PIL of the Month – a Study of Best Practice in Patient Information Leaflets

ObjectivesThe first aim of this study was to quantify the difficulty level of clinical research Patient Information Leaflets/Informed Consent Forms (PILs/ICFs) using validated and widely used readability criteria which provide a broad assessment of written communication. The second aim was to compare these findings with best practice guidelines.DesignRetrospective, quantitative analysis of clinical research PILs/ICFs provided by academic institutions, pharmaceutical companies and investigators.SettingPILs/ICFs which had received Research Ethics Committee approval in the last 5 years were collected from Ireland and the UK.InterventionNot applicable.Main outcome measuresPILs/ICFs were evaluated against seven validated readability criteria (Flesch Reading Ease, Flesh Kincaid Grade Level, Simplified Measure of Gobbledegook, Gunning Fog, Fry, Raygor and New Dale Chall). The documents were also scored according to two health literacy-based criteria: the Clear Communication Index (CCI) and the Suitability Assessment of Materials tool. Finally, the documents were assessed for compliance with six best practice metrics from literacy agencies.ResultsA total of 176 PILs were collected, of which 154 were evaluable. None of the PILs/ICFs had the mean reading age of <12 years recommended by the American Medical Association. 7.1% of PILs/ICFs were evaluated as ‘Plain English’, 40.3%: ‘Fairly Difficult’, 51.3%: ‘Difficult’ and 1.3%: ‘Very Difficult’. No PILs/ICFs achieved a CCI >90. Only two documents complied with all six best practice literacy metrics.ConclusionsWhen assessed against both traditional readability criteria and health literacy-based tools, the PILs/ICFs in this study are inappropriately complex. There is also evidence of poor compliance with guidelines produced by literacy agencies. These data clearly evidence the need for improved documentation to underpin the consent process.

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A Critical Analysis of the Exercise Prescription and Return to Activity Advice That Is Provided in Patient Information Leaflets Following Lumbar Spine Surgery

Medicina ◽

10.3390/medicina55070347 ◽

2019 ◽

Vol 55 (7) ◽

pp. 347 ◽

Cited By ~ 1

Author(s):

Matthew Low ◽

Louise C. Burgess ◽

Thomas W. Wainwright

Keyword(s):

Lumbar Spine ◽

Spine Surgery ◽

Patient Information ◽

Best Practice ◽

Exercise Prescription ◽

Normal Activity ◽

Lumbar Spine Surgery ◽

Patient Information Leaflets ◽

Information Leaflets ◽

Future Work

Background and objectives: Lumbar spine surgery may be considered if pharmacologic, rehabilitation and interventional approaches cannot provide sufficient recovery from low back-related pain. Postoperative physiotherapy treatment in England is often accompanied by patient information leaflets, which contain important rehabilitation advice. However, in order to be an effective instrument for patients, the information provided in these leaflets must be up to date and based on the best available evidence and clinical practice. This study aims to critically analyse the current postoperative aspects of rehabilitation (exercise prescription and return to normal activity) that are provided in patient information leaflets in England as part of an evaluation of current practice following lumbar spine surgery. Materials and Methods: Patient information leaflets from English National Health Service (NHS) hospitals performing lumbar spine surgery were sourced online. A content analysis was conducted to collect data on postoperative exercise prescription and return to normal activities. Results: Thirty-two patient information leaflets on lumbar surgery were sourced (fusion, n = 11; decompression, n = 15; all lumbar procedures, n = 6). Many of the exercises prescribed within the leaflets were not based on evidence of clinical best practice and lacked a relationship to functional activity. Return to normal activity advice was also wide ranging, with considerable variation in the recommendations and definitions provided. Conclusions: This study highlights a clear variation in the recommendations of exercise prescription, dosage and returning to normal activities following lumbar spine surgery. Future work should focus on providing a consistent and patient-centred approach to recovery.

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PIL of the month: A study of best practice in EU patient information leaflets

Journal of Applied Linguistics and Professional Practice ◽

10.1558/japl.v7.i1.9848 ◽

2010 ◽

Vol 7 (1) ◽

Author(s):

Karen Korning Zethsen ◽

Inger Askehave

Keyword(s):

Patient Information ◽

Best Practice ◽

Patient Information Leaflets ◽

Information Leaflets

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

Communication & Medicine ◽

10.1558/cam.v11i3.20700 ◽

2014 ◽

Vol 11 (3) ◽

Cited By ~ 2

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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