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Purpose: Patient-centered health care implies that medical decisions are made jointly by physician and patient, based on patient needs. Aims were to (a) identify treatment goals for a new questionnaire on patient needs and benefits in nail psoriasis treatment; (b) analyze the importance of treatment goals in patients with nail psoriasis in general and in defined subgroups; and (c) determine the association between overall treatment goal importance and quality of life.Methods: The study comprised the following steps: qualitative survey on needs and burdens in 120 patients; development of items by an interdisciplinary expert group; item testing in 55 patients in four countries; revision of the questionnaire and assessment in 203 patients in six countries (Germany, Denmark, Italy, Spain, USA, Japan). The percentage of patients rating the goals as 'quite/very important' was compared between various patient subgroups.Results: Based on 692 free-text statements, 26 items were developed which were reduced to 24 items after pilot testing. Each of these treatment goals applied to the majority of patients in the multi-center study. Goal importance increased with severity of nail psoriasis, but not with age or disease duration. Manual dexterity and social interaction were of particular importance. Goal importance and quality of life were associated, but not redundant (r = 0.612, p < 0.001).Conclusions: Patients with nail psoriasis have manifold and specific treatment goals. Goal importance is a construct different from disease-specific quality of life and should be assessed separately. The new questionnaire can support goal setting in clinical practice. [ABSTRACT FROM AUTHOR]

Chronic wounds are of high socio-economic importance. Accurate and efficient treatment includes the use of outcomes measures in clinical care and in research. To date, consented standards for documentation of chronic wounds, agreements on interpretation of wound outcomes and harmonisation about standardised goal setting in wound treatment are lacking. Objective (1) To establish a national German consensus group for the definition of standards in outcomes measurement of chronic wounds, (2) to agree on recommendations for practice and research based on a continuous decision process, including implementation of the standards. Methods The national consensus group includes delegates from the German scientific medical societies involved in health care for chronic wounds, the national boards on nursing, and the chairs of regional wound networks. Moreover, the roof organisations of the German health insurances, the German ministry of health and further single wound experts were invited. The consensus work is based on a structured decision process. Results The consensus group consists of 58 representatives and co-representatives of 26 societies and organisations. Since 2012, in the regular bi-annual meetings a Delphi-based workflow has been followed starting with standards for documentation and outcomes measurement in patients with leg ulcers. Additionally, web-based decision processes are conducted and the results are presented for finalisation in the face-to-face meetings. The following application areas of particular interests were defined: clinical routine, health services research, clinical research, and health economics. In the meantime, 245 single decisions have been approved. Conclusions Based on a national joint process involving medical societies, nursing groups, German sickness funds and health politics, a continuous decision process on standards for outcomes measurement and interpretation could be established. The Delphi based decision processes showed high levels of participations, thus providing a valid and robust set of standards. First results are in process of approval by the societies. [ABSTRACT FROM AUTHOR]

Background Psoriatic arthritis (PsA) is a chronic, systemic, inflammatory disorder characterized by the association of arthritis with psoriasis. Patients with PsA may have a heterogeneous and variable clinical course. Evidence that affected patients can have significant radiographic joint damage, functional impairment, reduced quality of life and long-term work disability is increasing. Objectives This study aims to determine the prevalence and clinical features of psoriatic arthritis and joint complaints in patients with psoriasis examined in a German national survey. Methods This study is a non-interventional, cross-sectional analysis on 2009 patients with psoriasis from 13 dermatological hospitals and 129 dermatological private practices and outpatient clinics in Germany. Patients showing rheumatological symptoms were further recorded with respect to active arthritis and PsA symptoms according to Group for Research and Assessment of Psoriasis and Psoriatic Arthritis criteria. Results Nineteen per cent of the patients had PsA, including 14.8% previously confirmed and 4.2% newly diagnosed disease. Another 7.7% had intermittent but clinically unspecific joint symptoms, which could not be clearly attributed to PsA. About half (49.7%) of the patients with PsA had at least 1 swollen joint and 84.9% ( n = 287) suffered from joint pain. Patients suffering from pain marked an average of 8.7 joints on a diagram as painful out of a possible 28. The mean number of swollen joints among the affected patients amounted to an average of 6.8. Conclusion Our results show that there is still a significant number of patients suspected of having joint involvement without ever having been diagnosed with PsA. Recently published data indicate that progression of joint damage and functional disability can be prevented if adequate treatment is started promptly. Early diagnosis and interdisciplinary care are thus crucial. Conflicts of interest None declared. [ABSTRACT FROM AUTHOR]

Background: Skin diseases in patients with skin of colour (Fitzpatrick skin types IV to VI) are underrepresented in dermatology training, which may lead to lower quality of care for these patients. To address this underrepresentation in medical education, a newly developed seminar on skin type diversity using an interactive teaching method was implemented in an undergraduate medical curriculum. This study examined the effects of a seminar on the self-assessed competence of medical students in managing skin conditions in patients with skin of colour., Methods: A questionnaire survey was conducted among fourth-year undergraduate medical students at the University of Hamburg (Germany) between October 2023 and February 2024. Students' self-assessed competence was compared before and after the obligatory seminar (pre- and post-design)., Results: In total, 158 students participated in the survey. After the seminar, knowledge of the presentation of skin diseases in patients with skin of colour and the associated psychological burden, differences in the incidence of skin diseases in different skin types, and the ability to diagnose skin diseases in darker skin types increased. Most participants stated that they wanted to attend more courses on this topic., Discussion: Appropriate courses for medical students can improve their competence in managing different skin diseases in patients with skin of colour. In the future, more attention should be paid to teaching the diversity of skin types in dermatology education., (© 2024. The Author(s).)

