Real-World Use and Treatment Outcomes of Ceftaroline Fosamil in Patients with Complicated Skin and Soft Tissue Infection: A Multinational Retrospective Study.

Background: Ceftaroline fosamil is approved for the treatment of complicated skin and soft tissue infections (cSSTI) and community-acquired pneumonia (CAP); however, data on its real-world use and effectiveness in Europe and Latin America are currently limited. This retrospective observational study assessed ceftaroline fosamil use and treatment outcomes in adults hospitalized with cSSTI or CAP treated with ceftaroline fosamil in a usual care setting in Europe and Latin America. Results for patients with cSSTI are reported. Methods: Data from patients with cSSTI who received ≥4 consecutive intravenous ceftaroline fosamil doses up to May 31, 2019, were collected from sites in Brazil, Colombia, France, Greece, Italy, and Spain. Patient characteristics, clinical management, hospitalization information, microbiological diagnosis, and clinical responses were summarized descriptively. Healthcare resource use variables were evaluated by clinical response to ceftaroline fosamil. Results: Data for 132 patients were included (58.3% male; mean age 58.5 years). Most common lesions were cellulitis/fasciitis (62.1%), abscess (34.1%), and post-surgical wounds (19.7%). Pathogens most frequently identified were methicillin-resistant (18.2%) and methicillin-susceptible Staphylococcus aureus (17.4%). Median (range) ceftaroline fosamil treatment duration was 8 (2-60) days (daily doses of 1200 [400-2400] mg); 78 patients (59.1%) received monotherapy. In total, 75 (56.8%) patients had additional antibiotics after ceftaroline fosamil. Clinical response occurred in 118 (89.4%) patients. All-cause 30-day readmission occurred in 13 (9.8%) patients, and all-cause 30-day mortality in 7 (5.3%). Clinical response to ceftaroline was associated with >25% shorter length of hospital and intensive care stay, and with ~40% lower hospital costs, versus non-responders. Conclusion: Ceftaroline fosamil was effective in treating adults with cSSTI and clinical response to ceftaroline fosamil was associated with reductions in healthcare resource use compared with non-responders, in Europe and Latin America. Clinicaltrialsgov Identifier: NCT04198571.

Ceftaroline fosamil treatment patterns and outcomes in adults with community-acquired pneumonia: a real-world multinational, retrospective study.

Background: This multicentre, observational, retrospective chart review study assessed ceftaroline fosamil treatment patterns and outcomes in adults hospitalized with community-acquired pneumonia (CAP) in usual care settings. Methods: Anonymized patient data were extracted from hospital records of adults with CAP who received ≥4 consecutive IV ceftaroline fosamil doses at sites in Brazil, Colombia, France, Greece, Italy, Russia and Spain. Results: The dataset included 185 patients (58.9% male; mean age 62.2 years), of whom 128 (69.2%) had severe CAP defined by CURB-65, PSI/PORT score or physician judgement. Streptococcus pneumoniae (n = 44; 23.8%) and Staphylococcus aureus [MSSA (n = 15) and MRSA (n = 14)] were the most frequently identified pathogens. Clinical response occurred in 151 (81.6%) patients overall, and in 104 (81.3%) severe CAP patients. Response within ≤4 and >4 days occurred in 79 (42.7%) and 62 (33.5%) patients (unknown, n = 10), respectively. Twenty (10.8%) patients required readmission within 30 days. Thirty-day all-cause mortality rates were 9.7% (n = 18) overall and 10.2% (n = 13) in severe CAP. In sensitivity analysis using ICU admission as a more objective marker of severe CAP (n = 75), clinical response and 30 day mortality occurred in 57 (76.0%) and 10 (13.3%) patients, respectively. Overall, clinical response to ceftaroline fosamil was associated with >60% shorter length of ICU stay (3.6 versus 9.2 days), and >30% lower hospital costs ($8449 versus $12 559) versus non-responders. Conclusions: Ceftaroline fosamil was effective in treating adults with CAP, including severe CAP, in Europe and Latin America. Clinical response to ceftaroline fosamil was associated with reductions in healthcare resource use compared with non-responders.

Pathological response in resectable non-small cell lung cancer: a systematic literature review and meta-analysis.

