Evidence map›Paper›PMID 31933255›Full record

ArticlePharmaceutical medicine2019

Danish Physicians' Views on the Appropriateness of the Involvement of Patients with Type 2 Diabetes in Regulatory Decision Making: A Qualitative Study.

Mikkel Lindskov Sachs, Morten Colding-Jørgensen, Per Helboe, Sofia Kälvemark Sporrong, Sven Frøkjaer, Katarina Jelic, Susanne Kaae

Abstract readComparative Study
PubMed Publisher
In one paragraph

Article in Pharmaceutical medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact, top 97% of its field
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

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 1 citations in OpenAlex.

  1. Pooled it
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

7 authors at 2 institutions in 1 country.

Mikkel Lindskov SachsUniversity of Copenhagen, Copenhagen, Denmark.
Morten Colding-JørgensenNovo Nordisk, Søborg, Denmark.
Per HelboeUniversity of Copenhagen, Copenhagen, Denmark.
Sofia Kälvemark SporrongUniversity of Copenhagen, Copenhagen, Denmark.
Sven FrøkjaerUniversity of Copenhagen, Copenhagen, Denmark.
Katarina JelicNovo Nordisk, Søborg, Denmark.
Susanne KaaeUniversity of Copenhagen, Copenhagen, Denmark. susanne.kaae@sund.ku.dk.ORCID http://orcid.org/0000-0002-8187-365X
University of Copenhagen · DKNovo Nordisk (Denmark) · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRegulators, the pharmaceutical industry, and patient organizations expect an increased inclusion of patients' risk preferences in medical regulatory decisions, for example, with regard to market approval. Merging of input from patients with, for example, multiple sclerosis, with expertise from health professionals in regulatory decisions has already occurred. The complex task of involving larger and more heterogeneous patient populations (e.g. with diabetes mellitus, asthma), however, remains.

objectiveThis study aimed to understand physicians' experiences with factors influencing patients with diabetes mellitus perceived risks of their medicines and to explore how physicians, based on these experiences, perceive patients with diabetes to be suited for involvement in regulatory decisions. This study will provide knowledge that can improve the inclusion of heterogeneous patient groups in regulatory decisions.

methodsWe conducted five semi-structured interviews with physicians with different types of experiences with patients' risk perceptions (for example, being in contact with individual patients vs. being involved in developing guidelines at the population level) and one focus group interview with eight general practitioners in Sjælland, Denmark. We applied a thematic analysis to explore physicians' experiences of the risk perceptions of patients with type 2 diabetes and their perceptions of patients' fitness for involvement in regulatory decisions.

resultsThe risk perceptions and preferences of patients with diabetes were perceived to be rather diverse. Four drivers behind this diversity were described: past experiences, personality, prognosis ability, and knowledge. The legitimacy of patient preferences was not questioned, but the diversity of risk perceptions made the respondents question the existence of a uniform 'patient voice' useful for regulatory decision making.

conclusionThe respondents acknowledged the relevance and legitimacy of the patient perspective, but it was a concern that patient risk perceptions, at present, are too diverse to be included in regulatory decisions. Whether patients make regulatory decisions as perceived by physicians needs to be confirmed by future studies.

Indexed as

Attitude of Health PersonnelDecision MakingDenmarkDiabetes Mellitus, Type 2Drug ApprovalFemaleFocus GroupsGuidelines as TopicHumansInterviews as TopicKnowledgeMaleMultiple SclerosisPatient ParticipationPatient PreferencePerception

Identifiers

PMID31933255
OpenAlexW2927586638

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

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.