Introduction: Adjuvant treatment with immune checkpoint inhibitors, such as PD1-antibodies (ICI) ± CTLA4-antibodies (cICI) or targeted therapy with BRAF/MEK inhibitors (TT), has shown a significant improvement in disease-free survival (DFS) for high-risk melanoma patients. However, due to specific side effects, the choice of treatment is often influenced by the risk of toxicity. Therefore, the role of physicians in treatment decisions of patients is crucial. This study investigated for the first time in a multicenter setting the attitudes and preferences of dermatooncologists in Germany and Switzerland regarding adjuvant treatment with (c)ICI and TT., Methods: In the GERMELATOX-A study, 108 physicians (median age: 32 yrs, 67.6% female) from 11 skin cancer centers were surveyed to rate typical side effect scenarios of (c)ICI and TT treatments and then compared to patients' ratings evaluated in a previous analysis from the same centers. The scenarios described mild-to-moderate or severe toxicity and included melanoma relapse leading to death. The physicians were asked about the level of side effects they would tolerate in exchange for a reduction in melanoma relapse and an increase in survival at 5 years., Results: The preferences of physicians and patients revealed significant differences regarding adjuvant melanoma treatment with (c)ICI and TT (p < 0.05). Compared to patients, physicians tend to value a melanoma relapse less severe, according to a visual analog scale. They were also less threatened by all scenarios of side effects during adjuvant treatment with (c)ICI or TT, compared to patients. Physicians required lower risk reductions for disease-free survival (DFS) and overall survival (OS) for both ICI and TT and their drug-related side effects to accept these treatments. In case of severe side effects, physicians required similar 5-year DFS rates for ICI and TT (60-65%), while patients needed a 15% improvement of 5-year DFS for ICI compared to TT (80%/65%). For survival, physicians expected an OS improvement of + 10% for all three treatment modalities, whereas patients required a higher increase: + 18-22% for ICI and + 15% for TT., Conclusion: Our study highlights the importance of understanding the patient's perspective and a potential difference to the doctor's view when making decisions about adjuvant melanoma treatment with (c)ICI and TT, especially as these treatments are increasingly being implemented in earlier stages., (© 2024. The Author(s).)

Objective: The main goals of our study were (I) the investigation of expectations and preferences as well as (II) the determination of needs of women in regard to midwifery care., Design: Descriptive phenomenology was used to investigate the ways in which women experienced childbirth and early parenthood. A descriptive qualitative research design was chosen, using focus groups., Setting: ix online focus groups were carried out with 19 women for this part of the Midwifery Care (MiCa) study, mainly from the north of Germany., Participants: Women shortly after birth, in puerperium and the first year after childbirth were recruited in Germany. A purposeful strategy according to maximum variation sampling was applied to reach diversity in the sample regarding age and previous children. Data were analysed using qualitative content analysis, according to Mayring, with support of the qualitative data analysis software MAXQDA 2022., Findings: Six main categories were derived for both childbirth and early parenthood: (a) involvement of family, (b) need for information, (c) physical and psychological aspects and (d) orientation in the healthcare system. In each group, one main category about provision of healthcare was developed: (e) care around childbirth and (f) midwifery care in early parenthood. Women attached great importance to the communication with midwives and favoured the involvement of their partners in the childbirth process and during parenting. Based on different experiences and inconsistency of information, women would prefer consistency in staff and communication as well as standardised information., Conclusions: From the user's perspective, midwifery care is crucial during childbirth and the child's first year of life. Current health care during and after childbirth and early parenthood lacks individualised care models, emotional support, adequate and professional communication between different health care providers, and consistency in midwifery care. Our findings should be translated into health care delivery with effective interprofessional teamwork within the continuity of midwifery care. Further quantitative research should analyse the individual healthcare situations of women in the reproductive phase of their life as well as of the applied healthcare models in order to personalise care and to improve healthcare quality., Competing Interests: Declaration of competing interest TMJ, NM, JS, CA, ME, and BCZ declare no conflict of interest. CB received grants or contracts to the institution from Amgen/Celgene, AstraZeneca, Bauerfeind, Pfizer, The EuroQol Group; spreaker honoraria from Amgen/Celgene, AstraZeneca, Hartmann, Helios Klinik Leisnig, medi; support for attending meetings and/or travel from AstraZeneca, Hartmann, Helios Klinik Leisnig., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Chronic pruritus is a common symptom, associated with several severe medical conditions, great psychological burden, and reduced quality of life. It also poses socio-economic challenges concerning patients' work loss and healthcare costs. In Germany, medical rehabilitation programmes represent an integral part of the medical care of patients with chronic inflammatory skin diseases. However, such programmes play only a rudimentary role in the treatment of other dermatological diseases, such as dermatological oncology, genetic skin diseases, and chronic pruritus. Therefore, a specific antipruritic dermatological rehabilitation programme was developed in cooperation between the Department of Dermatology of the Medical Rehabilitation Center Bad Bentheim and the Center for Chronic Pruritus of the University Hospital of Muenster, Germany. This prospective study compared short-term patient-reported outcomes (n = 121) at the beginning and end of the rehabilitation programme. The majority of subjects had chronic pruritus on primary diseased, inflamed skin. Significant improvements in pruritus intensity (p ≤ 0.001), quality of life (p ≤ 0.001), anxiety symptoms (p ≤ 0.001) and depression (p ≤ 0.001), as well as an overall patient-relevant benefit (Patient Benefit Index 2.6 ± 1.06) and treatment-related patients' satisfaction, were shown. This suggests that implementation of this standardized rehabilitation programme for treatment of patients with chronic pruritus was successful.

