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Open Access 01-12-2019 | Osteoarthrosis | Study protocol

An individualized patient-reported outcome measure (PROM) based patient decision aid and surgeon report for patients considering total knee arthroplasty: protocol for a pragmatic randomized controlled trial

Published in: BMC Musculoskeletal Disorders | Issue 1/2019

Abstract

Background

While the rates of total knee arthroplasty (TKA) continue to rise worldwide, there are concerns about whether all surgeries are appropriate. Guidelines for appropriateness suggest that patients should have realistic expectations for total knee arthroplasty (TKA), and that the patient and their surgeon should agree that the potential benefits outweigh the potential harms. The objective of this study is to evaluate whether routinely collected pre- and post-TKA patient-reported outcome measures (PROMs) could be integrated into a patient decision aid to better inform these appropriateness criteria. This randomised trial will evaluate the preliminary efficacy of a tailored PROM-based patient decision aid and surgeon report (compared to usual care) for patients considering TKA on decision quality.

Methods

This is a pragmatic, randomised controlled trial conducted at one site in Alberta, Canada. Adults over the age of 30 years, who have been scheduled for a TKA consultation at the Edmonton Bone and Joint Centre with a participating surgeon, who understand, speak, and read English, and can provide informed consent, are eligible to participate. Participants will be randomised to receive a PROM-based patient decision aid and surgeon report before their surgical consultation or usual care. The decision aid will provide patients with information on their expected outcomes based on the EQ-5D-5L PROM, and these estimates are individualized based on clinical and demographic characteristics. The primary outcome of this trial is decision quality. Analysis will consider outcomes intention to treat, and feasibility outcomes for implementing the trial to routine practise.

Discussion

This patient decision aid and surgeon report intervention could contribute to improved treatment decision-making for patients considering total knee arthroplasty.

Trial registration (registry and number)

ClinicalTrials.gov: NCT03240913. Registered on August 1, 2017.

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Title: An individualized patient-reported outcome measure (PROM) based patient decision aid and surgeon report for patients considering total knee arthroplasty: protocol for a pragmatic randomized controlled trial
Publication date: 01-12-2019
Keywords: Osteoarthrosis
Osteoarthrosis
Published in: BMC Musculoskeletal Disorders / Issue 1/2019
Electronic ISSN: 1471-2474
DOI: https://doi.org/10.1186/s12891-019-2434-2

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

An individualized patient-reported outcome measure (PROM) based patient decision aid and surgeon report for patients considering total knee arthroplasty: protocol for a pragmatic randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration (registry and number)

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration (registry and number)

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