Protocol for systematic review: patient decision aids for total hip and knee arthroplasty decision-making

Osteoarthritis (OA) is a leading cause of disability worldwide impacting health on an individual and population level [1, 2]. OA of the hip and knee is a highly prevalent disease in Canada affecting 38 to 45% of Canadians aged 50 years and older [3]. Clinical guidelines for the management of OA recommend arthritis education, structured land-based exercise programs, and pharmacologic treatment [4, 5]. When conservative treatment fails to alleviate symptoms, total joint arthroplasty (TJA) is the recommended treatment [6, 7]. Nonetheless, TJA requires trading off benefits and risks as it is one treatment option amongst many others with no single “best” choice [8]. TJA is an elective surgery and the third most performed inpatient surgery in Canada, with 58,492 total hip arthroplasty (THA) and 70,502 total knee arthroplasty (TKA) performed in 2018 [9]. This represents a volume increase of 17.0% compared to 2013 [9]. Similar trends are seen worldwide and numbers are expected to continue rising [10‐13]. This phenomenon is concerning for healthcare systems considering the inpatient and outpatient resources needed for TJA procedure [9, 14, 15].

OA represents 80% of the reason for undergoing TJA and the majority of recipients are 65 years and older [9, 13, 16]. TJA has been shown to successfully reduce pain and improve function, mobility, and health-related quality of life for patients with severe OA [17‐20]. Concurrently, there are potential harms associated with this surgery such as joint infection, venous thrombosis, cardiovascular complications, post-operative pain and stiffness, and life-threatening complications [21‐23].

Twenty to 45% of joint arthroplasty are considered of questionable appropriateness [8], and 10 to 30% of patients are not satisfied with the outcomes [24‐27]. The first factor contributing to these statistics is the limited evidence-based criteria for TJA appropriateness [8]. Therefore, healthcare professionals and surgeons use their expert opinion in the decision-making process. However, studies have shown discrepancies between healthcare professional opinion and patient preferences [8, 28‐34]. Additionally, many studies have shown insufficient information provided to patients [35, 36] and most patients have unrealistic outcome expectations [37, 38].

Involvement of patients in their healthcare decision is well documented to improve patient satisfaction, sense of control, health outcomes, treatment quality, and adherence, and reduce healthcare costs [39‐44]. Shared decision-making (SDM) is a process actively including patients as partners in making healthcare decisions together with their clinician(s) and involves providing them evidence-based knowledge on options and discussion of their values and preferences [45‐47]. A recent systematic review has demonstrated the effectiveness of SDM for elective surgery to improve decision quality and decrease decisional conflict [48].

To facilitate SDM, patient decision aids (PtDAs) are tools which can take many forms (pamphlets, videos, Internet-based) that can be used in the clinical encounter or in preparation for the clinical encounter. They support SDM by making the decision explicit and providing information about benefits, harms, and uncertainty of options. Furthermore, they also guide patients in values clarification to achieve agreement between features of the option chosen and personal values [49, 50]. Contrary to educational materials, PtDAs focuse on making explicit the decision, options, and associated outcomes and provides guidance on clarifying personal values [49]. A Cochrane review including 105 studies and 31,043 individuals demonstrated that PtDAs improve decision quality (increasing patient knowledge, fostering more accurate expectations and risk perceptions, supporting clarification of what is important to patients, and helping patients choose the best option associated to their values) and decision-making process (promoting clinician-patient decision discussion, increasing patient participation in the decision-making process, decreasing decisional conflict, and promoting a positive healthcare experience) [49]. Moreover, it was demonstrated that PtDAs used in the context of elective surgery, patients are less likely to choose surgery when they understand alternative options [48, 49, 51]. Further, PtDAs were shown to hold similar long-term cost and surgery rates compared to usual care [51], short-term cost saving [52], but unclear long-term cost-effective properties [52].

A recent systematic review exploring features and impact of SDM/PtDA interventions for knee arthritis TJA decision-making found that most trials did not include all key aspects of SDM [53]. The authors recognized the need for future research to focus on assessing the effect of PtDAs and SDM on treatment decision, functional outcomes, and satisfaction [53].

With the proportion of seniors living in industrialized countries growing rapidly [54, 55], it is fundamental to improve current TJA decision-making processes that can lead to improved healthcare efficiency, better patient expectations, better patient and surgeon experiences, and reduced burden on the healthcare system. To date, no systematic review has focused on assessing the effect of PtDAs for adults with OA considering primary elective THA and TKA.

The aim of this systematic review is to determine the effect of patient decision aids compared to alternative of care on quality and process of decision-making when provided to adults with hip and knee osteoarthritis considering primary elective TJA. Specifically, objectives related to the quality of the decision and decision-making process are:

Objectives related to decision-making outcomes are:

This protocol was guided by the Cochrane Handbook for Systematic Reviewer [56]. This protocol was reported based on the Preferred Reporting Items for Systematic Review and Meta-analysis Protocols (PRISMA-P) checklist guidelines [57].

To our knowledge, no systematic review has been conducted on PtDAs for adults with OA considering primary elective THA and TKA decision-making. This review will complement the systematic review of Riddle et al. [53] by focusing on PtDAs by (1) providing a summary of RCTs findings on PtDAs effect on decision-making quality and process of adults with knee and hip OA considering primary elective TJA and by (2) providing evidence comparing different types of PtDA used for hip and knee TJA decision-making.

With the increasing senior population leading to increase TJA demands [9, 54, 55], it is fundamental to improve current TJA decision-making processes that can lead to improved healthcare efficiency and better patient expectations. Further, SDM is consistent with patient-centered care, defined as “providing care that is respectful of and responsive to individual patient preferences, needs and values and ensuring that patient values guide all clinical decisions,” which is a national goal for medical practices [79, 80]. Findings from this systematic review will inform further research on joint replacement decision-making quality and processes and on ways PtDAs facilitate SDM for orthopedic surgery.

Strength of this review is the a priori rigorous study methods including selection criteria with associated justification, exhaustive literature search strategy, and study selection, data extraction, and appraisal by two independent reviewers. Rigorous protocol is fundamental for conducting a good-quality systematic review. The limitation of this review is solely focusing on RCTs evaluating the effect of PtDA compared to standard of care or another PtDA for quality purpose. This may lead to the exclusion of good-quality observational studies. Further, this review will only include studies with adults considering primary elective TJA; therefore, findings will not be generalizable to adults considering TJA for any other reasons.