Evidence map›Paper›PMID 40597226›Full record

ArticleBMC musculoskeletal disorders2025

Impact of an in-consult patient decision aid on decisional quality, involvement, and health outcome for patients with severe hip or knee osteoarthritis - a study protocol for a multicentre, cluster randomised controlled trial (PATI-study).

Trine Ahlmann Pedersen, Martin Lindberg-Larsen, Charlotte Myhre Jensen, Signe Timm, Karina Dahl Steffensen, Claus Varnum

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC musculoskeletal disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05972525 (What Matters to Patients With Severe Hip or Knee Osteoarthritis? Decisional Quality, Patient Involvement and Health Outcome), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT05972525 naactive not recruitingnot on this map

What Matters to Patients With Severe Hip or Knee Osteoarthritis? Decisional Quality, Patient Involvement and Health Outcome

TypeinterventionalSponsorVejle HospitalRan2023 to 2026Enrolled615ConditionsHip Osteoarthritis, Knee OsteoarthritisArmsShared decision-making supported by an in-consultation PtDA to patients with severe osteoarthritis in their hip or knee
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. 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.

Trine Ahlmann PedersenDepartment of Orthopaedic Surgery, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark. Trine.Ahlmann.Pedersen@rsyd.dk.ORCID http://orcid.org/0000-0002-7054-2476
Martin Lindberg-LarsenOrthopaedic Research Unit, Clinical Institute, University of Southern Denmark, Odense, Denmark.ORCID http://orcid.org/0000-0002-4483-677X
Charlotte Myhre JensenOrthopaedic Research Unit, Clinical Institute, University of Southern Denmark, Odense, Denmark.ORCID http://orcid.org/0000-0002-7058-4641
Signe TimmDepartment of Regional Health Research, University of Southern Denmark, Odense, Denmark.ORCID http://orcid.org/0000-0002-5862-7784
Karina Dahl SteffensenDepartment of Regional Health Research, University of Southern Denmark, Odense, Denmark.ORCID http://orcid.org/0000-0002-9217-3907
Claus VarnumDepartment of Orthopaedic Surgery, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark.ORCID http://orcid.org/0000-0002-0625-5691

Funding

Research Fund at Lillebaelt Hospital F21-38The Region of Southern Denmark A1412
6 · The paper itself

Abstract

backgroundOsteoarthritis (OA) is a joint disease with a high worldwide prevalence, often leading to replacement surgery. However, despite the high success rate of replacement surgery, some patients fail to experience the intended benefits. Given the importance of patient involvement, this trial aims to assess the effect of shared decision-making (SDM) on decisional quality for patients with severe OA. Specifically, it investigates whether an in-consult patient decision aid (PtDA) enhances decisional quality, involvement, and health outcomes for patients with severe hip or knee OA.

methodsThis protocol outlines a pragmatic two-armed multicentre cluster-randomised controlled trial (C-RCT), chosen for its ability to assess the combined effect of shared decision-making (SDM) and a newly developed in-consult patient decision aid (PtDA) in routine clinical practice. The PtDA is a tool designed to help patients make informed decisions during the consultation by providing personalised treatment options, benefits, and risks. The C-RCT design is particularly well-suited to this context, as it effectively minimises contamination and bias across treatment groups. A total of 19 orthopaedic surgeons will be randomised 1:1, stratified by centre, to either continue standard consultations without the PtDA or implement SDM using the PtDA. The trial will recruit 615 patients with severe hip or knee OA. Outcomes will be measured at one week, three months, and 12 months post treatment start. The primary outcome, decisional quality, will be assessed using the Hip/Knee OA Decision Quality Instrument, focusing on patients being well-informed and receiving their preferred treatment. The secondary outcomes include patient involvement in the decision-making process and consultation durations. The tertiary outcomes include patients' satisfaction, regret and health-related outcomes. The primary outcome will be analysed using a multilevel mixed-effects logistic regression with surgeons as random effects reporting odds ratios with 95% confidence intervals. DISCUSSION: This study aims to contribute insights into the use of SDM facilitated by a PtDA and its impact on improving decisional quality for future patients with hip or knee OA.

trial registrationwww. CLINICALTRIALS: gov (NCT05972525), Data of registration: 06.08.2023.

Indexed as

Decision Making, SharedDecision Support TechniquesOsteoarthritis, HipOsteoarthritis, KneePatient ParticipationHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicSeverity of Illness IndexTreatment OutcomeCluster-randomised trialDecisional qualityOsteoarthritisPatient-reported outcomeShared decision-makingTotal hip replacementTotal knee replacementUnicompartmental knee replacement

Identifiers

PMID40597226
PMCPMC12220521

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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.