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.
Objective To evaluate clinical effectiveness of a self management programme for arthritis in patients in primary care with osteoarthritis. Design Randomised controlled trial. Setting 74 general practices in the United Kingdom. Participants 812 patients aged 50 and over with osteoarthritis of hips or knees (or both) and pain or disability (or both). Intervention Participants were randomised to six sessions of self management of arthritis and an education booklet (intervention group) or the education booklet alone (control group). Main outcome measures Primary outcome was quality of life, as assessed by the short form health survey (SF-36). Several other physical and psychosocial secondary outcomes were assessed. Data were collected at baseline, four months, and 12 months. Results Response rates were 80% and 76% at four and 12 months. The two groups showed significant differences at 12 months on the anxiety subscore of the hospital anxiety and depression scale (mean difference − 0.62, 95% confidence interval − 1.08 to − 0.16), arthritis self efficacy scale for pain (0.98, 0.07 to 1.89), and self efficacy for other aspects of management (1.58, 0.25 to 2.90). Results were similar for intention to treat and per protocol analyses. No significant difference was seen in number of visits to the general practitioner at 12 months. Conclusions The self management of arthritis programme reduced anxiety and improved participants' perceived self efficacy to manage symptoms, but it had no significant effect on pain, physical functioning, or contact with primary care. Trial registration Current Controlled Trials ISRCTN79115352.
Executive Summary BackgroundThis Commission addresses several priority areas for psychiatry over the next decade, and into the 21st century. These represent challenges and opportunities for the profession to sustain and develop itself to secure the best possible future for the millions of people worldwide who will face life with mental illness. Part 1: The patient and treatmentWho will psychiatrists help? The patient population of the future will reflect general demographic shifts towards older, more urban, and migrant populations. While technical advances such as the development of biomarkers will potentially alter diagnosis and treatment, and digital tech-nology will facilitate assessment of remote populations, the human elements of practice such as cultural sensitivity and the ability to form a strong therapeutic alliance with the patient will remain central. Part 2: Psychiatry and health-care systemsDelivering mental health services to those who need them will require reform of the traditional structure of services. Few existing models have evidence of clinical effectiveness and acceptability to service users. Services of the future should consider stepped care, increased use of multidisciplinary teamwork, more of a public health approach, and the integration of mental and physical health care. These services will need to fit into the cultural and economic framework of a diverse range of settings in high-income, low-income, and middle-income countries. Part 3: Psychiatry and societyIncreased emphasis on social interventions and engagement with societal expectations might be an important a ea fo ps hiat s de elop e t. This ould e o pass ad o a fo the ights of individuals living with mental illnesses, political involvement concerning the social risk factors for mental illness, and, on a smaller scale, work with families and local social networks and communities. Psychiatrists should therefore possess communication skills and knowledge of the social sciences as well as the basic biological sciences. Part 4: The future of mental health lawMental health law worldwide tends to be based on concerns about risk rather than the protection of the rights of individuals experiencing mental illness. The United Nations Convention on the Rights of Persons with Disabilities, which states that compulsion based in whole or in part on mental disability is discriminatory, is a landmark document that should inform the future formulation and reform of mental health laws. An evidence-based approach needs to be taken: mental health legislation should mandate mental health training for all health professionals; ensure access to good-quality care; and cover wider societal issues, particularly access to housing, resources, and employment. All governments should include a mental health impact assessment when drafting relevant legislation. Part 5: Digital psychiatry-enhancing the future of mental healthDigital technology might offer psychiatry the potential for radical change in terms of service delivery and the development of new treatm...
Cognitive remediation therapy is associated with durable improvements in memory, which in turn are associated with social functioning improvements in people with severe mental illness.
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