Nurse-delivered sleep restriction therapy in primary care for adults with insomnia disorder: a mixed-methods process evaluation.

BACKGROUND: Sleep restriction therapy (SRT) is a behavioural therapy for insomnia. AIM: To conduct a process evaluation of a randomised controlled trial comparing SRT delivered by primary care nurses plus a sleep hygiene booklet with the sleep hygiene booklet only for adults with insomnia disorder. DESIGN AND SETTING: A mixed-methods process evaluation in a general practice setting. METHOD: Semi-structured interviews were conducted in a purposive sample of patients receiving SRT, the practice nurses who delivered the therapy, and also GPs or practice managers at the participating practices. Qualitative data were explored using framework analysis, and integrated with nurse comments and quantitative data, including baseline Insomnia Severity Index score and serial sleep efficiency outcomes to investigate the relationships between these. RESULTS: In total, 16 patients, 13 nurses, six practice managers, and one GP were interviewed. Patients had no previous experience of behavioural therapy, needed flexible appointment times, and preferred face-to-face consultations; nurses felt prepared to deliver SRT, accommodating patient concerns, tailoring therapy, and negotiating sleep timings despite treatment complexity and delays between training and intervention delivery. How the intervention produced change was explored, including patient and nurse interactions and patient responses to SRT. Difficulties maintaining SRT, negative attitudes towards treatment, and low self-efficacy were highlighted. Contextual factors, including freeing GP time, time constraints, and conflicting priorities for nurses, with suggestions for alternative delivery options, were raised. Participants who found SRT a positive process showed improvements in sleep efficiency, whereas those who struggled did not. CONCLUSION: SRT was successfully delivered by practice nurses and was generally well received by patients, despite some difficulties delivering and applying the intervention in practice.

Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial.

BACKGROUND: Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical and cost-effectiveness of sleep restriction therapy, a key component of CBT, which has the potential to be widely implemented. METHODS: We did a pragmatic, superiority, open-label, randomised controlled trial of sleep restriction therapy versus sleep hygiene. Adults with insomnia disorder were recruited from 35 general practices across England and randomly assigned (1:1) using a web-based randomisation programme to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only. There was no restriction on usual care for either group. Outcomes were assessed at 3 months, 6 months, and 12 months. The primary endpoint was self-reported insomnia severity at 6 months measured with the insomnia severity index (ISI). The primary analysis included participants according to their allocated group and who contributed at least one outcome measurement. Cost-effectiveness was evaluated from the UK National Health Service and personal social services perspective and expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The trial was prospectively registered (ISRCTN42499563). FINDINGS: Between Aug 29, 2018, and March 23, 2020 we randomly assigned 642 participants to sleep restriction therapy (n=321) or sleep hygiene (n=321). Mean age was 55·4 years (range 19-88), with 489 (76·2%) participants being female and 153 (23·8%) being male. 580 (90·3%) participants provided data for at least one outcome measurement. At 6 months, mean ISI score was 10·9 (SD 5·5) for sleep restriction therapy and 13·9 (5·2) for sleep hygiene (adjusted mean difference -3·05, 95% CI -3·83 to -2·28; p<0·0001; Cohen's d -0·74), indicating that participants in the sleep restriction therapy group reported lower insomnia severity than the sleep hygiene group. The incremental cost per QALY gained was £2076, giving a 95·3% probability that treatment was cost-effective at a cost-effectiveness threshold of £20 000. Eight participants in each group had serious adverse events, none of which were judged to be related to intervention. INTERPRETATION: Brief nurse-delivered sleep restriction therapy in primary care reduces insomnia symptoms, is likely to be cost-effective, and has the potential to be widely implemented as a first-line treatment for insomnia disorder. FUNDING: The National Institute for Health and Care Research Health Technology Assessment Programme.

Cost-effectiveness of a patient-centred approach to managing multimorbidity in primary care: a pragmatic cluster randomised controlled trial.

