Review of Relative effectiveness assessments (REAs) of pharmaceuticals at the European network for health technology assessment (EUnetHTA): A first step towards a consolidated European perspective on comparative effectiveness & safety?

OBJECTIVES: REAs from Joint Action (JA1-3) were reviewed and compared versus Health Technology Assessments (HTA) in France, Germany, UK, Italy. METHODS: EUnetHTA REAs published until end of 2019 were identified. Leveraging information derived from the HTA bodies' website key process (population; timing; national HTA bodies involved) and content characteristics (evidence base; comparative therapy, endpoints, subgroups) were determined and compared against national appraisals. RESULTS: All twelve pharmaceutical EUnetHTA assessment finalized until end of 2019 were included with Ustekinumab being the most recent (October 2019) and Pazopanib the first assessment (September 2012). In all but three assessments EUnetHTA's assessment did not cover the full EMA indication. Since JA3 time intervals between EMA approval and EUnetHTA assessment were < 80 days. Number of (co-)authoring HTA bodies ranged between 2 (in 6 REAs) and > 10 (Pazopanib). EUnetHTA did consider non - RCT evidence in 7 procedures; take a rather inclusive approach regarding appropriate comparative treatments; approach endpoints less restrictively than e.g. the German IQWiG/GBA; not apply a predetermined set of subgroups analyses. In seven REAs, national appraisal showed inhomogeneities across the 4 countries. National appraisals for Sotagliflozin and Ustekinumab were not yet available. CONCLUSIONS: A joint European HTA assessment has the potential to address the challenge of heterogeneity across the various national European HTA bodies and to determine joint European clinical development data standards that are aligned with regulatory requirements.

Different interpretation of additional evidence for HTA by the commissioned HTA body and the commissioning decision maker in Germany: whenever IQWiG and Federal Joint Committee disagree.

BACKGROUND: The purpose of this study was to analyse the impact of commissioned addenda by the Federal Joint Committee (FJC) to the HTA body (IQWiG) and their agreement with FJC decisions and to identify potential additional decisive factors of FJC. METHODS: All available relevant documents up to end of 2017 were screened and essential content extracted. Next to descriptive statistics, differences between IQWiG and FJC were tested and explored by agreement statistics (Cohen's kappa and Fleiss' kappa) and ordinal logistic regression. RESULTS: Most of the 90 addenda concerned oncological products. In all contingent comparisons, positive changes in added benefit or evidence level on a subpopulation basis (n = 124) prevailed negative ones. Fleiss' ordinal kappa for agreement of assessments, addenda, and appraisals reached a moderate strength for added benefit (0.474, 95%-CI, 0.408-0.540). Overall agreement between addenda and appraisals on a binary nominal basis is poor for added benefit (Cohen's kappa 0.183; 95%-CI: 0.010-0.357) ranging from "less than by chance" (respiratory diseases) to "perfect" (neurological diseases). The OR of the selected regression model showed that i) mortality, ii) unmet need, the positions of iii) the physicians' drug commission and iv) medical societies, and v) the annual therapeutic costs of the appropriate comparative therapy had a high influence on FJC's appraisals deviating from IQWiG's addenda recommendation. CONCLUSIONS: IQWiG's addenda have a high impact on decision-maker's appraisals offering additional analyses of supplementary evidence submitted by the manufacturers. Nevertheless, the agreement between addenda and appraisals varies, highlighting different decisive factors between IQWiG and FJC.

[Phase IV non-interventional studies in the treatment of rheumatoid arthritis with biologicals in Germany : real-life clinical practice data]. / Nichtinterventionelle Phase-IV-Studien zur Behandlung der rheumatoiden Arthritis mit Biologicals in Deutschland : Praxisbezogene klinische Daten.

