Implementing well-being in the management of psoriasis: An expert recommendation.

Psoriasis causes detriment in a person's physical, mental and social health which impairs their quality of life (QoL). However, the current psoriasis management may not adequately address all relevant health domains. Since the goal of healthcare is to restore or maintain health, health outcomes should include all areas of the patient's overall health. Life satisfaction, QoL and patient well-being are essential to a comprehensive approach to the disease. With the inclusion of more people-centred policies, care of patients with psoriasis should evolve towards a holistic and integrated assessment of the disease impact, including subjective measures of well-being in order to encompass all aspects of health. The main objective of this expert review is to give the concept of well-being a place as an entity within the holistic therapeutic approach for patients with psoriasis. Identifying and defining common goals beyond the skin with the patient and testing them throughout the course of treatment will benefit and enhance treatment success. We propose a series of recommendations for application in clinical practice, providing tangible clinical guidance for implementing well-being in the management of psoriasis. Among the recommendations are the need to initially listen to the patient, to know their level of empowerment or what they want to achieve, their preferences in decision making, the evaluation of not only the physical but also the emotional impact of the disease (well-being), the definition of the aspects that can generate a cumulative deterioration of the disease throughout life, and a continuous assessment of the patient's preferences with the opinion of the expert clinician and the integration of the knowledge of external clinical evidence.

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.

A Comparative Analysis of the Predictors, Extent and Impacts of Self-stigma in Patients with Psoriasis and Atopic Dermatitis.

The impact of dermatological diseases goes beyond symptoms and often includes psychosocial burden. Self-stigmatization plays a key role in this relationship and was compared in patients with psoriasis and atopic dermatitis to evaluate the validity of cross-disease stigmatization models. In total, 101 patients per indication were included in this cross-sectional study. Besides sociodemographic and clinical data, patient-reported outcome measures relating to self-stigmatization, depression, anxiety, and quality of life were compared across groups. Sociodemographic and clinical factors were tested for their moderating effects between self-stigmatization and quality of life. Group mean comparisons yielded no significant differences in self-stigmatization between patient groups. In both diseases, self-stigmatization significantly predicted depression and anxiety symptoms as well as quality of life. Current symptoms, not having close social relationships, and lower age predicted self-stigma in patients with psoriasis, whereas the involvement of sensitive body areas, the sum of previous treatments, and female sex were predictors in patients with atopic dermatitis. In both groups, symptoms had significantly moderating effects. The results underline the relevance of self-stigmatization in patients with chronic skin diseases. Awareness should be raised, screening implemented, and psychosocial support offered early on. Assessments, conceptual models of self-stigma, and interventions are probably applicable for both diseases.

Patient-reported well-being in value-based care using tildrakizumab in a real-world setting: protocol of a multinational, phase IV, 1-cohort prospective observational study (the POSITIVE study).

INTRODUCTION: Psoriasis is a chronic inflammatory skin disease that negatively impacts the quality of life of patients and their families. However, the most commonly used decision-making tools in psoriasis, Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA) and Dermatology Life Quality Index (DLQI), do not fully capture the impact of psoriasis on patients' lives. In contrast, the well-established 5-item WHO Well-being Index (WHO-5) assesses the subjective psychological well-being of patients. Moreover, while drug innovations became available for psoriasis, data on the impact of these therapies on patients' lives and their closest environment (family, physicians) are limited. This study will assess the effect of tildrakizumab, an interleukin-23p19 inhibitor, on the overall well-being of patients with moderate-to-severe psoriasis. Moreover, the long-term benefit of tildrakizumab on physicians' satisfaction and partners' lives of patients with psoriasis will be evaluated. METHODS AND ANALYSIS: This non-interventional, prospective, observational, real-world evidence study will involve multiple sites in Europe and approximately 500 adults with moderate-to-severe psoriasis treated with tildrakizumab. Each patient will be followed for 24 months. The primary endpoint is well-being measured by the WHO-5 questionnaire. Key secondary endpoints include Physician's Satisfaction and partner's quality of life (FamilyPso). Other endpoints will evaluate skin-generic quality of life (DLQI-R), Treatment Satisfaction Questionnaire for Medication (TSQM-9), Treatment-related Patient Benefit Index 'Standard', 10 items (PBI-S-10) and work productivity and activity impairment due to psoriasis (WPAI:PSO). Statistical analyses will be based on observed cases. Multiple imputations will be performed as a sensitivity analysis, and adverse events will be reported. ETHICS AND DISSEMINATION: The study will be conducted according to the protocol, which received ethics committee approval and applicable regulatory requirements of each participating country. The results will be disseminated through scientific publications and congress presentations. TRAIL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT04823247 (Pre-results).

