Users' views on the use of a smartwatch app to collect daily symptom data in individuals with multiple long-term conditions (Multimorbidity): A qualitative study.

Introduction: Long-term conditions are a major burden on health systems. One way to facilitate more research and better clinical care among patients with long-term conditions is to collect accurate data on their daily symptoms (patient-generated health data) using wearable technologies. Whilst evidence is growing for the use of wearable technologies in single conditions, there is less evidence of the utility of frequent symptom tracking in those who have more than one condition. Aims: To explore patient views of the acceptability of collecting daily patient-generated health data for three months using a smartwatch app. Methods: Watch Your Steps was a longitudinal study which recruited 53 patients to track over 20 symptoms per day for a 90-day period using a study app on smartwatches. Semi-structured interviews were conducted with a sub-sample of 20 participants to explore their experience of engaging with the app. Results: In a population of older people with multimorbidity, patients were willing and able to engage with a patient-generated health data app on a smartwatch. It was suggested that to maintain engagement over a longer period, more 'real-time' feedback from the app should be available. Participants did not seem to consider the management of more than one condition to be a factor in either engagement or use of the app, but the presence of severe or chronic pain was at times a barrier. Conclusion: This study has provided preliminary evidence that multimorbidity was not a major barrier to engagement with patient-generated health data via a smartwatch symptom tracking app.

Engagement with consumer smartwatches for tracking symptoms of individuals living with multiple long-term conditions (multimorbidity): A longitudinal observational study.

INTRODUCTION: People living with multiple long-term conditions (multimorbidity) (MLTC-M) experience an accumulating combination of different symptoms. It has been suggested that these symptoms can be tracked longitudinally using consumer technology, such as smartphones and wearable devices. AIM: The aim of this study was to investigate longitudinal user engagement with a smartwatch application, collecting survey questions and active tasks over 90 days, in people living with MLTC-M. METHODS: 'Watch Your Steps' was a prospective observational study, administering multiple questions and active tasks over 90 days. Adults with more than one clinician-diagnosed long-term conditions were loaned Fossil® Sport smartwatches, pre-loaded with the study app. Around 20 questions were prompted per day.Daily completion rates were calculated to describe engagement patterns over time, and to explore how these varied by patient characteristics and question type. RESULTS: Fifty three people with MLTC-M took part in the study. Around half were male ( = 26; 49%) and the majority had a white ethnic background (n = 45; 85%). About a third of participants engaged with the smartwatch app nearly every day. The overall completion rate of symptom questions was 45% inter-quartile range (IQR 23-67%) across all study participants. Older patients and those with greater MLTC-M were more engaged, although engagement was not significantly different between genders. CONCLUSION: It was feasible for people living with MLTC-M to report multiple symptoms per day over 3 months. User engagement appeared as good as other mobile health studies that recruited people with single health conditions, despite the higher daily data entry burden.

Co-designing new tools for collecting, analysing and presenting patient experience data in NHS services: working in partnership with patients and carers.

BACKGROUND: The way we collect and use patient experience data is vital to optimise the quality and safety of health services. Yet, some patients and carers do not give feedback because of the limited ways data is collected, analysed and presented. In this study, we worked together with researchers, staff, patient and carer participants, and patient and public involvement and engagement (PPIE) contributors, to co-design new tools for the collection and use of patient experience data in multiple health settings. This paper outlines how the range of PPIE and research activities enabled the co-design of new tools to collect patient experience data. METHODS: Eight public contributors represented a range of relevant patient and carer experiences in specialist services with varied levels of PPIE experience, and eleven members of Patient and Participation Groups (PPGs) from two general practices formed our PPIE group at the start of the study. Slide sets were used to trigger co-design discussions with staff, patient and carer research participants, and PPIE contributors. Feedback from PPIE contributors alongside verbatim quotes from staff, patient and carer research participants is presented in relation to the themes from the research data. RESULTS: PPIE insights from four themes: capturing experience data; adopting digital or non-digital tools; ensuring privacy and confidentiality; and co-design of a suite of new tools with guidance, informed joint decisions on the shaping of the tools and how these were implemented. Our PPIE contributors took different roles during co-design and testing of the new tools, which supported co-production of the study. CONCLUSIONS: Our experiences of developing multiple components of PPIE work for this complex study demonstrates the importance of tailoring PPIE to suit different settings, and to maximise individual strengths and capacity. Our study shows the value of bringing diverse experiences together, putting patients and carers at the heart of improving NHS services, and a shared approach to managing involvement in co-design, with the effects shown through the research process, outcomes and the partnership. We reflect on how we worked together to create a supportive environment when unforeseen challenges emerged (such as, sudden bereavement).

