Effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention for the prevention of low back pain recurrence in Australia (WalkBack): a randomised controlled trial.

BACKGROUND: Recurrence of low back pain is common and a substantial contributor to the disease and economic burden of low back pain. Exercise is recommended to prevent recurrence, but the effectiveness and cost-effectiveness of an accessible and low-cost intervention, such as walking, is yet to be established. We aimed to investigate the clinical effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention to prevent the recurrence of low back pain. METHODS: WalkBack was a two-armed, randomised controlled trial, which recruited adults (aged 18 years or older) from across Australia who had recently recovered from an episode of non-specific low back pain that was not attributed to a specific diagnosis, and which lasted for at least 24 h. Participants were randomly assigned to an individualised, progressive walking and education intervention facilitated by six sessions with a physiotherapist across 6 months or to a no treatment control group (1:1). The randomisation schedule comprised randomly permuted blocks of 4, 6, and 8 and was stratified by history of more than two previous episodes of low back pain and referral method. Physiotherapists and participants were not masked to allocation. Participants were followed for a minimum of 12 months and a maximum of 36 months, depending on the date of enrolment. The primary outcome was days to the first recurrence of an activity-limiting episode of low back pain, collected in the intention-to-treat population via monthly self-report. Cost-effectiveness was evaluated from the societal perspective and expressed as incremental cost per quality-adjusted life-year (QALY) gained. The trial was prospectively registered (ACTRN12619001134112). FINDINGS: Between Sept 23, 2019, and June 10, 2022, 3206 potential participants were screened for eligibility, 2505 (78%) were excluded, and 701 were randomly assigned (351 to the intervention group and 350 to the no treatment control group). Most participants were female (565 [81%] of 701) and the mean age of participants was 54 years (SD 12). The intervention was effective in preventing an episode of activity-limiting low back pain (hazard ratio 0·72 [95% CI 0·60-0·85], p=0·0002). The median days to a recurrence was 208 days (95% CI 149-295) in the intervention group and 112 days (89-140) in the control group. The incremental cost per QALY gained was AU$7802, giving a 94% probability that the intervention was cost-effective at a willingness-to-pay threshold of $28 000. Although the total number of participants experiencing at least one adverse event over 12 months was similar between the intervention and control groups (183 [52%] of 351 and 190 [54%] of 350, respectively, p=0·60), there was a greater number of adverse events related to the lower extremities in the intervention group than in the control group (100 in the intervention group and 54 in the control group). INTERPRETATION: An individualised, progressive walking and education intervention significantly reduced low back pain recurrence. This accessible, scalable, and safe intervention could affect how low back pain is managed. FUNDING: National Health and Medical Research Council, Australia.

Cost-effectiveness of a Novel Hypoglycaemia Programme: The 'HARPdoc vs BGAT' RCT.

AIMS: To assess the cost-effectiveness of HARPdoc (Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised care), focussed upon cognitions and motivation, versus BGAT (Blood Glucose Awareness Training), focussed on behaviours and education, as adjunctive treatments for treatment-resistant problematic hypoglycaemia in type 1 diabetes, in a randomised controlled trial. METHODS: Eligible adults were randomised to either intervention. Quality of life (QoL, measured using EQ-5D-5L); cost of utilisation of health services (using the adult services utilization schedule, AD-SUS) and of programme implementation and curriculum delivery were measured. A cost-utility analysis was undertaken using quality-adjusted life years (QALYs) as a measure of trial participant outcome and cost-effectiveness was evaluated with reference to the incremental net benefit (INB) of HARPdoc compared to BGAT. RESULTS: Over 24 months mean total cost per participant was £194 lower for HARPdoc compared to BGAT (95% CI: -£2498 to £1942). HARPdoc was associated with a mean incremental gain of 0.067 QALYs/participant over 24 months post-randomisation: an equivalent gain of 24 days in full health. The mean INB of HARPdoc compared to BGAT over 24 months was positive: £1521/participant, indicating comparative cost-effectiveness, with an 85% probability of correctly inferring an INB > 0. CONCLUSIONS: Addressing health cognitions in people with treatment-resistant hypoglycaemia achieved cost-effectiveness compared to an alternative approach through improved QoL and reduced need for medical services, including hospital admissions. Compared to BGAT, HARPdoc offers a cost-effective adjunct to educational and technological solutions for problematic hypoglycaemia.

