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.

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.

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.

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 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.

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.

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.

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.

Assessing the quality of life of people with chronic wounds by using the cross-culturally valid and revised Wound-QoL questionnaire.

The Wound-QoL is an often used reliable and valid measure, originally developed in Germany. It has been sequentially translated and validated for other languages/countries, for the measurement of health-related quality of life (HRQoL) in patients with chronic wounds. However, a study from the United States postulated its benefits from further adaptations. Furthermore, some patients struggled to provide an answer for some of the items. We aimed to test the cross-cultural structure and psychometric performance of the questionnaire to suggest necessary revisions. This cross-sectional analysis of existing data sets included 1185 patients from Germany, the US, the Netherlands, Spain, Sweden, and Israel. Patients in the U.S. Wound Registry completed the Wound-QoL during routine care. Different studies comprised the data collection in the other countries. Almost half of the patients were women (48.4%). Furthermore, 42.6% were diagnosed with leg ulcers. Their average age was 66 years. We used a confirmatory factor analysis and an unconstrained graded response model. We revised and shortened the Wound-QoL from 17 to 14 items. In addition, we supported the cross-cultural metric invariance of the revised Wound-QoL questionnaire. The new version with 14 items and three dimensions revealed good psychometric properties with Cronbach's alpha (α) of 0.913 for the total score, and 0.709-0.907 for different dimensions. Furthermore, we provided strict invariance for different clinical variables. In conclusion, the revised Wound-QoL is a reliable and cross-cultural instrument to measure the HRQoL on patients with chronic wounds. Future studies should analyse the revised Wound-QoL for convergent validity with generic HRQoL questionnaires as well as for determining its sensitivity to clinical change.

How to measure fluctuating impairments in people with MS: development of an ambulatory assessment version of the EQ-5D-5L in an exploratory study.

BACKGROUND: Health fluctuations even within a single day are typical in multiple sclerosis (MS), but are not captured by widely used questionnaires like the EQ-5D-5L. This exploratory study aimed to develop an ambulatory assessment (AA) version of the EQ-5D-5L (EQ-5D-AA) where patients rate their health on mobile phones multiple times per day over several days, and to assess its feasibility and face validity. METHODS: An initial EQ-5D-AA version was based on two patient focus groups. It was then tested and continuously developed in an iterative process: patients completed it over several days, followed by debriefing interviews. Findings were used to refine the EQ-5D-AA, with the resulting version being tested by the subsequent wave of patients until participants declared no need for changes anymore. Before and after the AA period, participants completed the standard paper-based EQ-5D-5L asking about 'today'. RESULTS: Focus group participants reported that their impairments often fluctuated between and within days. They regarded an AA with three assessments per day over seven days most appropriate; assessment should be retrospective to the previous assessment, but not all items should be assessed at each time point. Four waves of AA testing were conducted. Thirteen out of the 17 participants preferred the AA over standard assessment as they regarded it more informative, but not too burdensome. CONCLUSION: The newly developed one-week AA of the EQ-5D-5L captures within-day and day-to-day health fluctuations in people with MS. From the patients' perspective, it is a feasible and face valid way to provide important information beyond what is captured by the standard EQ-5D-5L.

Clinical evaluation of UrgoStart Plus dressings in real-life conditions: results of a prospective multicentre study on 961 patients.

