Quantifying the subjective cost of self-control in humans.

Since Odysseus committed to resisting the Sirens, mechanisms to limit self-control failure have been a central feature of human behavior. Psychologists have long argued that the use of self-control is an effortful process and, more recently, that its failure arises when the cognitive costs of self-control outweigh its perceived benefits. In a similar way, economists have argued that sophisticated choosers can adopt "precommitment strategies" that tie the hands of their future selves in order to reduce these costs. Yet, we still lack an empirical tool to quantify and demonstrate the cost of self-control. Here, we develop and validate an economic decision-making task to quantify the subjective cost of self-control by determining the monetary cost a person is willing to incur in order to eliminate the need for self-control. We find that humans will pay to avoid having to exert self-control in a way that scales with increasing levels of temptation and that these costs appear to be modulated both by motivational incentives and stress exposure. Our psychophysical approach allows us to index moment-to-moment self-control costs at the within-subject level, validating important theoretical work across multiple disciplines and opening avenues of self-control research in healthy and clinical populations.

Modelling the Cost-Effectiveness of Implementing a Dietary Intervention in Renal Transplant Recipients.

BACKGROUND: The Dietary Approach to Stop Hypertension (DASH) and potassium supplementation have been shown to reduce the risk of death with a functioning graft (DWFG) and renal graft failure in renal transplant recipients (RTR). Unfortunately, a key problem for patients is the adherence to these diets. The aim of this study is to evaluate the cost-effectiveness and budget impact of higher adherence to either the DASH or potassium supplementation. METHODS: A Markov model was used to simulate the life course of 1000 RTR in the Netherlands. A societal perspective with a lifetime time horizon was used. The potential effect of improvement of dietary adherence was modelled in different scenarios. The primary outcomes are the incremental cost-effectiveness ratio (ICER) and the budget impact. RESULTS: In the base case, improved adherence to the DASH diet saved 27,934,786 and gained 1880 quality-adjusted life years (QALYs). Improved adherence to potassium supplementation saved €1,217,803 and gained 2901 QALYs. Both resulted in dominant ICERs. The budget impact over a five-year period for the entire Dutch RTR population was €8,144,693. CONCLUSION: Improving dietary adherence in RTR is likely to be cost-saving and highly likely to be cost-effective compared to the current standard of care in the Netherlands.

A Systematic Review of Cost-Effectiveness Studies of Interventions With a Personalized Nutrition Component in Adults.

OBJECTIVES: Important links between dietary patterns and diseases have been widely applied to establish nutrition interventions. However, knowledge about between-person heterogeneity regarding the benefits of nutrition intervention can be used to personalize the intervention and thereby improve health outcomes and efficiency. We performed a systematic review of cost-effectiveness analyses (CEAs) of interventions with a personalized nutrition (PN) component to assess their methodology and findings. METHODS: A systematic search (March 2019) was performed in 5 databases: EMBASE, Medline Ovid, Web of Science, Cochrane CENTRAL, and Google Scholar. CEAs involving interventions in adults with a PN component were included; CEAs focusing on clinical nutrition or undernutrition were excluded. The CHEERS checklist was used to assess the quality of CEAs. RESULTS: We identified 49 eligible studies among 1792 unique records. Substantial variation in methodology was found. Most studies (91%) focused only on psychological concepts of PN such as behavior and preferences. Thirty-four CEAs were trial-based, 13 were modeling studies, and 4 studies were both trial- and model-based. Thirty-two studies used quality-adjusted life year as an outcome measure. Different time horizons, comparators, and modeling assumptions were applied, leading to differences in costs/quality-adjusted life years. Twenty-eight CEAs (49%) concluded that the intervention was cost-effective, and 75% of the incremental cost-utility ratios were cost-effective given a willingness-to-pay threshold of $50 000 per quality-adjusted life year. CONCLUSIONS: Interventions with PN components are often evaluated using various types of models. However, most PN interventions have been considered cost-effective. More studies should examine the cost-effectiveness of PN interventions that combine psychological and biological concepts of personalization.