Development of Measurement Tools to Assess Cumulative Life Course Impairment in Patients with Chronic Skin Diseases.

INTRODUCTION: Patients with chronic skin diseases suffer from physical, psychological, emotional and social impairments. The overall burden has significant impact on patients' life, contributing to irreversible damage across many domains, known as cumulative life course impairment (CLCI). The aim of this project was to develop instruments which (a) measure persisting CLCI and (b) identify patients at risk for developing future CLCI. METHODS: We identified key topics that negatively impact life course due to skin disease patient-reported open item selection. Subsequently, we conducted focus group interviews with patients and experts to conceptualize items and response scales, resulting in two preliminary measurement tools. These tools were tested in a cognitive debriefing before finalization. RESULTS: Consecutively, 162 patients participated in the open item selection and indicated the following topics were most relevant to their disease: disease symptoms, risk behaviour, comorbidities, psychological and emotional impairments, physical impairments, occupational impairments, treatment, sexuality, problems with family or friends, everyday life and positive event or decisions because of the disease. In the focus group interviews, patients reported stigmatization, support at disease onset, pre-existing diseases and age of onset as additional important topics. The cognitive debriefing resulted in minor changes to sentence structure. The final tools included: (1) DermCLCI-r, which assesses retrospective CLCI, and (2) DermCLCI-p, which assesses current CLCI and future risk. Each tool consisted of 30 items. DISCUSSION: The newly developed measures allow for early identification of CLCI, facilitate adequate dermatological and psychosocial interventions and may contribute to the prevention of CLCI. Further validation studies will be performed.

Psychosocial Burden in People with Atopic Dermatitis: Effects of a Substance-Free Basic Skincare in a Randomized Health Care Study.

INTRODUCTION: Atopic dermatitis (AD) is a physical, emotional, and social burden for patients. Most suffer from itching, pain, and dry skin as well as sleep disturbances, experienced stigmatization, anxiety, or depression. Therefore, it is important to consider the psychosocial well-being and also stigmatization in the treatment of people with AD. The aims of this study were to compare clinical and psychosocial parameters between patients with a different severity of AD and to analyse the effect of an omega-6-fatty-acid-skin therapy. METHODS: Adult patients with clinically confirmed AD were asked about quality of life, stigmatization, and well-being after dermatological diagnosis. A second examination took place after 2-5 weeks. Meanwhile, after randomization, half of the patients used an omega-6-fatty-acid-skin therapy. RESULTS: Seventy-nine patients were included in the study. The use of omega-6-fatty-acid-skin therapy resulted in a significant reduction in the severity of xerosis cutis compared to patients using another basic therapy. In addition, the health-related quality of life of all patients improved significantly in both groups (F = 7.56; p = 0.008), and no significant difference was found between the groups over time in the patient-reported outcomes. CONCLUSION: Basic therapy for AD leads to relevant improvements in clinical status as well as quality of life. Patients using omega-6-fatty-acid-skin therapy experience greater improvement in xerosis cutis compared to free-choice basic therapy.

Comparison of Patient-Reported Outcomes Measures and Quality-Adjusted Life Years Following One- and Two-Stage Septic Knee Exchange.

