efficacy, cost, and side effects associated with usual primary care. Conservative rehabilitation may offer a safe, effective, affordable alternative. We compared the effectiveness of a rehabilitation program integrating exercise, self-management, and active coping strategies (Enabling Self-management and Coping with Arthritic Knee Pain through Exercise [ESCAPEknee pain]) with usual primary care in improving functioning in persons with chronic knee pain. Methods. We conducted a single-blind, pragmatic, cluster randomized controlled trial. Participants age >50 years, reporting knee pain for >6 months, were recruited from 54 inner-city primary care practices. Primary care practices were randomized to continued usual primary care (i.e., whatever intervention a participant's primary care physician deemed appropriate), usual primary care plus the rehabilitation program delivered to individual participants, or usual primary care plus the rehabilitation program delivered to groups of 8 participants. The primary outcome was self-reported functioning (Western Ontario and McMaster Universities Osteoarthritis Index physical functioning [WOMAC-func]) 6 months after completing rehabilitation. Results. A total of 418 participants were recruited; 76 (18%) withdrew, only 5 (1%) due to adverse events. Rehabilitated participants had better functioning than participants continuing usual primary care (؊3.33 difference in WOMAC-func score; 95% confidence interval [95% CI] ؊5.88, ؊0.78; P ؍ 0.01). Improvements were similar whether participants received individual rehabilitation (؊3.53; 95% CI ؊6.52, ؊0.55) or group rehabilitation (؊3.16; 95% CI ؊6.55, ؊0.12). Conclusion. ESCAPE-knee pain provides a safe, relatively brief intervention for chronic knee pain that is equally effective whether delivered to individuals or groups of participants.
Objective. Chronic joint pain is a major cause of pain and disability. Exercise and self-management have short-term benefits, but few studies follow participants for more than 6 months. We investigated the long-term (up to 30 months) clinical and cost effectiveness of a rehabilitation program combining self-management and exercise: Enabling SelfManagement and Coping of Arthritic Knee Pain Through Exercise (ESCAPE-knee pain). Methods. In this pragmatic, cluster randomized, controlled trial, 418 people with chronic knee pain (recruited from 54 primary care surgeries) were randomized to usual care (pragmatic control) or the ESCAPE-knee pain program. The primary outcome was physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] function), with a clinically meaningful improvement in physical function defined as a >15% change from baseline. Secondary outcomes included pain, psychosocial and physiologic variables, costs, and cost effectiveness. Results. Compared to usual care, ESCAPE-knee pain participants had large initial improvements in function (mean difference in WOMAC function ؊5.5; 95% confidence interval [95% CI] ؊7.8, ؊3.2). These improvements declined over time, but 30 months after completing the program, ESCAPE-knee pain participants still had better physical function (difference in WOMAC function ؊2.8; 95% CI ؊5.3, ؊0.2); lower community-based health care costs (£؊47; 95% CI £؊94, £؊7), medication costs (£؊16; 95% CI £؊29, £؊3), and total health and social care costs (£؊1,118; 95% CI £؊2,566, £؊221); and a high probability (80 -100%) of being cost effective. Conclusion. Clinical and cost benefits of ESCAPE-knee pain were still evident 30 months after completing the program. ESCAPE-knee pain is a more effective and efficient model of care that could substantially improve the health, well-being, and independence of many people, while reducing health care costs.
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