OBJECTIVE: Patients with multiple chronic health conditions are often managed in a disjointed fashion in primary care, with annual review clinic appointments offered separately for each condition. This study aimed to determine the cost-effectiveness of the 3D intervention, which was developed to improve the system of care. DESIGN: Economic evaluation conducted alongside a pragmatic cluster-randomised trial. SETTING: General practices in three centres in England and Scotland. PARTICIPANTS: 797 adults with three or more chronic conditions were randomised to the 3D intervention, while 749 participants were randomised to receive usual care. INTERVENTION: The 3D approach: comprehensive 6-monthly general practitioner consultations, supported by medication reviews and nurse appointments. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary economic evaluation assessed the cost per quality-adjusted life year (QALY) gained from the perspective of the National Health Service (NHS) and personal social services (PSS). Costs were related to changes in a range of secondary outcomes (QALYs accrued by both participants and carers, and deaths) in a cost-consequences analysis from the perspectives of the NHS/PSS, patients/carers and productivity losses. RESULTS: Very small increases were found in both QALYs (adjusted mean difference 0.007 (-0.009 to 0.023)) and costs (adjusted mean difference £126 (£-739 to £991)) in the intervention arm compared with usual care after 15 months. The incremental cost-effectiveness ratio was £18 499, with a 50.8% chance of being cost-effective at a willingness-to-pay threshold of £20 000 per QALY (55.8% at £30 000 per QALY). CONCLUSIONS: The small differences in costs and outcomes were consistent with chance, and the uncertainty was substantial; therefore, the evidence for the cost-effectiveness of the 3D approach from the NHS/PSS perspective should be considered equivocal. TRIAL REGISTRATION NUMBER: ISCRTN06180958.

Management of multimorbidity using a patient-centred care model: a pragmatic cluster-randomised trial of the 3D approach.

BACKGROUND: The management of people with multiple chronic conditions challenges health-care systems designed around single conditions. There is international consensus that care for multimorbidity should be patient-centred, focus on quality of life, and promote self-management towards agreed goals. However, there is little evidence about the effectiveness of this approach. Our hypothesis was that the patient-centred, so-called 3D approach (based on dimensions of health, depression, and drugs) for patients with multimorbidity would improve their health-related quality of life, which is the ultimate aim of the 3D intervention. METHODS: We did this pragmatic cluster-randomised trial in general practices in England and Scotland. Practices were randomly allocated to continue usual care (17 practices) or to provide 6-monthly comprehensive 3D reviews, incorporating patient-centred strategies that reflected international consensus on best care (16 practices). Randomisation was computer-generated, stratified by area, and minimised by practice deprivation and list size. Adults with three or more chronic conditions were recruited. The primary outcome was quality of life (assessed with EQ-5D-5L) after 15 months' follow-up. Participants were not masked to group assignment, but analysis of outcomes was blinded. We analysed the primary outcome in the intention-to-treat population, with missing data being multiply imputed. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN06180958. FINDINGS: Between May 20, 2015, and Dec 31, 2015, we recruited 1546 patients from 33 practices and randomly assigned them to receive the intervention (n=797) or usual care (n=749). In our intention-to-treat analysis, there was no difference between trial groups in the primary outcome of quality of life (adjusted difference in mean EQ-5D-5L 0·00, 95% CI -0·02 to 0·02; p=0·93). 78 patients died, and the deaths were not considered as related to the intervention. INTERPRETATION: To our knowledge, this trial is the largest investigation of the international consensus about optimal management of multimorbidity. The 3D intervention did not improve patients' quality of life. FUNDING: National Institute for Health Research.

Predictors of patient self-report of chronic kidney disease: baseline analysis of a randomised controlled trial.