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.

The use of diet modifications and third-party disability in adult dysphagia: The unforeseen burden of caregivers in an economically developing country.

BACKGROUND: One of the interventions for dysphagia is diet modifications, involving a variety of resources and consumables. In South Africa, where 49% of the population live below the poverty line, the necessities for it are not always feasible for the patient and their family. This coupled with the responsibility of caring for a loved one with disability can culminate into caregivers experiencing third-party disability (TPD). OBJECTIVE: To describe the experiences of TPD of caregivers when implementing dysphagia management strategies at home within an economically developing country context. METHODS: This was a qualitative study using phenomenological principles. Data were collected using a semi-structured self-developed interview tool at three tertiary level public sector hospitals. Seven participants and six caregivers were interviewed. Rigour was obtained through credibility, triangulation, transferability, dependability and confirmability. The data were analysed using a thematic content analysis technique following a top-down approach to coding. RESULTS: The use of diet modification is an appropriate management strategy if the patients' access and contextual limitations have been taken into consideration. It was evident that the caregivers had multiple International Classification of Functioning, Disability and Health domains affected, which restricted their daily functioning including activities, participation and environmental and personal factors. CONCLUSION: The management of dysphagia needs to be family centred and the caregiver's role and needs have to be considered by all team members when determining long-term management plans. The specific area of how the caregiver's quality of life was experienced also required further exploration.

Difficulties and factors influencing purchase decision. The perspective of families with children with autism spectrum disorders on a gluten-free and casein-free diet. Preliminary study.

Background: Gluten-free and casein-free diet is frequently used in the support of therapy of children with autism spectrum disorders. In addition, many parents restrict the consumption of simple sugars for their children. Objective: The aim of this paper was to understand factors influencing purchase decision in case of family with children with autism spectrum disorders on gluten-free and/or casein-free and/or sugar-free diet and the difficulties associated with this type of nutrition. Material and methods: The study covered a group of 40 families with children with autism spectrum disorders (32 boys and 8 girls) aged 3 to 10 years. Data were collected with questionnaire included questions concerning overall characteristics of caregivers, availability of foods used in the special diet, factors affecting decision on the purchase of products, difficulties in maintaining the child nutrition method. Results: The factors having strongest impact on parents' decisions on the purchase of products were product composition, presence of a certificate confirming the absence of gluten and/or milk and taste values. Exclusion diet constituted a considerable obstruction for traveling, social gatherings and resulted in conflicts with family and the environment. The limited range of healthy gluten-free, casein-free and sugar-free foods, low taste quality and unsatisfactory quality impeded purchase and preparation of varied meals. Conclusions: The surveyed parents were aware consumers, paying attention primarily to product composition and safety. The respondents were looking for healthy, organic and nutritionally valuable products with low sugar content. Further development of the gluten/casein/ sugar free products market may considerably improve certain aspects of family's life with children with autism spectrum disorders.

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.

Cost effectiveness and cost-utility analysis of a group-based diet intervention for treating major depression - the HELFIMED trial.

Background/objectives: Major depression has a negative impact on quality of life, increasing the risk of premature death. It imposes social and economic costs on individuals, families and society. Mental illness is now the leading cause globally of disability/lost quality life and premature mortality. Finding cost-effective treatments for depression is a public health priority. We report an economic evaluation of a dietary intervention for treating major depression. Methods: This economic evaluation drew on the HELFIMED RCT, a 3-month group-based Mediterranean-style diet (MedDiet) intervention (including cooking workshops), against a social group-program for people with major depression. We conducted (i) a cost-utility analysis, utility scores measured at baseline, 3-months and 6-months using the AQoL8D, modelled to 2 years (base case); (ii) a cost-effectiveness analysis, differential cost/case of depression resolved (to normal/mild) measured by the DASS. Differential program costs were calculated from resources use costed in AUD2017. QALYs were discounted at 3.5%pa. Results: Best estimate differential cost/QALY gain per person, MedDiet relative to social group was AUD2775. Probabilistic sensitivity analysis, varying costs, utility gain, model period found 95% likelihood cost/QALY less than AUD20,000. Estimated cost per additional case of depression resolved, MedDiet group relative to social group was AUD2,225. Conclusions: A MedDiet group-program for treating major depression was highly cost-effective relative to a social group-program, measured in terms of cost/QALY gain and cost per case of major depression resolved. Supporting access by persons with major depression to group-based dietary programs should be a policy priority. A change to funding will be needed to realise the potential benefits.

