Search

Tim Bartling,1,2 Carina Oedingen,1,2 Harald Schrem,2,3 Thomas Kohlmann,4 Christian Krauth1,2 1Hannover Medical School, Institute of Epidemiology, Social Medicine and Health Systems Research, Hannover, Germany; 2Center for Health Economics Research Hannover, Hannover, Germany; 3General, Visceral and Transplant Surgery, Medical University Graz, Graz, Austria; 4Department of Methods of Community Medicine, Institute for Community Medicine, University of Greifswald, Greifswald, GermanyCorrespondence: Tim Bartling, Medizinische Hochschule Hannover / Hannover Medical School, Institute of Epidemiology, Social Medicine and Health Systems Research, Carl-Neuberg-Str, 1, Hannover, Lower Saxony, 30625, Germany, Tel +49 511 532 9462, Fax +49 511 532 5376, Email bartling.tim@mh-hannover.dePurpose: Organ transplantation systems benefit from guidelines that are harmonious with the preferences of the people involved. Discrete choice experiments are useful tools for eliciting preferences.Patients and Methods: This study evaluated the preferences of patients and their relatives (n=285) to identify their priorities in organ allocation using a discrete choice experiment. In eight hypothetical allocation decisions, the participants were asked to select the candidate they considered the most suitable The candidates differed in years of life gained after transplantation, quality of life after transplantation, waiting time until transplantation, age, compliance and social support.Results: The most important aspects for setting priority in organ allocation were lack of compliance (β= − 2.5, p< 0.001) and good quality of life after transplantation (β = +1.4, p< 0.001). The lack of social support (ß = − 0.8, p< 0.05) and the more years of life gained after transplantation (β = +0.5, p< 0.001) had less but still a significant amount of influence on this decision, while the waiting list was not considered significantly important (β = 0.1, p> 0.05). The comparison of the di

Tim Bartling,1,2 Carina Oedingen,1,2 Thomas Kohlmann,3 Harald Schrem,2,4,5 Christian Krauth1,2 1Institute of Epidemiology, Social Medicine and Health Systems Research, Hannover Medical School, Hannover, Germany; 2Center for Health Economics Research Hannover (CHERH), Hannover, Germany; 3Department for Methods of Community Medicine, Institute for Community Medicine, University of Greifswald, Greifswald, Germany; 4Transplant Center Graz, Medical University Graz, Graz, Austria; 5General, Visceral and Transplant Surgery, Medical University Graz, Graz, AustriaCorrespondence: Tim Bartling, Institute of Epidemiology, Social Medicine and Health Systems Research, Hannover Medical School, Carl-Neuberg-Str. 1, Hannover, 30625, Germany, Tel +49 511 532 9462, Fax +49 511 532 5376, Email bartling.tim@mh-hannover.dePurpose: The gap between the supply and demand for deceased donor organs is increasing worldwide, while patients on waiting lists for organ transplantation die. This situation requires ethical donor organ allocation rules. The patients’ perspective on donor organ allocation rules offers a highly relevant and unique perspective that may differ from the perspectives of physicians and the general public.Patients and Methods: Semi-structured telephone interviews were conducted with the regional group coordinators of the federal self-help organization for organ transplanted patients and their relatives in Germany in early 2021. Twelve interviews were conducted with patients and relatives of transplantation patients who received transplants for the affected organs including the lungs, heart, kidney, and liver. Transcripts were analyzed using the deductive framework method which was based on an earlier study. All criteria were reported following the COREQ statement.Results: Participants emphasized aspects of “medical urgency” and “effectiveness/benefit” of transplantation and associated trade-offs as well as the recipient’s responsibility for organ failure (“own

We analyzed symptoms and comorbidities as predictors of hospitalization in 710 outpatients in North-East Germany with PCR-confirmed SARS-CoV-2 infection. During the first 3 days of infection, commonly reported symptoms were fatigue (71.8%), arthralgia/myalgia (56.8%), headache (55.1%), and dry cough (51.8%). Loss of smell (anosmia), loss of taste (ageusia), dyspnea, and productive cough were reported with an onset of 4 days. Anosmia or ageusia were reported by only 18% of the participants at day one, but up to 49% between days 7 and 9. Not all participants who reported ageusia also reported anosmia. Individuals suffering from ageusia without anosmia were at highest risk of hospitalization (OR 6.8, 95% CI 2.5-18.1). They also experienced more commonly dyspnea and nausea (OR of 3.0, 2.9, respectively) suggesting pathophysiological connections between these symptoms. Other symptoms significantly associated with increased risk of hospitalization were dyspnea, vomiting, and fever. Among basic parameters and comorbidities, age > 60 years, COPD, prior stroke, diabetes, kidney and cardiac diseases were also associated with increased risk of hospitalization. In conclusion, due to the delayed onset, ageusia and anosmia may be of limited use in differential diagnosis of SARS-CoV-2. However, differentiation between ageusia and anosmia may be useful for evaluating risk for hospitalization.