Are education, exercise and diet interventions a cost-effective treatment to manage hip and knee osteoarthritis? A systematic review.

OBJECTIVE: To identify research gaps and inform implementation we systematically reviewed the literature evaluating cost-effectiveness of recommended treatments (education, exercise and diet) for the management of hip and/or knee OA. METHODS: We searched Medline, Embase, Cochrane Central Register of Controlled Trials, National Health Services Economic Evaluation Database, and EconLit from inception to November 2019 for trial-based economic evaluations investigating hip and/or knee OA core treatments. Two investigators screened relevant publications, extracted data and synthesized results. Risk of bias was assessed using the Consensus on Health Economic Criteria list. RESULTS: Two cost-minimization, five cost-effectiveness and 16 cost-utility analyses evaluated core treatments in six health systems. Exercise therapy with and without education or diet was cost-effective or cost-saving compared to education or physician-delivered usual care at conventional willingness to pay (WTP) thresholds in 15 out of 16 publications. Exercise interventions were cost-effective compared to physiotherapist-delivered usual care in three studies at conventional WTP thresholds. Education interventions were not cost-effective compared to usual care or placebo at conventional WTP thresholds in three out of four publications. CONCLUSIONS: Structured core treatment programs were clinically effective and cost-effective, compared to physician-delivered usual care, in five health care systems. Providing education about core treatments was not consistently cost-effective. Implementing structured core treatment programs into funded clinical pathways would likely be an efficient use of health system resources and enhance physician-delivered usual primary care.

Return on investment of self-management education and home visits for children with asthma.

OBJECTIVE: Priorities of the Centers for Disease Control and Prevention's 6|18 Initiative include outpatient asthma self-management education (ASME) and home-based asthma visits (home visit) as interventions for children with poorly-controlled asthma. ASME and home visit intervention programs are currently not widely available. This project was to assess the economic sustainability of these programs for state asthma control programs reimbursed by Medicaid. METHODS: We used a simulation model based on parameters from the literature and Medicaid claims, controlling for regression to the mean. We modeled scenarios under various selection criteria based on healthcare utilization and age to forecast the return on investment (ROI) using data from New York. The resulting tool is available in Excel or Python. RESULTS: Our model projected health improvement and cost savings for all simulated interventions. Compared against home visits alone, the simulated ASME alone intervention had a higher ROI for all healthcare utilization and age scenarios. Savings were primarily highest in simulated program participants who had two or more asthma-related emergency department visits or one inpatient visit compared to those participants who had one or more asthma-related emergency department visits. Segmenting the selection criteria by age did not significantly change the results. CONCLUSIONS: This model forecasts reduced healthcare costs and improved health outcomes as a result of ASME and home visits for children with high urgent healthcare utilization (more than two emergency department visits or one inpatient hospitalization) for asthma. Utilizing specific selection criteria, state based asthma control programs can improve health and reduce healthcare costs.

Cost-effectiveness of 12 weeks of supervised treatment compared to written advice in patients with knee osteoarthritis: a secondary analysis of the 2-year outcome from a randomized trial.