BACKGROUND: Surrogate endpoints for overall survival in patients with resectable non-small cell lung cancer receiving neoadjuvant therapy are needed to provide earlier treatment outcome indicators and accelerate drug approval. This study's main objectives were to investigate the association among pathological complete response, major pathological response, event-free survival and overall survival and to determine whether treatment effects on pathological complete response and event-free survival correlate with treatment effects on overall survival. METHODS: A comprehensive systematic literature review was conducted to identify neoadjuvant studies in resectable non-small cell lung cancer. Analysis at the patient level using frequentist and Bayesian random effects (hazard ratio [HR] for overall survival or event-free survival by pathological complete response or major pathological response status, yes vs no) and at the trial level using weighted least squares regressions (hazard ratio for overall survival or event-free survival vs pathological complete response, by treatment arm) were performed. RESULTS: In both meta-analyses, pathological complete response yielded favorable overall survival compared with no pathological complete response (frequentist, 20 studies and 6530 patients: HR = 0.49, 95% confidence interval = 0.42 to 0.57; Bayesian, 19 studies and 5988 patients: HR = 0.48, 95% probability interval = 0.43 to 0.55) and similarly for major pathological response (frequentist, 12 studies and 1193 patients: HR = 0.36, 95% confidence interval = 0.29 to 0.44; Bayesian, 11 studies and 1018 patients: HR = 0.33, 95% probability interval = 0.26 to 0.42). Across subgroups, estimates consistently showed better overall survival or event-free survival in pathological complete response or major pathological response compared with no pathological complete response or no major pathological response. Trial-level analyses showed a moderate to strong correlation between event-free survival and overall survival hazard ratios (R2 = 0.7159) but did not show a correlation between treatment effects on pathological complete response and overall survival or event-free survival. CONCLUSION: There was a strong and consistent association between pathological response and survival and a moderate to strong correlation between event-free survival and overall survival following neoadjuvant therapy for patients with resectable non-small cell lung cancer.

Impact of the Timing of Enzyme Replacement Therapy Initiation and Cognitive Impairment Status on Outcomes for Patients with Mucopolysaccharidosis II (MPS II) in the United States: A Retrospective Chart Review.

Background: Mucopolysaccharidosis II (MPS II; Hunter syndrome; OMIM 309900) is a rare, X-linked, lysosomal storage disease caused by deficient iduronate-2-sulfatase activity. Accumulation of glycosaminoglycans results in multisystemic disease manifestations, which may include central nervous system involvement and cognitive impairment (CI). Patients with MPS II experience a high disease burden, leading to extensive healthcare resource utilization (HRU) and reduced quality of life. Objectives: This study aimed to assess the impact of timing of enzyme replacement therapy (ERT) initiation and CI status on the clinical characteristics and HRU of patients with MPS II. Methods: A retrospective medical chart review of 140 male patients who received a diagnosis of MPS II between 1997 and 2017 was performed at 19 US sites; data on disease manifestations and HRU stratified by age at ERT initiation or CI status were analyzed for the full study population and a subgroup of patients who received a diagnosis of MPS II before the age of 6 years. Results: In patients initiating ERT before 3 years of age, there was a trend toward lower symptom burden and HRU compared with patients who initiated ERT at an older age. Evaluation of developmental and behavioral signs and symptoms in the full study population showed that communication delay (70.0% of patients), cognitive delay (62.1%), behavioral problems (52.9%), and toileting delay (50.0%) were particularly common; earliest documented signs and symptoms were motor delay (median [range] age at first documentation: 4.2 [0.9-18.7] years) and behavioral problems (4.4 [0.6-13.7] years). Patients with CI generally experienced greater symptom burden and higher HRU than those without CI, with the most notable differences documented for communication and toileting delays. Formal cognitive testing was documented in <30% of cognitively impaired patients diagnosed with MPS II before the age of 6 years. Conclusions: Our findings reinforce previous recommendations for ERT to be initiated early to maximally benefit patients with MPS II, especially those younger than 3 years old. Cognitively impaired patients experience a particularly high disease burden and HRU. Patient care could be improved with early cognitive assessments and the development of treatments that address cognitive decline.

Serial Changes in Exercise Capacity, NT-proBNP, and Adiponectin in Patients with Acute Coronary Syndrome before and after Phase II Rehabilitation as well as at the 12-Month Follow-Up.

