{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T23:06:47Z","timestamp":1793315207384,"version":"4.5.0"},"reference-count":43,"publisher":"MDPI AG","issue":"15","license":[{"start":{"date-parts":[[2021,7,21]],"date-time":"2021-07-21T00:00:00Z","timestamp":1626825600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Direction \u00e0 la Recherche Clinique et \u00e0 l\u2019Innovation\u2019 of Versailles, France and the \u2018Institut de Recherche en Sant\u00e9 de la Femme\u2019 (IRSF).","award":["Direction \u00e0 la Recherche Clinique et \u00e0 l\u2019Innovation\u2019 of Versailles, France and the \u2018Institut de Recherche en Sant\u00e9 de la Femme\u2019 (IRSF)."],"award-info":[{"award-number":["Direction \u00e0 la Recherche Clinique et \u00e0 l\u2019Innovation\u2019 of Versailles, France and the \u2018Institut de Recherche en Sant\u00e9 de la Femme\u2019 (IRSF)."]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Objectives: To study the measurement properties, the responsiveness and the minimal clinically important difference of the ENDOPAIN-4D: a new questionnaire for assessing pain in endometriosis. Methods: A prospective, observational, multicentre study was conducted including all women \u226518 years consulting for symptomatic proven endometriosis between 1 January 2017 and 30 June 2018 and volunteering to participate. Each patient had to answer a new self-administered patient-reported outcome (PRO) questionnaires (the ENDOPAIN-4D) at inclusion (T0) and 12 months after medical or surgical treatment (T1). Criteria defined by COSMIN were used to validate the questionnaire\u2019s measurement properties. The minimal clinically important difference was estimated by the anchor-based method. Results: The study included 199 women. The ENDOPAIN-4D score had a four dimensional structure with good internal consistency (measured by Cronbach \u03b1): (I) pain-related disability (\u03b1 = 0.79), (II) painful bowel symptoms (\u03b1 = 0.80), (III) dyspareunia (\u03b1 = 0.83), and (IV) painful urinary tract symptoms (\u03b1 = 0.77). They produced four subscores that can be summed to obtain a single score (\u03b1 = 0.61). The ENDOPAIN-4D total score ranged from 0 to 94.00 (mean \u00b1 SD: 46.7 \u00b1 22). The total score was significantly correlated with the PROs used in endometriosis. Sensitivity to change was good with large effect sizes (ES) (mean of the differences: 36.3 p = 1.8 10\u22127, ES 0.76). The minimal clinically important difference of the global score was determined to be 10.9. Conclusions: The ENDOPAIN-4D questionnaire is easy to use, valid, and effective in assessing patient reported pain symptoms in women treated for endometriosis. This new instrument can be used as the primary outcome for future clinical trials and as a tool for routine patient follow-up.<\/jats:p>","DOI":"10.3390\/jcm10153216","type":"journal-article","created":{"date-parts":[[2021,7,21]],"date-time":"2021-07-21T11:53:23Z","timestamp":1626868403000},"page":"3216","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["The ENDOPAIN 4D Questionnaire: A New Validated Tool for Assessing Pain in Endometriosis"],"prefix":"10.3390","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6348-2375","authenticated-orcid":false,"given":"Anne","family":"Puchar","sequence":"first","affiliation":[{"name":"EA 7285 Research Unit \u2018Risk and Safety in Clinical Medicine for Women and Perinatal Health\u2019, Versailles-Saint-Quentin University (UVSQ), 78180 Montigny-le-Bretonneux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre","family":"Panel","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics, Centre Hospitalier de Versailles, 78150 Le Chesnay, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Oppenheimer","sequence":"additional","affiliation":[{"name":"EA 7285 Research Unit \u2018Risk and Safety in Clinical Medicine for Women and Perinatal Health\u2019, Versailles-Saint-Quentin University (UVSQ), 78180 Montigny-le-Bretonneux, France"},{"name":"Department of Reproductive Medicine and Fertility Preservation, H\u00f4pital Universitaire Antoine B\u00e9cl\u00e8re, 157, Rue de la Porte de Trivaux, 92140 Clamart, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Du Cheyron","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics, Centre Hospitalier Intercommunal de Poissy-Saint-Germain-en-Laye, 78300 Poissy, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4987-8127","authenticated-orcid":false,"given":"Xavier","family":"Fritel","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, University