Psychometric validation of the generalized pustular psoriasis physician global assessment (GPPGA) and generalized pustular psoriasis area and severity index (GPPASI)

Background: Generalized pustular psoriasis (GPP) is a rare and life-threatening skin disease often accompanied by systemic inflammation. There are currently no standardized or validated GPP-specific measures for assessing severity. Objective: To evaluate the reliability, validity, and responder definitions of the generalized pustular psoriasis physician global assessment (GPPGA) and generalized pustular psoriasis area and severity index (GPPASI). Methods: The GPPGA and GPPASI were validated using outcome data from Week 1 of the Effisayil™ 1 study. The psychometric analyses performed included confirmatory factor analysis, item-to-item/item-to-total correlations, internal consistency reliability, test-retest reliability, convergent validity, known-groups validity, responsiveness analysis, and responder definition analysis. Results: Using data from this patient cohort (N=53), confirmatory factor analysis demonstrated unidimensionality of the GPPGA total score (root mean square error of approximation <0.08), and GPPGA item-to-item and item-to-total correlations ranged from 0.58–0.90. The GPPGA total score, pustulation subscore, and GPPASI total score all demonstrated good test-retest reliability (intraclass correlation coefficient: 0.70, 0.91, and 0.95, respectively), and good evidence of convergent validity. In anchor-based analyses, all three scores were able to detect changes in symptom and disease severity over time; reductions of -1.4, -2.2, and -12.0 were suggested as clinically meaningful improvement thresholds for the GPPGA total score, GPPGA pustulation subscore, and GPPASI total score, respectively. Anchor-based analyses also supported the GPPASI 50 as a clinically meaningful threshold for improvement. Conclusions: Overall, our findings indicate that the GPPGA and GPPASI are valid, reliable, and responsive measures for the assessment of GPP disease severity, and support their use in informing clinical endpoints in trials in GPP

Psychometric validation of the Psoriasis Symptom Scale, Functional Assessment of Chronic Illness Therapy–Fatigue and pain‐Visual Analogue Scale in patients with generalized pustular psoriasis

Background: Generalized pustular psoriasis (GPP) is a rare, chronic, inflammatory skin disease associated with considerable patient burden. The Psoriasis Symptom Scale (PSS), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-Fatigue) and pain-Visual Analogue Scale (pain-VAS) are patient-reported outcomes (PROs) that have not yet been validated in patients with GPP. Objectives: To evaluate the psychometric properties of the PSS, FACIT-Fatigue and pain-VAS using data from Effisayil 1, a randomised trial of spesolimab in patients with moderate-to-severe GPP. Methods: Inter-item correlations and confirmatory factor analysis (CFA) were performed using Week 1 data. Internal consistency was assessed with Cronbach's α coefficient using baseline and Week 1 data. Test–retest reliability was assessed using intraclass correlation coefficients (ICCs); change data for the GPP Physician Global Assessment total score and pustulation subscore were used to define a stable population. Convergent validity was assessed at baseline and Week 1 using Spearman's rank-order correlations. Known-groups validity was measured by analysis of variance using Week 1 data. Ability to detect change from baseline to Week 1 was evaluated by analysis of covariance. Results: Inter-item and item-to-total correlations were moderate or strong for most PSS and FACIT-Fatigue items. CFA demonstrated the unidimensionality of the PSS and FACIT-Fatigue, with high factor loadings for most items (PSS range, 0.75–0.94; FACIT-Fatigue range, 0.11–0.93) and acceptable fit statistics. Both scores demonstrated internal consistency (Cronbach's α, 0.71 and 0.95, respectively). The PSS, FACIT-Fatigue and pain-VAS demonstrated test–retest reliability (ICCs ≥0.70) and good evidence of convergent validity. Furthermore, the PROs could differentiate between known groups of varying symptom severity (range, p < 0.0001–0.0225) and detect changes in symptom severity from baseline to Week 1 (range, p < 0.0001–0.0002). Conclusions: Overall, these results support the reliability, validity and ability to detect change of the PSS, FACIT-Fatigue and pain-VAS as PROs in patients with GPP

Communication, social capital and workplace health management as determinants of the innovative climate in German banks