BACKGROUND: Acute coronary syndrome (ACS) causes pathophysiological changes in exercise capacity, N-terminal part of pro-brain natriuretic peptide (NT-proBNP), and adiponectin that impact the course of coronary artery disease and clinical outcomes after cardiac rehabilitation (CR). However, the serial changes and the relationship between the changes in these parameters for a prolonged term remain uninvestigated. METHODS: Eighty-one patients with ACS underwent a three- or four-week CR program after acute care and were followed up for 12 months. Exercise capacity on a cycle ergometer and blood levels of NT-proBNP and adiponectin were determined before and after CR as well as at the 12-month follow-up. RESULTS: Exercise capacity increased from 100 watts (in median) before CR to 138 watts after CR and 150 watts at 12 months. The NT-proBNP level (526 pg/ml before CR) remained almost unchanged after CR (557 pg/ml) and then decreased at 12 months (173 pg/ml). The adiponectin level (14.5 µg/ml before CR) increased after CR (16.0 µg/ml) and at 12 months (17.2 µg/ml). There was no significant correlation among the changes in these parameters at each observation time point. CONCLUSION: During the observation period from before CR to the 12-month follow-up, exercise capacity, NT-proBNP, and adiponectin underwent significant changes; however, these changes were independent from each other and not correlated linearly, and they provide complementary information in clinical practice. Thus, all these parameters should be included and determined at different time points for a prolonged period of time.

Osteoporotic fractures and subsequent fractures: imminent fracture risk from an analysis of German real-world claims data.

PURPOSE: In osteoporosis, prior fracture is a strong predictor of subsequent fracture. This study aimed to assess the imminent risk of subsequent fracture following an initial fracture in osteoporosis patients in Germany, and to identify clinical and demographic characteristics that are independently associated with subsequent fracture risk. METHODS: In this retrospective, observational cohort study using German real-world claims data, male and female patients aged ≥ 50 years with osteoporosis who experienced an initial ("index") hip/femur, vertebral, forearm/wrist/hand or shoulder/upper arm fracture between 2010 and 2014 were included. The incidence and timing of subsequent fractures during a 1-year follow-up period were analyzed. Independent risk factors for subsequent fracture were identified by multivariate regression analysis. RESULTS: A total of 18,354 patients (mean age: 77 years; standard deviation: 9.8) were included. Of these, 2918 (15.9%) suffered a subsequent fracture during the 1-year follow-up period. The incidence of subsequent fracture was higher following an index vertebral fracture (18.0%) than after an index forearm/wrist/hand fracture (14.1%) or index hip/femur fracture (12.1%). Subsequent 1-year fracture incidence was generally higher in older patients. Index fracture type, age, epilepsy/use of antiepileptics, and heart failure were all independently associated with subsequent fracture risk. CONCLUSION: Osteoporosis patients in Germany are at imminent risk of subsequent fracture during the first year following an initial fracture. They should be targeted for immediate post-fracture treatment to reduce the risk of further fractures, especially in the presence of specific risk factors such as old age or index vertebral fracture.

Cost-effectiveness analysis of ixekizumab versus secukinumab in patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis in Spain.

OBJECTIVE: To conduct a cost-effectiveness analysis from the perspective of the Spanish National Health System (NHS) comparing ixekizumab versus secukinumab. DESIGN: A Markov model with a lifetime horizon and monthly cycles was developed based on the York model. Four health states were included: a biological disease-modifying antirheumatic drug (bDMARD) induction period of 12 or 16 weeks, maintenance therapy, best supportive care (BSC) and death. Treatment response was assessed based on both Psoriatic Arthritis Response Criteria (PsARC) and ≥90% improvement in the Psoriasis Area Severity Index score (PASI90). At the end of the induction period, responders transitioned to maintenance therapy. Non-responders and patients who discontinued maintenance therapy transitioned to BSC. Clinical efficacy data were derived from a network meta-analysis. Health utilities were generated by applying a regression analysis to Psoriasis Area Severity Index and Health Assessment Questionnaire‒Disability Index scores collected in the ixekizumab SPIRIT studies. Results were subject to extensive sensitivity and scenario analysis. SETTING: Spanish NHS. PARTICIPANTS: A hypothetical cohort of bDMARD-naïve patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis was modelled. INTERVENTIONS: Ixekizumab and secukinumab. RESULTS: Ixekizumab performed favourably over secukinumab in the base-case analysis, although cost savings and quality-adjusted life-year (QALY) gains were modest. Total costs were €153 901 compared with €156 559 for secukinumab (difference -€2658). Total QALYs were 9.175 vs 9.082 (difference 0.093). Base-case results were most sensitive to the annual bDMARD discontinuation rate and the modification of PsARC and PASI90 response to ixekizumab or secukinumab. CONCLUSION: Ixekizumab provided more QALYs at a lower cost than secukinumab, with differences being on a relatively small scale. Sensitivity analysis showed that base-case results were generally robust to changes in most input parameters. TRIAL REGISTRATION NUMBER: SPIRIT-P1: NCT01695239; Post-results, SPIRIT-P2: NCT02349295; Post-results.