BACKGROUND: In contrast to the restrictive nature of randomised controlled trials (RCT), non-interventional studies (NIS) investigate the features of a therapy in daily clinical practice. The observational plan of NIS does not dictate a treatment strategy, but is based on the product label. Unlike RCT, NIS therefore have no actual inclusion and exclusion criteria, allowing the study of broad heterogeneous patient populations. METHODS: NIS carried out in Germany with support from the pharmaceutical industry and investigating the use of biologics for the treatment of rheumatoid arthritis were identified and their findings were compared with those from the RCT of the respective biologic. RESULTS: Analysis of the identified NIS revealed the following: (1) populations in NIS were on average more than twice as large as in RCT, (2) patient characteristics in NIS and RCT were different, (3) the effectiveness of biologics in NIS was comparable to the efficacy observed in RCT, and (4) NIS collected supplementary data, e.g. on usage and dosing in clinical practice. CONCLUSION: NIS represent an important tool for the assessment of daily clinical practice. Despite methodological drawbacks, NIS provide valuable data that contribute to a more complete picture of the value of treatment with biologics. The English version of this article is available at SpringerLink (under "Supplemental").

Content comparison of health status measures for obesity based on the international classification of functioning, disability and health.

OBJECTIVE: To compare the content covered by twelve obesity-specific health status measures using the International Classification of Functioning, Disability and Health (ICF). DESIGN: Obesity-specific health status measures were identified and then linked to the ICF separately by two trained health professionals according to standardized guidelines. The degree of agreement between health professionals was calculated by means of the kappa (kappa) statistic. Bootstrapped confidence intervals (CI) were calculated. The obesity-specific health-status measures were compared on the component and category level of the ICF. MEASUREMENTS: welve condition-specific health-status measures were identified and included in this study, namely the obesity-related problem scale, the obesity eating problems scale, the obesity-related coping and obesity-related distress questionnaire, the impact of weight on quality of life questionnaire (short version), the health-related quality of life questionnaire, the obesity adjustment survey (short form), the short specific quality of life scale, the obesity-related well-being questionnaire, the bariatric analysis and reporting outcome system, the bariatric quality of life index, the obesity and weight loss quality of life questionnaire and the weight-related symptom measure. RESULTS: In the 280 items of the eight measures, a total of 413 concepts were identified and linked to the 87 different ICF categories. The measures varied strongly in the number of concepts contained and the number of ICF categories used to map these concepts. Items on body functions varied form 12% in the obesity-related problem scale to 95% in the weight-related symptom measure. The estimated kappa coefficients ranged between 0.79 (CI: 0.72, 0.86) at the component ICFs level and 0.97 (CI: 0.93, 1.0) at the third ICF's level. CONCLUSION: The ICF proved highly useful for the content comparison of obesity-specific health-status measures. The results may provide clinicians and researchers with new insights when selecting health-status measures for clinical studies in obesity.

[Productivity costs of rheumatoid arthritis in Germany. Cost composition and prediction of main cost components]. / Produktivitätskosten der rheumatoiden Arthritis in Deutschland. Kostenzusammensetzung und Prädiktion der Hauptkostenkomponenten.

OBJECTIVE: Identification of predictors for the productivity cost components: (1) sick leave, and (2) work disability in gainfully employed and (3) impaired household productivity in unemployed patients with rheumatoid arthritis (RA) from the societal perspective. METHODS: Investigation of productivity costs was linked to a multicenter, randomized, controlled trial evaluating the effectiveness of clinical quality management in 338 patients with RA. The productivity losses were assessed according to the German Guidelines on Health Economic Evaluation. By means of multivariate logistic regression analyses, predictors of sick leave, work disability (employed patients, n=96), and for days confined to bed in unemployed patient (n=242) were determined. RESULTS: Mean annual costs of 970 EUR arose per person taking into consideration all patients (453 EUR sick leave, 63 EUR work disability, 454 EUR impaired productivity of unemployed patients). Disease activity, disease severity, and impaired physical function were global predictors for all of the cost components investigated. Sick leave costs were predicted by prior sick leave periods and the vocational status blue collar worker, work disability costs by sociodemographic variables (marital status, schooling), and the productivity costs of unemployed patients by impaired mental health and impaired physical functions. CONCLUSIONS: Interventions such as reduction in disease progression and control of disease activity, early vocational rehabilitation measures and vocational retraining in patients at risk of quitting working life, and self-management programs to learn coping strategies might decrease future RA-related productivity costs.

