EPHect – the Endometriosis Phenome (and Biobanking) Harmonisation Project – may be very helpful for clinicians and the women they are treating

The World Endometriosis Research Foundation (WERF) set up the Endometriosis Phenome and Biobanking Harmonisation Project (EPHect) which has recently published four papers^1–4 aimed at the standardisation of reporting and pathological processing. This consensus was reached after two workshops in 2013 covering all four topics (surgical phenotype;¹ clinical and covariate phenotype;² fluid biospecimen collection, processing and storage;³ tissue collection, processing and storage⁴) with 54 leaders in endometriosis research, sampling and management worldwide.

EPHect is, as far as we are aware, unprecedented in its attempt to provide standards to endeavour to harmonise phenotypic data collection and biological sampling protocols for a specific disease. It remains to be seen whether the initiative will truly attain its objective of facilitating global collaborative research in endometriosis, but the ball is now in the court of national leaders in endometriosis research to ensure that this unique opportunity is not missed.

EPHect is primarily designed to “facilitate large-scale internationally collaborative, longitudinal, epidemiologically robust, translational, biomarker and treatment target discovery research in endometriosis” (a more noble endeavour we cannot envisage – and we couldn’t have put it better ourselves!). Although not specifically designed (nor even intended) for such, we believe that this also presents an opportunity for clinical leaders and clinicians even in a purely clinical setting, to harmonise the collection of standardised clinical and co-variate phenotype data^1,2. Doing so will mean that we gradually become more fluent in a common endometriosis language and more versed in a true understanding of what has to date appeared a heterogeneous disease, not uncommonly described as an enigma^1,2. This level of standardisation of documentation will surely be just as important in the future for optimising patient-focused individualised care as for research. And familiarity with the standard documentation will facilitate clinical leaders to engage in collaborative research efforts seamlessly.

Certainly the collection of “standardized detailed information” and “thus optimizing the surgical phenotype”¹ should become a non-negotiable standard each time surgery is undertaken for endometriosis, as the recognition dawns that only a small percentage of women suffering from endometriosis worldwide will ever have the chance to undergo surgery. It is thus imperative that as much information as possible is gained each time a woman undergoes laparoscopic surgery for endometriosis and that this information is comparable with any other woman in the world having surgery for endometriosis.

Two surgical data forms were created¹. The standard (recommended) surgical form (EPHect SSF) and the minimum required surgical form (EPHect MSF). We believe that ‘surgeons with expertise’ (relating to the ‘networks of expertise’ that the World Endometriosis Society consensus group on current management of endometriosis has previously described⁵) should collect information to complete the SSF. The EPHect SSF has two parts. The first asks for clinical covariates (details of clinical relevance) such as last menstrual period, current medical therapy and previous endometriosis surgery and findings. The second part focuses on intraoperative findings such as duration of procedure, extent of endometriosis (location, size and colour of endometriotic lesions, as well as surgical treatment undertaken), location of biopsies, intraoperative complications, extent of residual endometriosis at the end of the surgery and any other pathological findings. Standardisation of the way in which we undertake surgery is a feature that we have now identified to be lacking in terms of diagnosis and classification of endometriosis⁵. Thus this EPHect initiative should produce a standardised way in which we all undertake laparoscopy and laparoscopic removal of endometriosis. Specifically, the EPHect laparoscopic surgical technique calls for:

Two clinical and covariate phenotype data forms have also been created in a similar fashion to the surgical phenotype data: a standard endometriosis patient questionnaire (EPQ-S) and the minimum required endometriosis patient questionnaire (EPG-M)². These clinical data, again, are geared towards research, however clinicians must seriously consider moving towards routine clinical data collection in order to manage their patients optimally and to determine how research data translates to their own patient population and to individual women. The EPQ-S includes questions on the following:

The third and fourth papers in this sequence dealt respectively with standard operating procedures for collection, processing and long term storage of fluid biospecimens³ and tissue⁴. These papers have less direct relevance to clinicians.

Summary

The four papers are freely available for clinicians to obtain further information. It is hoped that implementation should be easily achievable as much that is required is standard practice. The project will ensure there is full documentation of patient demographics, history, care, surgical findings and specimen control enabling clinicians everyday gold standard care to be used in robust research studies and finally allowing for a significant sample size to be obtained and hopefully for firm recommendations to be able to made on patient care.