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
Objectives 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 patien...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2025-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/3/e089447.full |
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| author | Nick A Maskell Christopher E Brightling Elizabeth Sapey Rachael A Evans Salman Siddiqui Mona Bafadhel Tim Felton Joanna Porter Stefan J Marciniak Tom Wilkinson Jane C Davies Samantha Walker Ling Pei Ho Alex Robert Horsley Ewan Gourlay |
| author_facet | Nick A Maskell Christopher E Brightling Elizabeth Sapey Rachael A Evans Salman Siddiqui Mona Bafadhel Tim Felton Joanna Porter Stefan J Marciniak Tom Wilkinson Jane C Davies Samantha Walker Ling Pei Ho Alex Robert Horsley Ewan Gourlay |
| author_sort | Nick A Maskell |
| collection | DOAJ |
| description | Objectives 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 9–11. We aimed to assess the readability and complexity of PISs/ICFs used for clinical trials of acute therapies during the COVID-19 pandemic.Design Retrospective document analysis.Setting 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.Primary and secondary outcome measures 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 1–18; higher is more complex), Gunning-Fog (GFOG) (range 1–20; higher is more complex) and Flesch Reading Ease Score (FRES) (range 0–100; below 60 is ‘difficult’ for comprehension).Results 13 documents were analysed with a median length of 5139 words (range 1559–7026), equating to a median reading time of 21.4 min (range 6.5–29.3 min) at 240 words per minute. Median FKGL was 9.8 (9.1–10.8), GFOG 11.8 (10.4–13) and FRES was 54.6 (47.0–58.3). All documents were classified as ‘difficult’ for comprehension and had a reading age of 14 years old or higher.Conclusions 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. |
| format | Article |
| id | doaj-art-91e092102ae14db1aceca93910532970 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-91e092102ae14db1aceca939105329702025-08-20T03:40:26ZengBMJ Publishing GroupBMJ Open2044-60552025-03-0115310.1136/bmjopen-2024-089447Readability and complexity of written information presented to hospitalised patients for trial consent during the COVID-19 pandemic in the UK: a retrospective document analysisNick A Maskell0Christopher E Brightling1Elizabeth Sapey2Rachael A Evans3Salman Siddiqui4Mona Bafadhel5Tim Felton6Joanna Porter7Stefan J Marciniak8Tom Wilkinson9Jane C Davies10Samantha Walker11Ling Pei Ho12Alex Robert Horsley13Ewan Gourlay1413 Academic Respiratory Unit, Department of Clinical Sciences, Bristol University, Bristol, UK5 Institute of Lung Health, University of Leicester, Leicester, UK16 Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK8 University of Leicester, Leicester, UK17 National Heart and Lung Institute, Imperial College London, London, UK4 King’s Centre for Lung Health, King’s College London, London, UK2 Division of Immunology, Immunity to Infection and Respiratory Medicine, The University of Manchester, Manchester, UK14 Centre for Inflammation & Tissue Repair, University College London Division of Medicine, London, UK11 Medicine, University of Cambridge, Cambridge, UK19 Clinical and Experimental Medicine, University of Southampton, Southampton, UK6 Gene Therapy, Imperial College, London, UK18 Research & Innovation, Asthma & Lung UK, London, UK9 MRC Human Immunology Unit, Weatherall Institute of Molecular Medicine, Oxford, UK2 Division of Immunology, Immunity to Infection and Respiratory Medicine, The University of Manchester, Manchester, UK1 North West Lung Centre, Manchester University NHS Foundation Trust, Manchester, UKObjectives 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 9–11. We aimed to assess the readability and complexity of PISs/ICFs used for clinical trials of acute therapies during the COVID-19 pandemic.Design Retrospective document analysis.Setting 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.Primary and secondary outcome measures 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 1–18; higher is more complex), Gunning-Fog (GFOG) (range 1–20; higher is more complex) and Flesch Reading Ease Score (FRES) (range 0–100; below 60 is ‘difficult’ for comprehension).Results 13 documents were analysed with a median length of 5139 words (range 1559–7026), equating to a median reading time of 21.4 min (range 6.5–29.3 min) at 240 words per minute. Median FKGL was 9.8 (9.1–10.8), GFOG 11.8 (10.4–13) and FRES was 54.6 (47.0–58.3). All documents were classified as ‘difficult’ for comprehension and had a reading age of 14 years old or higher.Conclusions 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.https://bmjopen.bmj.com/content/15/3/e089447.full |
| spellingShingle | Nick A Maskell Christopher E Brightling Elizabeth Sapey Rachael A Evans Salman Siddiqui Mona Bafadhel Tim Felton Joanna Porter Stefan J Marciniak Tom Wilkinson Jane C Davies Samantha Walker Ling Pei Ho Alex Robert Horsley Ewan Gourlay 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 BMJ Open |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/15/3/e089447.full |
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