Design and participant characteristics of a primary care adaptation of the Look AHEAD Lifestyle Intervention for weight loss in type 2 diabetes: The REAL HEALTH-diabetes study.

BACKGROUND/AIMS: The REAL HEALTH -Diabetes Study is a practice-based clinical trial that adapted the Look AHEAD lifestyle intervention for implementation in primary care settings. The trial will compare the effectiveness and cost-effectiveness of in-person group lifestyle intervention, telephone group lifestyle intervention, and individual medical nutrition therapy (MNT), the current recommended standard of care in type 2 diabetes. The primary outcome is percent weight loss at 6 months with outcomes also measured at 12, 18, 24 (intervention completion), and 36 months. Here, we describe the adaptation, trial design, implementation strategies, and baseline characteristics of enrolled participants. METHODS: The study is a three-arm, patient-level, randomized trial conducted in three community health centers (CHCs) and one diabetes practice affiliated with one academic medical center. RESULTS: The study used existing clinical infrastructure to recruit participants from study sites. Strategies for successful conduct of the trial included partnering with health-center based co-investigator clinicians, engaging primary care providers, and accommodating clinical workflows. Of 248 eligible patients who attended a screening visit, 211 enrolled, with 70 randomly assigned to in-person group lifestyle intervention, 72 to telephone group lifestyle intervention, and 69 to MNT. The cohort was 55% female, 29% non-white, with mean age 62 years and mean BMI 35 kg/m2. Enrollment rates were higher at CHC sites. CONCLUSIONS: A practice-based randomized trial of a complex behavioral lifestyle intervention for type 2 diabetes can be implemented in community health and usual clinical settings. Participant and provider engagement was higher at local CHC sites reflecting the study implementation focus. CLINICAL TRIAL REGISTRATION: NCT02320253.

Costes asociados a la desnutrición previa a la enfermedad y la desnutrición relacionada con la enfermedad en ancianos: una revisión sistemática / Cost associated with malnutrition prior to disease and disease-related malnutrition in the elderly: a systematic review

Introducción: la desnutrición es un problema de salud que afecta en un elevado porcentaje al colectivo de ancianos, ya que los cambios físicos y psicosociales propios de esta etapa de la vida favorecen la aparición de la misma. Además, la población anciana presenta una elevada prevalencia en enfermedades crónicas y patologías agudas que pueden afectar negativamente al estado nutricional, provocando desnutrición relacionada con la enfermedad. Objetivo: el propósito de esta revisión sistemática fue analizar el coste económico relacionado con la desnutrición en personas mayores y si existen diferencias entre los costes de la desnutrición previa a la enfermedad y la desnutrición relacionada con la enfermedad. Método: se realizó una búsqueda bibliográfica en las bases de datos Pubmed, Web of Science y Scopus, para el periodo comprendido entre 2000 y 2016. Resultados: se encontraron un total de 1.001 artículos y, utilizando los criterios de inclusión, se seleccionaron 19. De ellos, once analizaron los costes de la desnutrición previa a la enfermedad; siete, los costes de la desnutrición relacionada con la enfermedad, y uno, ambas situaciones. Conclusiones: la desnutrición en general incrementa el gasto sanitario debido al aumento de estancias hospitalarias, al mayor número de reingresos y a la mayor demanda de recursos sanitarios. Además, en los estudios analizados, la desnutrición previa a la enfermedad implicó mayores costes que la relacionada con la enfermedad, por lo que sería conveniente establecer políticas de cribado y prevención de la desnutrición en los ancianos (AU)

