A stepped-care approach to symptomatic endometriosis management: a participatory research initiative
To assess the proportion of patients with symptomatic endometriosis satisfied with their medical treatment 12 months after enrollment in a stepped-care management protocol. Prospective, single-arm, self-controlled study. Academic department. A cohort of 157 consecutive patients referred or self-refe...
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| Veröffentlicht in: | Fertility and sterility 2018-06, Vol.109 (6), p.1086-1096 |
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| creator | Vercellini, Paolo Donati, Agnese Ottolini, Federica Frassineti, Annalisa Fiorini, Jessica Nebuloni, Vanessa Frattaruolo, Maria Pina Roberto, Anna Mosconi, Paola Somigliana, Edgardo |
| description | To assess the proportion of patients with symptomatic endometriosis satisfied with their medical treatment 12 months after enrollment in a stepped-care management protocol.
Prospective, single-arm, self-controlled study.
Academic department.
A cohort of 157 consecutive patients referred or self-referred to our center for symptomatic endometriosis.
Systematic detailed information process on medical and surgical treatment followed by a shared decision to start a stepped-care protocol including three subsequent medical therapy steps (oral contraception [OC]; 2.5 mg/d norethindrone acetate [NETA]; 2 mg/d dienogest [DNG]) and a fourth surgical step. Stepping up was triggered by drug inefficacy/intolerance.
Satisfaction with treatment was assessed according to a five-category scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied). Variations were measured in pain symptoms with the use of a 0–10-point numeric rating scale (NRS), in quality of life with the use of the Short Form 12 questionnaire (SF-12), and in sexual functioning with the use of the Female Sexual Function Index (FSFI).
At the end of the 12-month study period, 106 women were still using OC, 23 were using NETA, three were using DNG, and four had undergone surgery. Twenty-one participants (13%) dropped out from the study. In intention-to-treat analysis, excluding five drop-outs for pregnancy desire, the overall satisfaction rate with the stepped-care protocol was 62% (95/152; 95% CI 55%–70%). By 12-month follow-up, significant improvements were observed in all pain symptom scores and in SF-12 physical and mental component summary scores, whereas FSFI scores did not vary substantially.
Most women with endometriosis-associated pelvic pain who chose a stepped-care approach were satisfied with OC and a low-cost progestin for the treatment of their symptoms. The need to step up to an expensive progestin or surgery was marginal. |
| doi_str_mv | 10.1016/j.fertnstert.2018.01.037 |
| format | Article |
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Prospective, single-arm, self-controlled study.
Academic department.
A cohort of 157 consecutive patients referred or self-referred to our center for symptomatic endometriosis.
Systematic detailed information process on medical and surgical treatment followed by a shared decision to start a stepped-care protocol including three subsequent medical therapy steps (oral contraception [OC]; 2.5 mg/d norethindrone acetate [NETA]; 2 mg/d dienogest [DNG]) and a fourth surgical step. Stepping up was triggered by drug inefficacy/intolerance.
Satisfaction with treatment was assessed according to a five-category scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied). Variations were measured in pain symptoms with the use of a 0–10-point numeric rating scale (NRS), in quality of life with the use of the Short Form 12 questionnaire (SF-12), and in sexual functioning with the use of the Female Sexual Function Index (FSFI).
At the end of the 12-month study period, 106 women were still using OC, 23 were using NETA, three were using DNG, and four had undergone surgery. Twenty-one participants (13%) dropped out from the study. In intention-to-treat analysis, excluding five drop-outs for pregnancy desire, the overall satisfaction rate with the stepped-care protocol was 62% (95/152; 95% CI 55%–70%). By 12-month follow-up, significant improvements were observed in all pain symptom scores and in SF-12 physical and mental component summary scores, whereas FSFI scores did not vary substantially.