Costs in rheumatology: results and lessons learned from the 'Hannover Costing Study'.

The objective of this study is to review the concept of the 'Hannover Costing Study' and to present and discuss the major insights generated during the course of the project. The costing study was performed in conjunction with a randomized controlled prospective trial assessing the effectiveness of a disease management module in rheumatoid arthritis (RA). A full set of clinical and cost data both from patient-reported and payer-derived cost data was developed. In particular the study included (1) the development of a matrix of cost domains which might be used as a common taxonomy in costing studies, (2) the descriptive analysis of payer derived cost data, (3) the analysis of cost data in patients with uncertain diagnosis; (4) the development and validation of a patient-reported costing instrument, and (5) an assessment of productivity costs. The following are the results (1) the developed matrix of cost domains included 16 separate cost domains: 7 outpatient, 3 inpatient, 4 other disease related, and 2 productivity domains; (2) the micro-costing analysis showed total direct costs of 3,815 per patient-year (standard error of mean, SEM: 267) and RA-related direct costs were 2,312 per patient-year; (3) in patients with uncertain diagnosis of RA and no treatment with 'Disease Modifying Antirheumatic Drugs' (DMARD) costs were significantly lower; (4) the comparison of patient-reported with payer-reported cost data generally supports the use of highly aggregated items to assess health care utilization in RA; (5) productivity costs in patients that are gainfully employed and in patients who receive RA-related retirement payments exceed RA-related direct costs. Furthermore, RA-patients reported their productivity losses adequately. The study added some additional insights to the following questions: What costs should be collected, what level of detail is required for that task, what patients should by analyzed, and what data sources should be used in further studies in RA.

Direct costs related to rheumatoid arthritis: the patient perspective.

OBJECTIVE: To determine rheumatoid arthritis related out of pocket expenditure (OOPE) in Germany and to disaggregate the total OOPE into contributing cost domains. METHODS: Data for the cost analysis were drawn from a multicentre randomised controlled prospective trial to assess the effectiveness of clinical quality management in patients with rheumatoid arthritis. Both payer sources and patient cost questionnaires were used to generate health care utilisation data. All cost domains of a recently published matrix were reviewed and potential sources of OOPE were determined. Health care utilisation data were developed throughout 2001. Co-payment regulations as per January 2004 were applied in order to indicate the most recent level of OOPE in Germany. Data were analysed in both physical and monetary units using descriptive statistics. RESULTS: In all, 136 patients with rheumatoid arthritis were included. Mean total OOPE per patient and year was 417.20 Euro (SEM 38.8, median 271.2). OOPE accounted for 15.3% of the total direct costs of rheumatoid arthritis. Total OOPE were further subdivided into cost domains: "non-physician service utilisation"' (194.40 Euro per patient and year; SEM 24.2), "medication" (99.00 Euro; 6.1), "transportation" (56.20 Euro; 17.4), "visits to physicians" (38.40 Euro; 0.6), "hospital facilities" (24.00 Euro; 5.6), and "devices and aids" (5.10 Euro; 0.8). CONCLUSIONS: Rheumatoid arthritis is associated with substantial OOPE, imposing a considerable economic burden for patients. OOPE contribute significantly to the total health care expenditure in rheumatoid arthritis. The patient perspective has to be taken into account when calculating the overall direct costs of rheumatoid arthritis from a societal point of view.

Cost-effectiveness of orlistat for the treatment of overweight and obese patients in Ireland.

