Illustrating the financial consequences of outcome-based payment models from a payers perspective- the case of autologous gene therapy atidarsagene autotemcel (Libmeldy®).

OBJECTIVE: To illustrate the financial consequences of implementing different managed entry agreements ((MEA) for the Dutch healthcare system for autologous gene therapy atidarsagene autotemcel (AA, Libmeldy®), while also providing a first systematic guidance on how to construct MEAs to aid future reimbursement decision-making and create patient access to high-cost, one-off potentially curative therapies. METHODS: Three payment models were compared: (1) an arbitrary 60% price discount, (2) an outcome-based spread payment with discounts, and (3) an outcome-based spread payment linked to a willingness to pay model with discounts. Financial consequences were estimated for full responders (A), patients responding according to the predicted clinical pathway presented in HTA reports (B), and unstable responders (C). The associated costs for an average patient during the timeframe of the payment agreement, the total budget impact, and associated benefits expressed in quality-adjusted life-years of the patient population were calculated. RESULTS: When patients responded according to the predicted clinical pathway presented in HTA reports (Scenario B), implementing outcome-based reimbursement models (models 2 and 3) had lower associated budget impacts while gaining similar benefits compared to the discount (Scenario 1, €8,9 million to €6,6 million vs. €9.2 million). In the case of unstable responders (Scenario C), costs for payers are lower in the outcome-based scenarios (€4.1 million and €3.0 million, Scenario 2.C and 3.C, respectively) compared to implementing the discount (€9.2 million, Scenario 1.C). CONCLUSION: Outcome-based models can mitigate the financial risk of reimbursing AA. This can be considerably beneficial over simple discounts when clinical performance was similar to or worse than predicted.

"Hypertension in Pregnancy Intervention Trial At Term" and "Disproportionate Intrauterine Growth Intervention Trial At Term" Studies.

In 2003, in the context of a national research funding program in which obstetric research was prioritized, several perinatal centers took the initiative to jointly submit a number of applications to the subsidy programs of Effectiveness Research and Prevention of ZonMw. This has led to the funding of the Obstetric Consortium with several projects, including the "Hypertension in Pregnancy Intervention Trial At Term" and the "Disproportionate Intrauterine Growth Intervention Trial At Term" studies. The studies showed that induction of labor for hypertension and growth restriction at term was the appropriate management. Subsequent implementation improved maternal and perinatal outcomes.

Predictive Factors for Delivery within 7 Days after Successful 48-Hour Treatment of Threatened Preterm Labor.

Objective The aim of this study was to assess which characteristics and results of vaginal examination are predictive for delivery within 7 days, in women with threatened preterm labor after initial treatment. Study Design A secondary analysis of a randomized controlled trial on maintenance nifedipine includes women who remained undelivered after threatened preterm labor for 48 hours. We developed one model for women with premature prelabor rupture of membranes (PPROM) and one without PPROM. The predictors were identified by backward selection. We assessed calibration and discrimination and used bootstrapping techniques to correct for potential overfitting. Results For women with PPROM (model 1), nulliparity, history of preterm birth, and vaginal bleeding were included in the multivariable analysis. For women without PPROM (model 2), maternal age, vaginal bleeding, cervical length, and fetal fibronectin (fFN) status were in the multivariable analysis. Discriminative capability was moderate to good (c-statistic 0.68; 95% confidence interval [CI] 0.60-0.77 for model 1 and 0.89; 95% CI, 0.84-0.93 for model 2). Conclusion PPROM and vaginal bleeding in the current pregnancy are relevant predictive factors in all women, as are maternal age, cervical length, and fFN in women without PPROM and nulliparity, history of preterm birth in women with PPROM.

Economic analysis comparing induction of labor and expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks (PPROMEXIL trial).