BACKGROUND: Improving the quality of care for patients with vascular disease is a priority. Clinical guidance has emphasised the importance of early identification and active management of chronic kidney disease (CKD) in primary care in order to maintain vascular health. However, awareness of stage 3 CKD amongst patients remains limited. We aimed to identify predictors of patient self-report of CKD to inform tailoring of conversations around CKD in primary care for diverse patient populations. METHODS: We conducted a cross-sectional analysis of baseline data from 436 patients with stage 3 CKD from 24 GP practices taking part in a randomised controlled trial (RCT) evaluating a complex self-management intervention, which aimed to support the maintenance of vascular health in patients with stage 3 CKD. Potential predictors of patient self-report of CKD included demographics, stage of CKD, cardiovascular risk, self-reported co-morbidities, health status, self-management ability, and health service utilisation. RESULTS: Around half (52%, n = 227) of patients did not self-report CKD. Self-report rates did not appreciably differ by practice. Multivariate analysis revealed that female patients (p = 0.004), and patients with stage 3b CKD (p < 0.001), and with higher anxiety levels (p < 0.001), were more likely to self-report CKD. CONCLUSIONS: Self-report of kidney problems by patients on CKD registers was variable and patterned by sociodemographic factors. Although it cannot be assumed that failure to self-report indicates a lack of awareness of CKD, our data do suggest the need for greater consistency in discussions around kidney health, with meaningful and relevant clinical dialogue that is aligned with existing clinical encounters to enable shared decision making and minimise anxiety.

Effect of information and telephone-guided access to community support for people with chronic kidney disease: randomised controlled trial.

BACKGROUND: Implementation of self-management support in traditional primary care settings has proved difficult, encouraging the development of alternative models which actively link to community resources. Chronic kidney disease (CKD) is a common condition usually diagnosed in the presence of other co-morbidities. This trial aimed to determine the effectiveness of an intervention to provide information and telephone-guided access to community support versus usual care for patients with stage 3 CKD. METHODS AND FINDINGS: In a pragmatic, two-arm, patient level randomised controlled trial 436 patients with a diagnosis of stage 3 CKD were recruited from 24 general practices in Greater Manchester. Patients were randomised to intervention (215) or usual care (221). Primary outcome measures were health related quality of life (EQ-5D health questionnaire), blood pressure control, and positive and active engagement in life (heiQ) at 6 months. At 6 months, mean health related quality of life was significantly higher for the intervention group (adjusted mean difference = 0.05; 95% CI = 0.01, 0.08) and blood pressure was controlled for a significantly greater proportion of patients in the intervention group (adjusted odds-ratio = 1.85; 95% CI = 1.25, 2.72). Patients did not differ significantly in positive and active engagement in life. The intervention group reported a reduction in costs compared with control. CONCLUSIONS: An intervention to provide tailored information and telephone-guided access to community resources was associated with modest but significant improvements in health related quality of life and better maintenance of blood pressure control for patients with stage 3 CKD compared with usual care. However, further research is required to identify the mechanisms of action of the intervention. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN45433299.

Implementation of a self-management support approach (WISE) across a health system: a process evaluation explaining what did and did not work for organisations, clinicians and patients.

BACKGROUND: Implementation of long-term condition management interventions rests on the notion of whole systems re-design, where incorporating wider elements of health care systems are integral to embedding effective and integrated solutions. However, most self-management support (SMS) evaluations still focus on particular elements or outcomes of a sub-system. A randomised controlled trial of a SMS intervention (WISE-Whole System Informing Self-management Engagement) implemented in primary care showed no effect on patient-level outcomes. This paper reports on a parallel process evaluation to ascertain influences affecting WISE implementation at patient, clinical and organisational levels. Normalisation Process Theory (NPT) provided a sensitising background and analytical framework. METHODS: A multi-method approach using surveys and interviews with organisational stakeholders, practice staff and trial participants about impact of training and use of tools developed for WISE. Analysis was sensitised by NPT (coherence, cognitive participation, collective action and reflective monitoring). The aim was to identify what worked and what did not work for who and in what context. RESULTS: Interviews with organisation stakeholders emphasised top-down initiation of WISE by managers who supported innovation in self-management. Staff from 31 practices indicated engagement with training but patchy adoption of WISE tools; SMS was neither prioritised by practices nor fitted with a biomedically focussed ethos, so little effort was invested in WISE techniques. Interviews with 24 patients indicated no awareness of any changes following the training of practice staff; furthermore, they did not view primary care as an appropriate place for SMS. CONCLUSION: The results contribute to understanding why SMS is not routinely adopted and implemented in primary care. WISE was not embedded because of the perceived lack of relevance and fit to the ethos and existing work. Enacting SMS within primary care practice was not viewed as a legitimate activity or a professional priority. There was failure to, in principle, engage with and identify patients' support needs. Policy presumptions concerning SMS appear to be misplaced. Implementation of SMS within the health service does not currently account for patient circumstances. Primary care priorities and support for SMS could be enhanced if they link to patients' broader systems of implementation networks and resources.