(1) Background: Periprosthetic joint infection (PJI) can be managed with one- or two-stage revision surgery protocol. Despite several studies analyzing the eradication rates between both procedures, there are no comparative studies that analyze patient-reported outcome measures (PROMs) and quality-adjusted life years (QALYs) in both treatment strategies. (2) Methods: All patients who underwent a two-stage knee revision between January 2017 to December 2018, due to a periprosthetic joint infection were included in the study. From the time interval, we selected a comparative group with the one-stage septic procedure. All patients received the following questionnaires: Oxford Knee Score, EQ-5D-5L, SSQ-8, and the SF-36. Additionally, demographic patient data were collected. The quality-adjusted life years (QALY) were calculated using the EQ-5D-5L. (3) Results: A total of 35 patients with a mean age of 67.7 years (SD = 8.9) were included in the final evaluation. The mean follow-up period was 54.5 months (SD = 5.5). There was no statistically significant difference regarding the Charlson Comorbidity Index (CCI), postoperative complications, or all evaluated questionnaires. There was no statistically significant difference in QALYs between the one- and two-stage revision. (4) Conclusion: Our study results show that the one-stage revision for PJI achieves similar PROMs compared to two-stage revision.

Psychological (co)morbidity in patients with psoriasis: the impact of pruritus and anogenital involvement on symptoms of depression and anxiety and on body dysmorphic concerns - a cross-sectional study.

OBJECTIVES: While stress plays a paramount role on the onset/exacerbation of psoriasis, via overactivation of the hypothalamic-pituitary-adrenal axis and increased release of pro-inflammatory cytokines, cutaneous inflammatory response induces, in turn, anxiety/depression symptoms, via body disfigurement and stigmatisation. The intensity of pruritus and anogenital involvement are additional risk factors for psychological comorbidity.Aims were to (1) examine the effects of intensity of pruritus and anogenital psoriasis on disease burden and psychological comorbidity and (2) identify the variables associated with the presence of clinically significant depression, anxiety, and dysmorphic concerns. DESIGN: Cross-sectional study. SETTING: Conducted at the University Medical Center Hamburg-Eppendorf (UKE). PARTICIPANTS: 107 patients with psoriasis (mean age = 46.3, SD = 14.6 years; 53.3% male): 64 with none/mild pruritus; 43 with moderate/severe pruritus; 31 with anogenital psoriasis; 76 not affected in the anogenital area. PRIMARY/SECONDARY OUTCOMES MEASURES: Disease severity was assessed with Psoriasis Area and Severity Index and intensity of pruritus was rated by patients. Patient-reported outcomes included the Dermatology Life Quality Index, ItchyQoL, Patient Benefit Index, Perceived Stigmatisation Questionnaire, and Relationship and Sexuality Scale. Psychological morbidity was assessed with the Patient Health Questionnaire, Generalised Anxiety Disorder, and Dysmorphic Concern Questionnaire. RESULTS: Patients with moderate/severe pruritus reported more quality of life impairments, depression, anxiety and dysmorphic concerns, and less treatment benefits than those with none/mild pruritus. Moderate/severe pruritus had a deleterious effect on depression and stigmatisation for patients without anogenital involvement. Less patient benefits were associated with a higher likelihood of clinically significant depression/anxiety. CONCLUSION: Pruritus induces significant burden and psychological morbidity, particularly for patients without anogenital involvement. However, coping strategies used by patients with anogenital psoriasis might be dysfunctional for overall psychosocial adaptation. Patient-centred healthcare might be the best way to prevent psychological comorbidity. ETHICS APPROVAL: Ethics Committee of the Medical Association of Hamburg (process number PV6083, 28 May 2019).

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.

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.

Skin Lesions, Skin Care, and Characteristics of Pruritus in Patients Undergoing Haemodialysis.

INTRODUCTION: Pruritus has been shown to be a common and burdensome complaint in the general population. In some diseases, there is an even higher rate and intensity of pruritus such as in chronic kidney diseases. In particular, patients requiring dialysis commonly suffer from pruritus with proportions between 22.0 and 90.0%. Few data on the characteristics and burden of such pruritus have been published. Therefore, the aim of this study was to investigate the extent and profiles of pruritus in such patients related to skin lesions and care. METHODS: A non-interventional cross-sectional study in 14 centres for haemodialysis across Germany was conducted. The survey explored the prevalence, severity, and resulting burden of pruritus and skin lesions. RESULTS: In total, 302 patients with uraemia (56.5% male, mean age 66.0 ± 14.4 years, mean duration of dialysis 3.9 ± 4.8 years) were included. Skin lesions appeared since start of dialysis in 50.0% of patients, with xerosis (94.7%) and desquamation (25.8%) being the most frequent and disturbing findings. Pruritus was reported by 60.9% of patients undergoing dialysis with a current mean numerical rating scale of 5.1 ± 2.4 occurring most frequently in the back, legs, and arms. About 89.0% of patients with xerosis and 69.0% with desquamation reported self-medication. However, only 40.0% and 28.0% sought medical help, respectively, indicating a remarkable lack of healthcare. DISCUSSION: The current data suggest a more intensive focus on the skin symptoms and signs related to uraemia in the patients with dialysis and thus underline claims from a previous German large-scale study. Recommendations for early treatment and prevention of skin lesions in dialysis patients should be developed. Further research should be conducted focusing on recognizing subgroups of patients of particular vulnerability to pruritus and skin lesions, which may facilitate identifying patients at risk in an early moment. Moreover, a more specific tool for screening of skin lesions as well as pruritus may be useful since the existing instruments lack such specificity.