OBJECTIVE: To assess the 24-month cost-effectiveness of supervised treatment compared to written advice in knee osteoarthritis (OA). DESIGN: 100 adults with moderate-severe OA not eligible for total knee replacement (TKR) randomized to a 12-week individualized, supervised treatment (exercise, education, diet, insoles and pain medication) or written advice. Effectiveness was measured as change in quality-adjusted life years (QALYs) from baseline to 24 months, including data from baseline, 3, 6, 12 and 24 months, while healthcare costs and transfer payments were derived from national registries after final follow-up. Incremental costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated. A sensitivity analysis resampling existing data was conducted and the probability of cost-effectiveness was estimated using a 22,665 Euros/QALY threshold. In a sensitivity analysis, cost-effectiveness was calculated for different costs of the supervised treatment (actual cost in study; cost in private practice; and in-between cost). RESULTS: Average costs were similar between groups (6,758 Euros vs 6,880 Euros), while the supervised treatment were close to being more effective (incremental effect (95% CI) of 0.075 (-0.005 to 0.156). In the primary analysis excluding deaths, this led the supervised treatment to be cost-effective, compared to written advice. The sensitivity analysis demonstrated that the results were sensitive to changes in the cost of treatment, but in all scenarios the supervised treatment was cost-effective (ICERs of 6,229 to 20,688 Euros/QALY). CONCLUSIONS: From a 24-month perspective, a 12-week individualized, supervised treatment program is cost-effective compared to written advice in patients with moderate-severe knee OA not eligible for TKR. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT01535001.

Systematic Review of Economic Evaluations of Primary Caries Prevention in 2- to 5-Year-Old Preschool Children.

OBJECTIVES: To describe and summarize evidence on economic evaluations (EEs) of primary caries prevention in preschool children aged 2 to 5 years and to evaluate the reporting quality of full EE studies using a quality assessment tool. METHODS: A systematic literature search was conducted in several databases. Full and partial EEs were included. The reporting quality of full EE studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. RESULTS: A total of 808 studies were identified, and 39 were included in the review. Most papers were published between 2000 and 2017 and originated in the United States and the United Kingdom. The most common type of intervention investigated was a complex multicomponent intervention, followed by water fluoridation. Cost analysis and cost-effectiveness analysis were the most frequently used types of EE. One study employed cost-utility analysis. The proportion of full EEs increased over time. The parameters not reported well included study perspective, baseline year, sensitivity analysis, and discount rate. The CHEERS items that were most often unmet were characterizing uncertainty, study perspective, study parameters, and estimating resources and costs. CONCLUSIONS: Within the past 2 decades, there has been an increase in the number of EEs of caries prevention interventions in preschool children. There was inconsistency in how EEs were conducted and reported. Lack of preference-based health-related quality-of-life measure utilization in the field was identified. The use of appropriate study methodologies and greater attention to recommended EE design are required to further improve quality.

Vestibular rehabilitation in multiple sclerosis: study protocol for a randomised controlled trial and cost-effectiveness analysis comparing customised with booklet based vestibular rehabilitation for vestibulopathy and a 12 month observational cohort study of the symptom reduction and recurrence rate following treatment for benign paroxysmal positional vertigo.

BACKGROUND: Symptoms arising from vestibular system dysfunction are observed in 49-59% of people with Multiple Sclerosis (MS). Symptoms may include vertigo, dizziness and/or imbalance. These impact on functional ability, contribute to falls and significant health and social care costs. In people with MS, vestibular dysfunction can be due to peripheral pathology that may include Benign Paroxysmal Positional Vertigo (BPPV), as well as central or combined pathology. Vestibular symptoms may be treated with vestibular rehabilitation (VR), and with repositioning manoeuvres in the case of BPPV. However, there is a paucity of evidence about the rate and degree of symptom recovery with VR for people with MS and vestibulopathy. In addition, given the multiplicity of symptoms and underpinning vestibular pathologies often seen in people with MS, a customised VR approach may be more clinically appropriate and cost effective than generic booklet-based approaches. Likewise, BPPV should be identified and treated appropriately. METHODS/ DESIGN: People with MS and symptoms of vertigo, dizziness and/or imbalance will be screened for central and/or peripheral vestibulopathy and/or BPPV. Following consent, people with BPPV will be treated with re-positioning manoeuvres over 1-3 sessions and followed up at 6 and 12 months to assess for any re-occurrence of BPPV. People with central and/or peripheral vestibulopathy will be entered into a randomised controlled trial (RCT). Trial participants will be randomly allocated (1:1) to either a 12-week generic booklet-based home programme with telephone support or a 12-week VR programme consisting of customised treatment including 12 face-to-face sessions and a home exercise programme. Customised or booklet-based interventions will start 2 weeks after randomisation and all trial participants will be followed up 14 and 26 weeks from randomisation. The primary clinical outcome is the Dizziness Handicap Inventory at 26 weeks and the primary economic endpoint is quality-adjusted life-years. A range of secondary outcomes associated with vestibular function will be used. DISCUSSION: If customised VR is demonstrated to be clinically and cost-effective compared to generic booklet-based VR this will inform practice guidelines and the development of training packages for therapists in the diagnosis and treatment of vestibulopathy in people with MS. TRIAL REGISTRATION: ISRCTN Number: 27374299 Date of Registration 24/09/2018 Protocol Version 15 25/09/2019.

