Abstract
BackgroundShared decision-making is an approach to making treatment-based decisions that rely on the patient encounter and clear discussions between the patient and the healthcare provider. Patients with arthritis of the knee frequently seek care, and depending on arthritis severity and impact on daily life, joint arthroplasty may be considered as a treatment option. We will conduct a systematic review of shared decision-making trials in knee arthroplasty to determine the types of shared decision-making approaches used and their impact on care received.MethodsOur systematic review will describe and critically appraise shared decision approaches used in randomized trials of patients undergoing knee arthroplasty, the types of outcomes reported, and the impact of these approaches on the patients’ care. We will use the following databases: PubMed, Web of Science, Embase, CINAHL, PsycINFO, and the Cochrane Library, from inception through December 2018. Additionally, we will assess ongoing research by querying experts and searching trial registries.DiscussionThis study will characterize shared decision-making (SDM) approaches in knee arthroplasty randomized clinical trials and will summarize their effects of SDM on clinical and patient-reported outcomes. We anticipate this review will bring to light knowledge gaps and inform further research into the design and use of shared decision-making approaches in lower extremity arthroplasty.Systematic review registrationPROSPERO CRD42019123586
Highlights
Shared decision-making is an approach to making treatment-based decisions that rely on the patient encounter and clear discussions between the patient and the healthcare provider
We found no systematic reviews of the Total knee arthroplasty (TKA) decision aid (DA)/shared decision-making (SDM) literature that determined the types of DA/ SDM approaches studied, their relationship to key elements of SDM, or the extent to which DA/SDMs impacted the care that the patients received
This review will provide a comprehensive summary of the clinical trial evidence related to the use of DA/SDM approaches as applied to patients undergoing TKA, the most common major surgical procedure conducted in the USA
Summary
Study design Our protocol design was based on the Preferred Reporting Items for Systematic Review and Meta-analysis Protocols (PRISMA-P) [12]. Interventions and comparators of interest All studies that randomize patients who plan to undergo TKA to a DA/SDM treatment arm and a usual care or active control arm will be included. Common outcome tools in SDM include but are not limited to the SDM-Q-9 [20] and the OPTION scale [21], both of which are used to collect detailed patient/clinician encounter data Both DA and SDM approaches have included proximal clinical outcomes including satisfaction with the clinical decision as well as distal clinical outcomes such as 30-day post-treatment adverse event rates [22]. Risk of bias in individual studies Bias risk for each trial will be assessed by two independent reviewers (DLR and TS) using the risk of bias tool (RoB 2) developed by the Cochrane Collaboration [17] This bias instrument assesses five domains of potential bias: the randomization process, deviations from intended interventions, outcome data missingness, outcome measurement, and reported result biases. The GRADEpro GDT software will be used to generate GRADE data [24]
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