Cost-Effectiveness Analysis of Sequential Biologic Therapy with Ixekizumab Versus Secukinumab in the Treatment of Active Psoriatic Arthritis with Concomitant Moderate-to-Severe Psoriasis in the UK.

BACKGROUND: Interleukin-17A (IL-17A) antagonists are a recent innovation for treating psoriatic arthritis (PsA). There are currently no cost-effectiveness analyses (CEAs) comparing the IL-17A antagonists ixekizumab and secukinumab in PsA from a UK perspective. OBJECTIVE: We conducted a CEA from the UK National Health Service perspective to compare ixekizumab versus secukinumab in patients with PsA and concomitant moderate-to-severe plaque psoriasis. METHODS: A Markov model was developed based on the widely accepted York model. In biologic disease-modifying antirheumatic drug (bDMARD)-naïve patients, ixekizumab → ustekinumab → best supportive care (BSC) was compared with secukinumab → ustekinumab → BSC. For bDMARD-experienced patients, ixekizumab → BSC was compared with secukinumab → BSC. At the end of the bDMARD trial period, Psoriatic Arthritis Response Criteria (PsARC) responders continued to receive the bDMARD in the continuous treatment period. PsARC nonresponders and patients who ceased continuous treatment transitioned to the trial period of the next treatment. RESULTS: Ixekizumab was less costly and provided more quality-adjusted life-years (QALYs) than secukinumab in bDMARD-naïve and -experienced patients based on list prices, although cost savings and QALY gains were small to modest. In bDMARD-naïve patients, total costs were £155,455 compared with £155,530 for secukinumab (year 2017 values). Total QALYs were 8.127 versus 7.989. In bDMARD-experienced patients, the corresponding values were £140,051 versus £140,264 for total costs and 3.996 versus 3.875 for total QALYs. CONCLUSION: Ixekizumab provided more QALYs at a marginally lower cost than secukinumab, and the results were most sensitive to changes in drug costs. Other factors, such as patient preferences for the number of injections and confidential price discounts, may be important considerations in clinical decision-making.

Assessing quality of life in a clinical study on heart rehabilitation patients: how well do value sets based on given or experienced health states reflect patients' valuations?

BACKGROUND: Quality of life as an endpoint in a clinical study may be sensitive to the value set used to derive a single score. Focusing on patients' actual valuations in a clinical study, we compare different value sets for the EQ-5D-3L and assess how well they reproduce patients' reported results. METHODS: A clinical study comparing inpatient (n = 98) and outpatient (n = 47) rehabilitation of patients after an acute coronary event is re-analyzed. Value sets include: 1. Given health states and time-trade-off valuation (GHS-TTO) rendering economic utilities; 2. Experienced health states and valuation by visual analog scale (EHS-VAS). Valuations are compared with patient-reported VAS rating. Accuracy is assessed by mean absolute error (MAE) and by Pearson's correlation ρ. External validity is tested by correlation with established MacNew global scores. Drivers of differences between value sets and VAS are analyzed using repeated measures regression. RESULTS: EHS-VAS had smaller MAEs and higher ρ in all patients and in the inpatient group, and correlated best with MacNew global score. Quality-adjusted survival was more accurately reflected by EHS-VAS. Younger, better educated patients reported lower VAS at admission than the EHS-based value set. EHS-based estimates were mostly able to reproduce patient-reported valuation. Economic utility measurement is conceptually different, produced results less strongly related to patients' reports, and resulted in about 20 % longer quality-adjusted survival. CONCLUSION: Decision makers should take into account the impact of choosing value sets on effectiveness results. For transferring the results of heart rehabilitation patients from another country or from another valuation method, the EHS-based value set offers a promising estimation option for those decision makers who prioritize patient-reported valuation. Yet, EHS-based estimates may not fully reflect patient-reported VAS in all situations.

