Occurrence and determinants of parental psychosocial stress and mental health disorders in parents and their children in early childhood: rationale, objectives, and design of the population-based SKKIPPI cohort study.

PURPOSE: The postnatal period is a vulnerable time for parents and children but epidemiological and health care utilisation data for Germany on parental mental health during early childhood is scarce. This protocol describes the rationale, aim and study design of a population-based cohort study to assess the occurrence and determinants of psychosocial stress and mental health disorders, as well as the use and cost of health care and social services in early childhood. METHODS: As part of the collaborative SKKIPPI project, we will contact a random sample of 30,000 infants listed in the residents' registration offices of three German towns and we expect to include 6,000 mother-child pairs. Both parents are invited to fill out an online screening questionnaire. Mothers with indications of psychosocial stress will be interviewed to assess mental health disorders, regulatory problems of their children, as well as health care and social services utilisation, with a follow-up assessment after 6 months. RESULTS: After description of sociodemographic and health data, we will analyse occurrences, patterns, and potential determinants (maternal age, social status, household factors, migration status etc.) of psychosocial stress and mental health disorders in the mothers and their children in early childhood. CONCLUSIONS: Our study will identify potential risk and protective factors for postnatal mental health and health care utilization of psychosocially burdened families. This will help to improve prevention and treatment strategies to strengthen the parent-child relationship, to reduce persisting vulnerability of children, and to improve health care and social services. TRIAL REGISTRATION: The study has been registered in the German Clinical Trial Registry on February 8th 2019 (DRKS-ID: DRKS00016653).

[Patients suffering from atrial fibrillation in Germany. Characteristics, resource consumption and costs]. / Patienten mit Vorhofflimmern in Deutschland. Charakteristika, Ressourcenverbrauch und Kosten.

INTRODUCTION: Atrial fibrillation (Afib) is considered to be the most frequent form of cardiac dysrhythmia and is well known as a key risk factor for arterial thromboembolism. The incidence of Afib will increase in the future due to demographic changes as well as improved treatment options for acute and chronic heart diseases. OBJECTIVE: The primary objectives of this analysis were to describe patient characteristics, to assess the resource consumption associated with Afib and to measure costs of direct treatment as well as consequential costs. A secondary objective was to identify factors that influence the costs or the type of Afib. METHODS: The analysis is based on the representative ATRIUM register (Ambulantes Register zur Morbidität des Vorhofflimmerns, Ambulatory register on morbidity of atrial fibrillation), a prospective, multicenter cohort study in which general practitioners and family doctors documented the characteristics and resource utilization of consecutively enrolled patients. The documented resource consumption use was subsequently valued with unit costs. The presented results are focused on the baseline documentation and refer to the period 12 months before enrollment. RESULTS: A total of 3,667 patients (mean age 72.1±9.2 years, 58% men) fulfilled all inclusion criteria and were included by a total of 730 doctors. The patients had an average of 2.4±1.0 risk factors and the most common was hypertension (84% of patients). The most commonly observed comorbidities were heart failure (43%) and coronary heart disease (CHD, 35%). Medicines for oral anticoagulation (86%) and beta blockers (75%) were the most frequently prescribed drugs. A total of 1/3 of all patients received a specific kind of Afib therapy (e. g. drug conversion, cardioversion) during the past 12 months. The disease-specific mean costs of the patients were 3,274±5,134 Euro, while the acute (inpatient) treatment represented the largest proportion of these total costs (1,639±3,623 Euro). Patients with high treatment costs were significantly younger and suffered from more concomitant diseases. CONCLUSION: Atrial fibrillation is associated with significant patient-related attributable costs that are caused particularly by expenditures of inpatient stay. New, innovative treatment strategies seem to offer particular potential savings if they are able to reduce the number of hospitalizations due to Afib itself or subsequent cardiac events.