The way we collect and use patient experience data is important because of concern that patients and carers may be excluded by the limited ways it is currently done in NHS services. In this study, we worked in partnership with researchers, staff, patient and carer participants, and patient and public involvement and engagement contributors, to co-design new tools for the collection, analysis and presentation of patient experience data. We focused on services for people with musculoskeletal conditions and services for people with severe mental health conditions. Our PPIE group, formed at the start of the study, represented a range of relevant and diverse health experiences from patients and carers of specialist services, and primary care. The aim of this paper is to share our experiences from working in partnership with our PPIE contributors on the co-design work of the study. Illustrations of how the PPIE activities added crucial insights in the shaping of the tools are given alongside the research data from patients, carers and staff participants. We experienced some challenges during the project. We discuss how we managed to work together to create a supportive environment when unforeseen challenges emerged (such as, sudden bereavement). Our experiences of developing multiple components of PPIE work for this study demonstrates the importance of tailoring PPIE to suit different settings, and to complement people's strengths and capacity. It also shows the value of bringing diverse experiences together enabling a shared approach to co-design. Researchers and PPIE contributors wrote this paper jointly.

Incidence, origins and avoidable harm of missed opportunities in diagnosis: longitudinal patient record review in 21 English general practices.

BACKGROUND: Diagnostic error is a global patient safety priority. OBJECTIVES: To estimate the incidence, origins and avoidable harm of diagnostic errors in English general practice. Diagnostic errors were defined as missed opportunities to make a correct or timely diagnosis based on the evidence available (missed diagnostic opportunities, MDOs). METHOD: Retrospective medical record reviews identified MDOs in 21 general practices. In each practice, two trained general practitioner reviewers independently conducted case note reviews on 100 randomly selected adult consultations performed during 2013-2014. Consultations where either reviewer identified an MDO were jointly reviewed. RESULTS: Across 2057 unique consultations, reviewers agreed that an MDO was possible, likely or certain in 89 cases or 4.3% (95% CI 3.6% to 5.2%) of reviewed consultations. Inter-reviewer agreement was higher than most comparable studies (Fleiss' kappa=0.63). Sixty-four MDOs (72%) had two or more contributing process breakdowns. Breakdowns involved problems in the patient-practitioner encounter such as history taking, examination or ordering tests (main or secondary factor in 61 (68%) cases), performance and interpretation of diagnostic tests (31; 35%) and follow-up and tracking of diagnostic information (43; 48%). 37% of MDOs were rated as resulting in moderate to severe avoidable patient harm. CONCLUSIONS: Although MDOs occurred in fewer than 5% of the investigated consultations, the high numbers of primary care contacts nationally suggest that several million patients are potentially at risk of avoidable harm from MDOs each year. Causes of MDOs were frequently multifactorial, suggesting the need for development and evaluation of multipronged interventions, along with policy changes to support them.

Protocol for a non-randomised feasibility study evaluating a codesigned patient safety guide in primary care.