Background: Chronic pruritus (CP) is a subjective symptom, and it is necessary to assess its intensity with validated patient-reported outcome tools in order to allow determination of the treatment course., Objectives: So far, the itch intensity scales were validated in small cohorts and in single languages. Here, we report the validation of the numerical rating scale, the verbal rating scale and the visual analogue scale for the worst and average pruritus intensity in the last 24h in several languages across Europe and across different pruritic dermatoses., Methods: After professional translation, the intensity scales were digitized for use as a tablet computer application. Validation was performed in clinics for Dermatology in Austria, France, Germany, Italy, Poland, Russia, Spain, Switzerland and Turkey., Results: A total of 547 patients with contact dermatitis, chronic nodular prurigo, psoriasis vulgaris, lichen planus or cutaneous T-cell lymphoma were included. The intensity scales showed a high level of reproducibility and inter-correlations with each other. The correlation with the Dermatology Life Quality Index was weak to strong in nearly all countries and dermatoses with the exception of France and patients with chronic nodular prurigo, for which no statistically significant correlations were found., Conclusions: The numerical rating scale, the verbal rating scale und the visual analogue scales are valid instruments with good reproducibility and internal consistency in German (Germany, Austria, Switzerland), French, Italian, Polish, Russian, Spanish and Turkish for different pruritic dermatoses. VAS worst was the best reproducible and consistent measuring instrument in all countries., (© 2021 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Objectives: To validate the newly developed Daily Experience Sampling Questionnaire (DESQ) that measures affective subjective well-being (SWB). The DESQ is an end-of-day diary in which respondents retrospectively rate their SWB at six different, randomly determined moments; it is completed over 1 week. The DESQ shall provide an alternative or complementary approach to existing methods of near-time SWB measurement (experience sampling, Day Reconstruction Method). The primary research objective was to determine criterion validity of the DESQ., Design: Prospective, non-interventional study., Setting: Participants were recruited in Hamburg, Germany, at a specialised outpatient clinic (patients) and via different channels (healthy participants)., Participants: 101 adults with diagnosed and stable psoriasis (46 women, 55 men); 105 adults without psoriasis (49 women, 56 men)., Primary and Secondary Outcome Measures: Participants completed the DESQ for 3 weeks. In weeks 2 and 3, they also performed experience sampling. Criterion validity was determined by weekwise intraclass correlations (ICC) between both methods. Sensitivity to change was determined by the correlation between changes in both methods from weeks 2 to 3. For convergent validity, related concepts such as life satisfaction were measured. Retest reliability was determined using DESQ values of weeks 2 and 3., Results: Criterion validity was excellent (ICC: patients=0.86, 95% CI 0.81 to 0.91; healthy participants=0.86, 95% CI 0.79 to 0.91). Sensitivity to change was r=0.57 and r=0.56, respectively. Correlations with convergent criteria were mostly significant and higher in constructs more proximal to SWB. The ICC indicating retest reliability was 0.77 in patients (95% CI 0.68 to 0.84) and 0.81 in healthy participants (95% CI 0.73 to 0.86)., Conclusions: The DESQ is a valid, reliable and feasible instrument for SWB measurement in people with psoriasis and healthy people. Its approach of end-of-day evaluations of single moments may also lend itself to the measurement of other highly time-variant constructs such as pain, fatigue or depression., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

People with chronic wounds perceive an impaired health-related quality of life (HRQoL). For the assessment of HRQoL, valid instruments are needed. Therefore, the Wound-QoL questionnaire was originally developed and psychometrically validated for use in Germany. As the Wound-QoL is to be used in numerous countries, international versions are required. Therefore, this study aimed to psychometrically validate the U.S. English Wound-QoL version. Upon translation into U.S. English, psychometric testing was performed based on cross-sectional data deriving from the U.S. Wound Registry. Besides descriptive statistics, internal consistency and concurrent validity were tested. In addition, a graded response model was used. The sample consisted of 599 people with chronic wounds of different etiologies. Participants were between 18 and 95 years old, mean age was 63.7 (SD = 15.9) years. Gender was distributed almost equally, with 47.4% female patients. High internal consistency, low floor and ceiling effects of the subscales could be largely confirmed. The internal consistency of the global score was excellent, with α > .9. Concurrent validity between the Wound-QoL and pain, the surface area of the largest wound, total surface area, and total number of active wounds could be confirmed. In contrast, item response theory (IRT) analyses could not fully confirm the factorial model underlying the Wound-QoL subscales. Furthermore, the items regarding smell and discharge and the items on problems with hitting the wound against something, climbing stairs and feeling dependent on help from others showed a low item information in their belonging dimensions. In conclusion, the newly validated Wound-QoL is available for HRQoL measurement in people with chronic wounds in the United States. It showed good psychometric properties, demonstrating its reliability and validity. Therefore, the instrument may be used to assess HRQoL in clinical practice. However, IRT analyses showed that the instrument may benefit from future refinement., (© 2020 The Authors. Wound Repair and Regeneration published by Wiley Periodicals LLC on behalf of by the Wound Healing Society.)