OBJECTIVE: To compare the costs of induction of labor and expectant management in women with preterm prelabor rupture of membranes (PPROM). DESIGN: Economic analysis based on a randomized clinical trial. SETTING: Obstetric departments of eight academic and 52 non-academic hospitals in the Netherlands. POPULATION: Women with PPROM near term who were not in labor 24 h after PPROM. METHODS: A cost-minimization analysis was done from a health care provider perspective, using a bottom-up approach to estimate resource utilization, valued with unit-costs reflecting actual costs. MAIN OUTCOME MEASURES: Primary health outcome was the incidence of neonatal sepsis. Direct medical costs were estimated from start of randomization to hospital discharge of mother and child. RESULTS: Induction of labor did not significantly reduce the probability of neonatal sepsis [2.6% vs. 4.1%, relative risk 0.64 (95% confidence interval 0.25-1.6)]. Mean costs per woman were €8094 for induction and €7340 for expectant management (difference €754; 95% confidence interval -335 to 1802). This difference predominantly originated in the postpartum period, where the mean costs were €5669 for induction vs. €4801 for expectant management. Delivery costs were higher in women allocated to induction than in women allocated to expectant management (€1777 vs. €1153 per woman). Antepartum costs in the expectant management group were higher because of longer antepartum maternal stays in hospital. CONCLUSIONS: In women with pregnancies complicated by PPROM near term, induction of labor does not reduce neonatal sepsis, whereas costs associated with this strategy are probably higher.

Economic analysis comparing induction of labour and expectant management for intrauterine growth restriction at term (DIGITAT trial).

OBJECTIVE: Pregnancies complicated by intrauterine growth restriction (IUGR) are at increased risk for neonatal morbidity and mortality. The Dutch nationwide disproportionate intrauterine growth intervention trial at term (DIGITAT trial) showed that induction of labour and expectant monitoring were comparable with respect to composite adverse neonatal outcome and operative delivery. In this study we compare the costs of both strategies. STUDY DESIGN: A cost analysis was performed alongside the DIGITAT trial, which was a randomized controlled trial in which 650 women with a singleton pregnancy with suspected IUGR beyond 36 weeks of pregnancy were allocated to induction or expectant management. Resource utilization was documented by specific items in the case report forms. Unit costs for clinical resources were calculated from the financial reports of participating hospitals. For primary care costs Dutch standardized prices were used. All costs are presented in Euros converted to the year 2009. RESULTS: Antepartum expectant monitoring generated more costs, mainly due to longer antepartum maternal stays in hospital. During delivery and the postpartum stage, induction generated more direct medical costs, due to longer stay in the labour room and longer duration of neonatal high care/medium care admissions. From a health care perspective, both strategies generated comparable costs: on average €7106 per patient for the induction group (N=321) and €6995 for the expectant management group (N=329) with a cost difference of €111 (95%CI: €-1296 to 1641). CONCLUSION: Induction of labour and expectant monitoring in IUGR at term have comparable outcomes immediately after birth in terms of obstetrical outcomes, maternal quality of life and costs. Costs are lower, however, in the expectant monitoring group before 38 weeks of gestation and costs are lower in the induction of labour group after 38 weeks of gestation. So if induction of labour is considered to pre-empt possible stillbirth in suspected IUGR, it is reasonable to delay until 38 weeks, with watchful monitoring.

Economic evaluation studies in reproductive medicine: a systematic review of methodologic quality.

OBJECTIVE: To evaluate the methodologic quality of economic analyses published in the field of reproductive medicine. DESIGN: Systematic review. SETTING: Centers for reproductive care. PATIENT(S): Infertility patients. INTERVENTION(S): We performed a Medline search to identify economic evaluation studies in reproductive medicine. We included studies that concerned interventions, evaluated costs and effects, and were published in a journal on reproductive medicine, gynecology, or a major general journal from 1997 through May 2011. MAIN OUTCOME MEASURE(S): Number of quality criteria adhered to. RESULT(S): Our search revealed 5,519 articles, of which 85 met our inclusion criteria. Seventy-seven (91%) of the economic analyses were on treatment, six (7%) on diagnosis, and two (2%) on screening. The mean number of quality criteria adhered to was 20 out of 30 items, and only one article met all 30 criteria. The mean number of criteria adhered to was higher if at least one of the authors was from a methodologic or health economics department (mean 23 [n = 30] versus mean 20 [n = 55]). The most common limitations of published economic evaluation studies were in methodology or presentation of incremental analyses, sensitivity analyses, and discounting. CONCLUSION(S): Economic analyses published in the past 15 years in the field of reproductive medicine seldom adhere to all recommended methodologic standards. A large majority of these publications evaluated treatments rather than diagnostic interventions.