Exploring the burden of xerosis cutis and the impact of dermatological skin care from patient's perspective.

BACKGROUND: Xerosis cutis is recognized as a burdensome and stressful condition of the skin, resulting in impaired health-related quality of life (HRQoL). Therefore, it should be treated as a relevant skin disease with detailed care and treatment recommendations. METHODS: This cross-sectional, exploratory study aimed to examine xerosis cutis-related burden from patient's perspective and compare it with individuals without xerosis cutis. Within-group comparisons were also performed among patients with xerosis cutis associated with atopic dermatitis (AD) or not. The second aim was to assess the effect of a routinely applied basic skin care therapy in terms of burden release. RESULTS: Overall, 127 participants were included in the study. Patients with xerosis cutis reported a lower quality of life (p = .041), more dysmorphic concerns (p < .001), and higher general anxiety (p = .029) than individuals without xerosis cutis. The presence of AD was associated with lower HRQoL (p = .023), more depression (p = .008) and anxiety symptoms (p = .003), and more stigmatization experiences at baseline (p < .001). CONCLUSION: Patients with xerosis cutis showed higher psychosocial burden than participants without xerosis cutis. Additionally, patients with xerosis and AD had more psychosocial impairments than patients with xerosis without AD.

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.

A Structured Intervention for Medical Students Significantly Improves Awareness of Stigmatisation in Visible Chronic Skin Diseases: A Randomised Controlled Trial.

People with visible skin diseases often experience stigmatisation. The aim of this study was to develop and evaluate a new intervention for medical students to counter the stigmatisation of people with skin diseases. The intervention was evaluated using a randomised controlled design. Effectiveness was assessed at 3 time points. Data from 127 participants were analysed. Regarding the outcome "social distance", a significant difference between the measurement points was observed for the intervention group (χ2(2) = 54.32, p < 0.001), which also showed a significant effect on agreement with negative stereotypes (F(1.67, 118.67) = 23.83, p < 0.001, partial η2 = 0.25). Regarding the outcome "agreement with disease-related misconceptions", a significant difference between the measurement time points was observed for the intervention group (χ2(2) = 46.33, p < 0.001); similar results were found for the outcome "stigmatising behaviour" (F(1.86, 131.89) = 6.16, p = 0.003, partial η2 = 0.08). The results should encourage medical faculties to invest in such courses in order to prevent stigmatisation of people with skin diseases.

Determining the Minimal Important Difference for the Wound-QoL Questionnaire.

BACKGROUND: The questionnaire for the quality of life with chronic wounds (Wound-QoL) is a valid and reliable instrument to determine the disease-specific health-related QoL of patients with chronic wounds. For the interpretation of HRQoL scores, it is additionally important to know which differences in scores are considered meaningful. The minimal important difference (MID) is defined as a change in HRQoL that a patient would consider meaningful, such that the patient would judge a treatment to be beneficial and worthy of repeating. OBJECTIVE: To interpret changes in the Wound-QoL scores and draw conclusions regarding the relevance of detected changes; the purpose of this study was to estimate the MID of the Wound-QoL global score and its subscales for patients with chronic wounds. PATIENTS AND METHODS: Patients completed the Wound-QoL before and four to six weeks after treatment and additionally gave a global rating of wound status change after treatment. The global rating of change served as an anchor question. MIDs were calculated based on an anchor-based and a distribution-based method. RESULTS: In total, 227 patients participated in the study. The mean age of the study population was 66.9 (± 12.7) median was 69.5, and 51.5% of the patients were female. MIDs for the Wound-QoL global score ranged from 0.47 to 0.52, proposing an overall estimation of 0.50. CONCLUSION: The results can be used to measure and interpret changes in wound-specific QoL over time.