The present study aims to measure the determinants of the innovative climate in German banks with a focus on workplace health management (WHM). We analyze the determinants of innovative climate with multiple regressions using a dataset based on standardized telephone interviews conducted with health promotion experts from 198 randomly selected German banks. The regression analysis provided a good explanation of the variance in the dependent variable (RA(2)A = 55%). Communication climate (beta = 0.55; p < 0.001), social capital (beta = 0.21; p < 0.01), the establishment of a WHM program (beta = 0.13; p < 0.05) as well as company size (beta = 0.15; p < 0.01) were found to have a significant impact on an organization's innovative climate. In order to foster an innovation-friendly climate, organizations should establish shared values. An active step in this direction involves strengthening the organizations' social capital and communication climate through trustworthy management decisions such as the implementation of a WHM program

Long-Term Costs of Stroke Using 10-Year Longitudinal Data From the North East Melbourne Stroke Incidence Study

Background and Purpose Stroke is costly, although little is known about the long-term costs of survivors of stroke. In previous cost-of-illness studies, lifetime costs have been modeled based on estimates to 5 years after stroke. Building on previous work from the North East Melbourne Stroke Incidence Study (NEMESIS), we aimed to describe resource use at 10 years and recalculate the lifetime societal costs of ischemic and hemorrhagic (intracerebral hemorrhage) stroke. Methods Ten-year patient-level resource use data were obtained and updated prices and population demographic statistics for 2010 were applied to our cost-of-illness models. We incorporated incidence data from a larger study region of NEMESIS than that used in the previous model and new 10-year survival and recurrent stroke rates. One-way sensitivity and probabilistic multivariable uncertainty analyses were undertaken. Results For ischemic stroke, the overall average annual direct costs at 10 years (US dollars [USD] 5207) were comparable to those for survivors between 3 and 5 years (USD5438). However, the contribution of some costs varied (eg, medications contributed 13% at 5 years and 20% at 10 years). For intracerebral hemorrhage, annual direct costs were considerably (24%) greater at 10 years than estimated using 3 to 5 year data. Greater average lifetime costs per case were found using the updated models (ischemic stroke: previous model USD51806 and current USD68 769; intracerebral hemorrhage: previous model USD43 786 and current USD54 956 per case). Following sensitivity and multivariable uncertainty analyses, the findings were robust. Conclusions Costs to 10 years after stroke have not previously been reported. Our findings demonstrate the importance of estimating resource use over longer periods for forecasting lifetime estimates

Symptom experience and content validity of the Psoriasis Symptom Scale (PSS) in patients with generalized pustular psoriasis (GPP)

Introduction: We sought to understand key symptoms of generalized pustular psoriasis (GPP) and to confirm the relevance to patients and content validity of the Psoriasis Symptom Scale (PSS) in GPP. Methods: A targeted literature review and clinical expert interviews were conducted as background research. Patients were interviewed individually (involving concept elicitation and cognitive interviews), and a separate patient workshop was conducted to determine disease-specific symptoms of importance. Results: Seven participants with moderate (n = 4), severe (n = 2), and mild (n = 1) GPP and clinician diagnosis were interviewed. During concept elicitation, all participants indicated that pustules may underlie other symptoms. Symptoms reported by all patients were pain, redness, itch, burning, and discomfort. The PSS symptoms of pain, itching, burning, and redness were reported by ≥ 86% of patients as most frequently experienced. Upon debriefing, the PSS was well understood. Relevance and importance of these symptoms was confirmed in the GPP patient workshop. Conclusion: Participant feedback found the PSS measure to be relevant and easy to understand. The symptoms included in the instrument, pain, redness, itch, and burning, were most frequently reported, important, and well understood by patients. Study results provided support for the content validity of the PSS for use as endpoints in GPP clinical trials

The initial clinical interview-can it reduce cancer patients' fear?

