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
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. INTERVENTION(S): 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 MEASURE(S): Standard recommended and minimum required questionnaires to capture detailed clinical and covariate data. RESULT(S): 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. CONCLUSION(S): 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.
endometriosis clinical phenotype data collection, World Endometriosis Research Foundation harmonization, endometriosis epidemiologic data standardization, nonsurgical endometriosis phenotyping, large-scale endometriosis collaborative research, endometriosis covariate data harmonization, international endometriosis phenome project, endometriosis research data tools, clinical classification endometriosis standardized
PMID 25256930 25256930 DOI 10.1016/j.fertnstert.2014.07.1244 10.1016/j.fertnstert.2014.07.1244 Vitonis et al. 2014, Vitonis 2014
Cite this article
Vitonis, A. F., Vincent, K., Rahmioglu, N., Fassbender, A., Buck Louis, G. M., Hummelshoj, L., Giudice, L. C., Stratton, P., Adamson, G. D., Becker, C. M., Zondervan, K. T., Missmer, S. A., & WERF EPHect Working Group (2014). World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonization Project: II. Clinical and covariate phenotype data collection in endometriosis research. Fertility and sterility, 102(5), 1223-1232. https://doi.org/10.1016/j.fertnstert.2014.07.1244
Vitonis AF, Vincent K, Rahmioglu N, Fassbender A, Buck Louis GM, Hummelshoj L, et al. World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonization Project: II. Clinical and covariate phenotype data collection in endometriosis research. Fertil Steril. 2014;102(5):1223-1232. doi:10.1016/j.fertnstert.2014.07.1244
Vitonis, A. F., et al. "World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonization Project: II. Clinical and covariate phenotype data collection in endometriosis research." Fertility and sterility, vol. 102, no. 5, 2014, pp. 1223-1232.
Endometriosis is characterized by frequent recurrences of symptoms and lesions even after extirpative surgery. Because medical therapies control but do not cure the disease, long periods of pharmacologic management may be needed until pregnancy desire or, sometimes, physiologic menopause. Hormonal drugs suppress ovulation and menstruation and have similar beneficial effects against pain. However, only estrogen-progestins and progestins have safety/tolerability/cost profiles that allow long-term use. These compounds induce atrophy of eutopic and ectopic endometrium, have antiinflammatory and proapoptotic properties, and can be delivered via different modalities, including oral, transdermal, subcutaneous, intramuscular, vaginal, and intrauterine routes. At least two-thirds of symptomatic women are relieved from pain and achieve appreciable improvements in health-related quality of life. Progesterone resistance may cause nonresponse in the remaining one-third. When using estrogen-progestins continuously, individualized, tailored cycling should be explained to improve compliance. All combinations demonstrated a similar effect on dysmenorrhea, independently from progestin type. Estrogen-progestins with the lowest possible estrogen dose should be chosen to combine optimal lesion suppression and thrombotic risk limitation. Progestins should be suggested in women who do not respond or manifest intolerance to estrogen-progestins and in those with dyspareunia and/or deep lesions. Progestins do not increase significantly the thrombotic risk and generally may be used when estrogens are contraindicated. Estrogen-progestins and progestins reduce the incidence of postoperative endometrioma recurrence and show a protective effect against endometriosis-associated epithelial ovarian cancer risk.
To determine long-term outcomes after complete laparoscopic excision done at a tertiary referral center in a teenager population, who were not specifically advised to take postoperative hormonal suppression. Prospective observational case series (Canadian Task Force II-3). A tertiary referral center that specializes in the laparoscopic treatment of endometriosis. PATIENT(S): Teenagers with symptoms suspicious for endometriosis who consented and were prospectively recruited to participate in the study. INTERVENTION(S): All patients underwent diagnostic laparoscopy and complete excision of all areas of abnormal peritoneum with typical and atypical endometriosis. Patients were not specifically advised to take postoperative hormonal suppression. MAIN OUTCOME MEASURE(S): Rate of recurrent (or persistent) endometriosis. RESULT(S): Twenty teenagers underwent complete laparoscopic excision of all areas of abnormal peritoneum with typical and atypical endometriosis. Seventeen patients had endometriosis confirmed by histology at initial surgery. Follow-up was up to 66 months (average 23.1 months). There was a statistically significant improvement in most pain symptoms, including bowel-related symptoms, during this time period. The rate of repeat surgery was 8 of 17 patients (47.1%), but the rate of endometriosis (diagnosed visually or histologically) found at surgery was zero. Only one-third of patients took postoperative hormonal suppression for any length of time. CONCLUSION(S): Complete laparoscopic excision of endometriosis in teenagers--including areas of typical and atypical endometriosis--has the potential to eradicate disease. These results do not depend on postoperative hormonal suppression. These data have important implications in the overall care of teenagers, regarding pain management, but also potentially for fertility. Further large comparative trials are needed to verify these results.
To investigate the reasons women experience delays in the diagnosis of endometriosis and the impact of this. A qualitative interview-based study of 32 women, 28 of whom were subsequently diagnosed with endometriosis. Southeast England. PATIENT(S): Women attending a pelvic pain clinic. INTERVENTION(S): Semistructured interviews. MAIN OUTCOME MEASURE(S): Women's reported experiences of being diagnosed with endometriosis. RESULT(S): Delays in the diagnosis of endometriosis occur at an individual patient level and a medical level, as both women and family doctors normalize symptoms, symptoms are suppressed through hormones, and nondiscriminatory investigations are relied upon. Women benefited from a diagnosis, because it provided a language in which to discuss their condition, offered possible management strategies to control symptoms, and provided reassurance that symptoms were not due to cancer. Diagnosis also sanctioned women's access to social support and legitimized absences from social and work obligations. CONCLUSION(S): Although recent guidelines for the management of chronic pelvic pain suggest that diagnostic laparoscopy may be considered a secondary investigation after the failure of therapeutic interventions, the present study highlights the importance of an early diagnosis for women who suffer at physical, emotional, and social levels when they remain undiagnosed.
To determine whether the surgical diagnosis of endometriosis can be predicted using symptoms, signs, and ultrasound findings. Prospective study (study sample); retrospective record review (test sample). Hospital of Desio (study sample) and Mangiagalli Hospital (test sample), Italy. PATIENT(S): Ninety women scheduled to undergo laparoscopy or laparotomy (study sample); 120 women who underwent laparoscopy (test sample). The study sample group was interviewed before surgery about infertility and dysmenorrhea, dyspareunia, and noncyclic pelvic pain and each member had a pelvic examination and a transvaginal ultrasound. At surgery, endometriosis was noted. For the test sample, the same information was abstracted from medical records after laparoscopy. MAIN OUTCOME MEASURE(S): The ability of symptoms, signs, and ultrasound to predict endometriosis at surgery. A classification tree was developed with the study sample and evaluated with the test sample. RESULT(S): Ovarian endometriosis, but not nonovarian endometriosis, could be reliably predicted with noninvasive tools. Ultrasound and examination best predicted ovarian endometriosis, correctly classifying 100% of cases with no false positive diagnoses in the study sample. Similar results were found in the test sample. CONCLUSION(S): Noninvasive tools may be used to identify women with ovarian, but not nonovarian endometriosis, with excellent agreement with surgical diagnosis.