{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T13:44:21Z","timestamp":1786455861782,"version":"build-2736575974"},"reference-count":27,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,6,18]],"date-time":"2024-06-18T00:00:00Z","timestamp":1718668800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,6,18]],"date-time":"2024-06-18T00:00:00Z","timestamp":1718668800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100010414","name":"Health Research Board","doi-asserted-by":"publisher","award":["HRB-TMRN-2017-001."],"award-info":[{"award-number":["HRB-TMRN-2017-001."]}],"id":[{"id":"10.13039\/100010414","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Evidence indicates that trial participants often struggle to understand participant information leaflets (PILs) for clinical trials, including the concept of randomisation. We analysed the language used to describe randomisation in PILs and determine the most understandable and acceptable description through public and participant feedback.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>We collected 280 PILs\/informed consent forms and one video animation from clinical research facilities\/clinical trial units in Ireland and the UK. We extracted text on how randomisation was described, plus trial characteristics. We conducted content analysis to group the randomisation phrases inductively. We then excluded phrases that appeared more than once or were very similar to others. The final list of randomisation phrases was then presented to an online panel of participants and the public. Panel members were asked to rate each phrase on a 5-point Likert scale in terms of their understanding of the phrase, confidence in their understanding and acceptability of the phrase.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Two hundred and\u00a0eighty PILs and the transcribed text from one video animation represented 229 ongoing or concluded trials. The pragmatic content analysis generated five inductive categories: (1) explanation of why randomisation is required in trials; (2) synonyms for randomisation; (3) comparative randomisation phrases; (4) elaborative phrases for randomisation (5) and\u00a0phrases that describe the process of randomisation. We had 48 unique phrases, which were shared with 73 participants and members of the public. Phrases that were well understood were not necessarily acceptable. Participants understood, but disliked, comparative phrases that referenced gambling, e.g. toss of a coin, like a lottery, roll of a die. They also disliked phrases that attributed decision-making to computers or automated systems. Participants liked plain language descriptions of what randomisation is and those that did not use comparative phrases.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Potential trial participants are clear on their likes and dislikes when it comes to describing randomisation in PILs. We make five recommendations for practice.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-024-08217-3","type":"journal-article","created":{"date-parts":[[2024,6,19]],"date-time":"2024-06-19T07:02:21Z","timestamp":1718780541000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Trial participants\u2019 self-reported understanding of randomisation phrases in participation information leaflets can be high, but acceptability of some descriptions is low, especially those linked to gambling and luck"],"prefix":"10.1186","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0969-8321","authenticated-orcid":false,"given":"Frances","family":"Shiely","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellen","family":"Murphy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katie","family":"Gilles","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kerry","family":"Hood","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lydia","family":"O\u2019Sullivan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola","family":"Harman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Talia","family":"Isaacs","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaun","family":"Treweek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,6,18]]},"reference":[{"key":"8217_CR1","unstructured":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Good Clinical Practice Guidelines. Brussels: World Health Organisation. 1990, 2013."},{"issue":"9","key":"8217_CR2","doi-asserted-by":"publisher","first-page":"e037994","DOI":"10.1136\/bmjopen-2020-037994","volume":"10","author":"L O\u2019Sullivan","year":"2020","unstructured":"O\u2019Sullivan L, Sukumar P, Crowley R, McAuliffe E, Doran P. Readability and understandability of clinical research patient information leaflets and consent forms in Ireland and the UK: a retrospective quantitative analysis. BMJ Open. 2020;10(9):e037994.","journal-title":"BMJ Open"},{"issue":"3","key":"8217_CR3","doi-asserted-by":"publisher","first-page":"420","DOI":"10.1016\/j.amjsurg.2009.02.010","volume":"198","author":"ME Falagas","year":"2009","unstructured":"Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G. Informed consent: how much and what do patients understand? Am J Surg. 2009;198(3):420\u201335.","journal-title":"Am J Surg"},{"issue":"5","key":"8217_CR4","doi-asserted-by":"publisher","first-page":"441","DOI":"10.1016\/j.cct.2006.04.006","volume":"27","author":"JM Griffin","year":"2006","unstructured":"Griffin JM, Struve JK, Collins D, Liu A, Nelson DB, Bloomfield HE. Long term clinical trials: how much information do participants retain from the informed consent process? Contemp Clin Trials. 