[Cardiovascular diseases in the focus of health economics. The example of drug-eluting vascular stents in coronary heart disease]. / Herz-Kreislauf-Erkrankungen im Fokus der Gesundheitsökonomie. Das Beispiel medikamentenfreisetzender Gefäßstents bei koronarer Herzerkrankung.

Coronary heart disease is an important disorder in Western industrialized societies, with regard to both the epidemiologic and economic burden of illness. A modern therapeutic strategy consists of coronary interventions and the implantation of drug-eluting vascular stents. The cost-effectiveness of such drug-eluting stents has been an important subject of health-economic evaluation research in recent years. This article presents two examples of such studies and deals with the question whether existing study projects are able to provide sufficient evidence for allocation decisions in health care. On this basis we discuss important challenges for future health economic analysis. A key conclusion is the need for long-term and cross-sectoral evaluation strategies that could be based on routinely collected health care data. Supplemented by health economic results from clinical trials, the use of such data would lead to a broader data basis for allocation decisions in health care.

Homeopathy for seasonal allergic rhinitis: rationale, design and methods of the three-armed randomized controlled HOMEOSAR trial.

BACKGROUND: Patients with seasonal allergic rhinitis (SAR) frequently use homeopathic therapy. Although there is some evidence that homeopathy may be effective in treating symptoms of SAR, there is a lack of high-quality clinical trials. Therefore, the aim of the homeopathy for SAR (HOMEOSAR) trial is to determine the efficacy of individualized or standardized homeopathic drug treatment compared to placebo regarding rhinitis-related quality of life in patients with SAR. METHODS: This randomized, placebo-controlled, double-blind, three-armed intervention study will be conducted at two university hospital outpatient clinics for complementary and integrative medicine in Berlin and in 12 office-based practices specializing in homeopathic treatment in Germany. A total of 270 patients with clinical symptoms of SAR and positive allergy test to birch and grass pollen will receive homeopathic anamnesis and subsequently be randomized into (a) standardized homeopathic drug treatment with Galphimia Glauca (potency D6), (b) individualized homeopathic drug treatment (D6), or (c) placebo. All three groups can receive on-demand rescue medication as needed. Treatment will consist of two consultations and daily intake of the study medication for 4 weeks during the pollen season. The primary outcome is the mean overall score of the Rhinitis Quality of Life Questionnaire (RQLQ) in weeks 3 and 4, analyzed using analysis of covariance (adjusted for baseline RQLQ overall score and study center). A closed testing procedure will be used to control the overall type I error comparing the 3 treatment groups. Secondary outcomes include the overall RQLQ and its seven domain scores, responder status (decrease in RQLQ overall score of at least 0.5 points compared to the baseline value), use of rescue medication, intensity of total and individual SAR symptoms based on visual analog scale, generic health-related quality of life, safety, utilization of health care resources and associated costs. In addition, a qualitative data analysis is planned. CONCLUSION: The results of our study will contribute to clarifying the possible therapeutic effects of homeopathic drug treatment for patients with SAR. TRIAL REGISTRATION: This study has been registered in the German Clinical Trial Registry with trial ID DRKS00018081 on June 09, 2020.

[Second-generation DES : New, but also cost-effective?]. / Medikamentenfreisetzende Stents der 2. Generation : Neu, aber auch kosteneffektiv?

BACKGROUND: The objective of the present review was to investigate the cost-effectiveness of second-generation drug-eluting stents (DES) compared to bare metal stents (BMS) as well as to first-generation DES. METHODS: A structured literature review in MEDLINE was conducted to identify all studies investigating the cost-effectiveness of second-generation DES published up to December 2010. Pre-specified selection criteria were applied to identify relevant studies. Standardized data extraction was performed to summarize clinical, economic, and cost-effectiveness outcomes of these studies. RESULTS: Of only five studies which met all selection criteria from the US, UK, and Spain, three investigated the cost-effectiveness of the zotarolimus-coated Endeavor stent (ZES) compared to BMS, and two studies the ZES with first-generation DES. CONCLUSION: In summary, there is currently a lack of evidence with regard to the cost-effectiveness of second-generation DES, especially in Germany. However, studies from other countries provide some evidence that second-generation DES appear to generally not be cost-effective compared to BMS. Also, there is no conclusive evidence of cost-effectiveness compared to first-generation DES. Moreover, there are currently no studies investigating the cost-effectiveness of the Everolimus-coated Xience V stent. Methodologically rigorous economic evaluations addressing these issues within the context of the German health care system are therefore urgently required.