Implementing, embedding and integrating self-management support tools for people with long-term conditions in primary care nursing: a qualitative study.

BACKGROUND: An implementation gap exists between policy aspirations for provision and the delivery of self-management support in primary care. An evidence based training and support package using a whole systems approach implemented as part of a randomised controlled trial was delivered to general practice staff. The trial found no effect of the intervention on patient outcomes. This paper explores why self-management support failed to become part of normal practice. We focussed on implementation of tools which capture two key aspects of self-management support - education (guidebooks for patients) and forming collaborative partnerships (a shared decision-making tool). OBJECTIVES: To evaluate the implementation and embedding of self-management support in a United Kingdom primary care setting. DESIGN: Qualitative semi-structured interviews with primary care professionals. SETTINGS: 12 General Practices in the Northwest of England located within a deprived inner city area. PARTICIPANTS: Practices were approached 3-6 months after undergoing training in a self-management support approach. A pragmatic sample of 37 members of staff - General Practitioners, nurses, and practice support staff from 12 practices agreed to take part. The analysis is based on interviews with 11 practice nurses and one assistant practitioner; all were female with between 2 and 21 years' experience of working in general practice. METHODS: A qualitative design involving face-to-face, semi-structured interviews audio-recorded and transcribed. Normalisation Process Theory framework allowed a systematic evaluation of the factors influencing the work required to implement the tools. FINDINGS: The guidebooks were embedded in daily practice but the shared decision-making tools were not. Guidebooks were considered to enhance patient-centredness and were minimally disruptive. Practice nurses were reluctant to engage with behaviour change discussions. Self-management support was not formulated as a practice priority and there was minimal support for this activity within the practice: it was not auditable; was insufficiently differentiated from existing content and processes of work to value in its own right, and considered too disruptive and time-consuming. CONCLUSION: Supporting self-management through the encouragement of lifestyle change was problematic to realise with limited evidence of the development of the needed collaborative partnerships between patients and practitioners required by the ethos of self-management support.

Implementation of self management support for long term conditions in routine primary care settings: cluster randomised controlled trial.

OBJECTIVE: To determine the effectiveness of an intervention to enhance self management support for patients with chronic conditions in UK primary care. DESIGN: Pragmatic, two arm, cluster randomised controlled trial. SETTING: General practices, serving a population in northwest England with high levels of deprivation. PARTICIPANTS: 5599 patients with a diagnosis of diabetes (n=2546), chronic obstructive pulmonary disease (n=1634), and irritable bowel syndrome (n=1419) from 43 practices (19 intervention and 22 control practices). INTERVENTION: Practice level training in a whole systems approach to self management support. Practices were trained to use a range of resources: a tool to assess the support needs of patients, guidebooks on self management, and a web based directory of local self management resources. Training facilitators were employed by the health management organisation. MAIN OUTCOME MEASURES: Primary outcomes were shared decision making, self efficacy, and generic health related quality of life measured at 12 months. Secondary outcomes were general health, social or role limitations, energy and vitality, psychological wellbeing, self care activity, and enablement. RESULTS: We randomised 44 practices and recruited 5599 patients, representing 43% of the eligible population on the practice lists. 4533 patients (81.0%) completed the six month follow-up and 4076 (72.8%) the 12 month follow-up. No statistically significant differences were found between patients attending trained practices and those attending control practices on any of the primary or secondary outcomes. All effect size estimates were well below the prespecified threshold of clinically important difference. CONCLUSIONS: An intervention to enhance self management support in routine primary care did not add noticeable value to existing care for long term conditions. The active components required for effective self management support need to be better understood, both within primary care and in patients' everyday lives. TRIAL REGISTRATION: Current Controlled Trials ISRCTN90940049.

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.

'Permission to participate?' A qualitative study of participation in patients from differing socio-economic backgrounds.