INTRODUCTION: Patients and carers should be active partners in patient safety with healthcare professionals and be empowered to use personalised approaches to identify safety concerns and work together to prevent them. This protocol paper details a study to examine the feasibility of a multicomponent intervention to involve patients and/or carers in patient safety in primary care in the UK. METHODS AND ANALYSIS: This is a two-phase, non-randomised feasibility mixed methods pragmatic study of a patient safety guide for primary care (PSG-PC). 8 general practices will recruit 120 patient and/or carer participants. All patient and/or carer participants will receive the PSG-PC. It will examine the feasibility and acceptability of the PSG-PC in primary care settings in patients aged 18 years or older who attend appointments at general practice with health professionals four or more times per year as either patients or carers. It will identify secondary outcomes for improving patient safety, health status and patient empowerment, and reducing health service utilisation over 6 months between baseline and 6-month follow-ups. The findings will inform whether a main effectiveness trial is feasible and, if so, how it should be designed, and how many patients and practices will be needed. The study will be undertaken between January 2020 and September 2021. ETHICS AND DISSEMINATION: Ethical approval was obtained from the National Health Service London-West London and Gene Therapy Advisory Committee Research Ethics Committee (reference: 19/LO/1289). Research findings will be disseminated with participating general practices and shared in a range of different ways to engage different audiences, including presenting at international and national conferences, publishing in open-access, peer-reviewed journals and facilitating dissemination workshops within local communities with patients, carers and healthcare professionals. TRIAL REGISTRATION NUMBER: ISRCTN90222092.

Implementing a digital patient feedback system: an analysis using normalisation process theory.

BACKGROUND: Patient feedback in the English NHS is now widespread and digital methods are increasingly used. Adoption of digital methods depends on socio-technical and contextual factors, alongside human agency and lived experience. Moreover, the introduction of these methods may be perceived as disruptive of organisational and clinical routines. The focus of this paper is on the implementation of a particular digital feedback intervention that was co-designed with health professionals and patients (the DEPEND study). METHODS: The digital feedback intervention was conceptualised as a complex intervention and thus the study focused on the contexts within which it operated, and how the different participants made sense of the intervention and engaged with it (or not). Four health care sites were studied: an acute setting, a mental health setting, and two general practices. Qualitative data was collected through interviews and focus groups with professionals, patients and carers. In total 51 staff, 24 patients and 8 carers were included. Forty-two observations of the use of the digital feedback system were carried out in the four settings. Data analysis was based on modified grounded theory and Normalisation Process Theory (NPT) formed the conceptual framework. RESULTS: Digital feedback made sense to health care staff as it was seen as attractive, fast to complete and easier to analyse. Patients had a range of views depending on their familiarity with the digital world. Patients mentioned barriers such as kiosk not being visible, privacy, lack of digital know-how, technical hitches with the touchscreen. Collective action in maintaining participation again differed between sites because of workload pressure, perceptions of roles and responsibilities; and in the mental health site major organisational change was taking place. For mental health service users, their relationship with staff and their own health status determined their digital use. CONCLUSION: The potential of digital feedback was recognised but implementation should take local contexts, different patient groups and organisational leadership into account. Patient involvement in change and adaptation of the intervention was important in enhancing the embedding of digital methods in routine feedback. NPT allowed for a in-depth understanding of actions and interactions of both staff and patients.

Assessing mental health service user and carer involvement in physical health care planning: The development and validation of a new patient-reported experience measure.

BACKGROUND: People living with serious mental health conditions experience increased morbidity due to physical health issues driven by medication side-effects and lifestyle factors. Coordinated mental and physical healthcare delivered in accordance with a care plan could help to reduce morbidity and mortality in this population. Efforts to develop new models of care are hampered by a lack of validated instruments to accurately assess the extent to which mental health services users and carers are involved in care planning for physical health. OBJECTIVE: To develop a brief and accurate patient-reported experience measure (PREM) capable of assessing involvement in physical health care planning for mental health service users and their carers. METHODS: We employed psychometric and statistical techniques to refine a bank of candidate questionnaire items, derived from qualitative interviews, into a valid and reliable measure involvement in physical health care planning. We assessed the psychometric performance of the item bank using modern psychometric analyses. We assessed unidimensionality, scalability, fit to the partial credit Rasch model, category threshold ordering, local dependency, differential item functioning, and test-retest reliability. Once purified of poorly performing and erroneous items, we simulated computerized adaptive testing (CAT) with 15, 10 and 5 items using the calibrated item bank. RESULTS: Issues with category threshold ordering, local dependency and differential item functioning were evident for a number of items in the nascent item bank and were resolved by removing problematic items. The final 19 item PREM had excellent fit to the Rasch model fit (x2 = 192.94, df = 1515, P = .02, RMSEA = .03 (95% CI = .01-.04). The 19-item bank had excellent reliability (marginal r = 0.87). The correlation between questionnaire scores at baseline and 2-week follow-up was high (r = .70, P < .01) and 94.9% of assessment pairs were within the Bland Altman limits of agreement. Simulated CAT demonstrated that assessments could be made using as few as 10 items (mean SE = .43). DISCUSSION: We developed a flexible patient reported outcome measure to quantify service user and carer involvement in physical health care planning. We demonstrate the potential to substantially reduce assessment length whilst maintaining reliability by utilizing CAT.

