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.

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

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

Nail Psoriasis and Quality-of-Life Measurement in Clinical Trials: Call for the Use of Nail-Specific Instruments.

Nail involvement is frequent in people with psoriasis. It can considerably impair health-related quality of life (HRQoL) beyond the impairments due to other psoriasis symptoms, for example, because patients feel ashamed of visible nail defects or because of the functional impairment in manual activities and walking. In clinical trials on nail psoriasis, it is therefore crucial to assess whether the treatment reduces HRQoL impairments that are specific to nail psoriasis. For this purpose, two validated patient questionnaires are available, the Nail Psoriasis Quality of Life Scale (NPQ10) and the Nail Assessment in Psoriasis and Psoriatic Arthritis-Quality of Life (NAPPA-QOL). The ten-item NPQ10 has the advantage of being short and thus quick to administer. The 20-item NAPPA-QOL, in contrast, assesses the different dimensions of HRQoL which is considered a multi-dimensional construct. Yet most randomized controlled trials on nail psoriasis do not evaluate HRQoL improvement. If they do, a number of different instruments are used, most of which are not nail specific. This makes comparison of trial outcomes difficult. Harmonizing the measurement of HRQoL in future clinical trials on nail psoriasis would improve comparability across studies and would also enhance the reliability of meta-analyses.

Patient needs and benefits of sublingual immunotherapy for grass pollen-induced allergic rhinitis: an observational study.

Aim: Clinical efficacy of sublingual immunotherapy for grass pollen-induced allergic rhinitis (AR) needs to translate into patient benefit. Patients & methods: Patients received Oralair (Stallergenes, Antony, France) in real-life medical practice. Patient-relevant treatment benefits were measured with the AR-specific Patient Benefit Index. Subgroups were analyzed regarding distinct patient characteristics. Results: Data of 883 patients (children, adolescents, and adults) were analyzed. The highest-ranked patient needs referred to having less AR symptoms, being able to go outdoors, and being free in the choice of leisure activities. Most patients (89.2-94.6%) attained at least minimally relevant benefit. All subgroups reported relevant benefits, with significantly higher scores in some subgroups. Conclusion: Treatment with Oralair was associated with considerable patient-relevant benefit in all age groups.

Increasing competence in compression therapy for venous leg ulcers through training and exercise measured by a newly developed score-Results of a randomised controlled intervention study.

Compression therapy with short-stretch bandages is the most common treating option for patients with venous leg ulcers in the decongestion phase in Germany. This randomised controlled intervention study examined whether a training is suitable to sustainably improve the skills of health care professionals. Altogether 55 nurses from hospitals and outpatient care participated. They were randomly assigned to case and control groups. Participants' abilities to properly apply a compression bandaging were assessed before and after a training session as well as after 1 and 3 months using a newly developed score (CCB score) based on six control parameters (CPs): padding, starting point, heel inclusion, heart direction, pressure at forefoot (A) and calf base (B1). After training, a significant increase in competence was observed, which only decreased non-significantly over the observation period: The average CCB score was 2.796 at V0, 4.89 at V1, 4.88 at V2, and 4.66 at V3. The CPs for pressure at A and B1 were met by a maximum of 42.6 and 43.6%, respectively, at all timepoints. The CP starting point was fulfilled by at least 61.7% after training, the CPs heart direction, heel and underpadding by at least 89.4, 96.4, and 97.9%, respectively. As a result of our study, it can be concluded that training improves the ability of users to apply compression bandagings, but one-off training does not appear to be suitable to improve the ability to apply compression bandagings with a therapy-relevant pressure. Therefor more training especially with pressure measuring devices would be necessary.

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.

Attitudes towards using electronic health records of patients with psoriasis and dermatologists: a cross-sectional study.

