World Endometriosis Research Foundation Endometriosis Phenome and Biobanking  Harmonization Project: II. Clinical and covariate phenotype data collection in  endometriosis research

Allison F Vitonis; Katy Vincent; Nilufer Rahmioglu; Amelie Fassbender; Germaine M Buck Louis; Lone Hummelshoj; Linda C Giudice; Pamela Stratton; G David Adamson; Christian M Becker; Krina T Zondervan; Stacey A Missmer; WERF EPHect Working Group

doi:10.1016/j.fertnstert.2014.07.1244

World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonization Project: II. Clinical and covariate phenotype data collection in endometriosis research

Vitonis AF, Vincent K, Rahmioglu N, Fassbender A, Buck Louis GM, Hummelshoj L, Giudice LC, Stratton P, Adamson GD, Becker CM, Zondervan KT, Missmer SA, WERF EPHect Working Group

Published November 2014 Fertility and Sterility, 102(5), 1223-1232

DOI 10.1016/j.fertnstert.2014.07.1244 PMID 25256930 PMC PMC4252538

RRM Academy Synopsis

Global Group Builds One Shared Endometriosis Research Questionnaire

A global group of endometriosis researchers built one shared questionnaire for studies worldwide. The 2013 project brought together 54 people from 34 research centers and three industry partners in 16 countries. The group made two forms: a longer standard form and a shorter minimum form.

Key Findings

The working group brought together 54 contributors: researchers at 34 clinical and academic centers plus staff at three industry partners, spanning 16 nations.
The questionnaire drew on tools already in use at eight centers that had each published data on more than 100 endometriosis cases.
Pilot testing at EPHect centers found the full standard questionnaire takes 25 to 40 minutes to complete, in either paper or electronic form.
The group agreed on two tiers during a July 2013 workshop: a standard recommended questionnaire and a shorter minimum required version.
The questionnaire asks about roughly 30 past medical conditions, rates pain intensity on an 11-point scale, and includes a 13-item pain catastrophizing scale.

Interpretation

This project is a consensus methods report that produced one shared research questionnaire for endometriosis studies. The working group used tools already in place at eight large research centers, plus a literature review and two 2013 workshops. The form asks about pelvic pain, menstrual and fertility history, past health problems, hormone use, and background details. The authors built it for research use. They state it is not designed for completion and immediate review during a clinic visit. A companion report in the series addresses surgical data. The authors state that shared definitions let large studies compare results and aid research into the disease's causes.

RRM Context

Endometriosis research has long been hard to pool because centers collect data in different ways. One study found that 47% of data fields could not be matched across 53 studies. Restorative reproductive medicine relies on this same kind of careful symptom tracking. Cycle-charting diagnosis needs steady, detailed records over time.

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

Abstract

Objective

To harmonize the collection of nonsurgical clinical and epidemiologic data relevant to endometriosis research, allowing large-scale collaboration.

Design

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

Setting

In 2013, two workshops followed by global consultation, bringing together 54 leaders in endometriosis research.

Patients

None.

Interventions

Development of a self-administered endometriosis patient questionnaire (EPQ), based on [1] systematic comparison of questionnaires from eight centers that collect data from endometriosis cases (and controls/comparison women) on a medium to large scale (publication on >100 cases); [2] literature evidence; and [3] several global consultation rounds.

Main Outcome Measures

Standard recommended and minimum required questionnaires to capture detailed clinical and covariate data.

Results

The standard recommended (EPHect EPQ-S) and minimum required (EPHect EPQ-M) questionnaires contain questions on pelvic pain, subfertility and menstrual/reproductive history, hormone/medication use, medical history, and personal information.

Conclusions

The EPQ captures the basic set of patient characteristics and exposures considered by the WERF EPHect Working Group to be most critical for the advancement of endometriosis research, but is also relevant to other female conditions with similar risk factors and/or symptomatology. The instruments will be reviewed based on feedback from investigators, and-after a first review after 1 year-triannually through systematic follow-up surveys. Updated versions will be made available through http://endometriosisfoundation.org/ephect.

Topics

Research Methods › Study Design › Survey Studies · General Gynecology › Pelvic Pain › Chronic Pelvic Pain

Allison F Vitonis, Katy Vincent, Nilufer Rahmioglu, Amelie Fassbender, Germaine M Buck Louis, Lone Hummelshoj, Linda C Giudice, Pamela Stratton, G David Adamson, Christian M Becker, Krina T Zondervan, Stacey A Missmer

A Vitonis, K Vincent, N Rahmioglu, A Fassbender, G Louis, L Hummelshoj, L Giudice, P Stratton, C Becker, K Zondervan, S Missmer

PMID 25256930 25256930 DOI 10.1016/j.fertnstert.2014.07.1244 10.1016/j.fertnstert.2014.07.1244 Vitonis et al. 2014, Vitonis 2014