Hospital of Poitiers, 86000 Poitiers, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arnaud","family":"Fauconnier","sequence":"additional","affiliation":[{"name":"EA 7285 Research Unit \u2018Risk and Safety in Clinical Medicine for Women and Perinatal Health\u2019, Versailles-Saint-Quentin University (UVSQ), 78180 Montigny-le-Bretonneux, France"},{"name":"Department of Obstetrics and Gynaecology, University Hospital of Poitiers, 86000 Poitiers, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2021,7,21]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1789","DOI":"10.1016\/S0140-6736(04)17403-5","article-title":"Endometriosis","volume":"364","author":"Giudice","year":"2004","journal-title":"Lancet"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"135","DOI":"10.3109\/0167482X.2015.1074173","article-title":"Impact of Endometriosis on Quality of Life and Mental Health: Pelvic Pain Makes the Difference","volume":"36","author":"Facchin","year":"2015","journal-title":"J. Psychosom. Obstet. Gynaecol."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1292","DOI":"10.1093\/humrep\/des073","article-title":"The Burden of Endometriosis: Costs and Quality of Life of Women with Endometriosis and Treated in Referral Centres","volume":"27","author":"Simoens","year":"2012","journal-title":"Hum. Reprod."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"S125","DOI":"10.1111\/j.1524-4733.2007.00275.x","article-title":"Patient-Reported Outcomes to Support Medical Product Labeling Claims: FDA Perspective","volume":"10","author":"Patrick","year":"2007","journal-title":"Value Health"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"878","DOI":"10.1016\/j.fertnstert.2004.03.046","article-title":"Laparoscopic Excision of Endometriosis: A Randomized, Placebo-Controlled Trial","volume":"82","author":"Abbott","year":"2004","journal-title":"Fertil. Steril."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"798","DOI":"10.1016\/j.fertnstert.2017.07.1165","article-title":"Ethinylestradiol 20 \u039cg\/Drospirenone 3 Mg in a Flexible Extended Regimen for the Management of Endometriosis-Associated Pelvic Pain: A Randomized Controlled Trial","volume":"108","author":"Harada","year":"2017","journal-title":"Fertil. Steril."},{"key":"ref_7","first-page":"178","article-title":"Beneficial Effects of Oral Lactobacillus on Pain Severity in Women Suffering from Endometriosis: A Pilot Placebo-Controlled Randomized Clinical Trial","volume":"13","author":"Khodaverdi","year":"2019","journal-title":"Int. J. Fertil. Steril."},{"key":"ref_8","first-page":"1000","article-title":"Comparison of Cyproterone Acetate and Danazol in the Treatment of Pelvic Pain Associated with Endometriosis","volume":"73","author":"Fedele","year":"1989","journal-title":"Obstet. Gynecol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"136","DOI":"10.1093\/humupd\/dmu046","article-title":"Systematic Review of Endometriosis Pain Assessment: How to Choose a Scale?","volume":"21","author":"Bourdel","year":"2015","journal-title":"Hum. Reprod. Update"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"2686","DOI":"10.1093\/humrep\/det310","article-title":"Comparison of Patient- and Physician-Based Descriptions of Symptoms of Endometriosis: A Qualitative Study","volume":"28","author":"Fauconnier","year":"2013","journal-title":"Hum. Reprod."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"69","DOI":"10.1016\/j.jogoh.2017.11.003","article-title":"A Self-Administered Questionnaire to Measure the Painful Symptoms of Endometriosis: Results of a Modified DELPHI Survey of Patients and Physicians","volume":"47","author":"Fauconnier","year":"2018","journal-title":"J. Gynecol. Obstet. Hum. Reprod."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"1417","DOI":"10.1016\/0895-4356(93)90142-N","article-title":"Cross-Cultural Adaptation of Health-Related Quality of Life Measures: Literature Review and Proposed Guidelines","volume":"46","author":"Guillemin","year":"1993","journal-title":"J. Clin. Epidemiol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"157","DOI":"10.1093\/humrep\/deg009","article-title":"Anatomical Distribution of Deeply Infiltrating Endometriosis: Surgical Implications and Proposition for a Classification","volume":"18","author":"Chapron","year":"2003","journal-title":"Hum. Reprod."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"886","DOI":"10.1016\/j.fertnstert.2017.10.026","article-title":"Diagnosis of Deep Endometriosis: Clinical Examination, Ultrasonography, Magnetic Resonance Imaging, and Other Techniques","volume":"108","author":"Bazot","year":"2017","journal-title":"Fertil. Steril."