Effect of maintenance tocolysis with nifedipine in threatened preterm labor on perinatal outcomes: a randomized controlled trial.

IMPORTANCE: In threatened preterm labor, maintenance tocolysis with nifedipine, after an initial course of tocolysis and corticosteroids for 48 hours, may improve perinatal outcome. OBJECTIVE: To determine whether maintenance tocolysis with nifedipine will reduce adverse perinatal outcomes due to premature birth. DESIGN, SETTING, AND PARTICIPANTS: APOSTEL-II (Assessment of Perinatal Outcome with Sustained Tocolysis in Early Labor) is a double-blind, placebo-controlled trial performed in 11 perinatal units including all tertiary centers in The Netherlands. From June 2008 to February 2010, women with threatened preterm labor between 26 weeks (plus 0 days) and 32 weeks (plus 2 days) gestation, who had not delivered after 48 hours of tocolysis and a completed course of corticosteroids, were enrolled. Surviving infants were followed up until 6 months after birth (ended August 2010). INTERVENTION: Randomization assigned 406 women to maintenance tocolysis with nifedipine orally (80 mg/d; n = 201) or placebo (n = 205) for 12 days. Assigned treatment was masked from investigators, participants, clinicians, and research nurses. MAIN OUTCOME MEASURES: Primary outcome was a composite of adverse perinatal outcomes (perinatal death, chronic lung disease, neonatal sepsis, intraventricular hemorrhage >grade 2, periventricular leukomalacia >grade 1, or necrotizing enterocolitis). Analyses were completed on an intention-to-treat basis. RESULTS: Mean (SD) gestational age at randomization was 29.2 (1.7) weeks for both groups. Adverse perinatal outcome was not significantly different between groups: 11.9% (24/201; 95% CI, 7.5%-16.4%) for nifedipine vs 13.7% (28/205; 95% CI, 9.0%-18.4%) for placebo (relative risk, 0.87; 95% CI, 0.53-1.45). CONCLUSIONS AND RELEVANCE: In patients with threatened preterm labor, nifedipine-maintained tocolysis did not result in a statistically significant reduction in adverse perinatal outcomes when compared with placebo. Although the lower than anticipated rate of adverse perinatal outcomes in the control group indicates that a benefit of nifedipine cannot completely be excluded, its use for maintenance tocolysis does not appear beneficial at this time. TRIAL REGISTRATION: trialregister.nl Identifier: NTR1336.

The methodological quality of economic evaluation studies in obstetrics and gynecology: a systematic review.

We evaluated the methodological quality of economic evaluation studies in the field of obstetrics and gynecology published in the last decade. A MEDLINE search was performed to find economic evaluation studies in obstetrics and gynecology from the years 1997 through 2009. We included full economic evaluation studies concerning tests or interventions in the field of obstetrics or gynecology. Each included study was evaluated by two reviewers using a quality checklist that was based on international guidelines for medical economic evaluation studies and a checklist used in a previous review. The mean number of quality criteria adhered to was 23 of 30 items, whereas five articles (3%) met all 30 criteria. Compliance was low for the description of the perspective (40%), the completeness of costs looking at the perspective (48%) or time horizon (48%), and reporting of quantities of resources (47%). Furthermore, if no discounting was applied, an explanation was infrequently given (14%). A comparison of study quality to that reported by Smith and Blackmore showed a considerable improvement in the following criteria: presentation perspective (from 19 to 40%), statement of primary outcome measure (from 72 to 81%), completeness costs looking at the time horizon (from 14 to 48%), the presentation of discount rates (from 10 to 54%), details of sensitivity analyses (from 21 to 61%), reporting incremental results (from 17 to 70%), and reporting a summary measure (from 57 to 74%). The quality of economic studies in obstetrics and gynecology has considerably improved in the last decade, but room for further improvement is present.

Induction of labor versus expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks: a randomized controlled trial.

