Background
Methods
Study setting and eligibility criteria
Decision aid and surgeon report arm (Fig. 1)
No decision aid arm (Fig. 1)
Outcomes
Primary outcome
Secondary outcomes
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 | 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 |
Participant timeline (Fig. 1)
Baseline assessment (t0)
Post-consultation assessment (t1)
Follow-up assessment (t2)
Sample size and recruitment
Assignment of interventions
Blinding (masking)
Data collection, management, and analysis
Data collection methods and data management
Statistical methods (Table 2)
Outcome | Categorical (Cat) Continuous (Con) | Decision aid arm (DA) | No decision aid arm (RP) | Notes |
---|---|---|---|---|
Decision quality | Cat | DQ2,DA | DQ2,RP | |
Quality of Life (Generic) | Con | E2,DA – E0,DA | E2,RP – E0,RP | |
Quality of Life (Condition-specific) | Con | W2,DA – W0,DA | W2,RP – W0,RP | |
Depression | Con | P2,DA – P0,DA | P2,RP – P0,RP | |
Knowledge | Cat | K0,DA | K0,RP | Modified version of the 5-item HK-DQI |
Decisional conflict | Cat | DC0i,DA | DC0i,RP | Evaluated for each question individually (i = 1–4) |
Treatment preference | Cat | Pref0,DA | Pref0,RP | |
Preference for involvement in decision-making | Cat | CPS0,DA | CPS0,RP | |
Willingness to have surgery | Cat | Will1,DA | Will1,RP | |
Patient-reported shared decision-making | Cat Con | C1,DA | C1,RP | Top-score: complete SDM vs. not complete Mean-score: complete SDM (12) to no SDM (0) |
Decisional regret | Con | R2,DA | R2,RP | |
Satisfaction | Con | S2,DA | S2,RP | Only for those who had surgery |
Expectations | Cat | EXP2,DA | EXP2,RP | Only for those who had surgery |
Surgical consult | Cat | Consult1,DA | Consult1,RP | |
Surgery | Cat | Surg2,DA | Surg2,RP | |
Concordance | Cat | Con2,DA | Con2,RP | |
Feasibility: Recruitment | Con | Recruit0,DA + RP | Evaluated for the trial and reported as a percentage | |
Feasibility: Questionnaire Completion | Con | Complete0,1,2,DA + RP | Evaluated for the trial and reported as a percentage |