Table 2.
NYCKidSeq participant outcomes by survey timepoint
| VARIABLE | SOURCEa | BLb | ROR1c | ROR2d |
|---|---|---|---|---|
| Understanding | ||||
| Perceived understanding of genomic testing results | NYCKidSeq (novel); CSER (novel); CSER measure adapted from Psychological Adaptation to Genetic Information Scale (PAGIS) [35] | – | X | X |
| Objective understanding of genomic testing results | NYCKidSeq (novel) | – | X | X |
| Understanding of medical follow up & actionability | Adapted from CSER (novel): Recommended Medical Actions and Follow Through on Recommendations Attributable to Genomic Testing (MRA) | – | X | – |
| Attitudes | ||||
| Expectations of genetic testing | Adapted from Patient Reported Utility (PrU) [36]; NYCKidSeq (novel) | X | – | – |
| Satisfaction with results and communication mode | CSER (novel) | – | X | – |
| Patient assessment of communication | CSER measure adapted from Patient Assessment of cancer Communication Experiences (PACE) [37, 38] | – | X | – |
| Evaluation of communication tool (GUÍA) | NYCKidSeq (novel) adapted from Lobb et al. 2006 [39) and Sanderson et al. 2016 [40] | – | X | – |
| Satisfaction with interpretation and perceived cultural concordance (Spanish speakers only) | CSER (novel) | – | X | – |
| Evaluation of provided patient resources | NYCKidSeq (novel) | – | – | X |
| Perceived Utility | ||||
| Patient reported utility | CSER measure adapted from Patient Reported Utility (PrU) [36] | – | X | X |
| Psychological Impact | ||||
| Feelings about genomic testing results | CSER measure adapted from Feelings About Genomic Testing Results (FACToR) [41] | – | X | X |
| Uncertainty | CSER measure adapted from Perceptions of Uncertainties in Genomic Sequencing (PUGS) [42] and FACToR subscale [41] | – | X | X |
| Decisional regret (for positive secondary findings only) | Adapted from Decision Regret Scale [43] | – | X | X |
| Behavioral Impact | ||||
| Information seeking | CSER (novel) | – | X | X |
| Adherence to medical follow up recommendations; Patient-Initiated actions attributable to genomic testing | CSER (novel): Recommended Medical Actions and Follow Through on Recommendations Attributable to Genomic Testing (MRA); Patient-Initiated Actions Attributable to Genomic Testing (PIA) | – | – | X |
| Family communication | CSER (novel) | – | – | X |
| Social Impact | ||||
| Access to care | CSER measure adapted from Medicare Expenditure Panel Survey, Household Component (MEPS-HC) [44] | X | – | – |
| Quality of life ascertainment (for child) | Pediatric Quality of Life Inventory (PedsQL) Parent Proxy Generic Core [45]; Adapted from EuroQol-Visual Analog Scale (VAS) [46] | X | – | X |
| Economic Impact | ||||
| Cost utility | Adapted from Hebert et al. 2008 [47] and Valuation of Informal Care Questionnaire (iVICQ) [48] | X | – | X |
| Sociodemographic Factors | ||||
| Health literacy; Subjective numeracy | CSER measure adapted from BRIEF Health Literacy Survey [49]; CSER measure adapted from Subjective Numeracy Scale (SNS-3) [50] | X | – | – |
| History of receiving genetic testing | NYCKidSeq (novel) adapted from Genetic testing to Understand and Address Renal Disease Disparities (GUARDD) study [51] | X | – | – |
| Trust in health care system | CSER measure adapted from Health Care System Distrust Scale [52] | X | – | – |
| Insurance status of child | CSER measure adapted from National Health and Nutrition Examination Survey (NHANES) [53] | X | – | X |
| Child only: sex, grandparent(s) country of origin | CSER measure adapted from GenIUSS [54], CSER (novel) | X | – | – |
| Child and Parent: age, race/ethnicity, country of origin, zip code | Date of birth, CSER measure adapted from US Census [55, 56], CSER (novel), Zip code | X | – | – |
| Parent only: education level, language, income, household, marital status |
Education and language: CSER (novel) Income and household: CSER measure adapted from NHANES [53] Marital status: NYCKidSeq (novel) |
X | – | – |
aNote: NYCKidSeq measures were developed specifically for the RCT. CSER measures were developed by a collaborative group of CSER investigators, as outlined in Goddard et al., 2020 [56]
bBL Baseline survey
cROR1 Return of results, visit 1 survey
dROR2 Return of results, visit 2 survey