Evidence map›Paper›PMID 39036527›Full record

ArticleLearning health systems2024

An ethics framework for the transition to an operational learning healthcare system.

Marieke J Hollestelle, Rieke van der Graaf, Miriam Cjm Sturkenboom, Johannes Jm van Delden

Abstract read
In one paragraph

Article in Learning health systems, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Marieke J HollestelleDepartment of Bioethics and Health Humanities Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University Utrecht The Netherlands.ORCID https://orcid.org/0000-0002-3924-0234
Rieke van der GraafDepartment of Bioethics and Health Humanities Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University Utrecht The Netherlands.ORCID https://orcid.org/0000-0003-4907-7044
Miriam Cjm SturkenboomDepartment Data science & Biostatistics Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University Utrecht The Netherlands.ORCID https://orcid.org/0000-0003-1360-2388
Johannes Jm van DeldenDepartment of Bioethics and Health Humanities Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University Utrecht The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: While Learning Healthcare Systems (LHSs) have received increasing attention in health care and research, the amount of operational LHSs remains limited. Given the investment of resources in these projects, a moral responsibility to pursue the transition toward an LHS falls on projects and their participating stakeholders. This paper provides an ethics framework for projects that have taken steps toward building an LHS and are in the position to transition to an operational LHS. Method: To articulate relevant ethical requirements, we analyze established ethics frameworks in the fields of LHSs, data-intensive health research, and transitioning or innovating health systems. The overlapping content and shared values are used to articulate overarching ethical requirements. To provide necessary context, we apply the insights from the analysis to the Innovative Medicines Initiative ConcePTION project. This project is specifically designed to generate knowledge on the safety of medications used during pregnancy and lactation through the establishment of an LHS. Results: Upon analyzing the consulted frameworks, we identified four overlapping ethical requirements that are also of significant relevance within the scope of our ethics framework. These requirements are: (1) public benefit and favorable harm-benefit ratio; (2) equity and justice; (3) stakeholder engagement; and (4) sustainability. Additionally, we apply these ethical requirements to the context of an LHS for pregnant and lactating people. Conclusion: Although tailored to the context of pregnancy and lactation, our ethics framework can provide guidance for the transition to an operational LHS across diverse healthcare domains.

Indexed as

ethicsethics frameworklearning healthcare systempregnancy and lactation

Identifiers

PMID39036527
PMCPMC11257051

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.