Effectiveness of a structured short intervention against stigmatisation in chronic visible skin diseases: Results of a controlled trial in future educators.

BACKGROUND: Chronic visible skin diseases are highly prevalent, and patients affected frequently report feeling stigmatised. Interventions to reduce stigmatisation are rare. OBJECTIVES: This study aimed to evaluate the effectiveness of a structured short intervention in reducing stigmatising attitudes towards psoriasis in future educators. METHODS: The intervention consisted of four components: (1) self-reflection, (2) education on skin diseases, (3) contact between participants and a person with psoriasis and (4) practising of knowledge via case studies. A quasi-experimental, pre-post study design was chosen with a nonrandomized contemporaneous control group that attended regular lessons. The main outcomes were participants' desire for social distance, stereotype endorsement, illness-related misconceptions and intended behaviour. Intervention effects were analysed using mixed repeated-measures analysis of variance, with Bonferroni post-hoc tests for pairwise comparisons. RESULTS: The sample consisted of 221 students attending vocational training as educators (n = 118 intervention group, n = 103 control group). While no effect of the intervention was found in social distance, small to large effect sizes were observed for intended behaviour (r = .14), illness-related misconceptions (r = .28) and stereotype endorsement (r = .42). The intervention group reported significantly higher satisfaction with the seminar compared to the control group. CONCLUSIONS: Overall, the short intervention was effective at reducing stigmatising attitudes in future educators. In perspective, revised versions could help in reducing stigmatisation in various demographics and promote patient empowerment by acknowledging and including them as experts on their own behalf. PATIENT OR PUBLIC CONTRIBUTION: Patient advocate groups were consulted and involved in the superordinate destigmatization research programme and intervention.

PHARMACOKINETIC BEHAVIOR OF MELOXICAM IN LOGGERHEAD (CARETTA CARETTA), KEMP'S RIDLEY (LEPIDOCHELYS KEMPII), AND GREEN (CHELONIA MYDAS) SEA TURTLES AFTER SUBCUTANEOUS ADMINISTRATION.

The objective of this study was to determine the pharmacokinetics of a single dose of meloxicam administered subcutaneously (SQ) to three species of sea turtles: loggerheads (Caretta caretta), Kemp's ridley (Lepidochelys kempii), and greens (Chelonia mydas). A dose of 1 mg/kg was given to the Kemp's ridleys and greens, whereas the loggerheads received 2 mg/kg. After SQ administration, the half-life (t1/2) of meloxicam administered at 1 mg/kg in the Kemp's ridleys was 5.51 hr but could not be determined in the greens. The half-life of meloxicam administered at 2 mg/kg in the loggerheads was 2.99 hr. The maximum concentration (Cmax) for meloxicam after SQ administration at 1 mg/kg in the Kemp's ridleys was 6.76 µg/ml and in the greens was 9.35 µg/ml. The Cmax in loggerheads for meloxicam after SQ administration at 2 mg/kg was 3.63 µg/mL. Meloxicam administered SQ at a dose of 1 mg/kg to the Kemp's ridley and greens provided measurable plasma concentrations of meloxicam for 48 and 120 hr, respectively, with no adverse side effects. In loggerheads, meloxicam administered SQ at a dose of 2 mg/kg provided measurable plasma levels of meloxicam for only 24 hr. Plasma levels of meloxicam of greater than 0.5 µg/ml are considered to be therapeutic in humans. Results suggested that administration of meloxicam SQ at 1 mg/kg in Kemp's ridleys and greens would result in plasma concentrations greater than 0.5 µg/ml for 12 and 120 hr, respectively. The administration of 2 mg/kg meloxicam to loggerhead turtles resulted in plasma concentrations greater than 0.5 µg/ml for only 4 hr.

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.

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.