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Table 1 Outline of outcomes, instruments, and data collection

From: 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

  Instrument Name Source Baseline (t0) Post-consult (t1) Follow-up (t2)
ENROLMENT
 Eligibility screen    X   
 Informed consent    X   
 Randomization    X   
INTERVENTIONS
 Decision aid plus surgeon report arm (decision aid, surgeon report, appropriateness checklist)    X   
 No decision aid arm (appropriateness checklist)    X   
ASSESSMENTS
 Decision quality * Primary Outcome Modified version of the HK-DQI [28]    DQ2 [K0, Pref0, Surg2]
 Demographics (Birthdate, Sex, Joint)    D0   
 QoL (Generic) EQ-5D-5L [29] E0   E2
 QoL (Condition-specific) WOMAC [31] W0   W2
 Depression PHQ-9   P0   
 Knowledge Modified version of the HK-DQI [28] K0   
 Decisional conflict SURE [32] DC0   
 Treatment preference   [4] Pref0   
 Preference for involvement in decision-making CPS [33] CPS0   
 Willingness to have surgery    Will1   
 Patient-reported shared decision-making CollaboRATE [34, 35]   C1  
 Decisional regret Decision Regret Scale [36]    R2
 Satisfaction   [7]    S2
 Expectations   [7]    EXP2
 Surgical consult EMR    Consult1  
 Surgery EMR     Surg2
 Concordance HK-DQI [28]    Con2 [Pref0, Surg2]
 Feasibility: Recruitment    Recruit0   
 Feasibility: Questionnaire Completion    Complete0 Complete1 Complete2
  1. QoL: Quality-of-Life; EQ-5D-5L: EuroQol 5-Dimensions Questionnaire (5-level); PHQ-9: Patient Health Questionnaire; WOMAC: Western Ontario and McMaster Universities Arthritis Index; HK-DQI: Hip and Knee Decision Quality Instrument; CPS: Control Preferences Scale; EMR: Electronic Medical Record