Feasibility, acceptability and cost efficiency of using webinars to deliver first-line patient education for people with Irritable Bowel Syndrome as part of a dietetic-led gastroenterology service in primary care.

BACKGROUND: Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disorder. International research suggests dietary intervention as a first-line approach, although dietetic services are struggling to cope with demand. Digital technology may offer a solution to deliver appropriate patient education. The present study aimed to assess the feasibility, acceptability and cost efficiency of using webinars to deliver first-line IBS advice to patients as part of a dietetic-led gastroenterology service in primary care. METHODS: Patients were directed to an IBS First Line Advice webinar on a specialist NHS website. Data were collected from patients pre- and post-webinar use using an online survey. RESULTS: In total, 1171 attendees completed the pre-webinar survey and 443 completed the post-webinar survey. Attendees ranged from under 17 years to over 75 years. Of the attendees, 95% found the webinar easy to access and 91% were satisfied with the content of the webinar. Those with excellent or good knowledge rose from 25% pre-webinar to 67% post-webinar, and confidence in managing their condition improved for 74% of attendees. Using the webinars led to a 44% reduction in referrals for one-to-one appointments with a specialist dietitian in the first year of use. The value of the clinical time saved is estimated at £3593 per annum. The one-off cost of creating the webinar was £3597. CONCLUSIONS: The use of webinars is a feasible, acceptable and cost-efficient way of delivering first-line patient education to people suffering with Irritable Bowel Syndrome as part of a dietetic-led gastroenterology service in primary care.

Socioeconomic status of patients in a Swedish national self-management program for osteoarthritis compared with the general population-a descriptive observational study.

BACKGROUND: First-line treatment for hip and knee osteoarthritis (OA) including education and supervised exercises, delivered as a self-management program, is considered one of the mainstays in OA treatment. However, the socioeconomic profile of the population that utilizes first-line treatment for hip and knee OA is unclear. The aim of this study was to describe the socioeconomic status (SES) of a population referred to a self-management program for OA, in comparison with that of the general Swedish population. METHODS: This is a cross-sectional study including 72,069 patients with hip or knee OA enrolled in the National Quality Register for Better management of patients with Osteoarthritis (BOA) between 2008 and 2016, and registered before participation in a structured OA self-management program. A reference cohort (n = 216,207) was selected from the general Swedish population by one-to-three matching by year of birth, sex and residence. Residential municipality, country of birth, marital status, family type, educational level, employment, occupation, disposable income and sick leave were analyzed. RESULTS: The BOA population had higher educational level than the reference group, both regarding patients with hip OA (77.5% vs 70% with ≥10 years of education), and with knee OA (77% vs 72% with ≥10 years of education). Their average disposable income was higher (median [IQR] in Euro (€), for hip €17,442 [10,478] vs €15,998 [10,659], for knee €17,794 [10,574] vs €16,578 [11,221]). Of those who worked, 46% of patients with hip OA and 45% of the reference group had a blue-collar occupation. The corresponding numbers for knee OA were 51 and 44% respectively. Sick leave was higher among those with hip and knee OA (26%) than those in the reference groups (13% vs 12%). CONCLUSIONS: The consistently higher SES in the BOA population compared with the general population indicates that this self-management program for OA may not reach the more socioeconomically disadvantaged groups, who are often those with a higher disease burden.

Does face-to-face pre-operative joint replacement education reduce hospital costs in a regional Australian hospital? A descriptive retrospective clinical audit.