Efficacy of Parent-Infant-Psychotherapy with mothers with postpartum mental disorder: study protocol of the randomized controlled trial as part of the SKKIPPI project.

BACKGROUND: After the birth of a child, many mothers and fathers experience postpartum mental disorders like depression, anxiety, obsessive-compulsive disorder, stress or other illnesses. This endangers the establishment of a secure attachment between the children and their primary caregivers. Early problems in parent-child interaction can have adverse long-term effects on the family and the child's well-being. In order to prevent a transgenerational transmission of mental disorders, it is necessary to evaluate psychotherapeutic interventions that target psychologically burdened parents of infants or toddlers. The aim of this trial is to investigate the efficacy of Parent-Infant-Psychotherapy (PIP) for mothers with postpartum mental disorder and their infants (0-12 months). METHODS/DESIGN: In this open, randomized controlled intervention trial 180 mother-infant-dyads will be included and randomly allocated to 12 sessions of PIP or care as usual. The interventions take place either in inpatient adult psychiatric departments or in outpatient settings with home visits. The primary outcome is the change in maternal sensitivity assessed by the Sensitivity subscale of the Emotional Availability Scale (EAS) through videotaped dyadic play-interactions after 6 weeks. Secondary outcomes are maternal psychopathology, stress, parental reflective functioning, infant development and attachment after 6 weeks and 12 months. In addition, maternal attachment (AAI) and reflective functioning (AAI) will be analyzed as potential moderators, and resource usage in the German health system as well as associated costs will be evaluated. DISCUSSION: There is increasing demand for well-controlled studies on psychotherapeutic interventions in the postpartum period that do not only focus on particular risk groups. This randomized controlled trial (RCT) represents one of the first studies to investigate the efficacy of PIP in inpatient psychiatric departments and outpatient care centers in Germany. The results will fill knowledge gaps on the factors contributing to symptom reduction in postpartum mental disorders and improvements in mother-child relationships and help in developing preventive and therapeutic strategies for the fragmented German health care system. TRIAL REGISTRATION: German Register for Clinical Trials, ID: DRKS00016353.

The costs of postoperative liver failure and the economic impact of liver function capacity after extended liver resection--a single-center experience.

PURPOSE: Postoperative liver failure (PLF) is a relatively frequent and life-threatening complication after extended liver resection. This study describes the economic burden of PLF from the hospitals' perspective and explores the role of liver function capacity. MATERIALS AND METHODS: Economic data of total costs and cost distribution were analyzed for 48 patients who had participated in a prospective study with the LiMAx test, a novel test for liver function capacity. For this population, detailed individual data were available. The economic data were analyzed and adjusted for relevant covariates. In addition, economic data of 916 patients who had undergone liver resection during 2005-2007 were retrieved from the hospitals' medical controlling office for comparison. RESULTS: A significant difference between the costs of patients with regular recovery (25,980 Euro [95% confidence interval (95%CI) = 9,559 to 42,401]) versus patients developing PLF (82,199 Euro [95%CI = 42,812 to 121,586]; p = 0.013) was observed. The mean additional costs of PLF were 56,219 Euro. An equivalent cost difference of mortality was obtained from the analysis of 916 patients. Patients developing PLF had a decreased LiMAx of 61 microg/kg/h compared to the regular group 122 microg/kg/h (p < 0.001) after surgery. Initial postoperative LiMAx and total costs revealed a linear correlation coefficient of r = -0.340 (p = 0.018). CONCLUSIONS: PLF is a very relevant medical and economic problem. Liver function capacity does not only predict PLF but also correlates with total costs in general.