2006;27(5):441\u20138.","journal-title":"Contemp Clin Trials"},{"issue":"6803","key":"8217_CR5","doi-asserted-by":"publisher","first-page":"610","DOI":"10.1136\/bmj.303.6803.610","volume":"303","author":"N Lyn\u00f6e","year":"1991","unstructured":"Lyn\u00f6e N, Sandlund M, Dahlqvist G, Jacobsson L. Informed consent: study of quality of information given to participants in a clinical trial. BMJ. 1991;303(6803):610\u20133.","journal-title":"BMJ"},{"issue":"6","key":"8217_CR6","doi-asserted-by":"publisher","first-page":"423","DOI":"10.1111\/jnu.12097","volume":"46","author":"W Montalvo","year":"2014","unstructured":"Montalvo W, Larson E. Participant comprehension of research for which they volunteer: a systematic review. J Nurs Scholarsh. 2014;46(6):423\u201331.","journal-title":"J Nurs Scholarsh"},{"issue":"13","key":"8217_CR7","doi-asserted-by":"publisher","first-page":"2708","DOI":"10.1200\/JCO.2004.10.034","volume":"22","author":"CM Simon","year":"2004","unstructured":"Simon CM, Siminoff LA, Kodish ED, Burant C. Comparison of the informed consent process for randomized clinical trials in pediatric and adult oncology. J Clin Oncol. 2004;22(13):2708\u201317.","journal-title":"J Clin Oncol"},{"issue":"12","key":"8217_CR8","doi-asserted-by":"publisher","first-page":"727","DOI":"10.1136\/jme.2004.009910","volume":"31","author":"K Moodley","year":"2005","unstructured":"Moodley K, Pather M, Myer L. Informed consent and participant perceptions of influenza vaccine trials in South Africa. J Med Ethics. 2005;31(12):727.","journal-title":"J Med Ethics"},{"issue":"1","key":"8217_CR9","doi-asserted-by":"publisher","first-page":"33","DOI":"10.1046\/j.1369-6513.1999.00028.x","volume":"2","author":"PM Ellis","year":"1999","unstructured":"Ellis PM, Dowsett SM, Butow PN, Tattersall MHN. Attitudes to randomized clinical trials amongst out-patients attending a medical oncology clinic. Health Expect. 1999;2(1):33\u201343.","journal-title":"Health Expect"},{"issue":"11","key":"8217_CR10","doi-asserted-by":"publisher","first-page":"664","DOI":"10.1136\/jme.2004.011064","volume":"31","author":"M Stead","year":"2005","unstructured":"Stead M, Eadie D, Gordon D, Angus K. \u201cHello, hello\u2014it\u2019s English I speak!\u201d: a qualitative exploration of patients\u2019 understanding of the science of clinical trials. J Med Ethics. 2005;31(11):664\u20139.","journal-title":"J Med Ethics"},{"key":"8217_CR11","doi-asserted-by":"publisher","first-page":"v643","DOI":"10.1093\/annonc\/mdx440.068","volume":"28","author":"CM Kelly","year":"2017","unstructured":"Kelly CM, Feighery R, McCaffrey J, Higgins M, Smith M, O\u2019Reilly S, et al. 1465P_PR - Do oncology patients understand clinical trials? A nationwide study by Cancer Trials Ireland. Ann Oncol. 2017;28:v643\u20134.","journal-title":"Ann Oncol"},{"issue":"1","key":"8217_CR12","doi-asserted-by":"publisher","first-page":"375","DOI":"10.1186\/1745-6215-15-375","volume":"15","author":"YN Shiono","year":"2014","unstructured":"Shiono YN, Zheng Y-F, Kikuya M, Kawai M, Ishida T, Kuriyama S, et al. Participants\u2019 understanding of a randomized controlled trial (RCT) through informed consent procedures in the RCT for breast cancer screening, J-START. Trials. 2014;15(1):375.","journal-title":"Trials"},{"issue":"2","key":"8217_CR13","doi-asserted-by":"publisher","first-page":"74","DOI":"10.1136\/jme.2010.035485","volume":"37","author":"C Behrendt","year":"2011","unstructured":"Behrendt C, G\u00f6lz T, Roesler C, Bertz H, W\u00fcnsch A. What do our patients understand about their trial participation? Assessing patients\u2019 understanding of their informed consent consultation about randomised clinical trials. J Med Ethics. 2011;37(2):74\u201380.","journal-title":"J Med Ethics"},{"key":"8217_CR14","doi-asserted-by":"crossref","unstructured":"Chappuy H, Bouazza N, Minard-Colin V, Patte C, Brugi\u00e8res L, Landman-Parker J, et al. Parental comprehension of the benefits\/risks of first-line randomised clinical trials in children with solid tumours: a two-stage cross-sectional interview study. BMJ open. 2013;3(5):e002733.","DOI":"10.1136\/bmjopen-2013-002733"},{"issue":"3","key":"8217_CR15","doi-asserted-by":"publisher","first-page":"186","DOI":"10.2471\/BLT.14.141390","volume":"93","author":"NT Tam","year":"2015","unstructured":"Tam NT, Huy NT, Thoa LTB, Long NP, Trang NTH, Hirayama K, et al. Participants\u2019 understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis. Bull World Health Organ. 