Introduction: Sublingual immunotherapy (SLIT) with birch pollen extract has been shown to be an efficacious treatment of allergic rhinitis (AR). An as-yet unanswered question is whether and how clinical benefit translates into patient benefit, i.e. what benefit patients derive from this treatment., Methods: This 1-year, open, prospective, multicenter, non-interventional study conducted in 75 German centers measured patient-relevant benefit of birch pollen SLIT (Staloral ® Birch) using the questionnaire "Patient Benefit Index for Allergic Rhinitis (PBI-AR)". At treatment onset, patients rated the importance of 25 treatment needs; after the first birch pollen season on treatment, goal achievement was evaluated. A preference-weighted benefit index was calculated and its association with gender, asthma, allergy status, and severity of AR symptoms was determined., Results: Mean age of the 291 adult patients was 38.8 years; 58.4% were female. The most important treatment goals were to "be able to stay outdoors without symptoms" (87.3% quite or very important), "no longer have a runny or stuffed-up nose" (86.9%), and "be able to breathe through your nose more freely" (86.9%). The treatment goals with the highest benefit ratings (referring to those patients to whom the respective goal applied) were to "have confidence in the therapy" (60.5% has helped "quite" or "very much"), "have an easily applicable treatment" (55.6%), and "be able to breathe through my nose more freely" (51.7%). The average PBI-AR global score was 2.19 (SD 1.04) (0-4; with 4 indicating maximum benefit). No significant differences in PBI-AR global score or subscales were found between men and women, poly- and monoallergic patients, or patients with severe versus mild rhinoconjunctivitis. Patients with asthma reported relevant but lower benefit than patients without asthma., Conclusion: After 1 year of birch pollen SLIT treatment, patients reported considerable benefit, mainly due to a reduction of physical symptoms and treatment burden.

Objective: This study aimed to quantify recall bias in the measurement of health-related quality of life (HRQoL), that is, the extent to which recollection is impaired and leads to distorted judgements., Design: Prospective observational study., Setting and Participants: One hundred patients with two paradigmatic chronic diseases (50 with multiple sclerosis and 50 with psoriasis) were recruited at two outpatient clinics., Methods and Outcome Measures: Patients completed the online version of the 12-Item Short Form Survey (SF-12) repeatedly for 28 consecutive days: (1) daily, considering the past 24 hours; (2) weekly, considering the past 7 days; and (3) on the last day of data collection, considering the past 4 weeks. SF-12 scores for all three measurement approaches were subsequently converted into preference-based utility indices (Short-Form Six-Dimension). Agreement of the three indices was analysed on group and individual patient levels., Results: The mean age of participants was 40.3 years (±12.0), and 63% were female. The utility index based on daily recall (0.74±0.13) was more positive than indices based on a weekly (0.70±0.13, p<0.001) or a monthly (0.70±0.14, p<0.001) recall. While agreement of measurement approaches was high on group level (intraclass correlation coefficient>0.85), it was lower for the subgroup of patients experiencing high variability of HRQoL over time. Bland-Altman plots revealed considerable differences on individual patient level., Conclusions: On the group level, retrospective overestimation and underestimation of HRQoL almost cancelled out one another and recall bias was relatively small. Therefore, a 4-week recall period could be appropriate when group-level data are used for research or economic evaluations. In contrast, recall bias can be considerable on the individual patient level and may thus impact decision-making in clinical practice., Trial Registration Number: VfD&#95;RECALL&#95;16&#95;003837., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Though patient needs are key drivers of treatment decisions, they are rarely systematically investigated in routine care., Objective: This study aimed at analysing needs and expectations from the patient perspective in the German and Swiss psoriasis registries PsoBest and Swiss Dermatology Network of Targeted Therapies (SDNTT) with respect to treatment choice, age and gender., Methods: The German and Swiss psoriasis registries observe patients recruited at first-time use of systemic drugs. Within 10 years, clinical [Psoriasis Area Severity Index (PASI), Body Surface Area (BSA)] and patient-reported outcomes are documented, including the Dermatology Quality of Life Index (DLQI) and the Patient Benefit Index (PBI), characterizing patient needs for treatment. The analysis data set includes n = 4894 patients from PsoBest and n = 449 from SDNTT with mean follow-up time of 7.5 months., Results: A total of 5343 patients registered between 2008 and 2016 were included in the analyses (at baseline: 59.6% male, mean age 47.6 years ± 14.5, PASI 14.2 ± 9.7, BSA 22.7 ± 19.7, DLQI 11.3 ± 7.2). The most important patient needs were to 'get better skin quickly' and to 'be healed of all skin defects'. Subgroup analyses by age revealed significant differences in needs, especially higher needs regarding social impairments in patients younger than 65 years. Patients 65 years or older attributed more importance to sleep quality, less dependency on medical visits, fewer side-effects and confidence in the therapy. Out of 25 items reflecting patient needs, 20 items were rated significantly more important by women than men, with the greatest differences regarding feeling of depression, sleep quality and everyday productivity. Divided by treatment, needs were rated differently, recommending individualized and targeted choice of therapy., Conclusion: Age and gender stratify patient needs. Women showed higher expectations and rated specific needs in psoriasis treatment higher than men. Analysing the patient needs on an individual level will facilitate shared decisions by patient and physician in finding the optimal personalized treatment., (© 2018 European Academy of Dermatology and Venereology.)

