Preferences of physicians for treatment-related toxicity vs. recurrence in melanoma (GERMELATOX-A): the doctors' perspective.

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.

Women's expectations, preferences and needs in midwifery care - results from the qualitative Midwifery Care (MiCa) study: Childbirth and early parenthood.

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.

Women's needs and expectations in midwifery care - Results from the qualitative MiCa (midwifery care) study. Part 1: Preconception and pregnancy.

Midwifery services play an important role in healthcare provision, birth preparation and prevention. Knowledge on women's expectations, preferences and needs regarding midwifery care is crucial not only for clinical care during preconception and pregnancy and research, but also for educational purposes. This descriptive qualitative study aimed to investigate the expectations, preferences and the needs of women concerning midwifery care in Germany. Experienced researcher team conducted interviews with women who have the desire to get pregnant and online focus groups with women in early and late pregnancy. A purposeful recruitment strategy with maximum variation sampling was applied to reach diversity in the sample regarding age, previous children and socioeconomic background. A total of 26 women participated. In the qualitative content analysis according to Mayring, seven main categories were developed for both preconceptional phase and pregnancy: (a) care by midwife, (b) care by obstetrician, (c) involvement of family, (d) need for information, (e) physical aspects, (f) psychological aspects and (g) orientation in healthcare system. One additional category referenced (h) organisation and bureaucracy in pregnant women. Women appreciated the personalised experience provided by midwives leading to trust and empowerment. Women's experiences with midwifery care varied. They reported contradictory information they received about services and care options. They valued interprofessional cooperation, continuity of care, structured information and personalised counselling. Midwives play an important role in healthcare provision, birth preparation and prevention. In order to depict the care situation quantitatively, to personalise care and to optimise healthcare models, a tool to assess the quality of healthcare and to evaluate women's needs and benefits of midwifery care will be developed based on the findings of this study. From the public health perspective, deficits in the German healthcare system concerning insufficient intra-sectoral communication, time pressure and low remuneration should be resolved in further research steps and policy action.

Goals and benefits in topical treatment for psoriasis: development and pilot validation of a patient-reported outcomes tool, the Patient Benefit Index for Topical Treatment (PBI-TOP).

BACKGROUND: Topical agents are an essential component of psoriasis therapy. OBJECTIVES: To develop a new version of the patient-reported Patient Benefit Index assessing the importance and achievement of treatment goals in topical psoriasis therapy in adult patients (PBI-TOP). METHODS: Through semi-structured interviews, focus groups and free-text questionnaires, patients reported their needs in topical treatment. Based on qualitative content analysis, items were developed by a consensus group and were refined in cognitive debriefing interviews. A pilot validation assessed the PBI-TOP and convergent criteria [Dermatology Life Quality Index (DLQI); Psoriasis Area and Severity Index (PASI); affected Body Surface Area (BSA)]. RESULTS: Thirty patients (26-72 years, mean 47; 60% male) reported various treatment goals relating to the themes 'effectiveness' and 'characteristics of the preparation'. Twenty patients took part in cognitive debriefings (22-84 years, mean 50.6, 50% male). There were 154 patients who participated in the pilot validation (18-85 years, mean 46.9, 63.6% male). An importance-weighted total score on overall effectiveness and three subscales based on exploratory factor analysis were defined: effectiveness on symptoms, effectiveness on quality of life (QoL), and characteristics of the preparation. All scores showed excellent internal consistency (α > 0.9). The global effectiveness score correlated significantly with DLQI (r = -0.41), PASI (r = -0.32) and BSA (r = -0.22). The effectiveness subscales (symptoms; QoL) correlated significantly with DLQI (r = -0.41; -0.32) and PASI (r = -0.27; -0.33). The score on characteristics of the preparation correlated significantly with the DLQI (r = -0.34). CONCLUSIONS: The PBI-TOP showed good feasibility and favourable psychometric characteristics in this pilot validation.

Validation of the Wound-QoL-17 and the Wound-QoL-14 in a European sample of 305 patients with chronic wounds.

