World Endometriosis Research Foundation Endometriosis Phenome and Biobanking  Harmonisation Project: I. Surgical phenotype data collection in endometriosis  research

Christian M Becker; Marc R Laufer; Pamela Stratton; Lone Hummelshoj; Stacey A Missmer; Krina T Zondervan; G David Adamson; WERF EPHect Working Group

doi:10.1016/j.fertnstert.2014.07.709

Research Methods Measurement and Statistics

World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonisation Project: I. Surgical phenotype data collection in endometriosis research

Becker CM, Laufer MR, Stratton P, Hummelshoj L, Missmer SA, Zondervan KT, Adamson GD, WERF EPHect Working Group

Published November 2014 Fertility and Sterility, 102(5), 1213-1222

DOI 10.1016/j.fertnstert.2014.07.709 PMID 25150390 PMC PMC4230690

RRM Academy Synopsis

Global group sets standard forms to record endometriosis surgery

34 centers and three companies in 16 countries agreed on two new surgery forms. The forms record what doctors see during endometriosis surgery, developed at two 2013 workshops so that endometriosis studies can be compared, with a standard recommended form (SSF) and a shorter minimum required form (MSF).

Study at a glance, international collaboration: Global group agreed two standard forms to record endometriosis surgery — Study at a glance, international collaboration of 34 clinical and academic centers: Global group agreed two standard forms to record endometriosis surgery. Source: Becker CM et al., 2014, PMID 25150390.

Key Findings

The project brought together 34 clinical and academic centers and three companies from 16 countries, for 54 people total, across two meetings held in March and July 2013.
The team built two tools: a longer form called the EPHect SSF for full detail, and a shorter form called the EPHect MSF for centers with less time or staff for research.
Of 54 invitees, 30 attended Workshop II either in person or by video link; during that meeting the standard recommended and minimum required forms were agreed upon.
After some practice, teams found the EPHect SSF usually takes 1 to 3 minutes to fill out, depending on disease extent and sample collection.
The group advises taking one photo of the pelvis right when surgery ends, to show any disease still present, as part of the standard photo record.

Interpretation

This design agreement came from a 2013 meeting of 34 clinical and academic centers and three companies from 16 countries. The group backs the fuller SSF form when a center has the staff for it, with the shorter MSF as a backup. The goal is to make future endometriosis studies easier to compare. The authors note that EPHect sets a shared record for surgical findings; surgical technique itself stays the surgeon's own judgment. The findings support wider adoption of these forms in future endometriosis surgery studies, and larger multi-center use would show how well they hold up across different surgical teams.

RRM Context

RRM surgeons use excision to treat endometriosis, which depends on careful notes about where lesions sit and how they look. Shared forms like the EPHect SSF and MSF give centers a common way to record these details. Wider use of such shared forms could help future studies compare excision results with other surgery methods on equal terms.

Our editorial summary of this paper, not the article's abstract.

Abstract

Objective

To standardize the recording of surgical phenotypic information on endometriosis and related sample collections obtained at laparoscopy, allowing large-scale collaborative research into the condition.

Design

An international collaboration involving 34 clinical/academic centers and three industry collaborators from 16 countries.

Setting

Two workshops were conducted in 2013, bringing together 54 clinical, academic, and industry leaders in endometriosis research and management worldwide.

Patients

None.

Interventions

A postsurgical scoring sheet containing general and gynecological patient and procedural information, extent of disease, the location and type of endometriotic lesion, and any other findings was developed during several rounds of review. Comments and any systematic surgical data collection tools used in the reviewers' centers were incorporated.

Main Outcome Measures

The development of a standard recommended (SSF) and minimum required (MSF) form to collect data on the surgical phenotype of endometriosis.

Results

SSF and MSF include detailed descriptions of lesions, modes of procedures and sample collection, comorbidities, and potential residual disease at the end of surgery, along with previously published instruments such as the revised American Society for Reproductive Medicine and Endometriosis Fertility Index classification tools for comparison and validation.

Conclusions

This is the first multicenter, international collaboration between academic centers and industry addressing standardization of phenotypic data collection for a specific disease. The Endometriosis Phenome and Biobanking Harmonisation Project SSF and MSF are essential tools to increase our understanding of the pathogenesis of endometriosis by allowing large-scale collaborative research into the condition.

Topics

Research Methods › Measurement and Statistics › Instrument Development and Validation · Clinical Guidelines and Standards › Diagnostic Criteria and Classification › Staging and Classification Systems

Christian M Becker, Marc R Laufer, Pamela Stratton, Lone Hummelshoj, Stacey A Missmer, Krina T Zondervan, G David Adamson

C Becker, M Laufer, P Stratton, L Hummelshoj, S Missmer, K Zondervan

PMID 25150390 25150390 DOI 10.1016/j.fertnstert.2014.07.709 10.1016/j.fertnstert.2014.07.709 Becker et al. 2014, Becker 2014