OBJECTIVE: To assess the cost-effectiveness of orlistat plus a calorie-controlled diet compared with a calorie-controlled diet alone for the treatment of overweight and obese patients in Ireland. DESIGN: Economic modelling techniques using published international efficacy data and Irish cost data were used to estimate the cost-effectiveness of orlistat in obese patients when only responders to treatment (ie achieve 5% weight loss after 3 months of treatment) continue orlistat after 3 months. The model incorporated known relationships between weight loss and quality of life (utility) gain, and weight loss and reduction in risk of type 2 diabetes (T2DM) to predict the impact of weight loss on quality-adjusted-life-years (QALYs) gained and on the onset of T2DM. The costs associated with each treatment arm included the acquisition cost of orlistat, cost of a calorie-controlled dietary programme and monitoring and treatment costs associated with T2DM. An Irish health-care perspective was taken for the analysis, based on 2003 costs. SUBJECTS: Weight loss data on 1386 patients from five pivotal orlistat clinical trials with at least 12 months duration were pooled (two American and three primarily European studies). All the studies were randomized, placebo-controlled, multicentre trials with a similar design. The inclusion criteria were BMI > or =28 kg / m(2), age > or =18 y, no diagnosed T2DM and the ability to lose 2.5 kg in weight during the introductory period. MEASUREMENTS: Cost effectiveness was modelled from these data and presented as incremental cost per QALY. RESULTS: When orlistat treatment plus a calorie-controlled diet was compared with a calorie-controlled diet alone, the incremental cost per year was euro 478. The number needed to treat (NNT) to gain one QALY was estimated to be 35. The incremental cost per QALY gained was within the range considered cost-effective at euro 16,954. Sensitivity analysis demonstrated an incremental cost per QALY of euro 11,000-35,000 under a variety of assumptions. CONCLUSIONS: Our model suggests that orlistat is effective and cost-effective in obese patients, if after 3 months of treatment, only treatment responders continue treatment.

Orlistat in responding obese type 2 diabetic patients: meta-analysis findings and cost-effectiveness as rationales for reimbursement in Sweden and Switzerland.

OBJECTIVE: The aim of this study is to review the clinical and economic rationale for the reimbursement of orlistat in responding obese patients with type 2 diabetes. METHODS: Data from seven randomized controlled clinical trials of orlistat in overweight and obese patients with type 2 diabetes were pooled. A subgroup analysis involving patients who achieved a response (defined as a weight loss of >/=5% after 12 weeks of treatment) was conducted. The outcomes of the pooled analysis were then used to construct a Markov health economic model covering an 11-y period. The incidences of diabetes-related micro- and macrovascular complications were derived from the United Kingdom Prospective Diabetes Study. The effects of changes in body mass index, and the impact of micro- and macrovascular complications on utilities were derived from published sources. Publicly available cost data were used and are presented here in 2001 Euros. Discounting of 3% was applied. A probabilistic sensitivity analysis was conducted to examine the robustness of results. RESULTS: A total of 1249 patients treated with orlistat and 1230 given placebo were eligible for the intent-to-treat analysis. At the end of the study period, 23% of orlistat patients achieved a weight reduction of >/=5%. These patients showed a mean decrease in HbA1C of 1.16%, a weight reduction of 8.6 kg, a reduction in total cholesterol of 5.3% and a reduction in systolic blood pressure of 5.2 mmHg. The base-case economic analysis revealed costs per quality-adjusted life year gained of euro14 000 in Sweden and euro13 600 in Switzerland. CONCLUSION: The data presented here support the utilization and reimbursement of orlistat in overweight and obese diabetic patients who respond to the treatment.

[Conceptual and methodological basics of cost assessments in rheumatology]. / Konzeptionelle und methodische Grundlagen von Krankheitskostenerhebungen in der Rheumatologie.