Exercise in the treatment of clinical anxiety in general practice - a systematic review and meta-analysis.

BACKGROUND: Anxiety disorders are common, yet treatment options in general practice are often limited to medication or CBT. There is a lack of evidence for the effectiveness of exercise in the treatment of anxiety in patients who present to general practice and also about the intensity of exercise required to lead to improvement. The aim of this systematic review was to assess the use of exercise versus waiting list control groups in the treatment of anxiety and also to assess the benefit of high intensity exercise vs low intensity exercise. Long term follow up scores were also analysed. We included patients who met diagnostic criteria for anxiety disorders or had clinically raised anxiety levels on a validated rating scale and performed a subgroup analysis of the outcomes between the two groups. The intervention was any aerobic exercise programme carried out for at least two weeks, or exercise carried out at high intensity for at least two weeks. The comparison groups were either a waiting list control group or low intensity exercise. METHOD: Systematic review of randomised controlled trials. Three databases were searched; CENTRAL, Medline and Embase. Outcome assessment was based on validated anxiety rating scales. The quality of the studies was appraised according to the Cochrane Risk of Bias tool. Effect sizes were calculated using the standardised mean difference. RESULTS: Fifteen studies were identified with a total of 675 patients. Nine trials had participants with diagnosed anxiety disorders and six trials had participants with raised anxiety on a validated rating scale. Aerobic exercise was effective in the treatment of raised anxiety compared to waiting list control groups (effect size - 0.41, 95% CI = - 0.70 to - 0.12). High intensity exercise programmes showed greater effects than low intensity programmes. There was no significant difference in outcomes between groups of patients with diagnosed anxiety disorders and patients who had raised anxiety on a rating scale. Conclusions were limited by the small number of studies and wide variation in the delivery of exercise interventions. CONCLUSION: Exercise programmes are a viable treatment option for the treatment of anxiety. High intensity exercise regimens were found to be more effective than low intensity regimens. The results have implications for the use of exercise schemes in General Practice.

Long-term clinical and cost-effectiveness of collaborative care (versus usual care) for people with mental-physical multimorbidity: cluster-randomised trial.

BACKGROUND: Collaborative care can support the treatment of depression in people with long-term conditions, but long-term benefits and costs are unknown.AimsTo explore the long-term (24-month) effectiveness and cost-effectiveness of collaborative care in people with mental-physical multimorbidity. METHOD: A cluster randomised trial compared collaborative care (integrated physical and mental healthcare) with usual care for depression alongside diabetes and/or coronary heart disease. Depression symptoms were measured by the symptom checklist-depression scale (SCL-D13). The economic evaluation was from the perspective of the English National Health Service. RESULTS: 191 participants were allocated to collaborative care and 196 to usual care. At 24 months, the mean SCL-D13 score was 0.27 (95% CI, -0.48 to -0.06) lower in the collaborative care group alongside a gain of 0.14 (95% CI, 0.06-0.21) quality-adjusted life-years (QALYs). The cost per QALY gained was £13 069. CONCLUSIONS: In the long term, collaborative care reduces depression and is potentially cost-effective at internationally accepted willingness-to-pay thresholds.Declaration of interestNone.

Understanding experiences of and preferences for service user and carer involvement in physical health care discussions within mental health care planning.