Demographics, clinical characteristics, health resource utilization and cost of chronic thromboembolic pulmonary hypertension patients: retrospective results from six European countries.

BACKGROUND: Chronic Thromboembolic Pulmonary Hypertension (CTEPH) results from incomplete resolution of a pulmonary embolus, leading to pulmonary hypertension and progressive right heart failure and death. We aimed to describe the demographics, treatment patterns, health resource utilization and related costs of patients with CTEPH. METHODS: In specialized PH centres across six European countries, medical charts of CTEPH patients on PH medication were retrospectively extracted (chart review between 2006 and 2009). Resource utilization was valued using country-specific unit costs. Descriptive statistical analyses were performed. RESULTS: Twenty-one hospitals documented 119 consecutive CTEPH patients over an average of 25.4 months. Patients were inoperable (83.9%) or persistent after surgery (16.0%) with mean age 67.5 ± 12.3 years, 61% were female. The average 6-minute walking distance was 298 ± 120 meters, and NYHA class II/III/IV was 27/59/14%. At baseline, 59.7% patients received endothelin receptor antagonist, 34.4% phosphodiesterase-5 inhibitors, and 5.8% prostacyclin. Adding a second PH medication was the most common regimen change. CTEPH patients experienced 1.8 ± 2.2 hospitalizations per year accounting for 14.8 ± 26.1 days in hospital. Patients paid on average 2.8 office visits per year to their general practitioner and 1.3 visits to a specialist. Unadjusted annual mortality rate was 6.0%. Annual cost of PH specific medication was the predominant economic factor averaging € 36,768 per year. Costs for hospitalizations (€ 4,496) and concomitant medications (€ 2,510) were substantially lower. Other health care resource items only accounted for marginal additional costs. CONCLUSION: CTEPH patients are characterised by substantial morbidity and mortality. Health care utilisation, predominantly due to off-label use of PH drugs, is significant.

Programme costing of a physical activity programme in primary prevention: should the costs of health asset assessment and participatory programme development count?

This analysis aims to discuss the implications of the "health asset concept", introduced by the WHO, and the "investment for health model" requiring a "participatory approach" of cooperative programme development applied on a physical activity programme for socially disadvantaged women and to demonstrate the related costing issues as well as the relevant decision context. The costs of programme implementation amounted to €48,700. Adding the costs for developing the programme design of €48,800 results in total costs of €97,500; adding on top of that the costs of asset assessment running to €35,600 would total €133,100. These four different cost figures match four different types of potentially relevant decisions contexts. Depending on the decision context the total costs, and hence the incremental cost-effectiveness ratio of a health promotion intervention, could differ considerably. Therefore, a detailed cost assessment and the identification of the decision context are of crucial importance.

Quality of life and depression in multiple sclerosis patients: longitudinal results of the BetaPlus study.

Enhancing quality of life (QoL) is an important objective of disease-modifying therapies in multiple sclerosis (MS). Strategies to substantiate the effect on QoL and depression have been suggested, including injection devices and nursing support. This study assesses QoL and depression in MS patients treated with interferon beta-1b (IFNB-1b) and evaluates the impact of different elements of a patient support programme and of coping strategies on QoL and depression. A prospective, observational, 2-year cohort study was conducted. MS patients were eligible if they had previously switched to IFNB-1b. Data were collected every 6 months. For the measurement of QoL the Functional Assessment of MS (FAMS) was used. Depression symptoms were assessed using the Center for Epidemiologic Studies Depression Scale (CES-D); coping strategies were assessed using the 66-item version of Ways of Coping Questionnaire. A total of 1,077 patients were recruited into the study. Seven hundred (65 %) patients completed the study. Within the subgroup completing questionnaires on QoL (N = 472) and depression (N = 363), QoL increased (110.4 vs. 115.8, p < 0.001), and the proportion of depressed patients decreased from 53.7 to 43.3 % (p < 0.001). Modelling QoL and depressions, the use of the autoinjector Betaject(®) over time showed a positive association with QoL (p = 0.049). The support from a nurse was positively associated with lower depressive symptoms (p = 0.039). The coping strategies 'planful problem-solving' and 'positive reappraisal' were associated with higher QoL and lower depressive symptoms. Patients on IFNB-1b treatment who were included in the patient support programme and completed the study showed an improvement in QoL. Moreover, compared to baseline the proportion of depressive patients decreased. Coping strategies as well as supportive elements such as autoinjectors and nurses had a significant impact on QoL and depression. However, the study had the general limitations of a non-controlled design.

