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 and Budget Impact of a Novel Antithrombotic Drug Removal System to Reduce Bleeding Risk in Patients on Preoperative Ticagrelor Undergoing Cardiac Surgery.

BACKGROUND: Antithrombotic drugs, including the P2Y12 inhibitor ticagrelor, increase the risk of perioperative bleeding in patients requiring urgent cardiac surgery. Perioperative bleeding can lead to increased mortality and prolong intensive care unit and hospital stays. A novel sorbent-filled hemoperfusion cartridge that intraoperatively removes ticagrelor via hemoadsorption can reduce the risk of perioperative bleeding. We estimated the cost-effectiveness and budget impact of using this device versus standard practices to reduce the risk of perioperative bleeding during and after coronary artery bypass grafting from the US healthcare sector perspective. METHODS: We used a Markov model to analyze the cost-effectiveness and budget impact of the hemoadsorption device in three cohorts: (1) surgery within 1 day from last ticagrelor dose; (2) surgery between 1 and 2 days from last ticagrelor dose; and (3) a combined cohort. The model analyzed costs and quality-adjusted life years (QALYs). Results were interpreted as both incremental cost-effectiveness ratios and net monetary benefits (NMBs) at a cost-effectiveness threshold of $100,000/QALY. We analyzed parameter uncertainty using deterministic and probabilistic sensitivity analyses. RESULTS: The hemoadsorption device was dominant for each cohort. Patients with less than 1 day of washout in the device arm gained 0.017 QALYs at a savings of $1748 (USD), for an NMB of $3434. In patients with 1-2 days of washout, the device arm yielded 0.014 QALYs and a cost savings of $151, for an NMB of $1575. In the combined cohort, device gained 0.016 QALYs and a savings of $950 for an NMB of $2505. Per-member-per-month cost savings associated with device was estimated to be $0.02 for a one-million-member health plan. CONCLUSION: This model found the hemoadsorption device to provide better clinical and economic outcomes compared with the standard of care in patients who required surgery within 2 days of ticagrelor discontinuation. Given the increasing use of ticagrelor in patients with acute coronary syndrome, incorporating this novel device may represent an important part of any bundle to save costs and reduce harm.

Ecological momentary assessment of outcomes in allergic rhinitis and chronic rhinosinusitis: A review.

BACKGROUND: Allergic rhinitis (AR) and chronic rhinosinusitis (CRS) rely on patient-reported symptoms and quality-of-life measures, which are subject to bias. Ecological momentary assessment (EMA) captures data in real time through repeated short surveys, thus reducing errors/biases. EMA's use in sinonasal conditions has not been well described, and the goal of this study was to examine the literature on EMA and AR/CRS.  METHODS: A literature review was performed using the following search terms: AR, CRS, and EMA. Inclusion criteria were the use of EMA reporting of sinonasal symptoms at more than one time point. Systematic reviews and non-full text articles were excluded. Population demographics, sinonasal disease, type of EMA platform used, type and severity of symptoms reported, medication use and symptom correlation with location/pollen/pollution were collected. RESULTS: Eight studies met the inclusion criteria, and all focused on AR. All studies were conducted outside the United States in both children and adults. Seven studies used a smartphone application for reporting symptoms, and one used WeChat surveys. EMA data collection varied, with repetitive survey intervals determined either by patients (n = 6) or research team (n = 2). All studies reported sinonasal severity scores, while six reported additional symptoms (e.g., ocular, pulmonary, sleep, general health). Five collected self-reported allergy medication use. Seven studies correlated symptoms with location, pollen, or pollution. CONCLUSIONS: Few studies in AR and no studies in CRS assessed the use of EMA. EMA may provide a better understanding of the real-time relationship of environmental triggers with symptoms, in turn guiding treatment decisions.

Radiological Assessment of High Anterior Septal Deviation and Its Impact on Sinus Access.