AIMS: This study aimed to evaluate the performances of lipid colloid technology with nano-oligosaccharide factor (TLC-NOSF) dressings with polyabsorbent fibres in an unselected population of patients under real-life conditions. METHODS: A large, prospective, multicentre, observational study with three polyabsorbent TLC-NOSF dressings (UrgoStart Plus Pad, UrgoStart Plus and UrgoStart Plus Border, Laboratoires Urgo, France) was conducted in Germany between January 2019 and June 2020. Main outcomes included wound healing rate, clinical assessment of wound healing progression, local tolerance and acceptance of dressings, and changes in health-related quality of life (HRQoL) of the patients, assessed with the validated Wound-QoL questionnaire. RESULTS: A total of 961 patients with wounds of various aetiologies (leg ulcers (LU), diabetic foot ulcers (DFU), pressure ulcers (PU) and other types of wounds) were treated with the evaluated dressings in 105 centres for a mean duration of 62 days (standard deviation 37 days). By the last visit, a wound closure or an improvement in wound healing was reported in 92.0% of the treated wounds. The highest wound closure rates were achieved when the dressings were used as first-line treatment: 71.3% in DFUs, 52.9% in LUs, 53.6% in PUs and 61.8% in the other wounds. Improvement of the wound healing process was also associated with an 87.5% relative reduction of sloughy tissue, a decrease of the level of exudate in 68.9% of the wounds, and an improvement in the periwound skin condition in 66.4% of the patients at the final visit. The dressings were 'very well' or 'well' tolerated and 'very well' or 'well' accepted by the large majority of patients. The HRQoL questionnaires were completed both at initial and final visits by 337 patients, representative of the total cohort. Despite the relatively short duration of the wounds, the HRQoL of the patients was already impaired at baseline, with 81.6% of the patients being severely affected in at least one aspect of their HRQoL. By the final visit, significant improvements in each dimension of the patients' HRQoL were reported (p<0.001), along with a reduction of the proportion of patients in need of intervention and in the number of actions needed per patient in relation to their HRQoL. CONCLUSIONS: These results are consistent with previous clinical evidence on TLC-NOSF dressings. They confirm the good healing properties and safety profile of these dressings, and that a significant improvement in patient HRQoL is achieved in non-selected patients treated in real-life practice. These data support the use of such dressings as a first-line intervention and until wound healing in the management of chronic wounds, in association with appropriate standard of care.

Social participation of people with chronic wounds: A systematic review.

Living with chronic ulcers can be burdensome and restrictive, with regard to not only physical and psychological but also social well-being. This review aims to analyse social participation in patients with chronic wounds and to compare results across different wound types. A search string was applied in several electronic databases. Results were screened according to predefined inclusion and exclusion criteria. Data of eligible articles were extracted and synthesised narratively. The search revealed 42 eligible publications. Only minor differences across different ulcer types could be detected. Overall, family members were the main social contacts for patients; they often provided wound care and emotional support. Patients had few non-family relations, but those existing were often very close. Patients felt guilty as their condition imposed burden on family and friends, as well. A close relationship with nurses was described. Restrictions were caused by direct and indirect consequences of the wound. Overall, social support and social connections were reduced in wound patients. Inconsistent results were found regarding social isolation. In summary, people with chronic wounds experience impairments in all aspects of social participation. Therefore, social participation deserves increased attention in routine care both as a trigger of burden and as an outcome of therapy.

Association of wound genesis on varying aspects of health-related quality of life in patients with different types of chronic wounds: Results of a cross-sectional multicentre study.

