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Table 1 Outcomes, covariates, time points and validated measures in quantitative surveys

From: Pediatric reporting of genomic results study (PROGRESS): a mixed-methods, longitudinal, observational cohort study protocol to explore disclosure of actionable adult- and pediatric-onset genomic variants to minors and their parents

Data Collection Method Domain Validated Measure Time Points Completed By
  Aim 1 – Psychosocial Outcomes among Study Groups
  Outcomes – All Groups
Quantitative survey General anxiety and depressiona Assessment of symptoms of DSM-IV anxiety and depression in children [56]
Hospital Anxiety & Depression Scale [57]
T1, T2, T3, T4 P/A
Family functioning and cohesiona General Functioning subscale (short form) of McMaster Family Assessment Device [58] T1, T2, T3, T4 P/A
Health-related quality of lifea CDC HRQOL– 4 [59] T1, T2, T3, T4 P/A
Body image Body Image Scale [60] T1, T2, T3, T4 A
Self-esteem Rosenberg Self-Esteem Scale [61] T1, T2, T3, T4 A
Decision regret Decision Regret Scale [62] T2, T4 P
Patient satisfaction Genetic Counseling Satisfaction [63] T2 P
Covariates – All Groups
Psychological flexibility Acceptance and Action Questionnaire – II [64]
Avoidance and Fusion Questionnaire for Youth [65]
T1, T2, T3, T4 P/A
Lifestyle behaviors Physical activity, diet, smoking and vaping [66]
Alcohol consumption [67]
T1, T3, T4 A
Information seeking Health Information Orientation Scale [68] T1 P
Personal utility Perceived utility of whole genome sequencing [69] T1, T2, T3, T4 P
Perceived risk Perceived cancer/heart disease risk [43, 70] T1, T2, T3, T4 P/A
Health literacy Brief health literacy scale [71] T1 P
Genomic literacy Knowledge of genome sequencing [72] T1 P
Outcomes – Participants with Genomic Result – Groups 1 and 2
Condition specific distress Children’s Revised Impact of Events Scale [73] T2, T3, T4 P/A
Adjustment to genetic information Psychological adaptation to genetic information scale [74] T2, T3, T4 P
Patient education and empowerment Health Education Impact Questionnaire [75] T2, T3, T4 P
Family communication Family communication of genetic test results [76] T3 P
Qualitative interview Constructs for which validated measures do not exist (e.g. vulnerable child syndrome, right to an open future) n/a T2, T4 P/A
Psychosocial assessment Disclosure Visit P/A
Observation of reactions to disclosure Disclosure Visit P/A
Aim 2 – Cascade Testing and Risk reduction Initiation among Group 1 and 2 Parents
Quantitative Survey Cascade testing uptakea Adapted from family communication of genetic test results [76] T4 P
Initiation of risk management behaviorsa Adapted from risk management in unaffected women with pathogenic BRCA1/2 variants [54]
EHR review Cascade testing uptakea n/a T4 n/a
Initiation of risk management behaviorsa n/a
  1. aPrimary outcomes, T1 = baseline; T2 = 1-month post-disclosure; T3 = 6-months post-disclosure; T4 = 12-months post-disclosure, P=Parent of minor (ages 0–17), A = Adolescent (ages 11–17), EHR = Electronic Health Record