Patient perspectives in the benefit-risk evaluation of drugs

Sietske de Vries

doi:10.1016/j.jpsychores.2013.11.003

Patient perspectives in the benefit-risk evaluation of drugs

Vertaalde titel van de bijdrage: Patiëntenperspectief in de benefit-risk evaluatie van medicijnen

Sietske de Vries

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Het patiëntenperspectief bij besluitvorming over medicijnen staat tegenwoordig hoog op de agenda. Dit blijkt uit het toegenomen gebruik van patiëntgerapporteerde instrumenten bij de evaluatie van medicijnen. Daarnaast is het zichtbaar in de huidige klinische praktijk waarin de patiënt centraal staat. Dit proefschrift bevat onderzoeken gericht op 1) de ontwikkeling en validatie van een patiëntgerapporteerde vragenlijst over bijwerkingen, en 2) de rol van patiëntkenmerken en –voorkeuren in behandelbeslissingen in de klinische praktijk. In het eerste deel is een generieke vragenlijst ontwikkeld om bijwerkingen vanuit het patiëntenperspectief in kaart te brengen. De vragenlijst bleek voldoende content en concurrent valide te zijn in het detecteren van bijwerkingen op een algemeen niveau. De vragenlijst was echter niet gevoelig genoeg om alle door patiënten ervaren bijwerkingen te detecteren. Suggesties worden gegeven om de vragenlijst te verbeteren voor toekomstig gebruik. In het tweede deel wordt inzicht verschaft in beslissingen om een behandeling te starten of te intensiveren met aandacht voor verschillende leeftijdsgroepen van patiënten. Het bleek dat leeftijd zowel voorschrijfgedrag als bereidheid een extra medicijn te gebruiken beïnvloedt. Voor alle patiënten waren het voorkomen van overlijden en bijwerkingen belangrijke overwegingen voor het kiezen van een extra medicijn. De invloed van medicatiepercepties op therapietrouw van een patiënt verschilde echter tussen therapeutische groepen. Deze bevindingen kunnen worden gebruikt om de evaluatie van bijwerkingen vanuit het patiëntenperspectief te verbeteren, om het patiëntenperspectief in ogenschouw te nemen bij behandelbeslissingen en om betere op maat gesneden interventies te ontwikkelen die als doel hebben therapietrouw te verbeteren.

Vertaalde titel van de bijdrage	Patiëntenperspectief in de benefit-risk evaluatie van medicijnen
Originele taal-2	English
Kwalificatie	Doctor of Philosophy
Toekennende instantie	Rijksuniversiteit Groningen
Begeleider(s)/adviseur	Denig, Petra, Supervisor Haaijer-Ruskamp, Floor, Supervisor de Zeeuw, Dick, Supervisor
Datum van toekenning	22-apr.-2015
Plaats van publicatie	[Groningen]
Uitgever	University of Groningen
Gedrukte ISBN's	978-90-367-7683-7
Elektronische ISBN's	978-90-367-7682-0
DOI's	https://doi.org/10.1016/j.jpsychores.2013.11.003
Status	Published - 2015

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10.1016/j.jpsychores.2013.11.003

Title and contents Final publisher's version, 550 KB
Chapter 1Final publisher's version, 666 KB
Chapter 2Final publisher's version, 451 KB
Chapter 3Final publisher's version, 568 KB
Chapter 4Final publisher's version, 631 KB
Chapter 5Final publisher's version, 2,25 MB
Chapter 6Final publisher's version, 374 KB
Summaries Final publisher's version, 551 KB
AppendicesFinal publisher's version, 883 KB
Complete dissertationFinal publisher's version, 4,56 MB
PropositionsFinal publisher's version, 289 KB

