A systematic literature review on patient-reported outcome domains and measures in nonsurgical efficacy trials related to chronic pain associated with endometriosis: an urgent call to action

被引:0
作者
Rosenberger, Daniela Constanze [1 ]
Mennicken, Emilia [1 ]
Schmieg, Iris [1 ]
Medkour, Terkia [2 ]
Pechard, Marie [2 ]
Sachau, Juliane [3 ]
Fuchtmann, Fabian [1 ]
Birch, Judy [4 ]
Schnabel, Kathrin [1 ]
Vincent, Katy [5 ]
Baron, Ralf [3 ]
Bouhassira, Didier [2 ]
Pogatzki-Zahn, Esther Miriam [1 ]
机构
[1] Univ Hosp Muenster, Dept Anesthesiol Intens Care & Pain Med, Munster, Germany
[2] UVSQ Paris Saclay Univ, Ambroise Pare Hosp, INSERM, U987, Boulogne Billancourt, Paris, France
[3] Univ Hosp Schleswig Holstein, Dept Neurol, Div Neurol Pain Res & Therapy, Campus Kiel, Kiel, Germany
[4] Pelv Pain Support Network, Poole, England
[5] Univ Oxford, John Radcliffe Hosp, Nuffield Dept Womens & Reprod Hlth, Oxford, England
关键词
Chronic pelvic pain; PROMs; Systematic literature research; Endometriosis; Core outcome set; QUALITY-OF-LIFE; DEPOT MEDROXYPROGESTERONE ACETATE; STAGE-III-IV; CHRONIC PELVIC PAIN; ADD-BACK THERAPY; HORMONE REPLACEMENT THERAPY; ORAL GNRH ANTAGONIST; LONG-TERM TREATMENT; LOW-DOSE DANAZOL; POSTOPERATIVE MEDICAL-TREATMENT;
D O I
10.1097/j.pain.0000000000003290
中图分类号
R614 [麻醉学];
学科分类号
100217 ;
摘要
Supplemental Digital Content is Available in the Text. Endometriosis, a common cause for chronic pelvic pain, significantly affects quality of life, fertility, and overall productivity of those affected. Therapeutic options remain limited, and collating evidence on treatment efficacy is complicated. One reason could be the heterogeneity of assessed outcomes in nonsurgical clinical trials, impeding meaningful result comparisons. This systematic literature review examines outcome domains and patient-reported outcome measures (PROMs) used in clinical trials. Through comprehensive search of Embase, MEDLINE, and CENTRAL up until July 2022, we screened 1286 records, of which 191 were included in our analyses. Methodological quality (GRADE criteria), information about publication, patient population, and intervention were assessed, and domains as well as PROMs were extracted and analyzed. In accordance with IMMPACT domain framework, the domain pain was assessed in almost all studies (98.4%), followed by adverse events (73.8%). By contrast, assessment of physical functioning (29.8%), improvement and satisfaction (14.1%), and emotional functioning (6.8%) occurred less frequently. Studies of a better methodological quality tended to use more different domains. Nevertheless, combinations of more than 2 domains were rare, failing to comprehensively capture the bio-psycho-social aspects of endometriosis-associated pain. The PROMs used showed an even broader heterogeneity across all studies. Our findings underscore the large heterogeneity of assessed domains and PROMs in clinical pain-related endometriosis trials. This highlights the urgent need for a standardized approach to both, assessed domains and high-quality PROMs ideally realized through development and implementation of a core outcome set, encompassing the most pivotal domains and PROMs for both, stakeholders and patients.
引用
收藏
页码:2419 / 2444
页数:26
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