A common phenomenon among cancer patients is a fear of cancer recurrence or cancer progression (FOP). The aim of the present study was to analyze whether the oncologist is able to reduce patients' FOP at the initial clinical interview. A prospective, longitudinal study included patients who were consulting private-practice oncologists in Germany for the first time. Recruitment was carried out by 44 members of the Professional Organization of Office-Based Hematologists and Oncologists. In the patient surveys, data on colon cancer patients' perceptions of communications with their oncologist and on patient-reported outcomes were collected over a period of 6 months. The present study analyzed the patients' data before their first consultation (T (0)) and within 3 days after the first consultation (T (1)). A total of 169 patients agreed to participate in the study. Backwards multiple regression analysis was conducted to determine whether the change (T (0)-T (1)) in FOP is associated with demographic, medical, or psychosocial determinants, or with the physician-patient communication. A significant association was found between the change in FOP and interruptions to the conversation, the comprehensibility of the information provided, the extent of perceived empathy from the physician, and the patient's social support and family status. Private social support and the initial medical encounter can help reduce FOP. Particularly, oncologists should ensure that they facilitate the presentation of information in a comprehensible way while avoiding interruptions and that they take particular care of patients with poor social support

Patients' Trust in Physician, Patient Enablement, and Health-Related Quality of Life During Colon Cancer Treatment

In cancer care, where patients and their families experience significant emotional distress and patients have to deal with complex medical information, patient centeredness is an important aspect of quality of care. The aim of this study is to examine the impact of patients' trust in their oncologists and patients' enablement on changes in health-related quality of life of colon cancer patients during follow-up care. We conducted a prospective study in a representative sample of private practices of German oncologists (N = 44). Patients (N = 131) filled out a standardized questionnaire prior to their first consultation (T0), directly after the first consultation (T1) and after two months (T2). Data were analyzed by structural equation modeling. Significant associations were found between trust in physician and changes in physical functioning between T1 and T2, and between trust in physician and patient enablement. Patient enablement is significantly associated with changes in physical functioning between T1 and T2. The results underline the importance of building a close and trustful patient-physician relationship in the oncology encounter. A central mechanism of the association between the quality of the relationship and health outcomes seems to be patient enablement. To enable patients to cope with their situation by making them understand their diagnosis, treatments, and side effects can impact health-related quality of life in physical domains

Patients' Trust in Physician, Patient Enablement, and Health-Related Quality of Life During Colon Cancer Treatment

In cancer care, where patients and their families experience significant emotional distress and patients have to deal with complex medical information, patient centeredness is an important aspect of quality of care. The aim of this study is to examine the impact of patients' trust in their oncologists and patients' enablement on changes in health-related quality of life of colon cancer patients during follow-up care. We conducted a prospective study in a representative sample of private practices of German oncologists (N = 44). Patients (N = 131) filled out a standardized questionnaire prior to their first consultation (T0), directly after the first consultation (T1) and after two months (T2). Data were analyzed by structural equation modeling. Significant associations were found between trust in physician and changes in physical functioning between T1 and T2, and between trust in physician and patient enablement. Patient enablement is significantly associated with changes in physical functioning between T1 and T2. The results underline the importance of building a close and trustful patient-physician relationship in the oncology encounter. A central mechanism of the association between the quality of the relationship and health outcomes seems to be patient enablement. To enable patients to cope with their situation by making them understand their diagnosis, treatments, and side effects can impact health-related quality of life in physical domains

Checklist for the Development and Assessment of Cost-of-Illness Studies

Background Cost-of-illness (CoI) studies are important instruments for estimating the socioeconomic burden of specified diseases. CoI studies provide important information about the cost structure of a disease, the resulting research need, approaches to improve aspects of care and, monetary consequences from different perspectives. This information can be useful for healthcare research and health policy. Due to heterogeneity of available Cost-of-Illness studies, the working group 'Health Economics' of the German Network for Healthcare Research (DNVF) in accordance with the German Society for Health Economics (DGGO) developed an instrument for the planning, conduct and assessment of CoI studies. Methods The checklist was developed based on a systematic literature search of published national and international checklists as well as guidelines and recommendations for development and assessment of CoI studies and health economic evaluations. Structure and subject matter of the generic checklist was designed, approved and, finally, examined in a pretest by the working group. Results Based on the results of the literature search (n = 2 454), 58 articles were used for the identification of relevant criteria for the checklist. With respect to the results of the pretest, 6 dimensions were included in the checklist: (i) general aspects, (ii) identification of resources, (iii) description and quantification of resource consumption, (iv) valuation of resources (v) analysis and presentation of results and (vi) discussion and conclusion. In total, the 6 dimensions were operationalized through 37 items. Conclusion This checklist is an initial approach to improve transparency and understanding of CoI studies in terms of the extent, structure and development of the socioeconomic burden of diseases. The checklist supports the comparability of different studies and facilitates study conception