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.

Attitudes Toward and Use of eHealth Technologies Among German Dermatologists: Repeated Cross-Sectional Survey in 2019 and 2021.

BACKGROUND: In recent years, legal and infrastructural conditions have been set to improve the adoption of digital applications in health care in Germany. The impact of these actions was amplified by the COVID-19 pandemic. So far, no studies have confirmed this progress in dermatology. OBJECTIVE: The aim of this study was to measure changes in knowledge, interest, expectation, and use of digital applications in health care among dermatologists in Germany in 2019 and 2021. METHODS: We administered a repeated cross-sectional survey among dermatologists in medical practices and clinics in Germany at 2 time points: t1 (2019; before the COVID-19 pandemic) and t2 (2021; during the COVID-19 pandemic). We used a standardized questionnaire, including items on respondents' knowledge, interest, expectation, and use of digital applications, as well as their demographics. The survey was distributed by post and email. The data were analyzed descriptively as well as with multiple logistic regressions. RESULTS: At t1, 585 (272/571, 47.6% female; mean age 52.4, SD 8.9 years) dermatologists and at t2, 792 (360/736, 48.9% female; mean age 54.3, SD 8.6 years) dermatologists participated in this survey. Interest in digital medicine was higher at t1 than at t2 (381/585, 65.1% vs 458/792, 57.8%; P≤.001). Nevertheless, 38.6% (306/792) had used digital applications more often since the beginning of the pandemic. For example, real-time telemedicine with patients (12/585, 2.1% vs 160/792, 7.6%; P≤.001) and other specialists did increase (33/385, 5.7% vs 181/792, 22.8%; P≤.001). Almost one-third expressed great concerns about digitalization (272/792, 34.3% vs 294/792, 37.1%; P=.21). Spatial analysis revealed higher interest in, more positive expectations toward, and higher use of digital applications in urban areas in comparison to rural areas. For instance, dermatologists from urban areas assessed future applications as having less risk (adjusted odds ratio [aOR] 0.51, 95% CI 0.35-0.76) than did dermatologists from rural areas. The situation was similar with the age groups, as, for example, dermatologists aged <50 years also expected lower risks (aOR 0.51, 95% CI 0.34-0.77) than those aged ≥50 years. There were no differences between sexes in use, but there were differences in knowledge and expectation; for example, male participants assessed their confidence in using digital applications as higher (aOR 1.44, 95% CI 1.01-2.04) than did female participants. CONCLUSIONS: During the pandemic, the use of digital applications in dermatology increased but still remained at a moderate level. The regional and age-related disparities identified indicate the need for further action to ensure equal access to digital care.

Effect of oral multispecies probiotic on wound healing, periodontitis and quality of life on patients with diabetes.

OBJECTIVE: Hard-to-heal (chronic) wounds are common in patients with diabetes and are associated with a decrease in quality of life (QoL). Pathogenic bacteria often colonise hard-to-heal wounds and hinder the healing process which poses a high risk for (systemic) infections. In this study, we aim to prove that probiotics are capable of displacing human pathogenic bacteria, ameliorating inflammation and positively influencing the microenvironment/microbiome of skin and mucosa. METHOD: In this pilot study, patients with diabetes and hard-to-heal wounds with a duration of 2-120 months received an oral multispecies probiotic daily for six months. Changes in oral, stool and wound microbiome were investigated, and the effects of the probiotic intervention on wound healing, periodontitis and wound-specific quality of life (Wound-QOL-17) were analysed throughout the course of this clinical study. RESULTS: In total, seven of the 20 patients included were unable to complete the study. After six months of oral probiotic intake supplementation in five out of the remaining 13 patients, the wounds had healed completely. Most patients reported an improvement in wound-specific QoL, with particular positive effects on pain and mobility. Microbiome analysis revealed a reduction in Staphylococcus aureus and Pseudomonas aeruginosa, and Staphylococcus epidermis in healed wounds. CONCLUSION: This findings of this study provide evidence for the beneficial effects of the oral application of a multispecies probiotic over six months in patients with diabetes and hard-to-heal wounds on wound closure, wound microbial pattern, QoL, and on dental health. A randomised, placebo-controlled, double-blinded clinical trial is required to verify the results.

Assessing health-related quality of life using the Wound-QoL-17 and the Wound-QoL-14-Results of the cross-sectional European HAQOL study using item response theory.

For assessing health-related quality of life in patients with chronic wounds, the Wound-QoL questionnaire has been developed. Two different versions exist: the Wound-QoL-17 and the Wound-QoL-14. For international and cross-cultural comparisons, it is necessary to demonstrate psychometric properties in an international study. Therefore, the aim of this study was to test both questionnaires in a European sample, using item response theory (IRT). Participants were recruited in eight European countries. Item characteristic curves (ICC), item information curves (IIC) and differential item functioning (DIF) were calculated. In both questionnaires, ICCs for most items were well-ordered and sufficiently distinct. For items, in which adjacent response categories were not sufficiently distinct, response options were merged. IICs showed that items on sleep and on pain, on worries as well as on day-to-day and leisure activities had considerably high informational value. In the Wound-QoL-14, the item on social activities showed DIFs regarding the country and age. The same applied for the Wound-QoL-17, in which also the item on stairs showed DIFs regarding age. Our study showed comparable results across both versions of the Wound-QoL. We established a new scoring method, which could be applied in international research projects. For clinical practice, the original scoring can be maintained.

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.

[Acquisition, status and transfer of knowledge in compression therapy : Cross-sectional study in healthcare professions using phlebological compression therapy]. / Wissenserwerb, Wissensstand und Wissenstransfer in der Kompressionstherapie : Querschnittsstudie in Gesundheitsberufen, die phlebologische Kompressionsversorgungen anwenden.

BACKGROUND: Due to scientific progress, healthcare professionals should regularly undergo appropriate continuing education. For this, knowledge transfer is essential. Therefore, the aim of this cross-sectional study was to investigate the acquisition, status and transfer of knowledge of professional groups applying phlebological compression therapy in Germany. MATERIALS AND METHODS: Healthcare professionals (physicians, nurses and medical assistants) received a questionnaire developed for this study, which queried different aspects of acquisition, status and transfer of knowledge. RESULTS: Responses from 522 participants were analysed. The topic of compression therapy was not taught in the nursing or medical education of 43.3%. Specialist journals that address compression therapy were read regularly (at least 6 times/year) by 16.1% of the participants; 63.0% had no specialist books on this subject. Only 6.7% were aware of AWMF ("Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften") guidelines on the topic and 16.3% of the corresponding DNQP ("Deutsches Netzwerk für Qualitätsentwicklung in der Pflege") expert standard. In all, 41.2% participated in at least one internal training on compression therapy per year, 72.0% in external training and 19.2% in online training. A total of 30.7% stated that they did not use any information sources to acquire knowledge. CONCLUSIONS: Possible sources of knowledge about compression therapy in Germany are insufficiently known within the investigated healthcare professional groups studied or are not regularly used. The result is a considerable knowledge deficit with a discrepancy between the current state of science and practice.

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.

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.