The 7-item Asthma Control Questionnaire (ACQ) has been validated to measure the goals of asthma management as defined by international guidelines (minimisation of day- and night-time symptoms, activity limitation, beta(2)-agonist use and bronchoconstriction). Responses are given on a 7-point scale and the overall score is the mean of the responses (0=totally controlled, 6=severely uncontrolled). The aim of this analysis was to determine the cut-point on the ACQ that best differentiates between 'well-controlled' and 'not well-controlled' for (a) clinical practice (low risk of missing 'not well-controlled') and (b) clinical trials (low risk of including 'well-controlled'). All 1323 patients who provided data sets at week 12 in the Gaining Optimal Asthma Control (GOAL) clinical trial were included in the analysis. The gold standard for 'well-controlled' was a composite based on the GINA/NIH guidelines and derived from data collected in the clinical trial diaries and clinic records. The analysis showed that the crossover point between 'well-controlled' and 'not well-controlled' is close to 1.00 on the ACQ. However, to be confident that a patient has well-controlled asthma, the optimal cut-point is 0.75 (negative predictive value=0.85). To be confident that the patient has inadequately controlled asthma, the optimal cut-point is 1.50 (positive predictive value=0.88). In conclusion, knowledge of these cut-points will enhance practising clinicians ability to identify patients whose asthma requires additional treatment, enable investigators to enroll poorly controlled patients into studies and for both clinicians and investigators to evaluate whether treatment goals are being achieved.

Objective-The objective of this study was to elicit and assess important symptom domains and the impact of fibromyalgia on patients' quality of life and functioning from a patient's perspective. The intention was to collect this information as part of an overall effort to overcome shortcomings of existing outcome measures in fibromyalgia.Methods-This was a qualitative study in which six focus group sessions with 48 women diagnosed with fibromyalgia were conducted to elicit concepts and ideas to assess the impact of fibromyalgia on their lives.Results-The focus groups conducted with fibromyalgia patients identified symptom domains that had the greatest impact on their quality of life including pain, sleep disturbance, fatigue depression, anxiety, and cognitive impairment. Fibromyalgia had a substantial negative impact on social and occupational function. Patients reported disrupted relationships with family and friends, social isolation, reduced activities of daily living and leisure activities, avoidance of physical activity, and loss of career or inability to advance in careers or education. Conclusion-The findings from the focus groups revealed that fibromyalgia has a substantial negative impact on patients' lives.Practice Implications-A comprehensive assessment of the multiple symptoms domains associated with fibromyalgia and the impact of fibromyalgia on multidimensional aspects of function should be a routine part of the care of fibromyalgia patients.

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Recently published articles have described criteria to assess qualitative research in the health field in general, but very few articles have delineated qualitative methods to be used in the development of Patient-Reported Outcomes (PROs). In fact, how PROs are developed with subject input through focus groups and interviews has been given relatively short shrift in the PRO literature when compared to the plethora of quantitative articles on the psychometric properties of PROs. If documented at all, most PRO validation articles give little for the reader to evaluate the content validity of the measures and the credibility and trustworthiness of the methods used to develop them. Increasingly, however, scientists and authorities want to be assured that PRO items and scales have meaning and relevance to subjects. This article was developed by an international, interdisciplinary group of psychologists, psychometricians, regulatory experts, a physician, and a sociologist. It presents rigorous and appropriate qualitative research methods for developing PROs with content validity. The approach described combines an overarching phenomenological theoretical framework with grounded theory data collection and analysis methods to yield PRO items and scales that have content validity.

Using emerging international guidelines, stringent procedures were used to develop and evaluate Canadian-French, German and UK translations/adaptions of the 50 item, parent-completed Child Health Questionnaire (CHQ-PF50). Multitrait analysis was used to evaluate the convergent and discriminant validity of the hypothesized item sets across countries relative to the results obtained for a representative sample of children in the US. Cronbach's alpha coefficient was used to estimate the internal consistency reliability for each of the health scales. Floor and ceiling effects were also examined. Seventy-nine percent of all the item-scale correlations achieved acceptable internal consistency (0.40 or higher). The tests of the item convergent and discriminant validity were successful at least 87% of the time across all scales and countries. Equal item variance was observed 90% of the time across all countries. The reliability coefficients ranged from a low of 0.43 (parental time impact, Canadian English) to a high of 0.97 (physical functioning index, Canadian French) across all scales (median 0.80). Negligible floor effects were observed across countries. Noteworthy ceiling effects were observed, as expected, for the hypothesized physical scales (mean effect 73%). Conversely, fewer ceiling effects were observed for the psychosocial scales (range 3-17% behaviour-parental emotional impact). The item-scaling results obtained in these pilot studies support the psychometric properties of the American-English CHQ-PF50 and its respective translations.