The Wound-QoL assesses the impact of chronic wounds on patients' health-related quality of life (HRQoL). A 17-item and a shortened 14-item version are available. The Wound-QoL-17 has been validated for multiple languages. For the Wound-QoL-14, psychometric properties beyond internal consistency were lacking. We aimed to validate both Wound-QoL versions for international samples representing a broad range of European countries, including countries for which validation data had yet been pending. Patients with chronic wounds of any aetiology or location were recruited in Austria, Lithuania, the Netherlands, Poland, Slovakia, Spain, Switzerland and Ukraine. Psychometric properties were determined for both Wound-QoL versions for the overall sample and, if feasible, country-wise. We included 305 patients (age 68.5 years; 52.8% males). Internal consistency was high in both Wound-QoL-17 (Cronbach's α: 0.820-0.933) and Wound-QoL-14 (0.779-0.925). Test-retest reliability was moderate to good (intraclass correlation coefficient: 0.618-0.808). For Wound-QoL-17 and Wound-QoL-14, convergent validity analyses showed highest correlations with global HRQoL rating (r = 0.765; r = 0.751) and DLQI total score (r = 0.684; r = 0.681). Regarding clinical data, correlations were largest with odour (r = -0.371; r = -0.388) and wound size (r = 0.381; r = 0.383). Country-wise results were similar. Both Wound-QoL versions are valid to assess HRQoL of patients with chronic wounds. Due to its psychometric properties and brevity, the Wound-QoL-14 might be preferrable in clinical practice where time is rare. The availability of various language versions allows for the use of this questionnaire in international studies and in clinical practice when foreign language patients are being treated.

How does a chronic wound change a patient's social life? A European survey on social support and social participation.

Chronic wounds can severely limit patient's social life. This cross-sectional study investigated quantitatively social support of patients with chronic wounds, its association with health-related quality of life as well as qualitatively changes in social participation of these patients. Overall, 263 patients from seven countries participated. The most frequent wound class was leg ulcer (49.2%). Results revealed generally high levels of social support (mean global score: 5.5) as measured with the Multidimensional Scale of Perceived Social Support. However, individuals differed considerably (range 1.0-7.0). All dimensions of social support differed by patients' family and living situations (p < 0.001 to p = 0.040) and were positively correlated with generic health-related quality of life (r = 0.136-0.172). Having children, living with others and being in a relationship were significant predictors of having higher global social support. Patients reported great support from family members. Many participants reported no changes in relationships with friends. Wound care managers took an important role and provided additional emotional support. Patients reported a range of discontinued activities. Despite the high overall level of social support, inter-individual differences should be acknowledged. The importance of family carers should be acknowledged to be able to reduce caregiver burden and to ensure high-qualitative wound care.

Development of a Specific Variant of Patient Benefit Index (PBI) Assessing Patient Needs, Goals and Benefits in Rosacea Treatment.

Introduction: Evaluation of patient-reported outcomes including health-related quality of life (HRQoL) and perceived benefits from treatment has become a fundamental component of medical decision-making. Standardized evaluation of treatment benefits in rosacea based on patient preferences is still lacking. Objective: Development and validation of an instrument for recording patient-defined benefits in rosacea therapy based on the Patient Benefit Index (PBI) methodology. Patients and Methods: In an open survey of n = 50 patients, potential benefits of therapy from the patient's perspective were examined. The generated item pool was combined with pre-existing PBI items for other skin conditions and reviewed by an expert panel of dermatologists, psychologists and patients. Items were condensed to n = 25 and converted into a Likert-scaled questionnaire. The validity and feasibility of the resulting Patient Benefit Index for rosacea (PBI-RO) were tested on individuals with rosacea recruited from a German rosacea patient organization. Results: N = 446 patients with rosacea completed the PBI-RO. The internal consistencies measured by Cronbach's alpha were high (Patient Needs Questionnaire [PNQ] 0.94). Mean PBI-RO was 1.9 ± 1.2 (scale from 0 = no benefit to 4 = maximum benefit), 23.5% of the patients experienced a PBI-RO < 1 (no clinically relevant benefit). The PBI-RO correlated with HRQoL, health state, current extent of rosacea lesions and treatment satisfaction. The highest correlation was found between PBI-RO and satisfaction with previous treatment (r = -0.59, p < 0.001); correlation with the extent of rosacea lesions was low (r = 0.16, p < 0.001). Conclusion: The PBI-RO shows satisfying internal consistency and construct validity. It offers the option of a patient-weighted evaluation of the therapeutic benefit of rosacea therapy and may add to more stringent goal orientation in therapy.

Measuring Quality of Life in Hidradenitis Suppurativa: Development and Validation of a Disease-specific Patient-reported Outcome Measure for Practice and Research.

