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The Wound-QoL assesses patients' health-related quality of life. Quick and valid interpretation of the results is crucial, but no thresholds have yet been established. Additionally, counting top box responses might be a quick approximation to the Wound-QoL score itself. The aim of this study was to develop Wound-QoL bands (i.e., thresholds) and to analyse top box responses. Patients from European countries completed the Wound-QoL and a global question. We grouped patients' Wound-QoL scores and mapped these on the global question score. Upon this, we developed sets of Wound-QoL bands and calculated the weighted kappa (κ) coefficient of agreement for each set. Moreover, we analysed the correlation of the sum of top box responses with patients' Wound-QoL. The 305 patients (mean age: 68.5 years; 52.8% male) had most frequently leg ulcers (49.2%). The final set of Wound-QoL bands with the highest κ coefficient (0.564 and 0.550) was 0–0.25, not at all/rarely impaired; > 0.25 to 1, a little; > 1 to 2, moderately; > 2 to 3, quite a lot; > 3 to 4, very much. Top box responses showed strong correlation with the Wound-QoL scores (0.961–0.961). We are confident that the Wound-QoL bands will facilitate interpretation of Wound-QoL data in routine care as well as in research.
Atopic dermatitis (AD) is a chronic, relapsing, heterogeneous skin disease affecting 2%–7% of adults, with roughly 30% having moderate-to-severe disease. AD symptoms, like intense itching and skin pain, carry a substantial disease burden that negatively impacts patients’ quality of life (QoL) and psychosocial well-being. Lebrikizumab is a novel, high-affinity monoclonal antibody that selectively binds to and neutralises interleukin-13 with high potency. Three clinical trials with lebrikizumab (ADvocate 1 and 2; ADhere) demonstrated significant clinical benefit in patients with AD, while the 3-year long-term extension study of lebrikizumab (ADjoin) further demonstrated long-term efficacy and safety in patients with AD. The ADTrust study will evaluate patient well-being, their relationship with their skin, long-term effectiveness, and safety of lebrikizumab, treatment satisfaction, and long-term effect of lebrikizumab treatment on different aspects of patients’ lives, including itch, pain, sleep, fatigue, work impairment and overall QoL among adult patients with moderate-to-severe AD in a real-world setting.
This non-interventional, prospective, observational, real-world evidence study will involve approximately 150 sites across Europe and approximately 1200 adults with moderate-to-severe AD treated with lebrikizumab for 2 years. The primary endpoint is patient well-being assessed by the 5-item WHO Well-Being Index (WHO-5) questionnaire. Key secondary endpoints include clinical effectiveness (Eczema Area and Severity Index and Investigator’s Global Assessment Scale), disease symptomatology and control (Patient-Oriented Eczema Measure, 24-hour peak pruritus, skin pain, fatigue and sleep quality Numerical Rating Scale, and safety and tolerability. Other validated endpoints will evaluate physician-reported and patient-reported QoL and treatment satisfaction (Dermatology Life Quality Index, Treatment Satisfaction Questionnaire-9), patients’ work productivity and impairment (Work Productivity and Activity Impairment (WPAI)-AD) and disease control (AD Control Tool). Novel experimental endpoints will also be evaluated with the aim to assess patients’ relationship with their skin (SkinLove questionnaire), disease control (intensity and frequency of flares) and an Effectiveness Diary+© (a brief monthly survey on a voluntary basis with the aim to assess the long-term impact of lebrikizumab on three fundamental aspects of the patients’ life: the well-being (WHO-5), the itch intensity (24 hours peak pruritus) and the frequency and intensity of flares). Statistical analyses will be descriptive and explorative and based on observed cases. Missing data imputation may be used to handle missing data for primary endpoints and secondary effectiveness endpoints.
This study will be conducted according to the protocol, which has ethics committee approval (Hamburg Ethic Committee in Germany: 2024-101358-BO-ff), and all applicable laws and regulatory requirements for each participating country. The results will be disseminated through scientific publications and congress presentations.
