Evidence map›Paper›PMID 26567256›Full record

Trial reportBMJ open2015

Informed shared decision-making programme on the prevention of myocardial infarction in type 2 diabetes: a randomised controlled trial.

Susanne Buhse, Ingrid Mühlhauser, Tabitha Heller, Nadine Kuniss, Ulrich Alfons Müller, Jürgen Kasper, Thomas Lehmann, Matthias Lenz

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05666544 (Developing and Effectiveness Evaluation of Web-based Situation Renal Replacement Therapies Patient Decision Aids), which is not on this map. Cited by 23 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 8 pooled it
6.7field-weighted citation impact, top 3% 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.

NCT05666544 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Developing and Effectiveness Evaluation of Web-based Situation Renal Replacement Therapies Patient Decision Aids

TypeinterventionalSponsorChina Medical University HospitalRan2022 to 2024Enrolled70ConditionsEnd-stage Renal Disease, Renal Replacement Therapy, Decision Aid, Decision-makingArmsWeb-based patient decision aid, Written health education leaflets
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 8 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
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  3. Decision aids for people facing health treatment or screening decisions.The Cochrane database of systematic reviews · 2024
    Pooled it
  4. Pooled it
  5. Decision coaching for people making healthcare decisions.The Cochrane database of systematic reviews · 2021
    Pooled it
  6. Guideline
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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

8 authors at 3 institutions in 2 countries.

Susanne BuhseFaculty of Mathematics, Informatics and Natural Sciences, Unit of Health Sciences and Education, University of Hamburg, Hamburg, Germany.
Ingrid MühlhauserFaculty of Mathematics, Informatics and Natural Sciences, Unit of Health Sciences and Education, University of Hamburg, Hamburg, Germany.
Tabitha HellerDepartment of Internal Medicine III, Endocrinology and Metabolic Diseases, Jena University Hospital, Jena, Germany.
Nadine KunissDepartment of Internal Medicine III, Endocrinology and Metabolic Diseases, Jena University Hospital, Jena, Germany.
Ulrich Alfons MüllerDepartment of Internal Medicine III, Endocrinology and Metabolic Diseases, Jena University Hospital, Jena, Germany.
Jürgen KasperFaculty of Health Sciences, Department of Health and Caring Sciences, University of Tromsø, Tromsø, Norway.
Thomas LehmannJena University Hospital, Centre for Clinical Studies, Jena, Germany.
Matthias LenzFaculty of Mathematics, Informatics and Natural Sciences, Unit of Health Sciences and Education, University of Hamburg, Hamburg, Germany.
Jena University Hospital · DEUniversität Hamburg · DEUiT The Arctic University of Norway · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate an informed shared decision-making programme (ISDM-P) for people with type 2 diabetes under high fidelity conditions.

designRandomised, single-blinded trial with sham control intervention and follow-up of 6 months.

settingSingle-centre diabetes clinic providing care according to the national disease management programme in Germany.

participants154 people with type 2 diabetes without diagnosis of ischaemic heart disease or stroke.

interventionsThe ISDM-P is executed by diabetes educators. Core component is a patient decision aid on the prevention of myocardial infarction supplemented by a 90 min group teaching session. The structurally equivalent control intervention addresses stress issues.

main outcome measuresPrimary outcome was risk comprehension, including realistic expectations about benefits and harms of interventions. It was assessed by a 12-item questionnaire after the teaching session when patients set and prioritise their treatment goals. Key secondary outcome was adherence to treatment goals, operationalised as achievement of individual goals and medication uptake. ISDM-P teaching sessions were video-taped to monitor intervention fidelity.

results72 of 77 ISDM-P and 71 of 77 control patients completed the questionnaire (score 0-12). ISDM-P patients achieved higher levels of risk comprehension, mean score 8.25 vs 2.62, difference 5.63 (95% CI 4.82 to 6.44), and realistic expectations (score 0-6), 4.51 vs 0.85, 3.67 (3.23 to 4.11). More ISDM-P patients wished to take statins, 59.2% vs 30.4%, 28.7% (12.9% to 44.5%); more prioritised blood pressure control, 51.4% vs 25.7%, and fewer intensive glucose control, 33.3% vs 60%, p=0.002. More ISDM-P patients achieved their glycated haemoglobin goals, 95.8% vs 85.7%, 10.1% (0.6% to 19.5%). Achievement of prioritised goals and medication uptake were comparable between groups.

conclusionsThe ISDM-P on preventive measures in type 2 diabetes was effective under high fidelity conditions. Involvement of diabetes educators may facilitate implementation of the informed shared decision-making. TRIAL REGISTRATION NUMBER: ISRCTN84636255.

Indexed as

Decision MakingAgedBlood PressureDiabetes Mellitus, Type 2FemaleGermanyHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedMyocardial InfarctionOutcome Assessment, Health CarePatient Education as TopicStrokeHydroxymethylglutaryl-CoA Reductase InhibitorsMEDICAL EDUCATION & TRAINING

Identifiers

PMID26567256
PMCPMC4654390
OpenAlexW2179447311

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

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 Socratic graph.