Hidradenitis suppurativa is a chronic disease that disrupts patients' physical and psychological well-being. A disease-specific measure was developed and validated for assessing health-related quality of life in hidradenitis suppurativa. After qualitative item development, the quality of life in hidradenitis suppurativa instrument was tested in 101 patients, applying convergent measures and a usability questionnaire. Descriptive and validation-specific analyses were conducted. There was no ceiling, but moderate floor effects (scores between 0 and 3.13 on a scale of 0-4). Few missing values were observed (21 of 23 items < 5%). Internal consistency was satisfying: 2 subscales with 6 and 16 items were identified (Cronbach's alpha=0.95 and 0.88). The quality of life in hidradenitis suppurativa instrument correlated significantly with all convergent criteria (including change in convergent patient-reported outcomes; p < 0.05) except for Hurley stage (p = 0.490). In conclusion, the quality of life in hidradenitis suppurativa questionnaire is an internally consistent, valid, responsive, and usable instrument to assess quality of life in patients with hidradenitis suppurativa.

Introduction of a Specific Dermatological Rehabilitation Programme for Patients with Chronic Pruritus: A Pilot Study.

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.

Development and validation of a tool for the assessment of benefit from treatment of allergic rhinitis in children and adolescents (PBI-AR-K).

BACKGROUND: Allergic rhinitis (AR) is frequent in children and adolescents and can severely affect their lives. This article describes the development and validation of a questionnaire to assess treatment needs and benefits in children and adolescents, the PBI-AR-K, in a sample of patients receiving grass pollen sublingual immunotherapy. PATIENTS AND METHODS: The PBI-AR-K was developed based on an open survey including children and adolescents and expert consensus between methodologists, patients, and physicians. The PBI-AR-K assesses patient needs before the treatment and perceived benefit during or at the end of a treatment. A weighted benefit score can be calculated ranging from 0 to 4 (4 = highest possible benefit). The validation was conducted in children (5-12 years) and adolescents (13-17 years) receiving sublingual immunotherapy. Subscales were developed based on factor analysis. Psychometric properties of items and scales were assessed with descriptive statistics, internal consistency, and convergent validity. RESULTS: The final PBI-AR-K consists of 19 items. For validation, data from 345 patients (mean age 11.1; 60.9% male; n = 223 children; n = 122 adolescents) was analysed. Factor analyses resulted in four subscales for children and three subscales for adolescents. The items with the highest importance ratings were about choice of leisure activities (mean value in children: 3.5) and about being free of AR symptoms (adolescents: 3.3). The weighted PBI-AR-K scores reflected considerable patient-reported benefit (2.08-2.82) in both children and adolescents. Internal consistency of all scales was good or acceptable. In the children's sample, the global scale and three of four subscales were quite consistently correlated with convergent variables, while the subscale 'treatment burden' was significantly correlated only with change in average impairments due to rhinitis symptoms. The adolescents' sample showed more inconsistent results with only change in rhinitis severity being significantly associate with all subscales. CONCLUSION: The newly developed PBI-AR-K is a reliable and valid questionnaire for use in children; for the use in adolescents, it should be further elaborated.

How important is subjective well-being for patients? A qualitative interview study of people with psoriasis.

PURPOSE: This qualitative study aimed to investigate the importance of subjective well-being (SWB) as an outcome of psoriasis treatment from patient's perspective. We focused on the affective component of SWB as assessed with the Daily Experience Sampling Questionnaire (DESQ), a validated daily diary. METHODS: Semi-structured qualitative telephone interviews were conducted with in-patients of a dermatological rehabilitation clinic, after participants had completed the DESQ for up to seven days to get familiar with the concept of SWB. Patients were asked to reflect on the importance of SWB as treatment goal and on its relative importance as compared with other treatment outcomes. We also addressed whether SWB could be an indirect measure of benefit in that it reflects other important outcomes. Transcripts were analyzed using content analysis. RESULTS: Eleven patients participated (24-63 years, mean 53 years, 8 male, 3 female). Participants uniformly confirmed that changes in SWB reflected treatment benefit. All but one considered SWB to be a central aspect of treatment benefit-either as the most important treatment goal or as an indirect benefit indicator. In particular, participants described positive associations of SWB with other outcomes, such as symptoms. They reported that both the disease and the medical treatment had an impact on their SWB, which was reflected in the DESQ. CONCLUSION: Our findings suggest that SWB is a relevant indicator of treatment benefit for patients with psoriasis. Therefore, SWB measures, such as the DESQ, could be used to operationalize patient-relevant benefit of psoriasis treatment, complementing outcome measures currently used.

The 27-Item Multiple Sclerosis Quality of Life Questionnaire: A New Brief Measure Including Treatment Burden and Work Life.