Patients with chronic wounds are significantly impaired in their health-related quality of life (HRQoL). The validated Wound-QoL questionnaire allows assessing the impact of chronic wounds on different aspects of HRQoL including physical, psychological, and everyday life-related impairments. The aim of our study was to investigate associations of these HRQoL dimensions with age, sex, and particularly wound genesis. In this retrospective, cross-sectional, multicentre study, Wound-QoL questionnaires from clinical routine of patients with venous leg ulcers, arterial leg ulcers, mixed leg ulcers, and diabetic foot ulcers (DFU) were evaluated. Effects of wound genesis, sex, and age were assessed with analysis of variance as well as correlation and multiple linear regression analyses. The completed questionnaires of 381 patients (f = 152/m = 229; mean age 68.9) were included. The wound genesis groups showed significantly different distributions of age and sex. We also found significant differences between those groups in everyday life-related QoL, with the greatest impairments in patients with DFU. Physical QoL scores showed significant differences between men and women depending on diagnosis group: in patients with venous leg ulcers, women had greater impairment of physical QoL than men. Independent of the underlying diagnosis, women had significantly higher scores in the psychological subscale as well as in the Wound-QoL sum scale. Within the subgroup of arterial leg ulcer patients, overall HRQoL sum score was significantly worse in older patients. Regression analyses supported negative effects of DFU diagnosis and female sex on HRQoL. Our data offer evidence that HRQoL shows clinically relevant differences between patients with chronic wounds of different genesis. Moreover, our data revealed that HRQoL is associated with age and sex, which should be considered when treating the patient groups. In order to be able to capture these important aspects and to offer individualised and patient-oriented treatments, the Wound-QoL should be implemented as a quick and uncomplicated standard instrument in daily routine. Patients with chronic wounds are significantly impaired in their health-related quality of life. Validated Wound-QoL questionnaire is a quick and easy-to-use instrument for daily practice. Wound-related quality of life shows clinically relevant differences between patients with chronic wounds of different genesis. Wound-related quality of life is associated with age and sex, which should be considered when treating these patient groups. Health-related quality of life should be regularly objectified in all patients with chronic wounds with a validated measuring instrument.

Development and psychometric evaluation of the U.S. English Wound-QoL questionnaire to assess health-related quality of life in people with chronic wounds.

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.

Challenges and lessons learned from using anchoring vignettes to explore quality of life response behavior.

PURPOSE: Asking patients to rate health-related quality of life (HRQoL) of hypothetical individuals described in anchoring vignettes has been proposed to enhance knowledge on how patients understand and respond to HRQoL questionnaires. In this article, we describe the development of anchoring vignettes and explore their utility for measuring response shift in patients' self-reports of HRQoL. METHODS: We conducted an explorative mixed-methods study. One hundred patients with multiple sclerosis or psoriasis participated in two interviews at intervals of 3-6 months. During both interviews, patients assessed HRQoL of 16 hypothetical individuals on the SF-12 questionnaire (two vignettes for each of the eight domains of the SF-12). In addition to these quantitative ratings, we used the think-aloud method to explore changes in patients' verbalization of their decision processes during vignette ratings. RESULTS: Agreement of vignette ratings at baseline and follow-up was low (ICCs < 0.55). In addition, paired sample t-tests revealed no significant directional mean changes in vignette ratings. Thus, ratings changed non-directionally, neither confirming retest reliability nor a systematic change of assessment. Furthermore, patients' verbalization of their decision processes did not indicate whether or not the assessment strategy of individual patients had changed. CONCLUSIONS: Patients' ratings of anchoring vignettes fluctuate non-directionally over time. The think-aloud method appears not to be informative in exploring whether these fluctuations are due to changes in the individual decision process. Overall, vignettes might not be an appropriate approach to explore response shift, at least with regard to the specific target population and the use of the SF-12.

A translation and preliminary validation of the Dutch Wound-QoL questionnaire.

BACKGROUND: Chronic wounds have a major impact on patients' health-related quality of life (HRQoL). Therefore, measuring HRQoL is an indispensable part of the treatment of patients with chronic wounds. The aim of this study was to translate and validate the Wound-QoL, a wound-specific HRQoL questionnaire, in a Dutch population. METHODS: The Wound-QoL was translated into Dutch according to the international standards. Patients with chronic wounds were asked to complete questionnaires at baseline (T0) and after six weeks (T1), including Wound-QoL, EQ-5D-3L (a generic questionnaire to measure HRQoL) and a visual analogue scale (VAS) measuring wound pain. If patients were not able to complete the questionnaire by themselves, it was read out to them by a nurse. Further data were obtained from medical records. RESULTS: Of the 120 patients included, 64 (53.3%) completed the questionnaire by themselves. To 55 patients (45.8%), the questionnaire was read out. The internal consistency of the Wound-QoL global score was high at both time points (T0: Cronbach's α = 0.89, T1: Cronbach's α = 0.92). The item selectivity for global score ranged from r = 0.25 to r = 0.77 at T0 and from r = 0.40 to r = 0.79 at T1. Overall, the self-completion and read-out subgroups showed similar internal consistency and item selectivity scores. With regard to convergent validity, significant correlations were found between Wound-QoL and EQ-5D-3L (T0: r = - 0.45, p < 0.001, T1: r = - 0.50, p < 0.001) as well as between Wound-QoL and pain VAS (T0: r = 0.23, p = 0.012, T1: r = 0.37, p = 0.001) at both time points. Responsiveness analyses showed significant correlations between changes in Wound-QoL and changes in EQ-5D-3L (r = - 0.37, p < 0.001), pain VAS (r = 0.24, p = 0.044) and wound size (r = 0.24, p = 0.013). The self-completion and read-out subgroups showed differences in convergent validity and responsiveness. CONCLUSIONS: The results indicate that the Dutch version of the Wound-QoL has positive psychometric properties. However, more research is needed to further explore the differences between self-completed and read-out questionnaires.