OBJECTIVES/HYPOTHESIS: High anterior septal deviation (HASD) is an underreported anatomic variant that can affect the decision to perform septoplasty for access during sinus surgery and ease of postoperative debridement. This study aims to 1) describe an objective method of assessing HASD, and 2) explore its prevalence and implications for performing septoplasty. STUDY DESIGN: Retrospective cross-sectional study. METHODS: Computed tomography scans from 2014 to 2020 were retrospectively reviewed. Two independent observers measured the following with respect to midline: distance to septum (SDD), distance to lateral nasal wall (LNW), and septal deviation angle (SDA). RESULTS: A total of 147 patients were included, with excellent interrater reliability across 99 patients (0.8-0.9). Mean measurements across all patients were SDD (2.77 mm ± 1.34), SDD/LNW (0.26 ± 0.12), and SDA (8.9° ± 4.0). Of 102 patients who underwent sinus surgery, 47 received septoplasty. Compared to the non-septoplasty cohort, the septoplasty cohort had a greater mean SDD (3.61 mm ± 1.48 vs. 2.27 mm ± 0.95; d = 1.10 [95% CI 0.67-1.51]), SDD/LNW (0.34 ± 0.13 vs. 0.21 ± 0.09; d = 1.18 [95% CI 0.76-1.60]), and SDA (11.1° ± 4.3 vs. 7.3° ± 3.4; d = 1.00 [95% CI 0.58-1.40]). Receiver operating characteristic cutoffs were SDD ≥2.43 mm, SDD/LNW ≥0.25, and SDA ≥7.6°, corresponding to a 49%-58% prevalence of HASD. CONCLUSION: HASD is relatively common and the methods described herein can reliably assess its dimensions. Measurements of SDD, SDD/LNW, and SDA exceeding cutoffs determined by this study may represent clinically significant deflections prompting consideration of septoplasty. These methods may aid in preoperative planning. LEVEL OF EVIDENCE: 4 Laryngoscope, 132:1166-1171, 2022.

The hidden cost of humanization: Individuating information reduces prosocial behavior toward in-group members.

This paper reports robust experimental evidence that humanization-in the form of individuating information about another's personal preferences-leads to decreased prosocial behavior toward in-group members. Previous research shows that this information increases prosocial behavior toward dehumanized out-group members. The consequences for in-group members, however, are less well understood. Using methods from social psychology and behavioral economics, four experiments show that individuating information decreases pro-social behavior toward in-group members in a variety of settings (charitable giving, altruistic punishment, and trust games). Moreover, this effect results from decreased reliance on group membership labels, and not from other potential explanations like the induction of new group identities. Understanding these effects sheds light on the motives behind intergroup conflict, which may not result from a difference in social perception (i.e., humanized in-groups and dehumanized out-groups), but rather from biases associated with group membership (i.e. in-group favoritism and out-group discrimination) that are eliminated by individuating information. Together, these results indicate that humanization carries a hidden cost for in-group members by disrupting group identities that would otherwise make them targets of altruistic actions.

Does memory reactivation during sleep support generalization at the cost of memory specifics?

Sleep is important for memory, but does it favor consolidation of specific details or extraction of generalized information? Both may occur together when memories are reactivated during sleep, or a loss of certain memory details may facilitate generalization. To examine these issues, we tested memory in participants who viewed landscape paintings by six artists. Paintings were cropped to show only a section of the scene. During a learning phase, each painting section was presented with the artist's name and with a nonverbal sound that had been uniquely associated with that artist. In a test of memory for specifics, participants were shown arrays of six painting sections, all by the same artist. Participants attempted to select the one that was seen in the learning phase. Generalization was tested by asking participants to view new paintings and, for each one, decide which of the six artists created it. After this testing, participants had a 90-minute sleep opportunity with polysomnographic monitoring. When slow-wave sleep was detected, three of the sound cues associated with the artists were repeatedly presented without waking the participants. After sleep, participants were again tested for memory specifics and generalization. Memory reactivation during sleep due to the sound cues led to a relative decline in accuracy on the specifics test, which could indicate the transition to a loss of detail that facilitates generalization, particularly details such as the borders. Generalization performance showed very little change after sleep and was unaffected by the sound cues. Although results tentatively implicate sleep in memory transformation, further research is needed to examine memory change across longer time periods.

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.

Prior authorization as a utilization management tool for elective superficial venous procedures results in high administrative cost and low efficacy in reducing utilization.