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"303.e1","DOI":"10.1016\/j.ajog.2010.11.011","article-title":"Urinary Dysfunction after Colorectal Resection for Endometriosis: Results of a Prospective Randomized Trial Comparing Laparoscopy to Open Surgery","volume":"204","author":"Ballester","year":"2011","journal-title":"Am. J. Obstet. Gynecol."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"824","DOI":"10.1093\/humrep\/dez037","article-title":"Validation of the Sexual Activity Questionnaire in Women with Endometriosis","volume":"34","author":"Oppenheimer","year":"2019","journal-title":"Hum. Reprod."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"1258","DOI":"10.1093\/humrep\/dex057","article-title":"Measuring Health-Related Quality of Life in Women with Endometriosis: Comparing the Clinimetric Properties of the Endometriosis Health Profile-5 (EHP-5) and the EuroQol-5D (EQ-5D)","volume":"32","author":"Aubry","year":"2017","journal-title":"Hum. Reprod."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"395","DOI":"10.1016\/S0895-4356(03)00044-1","article-title":"Defining Clinically Meaningful Change in Health-Related Quality of Life","volume":"56","author":"Crosby","year":"2003","journal-title":"J. Clin. Epidemiol."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"236","DOI":"10.1016\/j.injury.2010.11.042","article-title":"What Makes a Measurement Instrument Valid and Reliable?","volume":"42","author":"Scholtes","year":"2011","journal-title":"Injury"},{"key":"ref_20","doi-asserted-by":"crossref","unstructured":"(1997). Revised American Society for Reproductive Medicine Classification of Endometriosis: 1996. Fertil. Steril., 67, 817\u2013821.","DOI":"10.1016\/S0015-0282(97)81391-X"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"197","DOI":"10.1016\/S1297-9589(03)00045-6","article-title":"Deep pelvic endometriosis: Management and proposal for a \u201csurgical classification\u201d","volume":"31","author":"Chapron","year":"2003","journal-title":"Gynecol. Obstet. Fertil."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"407","DOI":"10.1016\/0197-2456(89)90005-6","article-title":"Measurement of Health Status. Ascertaining the Minimal Clinically Important Difference","volume":"10","author":"Jaeschke","year":"1989","journal-title":"Control Clin. Trials"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"69","DOI":"10.1186\/1477-7525-4-69","article-title":"How a Well-Grounded Minimal Important Difference Can Enhance Transparency of Labelling Claims and Improve Interpretation of a Patient Reported Outcome Measure","volume":"4","author":"Brozek","year":"2006","journal-title":"Health Qual. Life Outcomes"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1016\/j.jclinepi.2006.03.012","article-title":"Quality Criteria Were Proposed for Measurement Properties of Health Status Questionnaires","volume":"60","author":"Terwee","year":"2007","journal-title":"J. Clin. Epidemiol."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"290","DOI":"10.1016\/S0002-9343(01)01111-1","article-title":"Effects of Adjustment for Referral Bias on the Sensitivity and Specificity of Single Photon Emission Computed Tomography for the Diagnosis of Coronary Artery Disease","volume":"112","author":"Miller","year":"2002","journal-title":"Am. J. Med."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"155","DOI":"10.1016\/S0015-0282(16)53232-4","article-title":"Stage and Localization of Pelvic Endometriosis and Pain","volume":"53","author":"Fedele","year":"1990","journal-title":"Fertil. Steril."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"299","DOI":"10.1016\/S0015-0282(16)58089-3","article-title":"Endometriosis and Pelvic Pain: Relation to Disease Stage and Localization","volume":"65","author":"Vercellini","year":"1996","journal-title":"Fertil. Steril."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"36","DOI":"10.1016\/j.jmig.2010.08.692","article-title":"Preoperative Evaluation of Posterior Deep-Infiltrating Endometriosis Demonstrates a Relationship with Urinary Dysfunction and Parametrial Involvement","volume":"18","author":"Ballester","year":"2011","journal-title":"J. Minim. Invasive Gynecol."