Participation in health care is an important element of self-management in chronic illness, and policy emphasises patient's choice. Evidence suggests that this may be inequitable and inadequate, since active participation is strongly associated with socio-demographic variables. This qualitative study explores the perceptions of participation in people with differing socio-economic status with themes related to health literacy and relationship with health-care professionals. Patients perceive participation in different ways, related to their prior expectations of a health-care consultation, cultural expectations and social position. Policies aimed at simply improving 'health literacy' and choice will not be successful if these broader disparities are not addressed.

Patients' experiences of shared decision making in primary care practices in the United kingdom.

BACKGROUND: Shared decision making (SDM) and patient self-management support are key components of US and UK policy for chronic disease management, whereby SDM is seen as enhancing physician-patient negotiation around self-management. The WISE trial is implementing training in self-management support for primary care physicians in one UK region. This article describes preintervention levels of patient-reported SDM and explores how this varies with patient and practice characteristics. METHODS: We analyzed baseline data from a cluster randomized controlled trial for 2965 patients with diabetes, chronic obstructive pulmonary disease, and irritable bowel syndrome (IBS) from 29 family practices. Patient-level measures included self-report of chronic conditions, SDM (Health Care Climate Questionnaire [HCCQ]), health status, and demographic characteristics. Area and practice characteristics included chronic disease workload and socioeconomic deprivation. RESULTS: The mean SDM score was 75 (out of 100), but the range was wide. The mean score was lower for IBS patients but did not vary with other disease conditions. Younger patients and those with poorer health status reported lower degrees of SDM. No associations were found with practice characteristics. LIMITATIONS: The study was restricted to one socioeconomically deprived region, and hence results may not be nationally representative of the United Kingdom. Ceiling effects on SDM scores may limit the utility of the HCCQ. CONCLUSIONS: Lower ratings from some patient groups may reflect differences in expectations rather than differences in physician behavior. Overall levels of SDM were high, and no patient or practice characteristic represented a serious barrier to SDM. However, we cannot say to what extent SDM in this chronic population addressed self-management issues rather than clinical care. More nuanced measures of SDM are required that distinguish between different forms of care.

A cluster randomised controlled trial of the clinical and cost-effectiveness of a 'whole systems' model of self-management support for the management of long- term conditions in primary care: trial protocol.

BACKGROUND: Patients with long-term conditions are increasingly the focus of quality improvement activities in health services to reduce the impact of these conditions on quality of life and to reduce the burden on care utilisation. There is significant interest in the potential for self-management support to improve health and reduce utilisation in these patient populations, but little consensus concerning the optimal model that would best provide such support. We describe the implementation and evaluation of self-management support through an evidence-based 'whole systems' model involving patient support, training for primary care teams, and service re-organisation, all integrated into routine delivery within primary care. METHODS: The evaluation involves a large-scale, multi-site study of the implementation, effectiveness, and cost-effectiveness of this model of self-management support using a cluster randomised controlled trial in patients with three long-term conditions of diabetes, chronic obstructive pulmonary disease (COPD), and irritable bowel syndrome (IBS). The outcome measures include healthcare utilisation and quality of life. We describe the methods of the cluster randomised trial. DISCUSSION: If the 'whole systems' model proves effective and cost-effective, it will provide decision-makers with a model for the delivery of self-management support for populations with long-term conditions that can be implemented widely to maximise 'reach' across the wider patient population. TRIAL REGISTRATION NUMBER: ISRCTN: ISRCTN90940049.

Delivering the WISE (Whole Systems Informing Self-Management Engagement) training package in primary care: learning from formative evaluation.