BACKGROUND: Treatment- and work-related aspects have been neglected in health-related quality of life (HRQOL) measures in multiple sclerosis (MS). We aimed to develop a brief instrument covering all important impairment-, activity-, participation-, and treatment-related aspects for use in research and practice. METHODS: The 27-item Multiple Sclerosis Quality of Life Questionnaire (MS-QLQ27) was developed using open item collection, a multidisciplinary expert panel, and cognitive pretesting. It was evaluated for reliability, construct validity, and responsiveness in 100 patients presenting with relapse (84 at follow-up ~14 days later). Construct validity was analyzed by correlating the MS-QLQ27 with the disease-specific Hamburg Quality of Life Questionnaire in MS (HAQUAMS) and generic HRQOL instruments. The Expanded Disability Status Scale (EDSS) was used to analyze known-groups validity. Responsiveness was determined as the correlation of changes in MS-QLQ27 scores with changes in validation criteria. RESULTS: Internal consistency was high (Cronbach α = 0.94 at baseline and 0.93 at follow-up). Convergent validity was supported by direction and magnitude of associations with disease-specific and generic instruments. Correlations with change in convergent criteria were strong, indicating responsiveness. The HAQUAMS showed the strongest associations with the MS-QLQ27. The MS-QLQ27 showed the highest effect size compared with other patient-reported outcomes and the EDSS. It successfully distinguished between levels of disease severity. CONCLUSIONS: These results indicate that the MS-QLQ27 is a reliable, valid, and highly responsive instrument for assessing HRQOL during relapse evolution in MS. Its advantages are that it is brief yet comprehensive, covering work- and treatment-related aspects not addressed in previous measures.

Development and validation of a disease-specific quality of life questionnaire for patients with peripheral artery disease (QOLPAD).

BACKGROUND: The aim of this study was to develop and validate a short and feasible questionnaire to measure health-related quality of life (HRQoL) in patients with peripheral artery disease (PAD). The content of the new instrument is intended to correspond with the simultaneously developed instrument Patient Benefit Index for PAD (PBI-PAD), which evaluates treatment goals and benefits in this patient group. METHODS: Fifty patients stated their disease burden on free-text questionnaires, which was used by an interdisciplinary expert panel to develop 12 items for the new instrument, named Quality of Life questionnaire for patients with peripheral artery disease (QOLPAD). The validity of the instrument was tested in patients from Germany with PAD stages I to IV who completed the QOLPAD, EuroQol questionnaire (EQ-5D-3L; EuroQol visual analogue scale (EQ VAS)), and Vascular Quality of Life questionnaire (VascuQoL) before (baseline) and three months after (follow-up) treatment. RESULTS: One hundred and three patients were included at baseline (mean age: 68.6 years; 68% male), among whom, 57 provided data at follow-up. Most patients (86.4%) rated the completion of QOLPAD as being easy. Internal consistency was satisfactory, with a Cronbach's alpha of 0.74 (baseline) and 0.84 (follow-up). Convergent validity was indicated by significant correlations with the EQ-5D-3L (baseline: - 0.62; follow-up: - 0.81), EQ VAS (baseline: - 0.44, follow-up: - 0.79), VascuQoL global score (baseline: - 0.77; follow-up: - 0.87), global rating of impairment (baseline: 0.64; follow-up: 0.71), and PAD stage (baseline: 0.40; follow-up: 0.67). Sensitivity to change was confirmed by significant correlations of change in the QOLPAD with changes in convergent criteria; however, the high number of dropouts limits the generalizability of this finding. CONCLUSION: This study provided evidence that the QOLPAD is internally consistent and valid in patients receiving treatment for PAD in Germany.

Psychosocial issues and sleep quality among seafarers: a mixed methods study.

BACKGROUND: Seafarers, especially those working for a prolonged period of time, are exposed to a high number of social, psychological and physical stressors including irregular working hours. AIM: This study aims to identify important aspects of Asian seafarers' psychosocial wellbeing and quality of sleep that could affect safety and health of the seafarers in long voyage tankers. METHODS: In this mixed method study, psychological health issues were investigated through semi-structured interviews with 17 Asian male seafarers. Participants were selected through purposive sampling. In the quantitative phase, 179 seafarers completed the Pittsburgh Sleep Quality Index (PSQI) on sleep quality. RESULTS: From the interviews, three categories consisting of six themes emerged, including sleep abnormalities, inevitable stressors, and lack of social communication. The majority of the seafarers believed that their quality of sleep was affected by their physical work environment and by issues raised by their families. As reasons for stress at sea, they mentioned the nature of the occupation and the psychosocial work environment. Most participants pointed out that lack of social communications had adverse effects on both their work lives on board and their private lives at home. In the quantitative phase, the response rate was 81.4%. Mean PSQI index was 5.9 (SD 2.6 and range from 2 to 14). Sleep impairment was higher in academic than non-academic individuals (p < 0.001). CONCLUSION: Sleep abnormalities and lack of social communication should be considered as modifiable risk factors for seafarers' psychosocial well-being at sea.