BACKGROUND: People with severe mental illness suffer more physical comorbidity than the general population, which can require a tailored approach to physical health care discussions within mental health care planning. Although evidence pertaining to service user and carer involvement in mental health care planning is accumulating, current understanding of how physical health is prioritised within this framework is limited. Understanding stakeholder experiences of physical health discussions within mental health care planning, and the key domains that underpin this phenomena is essential to improve quality of care. Our study aimed to explore service user, carer and professional experiences of and preferences for service user and carer involvement in physical health discussions within mental health care planning, and develop a conceptual framework of effective user-led involvement in this aspect of service provision. METHODS: Six focus groups and four telephone interviews were carried out with twelve service users, nine carers, three service users with a dual service user and carer role, and ten mental health professionals recruited from one mental health Trust in the United Kingdom. Data was analysed utilising a thematic approach, analysed separately for each stakeholder group, and combined to aid comparisons. RESULTS: No service users or carers recalled being explicitly involved in physical health discussions within mental health care planning. Six prerequisites for effective service user and carer involvement in physical care planning were identified. Three themes confirmed general mental health care planning requirements: tailoring a collaborative working relationship, maintaining a trusting relationship with a professional, and having access to and being able to edit a living document. Three themes were novel to feeling involved in physical health care planning discussions: valuing physical health equally with mental health; experiencing coordination of care between physical-mental health professionals, and having a physical health discussion that is personalised. CONCLUSIONS: High quality physical health care discussions within the care planning process demands action at multiple levels. A conceptual framework is presented which provides an evidence-based foundation for service level improvement. Further work is necessary to develop a new patient reported outcome measure to enable meaningful quantification of health care quality and patient experience.

Living with complexity; marshalling resources: a systematic review and qualitative meta-synthesis of lived experience of mental and physical multimorbidity.

BACKGROUND: Multimorbidity poses a major health burden worldwide yet most healthcare is still orientated towards the management of single diseases. Literature on the experience of living with multimorbidity is accumulating but has not yet been synthesised in a manner conducive to informing the design of self-management interventions for this population. This study aimed to systematically review and synthesise findings from published, in-depth qualitative studies about the experience of multimorbidity, with a view to identifying the components and motivation for successful self-management in this population. METHODS: Systematic review of and meta-synthesis of qualitative studies that evaluated patient experience of living with and/or self-managing mental and/or physical multimorbidity. MEDLINE, Embase, PsycINFO, CINAHL, and ASSIA along with reference lists of existing reviews and content pages of non-indexed specialists comorbidity journals were searched. RESULTS: Nineteen studies from 23 papers were included. A line of argument synthesis was articulated around three third-order constructs: 1) Encounters with complexity; 2) Marshalling medicines, emotions, and resources; and 3) Self-preservation and prevention. Our interpretation revealed how mental and physical multimorbidity is experienced as moments of complexity rather than mere counts of illnesses. Successful self-management of physical symptoms was contingent upon the tactical use of medicines, whilst emotional health was more commonly managed by engaging in behavioural strategies, commonly with a social or spiritual component. Motivations for self-management were underpinned by a sense of moral purpose to take responsibility for their health, but also by a desire to live a purposeful life beyond an immediate context of multimorbidity. CONCLUSIONS: Understanding how people experience the complexities of mental and physical multimorbidity may be crucial to designing and delivering interventions to support successful self-management in this population. Future self-management interventions should aim to support patients to exert responsibility and autonomy for medical self-management and promote agency and self-determination to lead purposeful lives via improved access to appropriate social and psychological support.

Factors affecting recruitment into depression trials: Systematic review, meta-synthesis and conceptual framework.