OBJECTIVE: To evaluate whether attending a face-to-face pre-operative joint replacement education in a regional setting reduces overall hospital costs and length of stay (LOS) following total knee replacement (TKR) or total hip replacement (THR). METHODS: A retrospective clinical audit reviewed the medical records of all patients who underwent an elective THR or TKR at Rockhampton Hospital in regional Queensland, Australia, between 03/2015 and 12/2016 (22 months). The pre-operative joint replacement education class was provided by a multidisciplinary team that included a physiotherapist, an occupational therapist, a dietician, a pharmacist and a social worker. In addition to demographic data, we extracted and analysed data related to total acute care and total healthcare cost, prevalence of post-operative complications, discharge destination and comorbidities (using the Functional Comorbidity Index). RESULTS: Out of 326 cases that were included in the analysis, 115 cases with TKR and 51 cases with THR attended a pre-operative education class. Demographic characteristics between those attending and not attending the class were largely similar, except from more females attending in the THR group. There was no difference in hospital costs or LOS between those who attended the class compared to those who did not for both the TKR and THR groups. Outcomes related to total acute stay costs, total cost including travel and education and score for Functional Comorbidities Index were similar between those who attended the class and those who did not. CONCLUSION: Pre-operative education does not reduce hospital costs (surgery and hospital stay) in Central Queensland.

Exploring organizational support for the provision of structured self-management education for people with Type 2 diabetes: findings from a qualitative study.

AIM: To explore the organizational context in which Type 2 diabetes structured group education is provided. METHODS: Four Clinical Commissioning Groups in England providing Type 2 diabetes structured self-management education participated in a qualitative study exploring the context for provision of that education. Using UK National Diabetes Audit returns, two Clinical Commissioning Groups were selected that had non-attendance rates of ≤25%, and two that had non-attendance rates of ≥50%. Between May 2016 and August 2017, 20 interviews were conducted with Clinical Commissioning Group staff including: commissioners, healthcare professionals, managers, general practitioners and diabetes educators. Data gathering was prolonged as it proved challenging to engage with healthcare staff as a result of frequent local restructuring and service disruption. RESULTS: Local audits revealed discrepancies in basic data such as referral and attendance numbers compared with national audit data. There was a commonality in the themes identified from interviews: diabetes education was rarely embedded in service structure; where education uptake was poor, a lack of central support to delivery teams was noticeable; and where education uptake was positive, delivery teams were actively engaged, sometimes relying on enthusiastic individuals. Both situations put the local sustainability of diabetes education at risk. CONCLUSIONS: There appears to be a link between attendance rates and organizational issues, therefore, when considering how to increase attendance rates, the state of the diabetes education infrastructure should be reviewed. Good uptake of diabetes education can be too reliant on the enthusiastic commitment of small teams or individuals delivering the education.

The Role of the Clinical Pharmacist in a Preventive Cardiology Practice.

Background: Cardiovascular disease (CVD) remains the leading cause of morbidity and mortality worldwide. In response, a multidisciplinary team approach, which includes clinical pharmacists, is recommended to improve patient outcomes. The purpose of the study was to describe interventions associated with integration of a clinical pharmacist, with an emphasis on pharmacist-generated patient cost avoidance. Methods: This is a prospective observational study detailing pharmacist-initiated interventions within an academic preventive cardiology service. Interventions targeting pharmacotherapy optimization, side effect management, patient education, medication adherence, and cost avoidance were implemented during shared office visits with providers and/or on provider consultation for remote follow-up. Tabulation of cost avoidance was arranged into 2 formats: clinical interventions implemented by the pharmacist and direct patient out-of-pocket expense reduction. Money saved per clinical intervention was extrapolated from data previously published. Patient out-of-pocket expense prior to and after pharmacist involvement was calculated to assess aggregate yearly patient cost savings. Results: Over 12 months the pharmacist intervened on 974 patients, totaling 3725 interventions. Cost avoidance strategies resulted in yearly savings of $830 748 in aggregate-$149 566 from clinical interventions and $681 182 from patient out-of-pocket expense reduction. Monthly patient out-of-pocket expense was reduced from a median (interquartile range) of $217 ($83.5-$347) before to $5 ($0-$18) after pharmacist intervention. Conclusions: Addition of a clinical pharmacist within an academic preventive cardiology clinic generated substantial pharmacotherapy interventions, resulting in significant cost avoidance for patients. The resulting cost avoidance may result in improved medication adherence and clinical outcomes.

