{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T01:33:33Z","timestamp":1790904813170,"version":"4.1.0"},"reference-count":35,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2025,3,19]],"date-time":"2025-03-19T00:00:00Z","timestamp":1742342400000},"content-version":"unspecified","delay-in-days":18,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,2,11]]},"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Patient information sheets (PISs) and informed consent forms (ICFs) are essential tools to communicate and document informed consent for clinical trial participation. These documents need to be easily understandable, especially when used to take informed consent from acutely unwell patients. Health literacy guidance recommends written information should be at a level between reading ages 9\u201311. We aimed to assess the readability and complexity of PISs\/ICFs used for clinical trials of acute therapies during the COVID-19 pandemic.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Retrospective document analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>PISs\/ICFs used in trials involving pharmaceutical interventions recruiting hospitalised patients with COVID-19 during the first year of the pandemic were sourced from hospitals across the UK.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary and secondary outcome measures<\/jats:title>\n                    <jats:p>PISs\/ICFs were assessed for length, approximate reading time and subsection content. Readability and language complexity were assessed using Flesch-Kincaid Grade Level (FKGL) (range 1\u201318; higher is more complex), Gunning-Fog (GFOG) (range 1\u201320; higher is more complex) and Flesch Reading Ease Score (FRES) (range 0\u2013100; below 60 is \u2018difficult\u2019 for comprehension).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>13 documents were analysed with a median length of 5139 words (range 1559\u20137026), equating to a median reading time of 21.4\u2009min (range 6.5\u201329.3\u2009min) at 240 words per minute. Median FKGL was 9.8 (9.1\u201310.8), GFOG 11.8 (10.4\u201313) and FRES was 54.6 (47.0\u201358.3). All documents were classified as \u2018difficult\u2019 for comprehension and had a reading age of 14 years old or higher.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>All PISs\/ICFs analysed contained literary complexity beyond both recommendations and the reading level of many in the UK population. Researchers should seek to improve communications to improve trial volunteer comprehension and recruitment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-089447","type":"journal-article","created":{"date-parts":[[2025,3,23]],"date-time":"2025-03-23T23:42:57Z","timestamp":1742773377000},"page":"e089447","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Readability and complexity of written information presented to hospitalised patients for trial consent during the COVID-19 pandemic in the UK: a retrospective document analysis"],"prefix":"10.1136","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0905-8247","authenticated-orcid":false,"given":"Ewan","family":"Gourlay","sequence":"first","affiliation":[{"name":"North West Lung Centre, Manchester University NHS Foundation Trust, Manchester, UK"},{"name":"Division of Immunology, Immunity to Infection and Respiratory Medicine, The University of Manchester, Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tim","family":"Felton","sequence":"additional","affiliation":[{"name":"Division of Immunology, Immunity to Infection and Respiratory Medicine, The University of Manchester, Manchester, UK"},{"name":"Respiratory Medicine, Manchester University NHS Foundation Trust, Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mona","family":"Bafadhel","sequence":"additional","affiliation":[{"name":"King\u2019s Centre for Lung Health, King\u2019s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher E","family":"Brightling","sequence":"additional","affiliation":[{"name":"Institute of Lung Health, University of Leicester, Leicester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane C","family":"Davies","sequence":"additional","affiliation":[{"name":"Gene Therapy, Imperial College, London, UK"},{"name":"Royal Brompton Hospital, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1667-868X","authenticated-orcid":false,"given":"Rachael A","family":"Evans","sequence":"additional","affiliation":[{"name":"University of Leicester, Leicester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ling Pei","family":"Ho","sequence":"additional","affiliation":[{"name":"MRC Human Immunology Unit, Weatherall Institute of Molecular Medicine, Oxford, UK"},{"name":"Oxford Centre for Respiratory Medicine, Churchill Hospital, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8472-7183","authenticated-orcid":false,"given":"Stefan J","family":"Marciniak","sequence":"additional","affiliation":[{"name":"Medicine, University of Cambridge, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nick A","family":"Maskell","sequence":"additional","affiliation":[{"name":"North Bristol Lung Centre, Southmead Hospital, Bristol, UK"},{"name":"Academic Respiratory Unit, Department of Clinical Sciences, Bristol University, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanna","family":"Porter","sequence":"additional","affiliation":[{"name":"Centre for Inflammation & Tissue Repair, University College London Division of Medicine, London, UK"},{"name":"Interstitial Lung Disease Service, University College London Hospitals NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3454-5482","authenticated-orcid":false,"given":"Elizabeth","family":"Sapey","sequence":"additional","affiliation":[{"name":"Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salman","family":"Siddiqui","sequence":"additional","affiliation":[{"name":"National Heart and Lung Institute, Imperial College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5503-8258","authenticated-orcid":false,"given":"Samantha","family":"Walker","sequence":"additional","affiliation":[{"name":"Research & Innovation, Asthma & Lung UK, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"Wilkinson","sequence":"additional","affiliation":[{"name":"Clinical and Experimental Medicine, University of Southampton, Southampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1828-0058","authenticated-orcid":false,"given":"Alex Robert","family":"Horsley","sequence":"additional","affiliation":[{"name":"Division of Immunology, Immunity to Infection and Respiratory Medicine, 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