Introduction: Malnutrition is a health problem which affects a high percentage of old people since the physical and psychosocial changes common to this period of life favor it in this group. In addition, aging population has a high prevalence of chronic illnesses and acute pathologies which can affect their nutritional state negatively, leading to malnutrition related to illness. Objective: The aim of this systematic revision was to analyze the economic costs related to malnutrition in old people and to discover whether there were differences between economic costs of pre-existing malnutrition prior to illness and malnutrition because of disease. Method: A bibliographic search was carried out in the databases of Pubmed, Web of Science and Scopus, for the period between 2000 and 2016. Results: A total of 1,001 articles were found and 19 were selected using inclusion criteria. Of these, eleven analyzed the costs of pre-existing malnutrition prior to illness, seven analyzed the costs of malnutrition related to illness and one, both situations. Conclusions: In general, malnutrition increased health costs as a result of hospital admissions, greater number of readmissions and greater demand on health resources. Moreover, in the studies analyzed, pre-existing malnutrition prior to illness implied greater costs than those related to the actual illness; therefore, it would be convenient to establish selection and preventive policies on malnutrition in old people (AU)

Estimated Costs of Clinical and Surgical Treatment of Severe Obesity in the Brazilian Public Health System.

BACKGROUND: Obesity is a major global epidemic and a burden to society and health systems. This study aimed to estimate and compare the anual costs of clinical and surgical treatment of severe obesity from the perspective of the Brazilian Public Health System. METHODS: An observational and cross-sectional study was performed in three reference centers. Data collection on health resources utilization and productivity loss was carried out through an online questionnaire. Participants were divided in clinical (waiting list for a bariatric surgery) and surgical groups (open Roux-en-Y gastric bypass), and then allocated by the time of surgery (up to 1 year; 1-2 years; 2-3 years; and >3 years). Costs of visits, medications, exams, and surgeries were obtained from government sources. Data on non-medical costs, such as transportation, special diets, and caregivers, were also colleted. Productivity loss was estimated using self-reported income. Costs in local currency (Real) were converted to international dollars (Int$ 2015). RESULTS: Two hundred and seventy-four patients, 140 in surgical group and 134 in clinical group were included. In first postoperative year, the surgical group had higher costs than clinical group (Int$6005.47 [5000.18-8262.36] versus 2148.14 [1412.2-3506.8]; p = 0.0002); however, from the second year, the costs decreased progressively. In the same way, indirect costs decreased significantly after surgery (259.08 [163.63-662.72] versus 368.17 [163.62-687.27]; p = 0.06). CONCLUSION: Total costs were higher in the surgical group in the first 2 years after surgery. However, from the third year on, the costs were lower than in the clinical group.

Current coding practices and patterns of code use of registered dietitian nutritionists: the Academy of Nutrition and Dietetics 2013 coding survey.

Coding, coverage, and reimbursement for nutrition services are vital to the dietetics profession, particularly to registered dietitian nutritionists (RDNs) who provide clinical care. The objective of this study was to assess RDN understanding and use of the medical nutrition therapy (MNT) procedure codes in the delivery of nutrition services. Its design was an Internet survey of all RDNs listed in the Academy of Nutrition and Dietetics (Academy)/Commission on Dietetics Registration database as of September 2013 who resided in the United States and were not retired. Prior coding and coverage surveys provided a basis for survey development. Parameters assessed included knowledge and use of existing MNT and/or alternative procedure codes, barriers to code use, payer reimbursement patterns, complexity of the patient population served, time spent in the delivery of initial and subsequent care, and practice demographics and management. Results show that a majority of respondents were employed by another and provided outpatient MNT services on a part-time basis. MNT codes were used for the provision of individual services, with minimal use of the MNT codes for group services and subsequent care. The typical patient carries two or more diagnoses. The majority of RDNs uses internal billing departments and support staff in their practices. The payer mix is predominantly Medicare and private/commercial insurance. Managers and manager/providers were more likely than providers to carry malpractice insurance. Results point to the need for further education regarding the full spectrum of Current Procedural Terminology codes available for RDN use and the business side of ambulatory MNT practice, including the need to carry malpractice insurance. This survey is part of continuing Academy efforts to understand the complex web of relationships among clinical practice, coverage, MNT code use, and reimbursement so as to further support nutrition services codes revision and/or expansion.