Supportive strategies to improve adherence to IFN ß-1b in multiple sclerosis--results of the ßPlus observational cohort study.

BACKGROUND: Low adherence to treatment in Multiple Sclerosis (MS) has been shown to lead to poor health outcomes. Various strategies to improve adherence have been suggested including educative programs, injection devices and dedicated nurse assistance. OBJECTIVE: To assess the impact of elements of the patient support program on adherence; to explore disease factors affecting adherence; and to determine whether these factors influence the choices of supportive elements. METHODS: A prospective, observational cohort study was conducted. MS patients were eligible if they had switched to Interferon beta-1b (IFNB-1b) between 1 and 3 months prior to inclusion. Data were collected at months 6, 12, 18 and 24 after inclusion. Adherence was defined as completion of both study protocol and medication at 24 months. Patients underwent evaluations of disability, quality of life, depression, and coping styles. RESULTS: A total of 1077 patients from 15 countries were included, of which 61.8% were adherent to IFNB-1b after 24-months. Depression, quality of life and autoinjector devices were baseline predictors of adherence at 24-months. Coping styles did not show to have substantial impact on adherence. Lower quality of life increased the probability of choosing supportive elements. CONCLUSION: The study showed that the usage of autoinjector devices chosen during the study was the strongest predictor of drug adherence of all the supportive elements tested in this study.

Long term effects of comprehensive cardiac rehabilitation in an inpatient and outpatient setting.

OBJECTIVES: To compare the long-term effects of comprehensive outpatient versus inpatient rehabilitation with respect to morbidity and mortality, as well as to changes in physical performance and physical activity. DESIGN: A total of 163 consecutive patients were enrolled for comprehensive cardiac rehabilitation (CCR) following a recent coronary event, to outpatient or inpatient CCR according to treatment preference because randomisation was accepted by only 4 patients. CCR was six hours per day for 4 weeks and consisted of exercise training, education, psychological support, and nutritional and occupational advice. Examinations were before, after and 12 months after CCR. Primary outcome measures were event-free survival with or without interventions, EFS-I or EFS, respectively, 12 months after rehabilitation. RESULTS: Main patient characteristics were distributed equally in the cohorts. Results were adjusted by logistic regression for age, BMI, LV-function, exercise capacity and physical activity before the event. Adjusted EFS, EFS-I , overall survival and other morbidity outcome measures did not differ significantly. During CCR, physical activity was higher in outpatients, but this difference was not maintained in the follow up. Average physical activity was increased 12 month after CR with no difference between groups. CONCLUSION: Although influenced by patient preference, participation in either inpatient or outpatient CCR led to comparable results in terms of all-cause or cardiac overall survival, event-free survival and other secondary outcome measures like cardiac morbidity, physical performance and increased physical activity.

Intervention study shows outpatient cardiac rehabilitation to be economically at least as attractive as inpatient rehabilitation.

BACKGROUND: Since the late 1990 s, cost pressure has led to a growing interest in outpatient rehabilitation in Germany where predominantly inpatient rehabilitation has been provided. Taking into account the feasibility of a randomized design, the aim of this study was to compare outpatient and inpatient cardiac rehabilitation from a societal perspective. METHOD: A comprehensive cohort design was applied. Costs during rehabilitation were measured using individual documentation of the rehabilitation centers. Economic end points were quality of life (EQ-5D), and total direct and indirect costs. A propensity score approach, integrated into a simultaneous regression framework for cost and effects, was used to control for selection bias. Bootstrap analysis was applied for assessing uncertainty in cost-effectiveness. RESULTS: A total of 163 patients were included in the study (112 inpatients, 51 outpatients). As randomization was chosen by only 2.5% of participants, the study had to be analyzed as an observational study. Direct costs during inpatient rehabilitation were significantly higher by 600 euro (+/-318; p < 0.001) compared to outpatient rehabilitation (2,016 euro +/- 354 euro vs. 1,416 euro +/- 315), while there was no significant difference in health-related quality of life. Over the 12-month follow-up period, adjusted costs difference in total cost was estimated at -2,895 euro (p = 0.102) and adjusted difference in effects at 0.018 quality-adjusted life years (QALYs) (n.s.) in favor of outpatient treatment. CONCLUSION: The ratio of mean cost over mean effect difference (incremental cost-effectiveness ratio) indicates dominance of outpatient rehabilitation, but at a considerable statistical uncertainty. However, outpatient rehabilitation cannot be rejected from an economic perspective.

