Guidance on how to achieve comprehensible patient information leaflets in four steps

Lampert, Anette; Wien, Katharina; Haefeli, Walter E.; Seidling, Hanna M.

doi:10.1093/intqhc/mzw077

Cited by 13 publications

(8 citation statements)

References 19 publications

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“…different dosage forms or drugs with different dose strengths), 44 patient leaflets (e.g. illustrating how to use a particular dosage form), which were developed based on already existing educational material [ 24 – 26 ], 27 training videos from the Deutsche Atemwegsliga e.V. (German Airway League, a registered, charitable association informs patients and doctors about respiratory and lung diseases and is not sponsored by the pharmaceutical industry) for inhaler devices [ 25 ] and, 29 recommendations for action referring to three topics: Recommendations of aids that facilitate medication administration and therefore could be proposed to the patient, for instance a spacer.…”

Section: Resultsmentioning

confidence: 99%

Development of an algorithm to detect and reduce complexity of drug treatment and its technical realisation

Wurmbach

Schmidt

Lampert

et al. 2020

BMC Med Inform Decis Mak

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Background: The increasing complexity of current drug therapies jeopardizes patient adherence. While individual needs to simplify a medication regimen vary from patient to patient, a straightforward approach to integrate the patients' perspective into decision making for complexity reduction is still lacking. We therefore aimed to develop an electronic, algorithm-based tool that analyses complexity of drug treatment and supports the assessment and consideration of patient preferences and needs regarding the reduction of complexity of drug treatment. Methods: Complexity factors were selected based on literature and expert rating and specified for integration in the automated assessment. Subsequently, distinct key questions were phrased and allocated to each complexity factor to guide conversation with the patient and personalize the results of the automated assessment. Furthermore, each complexity factor was complemented with a potential optimisation measure to facilitate drug treatment (e.g. a patient leaflet). Complexity factors, key questions, and optimisation strategies were technically realized as tablet computer-based application, tested, and adapted iteratively until no further technical or contentrelated errors occurred. Results: In total, 61 complexity factors referring to the dosage form, the dosage scheme, additional instructions, the patient, the product, and the process were considered relevant for inclusion in the tool; 38 of them allowed for automated detection. In total, 52 complexity factors were complemented with at least one key question for preference assessment and at least one optimisation measure. These measures included 29 recommendations for action for the health care provider (e.g. to suggest a dosage aid), 27 training videos, 44 patient leaflets, and 5 algorithms to select and suggest alternative drugs.

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Section: Resultsmentioning

confidence: 99%

Development of an algorithm to detect and reduce complexity of drug treatment and its technical realisation

Wurmbach

Schmidt

Lampert

et al. 2020

BMC Med Inform Decis Mak

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“…También es fundamental que los organismos de control propongan una guía clara y estandarizada para la elaboración de los prospectos que tenga en cuenta el nivel de comprensión de la población ya que, como se señaló, el mal uso del medicamento -debido a la incomprensión de la información detallada en el prospecto-puede provocar iatrogenia en el usuario, con graves consecuencias para su salud 4 . Además y como plantean varios autores, la participación de los usuarios en el diseño y elaboración de los prospectos, siguiendo metodologías protocolizadas, podría mejorar en gran medida su legibilidad 4,9,18,19 . Otros autores han señalado también que las aplicaciones de buen diseño y lenguaje simplificado mejoran las percepciones, la comprensión, la capacidad de localizar la información y la legibilidad de los prospectos 20 .…”

Section: Discussionunclassified

Análisis de la información de medicamentos de venta libre y estrategias dirigidas a la población para mejorar su acceso y calidad

