{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T05:49:42Z","timestamp":1777873782416,"version":"3.51.4"},"reference-count":31,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Patient Education and Counseling"],"published-print":{"date-parts":[[2025,11]]},"DOI":"10.1016\/j.pec.2025.109261","type":"journal-article","created":{"date-parts":[[2025,7,15]],"date-time":"2025-07-15T15:12:21Z","timestamp":1752592341000},"page":"109261","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"C","title":["Risk communication of study drug side effects: An evaluation of informed consent forms from ClinicalTrials.gov"],"prefix":"10.1016","volume":"140","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3040-0876","authenticated-orcid":false,"given":"Chandler","family":"Coleman","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Owen","family":"Jokinen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Duhig","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"Best","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Linda","family":"Scarazzini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.pec.2025.109261_bib1","unstructured":"US Department of Health and Human Services. Protection of human subjects, \u00a746.116 requirements for informed consent; 2018. \u3008https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\/subpart-A\/section-46.116\u3009."},{"key":"10.1016\/j.pec.2025.109261_bib2","doi-asserted-by":"crossref","first-page":"149","DOI":"10.1097\/PTS.0000000000000310","article-title":"From the patient perspective, consent forms fall short of providing information to guide decision making","volume":"17","author":"Manta","year":"2021","journal-title":"J Patient Saf"},{"key":"10.1016\/j.pec.2025.109261_bib3","unstructured":"Lopienski K. Retention in clinical trials -- Keeping patients on protocols; 2015. \u3008https:\/\/forteresearch.com\/news\/infographic\/infographic-retention-in-clinical-trials-keeping-patients-on-protocols\/\u3009."},{"key":"10.1016\/j.pec.2025.109261_bib4","doi-asserted-by":"crossref","first-page":"148","DOI":"10.1016\/j.cpcardiol.2018.11.002","article-title":"Increasing diversity in clinical trials: overcoming critical barriers","volume":"44","author":"Clark","year":"2019","journal-title":"Curr Probl Cardiol"},{"key":"10.1016\/j.pec.2025.109261_bib5","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1186\/s12910-018-0318-x","article-title":"What information and the extent of information research participants need in informed consent forms: a multi-country survey","volume":"19","author":"Team","year":"2018","journal-title":"BMC M\u00e9d Ethics"},{"key":"10.1016\/j.pec.2025.109261_bib6","article-title":"Participants\u2019 understanding of informed consent in clinical trials: a systematic review and updated meta-analysis","volume":"19","author":"Wu","year":"2024","journal-title":"PLOS ONE"},{"key":"10.1016\/j.pec.2025.109261_bib7","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1111\/ans.12555","article-title":"Patients\u2019 recollection and understanding of informed consent: a literature review","volume":"84","author":"Sherlock","year":"2014","journal-title":"ANZ J Surg"},{"key":"10.1016\/j.pec.2025.109261_bib8","series-title":"A Guideline on the Readability of the Label and Package Leaflet of Medicinal Products for Human Use","author":"European Commission","year":"1998"},{"key":"10.1016\/j.pec.2025.109261_bib9","unstructured":"Guidelines for preparing core clinical-safety information on drugs second edition; 1999. \u3008https:\/\/cioms.ch\/wp-content\/uploads\/2018\/03\/Guidelines-for-Preparing-Core-Clinical-Safety-Info-Drugs-Report-of-CIOMS-Working-Group-III-and-V.pdf\u3009."},{"key":"10.1016\/j.pec.2025.109261_bib10","unstructured":"European Medicines Agency. Product-information templates version 10.3; 2022. \u3008https:\/\/www.ema.europa.eu\/en\/human-regulatory\/marketing-authorisation\/product-information\/product-information-templates\u3009."},{"key":"10.1016\/j.pec.2025.109261_bib11","first-page":"249","article-title":"Verbal labels can triple perceived risk in clinical trials","volume":"40","author":"Berry","year":"2006","journal-title":"Ther Innov Regul Sci"},{"key":"10.1016\/j.pec.2025.109261_bib12","doi-asserted-by":"crossref","first-page":"3820","DOI":"10.1007\/s11606-021-07050-7","article-title":"Imprecision and preferences in interpretation of verbal probabilities in health: a systematic review","volume":"36","author":"Andreadis","year":"2021","journal-title":"J Gen Intern Med"},{"key":"10.1016\/j.pec.2025.109261_bib13","doi-asserted-by":"crossref","first-page":"380","DOI":"10.3390\/healthcare11030380","article-title":"Association between risk communication format and perceived risk of adverse events after COVID-19 vaccination among US adults","volume":"11","author":"Rosen","year":"2023","journal-title":"Healthcare"},{"key":"10.1016\/j.pec.2025.109261_bib14","unstructured":"Medicines and Healthcare products Regulatory Agency. Always read the leaflet: getting the best information with every medicine. Report of the Committee on Safety of Medicines Working Group on Patient Information. London: The Stationery Office, 2005."