We analyzed symptoms and comorbidities as predictors of hospitalization in 710 outpatients in North-East Germany with PCR-confirmed SARS-CoV-2 infection. During the first 3 days of infection, commonly reported symptoms were fatigue (71.8%), arthralgia/myalgia (56.8%), headache (55.1%), and dry cough (51.8%). Loss of smell (anosmia), loss of taste (ageusia), dyspnea, and productive cough were reported with an onset of 4 days. Anosmia or ageusia were reported by only 18% of the participants at day one, but up to 49% between days 7 and 9. Not all participants who reported ageusia also reported anosmia. Individuals suffering from ageusia without anosmia were at highest risk of hospitalization (OR 6.8, 95% CI 2.5-18.1). They also experienced more commonly dyspnea and nausea (OR of 3.0, 2.9, respectively) suggesting pathophysiological connections between these symptoms. Other symptoms significantly associated with increased risk of hospitalization were dyspnea, vomiting, and fever. Among basic parameters and comorbidities, age > 60 years, COPD, prior stroke, diabetes, kidney and cardiac diseases were also associated with increased risk of hospitalization. In conclusion, due to the delayed onset, ageusia and anosmia may be of limited use in differential diagnosis of SARS-CoV-2. However, differentiation between ageusia and anosmia may be useful for evaluating risk for hospitalization.

Purpose: Although the EQ-5D has a long history of use in a wide range of populations, the newer five-level version (EQ-5D-5L) has not yet had such extensive experience. This systematic review summarizes the available published scientific evidence on the psychometric properties of the EQ-5D-5L. Methods: Pre-determined key words and exclusion criteria were used to systematically search publications from 2011 to 2019. Information on study characteristics and psychometric properties were extracted: specifically, EQ-5D-5L distribution (including ceiling and floor), missing values, reliability (test–retest), validity (convergent, known-groups, discriminate) and responsiveness (distribution, anchor-based). EQ-5D-5L index value means, ceiling and correlation coefficients (convergent validity) were pooled across the studies using random-effects models. Results: Of the 889 identified publications, 99 were included for review, representing 32 countries. Musculoskeletal/orthopedic problems and cancer (n = 8 each) were most often studied. Most papers found missing values (17 of 17 papers) and floor effects (43 of 48 papers) to be unproblematic. While the index was found to be reliable (9 of 9 papers), individual dimensions exhibited instability over time. Index values and dimensions demonstrated moderate to strong correlations with global health measures, other multi-attribute utility instruments, physical/functional health, pain, activities of daily living, and clinical/biological measures. The instrument was not correlated with life satisfaction and cognition/communication measures. Responsiveness was addressed by 15 studies, finding moderate effect sizes when confined to studied subgroups with improvements in health. Conclusions: The EQ-5D-5L exhibits excellent psychometric properties across a broad range of populations, conditions and settings. Rigorous exploration of its responsiveness is needed.

In recent years, a correlation of thrombocytosis and a worse prognosis was shown for many solid cancers, including glioblastoma multiforme (GBM). Methods A retrospective review was performed for all patients with a histologically proven and first-diagnosed GBM between 2005 and 2015 in our department. Clinical and paraclinical parameters were acquired from patient documentation and structured for subsequent data analysis. The association of potential risk factors with overall survival was assessed using the Kaplan–Meier survival analysis and Cox regression. The present study includes 309 patients first diagnosed with primary GBM. Our analyses validate well-known risk factors of a decreased overall survival such as higher patient age, a larger preoperative tumor volume, Karnofsky performance status, extent of resection, tumor localization, and adjuvant treatment. However, no correlation was observed between a preoperative thrombocytosis, the mean platelet volume, leucocyte count, activated partial thromboplastin time (apTT), fibrinogen level, and acetylsalicylic acid 100 co-medication. Patients with preoperative hemoglobin below 7.5mmol/L had decreased overall survival. The present study, enrolling the largest numbers of patients assessing this topic to date, did not find any association between a preoperative thrombocytosis and overall survival in 309 patients with GBM.

