PRO development: rigorous qualitative research as the crucial foundation.

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.

Perceived subject outcomes and impact on health-related quality of life associated with diet using the new Food Benefits Assessment (FBA) questionnaire: development and psychometric validation.

OBJECTIVE: To assess the perceived outcomes associated with diet/food intake in the general adult population. DESIGN AND SUBJECTS: The Food Benefits Assessment (FBA) questionnaire was developed from subjects' verbatim transcripts (n 18) and after comprehension tests (n 5). Normal-weight (n 130) and overweight (n 67) subjects then completed the final questionnaire twice, 7 d apart. Psychometric properties were assessed, including construct validity by principal components analysis (PCA), concurrent validity (Spearman coefficient) with the Short Form-36 scale (SF-36), known-group validity by comparing FBA dimension scores according to lifestyle and clinical variables, internal consistency reliability (Cronbach's alpha) and test-retest reproducibility in stable subjects over 1 week (intraclass correlation coefficient, ICC). RESULTS: PCA and Multitrait analysis confirmed the final version of the FBA comprising forty-one items split into seven dimensions (vitality; digestive comfort; physical appearance; well-being; snacking; disease prevention; aesthetics). All dimensions displayed good item convergent validity (0.44 to 0.80), good concurrent validity (highest correlation between well-being dimension of FBA and mental health scale of SF-36, r=0.83) and good known-group validity and reproducibility (ICC >or= 0.76); internal consistency reliability was good to excellent (Cronbach's alpha=0.79 to 0.91). CONCLUSION: The FBA is the first valid and reliable questionnaire that allows the assessment of diet effects and impact as perceived by subjects. It is a good candidate in the nutrition field for further use in specific population settings and with a particular food or daily diet. Linguistically validated English (UK and US) and German versions of the questionnaire are available.

Development of the conceptual framework for the Eye-Drop Satisfaction Questionnaire (EDSQ) in glaucoma using a qualitative study.

BACKGROUND: Compliance is a major issue in glaucoma care. It is usually poor in glaucomatous patients, and may ultimately result in an acceleration of the disease progression and a risk of blindness. Reasons for this poor compliance are complex and multifactorial, amongst which patient satisfaction can be counted. The objective of this study was to develop a questionnaire to assess patient satisfaction and compliance with eye-drop treatment. METHODS: A qualitative study was carried out to develop the questionnaire. An interview guide was developed based on a literature review. Structured interviews of fifteen French and English patients with primary open-angle glaucoma or intraocular hypertension were conducted by trained interviewers of the native language of the interviewees. General concepts and subconcepts were identified from the transcripts. The questionnaire was developed using the patient verbatim, and submitted to six patients (French and English) for cognitive debriefing. Following patients' comments, items were modified and restructured, and a pilot questionnaire was designed. RESULTS: Analysis of data from the interviews with patients and clinicians resulted in the elicitation of concepts related to patient satisfaction and compliance with glaucomatous treatment. These were further refined and used to generate a test questionnaire, which consisted of 46 items grouped into 6 domains: patient characteristics, treatment characteristics, patient-clinician relationship, patient experience with the disease and the treatment, interaction between the patient and the treatment, and patient knowledge of the disease and the treatment. CONCLUSION: The Eye-Drop Satisfaction Questionnaire (EDSQ) conceptual framework and items were developed simultaneously in French and in English. This questionnaire could be used to evaluate patient satisfaction and compliance with eye-drop treatment and would facilitate the identification of patients at risk of being non-compliant prior to clinical trials or innovative device tests. A psychometric study is under way to validate the questionnaire.