Most women with endometriosis-associated pelvic pain who chose a stepped-care approach were satisfied with OC and a low-cost progestin for the treatment of their symptoms. The need to step up to an expensive progestin or surgery was marginal.</description><identifier>ISSN: 0015-0282</identifier><identifier>EISSN: 1556-5653</identifier><identifier>DOI: 10.1016/j.fertnstert.2018.01.037</identifier><identifier>PMID: 29871796</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adolescent ; Adult ; Contraceptives, Oral - therapeutic use ; Endometriosis ; Endometriosis - complications ; Endometriosis - epidemiology ; Endometriosis - therapy ; Female ; Humans ; medical treatment ; Patient Participation - statistics & numerical data ; Patient Satisfaction ; Patient-Centered Care - methods ; Patient-Centered Care - statistics & numerical data ; pelvic pain ; Pelvic Pain - complications ; Pelvic Pain - epidemiology ; Pelvic Pain - therapy ; Quality of Life ; Self Report ; Sexual Dysfunction, Physiological - epidemiology ; Sexual Dysfunction, Physiological - etiology ; surgery ; Surveys and Questionnaires ; Young Adult</subject><ispartof>Fertility and sterility, 2018-06, Vol.109 (6), p.1086-1096</ispartof><rights>2018 American Society for Reproductive Medicine</rights><rights>Copyright © 2018 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c424t-f5229cea1f70e25166ca4fcd8dad91d92b3f4f024fc4f1007534f3644ccd7bad3</citedby><cites>FETCH-LOGICAL-c424t-f5229cea1f70e25166ca4fcd8dad91d92b3f4f024fc4f1007534f3644ccd7bad3</cites><orcidid>0000-0002-0223-0032 ; 0000-0003-4195-0996</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0015028218300633$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29871796$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vercellini, Paolo</creatorcontrib><creatorcontrib>Donati, Agnese</creatorcontrib><creatorcontrib>Ottolini, Federica</creatorcontrib><creatorcontrib>Frassineti, Annalisa</creatorcontrib><creatorcontrib>Fiorini, Jessica</creatorcontrib><creatorcontrib>Nebuloni, Vanessa</creatorcontrib><creatorcontrib>Frattaruolo, Maria Pina</creatorcontrib><creatorcontrib>Roberto, Anna</creatorcontrib><creatorcontrib>Mosconi, Paola</creatorcontrib><creatorcontrib>Somigliana, Edgardo</creatorcontrib><title>A stepped-care approach to symptomatic endometriosis management: a participatory research initiative</title><title>Fertility and sterility</title><addtitle>Fertil Steril</addtitle><description>To assess the proportion of patients with symptomatic endometriosis satisfied with their medical treatment 12 months after enrollment in a stepped-care management protocol.
Prospective, single-arm, self-controlled study.
Academic department.
A cohort of 157 consecutive patients referred or self-referred to our center for symptomatic endometriosis.
Systematic detailed information process on medical and surgical treatment followed by a shared decision to start a stepped-care protocol including three subsequent medical therapy steps (oral contraception [OC]; 2.5 mg/d norethindrone acetate [NETA]; 2 mg/d dienogest [DNG]) and a fourth surgical step. Stepping up was triggered by drug inefficacy/intolerance.
Satisfaction with treatment was assessed according to a five-category scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied). Variations were measured in pain symptoms with the use of a 0–10-point numeric rating scale (NRS), in quality of life with the use of the Short Form 12 questionnaire (SF-12), and in sexual functioning with the use of the Female Sexual Function Index (FSFI).
At the end of the 12-month study period, 106 women were still using OC, 23 were using NETA, three were using DNG, and four had undergone surgery. Twenty-one participants (13%) dropped out from the study. In intention-to-treat analysis, excluding five drop-outs for pregnancy desire, the overall satisfaction rate with the stepped-care protocol was 62% (95/152; 95% CI 55%–70%). By 12-month follow-up, significant improvements were observed in all pain symptom scores and in SF-12 physical and mental component summary scores, whereas FSFI scores did not vary substantially.