This study investigated the validity and feasibility of the Patient Benefit Index 2.0 (PBI 2.0), a short instrument to assess patient-relevant treatment benefit. In a cross-sectional study, patients with skin diseases completed the PBI 2.0 alongside instruments on quality of life and disease-specific PBI long versions to assess convergent validity. Feasibility questions appraise comprehensibility, completeness, length, and readability. Data from a longitudinal study were used to explore responsiveness and test-retest reliability. Most patients rated the PBI 2.0 easy to understand, complete, legible, and not too long. The amount of missing values was overall low. In all groups, except for vitiligo, correlation analyses indicated good convergent validity of PBI 2.0. Responsiveness of the PBI 2.0 could not be clearly confirmed. Retest-reliability achieved satisfactory results. Thus, the PBI 2.0 may be a suitable instrument for its use in different skin diseases. Its broad applicability allows for comparisons across diagnosis groups.

Background: Chronic lymphoedema (CLE) is a burdensome disease of multiple causes leading to significant reductions in health-related quality of life (HRQoL). A specific method to assess HRQoL is the Freiburg Life Quality Assessment for lymphoedema (FLQA-L), which consists of 92 items., Objectives: To develop and validate a short form of the FLQA-L with improved psychometric properties and feasibility., Methods: The FLQA-L validation data were reanalysed by patients and experts. The application of factor analysis enabled the exclusion of lower-load items. An optimized short version of the questionnaire (FLQA-LS) with 33 items was generated and tested in a validation study on patients with different forms of CLE., Results: In total, 348 patients with CLE of the upper or lower extremities were included (mean age 57.3 years, range 24-89; 90.8% female), and data from 301 patients could be analysed. Overall, 42.8% of the patients had secondary lymphoedema, 23.6% had primary lymphoedema, 9.5% had lipoedema and 24.1% had lipolymphoedema. The lower extremities were mostly affected (64.4% of the patients presented with leg involvement and 17.5% with both arm and leg impairment). The FLQA-LS showed good internal consistency, with high Cronbach's alpha in the subscales and in the global scale ranging between 0.79 and 0.94. Regarding convergent validity, a good correlation was found with the general HRQoL questionnaire EQ-5D (r = 0.72, P < 0.001)., Conclusions: FLQA-LS is an improved version of the FLQA-L questionnaire for chronic lymphoedema. It demonstrated validity and feasibility and can be easily used in clinical practice and research studies., (© 2018 British Association of Dermatologists.)

Lymphedema is a complex and burdensome medical problem and requires continuous specific therapy. The aim of this cross-sectional study of community lymphedema care in the metropolitan area of Hamburg, Germany, was to evaluate health-related quality of life (QoL) in lymphedema patients. Generic as well as disease-specific health-related QoL was assessed using EQ-5D and FLQA-LK, respectively. Pain was assessed using a visual analogue scale (VAS). About 301 patients (median age of 60.5 years, 90.8% female) with lymphedema of any origin were included. About 66.4% had lymphedema, 24.1% combined lipolymphedema, and 9.5% lipoedema. Mean disease-specific QoL (FLQA-LK) was 2.4 (range 0 = no to 4 = maximum burden). The highest impairment values were observed in subscales for physical complaints, everyday life, and emotional well-being. Mean EQ-5D VAS was 70.4, mean EQ-5D score 63.3. Lymphedema was associated with major impairments in QoL, which differed for subgroups of pain, clinical severity, and comorbidity. Pain as a common problem for lymphedema patients seemed to be underestimated and undertreated. Early diagnosis and structured treatment strategies are urgently needed., (© 2017 by the Wound Healing Society.)

Currently interferon alfa-2b (IFNα-2b) is an approved adjuvant drug for high-risk melanoma patients that leads to an improvement in disease-free survival (DFS). However, it is unclear whether it also impacts overall survival. Widespread use of adjuvant high-dose IFNα has been tempered by its significant toxicity and its limited efficacy. Current therapeutic strategies like immune checkpoint blockade or targeted therapy may also be useful in the adjuvant setting. Therefore, it is important to weigh the trade-offs between possible side effects and therapeutic benefit.We assessed patient utilities for health states associated with IFN therapy. Utilities are measures of preference for a specific health state on a scale of 0 (death) to 1 (perfect health).Utilities were determined for health states associated with adjuvant IFN among 130 German low-risk melanoma patients using the standard gamble technique. Four IFNα-2b toxicity scenarios and the following 3 posttreatment outcomes were assessed: disease-free health and melanoma recurrence (with or without previous use of IFNα-2b) resulting in cancer death. Patients were asked to trade-off the improvement in 5-year DFS and the IFN-related side effects.Utilities for melanoma recurrence (mean 0.60) were significantly lower than for all IFNα-2b toxicity scenarios (mean 0.81-0.90). Patients were willing to tolerate mild-to-moderate and severe toxicity for a 50% and 75% chance of 5-year DFS, respectively. Both utilities and threshold benefits were mostly independent from patient characteristics like gender, income, and social situation. Significant impact was only observed by age and previous personal experience with cancer.On average, German patients were willing to trade even severe IFNα-2b toxicity for reducing the rate of melanoma recurrence. This result points out the importance of a relapse-free survival for melanoma patients. The utilities measured in our study can be applied to decision-making processes in clinical trials of new adjuvant drugs., Competing Interests: The authors report no conflicts of interest.

