Developing Core Outcome Sets (COS) and Core Outcome Measures Sets (COMS) in Cosmetic Gynecological Interventions: Protocol for a Development and Usability Study.

BACKGROUND: Studies evaluating cosmetic gynecological interventions have followed variable methodology and reported a diversity of outcomes. Such variations limit the comparability of studies and the value of research-based evidence. The development of core outcome sets (COS) and core outcome measures sets (COMS) would help address these issues, ensuring a minimum of outcomes important to all stakeholders, primarily women requesting or having experienced cosmetic gynecological interventions. OBJECTIVE: This protocol describes the methods used in developing a COS and COMS for cosmetic gynecological interventions. METHODS: An international steering group within CHORUS, including health care professionals, researchers, and women with experience in cosmetic gynecological interventions from 4 continents, will guide the development of COS and COMS. Potential outcome measures and outcomes will be identified through comprehensive literature reviews. These potential COS and COMS will be entered into an international, multi-perspective web-based Delphi survey where Delphi participants judge which domains will be core. A priori thresholds for consensus will get established before each Delphi round. The Delphi survey results will be evaluated quantitatively and qualitatively in subsequent stakeholder group consensus meetings in the process of establishing "core" outcomes. RESULTS: Dissemination and implementation of the resulting COS and COMS within an international context will be promoted and reviewed. CONCLUSIONS: This protocol presents the steps in developing a COS and COMS for cosmetic gynecological interventions. Embedding the COS and COMS for cosmetic gynecological interventions within future clinical trials, systematic reviews, and practice guidelines could contribute to enhancing the value of research and improving overall patient care. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials (COMET) 1592; https://tinyurl.com/n8faysuh. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/28032

The inter-system association between the simplified pelvic organ prolapse quantification system (S-POP) and the standard pelvic organ prolapse quantification system (POPQ) in describing pelvic organ prolapse

The objective of this study is to determine the association between the POPQ and a simplified version of the POPQ. This was an observational study. The subjects with pelvic floor disorder symptoms underwent two exams: a POPQ exam and a simplified POPQ. To compare with the simplified POPQ, vaginal segments of the POPQ exam were defined using points Ba, Bp, C, and D. Primary outcome was the association between the overall ordinal stages from each exam. One hundred forty-three subjects with mean age of 56 +/- 13 years. Twenty three subjects were status post-hysterectomy. The Kendall's tau-b statistic for overall stage was 0.80, for the anterior vaginal wall the Kendall's tau-b was 0.71, for the posterior vaginal wall segment the Kendall's tau-b was 0.71, for the cervix the Kendall's tau-b was 0.88, for the posterior fornix/vaginal cuff the Kendall's tau-b was 0.85. There is substantial association between the POPQ and a simplified version of the POPQ.22334735

The FIGO assessment scoring system (FASS): a new holistic classification tool to assess women with pelvic floor dysfunction: validity and reliability.

The aim of our study was to assess the interobserver and intraobserver reliability as well as the content and construct validity of the FIGO prolapse assessment scoring system (FASS).Women with and without (controls) symptoms of pelvic organ prolapse (POP) attending gynaecology outpatient clinics in four different countries were recruited prospectively. Each woman was assessed using the FASS which included: (1) physical examination findings designated with the letter P; (2) presence of symptoms of prolapse, urinary and bowel symptoms designated with the letter S; and (3) assessment of degree of bother designated with the letter B. A scoring system was also developed. For interobserver reliability women were examined by two separate examiners using the FASS. For intraobserver reliability the FASS was repeated by the same examiner within 2 weeks. The interclass correlation coefficient (ICC) was also calculated to assess limits of agreements. Validity was assessed by comparing the FASS scores between symptomatic and asymptomatic women using the Mann-Whitney U test (p value <0.001).A total of 177 women (98 symptomatic and 79 controls) were recruited. Intraobserver reliability had ICCs between 0.716 and 1. Interobserver reliability had ICCs between 0.795 and 0.909. Domain and total scores were significantly different between symptomatic and asymptomatic women (p < 0.001, Mann-Whitney U test). There was a good correlation between FASS P scores and POP-Q scores (rho 0.763, p < 0.001).The FIGO prolapse assessment scoring system has good intraobserver and interobserver agreement and has demonstrated both content and construct validity