Most women with endometriosis-associated pelvic pain who chose a stepped-care approach were satisfied with OC and a low-cost progestin for the treatment of their symptoms. The need to step up to an expensive progestin or surgery was marginal.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Contraceptives, Oral - therapeutic use</subject><subject>Endometriosis</subject><subject>Endometriosis - complications</subject><subject>Endometriosis - epidemiology</subject><subject>Endometriosis - therapy</subject><subject>Female</subject><subject>Humans</subject><subject>medical treatment</subject><subject>Patient Participation - statistics & numerical data</subject><subject>Patient Satisfaction</subject><subject>Patient-Centered Care - methods</subject><subject>Patient-Centered Care - statistics & numerical data</subject><subject>pelvic pain</subject><subject>Pelvic Pain - complications</subject><subject>Pelvic Pain - epidemiology</subject><subject>Pelvic Pain - therapy</subject><subject>Quality of Life</subject><subject>Self Report</subject><subject>Sexual Dysfunction, Physiological - epidemiology</subject><subject>Sexual Dysfunction, Physiological - etiology</subject><subject>surgery</subject><subject>Surveys and Questionnaires</subject><subject>Young Adult</subject><issn>0015-0282</issn><issn>1556-5653</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkMtuHCEQRZGVyJ44_oWIZTbdqaKhH945Vl6SpWySNWKgcBhNN21gLM3fB2tsZ5kNJaFzb6kOYxyhRcD-0671lMqSS31bATi2gC10wxnboFJ9o3rVvWEbAFQNiFFcsHc57wCgx0GcswsxjQMOU79h7obXlnUl11iTiJt1TdHYP7xEno_zWuJsSrCcFhdnKinEHDKfzWLuaaalXHPDV5MqElZTYjryRJlMqg1hCSXU8CO9Z2-92We6ep6X7PfXL79uvzd3P7_9uL25a6wUsjReCTFZMugHIKGw762R3rrRGTehm8S289KDqH_SI8CgOum7Xkpr3bA1rrtkH0-99YaHA-Wi55At7fdmoXjIWoBCGKQYsaLjCbUp5pzI6zWF2aSjRtBPjvVO_3OsnxxrQF0d1-iH5y2H7UzuNfgitQKfTwDVWx8DJZ1toMWSC4ls0S6G_2_5Cz4BlgE</recordid><startdate>201806</startdate><enddate>201806</enddate><creator>Vercellini, Paolo</creator><creator>Donati, Agnese</creator><creator>Ottolini, Federica</creator><creator>Frassineti, Annalisa</creator><creator>Fiorini, Jessica</creator><creator>Nebuloni, Vanessa</creator><creator>Frattaruolo, Maria Pina</creator><creator>Roberto, Anna</creator><creator>Mosconi, Paola</creator><creator>Somigliana, Edgardo</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-0223-0032</orcidid><orcidid>https://orcid.org/0000-0003-4195-0996</orcidid></search><sort><creationdate>201806</creationdate><title>A stepped-care approach to symptomatic endometriosis management: a participatory research initiative</title><author>Vercellini, Paolo ; Donati, Agnese ; Ottolini, Federica ; Frassineti, Annalisa ; Fiorini, Jessica ; Nebuloni, Vanessa ; Frattaruolo, Maria Pina ; Roberto, Anna ; Mosconi, Paola ; Somigliana, Edgardo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c424t-f5229cea1f70e25166ca4fcd8dad91d92b3f4f024fc4f1007534f3644ccd7bad3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Contraceptives, Oral - therapeutic use</topic><topic>Endometriosis</topic><topic>Endometriosis - complications</topic><topic>Endometriosis - epidemiology</topic><topic>Endometriosis - therapy</topic><topic>Female</topic><topic>Humans</topic><topic>medical treatment</topic><topic>Patient Participation - statistics & numerical data</topic><topic>Patient Satisfaction</topic><topic>Patient-Centered Care - methods</topic><topic>Patient-Centered Care - statistics & numerical data</topic><topic>pelvic pain</topic><topic>Pelvic Pain - complications</topic><topic>Pelvic Pain - epidemiology</topic><topic>Pelvic Pain - therapy</topic><topic>Quality of Life</topic><topic>Self Report</topic><topic>Sexual Dysfunction, Physiological - epidemiology</topic><topic>Sexual Dysfunction, Physiological - etiology</topic><topic>surgery</topic><topic>Surveys and Questionnaires</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vercellini, Paolo</creatorcontrib><creatorcontrib>Donati, Agnese</creatorcontrib><creatorcontrib>Ottolini, Federica</creatorcontrib><creatorcontrib>Frassineti, Annalisa</creatorcontrib><creatorcontrib>Fiorini, Jessica</creatorcontrib><creatorcontrib>Nebuloni, Vanessa</creatorcontrib><creatorcontrib>Frattaruolo, Maria