Positive and cost-effectiveness effect of spa therapy on the resumption of occupational and non-occupational activities in women in breast cancer remission: a French multicentre randomised controlled trial.

PURPOSE OF THE RESEARCH: The main aim was to assess the effects of a spa treatment on the resumption of occupational and non-occupational activities and the abilities of women in breast cancer remission. A cost-effectiveness analysis (CEA) was also performed. METHODS AND SAMPLE: A multicentre randomised controlled trial was carried out between 2008 and 2010 in the University Hospital of Auvergne and two private hospitals in Clermont-Ferrand, France. Eligible patients were women in complete breast cancer remission without contraindication for physical activities or cognitive disorders and a body mass index between 18.5 and 40 kg/m(2). The intervention group underwent spa treatment combined with consultation with dietician whereas the control underwent consultations with the dietician only. Of the 181 patients randomised, 92 and 89 were included in the intervention and the control groups, respectively. The CEA involved 90 patients, 42 from the intervention group and 48 from the control group. KEY RESULTS: The main results showed a higher rate of resumption of occupational activities in the intervention group (p = 0.0025) and a positive effect of the intervention on the women's ability to perform occupational activities 12 months after the beginning of the study (p = 0.0014), and on their ability to perform family activities (p = 0.033). The stay in a thermal centre was cost-effective at 12 months. CONCLUSIONS: Spa treatment is a cost-effective strategy to improve resumption of occupational and non-occupational activities and the abilities of women in breast cancer remission.

A naturopathic approach to the prevention of cardiovascular disease: cost-effectiveness analysis of a pragmatic multi-worksite randomized clinical trial.

OBJECTIVE: To determine the cost-effectiveness of a worksite-based naturopathic (individualized lifestyle counseling and nutritional medicine) approach to primary prevention of cardiovascular disease (CVD). METHODS: Economic evaluation alongside a pragmatic, multi-worksite, randomized controlled trial comparing enhanced usual care (EUC; usual care plus biometric screening) to the addition of a naturopathic approach to CVD prevention (NC+EUC). RESULTS: After 1 year, NC+EUC resulted in a net decrease of 3.3 (confidence interval: 1.7 to 4.8) percentage points in 10-year CVD event risk (number needed to treat = 30). These risk reductions came with average net study-year savings of $1138 in societal costs and $1187 in employer costs. There was no change in quality-adjusted life years across the study year. CONCLUSIONS: A naturopathic approach to CVD primary prevention significantly reduced CVD risk over usual care plus biometric screening and reduced costs to society and employers in this multi-worksite-based study. Trial Registration clinicaltrials.gov Identifier: NCT00718796.

Is dietetic treatment for undernutrition in older individuals in primary care cost-effective?

OBJECTIVES: Undernutrition in older age is associated with adverse clinical outcomes and high health care costs. This study aimed to evaluate the cost-effectiveness of a dietetic treatment in primary care compared with usual care in older, undernourished, community-dwelling individuals. DESIGN: A parallel randomized controlled trial. SETTING: Primary care. PARTICIPANTS: A total of 146 undernourished, independently living older (≥65 years) individuals. INTERVENTION: Dietetic treatment. MEASUREMENTS: Main outcomes were change in kilogram body weight compared with baseline and quality-adjusted life years (QALYs) after 6 months. Costs were measured from a societal perspective. The main analysis was performed according to the intention-to-treat principle. Multiple imputation was used to impute missing data and bootstrapping was used to estimate uncertainty surrounding cost differences and incremental cost-effectiveness ratios. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated. RESULTS: The participants were randomized to receive either dietetic treatment (n = 72) or usual care (n = 74). After 6 months, no statistically significant differences were found between the dietetic treatment and usual care group in body weight change (mean difference 0.78 kg, 95% CI -0.26-1.82), QALYs (mean difference 0.001, 95% CI -0.04-0.04) and total costs (mean difference €1645, 95% CI -525-3547). The incremental cost-utility ratio (ICUR) for QALYs was not interpretable. The incremental cost-effectiveness ratio (ICER) for body weight gain was 2111. The probability that dietetic treatment is cost-effective compared with usual care was 0.78 for a ceiling ratio of €5000 for body weight and 0.06 for a ceiling ratio of €20.000 for QALY. CONCLUSION: In this study, dietetic treatment in older, undernourished, community-dwelling individuals was not cost-effective compared with usual care.