Post-traumatic stress disorder and mental health assessment of seafarers working on ocean-going vessels during the COVID-19 pandemic.

BACKGROUND: There are increasing concerns about mental health consequences of the COVID-19 pandemic among seafarers. This study aims to assess the effects of the current global health pandemic on life satisfaction and adverse psychological outcomes among seafarers. METHODS: In this cross-sectional study, 470 multinational seafarers working on board ships of two international shipping companies were assessed. Mental health outcomes were assessed by the general anxiety disorder (GAD-7) questionnaire, post-traumatic stress disorder (PTSD-8) questionnaire, and patient health questionnaire (PHQ-9) depressive severity score. Multivariate logistic regression was used to determine the association of demographic and work-related variables with mental health outcomes. RESULTS: Overall, 439 out of 470 invited seafarers with a mean age of 34.5 (SD: 8.05) years participated in this study (participation rate: 93.4%). The prevalence of anxiety, depressive, and post-traumatic stress symptoms was 12.4, 14.1, and 37.3%, respectively. In the multivariate model, the current vessel's signing duration was directly associated with the odds of depressive and intrusion symptoms. Moreover, the duration of work per week was inversely associated with hyper-vigilance and avoidance. Also, non-officers, compared to officers, experienced significantly lower anxiety and depressive symptoms, hyper-vigilance, and avoidance. CONCLUSION: The present study revealed a high prevalence of mental health problems among seafarers during the COVID-19 pandemic. We recommend that more evidence is generated regarding psychosocial health issues for this vulnerable occupation.

How do dermatologists' personal models inform a patient-centred approach to management: a qualitative study using the example of prescribing a new treatment (Apremilast).

BACKGROUND: The quality of dermatology consultations is partly determined by how clinicians approach patient care. The term 'Personal Models' describes the explanatory frameworks of thoughts, feelings and experiences that drive behaviour. One study found that clinicians' personal models, specifically their beliefs about autonomy and patient self-management, influenced the degree to which clinicians engage patients in shared decision making during consultations. Further research is needed to further explore how clinicians' personal models inform and affect the quality of patient care. OBJECTIVES: To explore how clinicians' personal models inform shared decision making and consultation style in managing people living with psoriasis in the context of a new treatment, Apremilast. METHODS: A framework analysis of qualitative semi-structured telephone interviews with 13 dermatologists from the UK and Germany who participated in a novel medicine trial for psoriasis called APPRECIATE. RESULTS: Two themes were derived from the data. Theme 1, 'personal working models of patient care', comprised two subthemes: 'patient-centredness: a continuum' and 'stereotypes and assumptions'. Theme 2, 'impact of personal working models on patient care', included three subthemes: 'shared decision making: a continuum', 'consultation skills' and 'impact of concerns about Apremilast on prescribing behaviour'. CONCLUSIONS: Although many dermatologists endorsed a patient-centred approach, not all reported working in this way. Clinicians' personal models, their beliefs, stereotypes, personal perceptions and assumptions about patients are likely to affect their prescribing behaviour and shared decision making. Additional specialized training and education could increase patient-centredness and whole-person management.

Psychometric properties of the short version of the Freiburg Life Quality Assessment for chronic venous disease.