Cost-effectiveness of interventions promoting physical activity.

BACKGROUND: Sedentary and inactive lifestyle continues to increase and is associated with a substantial economic burden in most industrialised countries. To implement effective physical activity interventions on a broad population basis, their cost-effectiveness needs to be evaluated. OBJECTIVE: To evaluate the cost-effectiveness of physical activity interventions targeted at healthy adults and to identify cost-effective intervention components. DESIGN: Systematic review. Methods and DATA SOURCES: The search strategy in electronic databases identified relevant literature published until June 2008. We included studies investigating the cost-effectiveness of interventions aiming to promote physical activity behaviour in healthy adults. Two researchers independently assessed publications according to predefined inclusion criteria and with regard to methodological quality. Study characteristics and predefined outcome measures were extracted and costs per participant to become sufficiently active were compared between interventions. RESULTS: Out of 6543 identified publications, eight studies investigating 11 intervention strategies met the inclusion criteria. There was substantial heterogeneity in study quality, intervention strategies and intervention effects. Behavioural interventions were able to promote physical activity, with participants meeting recommended levels of physical activity, for about 800 Euros per year. Environmental interventions and interventions targeted at general practitioners seemed to have the potential to be substantially more cost-effective. DISCUSSION: There was evidence that current physical activity intervention strategies can be a cost-effective means of resource allocation. But, despite the growing literature on physical activity promotion, appropriate cost-effectiveness analyses are rare and the generalisability of presented findings is limited. Further research is warranted to investigate the cost-effectiveness of behavioural and environmental intervention strategies.

[Health economic effects after DRG-implementation--a systematic overview]. / Gesundheitsökonomische Auswirkungen der DRG-Einführung in Deutschland--eine systematische Ubersicht.

BACKGROUND: Since 1 January 2004, inpatient treatment services in German hospitals have been reimbursed using a prospective payment method based on diagnosis-related groups (DRGs) rather than daily rates. The aim of the payment system reform was to decrease the length of inpatient stays and reduce overall healthcare expenditure, the latter of which had increased markedly during previous decades. OBJECTIVE: The primary objective of our study was to analyse and describe the health-economic consequences of implementing a DRG-based system of prospective payment in Germany. METHODS: A systematic search of the literature was performed on MEDLINE. Inclusion criteria were a focus on health economic variables from the German perspective and a publication date after 1 January 2004. The search was supplemented by a manual review of references, as well as internet-based hand search. The main health-economic conclusions were subsequently extracted from all of the included studies. RESULTS: A total of 19 quantitative and qualitative studies were included. There were substantial differences between them in terms of medical focus and hospital characteristics. The most common health-economic variables analysed were revenue generated by patient treatment, and length of inpatient stay. As expected, both variables showed a decreasing trend following the introduction of DRGs. The included studies also investigated the development of case numbers, the proportion of outpatient services provided, the number of diagnoses per case, and the homogeneity of case groups. For these variables, the studies showed a wide range of results. CONCLUSION: Similar to the experience with DRGs in many other countries, the introduction of DRGs in Germany has led to a reduction in the length of inpatient stay and a decrease in hospital revenues. The effects on other health-economic parameters are inconsistent. Additional studies in this area are needed.

Cost-effectiveness of acupuncture treatment in patients with headache.

The aim was to assess costs and cost-effectiveness of additional acupuncture treatment in patients with headache compared with patients receiving routine care alone. A randomized, controlled trial was conducted, including patients (> or =18 years old) with primary headache (more than 12 months, at least two headaches/month). Outcome parameters were quality of life (Short Form 36), direct and indirect costs differences during the 3-month study period and the incremental cost-effectiveness ratio (ICER) of acupuncture treatment. A total of 3182 patients (1613 acupuncture; 1569 controls) with headache were included (77.4% women, mean age and standard deviation 42.6 +/- 12.3; 22.6% men, 47.2 +/- 13.4). Over 3 months costs were higher in the acupuncture group compared with the control [euro857.47; 95% confidence interval 790.86, 924.07, vs. euro527.34 (459.81, 594.88), P < 0.001, mean difference: euro330.12 (235.27, 424.98)]. This cost increase was primarily due to costs of acupuncture [euro365.64 (362.19, 369.10)]. The ICER was euro11 657 per QALY gained. According to international cost-effectiveness threshold values, acupuncture is a cost-effective treatment in patients with primary headache.

