Dataset Information

Evaluation of instructions in patient information leaflets for the use of intranasal corticosteroid sprays: an observational study.

ABSTRACT:

Objectives

In this study, we analysed patient information leaflets (PILs) of intranasal corticosteroid sprays (INCS) of different manufacturers in the UK to determine if instructions for the use of INCS are complete and uniform.

Setting

PILs of all INCS of all manufacturers, available for patients in the UK, were collected from the British National Formulary website and the Medicines and Healthcare products Regulatory Agency website. All instructions in these PILs were analysed.

Participants

We identified PILs of INCS from 21 different manufacturers, available for patients in the UK.

Results

We analysed the instructions for the use of INCS in 21 different PILs and there is large variation in the PIL instructions for the technique of using INCS across PILs.

Conclusion

Complete and uniform instructions for the use of INCS are lacking in PILs for registered preparations in the UK. Structured and standardised instructions to be used by both professionals and patients are essential in order to optimise daily use of INCS.

SUBMITTER: Rollema C

PROVIDER: S-EPMC6340415 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Publications

Evaluation of instructions in patient information leaflets for the use of intranasal corticosteroid sprays: an observational study.

Rollema Corine C van Roon Eric M EM Schilder Anne Gm AG de Vries Tjalling W TW

BMJ open 20190115 1

<h4>Objectives</h4>In this study, we analysed patient information leaflets (PILs) of intranasal corticosteroid sprays (INCS) of different manufacturers in the UK to determine if instructions for the use of INCS are complete and uniform.<h4>Setting</h4>PILs of all INCS of all manufacturers, available for patients in the UK, were collected from the British National Formulary website and the Medicines and Healthcare products Regulatory Agency website. All instructions in these PILs were analysed.<h ...[more]

PMID: 30647049

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Project description:ObjectiveThe Patient Information Leaflet (PIL) is an authoritative document that all people with epilepsy in the EU receive when prescribed antiseizure medication (ASM). We undertook the first independent, comprehensive assessment to determine how understandable they are. Regulators state that when patients are asked comprehension questions about them, ≥80% should answer correctly. Also, recommended is that PILs have a maximum reading requirement of US grade 8.MethodsStudy 1: We obtained 140 current ASM PILs written in English. "Readability" was assessed using four tests, with and without adjustment for influence of familiar, polysyllabic words. A total of 179 online materials on epilepsy were also assessed. Study 2: Two PILs from Study 1 were randomly selected (Pregabalin Focus; Inovelon) and shown to 35 people from the UK epilepsy population. Their comprehension was assessed. Study 3: To understand whether the student population provides an accessible alternative population for future examination of ASM PILs, Study 3 was completed, using the same methods as Study 2, except that participants were 262 UK university students.ResultsStudy 1: No PIL had a reading level of grade 8. Median was grade 11. Adjusting for context, the PILs were still at grade 10.5. PILs for branded ASMs were most readable. PILs were no more readable than (unregulated) online materials. Study 2: Users struggled to comprehend the PILs' key messages. The eight questions asked about pregabalin were typically answered correctly by 54%. For Inovelon, it was 62%. Study 3: Most student participants comprehended the PILs' key messages. The questions about Inovelon were answered correctly by 90%; for pregabalin it was 86%.SignificanceThis is the first independent and comprehensive examination of ASM PILs. It found that PILs being used fail to meet recommendations and regulatory requirements and risk not being understandable to a substantial proportion of users. In finding that people from the epilepsy population differ markedly in comprehension of PILs compared to students, this study highlights the importance of completing user testing with the target population.

Project description:BackgroundThe 'AntibioCharte' randomised controlled study aimed at assessing the impact of a multifaceted antibiotic stewardship intervention targeting French general practitioners with higher-than-average antibiotic use. The intervention included a public commitment charter signed by the general practitioner, a non-prescription pad, and a patient information leaflet.ObjectivesWe conducted a qualitative study to evaluate general practitioners' fidelity in the intervention and its acceptability by patients and general practitioners.MethodsThis investigation was performed in northeastern France from July 2019 to May 2020, among the AntibioCharte intervention group after a 1-year implementation period. General practitioners' fidelity in the charter was assessed by direct observations; general practitioners' fidelity in the other tools, and acceptability of both general practitioners and patients were assessed through semi-structured face-to-face individual interviews.ResultsTwenty-seven general practitioners and 14 patients participated. General practitioners' fidelity varied according to the tool: the charter was clearly displayed in most waiting rooms; the non-prescription pad was used throughout the intervention period by most general practitioners while the leaflet was used by fewer general practitioners. Both general practitioners and patients found the charter's content and form relevant, but few general practitioners felt themselves publicly engaged. The waiting room may not be appropriate to display the charter as some general practitioners forgot it and patients did not always read the displayed documents. General practitioners appreciated the pad and found that it could help them change their practices. It was perceived as a good tool to educate patients and manage their expectations for antibiotics. Patients appreciated the pad too, especially information on the infections' symptoms and their duration. Still, some patients feared that it could encourage doctors not to prescribe antibiotics. Unlike general practitioners, who considered the leaflet redundant with the information given during the consultation, patients found it useful to raise awareness on antibiotics' specificities and risks, and remind them of good practices.ConclusionsThe AntibioCharte intervention was overall well accepted by general practitioners and patients. The non-prescription pad was the best perceived tool. Trial registration number ClinicalTrials.gov: NCT04562571.

Dataset Information

Evaluation of instructions in patient information leaflets for the use of intranasal corticosteroid sprays: an observational study.

Objectives

Setting

Participants

Results

Conclusion

Publications

Evaluation of instructions in patient information leaflets for the use of intranasal corticosteroid sprays: an observational study.

Similar Datasets

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