BACKGROUND: Chronic venous disease is a frequent vascular condition. International societies have recommended the use of health-related quality of life (HRQoL) instruments in the assessment of patients with vascular diseases. Thus, the Freiburg Life Quality Assessment for chronic venous disease, 10-item questionnaire (FLQA-VS-10) was developed. The aim of the present study was to validate the FLQA-VS-10 in a prospective study. METHODS: We recruited 100 patients with recurrent varicosis or incomplete or complete venous insufficiency undergoing interventional vein treatment (high ligation of the great or small saphenous vein or endovenous ablation therapy). These patients completed the FLQA-VS-10 and instruments assessing convergent validation criteria at four points: preoperatively (T1), postoperatively (T2) and twice 3 years later with a 1-week interval (T3 and T4). RESULTS: The mean age was 56.0 ± 13.7 years, and 66.0% were women. The patients had presented with recurrent varicosis of the saphenofemoral junction (28.0%), recurrent varicosis of the saphenopopliteal junction (1.0%), incomplete or complete insufficiency of the great saphenous vein (69.0%), or complete insufficiency of the small saphenous vein (2.0%). The items showed few missing values. The FLQA-VS-10 global score showed no ceiling effect (patients reporting the highest possible impairments in HRQoL) but did show a floor effect (patients reporting the lowest possible impairments in HRQoL), which was highest at the postoperative assessments. The internal consistency of the global score was high at all measurement points. A convergent validity and responsiveness analysis revealed that the FLQA-VS-10 correlated in the expected direction with the convergent instruments, including the Freiburg Life Quality Assessment for venous diseases (venous disease-specific HRQoL) and the five-level EQ-5D (generic HRQoL). Data from T3 and T4 revealed high test-retest reliability (intraclass correlation, 0.92). Overall, the patients stated that the FLQA-VS-10 was comprehensible, comprehensive, and easy to complete. CONCLUSIONS: Our data suggest that the FLQA-VS-10 is a reliable, valid, responsive, and feasible HRQoL questionnaire for patients with chronic venous diseases. This questionnaire can serve as short and easy-to-use instrument to assess patient-reported outcomes in the treatment of these patients.

Measurement Properties of Patient-Reported Outcome Measures for Pruritus: An Updated Systematic Review.

This systematic review aims to provide an update on measurement properties of patient-reported outcome measures for pruritus. A Medline literature search was conducted to update the systematic review published in this journal in 2017 and to identify new validation studies published between October 2015 and July 2019. The methodological quality of validation studies was assessed on the basis of the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist, and the measurement properties of patient-reported outcome measures were evaluated. A total of 19 new studies were included and added to the 22 studies identified in the previously published review. Evidence from all the 41 studies evaluating 38 different measures was summarized. Outcome measures were mapped to one of three constructs where possible: pruritus intensity, pruritus severity, pruritus-specific health-related QOL. COSMIN rating revealed mixed results, with deficiencies in the methodological quality of many studies across all constructs. The most appropriate pruritus severity measure was the Itch Severity Scale. ItchyQoL and the disease-specific Uremic Pruritus in Dialysis Scale achieved the most promising results considering the construct pruritus-specific health-related QOL. For pruritus intensity, nine measures performed similarly well.

Real-World Experience of Patient-Relevant Benefits and Treatment Satisfaction with Apremilast in Patients with Psoriasis: An Analysis of the APPRECIATE Study.

INTRODUCTION: In the real-world APPRECIATE study (NCT02740218), most patients with psoriasis demonstrated notable improvements on disease severity measures and reported clinically meaningful treatment benefits with apremilast. OBJECTIVE: We aim to further describe patient-relevant needs and benefits and patient satisfaction with apremilast, including subgroup analyses based on patient characteristics. METHODS: APPRECIATE, a multinational, retrospective, cross-sectional study, enrolled patients with chronic plaque psoriasis who started apremilast according to the European label. Patient Benefit Index (PBI; range 0 (no patient-relevant benefit) to 4 (maximum patient-relevant benefit), global PBI score ≥ 1 indicating minimum patient-relevant benefit and ≥ 3 indicating high benefit) and nine-item Treatment Satisfaction Questionnaire for Medication (TSQM-9; range 0-100) were assessed 6 (± 1) months after apremilast initiation and summarized descriptively. Relationships between global PBI and TSQM-9 assessments were analyzed by Pearson correlations. RESULTS: Of 480 enrolled patients, 347 (72.3%) had remained on apremilast at 6 (± 1) months; 90.9% (300/330) achieved global PBI score ≥ 1. Mean (standard deviation) global PBI score was 2.8 (1.2). Higher achievement of global PBI score ≥ 3 was observed in patients with no prior treatments (61.1% (22/36)) or prior phototherapy (64.6% (42/65)) versus prior conventional systemic (54.4% (100/184)) or biologic (38.6% (17/44)) treatment. Strong correlations were observed between the global PBI score and the TSQM-9 global satisfaction and effectiveness subscale scores. CONCLUSION: Patients continuing apremilast for 6 (± 1) months in APPRECIATE reported patient-relevant treatment benefits. Findings suggest that receiving apremilast earlier versus later in treatment management is consistent with greater improvements in patient-relevant treatment outcomes.