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

Table 2 Analysis of primary outcome and secondary outcomes

Outcome	Categorical (Cat) Continuous (Con)	Decision aid arm (DA)	No decision aid arm (RP)	Notes
Decision quality	Cat	DQ_2,DA	DQ_2,RP
Quality of Life (Generic)	Con	E_2,DA – E_0,DA	E_2,RP – E_0,RP
Quality of Life (Condition-specific)	Con	W_2,DA – W_0,DA	W_2,RP – W_0,RP
Depression	Con	P_2,DA – P_0,DA	P_2,RP – P_0,RP
Knowledge	Cat	K_0,DA	K_0,RP	Modified version of the 5-item HK-DQI
Decisional conflict	Cat	DC_0i,DA	DC_0i,RP	Evaluated for each question individually (i = 1–4)
Treatment preference	Cat	Pref_0,DA	Pref_0,RP
Preference for involvement in decision-making	Cat	CPS_0,DA	CPS_0,RP
Willingness to have surgery	Cat	Will_1,DA	Will_1,RP
Patient-reported shared decision-making	Cat Con	C_1,DA	C_1,RP	Top-score: complete SDM vs. not complete Mean-score: complete SDM (12) to no SDM (0)
Decisional regret	Con	R_2,DA	R_2,RP
Satisfaction	Con	S_2,DA	S_2,RP	Only for those who had surgery
Expectations	Cat	EXP_2,DA	EXP_2,RP	Only for those who had surgery
Surgical consult	Cat	Consult_1,DA	Consult_1,RP
Surgery	Cat	Surg_2,DA	Surg_2,RP
Concordance	Cat	Con_2,DA	Con_2,RP
Feasibility: Recruitment	Con	Recruit_{0,DA + RP}		Evaluated for the trial and reported as a percentage
Feasibility: Questionnaire Completion	Con	Complete_{0,1,2,DA + RP}		Evaluated for the trial and reported as a percentage

ISSN: 1471-2474