Evidence map›Paper›PMID 40763135›Full record

ArticlePloS one2025

Evaluating the feasibility of study methods for a future trial-based economic evaluation of a multistage shared decision-making program for type 2 diabetes mellitus: Protocol for a cluster-randomized controlled pilot study.

Anna Tichler, Dorijn F L Hertroijs, Ghislaine A P G van Mastrigt, Martijn C G J Brouwers, Dirk Ruwaard, Arianne M J Elissen

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06410768 (Evaluating the Feasibility of a Future Trial-based Economic Evaluation of a Multistage Shared Decision-making Program for the Treatment of Type 2 Diabetes Mellitus), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT06410768 naunknown statusnot on this map

Evaluating the Feasibility of a Future Trial-based Economic Evaluation of a Multistage Shared Decision-making Program for the Treatment of Type 2 Diabetes Mellitus: a Pilot Study

TypeinterventionalSponsorMaastricht University Medical CenterRan2024 to 2025Enrolled40ConditionsDiabetes Mellitus, Type 2Armsmultistage shared decision-making program
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

6 authors.

Anna TichlerDepartment of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences (FHML), Maastricht University, Maastricht, the Netherlands.ORCID 0000-0002-7747-0946
Dorijn F L HertroijsDepartment of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences (FHML), Maastricht University, Maastricht, the Netherlands.
Ghislaine A P G van MastrigtDepartment of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences (FHML), Maastricht University, Maastricht, the Netherlands.
Martijn C G J BrouwersCare and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences (FHML), Maastricht University, Maastricht, the Netherlands.
Dirk RuwaardDepartment of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences (FHML), Maastricht University, Maastricht, the Netherlands.
Arianne M J ElissenDepartment of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences (FHML), Maastricht University, Maastricht, the Netherlands.ORCID 0000-0001-9795-8095

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe developed a multistage shared decision-making program for type 2 diabetes that aims to support person-centered type 2 diabetes management in primary care. The program consists of an online patient decision aid, a preparatory consult for patients, and interprofessional training for healthcare professionals. The short- and long-term effectiveness of the multistage shared decision-making program needs to be researched in a trial-based economic evaluation. To evaluate the feasibility of study methods for such an evaluation, we will conduct a pilot study. In this article, we outline its protocol, which focuses on sample recruitment and retention, study management, and feasibility of outcome and cost measurements. METHODS AND ANALYSIS: The multistage shared decision-making program will be pilot-tested in a cluster-randomized controlled trial in four primary care practices (located in the region of Gorinchem, the Netherlands) using a convergent parallel mixed-methods approach. The intervention practices will adopt the program, whereas the control practices provide usual care. Data collection will include recruitment, retention, and consent rates, patients' sociodemographic and clinical characteristics, and the assessment of primary and secondary outcomes of the future trial-based economic evaluation. We will also collect data on the usage behavior of patients when completing questionnaires of the primary and secondary outcomes (i.e., time needed to complete questionnaires). Semi-structured interviews with patients will be conducted to obtain insights into the understandability and usability of measurement tools. Moreover, focus groups with healthcare professionals from participating practices will be organized to complement the quantitative data on sample representativeness and to assess the study management challenges of participating practices. DISCUSSION: The pilot will address uncertainties around the feasibility of a future trial-based economic evaluation, focusing on sample recruitment and retention, study management, and the feasibility of outcome and cost measurements. The results will guide the improvement of study procedures for the economic evaluation of our multistage shared decision-making program for type 2 diabetes.

trial registrationThe study is registered at ClinicalTrials.gov: NCT06410768.

Indexed as

Decision Making, SharedDiabetes Mellitus, Type 2Cost-Benefit AnalysisFeasibility StudiesFemaleHumansMaleNetherlandsPilot ProjectsPrimary Health CareRandomized Controlled Trials as Topic

Identifiers

PMID40763135
PMCPMC12324081

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Registered trials

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.