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"323","DOI":"10.2147\/IJWH.S119729","article-title":"Anxiety and Depression in Patients with Endometriosis: Impact and Management Challenges","volume":"9","author":"Rapisarda","year":"2017","journal-title":"Int. J. Womens Health"},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"110512","DOI":"10.1016\/j.jpsychores.2021.110512","article-title":"The Unbearable Burden of Endometriosis: Results from a Large Cohort about Anxiety Reduction during the First Outpatient Evaluation","volume":"147","author":"Arena","year":"2021","journal-title":"J. Psychosom. Res."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"1179","DOI":"10.1007\/s00404-010-1819-0","article-title":"A Structured Questionnaire Improves Preoperative Assessment of Endometriosis Patients: A Retrospective Analysis and Prospective Trial","volume":"284","author":"Hackethal","year":"2011","journal-title":"Arch. Gynecol. Obstet."},{"key":"ref_32","doi-asserted-by":"crossref","unstructured":"(2001). Gruppo Italiano per lo Studio dell\u2019Endometriosi Relationship between Stage, Site and Morphological Characteristics of Pelvic Endometriosis and Pain. Hum. Reprod., 16, 2668\u20132671.","DOI":"10.1093\/humrep\/16.12.2668"},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"507","DOI":"10.1093\/humrep\/deh627","article-title":"Presurgical Diagnosis of Posterior Deep Infiltrating Endometriosis Based on a Standardized Questionnaire","volume":"20","author":"Chapron","year":"2005","journal-title":"Hum. Reprod."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"2698","DOI":"10.1093\/humrep\/dem236","article-title":"Evaluation of a New Questionnaire for the Presurgical Diagnosis of Bladder Endometriosis","volume":"22","author":"Fedele","year":"2007","journal-title":"Hum. Reprod."},{"key":"ref_35","unstructured":"Center for Drug Evaluation and Research (2021, July 08). Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Guidance for Industry, Available online: https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"64","DOI":"10.1186\/1477-7525-8-64","article-title":"The Development and Validation of the Daily Electronic Endometriosis Pain and Bleeding Diary","volume":"8","author":"Deal","year":"2010","journal-title":"Health Qual. Life Outcomes"},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1186\/s12955-017-0819-1","article-title":"Development and Content Validation of a Patient-Reported Endometriosis Pain Daily Diary","volume":"16","author":"Cline","year":"2018","journal-title":"Health Qual. Life Outcomes"},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"1567","DOI":"10.1177\/1933719118789509","article-title":"Development and Validation of the Endometriosis Daily Pain Impact Diary Items to Assess Dysmenorrhea and Nonmenstrual Pelvic Pain","volume":"25","author":"Wyrwich","year":"2018","journal-title":"Reprod. Sci."},{"key":"ref_39","first-page":"CD001300","article-title":"Laparoscopic Surgery for Pelvic Pain Associated with Endometriosis","volume":"4","author":"Jacobson","year":"2009","journal-title":"Cochrane Database Syst. Rev."},{"key":"ref_40","first-page":"CD001019","article-title":"Oral Contraceptives for Pain Associated with Endometriosis","volume":"5","author":"Brown","year":"2018","journal-title":"Cochrane Database Syst. Rev."},{"key":"ref_41","doi-asserted-by":"crossref","first-page":"645","DOI":"10.1016\/0002-9378(81)90478-6","article-title":"Dosage Aspects of Danazol Therapy in Endometriosis: Short-Term and Long-Term Effectiveness","volume":"139","author":"Biberoglu","year":"1981","journal-title":"Am. J. Obstet. Gynecol."},{"key":"ref_42","doi-asserted-by":"crossref","first-page":"228","DOI":"10.1016\/j.ijgo.2012.01.009","article-title":"Detailed Analysis of a Randomized, Multicenter, Comparative Trial of Dienogest versus Leuprolide Acetate in Endometriosis","volume":"117","author":"Strowitzki","year":"2012","journal-title":"Int. J. Gynaecol. Obstet."},{"key":"ref_43","doi-asserted-by":"crossref","first-page":"62","DOI":"10.1016\/j.fertnstert.2008.09.056","article-title":"Pain Scoring in Endometriosis: Entry Criteria and Outcome Measures for Clinical Trials. Report from the Art and Science of Endometriosis Meeting","volume":"93","author":"Vincent","year":"2010","journal-title":"Fertil. Steril."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/10\/15\/3216\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T06:33:01Z","timestamp":1760164381000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/10\/15\/3216"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,7,21]]},"references-count":43,"journal-issue":{"issue":"15","published-online":{"date-parts":[[2021,8]]}},"alternative-id":["jcm10153216"],"URL":"https:\/\/doi.org\/10.3390\/jcm10153216","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,7,21]]}}}