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Endometriosis is one of the frequently occurred gynaecological problems which leads to levic pain and inflammation.
Endometriosis is an inflammatory and gynaecological
disorder. However, without a reliable and valid patient-reported outcome (PRO)
instrument it is difficult to measure the endometriosis-related pain in
clinical trials. Therefore, in this study, the author developed a PRO known as
Endometriosis Pain Daily Diary (EPDD) and showed its impacts on patients’
lives.
Endometriosis is one of the frequently occurred gynaecological problems
which leads to levic pain and inflammation. The patient-reported outcome (PRO)
measures identified the endometriosis-associated pain significantly, however in
the absence of valid and reliable PRO tool the evaluation of
endometriosis-associated pain in the clinical trials is difficult. This study
explains the development of an electronic PRO, the Endometriosis Pain Daily
Diary (EPDD) as a survey tool to determine endometriosis-associated pain and
its effect on patients’ lives.
By considering a targeted review of the suitable literature, open-ended
(concept elicitation) patient interviews in the Japan and United States (US)
which record patients’ experience, available Endometriosis Pain and Bleeding
Diary, clinical expert interviews, and with endometriosis, an EPDD was
initially developed. The evaluation of patient comprehension of the EPDD items
was done using the cognitive interviews of patients with endometriosis. A
conceptual model of endometriosis was invented.
A meeting with US and European regulatory authorities dispensed feedback
for affirming the EPDD in the context of clinical trials. The confirmation of
its appropriate elucidation and ease of completion over 17 languages was done
by using the translatability assessments of the EPDD.
The three versions of the instrument progressed the iterative development.
The EPDDv1 comprised 18 items associating to dyspareunia and sexual activity,
hot flashes, dysmenorrhea/pelvic pain, use of rescue medication, bleeding, and
daily activities. The EPDDv2 was a large-scale 43-item investigation examined
in cognitive interviews and eventually revised to yield the present 11-item
EPDDv3, comprising of six extension items connecting to daily activities, use
of rescue medication, and sexual activity, and five core items associating to
dyspareunia, non-menstrual pelvic pain, and dysmenorrhea.
The EPDD is a PRO for the determination of endometriosis-associated pain
and its effects on patients’ lives. The EPDD considered as an essential step to
design to assess the related pain and in dispensing a PRO.
Health Qual Life Outcomes. 2018; 16: 3.
Development and content validation of a patient-reported endometriosis pain daily diary
Floortje E. van Nooten et al.
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