Armando¹,

Moscardó²,

Tenllado³

et al. 2018

Rev Fac Cien Med Univ Nac Cordoba

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Introducción:La Disposición ANMAT 753/2012: establece definiciones y lineamientos generales sobre la información que deben contener prospectos, etiquetas y rótulos de medicamentos de venta libre (MVL).Objetivos: analizar la adecuación a la normativa de una muestra de MVL; promover y divulgar acciones estratégicas viables a desarrollar por los farmacéuticos a fin de mejorar la información para los pacientes.Métodos:En un curso, dirigido a farmacéuticos comunitarios, se desarrollaron una actividad práctica y un foro de debate sobre la adecuación a la Disposición ANMAT 753/2012. Se registró el cumplimiento de 17 pautas de la normativa en una muestra de 66 MVL. Duración del foro: 2 semanas. Se realizó un análisis de contenido sobre las estrategias aportadas por los participantes.Resultados:El 87,9% de los medicamentos de la muestra incumple con al menos 1 de las pautas analizadas. Los mayores incumplimientos se relacionaron a composición inadecuadamente descripta, ausencia de número telefónico para consultas, acción terapéutica incomprensible y requerimientos del envase. Se plantearon estrategias a desarrollar en farmacias individualmente, agrupadas o a través de los colegios profesionales.Conclusión principal:Se observó un alto incumplimiento en las pautas analizadas de la normativa. Las estrategias planteadas se encaminan a conseguir el empoderamiento del paciente a través de educación sanitaria sobre el uso de MVL y el acceso a fuentes de información confiables que sean comprensibles para el usuario. Es necesario fortalecer los circuitos de control de la información que deben contener los MVL y promover la participación y el compromiso del farmacéutico.

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“…Placebo eye-drops were provided by the pharmacy of Heidelberg University Hospital in a polyethylene dropper bottle containing 3 ml sterile 0.9% saline without preservatives. In both groups, pharmacy staff used information leaflets, which contained recommendations for correct eye-drop use and were previously validated for comprehensibility [19].…”

Section: Methodsmentioning

confidence: 99%

Improving eye-drop administration skills of patients – A multicenter parallel-group cluster-randomized controlled trial

Lampert¹,

Brückner²,

Haefeli³

et al. 2019

PLoS ONE

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Background Eye-drop administration errors occur in the majority of patients and increase the risk for treatment failure or systemic adverse events. While lacking knowledge is the principal error cause, most patients overestimate their skills and are unaware of often substantial knowledge gaps. Therefore, the impact of including motivational patient education on long-term eye-drop administration skills of patients was investigated. Methods This is a cluster-randomized controlled trial in German community pharmacies. Patient education in both groups comprised observation of the patient during eye-drop administration to identify individual errors, pharmaceutical counseling, and teach-back evaluation of the training. In the intervention group, motivational communication techniques were included to increase error awareness and readiness for patient education. In addition, intervention patients were trained on repeated errors until administration was performed correctly. In contrast, patients in the control group only received feedback on erroneous administration steps without another assessment and reinforced training. Results In total, 152 adult patients were eligible to the study and 91 patients (intervention group N = 46) agreed to participate in a 1-month, 6-month, and 12-month follow-up. Patient education significantly increased the proportion of patients correctly administering eye-drops from 6% (7 out of 56 intervention patients, 1 out of 82 control patients) at baseline to 35% (12 out of 30 intervention patients, 12 out of 39 control patients, p ≤ 0.001) at the 1-month follow-up, and 64% (11 out of 15 intervention patients, 17 out of 29 control patients, p ≤ 0.001) at the 6-month follow-up irrespective of group allocation. In some patients previously resolved errors recurred during follow-up visits. This emphasizes the need for periodical reevaluation of patient administration skills and the provision of prevention strategies besides education. Conclusion Patient education that included demonstration of administration skills and verbal and written counseling on observed errors improved eye-drop administration skills irrespective of the communication technique applied. Whereof, high drop-out rates limited the power to detect a difference between groups. In particular, periodic demonstration of administration skills seemed important for sustainable improvement of administration skills. However, further error prevention strategies such as additional education materials or support by a caregiver may be necessary in some patients.

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Guidance on how to achieve comprehensible patient information leaflets in four steps

Cited by 13 publications

References 19 publications

Development of an algorithm to detect and reduce complexity of drug treatment and its technical realisation

Development of an algorithm to detect and reduce complexity of drug treatment and its technical realisation

Análisis de la información de medicamentos de venta libre y estrategias dirigidas a la población para mejorar su acceso y calidad

Improving eye-drop administration skills of patients – A multicenter parallel-group cluster-randomized controlled trial

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