Trial of personalised care after treatment-Prostate cancer: A randomised feasibility trial of a nurse-led psycho-educational intervention.

OBJECTIVE: The present parallel randomised control trial evaluated the feasibility of a nurse-led psycho-educational intervention aimed at improving the self-management of prostate cancer survivors. METHODS: We identified 305 eligible patients from a district general hospital, diagnosed 9-48 months previously, who completed radical treatment, or were monitored clinically (ineligible for treatment). Ninety-five patients were recruited by blinded selection and randomised to Intervention (N = 48) and Control (N = 47) groups. Participant allocation was revealed to patients and researchers after recruitment was completed. For 36 weeks, participants received augmented usual care (Control) or augmented usual care and additional nurse support (Intervention) provided in two community hospitals and a university clinic, or by telephone. RESULTS: Data from 91 participants (Intervention, N = 45; Control, N = 46) were analysed. All feasibility metrics met predefined targets: recruitment rate (31.15%; 95% CI: 25.95%-36.35%), attrition rate (9.47%; 95% CI: 3.58%-15.36%) and outcome measures completion rates (77%-92%). Forty-five patients received the intervention, with no adverse events. The Extended Prostate Cancer Index Composite can inform the minimum sample size for a future effectiveness trial. The net intervention cost was £317 per patient. CONCLUSIONS: The results supported the feasibility and acceptability of the intervention, suggesting that it should be evaluated in a fully powered trial to assess its effectiveness and cost-effectiveness.

Cost-effectiveness of an educational healthcare circuit for bariatric surgery in France.

OBJECTIVES: An educational healthcare circuit (EHC) is proposed with the objective of preventing weight recovery of patients after bariatric surgery through education and lifestyle change. The objective of this study was to measure the viability of the EHC (shared medical appointments [SMAs] combined with bariatric surgery) through cost-effectiveness analysis. The EHC presented in this study is innovative because it offers a multidisciplinary approach based on medical, psychological and dietetic expertise to combat obesity. The strategy is to give the patient a diagnosis and then a personalised follow-up. STUDY DESIGN: A mathematical model based on a decision tree (1 year) and a Markov model (10 years) to measure the efficiency and cost of an EHC in comparison with the customary care offered in France were built. METHODS: The effects of the EHC were observed for the prevalence of type 2 diabetes and the risk of cardiovascular disease. The chosen financial perspective is from the point of view of the French social security system. RESULTS: The EHC records an incremental cost-effective ratio (ICER) of € 48,315.43 per quality-adjusted life year (QALY) over a 1-year horizon and € 28,283.77 per QALY over 10 years (with discount rate of 8%: € 25,362.85 per QALY). CONCLUSION: The results suggest that an EHC is more expensive yet more effective than usual care. That is, in the short term, the costs are high, but at 10 years, the treatment is cost-effective, representing a feasible alternative for those patients who qualify for bariatric surgery in France.

Essential elements of an outpatient total joint replacement programme.

PURPOSE OF REVIEW: To summarize the safety and feasibility of outpatient total joint arthroplasty (TJA) from the perspectives of short-term complications, long-term functional outcomes, patient satisfaction and financial impact, and to provide evidence-based guidance on how to establish an outpatient TJA programme. RECENT FINDINGS: TJA has been recently transitioned from an exclusively inpatient procedure for all Medicare and Medicaid patients to an outpatient surgery in properly selected total knee arthroplasty patients. This change may decrease costs while maintaining comparable rates of readmission, adverse events, positive surgical outcomes and patient satisfaction. SUMMARY: With a standardized clinical pathway, outpatient TJA can be safe and effective in a subset of patients. Essential components of a successful outpatient TJA programme include proper patient selection, preoperative patient/family education, perioperative multidisciplinary coordination and opioid-sparing analgesia, and early and effective postdischarge planning. More studies are needed to further assess and optimize this new care paradigm.