A cluster-randomized controlled trial to study the effectiveness of a protocol-based lifestyle program to prevent type 2 diabetes in people with impaired fasting glucose.

BACKGROUND: Effective diabetes prevention strategies that can be implemented in daily practice, without huge amounts of money and a lot of personnel are needed. The Dutch Diabetes Federation developed a protocol for coaching people with impaired fasting glucose (IFG; according to WHO criteria: 6.1 to 6.9 mmol/l) to a sustainable healthy lifestyle change: 'the road map towards diabetes prevention' (abbreviated: Road Map: RM). This protocol is applied within a primary health care setting by a general practitioner and a practice nurse. The feasibility and (cost-) effectiveness of care provided according to the RM protocol will be evaluated. METHODS/DESIGN: A cluster randomised clinical trial is performed, with randomisation at the level of the general practices. Both opportunistic screening and active case finding took place among clients with high risk factors for diabetes. After IFG is diagnosed, motivated people in the intervention practices receive 3-4 consultations by the practice nurse within one year. During these consultations they are coached to increase the level of physical activity and healthy dietary habits. If necessary, participants are referred to a dietician, physiotherapist, lifestyle programs and/or local sports activities. The control group receives care as usual. The primary outcome measure in this study is change in Body Mass Index (BMI). Secondary outcome measures are waist circumference, physical activity, total and saturated fat intake, systolic blood pressure, blood glucose, total cholesterol, HDL cholesterol, triglycerides and behaviour determinants like risk perception, perceived knowledge and motivation. Based on a sample size calculation 120 people in each group are needed. Measurements are performed at baseline, and after one (post-intervention) and two years follow up. Anthropometrics and biochemical parameters are assessed in the practices and physical activity, food intake and their determinants by a validated questionnaire. The cost-effectiveness is estimated by using the Chronic Disease Model (CDM). Feasibility will be tested by interviews among health care professionals. DISCUSSION: The results of the study will provide valuable information for both health care professionals and policy makers. If this study shows the RM to be both effective and cost-effective the protocol can be implemented on a large scale. TRIAL REGISTRATION: ISRCTN41209683. Ethical approval number: NL31342.075.10.

Management of hyperphosphataemia in chronic kidney disease: summary of National Institute for Health and Clinical Excellence (NICE) guideline.

Bone disease and ectopic calcification are the two main consequences of hyperphosphataemia of chronic kidney disease (CKD). Observational studies have demonstrated that hyperphosphataemia in CKD is associated with increased mortality. Furthermore, the use of phosphate binders in dialysis patients is associated with significantly lower mortality. The UK Renal Registry data show significant underachievement of phosphate targets in dialysis patients. It is believed to be due to wide variation in how management interventions are used. The National Institute for Health and Clinical Excellence (NICE) has developed a guideline on the management of hyperphosphataemia in CKD. This is based on the evidence currently available using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. This review outlines the recommendations including research recommendations and discusses methodology, rationale and challenges faced in developing this guideline and the health economic model used to assess the cost-effectiveness of different phosphate binders.

Insurance coverage of medical foods for treatment of inherited metabolic disorders.