BACKGROUND: At present, there is insufficient evidence to guide appropriate management of women with preterm prelabor rupture of membranes (PPROM) near term. METHODS AND FINDINGS: We conducted an open-label randomized controlled trial in 60 hospitals in The Netherlands, which included non-laboring women with >24 h of PPROM between 34(+0) and 37(+0) wk of gestation. Participants were randomly allocated in a 1:1 ratio to induction of labor (IoL) or expectant management (EM) using block randomization. The main outcome was neonatal sepsis. Secondary outcomes included mode of delivery, respiratory distress syndrome (RDS), and chorioamnionitis. Patients and caregivers were not blinded to randomization status. We updated a prior meta-analysis on the effect of both interventions on neonatal sepsis, RDS, and cesarean section rate. From 1 January 2007 to 9 September 2009, 776 patients in 60 hospitals were eligible for the study, of which 536 patients were randomized. Four patients were excluded after randomization. We allocated 266 women (268 neonates) to IoL and 266 women (270 neonates) to EM. Neonatal sepsis occurred in seven (2.6%) newborns of women in the IoL group and in 11 (4.1%) neonates in the EM group (relative risk [RR] 0.64; 95% confidence interval [CI] 0.25 to 1.6). RDS was seen in 21 (7.8%, IoL) versus 17 neonates (6.3%, EM) (RR 1.3; 95% CI 0.67 to 2.3), and a cesarean section was performed in 36 (13%, IoL) versus 37 (14%, EM) women (RR 0.98; 95% CI 0.64 to 1.50). The risk for chorioamnionitis was reduced in the IoL group. No serious adverse events were reported. Updating an existing meta-analysis with our trial results (the only eligible trial for the update) indicated RRs of 1.06 (95% CI 0.64 to 1.76) for neonatal sepsis (eight trials, 1,230 neonates) and 1.27 (95% CI 0.98 to 1.65) for cesarean section (eight trials, 1,222 women) for IoL compared with EM. CONCLUSIONS: In women whose pregnancy is complicated by late PPROM, neither our trial nor the updated meta-analysis indicates that IoL substantially improves pregnancy outcomes compared with EM. TRIAL REGISTRATION: Current Controlled Trials ISRCTN29313500

Disease burden of foodborne pathogens in the Netherlands, 2009.

To inform risk management decisions on control, prevention and surveillance of foodborne disease, the disease burden of foodborne pathogens is estimated using Disability Adjusted Life Years as a summary metric of public health. Fourteen pathogens that can be transmitted by food are included in the study (four infectious bacteria, three toxin-producing bacteria, four viruses and three protozoa). Data represent the burden in the Netherlands in 2009. The incidence of community-acquired non-consulting cases, patients consulting their general practitioner, those admitted to hospital, as well as the incidence of sequelae and fatal cases is estimated using surveillance data, cohort studies and published data. Disease burden includes estimates of duration and disability weights for non-fatal cases and loss of statistical life expectancy for fatal cases. Results at pathogen level are combined with data from an expert survey to assess the fraction of cases attributable to food, and the main food groups contributing to transmission. Among 1.8 million cases of disease (approx. 10,600 per 100,000) and 233 deaths (1.4 per 100,000) by these fourteen pathogens, approximately one-third (680,000 cases; 4100 per 100,000) and 78 deaths (0.5 per 100,000) are attributable to foodborne transmission. The total burden is 13,500 DALY (82 DALY per 100,000). On a population level, Toxoplasma gondii, thermophilic Campylobacter spp., rotaviruses, noroviruses and Salmonella spp. cause the highest disease burden. The burden per case is highest for perinatal listeriosis and congenital toxoplasmosis. Approximately 45% of the total burden is attributed to food. T. gondii and Campylobacter spp. appear to be key targets for additional intervention efforts, with a focus on food and environmental pathways. The ranking of foodborne pathogens based on burden is very different compared to when only incidence is considered. The burden of acute disease is a relatively small part of the total burden. In the Netherlands, the burden of foodborne pathogens is similar to the burden of upper respiratory and urinary tract infections.

Maternal health-related quality of life after induction of labor or expectant monitoring in pregnancy complicated by intrauterine growth retardation beyond 36 weeks.