BACKGROUND: Depression is common and clinical trials are crucial for evaluating treatments. Difficulties in recruiting participants into depression trials are well-documented, yet no study has examined the factors affecting recruitment. This review aims to identify the factors affecting recruitment into depression trials and to develop a conceptual framework through systematic assessment of published qualitative research. METHODS: Systematic review and meta-synthesis of published qualitative studies. Meta-synthesis involves a synthesis of themes across a number of qualitative studies to produce findings that are "greater than the sum of the parts". ASSIA, CINAHL, Embase, Medline and PsychInfo were searched up to April 2013. Reference lists of included studies, key publications and relevant reviews were also searched. Quality appraisal adopted the "prompts for appraising qualitative research". RESULTS: 7977 citations were identified, and 15 studies were included. Findings indicate that the decision to enter a depression trial is made by patients and gatekeepers based on the patient׳s health state at the time of being approached to participate; on their attitude towards the research and trial interventions; and on the extent to which patients become engaged with the trial. Our conceptual framework highlights that the decision to participate by both the patient and the gatekeeper involves a judgement between risk and reward. LIMITATIONS: Only English language publications were included in this review. CONCLUSIONS: Findings from this review have implications for the design of interventions to improve recruitment into depression trials. Such interventions may aim to diminish the perceived risks and increase the perceived rewards of participation.

Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials.

BACKGROUND: Randomized controlled trials play a central role in evidence-based practice, but recruitment of participants, and retention of them once in the trial, is challenging. Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and retention strategies. As with other healthcare initiatives, the fairest test of the effectiveness of a recruitment strategy is a trial comparing alternatives, which for recruitment would mean embedding a recruitment trial within an ongoing host trial. Systematic reviews indicate that such studies are rare. Embedded trials are largely delivered in an ad hoc way, with interventions almost always developed in isolation and tested in the context of a single host trial, limiting their ability to contribute to a body of evidence with regard to a single recruitment intervention and to researchers working in different contexts. METHODS/DESIGN: The Systematic Techniques for Assisting Recruitment to Trials (START) program is funded by the United Kingdom Medical Research Council (MRC) Methodology Research Programme to support the routine adoption of embedded trials to test standardized recruitment interventions across ongoing host trials. To achieve this aim, the program involves three interrelated work packages: (1) methodology - to develop guidelines for the design, analysis and reporting of embedded recruitment studies; (2) interventions - to develop effective and useful recruitment interventions; and (3) implementation - to recruit host trials and test interventions through embedded studies. DISCUSSION: Successful completion of the START program will provide a model for a platform for the wider trials community to use to evaluate recruitment interventions or, potentially, other types of intervention linked to trial conduct. It will also increase the evidence base for two types of recruitment intervention. TRIAL REGISTRATION: The START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial.

Care plans and care planning in the management of long-term conditions in the UK: a controlled prospective cohort study.

BACKGROUND: In the UK, the use of care planning and written care plans has been proposed to improve the management of long-term conditions, yet there is limited evidence concerning their uptake and benefits. AIM: To explore the implementation of care plans and care planning in the UK and associations with the process and outcome of care. DESIGN AND SETTING: A controlled prospective cohort study among two groups of patients with long-term conditions who were similar in demographic and clinical characteristics, but who were registered with general practices varying in their implementation of care plans and care planning. METHOD: Implementation of care plans and care planning in general practice was assessed using the 2009-2010 GP Patient Survey, and relationships with patient outcomes (self-management and vitality) were examined using multilevel, mixed effects linear regression modelling. RESULTS: The study recruited 38 practices and 2439 patients. Practices in the two groups (high and low users of written documents) were similar in structural and population characteristics. Patients in the two groups of practices were similar in demographics and baseline health. Patients did demonstrate significant differences in reported experiences of care planning, although the differences were modest. Very few patients in the cohort reported a written plan that could be confirmed. Analysis of outcomes suggested that most patients show limited change over time in vitality and self-management. Variation in the use of care plans at the practice level was very limited and not related to patient outcomes over time. CONCLUSION: The use of written care plans in patients with long-term conditions is uncommon and unlikely to explain a substantive amount of variation in the process and outcome of care. More proactive efforts at implementation may be required to provide a rigorous test of the potential of care plans and care planning.

Self-management support interventions to reduce health care utilisation without compromising outcomes: a systematic review and meta-analysis.