Parotid and cervical nodal status predict prognosis for patients with head and neck metastatic cutaneous squamous cell carcinoma.

BACKGROUND AND OBJECTIVES: The appreciation of parotid involvement being an independent prognostic factor for metastatic cutaneous squamous cell carcinoma (SCC) is relatively new. A more comprehensive clinical staging system that separates parotid (P) from neck (N) disease, and further stratifies the N category has been proposed [O'Brien et al., Head Neck 2002; 24: 417-422]. This paper presents the clinical outcome of patients with head and neck metastatic cutaneous SCC treated at the four major head & neck surgical oncology centers in New Zealand and tests the proposed staging system, with modifications for pathological staging. METHODS: Patients treated with a curative intent from 1990 to 2005 were identified and re-staged. Survival rates were calculated using the Kaplan-Meier method, and curves were compared with the log-rank test. Multivariate analysis using the Cox regression model was performed to assess the impact of each proposed P and N sub-group, and other parameters. RESULTS AND CONCLUSIONS: One hundred and seventy patients were identified. The 5-year disease-specific survival rate was 69%, and the loco-regional recurrence rate was 36%. The presence of parotid (P < 0.01) or neck (P = 0.01) disease, immunosuppression (P < 0.01) and the uptake of radiotherapy (P < 0.01) impacted significantly on survival. Increasing P or N category worsened the prognosis significantly.

Long-term effectiveness of behavioural interventions to prevent smoking among children and youth.

OBJECTIVES: To evaluate the long-term effectiveness of recent behavioural interventions in the prevention of cigarette use among children and youth and to compare the effectiveness of different school-based, community-based and multisectorial intervention strategies. METHODS: A structured search of databases and a manual search of reference lists was conducted. Randomised controlled trials published in English or German between August 2001 and August 2006 targeting youths up to 18 years of age were assessed independently by two researchers according to predefined inclusion criteria and with regard to methodological quality. Data abstraction was performed and crosschecked by two researchers. Where appropriate, pooled effect estimates were calculated and tested in sensitivity analyses. RESULTS: Of 3555 articles, 35 studies met the inclusion criteria. The follow-up duration ranged from 12 months to 120 months. Although the overall effectiveness of prevention programs showed considerable heterogeneity, the majority of studies reported some positive long-term effects for behavioural smoking prevention programs. There was evidence that community-based and multisectorial interventions were effective in reducing smoking rates; in contrast, the evidence for school-based programs alone was inconclusive. Regardless of the type of intervention, the reductions observed in smoking rates were only modest. CONCLUSIONS: The present work identified moderate evidence for the effectiveness of behavioural interventions to prevent smoking. Although evidence for the effectiveness of school-based interventions was inconclusive, evidence for the effectiveness of community-based and multisectorial interventions was somewhat stronger. Future research should investigate the effectiveness of specific intervention components and the cost-effectiveness of interventions analysed in methodologically high-quality studies.

Subcutaneous specific immunotherapy: Economic implications from the perspective of statutory health insurance - a population based cost-effectiveness estimation.