Pina</creatorcontrib><creatorcontrib>Roberto, Anna</creatorcontrib><creatorcontrib>Mosconi, Paola</creatorcontrib><creatorcontrib>Somigliana, Edgardo</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Fertility and sterility</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vercellini, Paolo</au><au>Donati, Agnese</au><au>Ottolini, Federica</au><au>Frassineti, Annalisa</au><au>Fiorini, Jessica</au><au>Nebuloni, Vanessa</au><au>Frattaruolo, Maria Pina</au><au>Roberto, Anna</au><au>Mosconi, Paola</au><au>Somigliana, Edgardo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A stepped-care approach to symptomatic endometriosis management: a participatory research initiative</atitle><jtitle>Fertility and sterility</jtitle><addtitle>Fertil Steril</addtitle><date>2018-06</date><risdate>2018</risdate><volume>109</volume><issue>6</issue><spage>1086</spage><epage>1096</epage><pages>1086-1096</pages><issn>0015-0282</issn><eissn>1556-5653</eissn><abstract>To assess the proportion of patients with symptomatic endometriosis satisfied with their medical treatment 12 months after enrollment in a stepped-care management protocol.
Prospective, single-arm, self-controlled study.
Academic department.
A cohort of 157 consecutive patients referred or self-referred to our center for symptomatic endometriosis.
Systematic detailed information process on medical and surgical treatment followed by a shared decision to start a stepped-care protocol including three subsequent medical therapy steps (oral contraception [OC]; 2.5 mg/d norethindrone acetate [NETA]; 2 mg/d dienogest [DNG]) and a fourth surgical step. Stepping up was triggered by drug inefficacy/intolerance.
Satisfaction with treatment was assessed according to a five-category scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied). Variations were measured in pain symptoms with the use of a 0–10-point numeric rating scale (NRS), in quality of life with the use of the Short Form 12 questionnaire (SF-12), and in sexual functioning with the use of the Female Sexual Function Index (FSFI).
At the end of the 12-month study period, 106 women were still using OC, 23 were using NETA, three were using DNG, and four had undergone surgery. Twenty-one participants (13%) dropped out from the study. In intention-to-treat analysis, excluding five drop-outs for pregnancy desire, the overall satisfaction rate with the stepped-care protocol was 62% (95/152; 95% CI 55%–70%). By 12-month follow-up, significant improvements were observed in all pain symptom scores and in SF-12 physical and mental component summary scores, whereas FSFI scores did not vary substantially.
Most women with endometriosis-associated pelvic pain who chose a stepped-care approach were satisfied with OC and a low-cost progestin for the treatment of their symptoms. The need to step up to an expensive progestin or surgery was marginal.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>29871796</pmid><doi>10.1016/j.fertnstert.2018.01.037</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-0223-0032</orcidid><orcidid>https://orcid.org/0000-0003-4195-0996</orcidid><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Elsevier ScienceDirect Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Adolescent Adult Contraceptives, Oral - therapeutic use Endometriosis Endometriosis - complications Endometriosis - epidemiology Endometriosis - therapy Female Humans medical treatment Patient Participation - statistics & numerical data Patient Satisfaction Patient-Centered Care - methods Patient-Centered Care - statistics & numerical data pelvic pain Pelvic Pain - complications Pelvic Pain - epidemiology Pelvic Pain - therapy Quality of Life Self Report Sexual Dysfunction, Physiological - epidemiology Sexual Dysfunction, Physiological - etiology surgery Surveys and Questionnaires Young Adult |
| title | A stepped-care approach to symptomatic endometriosis management: a participatory research initiative |
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