Modelling the prevalence and cost of back pain with neuropathic components in the general population.

BACKGROUND: Although there is increasing knowledge of the prevalence of neuropathic pain, little has been done to isolate the cost of neuropathic pain, especially with reference to the frequent complaint of back pain. AIMS: To estimate the prevalence of neuropathic components in back pain and associated costs. METHODS: We used available epidemiological data to model the prevalence of neuropathic back pain in the general adult population, combining three studies: painDETECT 1, painDETECT 2, and the German back pain research network (GBPRN) study, representing a total of 21,047 subjects. The painDETECT screening questionnaire was used in the former two surveys to assess neuropathic pain components. Costing data were obtained from 1718 participants in the GBPRN survey. RESULTS: According to our model, approximately 4% of the general adult population experienced back pain with a neuropathic component. Owing to the greater severity of neuropathic pain, its costs were found to be disproportionately high: among patients with persistent back pain, typical costs associated with a person suffering neuropathic back pain were higher than those of an average back pain patient, and as much as 67% higher than those of a patient with nociceptive back pain only. Approximately, 16% of the total costs associated with back pain were attributable to pain with a neuropathic component. CONCLUSIONS: Back pain with neuropathic components is likely to affect a relevant proportion of the general adult population and cause a disproportionately high share of back pain-related costs.

Quality of life several years after myocardial infarction: comparing the MONICA/KORA registry to the general population.

AIMS: The aim of this study was to assess the impact of myocardial infarction (MI) on health-related quality of life (HRQL) in MI survivors measured by EuroQol (EQ-5D) and to compare it with the general population. METHODS AND RESULTS: A follow-up study of all MI survivors included in the MONICA/KORA registry was performed. About 2950 (67.1%) patients responded. Moderate or severe problems were most frequent in EQ-5D dimension pain/discomfort (55.0%), anxiety/depression (29.2%), and mobility (27.9%). Mean EQ VAS score was 65.8 (SD 18.5). Main predictors of lower HRQL included older age, diabetes, increasing body mass index, current smoking, and experience of re-infarction. Type of revascularizational treatment showed no impact on HRQL. Compared with the general population, adjusted EQ VAS was 6.2 (95% confidence interval 3.4-8.9) points lower in 45-year-old MI patients converging with growing age up to the age of 80. With regard to HRQL dimensions, MI survivors had a significantly higher risk of incurring problems in the dimension pain/discomfort, usual activities, and especially in anxiety/depression which was more pronounced in younger age. Mobility was the single dimension, in which MI showed an inverse effect. CONCLUSION: MI is combined with significant reduction in HRQL compared with the general population. The main impairments occur in the dimension pain/discomfort, usual activities, and particularly anxiety/depression. The relative impairment decreases with higher ages.

Costs of back pain in Germany.

With 12-month prevalence rates of more than 70%, back pain is currently one of the major health problems for German adults and entails major economic consequences. The aim of this study was to estimate back pain-related costs from a societal perspective and to determine the impact of sociodemographic variables on costs. Based on back pain-related survey data of a large German adult sample (9267 respondents, response rate 60%), costs were assessed using a prevalence-based bottom-up approach. Direct costs caused by utilisation of healthcare services, as well as indirect costs due to back pain-related production losses were considered. All prices are expressed in 2005 Euros. Average total back pain costs per patient were estimated to be 1,322 euro (95% CI [1173-1487]) per year. These costs are split between direct (46%) and indirect (54%) costs. Bivariate analysis showed considerable differences in total costs between the Von Korff back pain grades (GCPS Group I: Mean 414.4, 95% CI [333.2-506.3]; II: 783.6 [574.5-1044.4]; III: 3017.2 [2392.9-3708.6]; IV: 7115.7 [5418.5-9006.5]). Male gender, increasing age, single status, low education, unemployment, and increasing back pain grade had a significant positive impact on the cost magnitude in multivariate analysis. Despite several limitations, this study provides important information concerning the relevance of back pain as a health problem and its socioeconomic consequences. The information may be of value for decision-making and allocation of research fund resources.

