Validity of two common asthma-specific quality of life questionnaires: Juniper mini asthma quality of life questionnaire and Sydney asthma quality of life questionnaire

Background This study explored the psychometric properties (internal consistency, construct validity, discriminative ability) of the Juniper Mini Asthma Quality of Life Questionnaire (Mini AQLQ-J) and the Sydney Asthma Quality of Life Questionnaire (AQLQ-S). Methods One hundred fourty-six adults (18-45 years) with asthma requiring regular inhaled corticosteroids were recruited to a trial of written emotional disclosure. Correlational analyses were performed to understand the relationship of the two measures with each other, with symptoms, lung function, asthma control, asthma bother and generic quality of life. Median quality of life scores were compared according to gender, health care usage and levels of asthma severity. Results AQLQ-J and AQLQ-S total scores correlated strongly with each other (rho = -0.80) and moderately with the EuroQol Current Health Status Scale (AQLQ-J: rho = 0.35; AQLQ-S: rho = -0.40). Domain score correlations between AQLQ-J and AQLQ-S were mostly moderate (0.5 < rho < 0.8). Both QoL measures were significantly correlated with symptom score. Correlations with the symptom score asthma module (AQLQ-J: rho = -0.69; AQLQ-S: rho = 0.50) were stronger compared with the total symptom score and the symptom score rhinitis module (AQLQ-J: rho = -0.41; AQLQ-M: rho =0.31). Neither QoL measure was significantly correlated with FEV1 % predicted at the total or the domain level. Total scores of both measures were significantly correlated with subjective asthma control (AQLQ-J: rho = 0.68; AQLQ-S: rho = -0.61) and asthma bother (AQLQ-J: rho = -0.73; AQLQ-M: rho = 0.73). Conclusions This study provides further evidence for the validity of the AQLQ-J and the AQLQ-S in a British population of adult patients with asthma managed in primary care. Correlations with lung function parameters were weak or absent. Correlations with generic quality of life were moderate, those with asthma symptoms, asthma control and asthma bother were strong. Both measures are able to discriminate between levels of asthma severity

Validity of three asthma-specific quality of life questionnaires: the patients’ perspective

Objectives: It is not known which of the many asthma-specific quality of life (QoL) questionnaires best capture the lived experience of people with asthma. The objective of this study was to explore patients' views of three commonly used asthma-specific QoL questionnaires. Design: Qualitative study using semistructured interviews. Setting: Primary and secondary care in Brighton and Hove, UK. Participants: 30 adult people with a physician-diagnosis of asthma who were asked to complete the Juniper Asthma Quality of Life Questionnaire (AQLQ-J), the Sydney Asthma Quality of Life Questionnaire (AQLQ-S) and the Living with Asthma Questionnaire (LWAQ) to elicit their views on the content validity of these. Results: Thematic content analysis revealed a lack of congruence between the concerns of people with asthma and the questionnaire content in terms of missing (eg, allergies) and irrelevant (eg, smoky restaurants) content. The AQLQ-J was perceived as a ‘narrow’, ‘medical’ questionnaire focused on symptoms, the environment and functional ability. In contrast, the LWAQ and the AQLQ-S were perceived to be ‘non-medical’. The LWAQ was described as a ‘test’ and as a wide-ranging, embracing and holistic questionnaire. Its strong emotional focus was irritating to some. The AQLQ-S was described as a simple, quick and easy questionnaire, although there was a perception that it was lacking in depth. Conclusions: Patient interviews highlighted strengths and shortcomings in the content validity of these three asthma-specific questionnaires. For patients, the AQLQ-S content seemed to be the most pertinent in its adequacy of coverage of medical, social and emotional aspects of health-related QoL in asthma

Measurement properties of quality-of-life measurement instruments for infants, children and adolescents with eczema: a systematic review