Health-related quality of life has not only been established as an important patient-reported outcome measure in patient care but has been defined as an evaluation criterion for therapies in the German Code of Social Law as well as in the guidelines of the American Food and Drug Administration and of the European Medicines Agency (EMA). Quality of life can be measured in a standardised manner. Validated questionnaires are available for recording specific problems of patients with, for example, skin diseases. Measuring quality of life has not yet been implemented into daily dermatological routine, although (1) studies have confirmed that the measurement of quality of life offers major benefits for the treatment of skin diseases, and (2) first experiences in implementing quality of life measurement into practice have been positive. The further implementation of systemically measuring quality of life requires advancements in automated measurement and the assumption of cost by social health insurances.

Background: According to German law, health-related quality of life is a relevant criterion in the early assessment of the benefits of drug treatment. In spite of its regulatory importance, the role of quality of life assessment in quantifying the additional benefits of novel vs standard treatments is not yet clear., Objectives: The paper is aimed at analyzing the theoretical foundation, the methodological foundation, and the empirical evaluation of the criterion "quality of life" in recent benefit dossiers, as published by the Federal Joint Committee (G-BA) and the German Institute for Quality and Efficiency in Health Care (IQWiG)., Materials and Methods: Benefit dossiers assessed by the end of 2013 were quantitatively analyzed regarding the choice, frequency of use, and consequences of quality of life assessment., Results: In 59 of the 66 dossiers quality of life assessment was performed, frequently using the EQ-5D (n = 16 procedures) and the SF-36 (n = 8 procedures). Of the 107 evaluations of the subpopulation within these 59 dossiers, in only 2 cases was an additional benefit due to the quality of life declared by the IQWiG and G-BA., Conclusions: In spite of the acceptance of quality of life measures and their inclusion in the dossiers, they have rarely been the basis for the declaration of additional benefits. This reluctance does not stem from the availability of instruments, but results from problems in their selection, the design and conduct of the study, data interpretation, together with shortcomings regarding the statistical and clinical significance of quality of life data.

Background: Clinical experience indicates that edema often remain undiagnosed. The aim of this study was to examine how much time passes between important events in the 'patient journey' and what predicts delayed consultation and diagnosis., Patients and Methods: 65 patients with secondary arm lymphedema and 161 patients with primary or secondary leg lymphedema were interviewed. The following latency times were computed: the time between (1) first symptoms and first visit to physician; (2) visit of physician and diagnosis; (3) diagnosis and lymph drainage therapy; (4) diagnosis and compression therapy. Associations of latency times with patient and clinical characteristics were analysed using t tests and multivariate linear regression., Results: All arm edema patients had consulted a physician in the year after first symptoms at the latest, and everyone except two received the diagnosis in the following year at the latest. For secondary leg edema, the average latency until physician consultation was also short with 0.5 ± 1.8 years, and latency until diagnosis was 1.7 ± 3.8 years. In contrast, latencies in primary leg edema were significantly longer: The average time between first symptoms and physician consultation was 5.2 ± 11.0 years, and edema diagnosis was made after further 6.7 ± 11.4 years. On average, it took 13.5 years from first symptoms to lymph drainage therapy in these patients and 13.7 years until compression therapy. Predictors of late consultation and late diagnosis in primary leg edema were age < 40, positive family anamnesis, and female gender., Conclusions: Primary leg lymphedema is diagnosed late in many cases, especially in younger women.

Background: Psoriasis vulgaris is a common disease that follows a chronic course. So far, few studies have addressed outcome methods which evaluate the benefits of drugs and medical devices by measuring patient preferences., Objective: Assessment of patients' outcomes using the "Patient benefit index" (PBI), a validated goal attainment scaling tool, in the treatment of psoriasis. Data were obtained within an epidemiological study in 2,009 patients with psoriasis vulgaris and/or psoriatic arthritis., Methods: Cross-sectional study in 133 nationwide German dermatological practices and hospital departments. The following were recorded a) in the doctors' questionnaire--previous treatments and diseases, clinical characteristics and psoriasis area and severity index (PASI), b) in the patients' questionnaire--quality of life (LQ), patient-relevant therapeutic benefits and satisfaction with care., Results: On average, patients achieved a total PBI of 2.5±1.1. 86.7% of patients showed a more than minimum benefit (PBI>1). Patients treated with biologicals had a higher benefit (mean PBI 3.0) than patients in other groups (e.g. PBI 2.6 in systemics)., Conclusion: PBI values indicate that systemic agents and biologics are of high therapeutic benefit to the vast majority of patients. The development of the PBI has enabled a decisive step to be taken in the area of scientifically-based outcome assessments.

Background: The management of lymphoedema is complex and should be based on guidelines. To date, no data assessing quality of care in lymphoedema in Germany are available., Objective: We aimed at evaluating the quality of care of lymphoedema in the metropolitan area of Hamburg using guideline-based indicators., Methods: Cross-sectional, community-based study including patients with lymphoedema. Assessment included a structured interview, clinical examination and patient-reported outcomes. Quality indicators derived from guidelines by a Delphi consensus were applied., Results: 348 patients (median age 60.5 years) with lymphoedema (66.4%), lipoedema (9.5%) or combined oedema (24.1%) were included. 86.4% performed compression therapy, 85.6% received lymphatic drainage. On average 55.0% of the quality of care criteria were met; 64.8% were satisfied with care. The distribution curve of the health care index was almost normal. Treatment by specialists led to a higher quality of care index., Conclusion: Although overall quality of care in lymphoedema is fair, many patients are not treated properly according to guidelines., (Copyright © 2013 S. Karger AG, Basel.)