OBJECTIVE: Prior authorization (PA) is a process used by payers for safety and cost savings purposes, but it has received criticism for being time-consuming and costly because of administrative burden. Our study evaluated efficacy of PA applied to in-office lower extremity superficial venous procedures. METHODS: All in-office lower extremity venous procedures scheduled to be performed at our institution in 2017 were included in the study. Variables of interest were type of procedure, initial PA status (approved or denied), rationale for the decision, and final status after appeal. Cost analysis was performed using Centers for Medicare and Medicaid Services allowable rates to approximate billing and reimbursement data (proprietary) as well as calculated using industry averages. RESULTS: For 2017, of 1959 procedures scheduled, 57.9% (n = 1134) required PA. Of these, only 6.1% (n = 69) received initial PA denial, and nearly 40% of the denials (n = 27) were overturned after appeal. Of the 42 denials that were upheld, 15 resulted in cancellations; the remainder were performed by patient self-pay (n = 11) or by the provider pro bono (n = 16). Overturned denials were a result of either submission of incomplete clinical data on initial PA request or insufficient documentation of clinical necessity. When Centers for Medicare and Medicaid Services allowable rates were applied for cost analysis, the denials resulted in <$60,000 payer savings. Administrative expenses totaled >$110,000 when industry standards were applied, which far exceeds any calculated payer savings using the same methods. The 15 denials resulting in procedure cancellations (1.3% of all PAs) could be considered a net savings to the health care system but only approximated a mere $30,000. CONCLUSIONS: Our study demonstrates that PA is not a cost-effective measure for utilization management of outpatient superficial venous procedures when surgeon practices are already well aligned with insurance guidelines. For these physicians and physician groups, the administrative cost associated with the PA process exceeds the savings seen by the insurance companies.

Integrating Allergen Analysis Within a Risk Assessment Framework: Approaches to Development of Targeted Mass Spectrometry Methods for Allergen Detection and Quantification in the iFAAM Project.

Allergen analysis is central to implementing and monitoring food allergen risk assessment and management processes by the food industry, but current methods for the determination of allergens in foods give highly variable results. The European Union-funded "Integrated Approaches to Food Allergen and Allergy Risk Management" (iFAAM) project has been working to address gaps in knowledge regarding food allergen management and analysis, including the development of novel MS and immuno-based allergen determination methods. Common allergenic food ingredients (peanut, hazelnut, walnut, cow's milk [Bos domesticus], and hen's egg [Gallus domesticus]) and common food matrixes (chocolate dessert and cookie) have been used for both clinical studies and analytical method development to ensure that the new methods are clinically relevant. Allergen molecules have been used as analytical targets and allergenic ingredients incurred into matrixes at levels close to reference doses that may trigger the use of precautionary allergen labeling. An interlaboratory method comparison has been undertaken for the determination of peanut in chocolate dessert using MS and immuno-based methods. The iFAAM approach has highlighted the need for methods to report test results in allergenic protein. This will allow food business operators to use them in risk assessments that are founded on clinical study data in which protein has been used as a measure of allergenic potency.

Healthy Living Behaviors Among Chinese-American Preschool-Aged Children: Results of a Parent Survey.

Associations between diet, physical activity, parenting, and acculturation among Chinese-American children are understudied. Parents/caregivers of children attending child-care programs in Boston Chinatown completed a self-administered survey on demographics, child's diet, physical activities, anthropometrics, and parenting practices. Associations were evaluated in multivariable regression analysis, stratified by survey language preference, a proxy for acculturation. Responding Asian families = 132; 86.4% were immigrants; 75.8% completed the Chinese-version survey. Children (mean ± SD: 4.9 ± 1.1 years) did not eat vegetables (31.8%), or play actively outside (45.4%) daily, 64.8% watched television/screens daily; 32.6% were overweight/obese (based on parent report). Parenting practices associated with obesity were apparent. Although healthy-living behavioral outcomes were less prevalent among less acculturated parents; multivariable adjustment attenuated the observed significant differences. Findings suggest opportunities for improvement in study children's diet and healthy-living behaviors, and underscore the need for further research on acculturation, and parenting styles in this population.

Supporting successful implementation of public health interventions: protocol for a realist synthesis.