Background: Cathepsin-D (CatD), owing to its dual role as a proteolytic enzyme and as a ligand, has been implicated in cancer progression. The role of CatD in pancreatic ductal adenocarcinoma is unknown. Methods: CatD expression quantified by immunohistochemistry of tumor-tissue microarrays of 403 resected pancreatic cancer patients from the ESPAC-Tplus trial, a translational study within the ESPAC (European Study Group for Pancreatic Cancer) trials, was dichotomously distributed to low and high H scores (cut off 22.35) for survival and multivariable analysis. The validation cohort (n = 69) was recruited based on the hazard ratio of CatD from ESPAC-Tplus. 5-fluorouracil-, and gemcitabine-resistant pancreatic cancer cell lines were employed for mechanistic experiments. All statistical tests were two-sided. Results: Median overall survival was 23.75 months and median overall survival for patients with high CatD expression was 21.09 (95% confidence interval [CI] = 17.31 to 24.80) months vs 27.20 (95% CI = 23.75 to 31.90) months for low CatD expression (chi(2)(LR), (1DF) = 4.00; P = .04). Multivariable analysis revealed CatD expression as a predictive marker in gemcitabine-treated (z stat = 2.33; P = .02) but not in 5-fluorouracil-treated (z stat = 0.21; P = .82) patients. An independent validation cohort confirmed CatD as a negative predictive marker for survival (chi(2)(LR), (1DF)= 6.80; P = .009) and as an independent predictive marker in gemcitabine-treated patients with a hazard ratio of 3.38 (95% CI = 1.36 to 8.38, P = .008). Overexpression of CatD was associated with a concomitant suppression of the acid sphingomyelinase, and silencing of CatD resulted in upregulation of acid sphingomyelinase with rescue of gemcitabine resistance. Conclusions: Adjuvant gemcitabine is less effective in pancreatic ductal adenocarcinoma with high CatD expression, and thus CatD could serve as a marker for biomarker-driven therapy.

Background: Cathepsin-D (CatD), owing to its dual role as a proteolytic enzyme and as a ligand, has been implicated in cancer progression. The role of CatD in pancreatic ductal adenocarcinoma is unknown. Methods: CatD expression quantified by immunohistochemistry of tumor-tissue microarrays of 403 resected pancreatic cancer patients from the ESPAC-Tplus trial, a translational study within the ESPAC (European Study Group for Pancreatic Cancer) trials, was dichotomously distributed to low and high H scores (cut off 22.35) for survival and multivariable analysis. The validation cohort (n = 69) was recruited based on the hazard ratio of CatD from ESPAC-Tplus. 5-fluorouracil-, and gemcitabine-resistant pancreatic cancer cell lines were employed for mechanistic experiments. All statistical tests were two-sided. Results: Median overall survival was 23.75 months and median overall survival for patients with high CatD expression was 21.09 (95% confidence interval [CI] = 17.31 to 24.80) months vs 27.20 (95% CI = 23.75 to 31.90) months for low CatD expression (chi(2)(LR), (1DF) = 4.00; P = .04). Multivariable analysis revealed CatD expression as a predictive marker in gemcitabine-treated (z stat = 2.33; P = .02) but not in 5-fluorouracil-treated (z stat = 0.21; P = .82) patients. An independent validation cohort confirmed CatD as a negative predictive marker for survival (chi(2)(LR), (1DF)= 6.80; P = .009) and as an independent predictive marker in gemcitabine-treated patients with a hazard ratio of 3.38 (95% CI = 1.36 to 8.38, P = .008). Overexpression of CatD was associated with a concomitant suppression of the acid sphingomyelinase, and silencing of CatD resulted in upregulation of acid sphingomyelinase with rescue of gemcitabine resistance. Conclusions: Adjuvant gemcitabine is less effective in pancreatic ductal adenocarcinoma with high CatD expression, and thus CatD could serve as a marker for biomarker-driven therapy.