Background: In 2008, routine skin cancer screening (rSCS) was introduced into routine care for persons ≥35 years in Germany. To date, about 95% of approximately 3,500 office-based dermatologists participate in this program paid by the statutory health insurances., Objective: To evaluate German rSCS from the dermatologists' perspective., Methods: Since 2009, every year standardized questionnaires were sent nationwide to about 2,000 dermatologists, once yearly addressing the actual patients, screenings and treatments, the personal experiences and the dermatologists' attitudes towards rSCS. Descriptive data analysis from 2009, 2010 and 2011 was performed., Results: The average dermatologist -performed 1,380/1,364/1,348 screenings annually (2009/ 2010/2011), with a mean remuneration of EUR 21.50/22.10/ 21.93. 32.9/46.6/53.3% of the dermatologists were rather or very satisfied with rSCS, and a rising number of dermatologists (69.4/80.0/83.1%) perceived a better quality of health care for skin cancer since 2008., Conclusion: rSCS is widely accepted by German dermatologists and is conducted with increasing frequency., (Copyright © 2013 S. Karger AG, Basel.)

Assessing therapeutic benefit of any drug and medical device is essential in registration and cost reimbursement decisions in Germany and in many nations. In this study, a method for the assessment of patient-relevant benefits in wound therapy was developed and validated. A total of 83 items on treatment benefit from the patients' perspective were collected in an open survey, including n = 50 patients with chronic wounds. The item pool was compiled to a list of 22 items by an interdisciplinary panel of experts including patients. The item list is presented prior to therapy to assess patient-relevant treatment needs and during or after therapy to establish if benefits have been attained. A weighed patient benefit index (PBI) is calculated from the items of both questionnaires. The instrument was examined for practical feasibility, reliability, and validity in a prospective study involving n = 172 patients with acute or chronic wounds treated by vacuum-assisted therapy. Validation criteria were: change in generic and disease-specific quality of life; judgment of efficacy by patients and physicians; treatment satisfaction; patients' willingness to recommend the therapy to others. Construct validity was given for all criteria applied. Cronbach's alpha was 0.88. The instrument was well-accepted by patients and rated relevant for the assessment of benefit in wound treatment., (© 2011 by the Wound Healing Society.)

Background: Leg ulcers have a major socio-economic impact because of their frequency and societal costs. Patients with leg ulcers experience major Health related Quality of Life (HrQoL) impairments. The aim of the present study was to assess the disease-specific HrQoL and the influence of care on HrQoL with leg ulcer., Patients and Methods: A cross-sectional study was conducted in the metropolitan area of Hamburg to assess the quality of care as well as HrQoL in an unrestricted sample of patients with leg ulcers by questionnaires and subsequent clinical examinations., Results: A total of 530 patients were consecutively recruited across all wound care provider sections in the metropolitan area of Hamburg. 53 % of the patients were highly or very satisfied with the health services provided. Significant correlations were found between the disease-specific HrQoL, patient satisfaction and satisfaction with wound treatment. Furthermore, significant predictors of HrQoL were: inadequate pain therapy, insurance status, wound size, time required for dressing changes and wound etiology. Most relevant predictors for satisfaction with health services were: HrQoL, duration of wound, health insurance status and treatment by office-based physicians. In contrast, no statistically significant association with HrQoL and satisfaction was found for gender, living district, education, number of dressing changes per week and the number of comorbidities., Conclusions: The results show that chronic leg ulceration has a major impact on patients HrQoL. Clinical and treatment characteristics, but not socio-demographic data, were predictors of HrQoL and satisfaction with health services. The systematic assessment of HrQoL in patients with leg ulcers across all sectors of health-care is a novum and provides important insights into the reality and quality of care.

Many patients with chronic wounds suffer not only directly from their wounds but also from high financial, social and psychological impairments, significantly reducing their quality of life. In order to provide an instrument both applicable to different patient populations and sensitive to areas of impact specific to certain skin diseases, the modular instrument 'Freiburg Life Quality Assessment' has been developed. Each disease-specific version of the instrument consists of a core module of generic items and items specific for a distinct skin disease. Objective of the study was to assess reliability, sensitivity to change, and validity of the module for chronic ulcers. The instrument was implemented in a longitudinal observational study on vacuum-seal therapy (n = 175), in a cross-sectional observational study involving patients with chronic leg ulcers (n = 384) and in a randomised clinical trial on keratinocyte transplantation (n = 198). The instrument showed good internal consistency (Cronbach's alpha ≥0·85). There were minor floor effects ≤4·3%, but no ceiling effects. Retest-reliability and convergent validity with the EuroQol quality of life questionnaire (EQ-5D) (visual analogue scale) were satisfactory. Change scores correlated with change in other quality-of-life instruments (r = 0·59-0·61), but not with change in wound status., (© 2010 The Authors. Journal Compilation © 2010 Blackwell Publishing Ltd and Medicalhelplines.com Inc.)

