Correction to: Trials 22, 56 (2021)
https://doi.org/10.1186/s13063-020-04953-4
Following publication of the original article [1], we were notified that the originally published Table 2 was incorrect. References 1–33 were not impacted by the table update and remain unchanged, but are updated from reference 34 onward.
Originally published Table 2
Table 2.
NYCKidSeq participant outcomes by survey timepoint
| Variable | Source | BL1 | ROR12 | ROR23 |
|---|---|---|---|---|
| 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 | – | |
1BL = baseline survey
2ROR1 = return of results, visit 1 survey
3ROR2 = return of results, visit 2 survey
Corrected Table 2
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
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The original article has been corrected.
Footnotes
Jacqueline A. Odgis, Katie M. Gallagher and Sabrina A. Suckiel contributed equally to this work.
Reference
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