Cost-of-illness studies in rheumatic conditions show an enormous variability in reported costs. Reasons are-among others-a lack of standardization with regards to relevant cost domains and the utilization of various insufficiently validated costing sources. A flow scheme is presented which may serve as a systematic basis for a valid costing analysis. The scheme includes: i) Selection of relevant cost domains. A comprehensive matrix of cost domains may be used as a framework. According to the specific aims of any costing study individual domains might be selected. ii) An adequate level of detail has to be determined taking into account factors such as the validity of the data collection and the feasibility. iii) Appropriate objective (i. e. usage of administrative data) or subjective (i. e. patient-derived) data sources have to be identified under consideration of respective strengths and weaknesses. While administrative sources provide a valid access to costing data accessibility and feasibility are important advantages of patient-derived costing procedures. iv) During data collection the potential bias due to protocol-driven costs and the differentiation of disease-related from other health care costs should be considered. v) The data analysis should support a transparent presentation of the costing data both in physical and monetary units. In summary, no 'gold standard' has been established for costing studies yet. However, valid costing approaches might follow the flow scheme presented in this analysis.

Costs of rheumatoid arthritis in Germany: a micro-costing approach based on healthcare payer's data sources.

OBJECTIVE: To develop a systematic set of German cost data in rheumatoid arthritis (RA) based solely on valid healthcare payer's cost data sources. METHODS: Retrospectively one year cost data of 338 patients with RA were generated and analysed. The cost data were derived from a major statutory health insurance plan ("Allgemeine Ortskrankenkasse Niedersachsen") and the regional physicians' association ("Kassenärztliche Vereinigung Niedersachsen"). The recently published matrix of cost domains in RA was applied to structure the analysis. Descriptive statistics were used to analyse the data. RESULTS: The total direct costs for the 338 patients during one year (third quarter 2000 to second quarter 2001) were euro 3815 per patient-year. RA related direct costs were euro 2312 per patient-year. Outpatient costs accounted for 73.7%, inpatient costs for 24.0%, and other disease related costs for 2.3% of RA related direct costs. Outpatients cost drivers were RA related drugs (euro 1019 per patient-year), physician visits (euro 323 per patient-year), diagnostic and therapeutic procedures and tests (euro 185 per patient-year), and devices and aids (euro;168 per patient-year). 98 patients were retired prematurely owing to RA related work disability and incurred costs of euro;8358 per retired patient-year. 96 patients were gainfully employed and incurred sick leave costs of euro 2835 per employed patient-year. CONCLUSION: Micro-costing based on healthcare payer's data provides a relatively conservative albeit highly accurate estimate of costs in RA. Both RA related and non-RA related costs must be taken into account. In gainfully employed patients and in patients who receive RA related retirement payments productivity costs exceed direct costs.

Implementing standardized cost categories within economic evaluations in musculoskeletal diseases.

We present a matrix of relevant resource utilization domains for use in standardizing applied cost assessment in musculoskeletal conditions. In addition,we highlight the importance of selecting cost categories during the development of an economic evaluation. A set of four steps was applied: (a) literature search identifying economic evaluations in osteoarthritis and osteoporosis, (b) listing and aggregation of cost categories mentioned in the identified articles, (c) development of a matrix of resource utilization domains, and (d) qualitative discussion regarding the generalizability of the matrix to other musculoskeletal conditions such as rheumatoid arthritis. We examined 41 full-length articles (25 cost-of-illness studies or cost-comparisons, 14 cost-effectiveness analyses, and 2 cost-utility analyses), of which 16 studies focused on osteoarthritis and 25 on osteoporosis. The reviewed studies used a total of 151 different cost categories which, after adjustment for synonymous labeling, made up 34 cost categories. A matrix of 16 separate resource utilization domains was developed including seven outpatient, three inpatient, four other disease-related, and two productivity cost domains. We found that cost assessment in economic evaluation in the key musculo-skeletal diseases (osteoarthritis, osteoporosis, and rheumatoid arthritis) is performed rather inhomogeneously. A generalized matrix of applicable resource utilization domains and a flowchart facilitating the development of appropriate resource utilization data have been developed.

[Current aspects of cost effectiveness of TNF-alpha blocking agents in patients with rheumatoid arthritis]. / Betrachtungen zur Kosteneffektivität der Therapie mit TNF-alpha blockierenden Substanzen bei Patienten mit chronischer Polyarthritis.

