"New Pain Dairy" Could Help Better Evaluate the Impact of Endometriosis on Women’s Daily LivesApr 12, 2018
It can also be an invaluable tool to assess patients’ response to new treatments in clinical trials.
- Researchers developed a new diary that could help evaluate the impact of endometriosis pain on daily life.
- A patient-reported outcome is of paramount importance to assess the effect of new treatments in clinical trials.
What's done here:
- A self-reported diary was developed based on an existing endometriosis pain and bleeding diary.
- The final version of the diary includes items about pelvic pain, period pain, and pain during intercourse, as well as sexual activity, daily activities, and use of medication to relieve pain.
- The diary was explicitly designed to be used in clinical trials to assess the patients’ response to treatment, so items about the patients’ personal experience with endometriosis such as work impairment, hot flashes, and impact on sleep were not included in the final version.
- The diary does not address pain during defecation or exercise, nor does it treat other symptoms of the disease such as bloating, dizziness, nausea, vomiting, difficulties with physical functioning, work/school limitations, relationship interference, or emotional functioning.
- The diary’s reliability, construct validity, and ability to detect change have not been established.
Researchers developed a new patient-reported endometriosis pain daily diary.
The diary can help evaluate endometriosis-related pain and the impacts this can have on patients' lives as well as be used in clinical trials to assess patients’ response to treatment.
“The [diary] represents an important step in providing an effective [patient-reported outcome] to evaluate pain associated with endometriosis and its related impacts on patients,” the researchers wrote in their article that was published in the journal Health and Quality of Life Outcomes.
It is difficult to assess endometriosis-related pain and how potential new drugs and procedure impact on this pain without having a reliable patient-reported outcome measure. So the team led by Dr. Matthew Reaney at ERT in Peterborough, UK developed the endometriosis pain daily diary.
The dairy was initially developed using an existing diary called the endometriosis pain and bleeding diary. The researchers conducted interviews with patients with endometriosis to evaluate their comprehension of the diary. They also had meetings with US and European regulatory authorities to validate the diary in the context of clinical trials.
The diary went through three versions before reaching its final state. The first version had 18 items about pelvic pain/painful periods, pain during intercourse, bleeding, hot flashes, daily activities, and the use of medication to relieve pain.
The second version was more extensive and included 43 items, which were then revised and cut down to 11 items for the third and final version of the diary. This third version consists of five core items about painful periods, pelvic pain not related to periods, and painful intercourse as well as six extension items about sexual activity, daily activities, and use of medication to relieve pain.
Research Source: https://www.ncbi.nlm.nih.gov/pubmed/29301557
Pain diary clinical trial outcome measure quality of life