Background: There is little evidence on differences across health care systems in choice and outcome of the treatment of chronic low back pain (CLBP) with spinal surgery and conservative treatment as the main options. At least six randomised controlled trials comparing these two options have been performed; they show conflicting results without clear-cut evidence for superior effectiveness of any of the evaluated interventions and could not address whether treatment effect varied across patient subgroups. Cost-utility analyses display inconsistent results when comparing surgical and conservative treatment of CLBP. Due to its higher feasibility, we chose to conduct a prospective observational cohort study. Methods: This study aims to examine if: 1. Differences across health care systems result in different treatment outcomes of surgical and conservative treatment of CLBP 2. Patient characteristics (work-related, psychological factors, etc.) and co-interventions (physiotherapy, cognitive behavioural therapy, return-to-work programs, etc.) modify the Outcome of treatment for CLBP 3. Cost-utility in terms of quality-adjusted life years differs between surgical and conservative treatment of CLBP. This study will recruit 1000 patients from orthopaedic spine units, rehabilitation centres, and pain clinics in Switzerland and New Zealand. Effectiveness will be measured by the Oswestry Disability Index (ODI) at baseline and after six months. The change in ODI will be the primary endpoint of this study. Multiple linear regression models will be used, with the change in ODI from baseline to six months as the dependent variable and the type of health care system, type of treatment, Patient characteristics, and co-interventions as independent variables. Interactions will be incorporated between type of treatment and different co-interventions and patient characteristics. Cost-utility will be measured with an index based on EQol-5D in combination with cost data. Conclusion: This s

Background: There is little evidence on differences across health care systems in choice and outcome of the treatment of chronic low back pain (CLBP) with spinal surgery and conservative treatment as the main options. At least six randomised controlled trials comparing these two options have been performed; they show conflicting results without clear-cut evidence for superior effectiveness of any of the evaluated interventions and could not address whether treatment effect varied across patient subgroups. Cost-utility analyses display inconsistent results when comparing surgical and conservative treatment of CLBP. Due to its higher feasibility, we chose to conduct a prospective observational cohort study. Methods: This study aims to examine if: 1. Differences across health care systems result in different treatment outcomes of surgical and conservative treatment of CLBP 2. Patient characteristics (work-related, psychological factors, etc.) and co-interventions (physiotherapy, cognitive behavioural therapy, return-to-work programs, etc.) modify the Outcome of treatment for CLBP 3. Cost-utility in terms of quality-adjusted life years differs between surgical and conservative treatment of CLBP. This study will recruit 1000 patients from orthopaedic spine units, rehabilitation centres, and pain clinics in Switzerland and New Zealand. Effectiveness will be measured by the Oswestry Disability Index (ODI) at baseline and after six months. The change in ODI will be the primary endpoint of this study. Multiple linear regression models will be used, with the change in ODI from baseline to six months as the dependent variable and the type of health care system, type of treatment, Patient characteristics, and co-interventions as independent variables. Interactions will be incorporated between type of treatment and different co-interventions and patient characteristics. Cost-utility will be measured with an index based on EQol-5D in combination with cost data. Conclusion: This s

OBJECTIVES: Determination of cardiac troponin (cTn) is central in the emergency department (ED) for the diagnosis of myocardial infarction. In view of adverse effects of long waiting time on patient outcome, implementation of point-of-care-testing (POCT) is suggested if the turn-around-time is longer than 60min. The present study aimed to determine the 99th percentile and imprecision of two POCT in a healthy population measuring cTnI and cTnT and compare these analytical characteristics against three central laboratory test (CLT) for cTnI. DESIGN & METHODS: CTnI and cTnT were determined in parallel by means of the AQT90 FLEX analyzer in about 2250 plasma samples from individuals with known health status. Results were compared to previously determined performance data of three CLT. RESULTS: The 99th percentile of cTnI in the POCT was determined at 19ng/L, the lowest concentration with an imprecision of 10% was reached at 22ng/L while an imprecision of 20% was reached at 13ng/L. Age, sex, or physical activity did not affect the 99th percentile of cTnI. Compared to CLT the AQT90 cTnI POCT the analytical performance was equivalent. The cTnT POCT could not be assessed due a considerable number of high values and an inadequate imprecision profile. CONCLUSION: While the cTnI POCT showed analytical performance comparable to CLT, the results of the cTnT assay on the same device did not suffice to determine a reliable 99th percentile. The present evaluation supports the usage of the cTnI POCT, but application of the cTnT POCT needs further evaluation.

