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Using discreet choice experiments to elicit patient perception of acceptable risk in total knee arthroplasty: study protocol for a randomised controlled trial

Maximum Acceptable Risk of Complication in Total Knee Arthroplasty (MARKA) Study: using discreet choice experiments to elicit patient and surgeon perception of acceptable risk in total knee arthroplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001226594
Acronym
MARKA Study
Enrollment
135
Registered
2015-11-09
Start date
2016-08-11
Completion date
2018-08-15
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Osteoarthritis (OA) is a leading cause of disability in developed nations. Total knee arthroplasty (TKA) is the mainstay of treatment for people with end-stage knee OA, and represents one of the highest volume medical interventions globally. Despite a high overall success rate with this operation, up to 1 in 3 patients remain dissatisfied following TKA. The reasons for this dissatisfaction include ongoing pain and functional limitation, which patients view as markers of poor outcome following surgery. Research indicates that the strongest predictor of patient dissatisfaction following TKA is unmet expectations. This is known to occur when patients and surgeons have different expectations of surgery. Decision making aids have been effective in aligning patient and surgeon expectations of surgery and improve health outcomes. This study will use a discrete choice experiment (DCE) as a type of decision making aid applied to patients prior to surgery to improve patient knowledge and realistic expectations of TKA. This study will test if this leads to greater health outcome and satisfaction amongst patients following TKA. 132 people with end stage OA on the waiting list for TKA will be recruited and randomly allocated to one of 2 groups using computer-generated block randomisation. A randomised controlled trial (RCT) adhering to CONSORT guidelines will evaluate the effect of applying a DCE prior to surgery on patient expectations, health outcomes and satisfaction following TKA. Patients in the intervention arm will complete a survey containing the DCE decision aiding tool, compared to the control group who will complete a modified survey that does not contain the DCE activity. Participants in both groups will be required to complete the survey prior to surgery during their routine pre-admission appointment at SVHM. Patients will also be required to complete a brief patient expectation survey 1-week prior to scheduled TKR. In addition, orthopaedic surgeons will complete a brief expectations survey for patients consented to TKA to compare matched surgeon and patient expectations for recovery following TKA. Primary outcomes will be evaluated by a blinded examiner at 12 months post-surgery using a validated self-reported pain and physical function scale. Secondary outcomes will include a range of validated measures of health and psychological wellbeing. All analyses will be conducted on an intention to treat basis using linear regression models. This study is the first of its kind to use this approach to elicit risk-benefit tolerance in surgery and to evaluate if guiding patients through a decision making process in the form of a DCE-based survey prior to surgery will improve patient expectations, health outcomes and satisfaction following TKA. Reducing the rate of patient dissatisfaction commonly seen in patients following TKA will help to reduce the burden associated with poor outcomes on the health system.

Interventions

Patients in the intervention arm will complete a survey containing a risk-benefit preference decision aiding tool: a discrete choice experiment (DCE) survey. The DCE tool includes items about post-operative pain, stiffness, quality of life, complications and adverse events (health states) following knee replacement surgery. These items are organised into a number of scenarios and then organised into pairs, and patients are asked to choose between a number of these pairs of choices. The remainder

Patients in the intervention arm will complete a survey containing a risk-benefit preference decision aiding tool: a discrete choice experiment (DCE) survey. The DCE tool includes items about post-operative pain, stiffness, quality of life, complications and adverse events (health states) following knee replacement surgery. These items are organised into a number of scenarios and then organised into pairs, and patients are asked to choose between a number of these pairs of choices. The remainder of the survey includes items about how much improvement in symptoms patients expect following knee surgery, the level of control over things in your life, and attitude towards taking risks, and the physical and emotional experiences associated with knee pain. Participants are required to complete the survey prior to total knee replacement (TKR) during their routine pre-admission appointment at St Vincent's Hospital, Melbourne. The survey will take approximately 30 minutes to complete. Patients will also be required to complete a brief patient expectation survey 1-week prior to scheduled TKR, which will take approximately 5-minutes to complete. Surveys can be completed electronically or paper-based hardcopy. Electronic surveys will be completed using a portable computer with administrative assistance provided from the study coordinator

Sponsors

Dr Michelle Dowsey
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

(i) Patients on the surgical waiting list for primary TKA for end stage OA at St Vincent's Hospital, Melbourne; (ii) orthopaedic surgeons/registrars who consult at the orthopaedic clinics at St Vincent's Hospital, Melbourne.

Exclusion criteria

(i) Patients undergoing revision surgery or surgery for neoplastic disease; (ii) Inability to provide informed consent due to mental incompetence (e.g., intellectual disability, dementia) (iii) active drug or alcohol use disorder which in the opinion of the investigators makes the patient unsuitable for participation in the trial (iv) limited English language fluency.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 12, 2026