The development and validation of the daily electronic Endometriosis Pain and Bleeding Diary

Abstract

BackgroundThe 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.MethodsThe 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.ResultsFocus 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 (i.e., worse) compared with subjects with mild symptoms. Item-total correlations for the EPBD pain items (range 0.40-0.89) 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 0.46-0.61). Women with severe endometriosis symptoms reported significantly higher intermittent and continuous dysmenorrhea and intermittent and continuous pelvic pain ratings and greater interference with daily activities compared with women with mild symptoms (all p < 0.01).ConclusionsThe results of this study show that the 17-item EPBD reliably and validly characterizes the types of pain that endometriosis patients identified as being important. As a daily patient-reported assessment, it overcomes the significant potential for intra- and inter-rater variability and rater and recall bias that is inherent in the Biberoglu and Behrman Scale. Additional studies are required to confirm the dimensionality and optimal scoring of the EPBD, to corroborate the present results, and to assess other important measurement properties, such as responsiveness.

Development and content validation of two new patient-reported outcome measures for endometriosis: the Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (EIS)

“…Pain was reported to be experienced at any time, although pain specifically associated with menstrual bleeding [7,23,38] and sexual intercourse [2,3,5,23,39] was commonly reported. Women with endometriosis characterized pain using a variety of sensory descriptors which can be broadly categorized as either continuous/constant or intermittent/ short-term [7,37].…”

Comparison of the paper‐based and electronic versions of the Dermatology Life Quality Index: evidence of equivalence

“…PROs in electronic formats are increasingly being used over their paper counterparts due to their inherent benefits, including a more streamlined process as well as increased reliability of data . If not validated alongside the paper format, several new PROs are being validated initially in electronic format to facilitate easier and higher quality data analysis and to reduce the overall cost of administration and storage. Paper‐based instruments have a number of limitations such as higher rate of missing values; higher error rates in selecting multiple responses for single‐option items; data entry error in transferring responses from paper to electronic databases; and higher costs associated with administration, collection and processing the data .…”

A self-administered questionnaire to measure the painful symptoms of endometriosis: Results of a modified DELPHI survey of patients and physicians

“…As in our study, participants highlighted that two distinct types of pain (intermittent and continuous) existed and were important to measure. Again as in our study, the participants in the qualitative part of the study agreed that a 0-to 10-NRS would be appropriate to rate the pain symptoms [30]. The collection of symptoms is based on a digital daily diary allowing the change of pain over time to be recorded, to avoid recall bias and to take into account the cyclicity of the symptoms [31].…”

“…The items were developed based on clinician input, but the content validity was assessed by the mean of several focus groups and three iterative sets of cognitive interviews with endometriosis patients [30]. The diary covers four aspects: dysmenorrhea, chronic pelvic pain, dyspareunia, and pain interference.…”