A new self-administered scale to assess painful symptoms of endometriosis in research trials was recently developed by European obstetrician/gynecologists, the first time such a scale has been created with input from both clinicians and patients. (Previous scales relied on clinician input only, including one tool that the same group developed in the early 2000s.)
A modified DELPHI survey process—a structured method to achieve consensus—was used to develop the questionnaire followed by an in-person meeting to finalize it. The process demanded that participants anonymously rate statements over the course of several rounds to weed out inappropriate statements, formulate appropriate statements, and arrive at agreement on final statements. In this instance, there were two rounds of emailed questionnaires, which were sent to both ob/gyns who treat endometriosis and patients with endometriosis. Seventy-six clinicians and patients were invited to participate and 56 accepted (23 ob/gyns and 33 patients) for the first round and 40 (20 ob/gyns and 20 patients) for the second round. Six ob/gyns and three patients attended the in-person meeting. The practitioners, who were selected to represent a broad range of ages and years of practice, were from a variety of geographic regions in France and Belgium, and were employed by university teaching hospitals, general hospitals, and private practices. Patients had been surgically diagnosed with endometriosis and were recruited from a French endometriosis association and by participating clinicians.
Questions for the first-round questionnaire were derived from past research plus a focus group with 8 patients with endometriosis. Forty-eight statements were included and represented 5 general pain categories: severe pelvic pain and dysmenorrhea, dyspareunia, gastrointestinal symptoms, urinary tract symptoms, and other symptoms. The participants rated the statements for diagnostic validity and clarity. Twenty-eight statements were evaluated in the second round; 17 were discarded and a total of 11 statements were selected. Twenty-eight statements were discussed at the live meeting, and the questionnaire was honed to a final total of 21 questions covering spontaneous pelvic pain and dysmenorrhea, dyspareunia, painful bowel symptoms, and other symptoms. The questionnaire was then translated from French to English (UK).
Once finalized, the questionnaire was validated in a pilot study in which 6 patients completed a first draft of the tool and 12 patients completed the second and final draft (which underwent some minor modifications).
A summary of the methodology used to arrive at the questionnaire was published in the Journal of Gynecology Obstetrics and Human Reproduction.
Difficulties Assessing Pain in Patients with Endometriosis
The authors noted the difficulty in measuring pain in endometriosis due to the heterogeneity of the population and the subjective nature of pain. The Delphi method and inclusion of patients and clinicians in the questionnaire process was designed to address this challenge. Another problem was the issue of pain sensitization, a nonspecific mechanism of pain, which their questionnaire and process did not address. Instead, the panelists chose to focus solely on pain symptoms that were directly related to endometriosis lesions.
Nevertheless, they suggested that their questionnaire is superior to others in use, including the Biberoglu and Behrman scale, which was not developed utilizing patient-reported outcomes, and the Endometriosis and Pain and Bleeding Diary, which was, and they recommended use of the questionnaire in diagnostic and therapeutic studies of endometriosis