Background: Although nail psoriasis affects a marked proportion of patients with psoriasis and causes significant psychological stress, only few epidemiological data characterizing patients with nail involvement are available., Objectives: To gain robust data on the epidemiology and disease burden of nail psoriasis in Germany., Methods: Two nationwide, noninterventional, cross-sectional studies on psoriasis health care were conducted in 2005 and 2007, involving 48 (2005) and 130 (2007) German office-based and clinic-based dermatological centres. Data of n=3531 patients with psoriasis were collected using standardized questionnaires and physical examinations by trained dermatologists. Patients with nail psoriasis were compared with patients without any nail involvement concerning sex, age, disease duration, family history, disease severity, presence of psoriatic arthritis (PsA), health-related quality of life (HRQoL), number of inpatient therapies, and days off work., Results: Nail psoriasis was diagnosed in 40·9% of the patients; prevalence was 11·2 percentage points higher in men than in women. Patients with nail involvement had a longer disease duration (21·9 vs. 18·1 years), higher disease severity (mean Psoriasis Area and Severity Index 12·7 vs. 9·3), higher frequency of PsA (26·0% vs. 12·7%), stronger impairment of HRQoL (mean Dermatology Life Quality Index 8·9 vs. 7·3), and a 2·5-fold higher rate of inpatient treatments., Conclusions: Nail involvement is a relevant manifestation of psoriasis and is associated with a higher disease severity and quality of life impairment. Accordingly, management of psoriasis should include a special focus on nail involvement., (© 2010 The Authors. Journal Compilation © 2010 British Association of Dermatologists.)

Background: Two national surveys conducted in 2005 and 2007 indicated deficits in psoriasis care in Germany, although there has been a notable nationwide improvement within this period. It remained unclear whether regional differences in psoriasis health care have an influence on patient outcomes in Germany., Aim: Assessment of regional differences in the health care situation of patient with psoriasis in Germany., Patients and Methods: Nation-wide cross-sectional study in 130 dermatological practices and clinics. Regional classification was based on the affiliation to the Associations of Statutory Health Insurance Physicians. A panel of experts developed eight criteria as indicators of quality of care, among them clinical characteristics and severity of psoriasis (PASI), previous treatments, quality of life and patient-relevant therapeutic benefits., Results: Care indicators showed marked regional differences. The proportion of patients with preceding systemic or biologic treatment varied between regions. Those regions with high proportions had better results in patient-reported outcomes., Conclusions: Differences in economic and regulatory conditions of health care might account for the observed regional variations. Thus, further analyses of these factors are of great importance to assure consistent psoriasis health care in Germany.

Background: Pruritus is a frequent symptom in many diseases; its prevalence in German adults is unknown., Objective: Our purpose was to assess the prevalence, severity and health care of chronic pruritus in the German working population., Methods: A cross-sectional observational study was conducted in employees of 144 German companies. Pruritus-specific data were obtained by standardized questions., Results: 11,730 people (53.2% male, 16-70 years, mean = 43.7 years) were suitable for analysis. The point prevalence of chronic pruritus (at least 6 weeks prior to data collection) was 16.8%. The prevalence increased with age from 12.3% (16-30 years) to 20.3% (61-70 years). A quarter of the affected persons had suffered from pruritus for >5 years, 47% had never sought medical advice, and 94% had not undergone any treatment., Conclusions: Chronic pruritus is a prevalent symptom in the working age population. A high proportion of people affected are not medically treated., (Copyright © 2010 S. Karger AG, Basel.)

Background: The assessment of patient-relevant treatment benefit gains importance in treatment evaluation. The 'Patient Benefit Index' (PBI) is a validated instrument for the assessment of such benefits in patients with skin diseases. Patients rate the importance of specific treatment needs before treatment and benefits achieved after treatment. To date, no specific instrument for chronic hand eczema (CHE) has been published., Objectives: Development and validation of a specific PBI for treatment evaluation in patients with CHE., Methods: Items reflecting disease burden and treatment needs were collected in 20 patients with CHE. Relevant items were selected by an expert panel of dermatologists, psychologists, and patients. The resulting 'Patient Benefit Index for chronic hand eczema' (PBI-HE) was validated in an open label treatment study with alitretinoin in n = 249 patients., Results: Cronbach's alpha was 0.93. High convergent validity was demonstrated for clinical improvement and treatment success (Spearman r = 0.60-0.78, P < 0.001); 84.3% of patients reached a PBI >or= 1, indicating more than minimum patient-relevant benefit of alitretinoin. Feasibility was high, with a rate of missing data < 1%., Conclusions: The PBI-HE is a feasible, reliable, and valid instrument for the assessment of patient-relevant treatment benefits in CHE.

Background: To date, no standardised indicators for quality of care in psoriasis have been published., Aims: Development and testing of evidence-based indicators of quality of care and guideline compliance in the treatment of psoriasis., Methods: Indicators of process and outcome quality were extracted and evaluated in a Delphi process according to international standards. The primary reference was the S3 German guideline for psoriasis treatment. The indicators were validated with data from two nationwide studies on psoriasis care involving 1,511 and 2,009 patients., Results: Eight quality indicators were defined: mean PASI, mean quality of life (Dermatology Life Quality Index; DLQI), proportion of patients with PASI >20, with DLQI >10, with previous systemic treatment, with PASI >20 and systemic treatment, with inpatient treatment, and number of work days lost. All indicators proved suitable for application, and were sensitive to change., Conclusions: Guideline-based indicators of quality of care are useful in the analysis of health care and the implementation of treatment guidelines in psoriasis., (2009 S. Karger AG, Basel.)