OBJECTIVE: Pregnancies complicated by intrauterine growth retardation (IUGR) beyond 36 weeks of gestation are at increased risk of neonatal morbidity and mortality. Optimal treatment in IUGR at term is highly debated. Results from the multicenter DIGITAT (Disproportionate Intrauterine Growth Intervention Trial At Term) trial show that induction of labor and expectant monitoring result in equal neonatal and maternal outcomes for comparable cesarean section rates. We report the maternal health-related quality of life (HR-QoL) that was measured alongside the trial at several points in time. METHODS: Both randomized and non-randomized women were asked to participate in the HR-QoL study. Women were asked to fill out written validated questionnaires, covering background characteristics, condition-specific issues and the Short Form (SF-36), European Quality of Life (EuroQoL 6D3L), Hospital Anxiety and Depression scale (HADS), and Symptom Check List (SCL-90) at baseline, 6 weeks postpartum and 6 months postpartum. We compared the difference scores of all summary measures between the two management strategies by ANOVA. A repeated measures multivariate mixed model was defined to assess the effect of the management strategies on the physical (PCS) and mental (MCS) components of the SF-36. Analysis was by intention to treat. RESULTS: We analyzed data of 361 randomized and 198 non-randomized patients. There were no clinically relevant differences between the treatments at 6 weeks or 6 months postpartum on any summary measures; e.g., on the SF-36 (PCS: P = .09; MCS: P = .48). The PCS and the MCS were below norm values at inclusion. The PCS improved over time but stayed below norm values at 6 months, while the MCS did not improve. CONCLUSION: In pregnancies complicated by IUGR beyond 36 weeks, induction of labor does not affect the long-term maternal quality of life.

Cost-effectiveness of cardiotocography plus ST analysis of the fetal electrocardiogram compared with cardiotocography only.

OBJECTIVE: To assess the cost-effectiveness of addition of ST analysis of the fetal electrocardiogram (ECG; STAN) to cardiotocography (CTG) for fetal surveillance during labor compared with CTG only. DESIGN: Cost-effectiveness analysis based on a randomized clinical trial on ST analysis of the fetal ECG. SETTING: Obstetric departments of three academic and six general hospitals in The Netherlands. Population. Laboring women with a singleton high-risk pregnancy, a fetus in cephalic presentation, a gestational age >36 weeks and an indication for internal electronic fetal monitoring. METHODS: A trial-based cost-effectiveness analysis was performed from a health-care provider perspective. MAIN OUTCOME MEASURES: Primary health outcome was the incidence of metabolic acidosis measured in the umbilical artery. Direct medical costs were estimated from start of labor to childbirth. Cost-effectiveness was expressed as costs to prevent one case of metabolic acidosis. RESULTS: The incidence of metabolic acidosis was 0.7% in the ST-analysis group and 1.0% in the CTG-only group (relative risk 0.70; 95% confidence interval 0.38-1.28). Per delivery, the mean costs per patient of CTG plus ST analysis (n= 2 827) were €1,345 vs. €1,316 for CTG only (n= 2 840), with a mean difference of €29 (95% confidence interval -€9 to €77) until childbirth. The incremental costs of ST analysis to prevent one case of metabolic acidosis were €9 667. CONCLUSIONS: The additional costs of monitoring by ST analysis of the fetal ECG are very limited when compared with monitoring by CTG only and very low compared with the total costs of delivery.

Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial).

BACKGROUND: Preterm labour is the main cause of perinatal morbidity and mortality in the Western world. At present, there is evidence that tocolysis for 48 hours is useful in women with threatened preterm labour at least before 32 weeks. This allows transfer of the patient to a perinatal centre, and maximizes the effect of corticosteroids for improved neonatal survival. It is questionable whether treatment with tocolytics should be maintained after 48 hours. METHODS/DESIGN: The APOSTEL II trial is a multicentre placebo-controlled study. Pregnant women admitted for threatened preterm labour who have been treated with 48 hours corticosteroids and tocolysis will be eligible to participate in the trial between 26+0 and 32+2 weeks gestational age. They will be randomly allocated to nifedipine (intervention) or placebo (control) for twelve days or until delivery, whatever comes first.Primary outcome is a composite of perinatal death, and severe neonatal morbidity up to evaluation at 6 months after birth. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days of the first 6 months out of hospital. In addition a cost-effectiveness analysis will be performed. Analysis will be by intention to treat. The power calculation is based on an expected 11% difference in adverse neonatal outcome. This implies that 406 women have to be randomised (two sided test, beta 0.2 at alpha 0.05). DISCUSSION: This trial will provide evidence as to whether maintenance tocolysis reduces severe perinatal morbidity and mortality in women with threatened preterm labour before 32 weeks. CLINICAL TRIAL REGISTRATION: http://www.trialregister.nl, NTR 1336, date of registration: June 3rd 2008.

Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia after 36 weeks' gestation (HYPITAT): a multicentre, open-label randomised controlled trial.

BACKGROUND: Robust evidence to direct management of pregnant women with mild hypertensive disease at term is scarce. We investigated whether induction of labour in women with a singleton pregnancy complicated by gestational hypertension or mild pre-eclampsia reduces severe maternal morbidity. METHODS: We undertook a multicentre, parallel, open-label randomised controlled trial in six academic and 32 non-academic hospitals in the Netherlands between October, 2005, and March, 2008. We enrolled patients with a singleton pregnancy at 36-41 weeks' gestation, and who had gestational hypertension or mild pre-eclampsia. Participants were randomly allocated in a 1:1 ratio by block randomisation with a web-based application system to receive either induction of labour or expectant monitoring. Masking of intervention allocation was not possible. The primary outcome was a composite measure of poor maternal outcome--maternal mortality, maternal morbidity (eclampsia, HELLP syndrome, pulmonary oedema, thromboembolic disease, and placental abruption), progression to severe hypertension or proteinuria, and major post-partum haemorrhage (>1000 mL blood loss). Analysis was by intention to treat and treatment effect is presented as relative risk. This study is registered, number ISRCTN08132825. FINDINGS: 756 patients were allocated to receive induction of labour (n=377 patients) or expectant monitoring (n=379). 397 patients refused randomisation but authorised use of their medical records. Of women who were randomised, 117 (31%) allocated to induction of labour developed poor maternal outcome compared with 166 (44%) allocated to expectant monitoring (relative risk 0.71, 95% CI 0.59-0.86, p<0.0001). No cases of maternal or neonatal death or eclampsia were recorded. INTERPRETATION: Induction of labour is associated with improved maternal outcome and should be advised for women with mild hypertensive disease beyond 37 weeks' gestation. FUNDING: ZonMw.

Cost-effectiveness of a low-calorie diet and orlistat for obese persons: modeling long-term health gains through prevention of obesity-related chronic diseases.

OBJECTIVE: Our study estimated the cost-effectiveness of pharmacologic treatment of obesity in combination with a low-calorie diet in The Netherlands. METHODS: Costs and effects of a low-calorie diet-only intervention and of a low-calorie diet in combination with 1 year of orlistat were compared to no treatment. The RIVM Chronic Disease Model was used to project the differences in quality adjusted life years (QALYs) and lifetime health-care costs because of the effects of the interventions on body mass index (BMI) status. This was done by linking BMI status to the occurrence of obesity-related diseases and by relating quality of life to disease status. Probabilistic sensitivity analysis was employed to study the effect of uncertainty in the model parameters. In univariate sensitivity analysis, we assessed how sensitive the results were to several key assumptions. RESULTS: Incremental costs per QALY gained were Euro 17,900 for the low-calorie diet-only intervention compared to no intervention and Euro 58,800 for the low-calorie diet + orlistat compared to the low-calorie diet only. Assuming a direct relation between BMI and quality of life, these ratios decreased to Euro 6000 per QALY gained and Euro 24,100 per QALY gained. Costs per QALY gained were also sensitive to assumptions about long-term weight loss maintenance. CONCLUSIONS: Cost-effectiveness ratios of interventions aiming at weight reduction depend strongly on assumptions regarding the relation between BMI and quality of life. We recommend that a low-calorie diet should be the first option for policymakers in combating obesity.

