|
Primary outcome
|
|
Perceived understanding of genomic testing results
|
NYCKidSeq developed measure (novel)
|
–
|
X
|
X
|
|
Secondary outcomes
|
|
Objective understanding of genomic testing results
|
NYCKidSeq developed measure (novel)
|
–
|
X
|
X
|
|
Medical actions and non-medical/patient-initiated actions attributable to genomic testing
|
CSER developed measures (novel): Attributable to Genomic Testing (RMA) and Patient-Initiated Actions Attributable to Genomic Testing (PIA)
|
–
|
–
|
X
|
|
Attitudes
|
|
Satisfaction with the mode of delivery
|
CSER developed measure (novel) adapted from Patient Assessment of cancer Communication Experiences (PACE) [34, 35]
|
–
|
X
|
–
|
|
Satisfaction with results
|
Satisfaction with information about medicine (SIMS) [36]
|
–
|
X
|
–
|
|
Attitudes toward genetic testing
|
Adapted from Genetic testing to Understand and Address Renal Disease Disparities (GUARDD) study [37, 38]
|
X
|
X
|
X
|
|
Empowerment
|
Adapted from GUARDD study [37]
|
X
|
X
|
X
|
|
Decisional conflict
|
Decisional Conflict Scale (Low Literacy) [39]
|
X
|
X
|
X
|
|
Perceived utility
|
|
Impact of genomic testing on health status
|
Functional status II-R (child) [40]
|
X
|
–
|
X
|
|
Impact of genomic testing on quality of life
|
Child Health Utility Instrument (CHU9D; parent as proxy) [41]; SF-12 health survey (for parent) [42]
|
X
|
–
|
X
|
|
Clinical utility
|
Patient-reported utility (PrU) [43]
|
–
|
X
|
X
|
|
Psychological impact
|
|
Feelings about genomic testing results
|
Feelings About Genomic Testing Results (FACToR) [44]
|
–
|
X
|
X
|
|
Uncertainty
|
Perceptions of Uncertainties in Genomic Sequencing (PUGS) [45]; FACToR subscale [44]
|
–
|
X
|
X
|
|
Depression
|
8-item Patient Health Questionnaire depression scale (PHQ-8) [46]
|
X
|
X
|
X
|
|
Anxiety
|
Generalized Anxiety Disorder Screener (GAD-2) [47, 48]
|
X
|
X
|
X
|
|
Perceived stress
|
Perceived Stress Scale 4-item (PSS-4) [49]
|
X
|
X
|
X
|
|
Self-efficacy
|
Decision Self-Efficacy Scale [50]
|
X
|
–
|
–
|
|
Patient activation
|
Short Form Patient Activation Measure (PAM) [51]
|
X
|
–
|
–
|
|
Decisional regret
|
Decision Regret Scale [52]
|
–
|
X
|
X
|
|
Behavioral impact
|
|
Information seeking
|
CSER developed measure (novel); Adapted from Psychological Adaptation to Genetic Information Scale [53]
|
–
|
X
|
X
|
|
Family communication
|
CSER developed measure (novel)
|
–
|
–
|
X
|
|
Social impact
|
|
Support
|
Low-Literacy Decisional Conflict Scale (Q6 and Q8) [54]
|
X
|
X
|
X
|
|
Access to care
|
CSER developed measure (novel)
|
X
|
X
|
X
|
|
Life chaos
|
Chaos Scale [55]
|
X
|
–
|
–
|
|
Family and community
|
Medical Outcomes Study Social Support Survey (mMOS-SS) [56]
|
X
|
–
|
–
|
|
Quality of life ascertainment (for child)
|
PedsQL Parent Proxy Generic Core [57]; EuroQol-Visual Analog Scale (VAS) [58]
|
X
|
–
|
X
|
|
Economic impact
|
|
Cost/value
|
CSER developed measure (novel)
|
–
|
X
|
X
|
|
Healthcare utilization
|
Self-reported Utilization of Health Care Services [59]
|
–
|
X
|
X
|
|
Sociodemographic factors
|
|
Literacy; numeracy
|
BRIEF Health Literacy Survey [60]; Subjective Numeracy Scale (SNS-3) [61]
|
X
|
–
|
–
|
|
History of receiving genetic testing
|
Adapted from the GUARDD study [37]
|
X
|
–
|
–
|
|
Trust in healthcare system
|
CSER developed measure (novel) adapted from Health Care System Distrust Scale [62]
|
X
|
–
|
–
|
|
Health beliefs
|
Brief Illness Perception Questionnaire (IPQ) [63]
|
X
|
–
|
–
|
|
Child and parent: sex, age, race/ethnicity, country of origin, language, insurance status, residential history, zip code
|
CSER developed measure (novel); Adapted from HCHS/SOL Personal Information Questionnaire [64]
|
X
|
–
|
–
|
|
Parent only: education level, employment, income, household, marital status
|
CSER developed measure (novel); Adapted from HCHS/SOL Personal Information Questionnaire [64]
|
X
|
–
|
–
|
|
Grandparents of child: residential history
|
Adapted from HCHS/SOL Personal Information Questionnaire [64]
|
X
|
–
| |