Introduction: Recently, FOLFIRINOX and gemcitabine + nab-paclitaxel have been introduced as a novel intensified chemotherapy regimen for patients with metastasized pancreatic cancer. This study aims to analyze the real-world clinical practice with FOLFIRINOX and gemcitabine + nab-paclitaxel across Europe. Methods: Invitations to participate in an anonymous web-based questionnaire were sent via e-mail to 5,420 doctors in 19 European countries through the network of national gastroenterological, oncological, surgical and pancreatic societies as well as the European Pancreatic Club. The questionnaire consisted of 20 questions, 14 regarding the use of intensified chemotherapy, 4 regarding demographics of the participants, and 1 to verify the active involvement in the management of metastatic pancreatic cancer. Results: Two hundred and thirteen responses were received and 153 entries were valid for analysis. Of those, 63.4% came from an academic institution, 51% were oncologists, and 52% treated more than 25 cases per year. A majority of responses (71%) were from Italy (40%), Germany (23%), and Spain (8%). As first-line therapy, 11% used gemcitabine +/- erlotinib, 42% used FOLFIRINOX, and 47% used gemcitabine + nab-paclitaxel. Of the intensified regimens, both were applied to equal parts, but the likelihood of protocol deviation was higher when using FOLFIRINOX (p < 0.01). FOLFIRINOX was considered more toxic than gemcitabine + nab-paclitaxel (neutropenia 88 vs. 68%; polyneuropathy 42 vs. 41%; rapid deterioration 42 vs. 31%). FOLFIRINOX was rated to achieve longer survival with an acceptable quality of life (52 vs. 44%). Moreover, 57% of participants thought that gemcitabine + nab-paclitaxel should be the backbone for further clinical trials in pancreatic cancer. Conclusion: Intensified chemotherapy is widely used in pancreatic cancer patients in Europe following its recent clinical approval. Interestingly, nab-paclitaxel and FOLFIRINOX were used at comparable frequen

Determination of cardiac troponin I (cTnI) is one central means for diagnosis of myocardial infarction. Assay performance of three troponin I assays was compared previously in a large reference population detecting sex-differences in the 99th percentile only for the Dimension Vista cTnI assay. The present study examined the underlying effects. Values for cTnI were reused. Creatine kinase (CK) activity was determined in 2358 samples from blood donors. Information on physical activity was evaluated from health questionnaires. Using quantile regression data were analysed to investigate the impact of sex, physical activity, and CK on the 99th percentile of the cTnI assay. We report significant sex-differences for the 99th percentile of cTnI. Physical activity was significantly associated with cTnI values. Strong association of CK activity with cTnI values was detected only in men. Adjustment for CK in quantile regression abolished sex -differences in the 99th percentile. Two other contemporary sensitive cTnI assays were not relevantly affected by physical activity or CK. Sex -differences in the 99th percentile for the Dimension Vista cTnI assay arise from a positive association between cTnI and physical activity and were abrogated when data were adjusted for CK activity. These findings should be taken into account when using this assay.

Psychosocial, emotional, and physical problems can emerge after traumatic brain njury (TBI), potentially impacting health-related quality of life (HRQoL). Until now, however, neither the discriminatory power of disease-specific (QOLIBRI) and generic (SF-36) HRQoL nor their correlates have been compared in detail. These aspects as well as some psychometric item characteristics were studied in a sample of 795 TBI survivors. The Shannon H耠 index absolute informativity, as an indicator of an instrument’s power to differentiate between individualswithin a specific group or health state,was investigated. Psychometric performance of the two instruments was predominantly good, generally higher, and more homogenous for the QOLIBRI than for the SF-36 subscales. Notably, the SF-36 “Role Physical,” “Role Emotional,” and “Social Functioning” subscales showed less satisfactory discriminatory power than all other dimensions or the sum scores of both instruments. The absolute informativity of disease-specific as well as generic HRQoL instruments concerning the different groups defined by different correlates differed significantly.When the focus is on how a certain subscale or sum score differentiates between individuals in one specific dimension/health state, the QOLIBRI can be recommended as the preferable instrument.