BACKGROUND: There is increasing interest in the role of 'self-management' interventions to support the management of long-term conditions in health service settings. Self-management may include patient education, support for decision-making, self-monitoring and psychological and social support. Self-management support has potential to improve the efficiency of health services by reducing other forms of utilisation (such as primary care or hospital use), but a shift to self-management may lead to negative outcomes, such as patients who feel more anxious about their health, are less able to cope, or who receive worse quality of care, all of which may impact on their health and quality of life. We sought to determine which models of self-management support are associated with significant reductions in health services utilisation without compromising outcomes among patients with long-term conditions. METHODS: We used systematic review with meta-analysis. We included randomised controlled trials in patients with long-term conditions which included self-management support interventions and reported measures of service utilisation or costs, as well as measures of health outcomes (standardized disease specific quality of life, generic quality of life, or depression/anxiety).We searched multiple databases (CENTRAL, CINAHL, Econlit, EMBASE, HEED, MEDLINE, NHS EED and PsycINFO) and the reference lists of published reviews. We calculated effects sizes for both outcomes and costs, and presented the results in permutation plots, as well as conventional meta-analyses. RESULTS: We included 184 studies. Self-management support was associated with small but significant improvements in health outcomes, with the best evidence of effectiveness in patients with diabetic, respiratory, cardiovascular and mental health conditions. Only a minority of self-management support interventions reported reductions in health care utilisation in association with decrements in health. Evidence for reductions in utilisation associated with self-management support was strongest in respiratory and cardiovascular problems. Studies at higher risk of bias were more likely to report benefits. CONCLUSIONS: Self-management support interventions can reduce health service utilization without compromising patient health outcomes, although effects were generally small, and the evidence was strongest in respiratory and cardiovascular disorders. Further work is needed to determine which components of self-management support are most effective.

Telephone based self-management support by 'lay health workers' and 'peer support workers' to prevent and manage vascular diseases: a systematic review and meta-analysis.

BACKGROUND: Improved prevention and management of vascular disease is a global priority. Non-health care professionals (such as, 'lay health workers' and 'peer support workers') are increasingly being used to offer telephone support alongside that offered by conventional services, to reach disadvantaged populations and to provide more efficient delivery of care. However, questions remain over the impact of such interventions, particularly on a wider range of vascular related conditions (such as, chronic kidney disease), and it is unclear how different types of telephone support impact on outcome. This study assessed the evidence on the effectiveness and cost-effectiveness of telephone self-management interventions led by 'lay health workers' and 'peer support workers' for patients with vascular disease and long-term conditions associated with vascular disease. METHODS: Systematic review of randomised controlled trials. Three electronic databases were searched. Two authors independently extracted data according to the Cochrane risk of bias tool. Random effects meta-analysis was used to pool outcome measures. RESULTS: Ten studies were included, primarily based in community settings in the United States; with participants who had diabetes; and used 'peer support workers' that shared characteristics with patients. The included studies were generally rated at risk of bias, as many methodological criteria were rated as 'unclear' because of a lack of information.Overall, peer telephone support was associated with small but significant improvements in self-management behaviour (SMD = 0.19, 95% CI 0.05 to 0.33, I2 = 20.4%) and significant reductions in HbA1c level (SMD = -0.26, 95% CI -0.41 to -0.11, I2 = 47.6%). There was no significant effect on mental health quality of life (SMD = 0.03, 95% CI -0.12 to 0.18, I2 = 0%). Data on health care utilisation were very limited and no studies reported cost effectiveness analyses. CONCLUSIONS: Positive effects were found for telephone self-management interventions via 'lay workers' and 'peer support workers' for patients on diabetes control and self-management outcomes, but the overall evidence base was limited in scope and quality. Well designed trials assessing non-healthcare professional delivered telephone support for the prevention and management of vascular disease are needed to identify the content of effective components on health outcomes, and to assess cost effectiveness, to determine if such interventions are potentially useful alternatives to professionally delivered care.

Patient empowerment in long-term conditions: development and preliminary testing of a new measure.