PURPOSE: Treatment of inherited metabolic disorders is accomplished by use of specialized diets employing medical foods and medically necessary supplements. Families seeking insurance coverage for these products express concern that coverage is often limited; the extent of this challenge is not well defined. METHODS: To learn about limitations in insurance coverage, parents of 305 children with inherited metabolic disorders completed a paper survey providing information about their use of medical foods, modified low-protein foods, prescribed dietary supplements, and medical feeding equipment and supplies for treatment of their child's disorder as well as details about payment sources for these products. RESULTS: Although nearly all children with inherited metabolic disorders had medical coverage of some type, families paid "out of pocket" for all types of products. Uncovered spending was reported for 11% of families purchasing medical foods, 26% purchasing supplements, 33% of those needing medical feeding supplies, and 59% of families requiring modified low-protein foods. Forty-two percent of families using modified low-protein foods and 21% of families using medical foods reported additional treatment-related expenses of $100 or more per month for these products. CONCLUSION: Costs of medical foods used to treat inherited metabolic disorders are not completely covered by insurance or other resources.

Cost-effectiveness of nutritional intervention on healing of pressure ulcers.

BACKGROUND & AIMS: Pressure ulcers not only affect quality of life among the elderly, but also bring a large economic burden. There is limited evidence available for the effectiveness of nutritional interventions for treatment of pressure ulcers. In Japan, recently, a 60-patient randomized controlled trial of nutritional intervention on pressure ulcers demonstrated improvement in healing of pressure ulcers, compared with conventional management. To evaluate value for money of nutritional intervention on healing of pressure ulcers, cost-effective analysis was carried out using these trial results. METHODS: The analysis was carried out from a societal perspective. As effectiveness measures, pressure ulcer days (PUDs) and quality-adjusted life years (QALYs) were estimated. Prevalence of pressure ulcers was estimated by the Kaplan-Meier method. Utility score for pressure ulcers is derived from a cross-sectional survey among health professionals related to pressure ulcers. Costs (e.g., nutritional interventions and management of pressure ulcers) were estimated from trial data during observation and follow-up. Stochastic and qualitative sensitivity analyses were performed to examine the robustness of results. RESULTS: For observation (12 weeks) and follow-up (12-week observation plus 4-week follow-up), nutritional intervention reduced PUDs by 9.6 and 16.2 per person, and gained 0.226 × 10(-2) QALYs and 0.382 × 10(-2) QALYs per person, respectively. In addition, costs were reduced by $542 and $881 per person, respectively. This means nutritional intervention is dominant (cost savings and greater effectiveness). The sensitivity analyses showed the robustness of these results. CONCLUSION: Economic evaluation of nutritional intervention on healing pressure ulcers from a small randomized controlled trial showed that this intervention is cost saving with health improvement. Further studies are required to determine whether this is a cost-effective intervention for widespread use.

Cost effectiveness of treatments for inflammatory bowel disease.

Traditionally, half of the direct costs associated with chronic inflammatory bowel diseases (IBD) [Crohn's disease (CD) and ulcerative colitis (UC)] have related to hospital inpatient treatment for a sub-group of more severely affected, often therapy-resistant individuals. The advent of effective but relatively expensive biological agents has increased the contribution of drugs to overall medical care costs. This has focussed interest on the relative cost effectiveness of rival therapies for IBD and, in particular, on the affordability of long-term biological therapy. The purpose of this article is to review the available literature on this topic and to identify areas for future research. Head-to-head trials of competing treatment options are uncommon and clinical trials have seldom addressed cost effectiveness. In UC, models have explored the cost utility of 'high-' versus 'standard-' dose 5-aminosalicylic acid (5-ASA) therapy and the theoretical impact of improved adherence with once-daily formulations. In CD, cost-utility models for anti-tumour necrosis factor (TNF) drugs versus standard care have suggested consistently that incremental benefits are achieved at increased overall cost. However, studies of varying design have produced a wide spectrum of incremental cost-effectiveness ratio estimates, which highlights the challenges and limitations of existing modelling techniques.