Trial reportBMJ open2018

Informed shared decision-making programme for patients with type 2 diabetes in primary care: cluster randomised controlled trial.

Susanne Buhse, Nadine Kuniss, Kathrin Liethmann, Ulrich Alfons Müller, Thomas Lehmann, Ingrid Mühlhauser

Erratum issuedOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2018. The graph read 4 numbers from its abstract, feeding 2 cells of the map: it favours the comparator in 1. An erratum has been issued. Cited by 11 papers, 8 of them syntheses that pooled it.

4numbers the graph read from it
1cell of the map it votes in
11citing papers in PubMed, 8 pooled it
6.4field-weighted citation impact, top 4% 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.

← favours the treatmentfavours the comparator →
24101 · no effect
Blood pressurefavours the comparator · against placebo · hypertension, t2dfeeds one cell of the map
OR 26.06.50 to 105
More ISDM-P patients made informed choices regarding statin intake, 34% vs 3%, OR 16.6 (95% CI 4.4 to 63.0), blood pressure control, 39% vs 3%, OR 22.2 (95% CI 5.3 to 93.3) and glycated haemoglobin, 43% vs 3%, OR 26.0 (95% CI 6.5 to 104.8).
Blood pressurefavours the comparator · against placebo · hypertension, t2dfeeds one cell of the map
OR 22.25.30 to 93.3
More ISDM-P patients made informed choices regarding statin intake, 34% vs 3%, OR 16.6 (95% CI 4.4 to 63.0), blood pressure control, 39% vs 3%, OR 22.2 (95% CI 5.3 to 93.3) and glycated haemoglobin, 43% vs 3%, OR 26.0 (95% CI 6.5 to 104.8).
Blood pressurefavours the comparator · against placebo · hypertension, t2dfeeds one cell of the map
OR 16.64.40 to 63.0
More ISDM-P patients made informed choices regarding statin intake, 34% vs 3%, OR 16.6 (95% CI 4.4 to 63.0), blood pressure control, 39% vs 3%, OR 22.2 (95% CI 5.3 to 93.3) and glycated haemoglobin, 43% vs 3%, OR 26.0 (95% CI 6.5 to 104.8).

Read, but not usablea number the graph found but could not read as for or against

Quality of life & behaviourcomparator not stated · hypertension, t2dfeeds one cell of the map
Δ 4.062.96 to 5.17
ISDM-P patients achieved higher levels of risk knowledge, with a mean score of 6.96 vs 2.86, difference 4.06 (95% CI 2.96 to 5.17).

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Statins×blood pressure

ContradictsOpen on the map →What to test next →

9 readable studies in this cell: 4 favour the treatment, 4 find no difference, 1 favour the comparator.

Belief with this paper
0.83replicated · 5 families support, 1 contradict · against placebo
Without it
1.00This paper moves it by −0.17.
← favours the treatmentfavours the comparator →
1 · no effect
This paper · 2018
OR 26.06.50 to 105
NCT03944512102 enrolled · 2019
RR 3.000.32 to 77.2

Antihypertensives×quality of life & behaviour

No readable resultOpen on the map →What to test next →

No other readable study in this cell yet. This paper is the evidence.

Belief with this paper
0.25no deciding trial · 0 families support, 0 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
4 · 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.

5 · Its place in the literature

Who cites it

11 citing papers in PubMed, 8 syntheses or guidelines pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Decision aids for people facing health treatment or screening decisions.The Cochrane database of systematic reviews · 2024
    Pooled it
  5. Pooled it
  6. Decision coaching for people making healthcare decisions.The Cochrane database of systematic reviews · 2021
    Pooled it
  7. Pooled it
  8. Pooled it
  9. Article
  10. Article
  11. Article
6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Susanne BuhseHealth Sciences and Education, University of Hamburg, Hamburg, Germany.ORCID 0000-0002-0308-2561
Nadine KunissDepartment of Internal Medicine III, Endocrinology and Metabolic Diseases, Jena University Hospital, Jena, Germany.
Kathrin LiethmannHealth Sciences and Education, University of Hamburg, Hamburg, Germany.
Ulrich Alfons MüllerDepartment of Internal Medicine III, Endocrinology and Metabolic Diseases, Jena University Hospital, Jena, Germany.
Thomas LehmannCentre for Clinical Studies, Jena University Hospital, Jena, Germany.
Ingrid MühlhauserHealth Sciences and Education, University of Hamburg, Hamburg, Germany.
Jena University Hospital · DEUniversität Hamburg · DE

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

objectiveTo translate an informed shared decision-making programme (ISDM-P) for patients with type 2 diabetes from a specialised diabetes centre to the primary care setting.

designPatient-blinded, two-arm multicentre, cluster randomised controlled trial of 6 months follow-up; concealed randomisation of practices after patient recruitment and acquisition of baseline data.

setting22 general practices providing care according to the German Disease Management Programme (DMP) for type 2 diabetes.

participants279 of 363 eligible patients without myocardial infarction or stroke.

interventionsThe ISDM-P comprises a patient decision aid, a corresponding group teaching session provided by medical assistants and a structured patient-physician encounter.Control group received standard DMP care. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary endpoint was patient adherence to antihypertensive or statin drug therapy by comparing prescriptions and patient-reported uptake after 6 months. Secondary endpoints included informed choice, risk knowledge (score 0-11 from 11 questions) and prioritised treatment goals of patients and doctors.

resultsISDM-P: 11 practices with 151 patients; standard care: 11 practices with 128 patients; attrition rate: 3.9%. There was no difference between groups regarding the primary endpoint. Mean drug adherence rates were high for both groups (80% for antihypertensive and 91% for statin treatment). More ISDM-P patients made informed choices regarding statin intake, 34% vs 3%, OR 16.6 (95% CI 4.4 to 63.0), blood pressure control, 39% vs 3%, OR 22.2 (95% CI 5.3 to 93.3) and glycated haemoglobin, 43% vs 3%, OR 26.0 (95% CI 6.5 to 104.8). ISDM-P patients achieved higher levels of risk knowledge, with a mean score of 6.96 vs 2.86, difference 4.06 (95% CI 2.96 to 5.17). In the ISDM-P group, agreement on prioritised treatment goals between patients and doctors was higher, with 88.5% vs 57%.

conclusionsThe ISDM-P was successfully implemented in general practices. Adherence to medication was very high making improvements hardly detectable. TRIAL REGISTRATION NUMBER: ISRCTN77300204; Results.

Indexed as

Decision MakingPatient ParticipationAdultAgedAntihypertensive AgentsDiabetes Mellitus, Type 2Diabetic AngiopathiesFollow-Up StudiesGlycated HemoglobinHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypertensionMedication AdherenceMiddle AgedPatient Education as TopicPhysician-Patient RelationsAntihypertensive AgentsGlycated Hemoglobinhemoglobin A1c protein, humanHydroxymethylglutaryl-CoA Reductase Inhibitorsdecision support techniquesdiabetes mellitus, Type 2health educatorshealth knowledge, attitudes, practicepatient education as topicprimary care

Identifiers

PMID30552272
PMCPMC6303685
OpenAlexW2903908673

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

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 Socratic graph.