Negotiating clinical practice guidelines
Doctors' experiences with implementing and rationing high-cost cystic fibrosis treatment
Bibliographic Data
| ID | 4594335 |
|---|---|
| Authors | Audun Brendbekken (0000-0003-0115-0353, University of Bergen), Ole F Norheim (0000-0002-5748-5956, University of Bergen), Frode Lindemark, Lindemark Frode (Haukeland University Hospital), Gunnar Houge (0000-0002-6102-1513, Haukeland University Hospital), Arne Melberg (0000-0002-0820-8813, University of Bergen) |
| Year | 2025 |
| Volume | 381 |
| Pages | 118293 |
| Publication date | 2025-09-01 |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | Social Science & Medicine (JOURNAL) |
| Journal identifiers | ISSN: 0277-9536 • E-ISSN: 1873-5347 |
| Publisher | Elsevier BV (PUBLISHER) |
| DOI | 10.1016/j.socscimed.2025.118293 |
| PMID | 40517648 |
| OpenAlex | W4411162994 |
| Language | EN |
| References cited | 25 |
In all societies, demand for healthcare exceeds available resources. When resources for healthcare are limited, clinicians inevitably engage in distributive decisions that affect the care of individual patients: so-called bedside rationing. Clinical practice guidelines intend to steer bedside rationing through transparent eligibility criteria. Still, the distributive challenge is exacerbated by increasingly available high-cost treatments for rare diseases, treatments entrenched in a great deal of uncertainty due to limited evidence of therapeutic effect. In this qualitative study, we investigated the real-life implementation of a clinical practice guideline for a costly cystic fibrosis treatment, elexacaftor/tezacaftor/ivacaftor (Kaftrio), reimbursed in Norway since 2022. Thereby, we provide empirical and theoretical contributions to the health economics literature on priority setting by drawing on policy enactment theory and the clinical decision-making literature. Using data from 18 in-depth interviews analysed by reflexive thematic analysis, we found that clinicians perceived Kaftrio to be exceptionally effective, making it very difficult to withdraw treatment in cases of uncertain or inadequate effect as suggested by the start-stop criteria intended to steer initiation and discontinuation of treatment. Clinicians enacted the guideline to deliver, not withhold treatment in cases of uncertain eligibility by shaping the guideline's meaning. Building on the empirical findings, we propose a model that theorises how clinicians negotiated the treatment's therapeutic effect across various axes of medical knowledge from observed to justified effects. In the era of high-cost genetic therapeutics, our study provides an important contribution to the understanding of tools and mechanisms to ensure fair and open priority setting
Clinical Practice · Cystic fibrosis · Family medicine · Health care · Health care rationing · Intensive care medicine · Negotiation · Political science · Rationing · Social science · Sociology · Cystic Fibrosis Research Advances · Health Systems, Economic Evaluations, Quality of Life · Law · Medicine · Nursing · Patient-Provider Communication in Healthcare · Internal Medicine
Evidence based medicine
National clinical guidelines and treatment centralization do not guarantee consistency in healthcare delivery. A mixed-methods study of wet age-related macular degeneration treatment in Denmark
Thematic Analysis
The sociology of rationing
Strategies of stratification
Using thematic analysis in psychology
Diversity in clinical guidelines
Open and opaque? The performativity of open priorities in a Norwegian hospital
Expansion and uncertainty
Good conduct in a context of rationing
| Highly cited | No |
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