Background: Quality of life (QoL) is one of the core outcome domains identified by the Harmonising Outcome Measures for Eczema (HOME) initiative to be assessed in every eczema trial. There is uncertainty about the most appropriate QoL instrument to measure this domain in infants, children and adolescents. Objectives: To systematically evaluate the measurement properties of existing measurement instruments developed and/or validated for the measurement of QoL in infants, children and adolescents with eczema. Methods: A systematic literature search in PubMed and EMBASE, complemented by a thorough hand search of reference lists, retrieved studies on measurement properties of eczema QoL instruments for infants, children and adolescents. For all eligible studies, we judged the adequacy of the measurement properties and the methodological study quality with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Results from different studies were summarized in a best evidence synthesis and formed the basis to assign four degrees of recommendation. Results: 17 articles, 3 of which were found by hand search, were included. These 17 articles reported on 24 instruments. No instrument can be recommended for use in all eczema trials because none fulfilled all required adequacy criteria. With adequate internal consistency, reliability and hypothesis testing, the US version of the Childhood Atopic Dermatitis Impact Scale (CADIS), a proxy-reported instrument, has the potential to be recommended depending on the results of further validation studies. All other instruments, including all self-reported ones, lacked significant validation data. Conclusions: Currently, no QoL instrument for infants, children and adolescents with eczema can be highly recommended. Future validation research should primarily focus on the CADIS, but also attempt to broaden the evidence base for the validity of self-reported instruments

protocol for a prospective, observational, multi-centre patient cohort study (DACAPO)

Background Health-related quality of life (HRQoL) and return to work are important outcomes in critical care medicine, reaching beyond mortality. Little is known on factors predictive of HRQoL and return to work in critical illness, including the acute respiratory distress syndrome (ARDS), and no evidence exists on the role of quality of care (QoC) for outcomes in survivors of ARDS. It is the aim of the DACAPO study (“Surviving ARDS: the influence of QoC and individual patient characteristics on quality of life”) to investigate the role of QoC and individual patient characteristics on quality of life and return to work. Methods/Design A prospective, observational, multi-centre patient cohort study will be performed in Germany, using hospitals from the “ARDS Network Germany” as the main recruiting centres. It is envisaged to recruit 2400 patients into the DACAPO study and to analyse a study population of 1500 survivors. They will be followed up until 12 months after discharge from hospital. QoC will be assessed as process quality, structural quality and volume at the institutional level. The main outcomes (HRQoL and return to work) will be assessed by self-report questionnaires. Further data collection includes general medical and ARDS-related characteristics of patients as well as sociodemographic and psycho-social parameters. Multilevel hierarchical modelling will be performed to analyse the effects of QoC and individual patient characteristics on outcomes, taking the cluster structure of the data into account. Discussion By obtaining comprehensive data at patient and hospital level using a prospective multi-centre design, the DACAPO-study is the first study investigating the influence of QoC on individual outcomes of ARDS survivors

Validation of the German Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire in Peri- and Postmenopausal Women.

BACKGROUND The Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire is a validated patient-reported outcome measure (PROM) capturing the impacts of vaginal symptoms in postmenopausal women. AIM We aimed to psychometrically validate the German version of the DIVA questionnaire. METHODS Data was collected online and by paper-pencil. We ran confirmatory factor analyses to confirm the a priori four-factor structure of the DIVA. Internal consistency was calculated using Cronbach's alpha. Correlations with other outcome measures such as the Patient Health Questionnaire-4 (PHQ-4), the SF-12 SOEP (socio-economic panel) version and self-created anchor questions were calculated regarding convergent validity. Known groups regarding age, home country and disease severity were analyzed. Test-retest reliability after 1 week and responsiveness after 4 weeks were only descriptively assessed due to low sample sizes. MAIN OUTCOME MEASURES The DIVA questionnaire, the Menopause Rating Scale (MRS II), the PHQ-4 and the SF-12 SOEP version were the main outcome measures. RESULTS 185 postmenopausal women reporting vaginal complaints participated in the survey. The mode of administration did not influence the severity of vaginal symptoms. The four-factor structure of the DIVA could be confirmed and the model fit indicated sufficient structural validity. Furthermore, strong internal consistency in all of the DIVA domains was found. Regarding convergent validity, no hypothesis has failed completely. The results regarding known-groups validity were mostly in line with our a priori hypotheses. Descriptive evidence for sufficient test-retest reliability and responsiveness was given, however, the sample size for the assessment of those two measurement properties was low. CONCLUSION This study supports the excellent structural validity, internal consistency and construct validity of the German version of the DIVA questionnaire. It can be recommended for the assessment of the impacts of vaginal symptoms in postmenopausal women in future clinical GSM trials. Gabes M, Stute P, Apfelbacher C. Validation of the German Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire in Peri- and Postmenopausal Women. Sex Med 2021;9:100382

