Quality of life assessment as an outcome in clinical trials on nonsurgical options for pain management in endometriosis. Meta-epidemiological study.

• Grant number: 22/12744-3
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: February 01, 2023
• End date: January 31, 2024
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Rachel Riera
• Grantee: Maria Clara Santos Lessa
• Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil

Abstract

Introduction and rationale: Endometriosis affects 5-15% of women in the reproductive period and, in infertile women, the prevalence is approximately 30%. As with any health condition, the choice of therapy should be guided by the results of relevant outcomes evaluated preferably in clinical trials. Thus, it is essential that clinical trials identify clinically relevant outcomes and that they are evaluated using appropriate tools and within an adequate follow-up period. Based on the broad spectrum in which endometriosis impacts the quality of life of patients, given its broad and unspecific clinical picture, the importance of assessing quality of life is highlighted as an important outcome to be analyzed in clinical trials that evaluate therapies and prognosis of endometriosis. Objectives: To evaluate the frequency and characteristics of quality of life measurement in randomized controlled trials of non-surgical interventions for pain management in women with endometriosis. Methods: A meta-epidemiological (descriptive cross-sectional) study of critical evaluation carried out at the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Federal University of São Paulo (Unifesp). Randomized clinical trials will be evaluated, with women who received any non-surgical intervention for endometriosis-related pain. The outcomes of interest to be analyzed will be the frequency of trials of pain interventions that included quality of life as a primary or secondary outcome; frequency and characteristics of the tools used to assess quality of life; way of reporting the variable used to assess quality of life; frequency of measures used to report quality of life and to compare the size of the effect of interventions on quality of life; and frequency of completeness of presentation of numerical results for the quality of life outcome. Randomized clinical trials will be identified in the Medical Literature Analysis and Retrieval System Online database (MEDLINE, via PubMed), the relevant MeSH terms will be used, as well as the related terms in the PubMed hierarchical tree and other synonyms manually identified by the authors. The selection of studies will be carried out in two phases using the Rayyan platform, two researchers will independently extract data from the included studies, considering general information, methodological aspects and details on the included outcomes. Descriptive statistics will be used, with presentation of absolute and relative frequencies (in percentages). Descriptive statistics will also be summarized with summary measures, in graphs and tables. The analyzes will be performed using Microsoft Excel® and STATA® software.