Recommendations for assessing patient-reported outcomes and health-related quality of life in patients with urticaria: a GA2LEN taskforce position paper

The aim of this Global Allergy and Asthma European Network (GA2LEN) consensus report is to provide recommendations and suggestions for assessing patient-reported outcomes (PROs) including health-related quality of life in patients with urticaria. We recommend that PROs should be used both in clinical trials and routine practice for the evaluation of urticaria patients. We suggest that PROs should be considered as the primary outcome of future clinical trials. Two validated and disease-specific instruments for assessing PROs are available, the urticaria activity score (for symptoms) and the chronic urticaria questionnaire on quality of life CU-Q2oL. This latter tool, CU-Q2oL, is available in many languages and should be preferred, where available, over more generic instruments for assessing urticaria-specific effects on quality of life. CU-Q2oL is only suited for the investigation of patients with chronic spontaneous urticaria. Similar instruments for other forms of urticaria have yet to be developed and validated. Also, tools for assessing other chronic spontaneous urticaria PROs besides quality of life and symptoms are needed

Generic and diabetes-specific well-being in the AT.LANTUS follow-on study : further psychometric validation of the W-BQ28 indicates its utility in research and clinical practice in type 2 diabetes in the UK

Aims&ensp; To undertake further psychometric validation of the W-BQ28 to determine its suitability for use in adults with Type 2 diabetes in the UK using data from the AT.LANTUS follow-on study.Methods&ensp; A total of 353 people with Type 2 diabetes participated in the AT.LANTUS Follow-on study, completing measures of well-being (W-BQ28), treatment satisfaction (DTSQ) and self-care (SCI-R). Confirmatory factor analyses was used to confirm the W-BQ28 structure and internal consistency reliability was assessed. Additional statistical tests were conducted to explore convergent, divergent and known-groups validity. Minimal important differences were calculated using distribution and anchor-based techniques.Results&ensp; Structure of the W-BQ28 (seven four-item subscales plus 16-item generic and 12-item diabetes-specific scales) was confirmed (comparative fit index = 0.917, root mean square error of approximation (RMSEA) = 0.057). Internal consistency reliability was satisfactory (four-item subscales: alpha = 0.73&ndash;0.90; 12/16-item scales: &alpha; = 0.84&ndash;0.90). Convergent validity was supported by expected moderate to high correlations (rs = 0.35&ndash;0.67) between all W-BQ28 subscales (except Energy); divergent validity was supported by expected low to moderate correlations with treatment satisfaction (rs = &minus;0.03&ndash;0.52) and self-care (rs = 0.02&ndash;0.22). Known-groups validity was supported with statistically significant differences by sex, age and HbA1c for expected subscales. Minimal important differences were established (range 0.14&ndash;2.90).Conclusions&ensp; The W-BQ28 is a valid and reliable measure of generic and diabetes-specific well-being in Type 2 diabetes in the UK. Confirmation of the utility of W-BQ28 (including establishment of minimal important differences) means that its use is indicated in research and clinical practice.<br /

Recommendations for assessing Patient-Reported Outcomes and Health-Related quality of life in clinical trials on allergy: a GA2LEN taskforce position paper

The aim of this GA2LEN consensus report is to provide recommendations for Patient-Reported Outcomes evaluation in clinical trials for allergic diseases, which constitute a global health problem in terms of physical, psychological, economic and social impact. During the last 40 years PROs have gained large consideration and use in the scientific community, in order to gain a better understanding of patients’ subjective assessment with respect to elements concerning their health condition. They include all health-related reports coming from the patient, without involvement or interpretation by physician or others. PROs assessment should be performed by validated tools (disease-specific tools when available, or generic ones) selected taking into account the aim of the study, the expected intervention effects and the determinant and confounding factors or patient related factors which could influence PROs. Moreover, each tool should be used exclusively in the patient population following the authors’ indications without modification and performing a crosscultural validation if the tool must be used in a language that differs from the original. The result analysis also suggests that the relevance of PROs results in any interventional study should include a pre-post assessment providing information concerning statistical differences within or among groups, rates of response for the PROs outcome and a minimal important difference for the population. The report underlines the importance of further investigation on some topics, such as the quality assessment of existing PROs tools, the definition of inclusion and exclusion criteria and a more extensive evaluation of the correlation between PROs, besides HRQoL, and clinical data

Measuring asthma-specific quality of life: structured review

Measuring quality of life (QoL) has become an increasingly important dimension of assessing patient well-being and drug efficacy. As there are now several asthma QoL questionnaires to choose from, it is important to appreciate their strengths and weaknesses. To assist in this choice, we have reviewed the existing questionnaires in a structured way. Information relating to the conceptual and measurement model, reliability, validity, interpretability, burden, administration format and translations was extracted from the published literature. The instruments differ in almost all criteria considered, and therefore it cannot be assumed that they measure the same thing. We recommend the selection of questionnaires that are designed only for asthma and that do not assess symptoms as part of QoL. Only two of the questionnaires reviewed fulfill these requirements: the Sydney Asthma QoL Questionnaire (AQLQ-S) and the Living with Asthma Questionnaire (LWAQ). However, for multinational studies, it may be convenient or practical to use questionnaires that have been linguistically validated in many languages (AQLQ-J, SGRQ). It remains unclear which of these questionnaires best reflects patient perceptions of QoL. Our review did not involve patients, so for the time being choosing from existing questionnaires requires a compromise based on the rigor of the development process and the target patient grou

Specific recommendations for PROs and HRQoL assessment in allergic rhinitis and/or asthma: a GA2LEN taskforce position paper

The GA2LEN taskforce on Patient-Reported Outcomes (PROs) and Health-Related Quality of Life (HRQoL) published in 2009 a position paper concerning PROS and HRQoL assessment in clinical trials on allergy. Because of the specificity of this topic in asthma and rhinitis, specific recommendations are needed. The aim of this position paper is to define PROs and their meaning in asthma and rhinitis research, explore the available tools to provide criteria for a proper choice, identify patientrelated factor which could influence PROs assessment, define specific recommendations for assessment, analysis and results spreading, underline the unexplored areas and unmet needs. PROs assessment is gaining increasing importance, and it must be performed with a rigorous methodological procedure and using validated tools. This approach enables to better understand patient-related factors influencing clinical trials and real-life management outcomes, identify patients subgroups that can benefit from specific treatment and management plan and tailor treatment to address PROs (not only physician-defined targets) to improve asthma and rhinitis management