BACKGROUND: Specific immunotherapy is the only potentially curative therapy in patients with allergic rhinitis (AR) and allergic asthma (AA). The present study examined the effects of subcutaneous immunotherapy (SCIT) on the financial situation of the German statutory health insurance systems and measures the impact on AR/AA prevalence during the next decades. A further objective was to identify possible SCIT-treatment strategies in order to reach an efficient SCIT-use. METHODS: Taking population projections of the German Statistical Federal Office, the number of expected new cases (AR, AA) was calculated until 2050. Based on assumptions about the proportion of patients who received SCIT in the future, age cohorts run through a model-calculation based on Markov chains. Data on effectiveness were extracted from published literature. For determining the cost situation of SCIT pharmacies we used selling prices for Allergovit®. All future costs are discounted at a mean rate of 2%. The model calculation was supplemented by a Delphi panel. RESULTS: Based on the current situation, a total annual economic burden of 540 million Euros is to be expected for care of about yearly 6 million patients with AR and AA in Germany between 2011 and 2050. Several scenarios have shown that the use of SCIT seems to be associated with cost savings from the perspective of statutory health insurances, when SCIT is offered to a larger amount of patients with moderate to severe symptoms. That would result in reduced number of expensive patients who suffer from AA. The best effects on the future number of diseased patients could be achieved, however, if SCIT additionally would be applied to patients in earlier stages of disease. Due to the large number of patients receiving SCIT in such a scenario, the initial costs would not completely compensated by cost savings. Nevertheless, the additional costs of 300 to 350 Euros per additionally healed patient seem to be justifiable. CONCLUSION: From the perspective of the SHI, SCIT is a useful strategic option for preventing the progression of allergic diseases. Particularly with increased use in early disease stages, the number of healed patients is high. Potential cost savings may result from increased treatment rates in patients with advanced disease stages.

Patient characteristics in German allergological practices - a nationwide survey.

INTRODUCTION: In Western societies a significant incidence and prevalence of allergic asthma and other allergic diseases is observable. The present study investigated epidemiological patterns of allergic diseases and the utilization of health care resources by subjects who are already under specialized allergological treatment. Furthermore the study was performed to identify factors which had a significant impact on accessibility to specific immunotherapy (SIT). METHODS: The study was based on a cross-sectional survey on patient characteristics, which was performed by participating physicians, who were specialized in the field of allergological disorders and SIT, in collaboration with their patients. The analysis of data was divided into descriptive analyses and an analytical part, in which influencing factors for accessibility to specific immunotherapy were investigated. Logistic regression models to identify several predictor variables were used. RESULTS: 495 physicians documented the data of 19,990 patients. 18,177 patients were included in the analyses. Patients had a mean age of 31.5 ± 15.5 years and 53.2% were female. The most frequent and most severe allergic disorders observable in German allergological practices were conjunctivitis and rhinitis. The seasonal symptoms occurred mainly during March to August, while seasonal disease manifestation was 2.5 times more frequent than perennial forms. The most received anti-symptomatic medications are antihistamines and corticosteroids. Patients who receive SIT were mainly treated using subcutaneous immunotherapy (SCIT) - only in lower age groups, the likelihood of receiving sublingual immunotherapy (SLIT) was increased. CONCLUSION: In Germany, conjunctivitis and rhinitis are the most severe allergic disorders in allergological practices. Compared to the German general patient population, people who were already in allergological treatment had better access to SIT.

[Treatment costs of localized prostate cancer in Germany : Economic results from the HAROW observational study]. / Behandlungskosten des lokal begrenzten Prostatakarzinoms in Deutschland : Ökonomische Ergebnisse der HAROW-Beobachtungsstudie.

BACKGROUND: Prostate cancer (PCa) is the most common cancer in men. For medical treatment of PCa, a number of therapies are available. The economic consequences associated with these individual treatment options in routine care in Germany are unclear so far. METHODS: The present analysis was based on the Germany-wide HAROW observational study, which was conducted from 2008-2013. During this study, all participating physicians and involved patients reported and documented individual health care resource consumption. These data were evaluated in monetary terms stratified by treatment regime (hormone therapy, HT; active surveillance, AS; radiotherapy, RT; radical prostatectomy, RP; watchful waiting, WW). RESULTS: Overall, the data of 2672 patients were available for analysis. Based on the observational study design, the included patient groups were heterogeneous in their baseline characteristics. The annual total costs from the societal perspective were the largest for patient undergoing RP (9254 €; 95 % CI 8353-10,154), mainly driven by the costs for the initial hospital stay for surgery. HT, AS, RT, and WW seem to be comparable in terms of direct costs, ranging from 805 € (95 % CI 154-1455) for WW up to 1115 € (95 % CI 826-1405) for RT. The highest indirect costs were observed for patients receiving RT (3928 €; 95 % CI 0-10,675), which can be justified by the frequent incapacity to work in this patient group. CONCLUSION: The treatment of prostate cancer can lead to significant economic follow-up costs which vary greatly depending on the type of treatment. The analysis indicates a need for the implementation of a long-term health economic study in the future, which will be more suitable to show treatment-specific differences in the temporal occurrence of costs.