Cost-effectiveness of the psycho-educational blended (group and online) intervention HypoAware compared with usual care for people with Type 1 and insulin-treated Type 2 diabetes with problematic hypoglycaemia: analyses of a cluster-randomized controlled trial.

AIMS: To evaluate the cost-effectiveness of HypoAware, a blended (group and online) psycho-educational intervention based on the evidence-based Blood Glucose Awareness Training, in comparison with usual care in people with Type 1 and Type 2 diabetes with a high risk of severe hypoglycaemia. METHODS: We performed an economic evaluation, from a societal and healthcare perspective, that used data from a 6-month, multicentre, cluster-randomized controlled trial (n = 137). RESULTS: The proportion of people with at least one severe hypoglycaemic event per 6 months was 0.22 lower (95% CI -0.39 to -0.06) and the proportion of people with impaired hypoglycaemia awareness was 0.16 lower (95% CI -0.34 to 0.02) in the HypoAware group. There was no difference in quality-adjusted life-years (-0.0; 95% CI -0.05 to 0.05). The mean total societal costs in the HypoAware group were EUR708 higher than in the usual care group (95% CI -951 to 2298). The mean incremental cost per severe hypoglycaemic event prevented was EUR2,233. At a willingness-to-pay threshold of EUR20,000 per event prevented, the probability that HypoAware was cost-effective in comparison with usual care was 54% from a societal perspective and 55% from a healthcare perspective. For quality-adjusted life-years the incremental cost-effectiveness ratio was EUR119,360/quality-adjusted life-year gained and the probability of cost-effectiveness was low at all ceiling ratios. CONCLUSIONS: Based on the present study, we conclude that HypoAware is not cost-effective compared to usual care. Further research in less well-resourced settings and more severely affected patients is warranted. (Clinical Trials Registry no: Dutch Trial Register NTR4538.).

An innovative lab-based training program to help patient groups understand their disease and the research process.

Genuine partnership between patient groups and medical experts is important but challenging. Our training program meets this challenge by organizing hands-on, lab-based training sessions for members of patient groups. These sessions allow "trainees" to better understand their disease and the biomedical research process, and strengthen links between patients and local researchers. Over the past decade, we and our partner institutes have received more than 900 French patients, with the participation of over 60 researchers and clinicians.

Costs of an ostomy self-management training program for cancer survivors.

OBJECTIVE: To measure incremental expenses to an oncologic surgical practice for delivering a community-based, ostomy nurse-led, small-group, behavior skills-training intervention to help bladder and colorectal cancer survivors understand and adjust to their ostomies and improve their health-related quality of life, as well as assist family caregivers to understand survivors' needs and provide appropriate supportive care. METHODS: The intervention was a 5-session group behavior skills training in ostomy self-management following the principles of the Chronic Care Model. Faculty included Wound, Ostomy, and Continence Nurses (WOCNs) using an ostomy care curriculum. A gender-matched peer-in-time buddy was assigned to each ostomy survivor. The 4-session survivor curriculum included the following: self-management practice and solving immediate ostomy concerns; social well-being; healthy lifestyle; and a booster session. The single family caregiver session was coled by a WOCN and an ostomy peer staff member and covered relevant caregiver and ostomate support issues. Each cohort required 8 weeks to complete the intervention. Nonlabor inputs included ostomy supplies, teaching materials, automobile mileage for WOCNs, mailing, and meeting space rental. Intervention personnel were employed by the University of Arizona. Labor expenses included salaries and fringe benefits. RESULTS: The total incremental expense per intervention cohort of 4 survivors was $7246 or $1812 per patient. CONCLUSIONS: A WOCN-led group self-help ostomy survivorship intervention provided affordable, effective, care to cancer survivors with ostomies.