BACKGROUND: There is a growing emphasis in public health on the importance of evidence-based interventions to improve population health and reduce health inequities. Equally important is the need for knowledge about how to implement these interventions successfully. Yet, a gap remains between the development of evidence-based public health interventions and their successful implementation. Conventional systematic reviews have been conducted on effective implementation in health care, but few in public health, so their relevance to public health is unclear. In most reviews, stringent inclusion criteria have excluded entire bodies of evidence that may be relevant for policy makers, program planners, and practitioners to understand implementation in the unique public health context. Realist synthesis is a theory-driven methodology that draws on diverse data from different study designs to explain how and why observed outcomes occur in different contexts and thus may be more appropriate for public health. METHODS: This paper presents a realist review protocol to answer the research question: Why are some public health interventions successfully implemented and others not? Based on a review of implementation theories and frameworks, we developed an initial program theory, adapted for public health from the Consolidated Framework for Implementation Research, to explain the implementation outcomes of public health interventions within particular contexts. This will guide us through the review process, which comprises eight iterative steps based on established realist review guidelines and quality standards. We aim to refine this initial theory into a 'final' realist program theory that explains important context-mechanism-outcome configurations in the successful implementation of public health interventions. DISCUSSION: Developing new public health interventions is costly and policy windows that support their implementation can be short lived. Ineffective implementation wastes scarce resources and is neither affordable nor sustainable. Public health interventions that are not implemented will not have their intended effects on improving population health and promoting health equity. This synthesis will provide evidence to support effective implementation of public health interventions taking into account the variable context of interventions. A series of knowledge translation products specific to the needs of knowledge users will be developed to provide implementation support. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015030052.

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.

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.

Effectiveness and cost-effectiveness of pediatric rotavirus vaccination in British Columbia: a model-based evaluation.

BACKGROUND: Rotavirus gastroenteritis (RVGE) is associated with widespread morbidity and mortality in children worldwide. In high-income countries, including Canada, the burden of RVGE relates largely to morbidity and healthcare utilization. Two live rotavirus vaccines (RotaTeq(®) (Merck Frosst Canada Ltd.) and Rotarix™ (GlaxoSmithKline Inc.)), are now approved for use in Canada, but their economic attractiveness has not been evaluated in the Canadian context. METHODS: We performed a model-based economic analysis using a Markov chain Monte Carlo simulation of RVGE in populations of British Columbia children. Models were parameterized based on best available data on disease natural history and epidemiology, vaccine effectiveness and cost, and healthcare costs, and calibrated such that projections of healthcare utilization and vaccine coverage closely matched empirical estimates. Robustness of projections was evaluated in deterministic and probabilistic sensitivity analyses. RESULTS: Based on the best available data, childhood immunization against RVGE was projected to prevent 63-81 infections per 100 children vaccinated, and to prevent substantial numbers of outpatient medical visits. It was projected that either vaccine would prevent 1-2 hospitalizations per 100 children immunized. Vaccination was projected to increase healthcare costs: immunization with Rotarix™ would prevent incident infections at a cost of approximately $10 per infection prevented or $2400 per quality-adjusted life-year gained. Vaccination with RotaTeq™ would be more costly and less effective and would not be preferred. Projections were robust in the face of wide-ranging sensitivity analyses. INTERPRETATION: The use of currently available vaccines against RVGE in British Columbia children is projected to result in a substantial reduction in the burden of illness and healthcare utilization associated with RVGE, with a modest increase in healthcare costs. RVGE vaccination should be considered "highly cost-effective" relative to other commonly available health interventions.

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.

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.

Functional bowel disorders in primary care: factors associated with health-related quality of life and doctor consultation.

BACKGROUND: The role of psychological factors in irritable bowel syndrome (IBS) remains unclear, particularly in a primary care setting, where relatively little research on this common and costly condition has been carried out. The aim of this study was to investigate the relative contribution of physical and psychological factors to health-related quality of life and health-care utilization in patients with functional bowel disease (IBS-like symptoms) in primary care. We also wished to establish the relevance of formal diagnostic criteria to IBS in the primary care setting. METHODS: This study used a cross-sectional design. Four hundred twenty patients with functional bowel disorders in primary care completed a series of measures, including bowel symptom status and severity, severity of psychological distress, personality, and quality of life. The number of visits to a general practitioner (GP) in the previous 12 months was recorded. RESULTS: The following variables were independently and highly significantly associated with health-related quality of life in patients with functional bowel disorders in primary care: total psychological symptom score, diarrhea severity, abdominal pain for >12 weeks, and abdominal distension. A similar pattern emerged between patients who met meet Rome II criteria for IBS and patients who did not meet Rome II criteria for IBS. Relatively few variables (either physical or psychological) had a major impact on the number of GP consultations, with the exception of frequency of bowel movements. CONCLUSION: This study confirms that psychological factors are significantly associated with health-related quality of life in patients with IBS in primary care. Physical symptom severity is also important. Relatively few symptom measures, either physical or psychological, have a major impact on doctor consultation rates in primary care.

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.