BACKGROUND: The WISE (Whole System Informing Self-management Engagement) approach encompasses creating, finding, and implementing appropriate self-care support for people with long-term conditions. A training package for primary care to introduce the approach was developed and underwent formative evaluation. This entailed exploring the acceptability of the WISE approach and its effectiveness in changing communication within consultations. The study aimed to refine the patient, practitioner, and patient level components of the WISE approach and translate the principles of WISE into an operational intervention deliverable through National Health Service training methods. METHODS: Normalisation Process Theory provided a framework for development of the intervention. Practices were recruited from an inner city Primary Care Trust in NW England. All practice staff were expected to attend two afternoon training sessions. The training sessions were observed by members of the training team. Post-training audio recordings of consultations from each general practitioner and nurse in the practices were transcribed and read to provide a narrative overview of the incorporation of WISE skills and tools into consultations. Face-to-face semi-structured interviews were conducted with staff post-training. RESULTS: Two practices out of 14 deemed eligible agreed to take part. Each practice attended two sessions, although a third session on consultation skills training was needed for one practice. Fifty-four post-training consultations were recorded from 15 clinicians. Two members of staff were interviewed at each practice. Significant elements of the training form and methods of delivery fitted contemporary practice. There were logistical problems in getting a whole practice to attend both sessions, and administrative staff founds some sections irrelevant. Clinicians reported problems incorporating some of the tools developed for WISE, and this was confirmed in the overview of consultations, with limited overt use of WISE tools and missed opportunities to address patients' self-management needs. CONCLUSIONS: The formative evaluation approach and attention to normalisation process theory allowed the training team to make adjustments to content and delivery and ensure appropriate staff attended each session. The content of the course was simplified and focussed more clearly on operationalising the WISE approach. The patient arm of the approach was strengthened by raising expectations of a change in approach to self-care support by their practice.

What outcomes are important to patients with long term conditions? A discrete choice experiment.

OBJECTIVE: To assess how much patients with long-term conditions value self-efficacy (i.e., confidence in their ability to manage their condition) compared with other health outcomes, including measures of quality of life, and process outcomes including access to General Practitioners. METHODS: Discrete Choice Experiment (DCE) set in UK community settings. PARTICIPANTS: 367 patients (mean age 57.5) living in the community with a wide range of self-defined long-term conditions. MAIN OUTCOME MEASURES: The relative value that individuals place on four specific outcomes, namely, self-efficacy, Health Related Quality of Life (HRQoL), access to General Practitioners, and level of isolation. RESULTS: Most responders completed their questionnaire in a consistent manner. Most valuations of outcomes were in the expected direction and were statistically significant. A substantial minority of responders exhibited counter-intuitive preferences. The existence of a significant constant in all models raised concerns about model misspecification. Nevertheless, all models showed that participants were willing to trade substantial reductions in their HRQoL for improvements in their self-efficacy. CONCLUSIONS: The majority of patients with chronic conditions were able to complete the DCE questionnaires. However, the existence of counter-intuitive preferences and evidence of model misspecification require further investigation. These issues are largely overlooked in the health economics literature. Self-efficacy is an important outcome for this group and is not included explicitly in conventional HRQoL measures. This is potentially important where decisions are made on the basis of cost-effectiveness using Quality Adjusted Life Years as the metric. Exclusion of these outcomes may lead to the cost-effectiveness of these interventions being understated.

Predicting who will benefit from an Expert Patients Programme self-management course.

BACKGROUND: In England, the Expert Patients Programme, a lay-led chronic disease self-management course, was developed to improve self-care support and skills. The course is designed for anyone with a self-defined long-term condition, and attracts a heterogeneous group of patients. A randomised controlled trial has demonstrated effectiveness in improving subjective health. However, it is not known whether particular patient characteristics predict the impact of the course. AIM: To determine whether baseline characteristics predict clinical outcomes from attendance at a chronic disease self-management course; and to assess whether identification of such characteristics assists in targeting the course to individuals most likely to benefit. DESIGN OF STUDY: A post-hoc subgroup analysis of data from a randomised controlled trial to explore predictors of three trial outcomes: self-efficacy, energy, and health-related quality of life. SETTING: Participants with self-defined long-term conditions (n = 629) were recruited from community settings in all 28 strategic health authorities in England. METHOD: Multiple regression was used to examine interactions between baseline variables and trial outcomes. RESULTS: The predictors demonstrating significant interactions were: age and general health, and baseline values for self-efficacy, energy levels, and health-related quality of life. CONCLUSION: Participants with lower self-efficacy and health-related quality of life at baseline demonstrated more positive health outcomes. The Expert Patients Programme may have a protective effect on health-related quality of life for patients with poor health and low confidence. Younger people benefited substantially more than older people. Results suggest that positive outcomes associated with the course will be demonstrated with a wide variety of patients, although it may be worthwhile encouraging attendance of younger patients, those lacking confidence, and those coping poorly with their condition.