Development and first assessment of a questionnaire for health care utilization and costs for cardiac patients.

BACKGROUND: The valid and reliable measurement of health service utilization, productivity losses and consequently total disease-related costs is a prerequisite for health services research and for health economic analysis. Although administrative data sources are usually considered to be the most accurate, their use is limited as some components of utilization are not systematically captured and, especially in decentralized health care systems, no single source exists for comprehensive utilization and cost data. The aim of this study was to develop and test a questionnaire for the measurement of disease-related costs for patients after an acute cardiac event (ACE). METHODS: To design the questionnaire, the literature was searched for contributions to the assessment of utilization of health care resources by patient-administered questionnaires. Based on these findings, we developed a retrospective questionnaire appropriate for the measurement of disease-related costs over a period of 3 months in ACE patients. Items were generated by reviewing existing guidelines and by interviewing medical specialists and patients. In this study, the questionnaire was tested on 106 patients, aging 35-65 who were admitted for rehabilitation after ACE. It was compared with prospectively measured data; selected items were compared with administrative data from sickness funds. RESULTS: The questionnaire was accepted well (response rate = 88%), and respondents completed the questionnaire in an average time of 27 minutes. Concordance between retrospective and prospective data showed an intraclass correlation (ICC) ranging between 0.57 (cost of medical intake) and 0.9 (hospital days) with the other main items (physician visits, days off work, medication) clustering around 0.7. Comparison between self-reported and administrative data for days off work and hospitalized days were possible for n = 48. Respective ICCs ranged between 0.92 and 0.94, although differences in mean levels were observed. CONCLUSION: The questionnaire was accepted favorably and correlated well with alternative measurement approaches. This first assessment showed promising characteristics of this questionnaire in different aspects of validity for patients with ACE. However, additional research and more extensive tests in other patient groups would be worthwhile.

Disease management programmes for patients with coronary heart disease--an empirical study of German programmes.

OBJECTIVE: To evaluate healthcare and outcomes of disease management programmes (DMPs) for patients with coronary heart disease (CHD) in primary care, and to assess selection of enrollment for these programmes. METHODS: A cross-sectional survey of 2330 statutorily insured patients with a history of acute myocardial infarction (AMI) was performed in 2006 by the population-based KORA Myocardial Infarction Register from the region of Augsburg, Germany. Patients enrolled in DMP-CHDs receive evidence-based care, with patients not enrolled receiving standard care. To control for selection bias, a propensity score approach was used. RESULTS: Main factors influencing DMP participation were age (OR 0.98, 95% CI 0.96-0.99), diabetes (OR 1.56, CI 1.25-1.95) and time since last heart attack (OR 0.98, CI 0.95-0.99). Significantly more patients enrolled in DMP-CHDs stated that they received medical counselling for smoking (OR 3.77, CI 1.07-13.34), nutrition (OR 2.15, 1.69-2.74) and for physical activity (OR 2.58, 1.99-3.35). Furthermore, prescription of statins (OR 1.58, CI 1.24-2.00), antiplatelets (OR 1.96, CI 1.43-2.69) and beta-blockers (not significant) were higher in the DMP group. With respect to outcomes, we did not see relevant differences in quality of life and body mass index, and only a minor reduction in smoking. CONCLUSIONS: Enrollment into DMPs for CHD exhibits systematic selection effects. Participants tend to experience--at least on a short to medium term and for AMI patients--better quality of healthcare services. However, since DMP-CHDs were initiated only 2 years ago, we were unable to identify significant improvements in health outcomes. Only the reduction in smoking provides a first indication of better quality outcomes following DMP-CHD. Thus, policy-makers must provide appropriate incentives to sickness funds and physicians in order to ensure initiation and continuation of high quality DMPs.