},{"key":"10.1016\/j.pec.2025.109261_bib15","doi-asserted-by":"crossref","first-page":"277","DOI":"10.1186\/s12911-020-01296-7","article-title":"Communicating tailored risk information of cancer treatment side effects: only words or also numbers?","volume":"20","author":"Vromans","year":"2020","journal-title":"BMC Med Inf Decis Mak"},{"key":"10.1016\/j.pec.2025.109261_bib16","doi-asserted-by":"crossref","first-page":"478","DOI":"10.1002\/pon.3678","article-title":"Low subjective health literacy is associated with adverse health behaviors and worse health-related quality of life among colorectal cancer survivors: results from the profiles registry","volume":"24","author":"Husson","year":"2015","journal-title":"Psycho-Oncology"},{"issue":"3","key":"10.1016\/j.pec.2025.109261_bib17","doi-asserted-by":"crossref","first-page":"232","DOI":"10.1177\/1740774515571139","article-title":"Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level","volume":"12","author":"Kim","year":"2015","journal-title":"Clin Trials"},{"issue":"2","key":"10.1016\/j.pec.2025.109261_bib18","doi-asserted-by":"crossref","first-page":"210","DOI":"10.1037\/a0014474","article-title":"Using icon arrays to communicate medical risks: overcoming low numeracy","volume":"28","author":"Galesic","year":"2009","journal-title":"Health Psychol"},{"key":"10.1016\/j.pec.2025.109261_bib19","article-title":"Do risk visualizations improve the understanding of numerical risks? A randomized, investigator-blinded general population survey","volume":"135","author":"Etnel","year":"2020","journal-title":"Int J M\u00e9d Inf"},{"key":"10.1016\/j.pec.2025.109261_bib20","unstructured":"Menhert, R. & Cravedi, K.G. National Institutes of Health launches \"ClinicalTrials.gov\"; 2000. \u3008https:\/\/www.nlm.nih.gov\/archive\/20040831\/news\/press_releases\/clntrlpr00.html\u3009."},{"key":"10.1016\/j.pec.2025.109261_bib21","article-title":"Clinical trials registration and results information submission","author":"Health and Human Services Department","year":"2016","journal-title":"Fed Regist"},{"issue":"1","key":"10.1016\/j.pec.2025.109261_bib22","doi-asserted-by":"crossref","DOI":"10.5688\/ajpe7113","article-title":"Demystifying content analysis","volume":"84","author":"Kleinheksel","year":"2020","journal-title":"Am J Pharm Educ"},{"key":"10.1016\/j.pec.2025.109261_bib23","doi-asserted-by":"crossref","first-page":"305","DOI":"10.2165\/00002018-200831040-00004","article-title":"Adequacy of patient information on adverse effects: an assessment of patient information leaflets in the UK","volume":"31","author":"Carrigan","year":"2008","journal-title":"Drug Saf"},{"issue":"10","key":"10.1016\/j.pec.2025.109261_bib24","doi-asserted-by":"crossref","first-page":"837","DOI":"10.2165\/11316570-000000000-00000","article-title":"Communicating the risk of side effects to patients: an evaluation of UK regulatory recommendations","volume":"32","author":"Knapp","year":"2009","journal-title":"Drug Saf"},{"issue":"4","key":"10.1016\/j.pec.2025.109261_bib25","doi-asserted-by":"crossref","first-page":"e766","DOI":"10.1097\/SLA.0000000000005255","article-title":"Verbal descriptions of the probability of treatment complications lead to high variability in risk perceptions: a survey study","volume":"277","author":"Rosen","year":"2023","journal-title":"Ann Surg"},{"issue":"1","key":"10.1016\/j.pec.2025.109261_bib26","doi-asserted-by":"crossref","first-page":"1","DOI":"10.2165\/00002018-200326010-00001","article-title":"Patients' understanding of risk associated with medication use: impact of European Commission guidelines and other risk scales","volume":"26","author":"Berry","year":"2003","journal-title":"Drug Saf"},{"issue":"8","key":"10.1016\/j.pec.2025.109261_bib27","doi-asserted-by":"crossref","first-page":"721","DOI":"10.1007\/s40264-015-0307-7","article-title":"Changes in side effect risk communication in patient information leaflets over the past decade: results of a survey","volume":"38","author":"Harris","year":"2015","journal-title":"Drug Saf"},{"key":"10.1016\/j.pec.2025.109261_bib28","doi-asserted-by":"crossref","first-page":"487","DOI":"10.1177\/0272989X15576487","article-title":"The effect of different graphical and numerical likelihood formats on perception of likelihood and choice","volume":"35","author":"Oudhoff","year":"2015","journal-title":"Med Decis Mak"},{"key":"10.1016\/j.pec.2025.109261_bib29","article-title":"Characterization of informed consent forms posted on ClinicalTrials.gov","volume":"4","author":"Tse","year":"2021","journal-title":"J Am Med Assoc Netw Open"},{"key":"10.1016\/j.pec.2025.109261_bib30","unstructured":"National Institute on Minority Health and Health Disparities. Diversity and inclusion in clinical trials. National Institute of Health; 2024. \u3008https:\/\/www.federalregister.gov\/documents\/2024\/12\/04\/2024-28082\/national-institute-on-minority-health-and-health-disparities-research-endowment-programs\u3009."},{"key":"10.1016\/j.pec.2025.109261_bib31","unstructured":"National Center for Education Statistics. U.S. adults with low literacy and numeracy skills: 2012\/14 to 2017; 2022. \u3008https:\/\/nces.ed.gov\/pubs2022\/2022004\/\u3009."}],"container-title":["Patient Education and Counseling"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0738399125006287?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0738399125006287?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T18:22:00Z","timestamp":1777573320000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0738399125006287"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11]]},"references-count":31,"alternative-id":["S0738399125006287"],"URL":"https:\/\/doi.org\/10.1016\/j.pec.2025.109261","relation":{},"ISSN":["0738-3991"],"issn-type":[{"value":"0738-3991","type":"print"}],"subject":[],"published":{"date-parts":[[2025,11]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Risk communication of study drug side effects: An evaluation of informed consent forms from ClinicalTrials.gov","name":"articletitle","label":"Article Title"},{"value":"Patient Education and Counseling","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.pec.2025.109261","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2025 Elsevier B.V. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}],"article-number":"109261"}}