BACKGROUND: Electronic health records (EHRs) offer various advantages for healthcare delivery, especially for chronic and complex diseases such as psoriasis. However, both patients' and physicians' acceptability is required for EHRs to unfold their full potential. Therefore, this study compares patients' and physicians' attitudes towards using EHRs in routine psoriasis care. METHODS: For the purpose of this study, a questionnaire was developed based on literature research and analyses of previously conducted focus groups. Participants completed either a paper-based or an electronic version of the questionnaire. Patient recruitment took place at an dermatological outpatient clinic and via several online pathways (patient associations, and social media). Physicians were recruited via a mailing list of a dermatological association and at a dermatological conference. Patients' and physicians' responses were compared using χ2 tests and Fisher's exact tests. RESULTS: The study consisted of 187 patients and 44 dermatologists. Patients compared to physicians rated almost all potential EHR uses as significantly more important and expected significantly more potential benefits from EHRs. CONCLUSIONS: Patients showed positive expectations towards using EHRs, whereas there was more scepticism in the physician sample. This aligns with previous findings. These differences illustrate the necessity to involve all stakeholders, especially patients and physicians, into the process of developing and implementing EHRs.

How should electronic health records be designed? A cross-sectional study in patients with psoriasis.

BACKGROUND: Electronic health records (EHRs) are promising tools for routine care. These applications might not only enhance the interaction between patient and physician but also support therapy management. This is crucial in complex and chronic conditions like psoriasis. However, EHRs can only unfold their full potential when being accepted by the users. Therefore, this study aims to analyse how EHRs should be designed for patients with psoriasis and to identify differences between patient subgroups. METHODS: We developed a questionnaire on the acceptability of EHRs based on literature research and results from focus groups. Participants completed a paper-based or electronic version of the questionnaire. We recruited participants at an outpatient clinic as well as online via patient associations and a social media platform. We analysed data using descriptive statistics and bivariate analyses applying Chi-square and Fisher's exact test. RESULTS: The sample encompassed 187 patients with psoriasis. Data reveals that 84.4% of the participants can think of entering data into an EHR. Participants prefer entering data at home (72.2%) instead of entering data in the waiting room (44.9%) and using an own internet-ready device (laptop/computer: 62.6%; smartphone/tablet: 61.5%) instead of a provided device (46.0%). Altogether, 55.6% of participants would accept entering data on a monthly basis when this lasts between one and 10 minutes and further 27.8% would accept even longer lasting data entry. Data privacy is of great concern (e.g. patient should decide who has access to data: 96.7%). Subgroup analyses reveal differences with regard to age, educational level, burden due to psoriasis, number of internet activities, use of electronic questionnaires and mode of administration. CONCLUSION: The high acceptance of entering data is favourable for the implementation of EHRs. The results suggest technical and structural recommendations: Differences between subgroups support the development of flexible EHRs encompassing a basic module, which is expandable with further add-ons, and compatible to different devices. Furthermore, involving patients by entering data into an EHR requires that physicians communicate open-mindedly with the patient and consider data throughout decision-making. Patients should remain owner of their own health data and decide about its processing.

Validation of the Arabic and Tunisian Arabic version of the KINDL questionnaires for children with diabetes type 1.

AIM: We aimed to validate the Arabic and Tunisian Arabic versions of diabetes- specific quality of life (QOL) instrument KINDL-R Diabetes Module for Tunisian children population with type 1 diabetes. PATIENTS AND METHODS: This a cross-sectional study to validate Arabic and Tunisian KINDL QOL instrument that we translate in literary and dialectal Arabic. Both forward and backward translations from the German version of KINDL QOL into Arabic version were performed. Our project received a GPED grant in August 2014. After the face validity of the Arabic version was established, it was then pilot-tested. Finally, the validity and reliability of the final version of the Arabic KINDL questionnaire were evaluated. RESULTS: The KINDL-R Diabetes Module (DM) questionnaire of QOL was given to 212 persons : 108 children (aged 3-17 years) with T1DM and 104 parents. The Cronbach's alpha coefficients of the overall items and the main domains was about 0.7. The mean total score of the KINDL-R DM was 69,56  ± 14,01 in children aged 7-13 years, 59.93± 15.17 in children aged 13-17 years and 56.6± 9.9 in parents (higher scores indicate better QOL). The parents reported lower diabetes-specific HRQOL than the children themselves (p < 0.01).Emotional score was correlated to environment (p = 0,03). Self-esteem was reported to environment (p = 0,02) and mother's instruction level's (p = 0,014). CONCLUSIONS: The KINDL-R Diabetes Module (DM) of QOL in literary and dialectal Arabic have sufficient acceptability, reliability and validity so as to be used for the purposes of a comparative in Tunisian and Arabic populations.