tailieunhanh - báo cáo khoa học:" The development and validation of the daily electronic Endometriosis Pain and Bleeding Diary"

Tuyển tập báo cáo các nghiên cứu khoa học quốc tế ngành y học dành cho các bạn tham khảo đề tài: The development and validation of the daily electronic Endometriosis Pain and Bleeding Diary | Deal et al. Health and Quality of Life Outcomes 2010 8 64 http content 8 1 64 I HEALTH AND QUALITY OF LIFE OUTCOMES RESEARCH Open Access The development and validation of the daily electronic Endometriosis Pain and Bleeding Diary Linda S Deal 1 Dana Britt DiBenedetti2 Valerie SL Williams2 and Sheri E Fehnel2 Abstract Background The objective of this study was to develop and validate a daily electronic Endometriosis Pain and Bleeding Diary EPBD for assessing treatment-related changes in endometriosis symptoms from the patient s perspective in a clinical trial setting. Methods The EPBD items were developed based on clinician input and the results of 5 focus groups N 38 and 3 iterative sets of cognitive interviews N 22 . The psychometric properties were evaluated using data collected in a usual-practice non-intervention study conducted at 4 sites in the United States. Existing questionnaires were also administered to explore the construct validity of the EPBD. The development and validation processes were consistent with the recommendations in the 2009 FDA Patient Reported Outcomes Guidance to Industry. Results Focus group participants described 2 distinct types of pain intermittent and continuous which they felt were relevant and important to monitor. Participants also indicated that pain and bleeding spotting associated with intercourse were important symptoms related to endometriosis. Cognitive interviews with additional endometriosis patients served to optimize item content wording and response options. Psychometric analyses found the EPBD items to behave as expected for example item-level means for subjects with severe endometriosis symptoms were higher . worse compared with subjects with mild symptoms. Item-total correlations for the EPBD pain items range indicated that the items were related but not redundant. EPBD pain ratings correlated highly with the modified Brief Pain Inventory-Short Form Pain Intensity score range . .