The effects of integrated care on quality of work in nursing homes: a quasi-experiment.

BACKGROUND: In nursing homes there is a gradual move from traditional care to integrated care. Integrated care means a demand-oriented, small-scale, co-operated and coordinated provision of services by different caregivers. This integration has direct effect on the work of these separate disciplines. With the introduction of integrated care the quality of work of these caregivers should be assured or even be improved. OBJECTIVES: The purpose of this study was to examine the implementation of integrated care in the nursing home sector and its effects on the quality of work of the caregivers (work content, communication and co-operation and worker's outcomes). DESIGN: A non-equivalent pre-test/post-test control group design was used in this study. SETTINGS AND PARTICIPANTS: Two nursing homes in the Netherlands participated in the study. One nursing home provided the five experimental nursing wards and the other nursing home provided four control wards. METHOD: Data were selected by means of written questionnaires. RESULTS: The results showed that the intervention appeared to be only successful on the somatic wards. The caregivers of these wards were more able to create a home-like environment for their residents, to use a demand-oriented working method and to integrate the provision of care and services. Regarding the effects of the intervention on quality of work factors, the results included an increase of social support by the supervisor, an increase of the degree of collaboration and a decrease in job demands. No changes were found for the worker's outcomes such as job satisfaction. CONCLUSIONS: The intervention on the psycho-somatic wards was unsuccessful. Although the introduction of integrated care on the somatic wards was successful, the effects on quality of work were limited. Next to quantitative research, more qualitative in-depth research is needed to examine models of integrated care and their effects on the work of caregivers within health care organisations, with special attention for specific characteristics of different types of nursing home care (somatic vs. psycho-geriatric).

Lifestyle interventions are cost-effective in people with different levels of diabetes risk: results from a modeling study.

OBJECTIVE: In the current study we explore the long-term health benefits and cost-effectiveness of both a community-based lifestyle program for the general population (community intervention) and an intensive lifestyle intervention for obese adults, implemented in a health care setting (health care intervention). RESEARCH DESIGN AND METHODS: Short-term intervention effects on BMI and physical activity were estimated from the international literature. The National Institute for Public Health and the Environment Chronic Diseases Model was used to project lifetime health effects and effects on health care costs for minimum and maximum estimates of short-term intervention effects. Cost-effectiveness was evaluated from a health care perspective and included intervention costs and related and unrelated medical costs. Effects and costs were discounted at 1.5 and 4.0% annually. RESULTS: One new case of diabetes per 20 years was prevented for every 7-30 participants in the health care intervention and for every 300-1,500 adults in the community intervention. Intervention costs needed to prevent one new case of diabetes (per 20 years) were lower for the community intervention (2,000-9,000 euros) than for the health care intervention (5,000-21,000 euros). The cost-effectiveness ratios were 3,100-3,900 euros per quality-adjusted life-year (QALY) for the community intervention and 3,900-5,500 euros per QALY for the health care intervention. CONCLUSIONS: Health care interventions for high-risk groups and community-based lifestyle interventions targeted to the general population (low risk) are both cost-effective ways of curbing the growing burden of diabetes.

Cost effectiveness of preventive interventions in type 2 diabetes mellitus: a systematic literature review.

A systematic review of the literature was conducted to give an overview of economic evaluations of preventive interventions in type 2 diabetes mellitus. The interventions were sorted by type of preventive intervention (primary, secondary or tertiary) and by category (e.g. education, medication for hypertension). Several databases were searched for studies published between January 1990 and May 2004 on the three types of preventive intervention. For each study selected, inclusion of specific components from a standardised list of items, including quality, was recorded in a database. Summary tables were generated based on the database.A number of conclusions were drawn from this review. The most important was that strict blood pressure control was a more cost-effective intervention than less strict control, as shown by six studies reporting cost savings to very low costs per life-year gained. Primary and secondary prevention of type 2 diabetes were also highly cost effective, but these results were based on very few studies. Medications to reduce weight and hyperglycaemia together were cost effective compared with conventional interventions. Finally, the separate results regarding medications to reduce weight, hyperglycaemia and hypercholesterolaemia varied enormously, thus no conclusion could be drawn and further economic analysis is required.