Integration of metallic endoprotheses in dog femur studied by near-infrared Fourier-transform Raman microscopy.

The integration of hydroxyapatite-coated implants in dog femur was studied by near-infrared Fourier-transform Raman microscopy. Raman spectra were taken in lateral scans in step widths of 10-40 microm from the implant surface up to a distance of 320 microm into the bone tissue. The spectra were subjected to a component analysis for the quantitative determination of the protein and the inorganic components. This quantitative analysis is shown to be more reliable than conventional band fitting procedures and allows, for the first time, the quantitative distinction between the hydroxyapatite form of mature bone tissue and synthetic hydroxyapatite introduced by the implant coating. It is demonstrated that full mineralization of the ongrowing bone is not achieved after 6 months. In contrast, after a residence time of 18 months in the body, the Raman spectra reveal a complete calcification of the new bone tissue as indicated by content of biological hydroxyapatite that is the same as in mature bone tissue throughout the whole implant/bone interface. On the other hand, the content of synthetic hydroxyapatite is strongly reduced in the sample prepared after eighteen months implantation whereas for the shorter implantation time. substantial contributions of synthetic hydroxyapatite are found even at positions beyond the thickness of the implant coating. These results indicate that the coating material is actively involved in the mineralization of ongrowing bone. Possible mechanisms for the underlying transport processes in the implant/bone interface are discussed.

Cost-effectiveness of a 3-month intervention with oral nutritional supplements in disease-related malnutrition: a randomised controlled pilot study.

BACKGROUND/OBJECTIVES: Nutritional intervention with oral nutritional supplements (ONS) has been shown to increase quality of life in malnourished patients. We investigated whether post-hospital supplementation with ONS is cost-effective according to international benchmarks in malnourished patients. SUBJECTS/METHODS: In total, 114 malnourished patients (50.6±16.1 years, 57 female) with benign gastrointestinal disease were included and randomised to receive either ONS for 3 months and dietary counselling at discharge (intervention, n=60) or only dietary counselling at discharge (control group, n=54). Nutritional status was assessed with Subjective Global Assessment. Intervention patients documented daily intake of ONS; quality of life was assessed with Short-Form (SF)-36 Health Survey and SF-36 values were transformed into health-status utilities. Quality-adjusted life years (QALYs) were calculated by adopting the area under the curve method. We used two different pricing scenarios for ONS (minimum price: [euro]2.30 and maximum: [euro]2.93/tetrapack). The incremental cost-effectiveness ratio (ICER) of supplementation with ONS was calculated for both price scenarios. All analyses were corrected for age and gender. RESULTS: Intervention patients consumed 2.4±0.8 ONS per day. Intervention and control patients did not differ in their health status utilities at baseline (0.594±0.017 vs 0.619±0.018), but after 3 months, the health status utilities were significantly higher in intervention patients than in control patients (0.731±0.015 vs 0.671±0.016, P=0.028). Intervention was associated with significantly higher costs (ICER: [euro]9497 and [euro]12,099/additional QALY, respectively) but deemed cost-effective according to international thresholds (< [euro]50,000/QALY). CONCLUSIONS: A 3-month intervention with ONS increases quality of life in malnourished patients. This treatment appears to be cost-effective according to international benchmarks.