The United Kingdom Expert Patients Programme: results and implications from a national evaluation.

The Expert Patients Programme (EPP) is a central element of chronic disease management policy in the United Kingdom. It aims to deliver self-care support by developing peoples' self-care skills, confidence and motivation to take more effective control over their long-term conditions. A large, national randomised controlled trial found that the EPP's lay-led skills training was effective in improving self-efficacy and energy levels among patients with long-term conditions, and was likely to be cost-effective. Key questions remain as to whether existing outcome measures capture the core outcomes that are important to patients with long-term conditions. The development and evaluation of self-care support initiatives should take into account the extent to which self-care support initiatives can be integrated into peoples' everyday lives, and the degree of fit with patients' existing adaptations and strategies. Rather than being concentrated on a single course, central resources for self-management support should be directed at a variety of systems and interventions that are able to meet the wide range of needs of patients with chronic conditions.

The effectiveness and cost effectiveness of a national lay-led self care support programme for patients with long-term conditions: a pragmatic randomised controlled trial.

OBJECTIVE: Supporting patients' self care could have a major effect on the management of long-term conditions, which has led to worldwide interest in effective self care interventions. In England, self care support is being developed through the "Expert Patients Programme", which provides lay-led generic courses to improve patients' self care skills. However, the clinical and cost effectiveness of such courses remains unclear. METHODS: Two-arm pragmatic randomised controlled trial design with waiting list control in community settings in England. 629 patients with a wide range of self-defined long-term conditions were studied. The lay-led self care support group involved 6-weekly sessions to teach self care skills. Primary outcomes were self-efficacy, reported energy and routine health services utilisation at 6 months. A cost-effectiveness analysis was also conducted. RESULTS: Patients receiving immediate course access reported considerably greater self-efficacy and energy at 6-month follow-up, but reported no statistically significant reductions in routine health services utilisation over the same time period. The cost-effectiveness analysis showed that patients receiving immediate course access reported considerably greater health related quality of life, and a small reduction in costs. If a quality adjusted life year was valued at 20,000 pounds (39,191 dollars; 30,282 Euro), there was a 70% probability that the intervention was cost effective. CONCLUSIONS: Lay-led self care support groups are effective in improving self-efficacy and energy levels among patients with long-term conditions, and are likely to be cost effective over 6 months at conventional values of a decision-maker's willingness to pay. They may be a useful addition to current services in the management of long-term conditions.

Three-dimensional growth of endothelial cells in the microgravity-based rotating wall vessel bioreactor.

We characterized bovine aortic endothelial cells (BAEC) continuously cultured in the rotating wall vessel (RWV) bioreactor for up to 30 d. Cultures grew as large tissue-like aggregates (containing 20 or more beads) after 30 d. These cultures appeared to be growing in multilayers around the aggregates, where single beads were covered with confluent BAEC, which displayed the typical endothelial cell (EC) morphology. The 30-d multibead aggregate cultures have a different and smoother surface when viewed under a higher-magnification scanning electron microscope. Transmission electron microscopy of these large BAEC aggregates showed that the cells were viable and formed multilayered sheets that were separated by an extracellular space containing matrix-like material. These three-dimensional cultures also were found to have a basal production of nitric oxide (NO) that was 10-fold higher for the RWV than for the Spinner flask bioreactor (SFB). The BAEC in the RWV showed increased basal NO production, which was dependent on the RWV rotation rate: 73% increase at 8 rpm, 262% increase at 15 rpm, and 500% increase at 20 rpm as compared with control SFB cultures. The addition of l-arginine to the RWV cultures resulted in a fourfold increase in NO production over untreated RWV cultures, which was completely blocked by L-NAME [N(G)-nitro-L-arginine-methylester]. Cells in the SFB responded similarly. The RWV cultures showed an increase in barrier properties with an up-regulation of tight junction protein expression. We believe that this study is the first report of a unique growth pattern for ECs, resulting in enhanced NO production and barrier properties, and it suggests that RWV provides a unique model for investigating EC biology and differentiated function.