Objectives: Since the introduction of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs), an additional treatment option, apart from VKAs, has become available for stroke prevention in patients with atrial fibrillation (AF). For various reasons, it is important to consider patients’ preferences regarding type of medication, particularly in view of the established relationship between preferences towards treatment, associated burden of treatment, and treatment adherence. This review aimed to systematically analyse the scientific literature assessing the preferences of AF patients with regard to long-term oral anticoagulant (OAC) treatment. Methods: We searched the MEDLINE, Scopus and EMBASE databases (from 1980 to 2015), added records from reference lists of publications found, and conducted a systematic review based on all identified publications. Outcomes of interest included any quantitative information regarding the opinions or preferences of AF patients towards OAC treatment, ideally specified according to different clinical or convenience attributes describing different OAC treatment options. Results: Overall, 27 publications describing the results of studies conducted in 12 different countries were included in our review. Among these, 16 studies analysed patient preferences towards OACs in general. These studies predominantly assessed which benefits (mainly lower stroke risk) AF patients would require to tolerate harms (mainly higher bleeding risk) associated with an OAC. Most studies showed that patients were willing to accept higher bleeding risks if a certain threshold in stroke risk reduction could be reached. Nevertheless, most of the publications also showed that the preferences of AF patients towards OACs may differ from the perspective of clinical guidelines or the perspective of physicians. The remaining 11 studies included in our review assessed the preferences of AF patients towards specific OAC medication options, namely NOACs versus VKAs.

The objective of this study was to identify, document, and weight attributes of a pain medication that are relevant from the perspective of patients with chronic pain. Within the sub-population of patients suffering from chronic neuropathic pain, three groups were analyzed in depth: patients with neuropathic back pain, patients with painful diabetic polyneuropathy, and patients suffering from pain due to post-herpetic neuralgia. The central question was: On which features do patients base their assessment of pain medications and which features are most useful in the process of evaluating and selecting possible therapies? A detailed literature review, focus groups with patients, and face-to-face interviews with widely recognized experts for pain treatment were conducted to identify relevant treatment attributes of a pain medication. A pre-test was conducted to verify the structure of relevant and dominant attributes using factor analyses by evaluating the most frequently mentioned representatives of each factor. The Discrete-Choice Experiment (DCE) used a survey based on self-reported patient data including socio-demographics and specific parameters concerning pain treatment. Furthermore, the neuropathic pain component was determined in all patients based on their scoring in the painDETECT(A (R)) questionnaire. For statistical data analysis of the DCE, a random effect logit model was used and coefficients were presented. A total of 1,324 German patients participated in the survey, of whom 44 % suffered from neuropathic back pain (including mixed pain syndrome), 10 % complained about diabetic polyneuropathy, and 4 % reported pain due to post-herpetic neuralgia. A total of 36 single quality aspects of pain treatment, detected in the qualitative survey, were grouped in 7 dimensions by factor analysis. These 7 dimensions were used as attributes for the DCE. The DCE model resulted in the following ranking of relevant attributes for treatment decision: no character change

The objective of this study was to identify, document, and weight attributes of a pain medication that are relevant from the perspective of patients with chronic pain. Within the sub-population of patients suffering from chronic neuropathic pain, three groups were analyzed in depth: patients with neuropathic back pain, patients with painful diabetic polyneuropathy, and patients suffering from pain due to post-herpetic neuralgia. The central question was: On which features do patients base their assessment of pain medications and which features are most useful in the process of evaluating and selecting possible therapies? A detailed literature review, focus groups with patients, and face-to-face interviews with widely recognized experts for pain treatment were conducted to identify relevant treatment attributes of a pain medication. A pre-test was conducted to verify the structure of relevant and dominant attributes using factor analyses by evaluating the most frequently mentioned representatives of each factor. The Discrete-Choice Experiment (DCE) used a survey based on self-reported patient data including socio-demographics and specific parameters concerning pain treatment. Furthermore, the neuropathic pain component was determined in all patients based on their scoring in the painDETECT(A (R)) questionnaire. For statistical data analysis of the DCE, a random effect logit model was used and coefficients were presented. A total of 1,324 German patients participated in the survey, of whom 44 % suffered from neuropathic back pain (including mixed pain syndrome), 10 % complained about diabetic polyneuropathy, and 4 % reported pain due to post-herpetic neuralgia. A total of 36 single quality aspects of pain treatment, detected in the qualitative survey, were grouped in 7 dimensions by factor analysis. These 7 dimensions were used as attributes for the DCE. The DCE model resulted in the following ranking of relevant attributes for treatment decision: no character change