Facing increasing health-related costs and limited health care resources, the assessment of cost effectiveness (CE) of medical procedures is also gaining considerable importance in the field of rheumatology. Since high annual therapy costs of 17,000-21,000 Euro are related to the employment of TNF-alpha blocking agents such as etanercept and infliximab (compared to annual costs of 350-5000 Euro of other disease modifying drugs (DMARDs) in the treatment of rheumatoid arthritis (RA)), their CE has become an important issue. The present investigation summarizes economic evaluations of cost and effectiveness of TNF-alpha blocking agents and compares the results to those of traditional DMARD therapies in patients with RA. The implications of these economic results on the further use of TNF-alpha blocking drugs and methodological improvements of their economic evaluation are discussed. The current literature provides evidence for the CE of the combination therapy with methotrexate (MTX), hydroxychloroquine (HCQ), and sulfasalazine (SASP). In comparison to this finding, the use of etanercept and MTX yields much higher costs, although the highest rate of ACR20 responses is achieved by this combination (additional costs of $42,000 per ACR20 response compared to combination of MTX, HCQ, and SASP). Two recent studies show more promising results of about $12,000/QUALY and even cost savings per QUALY administering etanercept and infliximab, respectively. The wide range of the CE ratios is mainly explained by different methodological approaches. Whether the wider employment of TNF-alpha blocking drugs (comprising not only selected patients) proves to be economically effective, remains to be investigated by further economic analyses. In contrast to the initial disappointing results of the comparison of established DMARD therapies and TNF-alpha blocking drugs in terms of CE, recently published data renders evidence that the CE of the TNF-alpha blocking drugs is comparable to other accepted therapies in internal medicine.

Lipid-lowering medication for secondary prevention of coronary heart disease in a German outpatient population: the gap between treatment guidelines and real life treatment patterns.

BACKGROUND: Few published data in particular from the United States indicate that the implementation of guidelines for prevention of coronary heart disease (CHD) is far from optimal. The objective of our study was to identify the type and prevalence of lipid-lowering medications in a German outpatient CHD population and to examine the impact of applied treatment regimens on serum lipid levels. METHODS: Retrospective analysis of the washout phase of 2,856 CHD patients requiring lipid-lowering medication. Data are derived from a multicenter, randomized, open-label, parallel group clinical trial comparing the safety and efficacy of atorvastatin versus simvastatin in 591 centers in Germany. Medical history, physical examination, and serum lipid levels were obtained at the beginning of the washout phase (Week -6) and at the end of the washout phase (Week -1, i.e., 5 weeks after the discontinuation of all prior lipid-lowering medications). The data at Week -6 represented the lipid levels under real life conditions. The difference from the data at Week -1 reflected the therapeutic effects achieved by the previous lipid-lowering treatment. RESULTS: The mean low-density lipoprotein cholesterol (LDL-C) level at Week -6 was 173.4 +/- 42.5 mg/dl. Only 176 (6.2%) of 2,856 CHD patients were found to meet the target LDL-C level of <115 mg/dl at Week -6, only 76 (2.7%) patients had LDL-C levels <100 mg/dl, and 363 (12.7%) patients had LDL-C levels <130 mg/dl. After discontinuation of all prior lipid-lowering medications, mean LDL-C increased to 187.2 +/- 44.0 mg. This means that only a marginal 7.4% reduction in LDL-C level was achieved under real life treatment conditions. This limited LDL-C reduction was due mainly to the low prevalence of lipid-lowering treatment (65.5% of patients did not receive any medication at all) and inadequate dosing. With respect to the effect on LDL-C and total cholesterol, statins alone were superior to fibrates. CONCLUSION: The study shows that there is a wide gap between treatment guidelines and real life treatment patterns in Germany. Awareness of the risks of high cholesterol levels has to be increased among both patients and physicians. Available treatment guidelines should be better implemented.

[Health economics research in the area of chronic polyarthritis]. / Gesundheitsökonomische Forschung im Bereich der chronischen Polyarthritis.