Improving type 2 diabetes mellitus glycaemic outcomes is possible without spending more on medication: Lessons from the UK National Diabetes Audit.

AIMS: To determine the factors at general practice level that relate to glycaemic control outcomes in people with type 2 diabetes (T2DM). METHODS: Data were accessed from 4050 general practices (50% of total) covering 1.6 million patients with T2DM in the UK National Diabetes Audit 2013 to 2014 and 2014 to 2015. This audit reported characteristics, services and outcomes in the T2DM population, including percentage of patients who had total glycaemic control (TGC), defined as glycated haemoglobin (HbA1c) ≤7.5% (58 mmol/mol), and the percentage who were at higher glycaemic risk (HGR), defined as HbA1c >10% (86 mmol/mol); the respective figures were 67.2% and 6.2%. The medication data were examined in terms of annual defined daily doses (DDDs). Multivariate linear regression analysis was used to identify associations between DDD and patient and practice characteristics. RESULTS: Over the period 2012/2013 to 2015/2016, patient numbers grew 4% annually and annual medication expenditure by 8%, but glycaemic control outcomes did not improve. The main findings were that practices with better outcomes: had a higher percentage of patients aged >65 years; provided more effective diabetes services (including case identification, care checks, patient education, percentage of patients with blood pressure and cholesterol under control and more patients with type 1 diabetes achieving target HbA1c levels); spent less overall on prescribing per patient with T2DM; and on average, prescribed fewer sulphonylureas, less insulin (for patients with T2DM), fewer glucagon-like peptide-1 agonists, more metformin, more dipeptidyl peptidase-4 inhibitors, and more blood glucose monitoring strips. Ethnicity and social disadvantage and levels of thiazolidinedione (glitazone) prescribing had no significant impact on outcomes. Sodium-glucose co-transporter-2 inhibitor use was too low for an effect to be observed in the period examined. CONCLUSIONS: If all practices brought their service and medication to the level of the top decile practices, they could achieve 74.7% compared with the median of 67.3% of patients achieving TGC, showing an increase of 213 000 in patients achieving TGC, while reducing the number at HGR to 3.8% compared with 6.1%, benefiting 62 000 patients. This could have a major impact on the overall consequent healthcare costs of managing diabetes complications with their attendant mortality risks.

Cost-Effectiveness of a Comprehensive Approach for Hypertension Control in Low-Income Settings in Argentina: Trial-Based Analysis of the Hypertension Control Program in Argentina.

BACKGROUND: A recent cluster randomized trial evaluating a multicomponent intervention showed significant reductions in blood pressure in low-income hypertensive subjects in Argentina. OBJECTIVES: To assess the cost-effectiveness of this intervention. METHODS: A total of 1432 hypertensive participants were recruited from 18 primary health care centers. The intervention included home visits led by community health workers, physician education, and text messaging. Resource use and quality of life data using the three-level EuroQol five-dimensional questionnaire were prospectively collected. The study perspective was that of the public health care system, and the time horizon was 18 months. Intention-to-treat analysis was used to analyze cost and health outcomes (systolic blood pressure [SBP] change and quality-adjusted life-years [QALYs]). A 1 time gross domestic product per capita per QALY was used as the cost-effectiveness threshold (US $14,062). RESULTS: Baseline characteristics were similar in the two arms. QALYs significantly increased by 0.06 (95% confidence interval [CI] 0.04-0.09) in the intervention group, and SBP net difference favored the intervention group: 5.3 mm Hg (95% CI 0.27-10.34). Mean total costs per participant were higher in the intervention arm: US $304 in the intervention group and US $154 in the control group (adjusted difference of US $140.18; 95% CI US $75.41-US $204.94). The incremental cost-effectiveness ratio was $3299 per QALY (95% credible interval 1635-6099) and US $26 per mm Hg of SBP (95% credible interval 13-46). Subgroup analysis showed that the intervention was cost-effective in all prespecified subgroups (age, sex, cardiovascular risk, and body mass index). CONCLUSIONS: The multicomponent intervention was cost-effective for blood pressure control among low-income hypertensive patients.