BACKGROUND: The Patient-Reported Indices for Multiple Sclerosis (PRIMUS) comprises a suite of three scales for assessing symptoms, activity limitations, and quality of life in multiple sclerosis (MS). It was developed in the UK and has been shown to have excellent psychometric properties. This study describes the adaptation of eight language versions for Canadian English, Canadian French, French, German, Italian, Spanish, Swedish, and US English. METHODS: The PRIMUS was translated using the dual-panel process. Cognitive debriefing interviews conducted with MS patients assessed face and content validity. Psychometric and scaling properties were assessed via a two-administration postal survey conducted in each country involving the PRIMUS, the Nottingham Health Profile (NHP), the Unidimensional Fatigue Impact Scale (U-FIS), and demographic questions. RESULTS: Cognitive debriefing interviews demonstrated the acceptability of the new language versions. Analysis of survey data showed that the new language versions of the three PRIMUS scales were unidimensional (as indicated by fit to the Rasch model) and that they had good internal consistency and reproducibility. PRIMUS scale scores correlated as expected with those on the NHP and the U-FIS. The scales in all countries were able to discriminate between groups of patients on the basis of their self-reported MS severity, general health, and employment status. CONCLUSIONS: The PRIMUS was successfully adapted into eight new languages. Most of the tests showed the PRIMUS to have good unidimensionality and to have good internal consistency, reproducibility, and construct validity. The measure is now available for use in clinical studies and trials involving these countries and the UK. Further work is required to assess the measure's responsiveness.

OBJECTIVE: The 22-item Unidimensional Fatigue Impact Scale (U-FIS) provides an index of the impact of fatigue on patients with multiple sclerosis (MS). The objective is to produce eight new language versions of the U-FIS: Canadian-English, Canadian-French, French, German, Italian, Spanish, Swedish, and US-English. METHODS: The U-FIS was translated via two translation panels. Cognitive debriefing interviews conducted with patients in each country assessed face and content validity. Scaling and psychometric properties were assessed via survey data with patients in each country completing the U-FIS, Nottingham Health Profile (NHP), and demographic questions. RESULTS: Cognitive debriefing interviews demonstrated U-FIS acceptability. Analysis of postal survey data showed all new language versions to be unidimensional. Reliability was high, with test-retest correlations and internal-consistency coefficients exceeding 0.85. Initial evidence of validity was provided by moderate to high correlations with NHP scales. The U-FIS was able to discriminate between groups based on employment status, perceived MS severity, and general health. CONCLUSION: The U-FIS is a practical new measure of the impact of fatigue. It was successfully adapted into eight new languages to broaden availability for researchers. Psychometric analyses indicated that the new language versions were unidimensional and reproducible with promising construct validity.

Objective: To analyse 12-month response to GH treatment in a single-country cohort of hypopituitary adult patients with GH deficiency (GHD) in regards to health-related quality of life (HRQoL) and insulin-like growth factor-1 (IGF-1) compared with values from general population sample. Moreover, association between the response in HRQoL and the IGF-1 values in patients and in the background population was investigated. Design: HRQoL was assessed by quality of life assessment of GH deficiency in adults (QoL-AGHDA) in 651 patients retrieved from the German KIMS (Pfizer International Metabolic Database) before and after 12 months of GH replacement and in a sample drawn from a cross-sectional study in Germany (n=2734). IGF-1 was measured in KIMS patients and in the population-based study with the same assay technique. Results: in KIMS patients, mean QoL-AGHDA scores before GH replacement were 9.2 +/- 6.8 (8.7 +/- 6.8) in women (men) and in the general population sample 4.5 +/- 5.3 (4.3 +/- 5.0) in women (men). Mean differences in QoL-AGHDA scores were statistically significant for all age categories (P<0.05). The mean IGF-1 SDS of KIMS patients before GH replacement was -1.1 +/- 1.4 (-0.8 +/- 1.4) in women (men). After GH replacement, a significant increase of IGF-1 concentration and a significant decrease of QoL-AGHDA scores near to age- and gender-specific population-based values were observed. Conclusions: This Study confirms an improvement in HRQoL and an increase of IGF-1 SDS in GH-replaced adults, which approximated the values of general population. However, there was no association between IGF-1 values and HRQoL assessment as one of the important treatment outcomes.

