scholarly journals Developing Core Principles for Sharing Information about Potential Intervention Benefits and Harms in Patient Information Leaflets Using a Modified Delphi Survey

2021 ◽  
Author(s):  
Martina Svobodova ◽  
Rachel Hale ◽  
Kerry Hood ◽  
Katie Gillies ◽  
Jennifer Bostock ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Information ◽  
Side Effect ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Patient Information Leaflets ◽  
Modified Delphi ◽  
Information Leaflets ◽  
Potential Risks ◽  
Participant Information

Patients need to be informed about potential risks of taking part in clinical trials. A problem is that there are no standards telling researchers or ethics committees how these risks need to be communicated. Our background research suggests that the way harms are communicated can actually increase the risks of the harms occurring. Over half of our sample of 250,000 patients who took placebo pills (like sugar pills) in clinical trials reported some negative side effect (like pain or nausea but also more serious things). The aim of this study is to understand what information about trial harms and benefits stakeholders consider to be important for ‘principled participant information leaflets’ or ‘PrinciPILs’ to contain. The stakeholders will include patients, ethics committee members, industry representatives, medico-legal experts, psychologists, and trial managers.

scholarly journals Changes in Side Effect Risk Communication in Patient Information Leaflets over the Past Decade: Results of a Survey

Drug Safety ◽  
2015 ◽  
Vol 38 (8) ◽  
pp. 721-727 ◽  
Author(s):  
Katherine Harris ◽  
Rebecca Dickinson ◽  
David K. Raynor ◽  
Jan MacDonald ◽  
Peter Knapp
Keyword(s):  
Risk Communication ◽  
Patient Information ◽  
Side Effect ◽  
Patient Information Leaflets ◽  
The Past ◽  
Information Leaflets

Patient information leaflet on mastoid surgery risks: assessment of readability and patient understanding

2013 ◽  
Vol 127 (11) ◽  
pp. 1078-1083 ◽  
Author(s):  
M B Pringle ◽  
B G Natesh ◽  
K M Konieczny
Keyword(s):  
Patient Information ◽  
Patient Information Leaflet ◽  
Quality Information ◽  
Information Leaflet ◽  
Patient Information Leaflets ◽  
Information Leaflets ◽  
Potential Risks ◽  
Risks Assessment ◽  
Patient Advice ◽  
Mastoid Surgery

AbstractIntroduction:It is important that patients have a good understanding of surgery-related risks, particularly for mastoid surgery, which exposes patients to the risk of very serious complications, despite addressing conditions which often have only minor symptoms.Materials and methods:A patient information leaflet describing the risks of mastoid surgery was prepared. However, the Hospital Patient Advice and Liaison Services team thought it was too long and complicated. It was introduced unchanged. Fifty-four consecutive mastoidectomy patients were given a questionnaire asking for their opinion of the leaflet. The leaflet was also assessed with readability formulae and the Ensuring Quality Information for Patients tool.Results and analysis:Ninety-eight per cent of respondents thought the leaflet's writing style was easy to understand. The majority (96 per cent) thought the length was ‘just right’. The 7 readability formulae used established readability at a grade 9 level (i.e. appropriate for a reading age of 13–15 years). The Ensuring Quality Information for Patients score was 87.5 per cent.Discussion:Despite the drive to simplify patient information leaflets, quite detailed information is sometimes required. A style which is too simple may be perceived as patronising and may encourage patients to underestimate potential risks. It is important to ask patients their opinion.

scholarly journals Reducing attrition within clinical trials: The communication of retention and withdrawal within patient information leaflets

PLoS ONE ◽  
2018 ◽  
Vol 13 (10) ◽  
pp. e0204886 ◽  
Author(s):  
Anna Kearney ◽  
Anna Rosala- Hallas ◽  
Naomi Bacon ◽  
Anne Daykin ◽  
Alison R. G. Shaw ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Information ◽  
Patient Information Leaflets ◽  
Information Leaflets

A comparative analysis of the lay-friendliness of Danish EU patient information leaflets from 2000 to 2012

2014 ◽  
Vol 11 (3) ◽  
Author(s):  
Inger Askehave ◽  
Karen Korning Zethsen
Keyword(s):  
Comparative Analysis ◽  
Patient Information ◽  
Patient Information Leaflet ◽  
General Interest ◽  
Information Leaflet ◽  
Empirical Results ◽  
Patient Information Leaflets ◽  
Information Leaflets ◽  
The Subject ◽  
The Eu

Since becoming mandatory in the EU in 1992, the patient information leaflet (PIL) has been the subject of an on-going discussion regarding its ability to provide easily understandable information. This study examines whether the lay-friendliness of Danish PILs has improved from 2000 to 2012 according to the Danish consumers. A reproduction of a questionnaire study from 2000 was carried out. The responses of the 2012 survey were compared to those of the 2000 survey and the analysis showed that Danes are less inclined to read the PIL in 2012 compared to 2000 and that the general interest in PILs has decreased. The number of respondents who deem the PIL easy to read has gone down. According to Danish consumers, the lay-friendliness of PILs has not improved from 2000 to 2012 and a very likely explanation could be that the PIL as a genre has become far too regulated and complex to live up to its original intentions. On the basis of the empirical results the article furthermore offers suggestions for practice changes.

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