2015;93(3):186\u201398.","journal-title":"Bull World Health Organ"},{"key":"8217_CR16","doi-asserted-by":"publisher","unstructured":"Houghton C, Dowling M, Meskell P, Hunter A, Gardner H, Conway A, et al. Factors that impact on recruitment to randomised trials in health care: a qualitative evidence synthesis. Cochr Database Syst Rev. 2020(10):MR000045. https:\/\/doi.org\/10.1002\/14651858.MR000045.pub2.","DOI":"10.1002\/14651858.MR000045.pub2"},{"issue":"8","key":"8217_CR17","doi-asserted-by":"publisher","first-page":"854","DOI":"10.1038\/sj.bjc.6600527","volume":"87","author":"V Jenkins","year":"2002","unstructured":"Jenkins V, Leach L, Fallowfield L, Nicholls K, Newsham A. Describing randomisation: patients\u2019 and the public\u2019s preferences compared with clinicians\u2019 practice. Br J Cancer. 2002;87(8):854\u20138.","journal-title":"Br J Cancer"},{"issue":"7102","key":"8217_CR18","first-page":"248","volume":"315","author":"D Elbourne","year":"1997","unstructured":"Elbourne D, Snowdon C, Garcia J. Informed consent. Subjects may not understand concept of clinical trials. BMJ Brit Med J. 1997;315(7102):248.","journal-title":"BMJ Brit Med J."},{"key":"8217_CR19","doi-asserted-by":"crossref","unstructured":"Appelbaum PS, Lidz CW, Grisso T. Therapeutic misconception in clinical research: frequency and risk factors. IRB: Ethics & Human Research. 2004.","DOI":"10.2307\/3564231"},{"key":"8217_CR20","doi-asserted-by":"publisher","first-page":"75","DOI":"10.1016\/j.jclinepi.2018.02.018","volume":"99","author":"M Jepson","year":"2018","unstructured":"Jepson M, Elliott D, Conefrey C, Wade J, Rooshenas L, Wilson C, et al. An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment. J Clin Epidemiol. 2018;99:75\u201383.","journal-title":"J Clin Epidemiol"},{"key":"8217_CR21","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/1745-6215-12-S1-A121","volume":"12","author":"K Gillies","year":"2011","unstructured":"Gillies K, Huang W, Skea Z, Cotton S. Analysis of patient information leaflets (PILs), used in clinical trials using the Informed Consent Evaluation instrument (ICEi). Trials. 2011;12:1\u20132.","journal-title":"Trials"},{"issue":"2","key":"8217_CR22","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1080\/15265160802654145","volume":"9","author":"D Wendler","year":"2009","unstructured":"Wendler D. Must research participants understand randomization? Am J Bioeth. 2009;9(2):3\u20138.","journal-title":"Am J Bioeth"},{"key":"8217_CR23","doi-asserted-by":"publisher","first-page":"8","DOI":"10.1016\/j.npls.2016.01.001","volume":"2","author":"M Bengtsson","year":"2016","unstructured":"Bengtsson M. How to plan and perform a qualitative study using content analysis. NursingPlus Open. 2016;2:8\u201314.","journal-title":"NursingPlus Open"},{"issue":"2","key":"8217_CR24","doi-asserted-by":"publisher","first-page":"105","DOI":"10.1016\/j.nedt.2003.10.001","volume":"24","author":"UH Graneheim","year":"2004","unstructured":"Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004;24(2):105\u201312.","journal-title":"Nurse Educ Today"},{"issue":"10","key":"8217_CR25","doi-asserted-by":"publisher","first-page":"1","DOI":"10.3310\/hta25100","volume":"25","author":"NJ Hall","year":"2021","unstructured":"Hall NJ, Sherratt FC, Eaton S, Reading I, Walker E, Chorozoglou M, et al. Conservative treatment for uncomplicated appendicitis in children: the CONTRACT feasibility study, including feasibility RCT. Health Technol Assessm (Winchester, England). 2021;25(10):1.","journal-title":"Health Technol Assessm (Winchester, England)"},{"issue":"5","key":"8217_CR26","doi-asserted-by":"publisher","first-page":"807","DOI":"10.1038\/sj.bjc.6602445","volume":"92","author":"V Jenkins","year":"2005","unstructured":"Jenkins V, Fallowfield L, Cox A. The preferences of 600 patients for different descriptions of randomisation. Br J Cancer. 2005;92(5):807\u201310.","journal-title":"Br J Cancer"},{"key":"8217_CR27","doi-asserted-by":"publisher","first-page":"105","DOI":"10.1016\/j.jclinepi.2023.02.023","volume":"156","author":"F Shiely","year":"2023","unstructured":"Shiely F, Daly A. Trial lay summaries were not fit for purpose. J Clin Epidemiol. 2023;156:105\u201312.","journal-title":"J Clin Epidemiol"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08217-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-024-08217-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08217-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,12]],"date-time":"2024-07-12T13:14:30Z","timestamp":1720790070000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-024-08217-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6,18]]},"references-count":27,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["8217"],"URL":"https:\/\/doi.org\/10.1186\/s13063-024-08217-3","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6,18]]},"assertion":[{"value":"13 December 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 June 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 June 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Ethics approval for this study was obtained from the Clinical Research Ethics Committee of the Cork Teaching Hospitals, May 2022. Ref: ECM 4 (n) 17\/05\/2022.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"All authors approved the final draft.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"ST is an editor in chief of <i>Trials<\/i>.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"391"}}