BACKGROUND: Patient empowerment is viewed by policy makers and health care practitioners as a mechanism to help patients with long-term conditions better manage their health and achieve better outcomes. However, assessing the role of empowerment is dependent on effective measures of empowerment. Although many measures of empowerment exist, no measure has been developed specifically for patients with long-term conditions in the primary care setting. This study presents preliminary data on the development and validation of such a measure. METHODS: We conducted two empirical studies. Study one was an interview study to understand empowerment from the perspective of patients living with long-term conditions. Qualitative analysis identified dimensions of empowerment, and the qualitative data were used to generate items relating to these dimensions. Study two was a cross-sectional postal study involving patients with different types of long-term conditions recruited from general practices. The survey was conducted to test and validate our new measure of empowerment. Factor analysis and regression were performed to test scale structure, internal consistency and construct validity. RESULTS: Sixteen predominately elderly patients with different types of long-term conditions described empowerment in terms of 5 dimensions (identity, knowledge and understanding, personal control, personal decision-making, and enabling other patients). One hundred and ninety seven survey responses were received from mainly older white females, with relatively low levels of formal education, with the majority retired from paid work. Almost half of the sample reported cardiovascular, joint or diabetes long-term conditions. Factor analysis identified a three factor solution (positive attitude and sense of control, knowledge and confidence in decision making and enabling others), although the structure lacked clarity. A total empowerment score across all items showed acceptable levels of internal consistency and relationships with other measures were generally supportive of its construct validity. CONCLUSION: Initial analyses suggest that the new empowerment measure meets basic psychometric criteria. Reasons concerning the failure to confirm the hypothesized factor structure are discussed alongside further developments of the scale.

The clinical and cost-effectiveness of the BRinging Information and Guided Help Together (BRIGHT) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: study protocol for a randomized controlled trial.

BACKGROUND: Improving the quality of care for people with vascular disease is a key priority. Chronic kidney disease (CKD) has recently been included as a target condition for general practices to add to registers of chronic conditions as part of the Quality and Outcome Framework. This paper outlines the implementation and evaluation of a self-management intervention involving an information guidebook, tailored access to local resources and telephone support for people with stage 3 chronic kidney disease. METHODS/DESIGN: The study involves a multi-site, longitudinal patient-level randomized controlled trial. The study will evaluate the clinical use and cost-effectiveness of a complex self-management intervention for people with stage 3 chronic kidney disease in terms of self-management capacity, health-related quality of life and blood pressure control compared to care as usual. We describe the methods of the patient-level randomized controlled trial. DISCUSSION: The management of chronic kidney disease is a developing area of research. The BRinging Information and Guided Help Together (BRIGHT) trial aims to provide evidence that a complementary package of support for people with vascular disease that targets both clinical and social need broadens the opportunities of self-management support by addressing problems related to social disadvantage. TRIAL REGISTRATION: Trial registration reference: ISRCTN45433299.

Changes in patient experiences of primary care during health service reforms in England between 2003 and 2007.

PURPOSE: Major primary care reforms have been introduced in recent years in the United Kingdom, including financial incentives to improve clinical quality and provide more rapid access to care. Little is known about the impact of these changes on patient experience. We examine patient reports of quality of care between 2003 and 2007, including random samples of patients on practice lists and patients with long-term conditions. METHODS: We conducted a cross-sectional design study of family practices in which questionnaires were sent to serial samples of patients in 42 representative general practices in England. Questionnaires sent to samples of patients with chronic disease (asthma, angina, and diabetes) and random samples of adult patients (excluding patients who reported any long-term condition) in 2003, 2005, and 2007 addressed issues of access, communication, continuity of care, coordination, nursing care, and overall satisfaction. RESULTS: There were no significant changes in quality of care reported by either group of patients between 2003 and 2007 for communication, nursing care, coordination, and overall satisfaction. Some aspects of access improved significantly for patients with chronic disease, but not for the random samples of patients. Patients in both samples reported seeing their usual physician less often and gave lower satisfaction ratings for continuity of care. Most scores were significantly higher for the chronic illness samples than for the random samples of patients in 2003, even after adjusting for age. CONCLUSIONS: There was a modest improvement in access to care for patients with chronic illness, but all patients now find it somewhat harder to obtain continuity of care. This outcome may be related to the incentives to provide rapid appointments or to the increased number of specialized clinics in primary care. The possibility of unintended effects needs to be considered when introducing pay for performance schemes.