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Table 1 Outcome measures according to data collection periods

From: What matters most: protocol for a randomized controlled trial of breast cancer surgery encounter decision aids across socioeconomic strata

  TIMEPOINT
  -T0 T0
Baseline
T1
In-Visit
T2
Post-Visit
T3
1 wk. PSa
T4
12 wks PSb
T5
1 yr. PS
CONSENT AND ENROLLMENT
 Eligibility Screen X       
 Informed Consent X       
 Allocation (via surgeon confirmation) X       
INTERVENTIONS
 Arm 1: Option Grid    X     
 Arm 2: Picture Option Grid    X     
 Arm 3: Usual Care    X     
OUTCOME MEASURES
 Rates of recruitment – documented and tracked in REDCap   X      
 Discontinuation rates – documented and tracked in REDCap   X   X X X X
 Demographic data – 6 items, self-reported   X      
 Health literacy – 1-item Chew’s health literacy screening   X      
 Decision quality (primary outcome measure) – validated 16-item DQI, subscale adapted for low SES     X X   
 Knowledge – validated 5-item DQI knowledge subscale   X   (X) (X)   
 Treatment intention – self-reported via DQI     (X)    
 Treatment choice – obtained from medical records      X   
 Quality of life – validated 6-item EQ-5D-5 L   X     X  
 Anxiety – validated 8-item PROMIS anxiety short form   X   X X X  
 Shared decision-making (observed) – validated OPTION5    X     
 Shared decision-making (self-reported) – validated 3-item CollaboRATE     X    
 Decision regret – validated 5-item decision regret scale      X X X
 Integration of health care delivery – validated 4-item IntegRATE   X     X  
 Financial toxicity – four items from validated COST measure and self-report of out-of-pocket medical expenses in the past month      X X X
 Intervention’s patterns of use – questions and photos of intervention     X X   
System level factors + feasibility and acceptability in routine care
 Ethnographic methods   X X X X X  
 Semi-structured interviews       X  
  1. PS post-surgery
  2. (X) included in full DQI
  3. aor first post-operative visit
  4. bor second post-operative visit