NCT06815380 (Pre-results).
by Moses Kelly Kumwenda, Madalo Mukoka, Elena Reipold-Ivanova, Owen Mhango, Yasmin Dunkley, Florence Abok, Euphemia Sibanda, Constancia Watadzaushe, Elizabeth L. Corbett, Augustine Talumba Choko
Simple and easy to use kits for SARS-Cov-2 self-testing during epidemic waves are needed to optimize diagnostic capacity in low- and middle-income countries. SARS-Cov-2 self-testing kits are available, but application of these novel diagnostic technologies is less understood in low and middle-income contexts. We investigated the ability to understand and perform instructions for use (IFUs) for STANDARD Q COVID-19 Ag Test (SD Biosensor) and Panbio COVID-19 Ag Rapid Test Device (Abbott Rapid Diagnostics) for anterior nares (AN) nasal self-sampling and self-testing for COVID-19 in rural and urban Malawi. Qualitative research methods using iterative cognitive interview approach was used to investigate the ability of healthcare providers and lay community members to understand and perform a COVID-19 self-sample or self-test using the manufacturer’s instructions for use. A total of 120 iterative cognitive interviews were done with healthcare providers and lay community members for self-sampling (N = 76) and self-testing (N = 44). Cognitive interviews began with the manufacturers version of instructions for use followed by subsequent iterations to refine problematic instructions. Structured interview guide and an observation checklist were used to collect data which was then coded inductively. A framework analysis approach was used to synthesize qualitative data. Study participants were generally proficient at performing a COVID-19 self-sampling and self-testing using the two COVID-19 Rapid Testing Devices. Several of design and content problems within manufacturer’s instructions for use made their contextual application sub-optimal. Overall, participants experienced difficulties because of the omission of essential elements within instructions, use of short texts/phrase or lack of a word instruction, the lack of labels on where to open the package; the inconsistencies between word instructions within the instructions for use and the physical contents of the test package; the inability to digest and apply certain technical concepts and the lack of clarity in the phrasing of some text instructions. As expected, healthcare providers experienced fewer problems compared to lay community members. The refinement of these instructions greatly improved comprehension among lay community members. Self-sampling and self-testing for COVID-19 can be performed lay community members with fidelity in a scaled context if the manufacturer’s instructions for use have been refined and tailored to the context. In the current study, we have used the study findings to map the optimisation process of manufacturer’s IFU’S for self-testing RDT’s intended for low literacy contexts including Malawi.by Tamara Taggart, Allison Mathews, Toni Junious, Joseph A. Lindsey, Andrea Augustine, Charles Debnam, Yavonne Boyd, Seraiya Wright, Joseph D. Tucker, Manya Magnus
HIV incidence among young people (Black and Latinx women and men who have sex with men ages 16–24 years), in the United States is high. Traditional top-down approaches for pre-exposure prophylaxis (PrEP) social marketing are not effectively reaching this population. Crowdsourcing is a promising approach to engaging young people in the development of innovative solutions to raise awareness and use of PrEP among those at highest risk of HIV. This study engaged young people in the design and evaluation of an online crowdsourcing contest to promote PrEP among Washington, DC youth. The contest used standard methods recommended by the World Health Organization and feedback from our community partners. Online recruitment using social media elicited online votes and survey responses. We analyzed cross-sectional surveys using descriptive statistics, and semi-structured interviews with contest participants using thematic coding to explore barriers and facilitators to contest engagement. Approximately 82% of entries were from young people in DC. A convenience sample of 181 people voted on their favorite crowdsourced PrEP messages and shared their awareness and attitudes about PrEP. The contest website received 2,500 unique visitors and 4,600 page views. Themes from semi-structured interviews (n = 16) included the need for more community engagement in developing PrEP messaging and positive attitudes towards crowdsourcing. Survey data (n = 887) showed that the crowdsourced messages were well-liked and resonated with the community. Most preferred to see PrEP messages in social media (23%), email (17%) and videos (14%). Approximately 70% of survey participants reported that after viewing the crowdsourced message they would talk to their sexual partner or medical provider (63%) about PrEP, use PrEP (58%), and learn more about PrEP (56%). Crowdsourced messages solicit substantial online viewership. More implementation research is needed to understand the public health impact of integrating social media, crowdsourcing, and community engagement to develop PrEP promotional messages.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.
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.
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.
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