Towards patients' understanding of health-related quality of life-a mixed-method study in psoriasis and multiple sclerosis.

PURPOSE: Patients' individual understanding of health-related quality of life (HRQoL) varies widely, making the measurement of this complex and subjective construct challenging. Anchoring vignettes, i.e., descriptions of fictive patients may provide insights into patients' individual questionnaire reference frames, assessment processes, and understanding of HRQoL. This study analyzes how patients assess HRQoL of vignettes. METHODS: This exploratory mixed-method study included 100 patients with a chronic disease (50 multiple sclerosis (MS); 50 psoriasis). Sixteen vignettes, two for each domain of the SF-12v2, were developed based on literature recommendations and pretested in a convenience sample of seven healthy individuals. Patients assessed their own HRQoL and HRQoL of the vignettes on the SF-12v2. In semi-structured interviews, they justified their assessments. We quantitatively analyzed associations of vignette assessments with individual characteristics using linear regression models and qualitatively analyzed assessment justifications. RESULTS: Patients' age and disease were significant (p < 0.05) predictors for ten and seven vignette assessments, respectively. Older patients assessed vignettes being less extreme; patients diagnosed with MS rated them more positively. Overall, adjusted R2 values ranged from 0.033 to 0.172. Qualitatively, most of the ratings were based on the evaluation of symptoms or impairments in daily life. Fewer participants ranked different dimensions of HRQoL in a personal hierarchy or assumed impairments beyond the vignette description. CONCLUSIONS: The understanding of HRQoL may vary substantially and is associated with individual characteristics, individual assessment strategies, and probably other intrinsic factors as explained variance was quite low. Therefore, usage of generic instruments only allows for limited comparison across groups.

Measuring Patient Needs and Benefits in Dermatology using the Patient Benefit Index 2.0: A Validation Study.

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.

Validation of a Comprehensive Set of Pruritus Assessment Instruments: The Chronic Pruritus Tools Questionnaire PRURITOOLS.

Few studies have validated standard measurement instruments for evaluation of chronic pruritus. The Chronic Pruritus Tools Questionnaire PRURITOOLS assembles a set of instruments for the assessment of pruritus, such as the visual analogue scale (horizontal 100-mm line), numerical rating scale (0-10), verbal rating scale, and information on pruritus quality and improvement during therapy. This study, with 40 subjects, analysed PRURITOOLS regarding convergent validity and test-retest reliability (60 min), followed by a feasibility questionnaire. Test-retest reliability for PRURITOOLS items was excellent (intraclass correlation coefficient 0.84-1). Strong to very strong correlations between the pruritus intensity scales indicated convergent validity. The feasibility questionnaire showed an overall acceptance of PRURITOOLS, and the majority of subjects (82.5%) considered it an appropriate questionnaire to measure pruritus. In conclusion, PRURITOOLS offers validated tools for rapid pruritus assessment in routine care or endpoints of clinical trials.