Measurement properties of quality-of-life outcome measures for children and adults with eczema: an updated systematic review

Objective The aim of this updated systematic review was to systematically assess the measurement properties of previously discussed and new quality‐of‐life patient‐reported outcome measures (PROMs) in children and adults with eczema using the new COSMIN guideline. Methods A systematic literature search was conducted in PubMed and EMBASE. Eligible studies reported on measurement properties of quality‐of‐life PROMs for children and adults with eczema. The methodological quality of selected already known PROMs and new evidence identified through the literature search was assessed with the COSMIN Risk of Bias checklist. The adequacy of included PROMs was judged with updated quality criteria, and the quality of evidence of the summarized results was graded. Finally, PROMs were placed in a recommendation category (A‐C). Results In total, 133 measurement properties of nine different PROMs were assessed. No PROM could be placed in category A due to a lack of validation studies. Only the DLQI fulfilled the criteria for category C and therefore should not be recommended for use. All other PROMs were placed in category B, that is, they still have the opportunity to be recommended, but need further validation. Conclusions Currently, no PROM for quality of life can be recommended for use in children and adults with eczema. Further validation is needed. The DLQI cannot be recommended for future use

The German RECAP questionnaire : linguistic validation and cognitive debriefing in German adults with self-reported atopic eczema and parents of affected children

Background: Recap of atopic eczema (RECAP) is a patient-reported outcome measure (PROM) assessing eczema control. Long-term control of eczema is one of the four core outcome domains for atopic eczema trials. This instrument has been recently developed in the UK. Objective: This study aimed to translate the English RECAP into German and test its content validity in a German population with self-reported atopic eczema. Methods: A six-step procedure including two forward and one backward translations, two consensus decisions and an expert review was performed to obtain a German version of RECAP. We conducted semi-standardized cognitive interviews with adults with atopic eczema (n = 7) and parents having children affected by this disease (n = 5). A “think-aloud” method was used and aspects of comprehensibility, comprehensiveness and relevance according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria were examined. Interviews were coded using qualitative content analysis. Results: No particular linguistic problems were encountered during forward-backward translation. Minor wording changes were made as required. The title was adjusted to a more familiar German term of the disease (which is ‘Neurodermitis’). The recall period was rephrased from ‘over the last week’ to ‘over the last seven days’ since there was a different cultural understanding of the time frame. Regarding content validity, the items of the German RECAP were considered to be comprehensible, comprehensive and relevant for the participants and parents of affected children. The participants understood the instruction and considered the one-week recall period and the response options as appropriate. Conclusions: A German version of RECAP that is linguistically equivalent to the original version is now available but further assessment of its measurement properties is needed.Projekt DEAL 202

Refinement and validation of the ItchyQoL using classical test theory and item response theory resulted in a reduction of the response categories from a 5-point to a 3-point scale

Background The ItchyQoL is an itch-specific patient-reported outcome measure used to assess quality of life in patients with chronic pruritus (CP). Objectives We aimed to assess and extend the psychometric properties of the Itchy- QoL using classical test theory (CTT) and item response theory (IRT). Methods Item characteristic curves were analysed to investigate whether the response categories were functioning optimally. Confirmatory factor analyses were carried out on the ItchyQoL prior to and after rescoring of the response categories. We conducted a Rasch analysis for the ItchyQoL with revised response options and assessed the mean fit residuals in addition to the assumptions of unidimensionality and local independence. Results In total, 551 patients with CP from nine European countries completed the 22 items of the ItchyQoL. IRT analysis supported the revision of response options from five points to three. This revision was supported by excellent structural validity using CTT. The overall fit to the Rasch model was adequate. Unidimensionality was supported by the ItchyQoL overall scale and by the single subscales; however, local independence was violated in eight cases. Conclusions We suggest a revision of the response categories of the ItchyQoL from a 5-point to a 3-point scale. When this revision was applied, the ItchyQoL showed excellent structural validity according to CTT and IRT/Rasch. The calculation of an overall ItchyQoL sum score is allowed.Projekt DEAL 202