Evidence map›Paper›PMID 27456328›Full record

Trial reportBMJ open2016

Pilot study to test the feasibility of a trial design and complex intervention on PRIoritising MUltimedication in Multimorbidity in general practices (PRIMUMpilot).

Christiane Muth, Sebastian Harder, Lorenz Uhlmann, Justine Rochon, Birgit Fullerton, Corina Güthlin, Antje Erler, Martin Beyer, Marjan van den Akker, Rafael Perera and 4 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 7 pooled it
2.1field-weighted citation impact, top 14% 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

26 citing papers in PubMed, 7 syntheses or guidelines pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Patient and family engagement interventions in primary care patient safety: systematic review and meta-analysis of randomised controlled trials.The British journal of general practice : the journal of the Royal College of General Practitioners · 2025
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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

14 authors at 6 institutions in 4 countries.

Christiane MuthInstitute of General Practice, Johann Wolfgang Goethe University, Frankfurt/Main, Germany.
Sebastian HarderInstitute for Clinical Pharmacology, Johann Wolfgang Goethe University Hospital, Frankfurt/Main, Germany.
Lorenz UhlmannInstitute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
Justine RochonInstitute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
Birgit FullertonInstitute of General Practice, Johann Wolfgang Goethe University, Frankfurt/Main, Germany.
Corina GüthlinInstitute of General Practice, Johann Wolfgang Goethe University, Frankfurt/Main, Germany.
Antje ErlerInstitute of General Practice, Johann Wolfgang Goethe University, Frankfurt/Main, Germany.
Martin BeyerInstitute of General Practice, Johann Wolfgang Goethe University, Frankfurt/Main, Germany.
Marjan van den AkkerInstitute of General Practice, Johann Wolfgang Goethe University, Frankfurt/Main, Germany Department of Family Medicine, School CAPHRI, Maastricht University, Maastricht, The Netherlands Department of General Practice, KU Leuven, Leuven, Belgium.
Rafael PereraDepartment of Primary Care Health Sciences, University of Oxford, Oxford, UK.
André KnottnerusDepartment of Family Medicine, School CAPHRI, Maastricht University, Maastricht, The Netherlands.
Jose M ValderasHealth Services & Policy Research Group, School of Medicine, University of Exeter, Exeter, UK.
Ferdinand M GerlachInstitute of General Practice, Johann Wolfgang Goethe University, Frankfurt/Main, Germany.
Walter E HaefeliDepartment of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany.
Goethe University Frankfurt · DEHeidelberg University · DEMaastricht University · NLUniversity of Exeter · GBUniversity of Oxford · GBZimmer Biomet (Germany) · DE

Funding

Department of Health NIHR/CS/010/024
6 · The paper itself

Abstract

objectiveTo improve medication appropriateness and adherence in elderly patients with multimorbidity, we developed a complex intervention involving general practitioners (GPs) and their healthcare assistants (HCA). In accordance with the Medical Research Council guidance on developing and evaluating complex interventions, we prepared for the main study by testing the feasibility of the intervention and study design in a cluster randomised pilot study.

setting20 general practices in Hesse, Germany.

participants100 cognitively intact patients ≥65 years with ≥3 chronic conditions, ≥5 chronic prescriptions and capable of participating in telephone interviews; 94 patients completed the study.

interventionThe HCA conducted a checklist-based interview with patients on medication-related problems and reconciled their medications. Assisted by a computerised decision-support system (CDSS), the GPs discussed medication intake with patients and adjusted their medication regimens. The control group continued with usual care. OUTCOME MEASURES: Feasibility of the intervention and required time were assessed for GPs, HCAs and patients using mixed methods (questionnaires, interviews and case vignettes after completion of the study). The feasibility of the study was assessed concerning success of achieving recruitment targets, balancing cluster sizes and minimising drop-out rates. Exploratory outcomes included the medication appropriateness index (MAI), quality of life, functional status and adherence-related measures. MAI was evaluated blinded to group assignment, and intra-rater/inter-rater reliability was assessed for a subsample of prescriptions.

results10 practices were randomised and analysed per group. GPs/HCAs were satisfied with the interventions despite the time required (35/45 min/patient). In case vignettes, GPs/HCAs needed help using the CDSS. The study made no patients feel uneasy. Intra-rater/inter-rater reliability for MAI was excellent. Inclusion criteria were challenging and potentially inadequate, and should therefore be adjusted. Outcome measures on pain, functionality and self-reported adherence were unfeasible due to frequent missing values, an incorrect manual or potentially invalid results.

conclusionsIntervention and trial design were feasible. The pilot study revealed important limitations that influenced the design and conduct of the main study, thus highlighting the value of piloting complex interventions. TRIAL REGISTRATION NUMBER: ISRCTN99691973; Results.

Indexed as

Decision Support Systems, ClinicalGeneral PracticeMedication ReconciliationPolypharmacyAdultAgedAged, 80 and overChecklistChronic DiseaseFeasibility StudiesFemaleGeneral PractitionersGermanyHumansMaleMultimorbiditycomorbiditycomplex interventiondrug therapy, computer-assistedmedication adherenceMultimorbiditypolypharmacy

Identifiers

PMID27456328
PMCPMC4964238
OpenAlexW2499337901

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.