Costs of illness are of major economic relevance in rheumatoid arthritis (RA) as in other chronic diseases. Overall costs of 15,000 Euro/year: 10,000 Euro indirect costs, and 5000 Euro direct costs are estimated, respectively. A further detailed analysis of direct costs underlines that inpatient care (50%) is the most prominent cost driver. Medication costs are also evaluated in detail since they are expected to gain importance with the introduction of the more expensive biologicals. While annual costs for regular disease modifying drugs (DMARDs) vary from 160 to 5000 Euro per patient, costs for the new biologicals amount up to 20,000 Euro (100-125% of the current estimated overall costs). For a comparison of different therapeutic strategies, costs are related to effectiveness in cost-effectiveness analyses. Based on present clinical trials, the ratios of medication costs and response according to the ACR 20-criteria of various DMARDs and biologicals are compared. The most cost-effective medication is sulfasalzine, followed by methotrexate, and leflunomide. Combining etanercept and methotrexate is preferable to methotrexate monotherapy and the combination of infliximab and methotrexate. This review shows that important economic issues in RA have already been addressed by applying cost-of-illness analyses and cost-effectiveness analyses. However, the knowledge about cost-effective therapeutic options is still scarce. Thus, primary data will have to be obtained using standardized approaches. These economic findings can be taken into account in the development of disease-management recommendations for RA-therapy.

Quality of partnership in patients with erectile dysfunction after sildenafil treatment.

OBJECTIVE: A comprehensive investigation on the quality of partnership of male patients with erectile dysfunction (ED) after treatment with sildenafil vs. untreated patients, as perceived by both the patients and their female partners. METHODS: This report describes an observational, cross-sectional exploratory study comparing ED patients responsive to sildenafil with ED patients prior to therapy. Assessments included the 'International Index of Erectile Function' (IIEF) and the 'Partnerschaftsfragebogen' (PFB), a partnership questionnaire used in German-speaking countries. The comparability of the two study groups was examined using a stepwise logit model. Significant intergroup differences regarding demographics and history were identified and included as confounding variables in the assessment of Quality of Partnership differences using ANCOVA. A regression analysis was performed to determine the association between the mean total IIEF scores and Quality of Partnership measures. RESULTS: 105 patients were included in the study. After adjustment for confounding variables, the groups varied significantly with respect to Quality of Partnership as perceived by men (mean score PFB 61.8 +/- 13.9 vs. 54.4 +/- 15.5; p<0.001) and women (mean score PFB 63.1 +/- 13.6 vs. 57.0 +/- 14.7; p = 0.006). In men, all three PFB subscales (quarreling, tenderness, togetherness) differed significantly between the two study groups. In the female partners, the tenderness and togetherness domains varied significantly. Erectile function correlated highly significantly with tenderness and togetherness in both the male patients and their partners. CONCLUSION: Our data indicate that the Quality of Partnership reported by both the men and their female partners is significantly better in appropriately treated ED patients than in untreated controls.

Development of a matrix of cost domains in economic evaluation of rheumatoid arthritis.

The aim of our study was to comprehensively review and critically appraise the cost domains used in economic evaluations of the rheumatic diseases and to use this information to propose standardization of cost domains. The literature search identified 210 abstracts, 32 of which included original cost data. The listed cost categories were grouped into 3 major areas: (direct) health care costs, other (direct) disease related costs, and productivity costs (indirect costs). The number of individual cost categories was reduced by considering the following criteria: (1) inclusion of all relevant cost domains; (2) avoidance of double counting; (3) summarizing of related categories under one representative heading; (4) feasibility of level of aggregation. After adjustment for synonymous labeling, 38 cost categories remained. The subsequent development of a classification scheme of cost categories led to a set of 19 separate cost domains including 7 outpatient, 3 inpatient, 6 other disease related, and 3 productivity cost domains. This literature review indicates that cost assessment in economic evaluations in rheumatoid arthritis lacks standardization. A preliminary scheme to categorize cost assessment in rheumatic conditions is presented. The adoption of standards for economic evaluation would greatly facilitate national and international comparisons.