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@phdthesis{51015895cc11463e9992f90b7b6331e3,

title = "Patient perspectives in the benefit-risk evaluation of drugs",

abstract = "The patient perspective in the process of drug evaluation and drug use is high on the agenda, which is demonstrated by an increased use of patient-reported outcome instruments to evaluate drugs and a shift towards patient-centred care in clinical practice. This thesis contains studies focusing on 1) the development and validation of a patient-reported outcome instrument to assess adverse drug events (ADEs), and 2) the role of patient characteristics and preferences on treatment decisions in clinical practice. The first part presents the development of a generic questionnaire to assess ADEs from the patient perspective. Although this questionnaire showed sufficient content and concurrent validity to detect ADEs at a general level, it was not sensitive enough to detect all ADEs perceived by patients. Suggestions are provided to improve the questionnaire for future use. In the second part, insight in decisions to start or intensify treatment with special attention for different patient age groups is provided. It was found that age influenced prescribing behaviour as well as the patient's willingness to add a drug. For all patients, preventing death and ADEs were important considerations when choosing an additional drug. The influence of beliefs about benefits and risks on patients{\textquoteright} drug adherence, however, differed among types of drugs. These findings can be used to improve the assessment of ADEs from the patient perspective, to incorporate the patient perspective in treatment decisions and to develop better tailored interventions for improving drug adherence.",

author = "{de Vries}, Sietske",

year = "2015",

doi = "10.1016/j.jpsychores.2013.11.003",

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AU - de Vries, Sietske

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N2 - The patient perspective in the process of drug evaluation and drug use is high on the agenda, which is demonstrated by an increased use of patient-reported outcome instruments to evaluate drugs and a shift towards patient-centred care in clinical practice. This thesis contains studies focusing on 1) the development and validation of a patient-reported outcome instrument to assess adverse drug events (ADEs), and 2) the role of patient characteristics and preferences on treatment decisions in clinical practice. The first part presents the development of a generic questionnaire to assess ADEs from the patient perspective. Although this questionnaire showed sufficient content and concurrent validity to detect ADEs at a general level, it was not sensitive enough to detect all ADEs perceived by patients. Suggestions are provided to improve the questionnaire for future use. In the second part, insight in decisions to start or intensify treatment with special attention for different patient age groups is provided. It was found that age influenced prescribing behaviour as well as the patient's willingness to add a drug. For all patients, preventing death and ADEs were important considerations when choosing an additional drug. The influence of beliefs about benefits and risks on patients’ drug adherence, however, differed among types of drugs. These findings can be used to improve the assessment of ADEs from the patient perspective, to incorporate the patient perspective in treatment decisions and to develop better tailored interventions for improving drug adherence.

AB - The patient perspective in the process of drug evaluation and drug use is high on the agenda, which is demonstrated by an increased use of patient-reported outcome instruments to evaluate drugs and a shift towards patient-centred care in clinical practice. This thesis contains studies focusing on 1) the development and validation of a patient-reported outcome instrument to assess adverse drug events (ADEs), and 2) the role of patient characteristics and preferences on treatment decisions in clinical practice. The first part presents the development of a generic questionnaire to assess ADEs from the patient perspective. Although this questionnaire showed sufficient content and concurrent validity to detect ADEs at a general level, it was not sensitive enough to detect all ADEs perceived by patients. Suggestions are provided to improve the questionnaire for future use. In the second part, insight in decisions to start or intensify treatment with special attention for different patient age groups is provided. It was found that age influenced prescribing behaviour as well as the patient's willingness to add a drug. For all patients, preventing death and ADEs were important considerations when choosing an additional drug. The influence of beliefs about benefits and risks on patients’ drug adherence, however, differed among types of drugs. These findings can be used to improve the assessment of ADEs from the patient perspective, to incorporate the patient perspective in treatment decisions and to develop better tailored interventions for improving drug adherence.

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DO - 10.1016/j.jpsychores.2013.11.003

M3 - Thesis fully internal (DIV)

SN - 978-90-367-7683-7

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Patient perspectives in the benefit-risk evaluation of drugs

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