{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T05:45:49Z","timestamp":1775713549427,"version":"3.50.1"},"reference-count":24,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T00:00:00Z","timestamp":1767916800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T00:00:00Z","timestamp":1767916800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100001786","name":"University of Adelaide","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001786","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100011522","name":"Society of Obstetric Medicine of Australia and New Zealand","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011522","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000272","name":"National Institute for Health and Care Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJOG"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To define standardised outcomes, the Core Outcome Set (COS) for reporting in studies of Intrahepatic Cholestasis of Pregnancy (ICP).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>e\u2010Delphi survey and consensus process.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>International.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Population<\/jats:title>\n                    <jats:p>155 individuals from Asia, Europe, Oceania, North and South America: 31 patients (20%), 121 clinicians (78%), and 3 researchers (2%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Maternal and perinatal outcomes reported in studies of ICP were collated. Stakeholders in ICP research and clinical care scored the importance of each outcome using a 9\u2010point Likert scale over three rounds; short\u2010listed outcomes were ranked during face\u2010to\u2010face consensus meetings. The final COS was agreed by the Study Steering Committee. The study was registered prospectively with Core Outcome Measures in Effectiveness Trials. Ethical approval was granted by the King's College London Research Ethics Committee (KCL MRA\u201023\/24\u201039574).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main Outcome Measures<\/jats:title>\n                    <jats:p>From 54 manuscripts, 97 individual clinical outcomes were attributed to ICP. Twenty three outcomes were shortlisted by the e\u2010Delphi surveys, the ranking of which enabled selection of 10 core outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Maternal core outcomes comprise: total maternal bile acid (BA) concentration (maximum), gestational age at peak BA concentration, and itch impact on maternal wellbeing. Birth core outcomes comprise: stillbirth, gestational age at birth, and spontaneous preterm birth versus induced preterm birth. Neonatal core outcomes comprise: perinatal death within 7\u2009days of birth, perinatal asphyxia, neonatal unit admission, and mechanical ventilation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Given the heterogeneity of reported outcomes, we have confirmed the need for a COS in ICP, standardising the minimum reported outcomes to reduce outcome reporting bias and research wastage.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/1471-0528.70144","type":"journal-article","created":{"date-parts":[[2026,1,10]],"date-time":"2026-01-10T01:33:37Z","timestamp":1768008817000},"page":"1065-1073","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Core Outcome Set for Studies of Intrahepatic Cholestasis of Pregnancy: Results of International e\u2010Delphi and Consensus Processes"],"prefix":"10.1111","volume":"133","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9492-9491","authenticated-orcid":false,"given":"Nadejda","family":"Capatina","sequence":"first","affiliation":[{"name":"Undergraduate Medical Education, Guy's and St Thomas' NHS Foundation Trust  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William","family":"Hague","sequence":"additional","affiliation":[{"name":"Robinson Research Institute The University of Adelaide  Adelaide Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6022-1719","authenticated-orcid":false,"given":"Jenny","family":"Chambers","sequence":"additional","affiliation":[{"name":"Founder, ICP Support  West Midlands UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catherine","family":"Williamson","sequence":"additional","affiliation":[{"name":"Institute of Reproductive and Developmental Biology Imperial College London  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4859-0324","authenticated-orcid":false,"given":"Caroline","family":"Ovadia","sequence":"additional","affiliation":[{"name":"Centre for Reproductive Health, Institute for Regeneration and Repair The University of Edinburgh  Edinburgh UK"},{"name":"Department of Women and Children's Health King's College London  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,1,9]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000000346"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD000493.pub3"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(18)31877\u20104"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471\u20100528.14363"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.maturitas.2016.06.007"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen\u20102021\u2010056629"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471\u20100528.15397"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125\u2010020\u201005123\u20106"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471\u20100528.16319"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471\u20100528.16172"},{"key":"e_1_2_13_12_1","unstructured":"N.Capatina C.Williamson W.Hague J.Chambers andC.Ovadia \u201cDesigning a Core Outcome Set for Studies of Intrahepatic Cholestasis of Pregnancy \u201d Core Outcome Measures in Effectiveness Trials Initiative (COMET) (2023) accessed May 26 2024 https:\/\/comet\u2010initiative.org\/Studies\/Details\/2800."},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1002447"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1002148"},{"key":"e_1_2_13_15_1","unstructured":"ICP Support \u201cAbout Us \u201dhttps:\/\/www.icpsupport.org\/."},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000032829"},{"key":"e_1_2_13_17_1","first-page":"1","article-title":"A Technique for the Measurement of Attitudes","volume":"22","author":"Likert R.","year":"1932","journal-title":"Archives of 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