Objective: The international development of the Parents’ Index of Quality of Life in Atopic Dermatitis (PIQoL-AD), a quality of life (QoL) instrument specific to parents of children with atopic dermatitis (AD) is described. Method: The instrument was developed simultaneously in several countries. Its content was derived from 65 qualitative interviews with parents in the UK, Netherlands and Italy. The measure was then produced for the UK, Netherlands, Italy, Germany, France, US and Spain. Field-test interviews were conducted with approximately 20 patients in each country to assess face and content validity. A two time-point survey was conducted with between 45 and 328 parents in each country to finalise the instrument through application of the Rasch model and to evaluate the psychometric properties of the final instrument. Results: Application of the Rasch model to the survey data identified the final 28-item version. All language versions had good item fit, test–retest reliability (above 0.85), internal consistency and promising validity. Conclusions: The PIQoL-AD is a valuable instrument for inclusion in clinical trials and routine clinical practice. It provides distinct and complementary information to that of existing dermatology-specific measures and has been shown to be responsive to changes in QoL in clinical trials.

Objective: The international development of the Parents’ Index of Quality of Life in Atopic Dermatitis (PIQoL-AD), a quality of life (QoL) instrument specific to parents of children with atopic dermatitis (AD) is described. Method: The instrument was developed simultaneously in several countries. Its content was derived from 65 qualitative interviews with parents in the UK, Netherlands and Italy. The measure was then produced for the UK, Netherlands, Italy, Germany, France, US and Spain. Field-test interviews were conducted with approximately 20 patients in each country to assess face and content validity. A two time-point survey was conducted with between 45 and 328 parents in each country to finalise the instrument through application of the Rasch model and to evaluate the psychometric properties of the final instrument. Results: Application of the Rasch model to the survey data identified the final 28-item version. All language versions had good item fit, test–retest reliability (above 0.85), internal consistency and promising validity. Conclusions: The PIQoL-AD is a valuable instrument for inclusion in clinical trials and routine clinical practice. It provides distinct and complementary information to that of existing dermatology-specific measures and has been shown to be responsive to changes in QoL in clinical trials.

Objective: The international development of the Parents’ Index of Quality of Life in Atopic Dermatitis (PIQoL-AD), a quality of life (QoL) instrument specific to parents of children with atopic dermatitis (AD) is described. Method: The instrument was developed simultaneously in several countries. Its content was derived from 65 qualitative interviews with parents in the UK, Netherlands and Italy. The measure was then produced for the UK, Netherlands, Italy, Germany, France, US and Spain. Field-test interviews were conducted with approximately 20 patients in each country to assess face and content validity. A two time-point survey was conducted with between 45 and 328 parents in each country to finalise the instrument through application of the Rasch model and to evaluate the psychometric properties of the final instrument. Results: Application of the Rasch model to the survey data identified the final 28-item version. All language versions had good item fit, test–retest reliability (above 0.85), internal consistency and promising validity. Conclusions: The PIQoL-AD is a valuable instrument for inclusion in clinical trials and routine clinical practice. It provides distinct and complementary information to that of existing dermatology-specific measures and has been shown to be responsive to changes in QoL in clinical trials.

Objective: The international development of the Parents’ Index of Quality of Life in Atopic Dermatitis (PIQoL-AD), a quality of life (QoL) instrument specific to parents of children with atopic dermatitis (AD) is described. Method: The instrument was developed simultaneously in several countries. Its content was derived from 65 qualitative interviews with parents in the UK, Netherlands and Italy. The measure was then produced for the UK, Netherlands, Italy, Germany, France, US and Spain. Field-test interviews were conducted with approximately 20 patients in each country to assess face and content validity. A two time-point survey was conducted with between 45 and 328 parents in each country to finalise the instrument through application of the Rasch model and to evaluate the psychometric properties of the final instrument. Results: Application of the Rasch model to the survey data identified the final 28-item version. All language versions had good item fit, test–retest reliability (above 0.85), internal consistency and promising validity. Conclusions: The PIQoL-AD is a valuable instrument for inclusion in clinical trials and routine clinical practice. It provides distinct and complementary information to that of existing dermatology-specific measures and has been shown to be responsive to changes in QoL in clinical trials.