Ethical, legal, and social implications (ELSI) and challenges in the design of a randomized controlled trial to test the online return of cancer genetic research results to U.S. Black women.

BACKGROUND: A central challenge to precision medicine research efforts is the return of genetic research results in a manner that is effective, ethical, and efficient. Formal tests of alternate modalities are needed, particularly for racially marginalized populations that have historically been underserved in this context. METHODS: We are conducting a randomized controlled trial (RCT) to test scalable modalities for results return and to examine the clinical utility of returning genetic research results to a research cohort of Black women. The primary aim is to compare the efficacy of two communication modalities for results return: 1) a conventional modality that entails telephone disclosure by a Board-certified genetic counselor, and 2) an online self-guided modality that entails results return directly to participants, with optional genetic counselor follow-up via telephone. The trial is being conducted among participants in the Black Women's Health Study (BWHS), where targeted sequencing of 4000 participants was previously completed. RESULTS: Several ethical, legal, and social implications (ELSI) and challenges presented, which necessitated substantial revision of the original study protocol. Challenges included chain of custody, re-testing of research results in a CLIA lab, exclusion of VUS results, and digital literacy. Bioethical principles of autonomy, justice, non-maleficence, and beneficence were considered in the design of the study protocol. CONCLUSION: This study is uniquely situated to provide critical evidence on the effectiveness of alternative models for genetic results return and provide further insight into the factors influencing access and uptake of genetic information among U.S. Black women. CLINICALTRIALS: gov: NCT04407611.

Utility of a virtual counselor (VICKY) to collect family health histories among vulnerable patient populations: A randomized controlled trial.

OBJECTIVES: This study is a randomized controlled trial comparing the efficacy of a virtual counselor (VICKY) to the My Family Health Portrait (MFHP) tool for collecting family health history (FHx). METHODS: A total of 279 participants were recruited from a large safety-net hospital and block randomized by health literacy to use one of the digital FHx tools, followed by a genetic counselor interview. A final sample of 273 participants were included for analyses of primary study aims pertaining to tool concordance, which assessed agreement between tool and genetic counselor. RESULTS: Tool completion differed significantly between tools (VICKY = 97%, MFHP = 51%; p < .0001). Concordance between tool and genetic counselor was significantly greater for participants randomized to VICKY compared to MFHP for ascertaining first- and second-degree relatives (ps<.0001), and most health conditions examined. There was significant interaction by health literacy, with greater differences in concordance observed between tools among those with limited literacy. CONCLUSIONS: A virtual counselor overcomes many of the literacy-related barriers to using traditional digital tools and highlights an approach that may be important to consider when collecting health histories from vulnerable populations. PRACTICE IMPLICATIONS: The usability of digital health history tools will have important implications for the quality of the data collected and its downstream clinical utility.

Designing and Evaluating a Digital Family Health History Tool for Spanish Speakers.

Digital family health history tools have been developed but few have been tested with non-English speakers and evaluated for acceptability and usability. This study describes the cultural and linguistic adaptation and evaluation of a family health history tool (VICKY: VIrtual Counselor for Knowing Your Family History) for Spanish speakers. In-depth interviews were conducted with 56 Spanish-speaking participants; a subset of 30 also participated in a qualitative component to evaluate the acceptability and usability of Spanish VICKY. Overall, agreement in family history assessment was moderate between VICKY and a genetic counselor (weighted kappa range: 0.4695 for stroke-0.6615 for heart disease), although this varied across disease subtypes. Participants felt comfortable using VICKY and noted that VICKY was very likeable and possessed human-like characteristics. They reported that VICKY was very easy to navigate, felt that the instructions were very clear, and thought that the time it took to use the tool was just right. Spanish VICKY may be useful as a tool to collect family health history and was viewed as acceptable and usable. The study results shed light on some cultural differences that may influence interactions with family history tools and inform future research aimed at designing and testing culturally and linguistically diverse digital systems.

Pregnant women in treatment for opioid use disorder: Material hardships and psychosocial factors.

BACKGROUND: While pregnant women in treatment for opioid use disorder (OUD) face considerable challenges, common material hardships- food insecurity and housing instability, known to negatively impact maternal-child health, have been inadequately researched within this population. This study describes food/housing hardships and evaluates associations with key psychosocial factors. METHODS: A single-site prospective study, 100 3rd trimester women receiving prenatal care and medication-assisted treatment for OUD were interviewed, including screening for food/housing hardships, depressive symptoms, intimate partner vulnerability; and self-reported post-traumatic stress disorder (PTSD) history. We developed a three-level categorization combining food/housing screening outcomes: 1) "both insecure"; 2) "either secure"; and 3) "both secure". Bivariate analyses and linear path analyses evaluated associations among psychosocial variables using "both secure" as the referent group. RESULTS: Of 100 women, 56% reported food insecurity; 61% housing instability; 42% "both insecure"; 33% "either insecure"; 25% "both secure". In unadjusted food/housing groups "either insecure" and "both insecure" reported significantly greater depressive symptoms; "both insecure" additionally reported significantly greater intimate partner vulnerability. Path analyses adjusted for PTSD and compared with "both secure" (adjusted mean = 6.2): "either insecure" had greater depressive symptom scores (adjusted means = 9.8, p = .01) while "both insecure" had greater depressive scores (adjusted means 10.5, p = .002). In addition, "both insecure" had a clinically important 5.7 point greater intimate partner vulnerability score. There were no significant interactions between food/housing and PTSD. CONCLUSIONS: Even in women receiving prenatal care and treatment for OUD, food/housing material hardships and associated psychosocial factors are of major concern, requiring screening and remediation.

Could prenatal food insecurity influence neonatal abstinence syndrome severity?

BACKGROUND AND AIMS: In general populations, prenatal food insecurity negatively affects maternal and infant health. Our aim was to estimate and test the association between prenatal food insecurity and neonatal abstinence syndrome (NAS) severity. DESIGN/SETTING: Single-site prospective cohort design. Women receiving opioid agonist treatment with methadone or buprenorphine were interviewed (including demographics and food insecurity) during the third trimester at the combined obstetric/opioid use disorder treatment clinic at Boston Medical Center (BMC) in Boston, MA, USA, a large urban safety-net hospital. During postnatal hospitalization, infants were assessed and treated per hospital NAS protocol. Maternal clinic and infant hospitalization data were abstracted from medical records. PARTICIPANTS: Women (n = 75; aged ≥ 18 years; fluent English; singleton pregnancy; intending to deliver at BMC and maintain parental custody) receiving care in the specialized clinic were study eligible (2013-15). Women who delivered infants < 36 weeks gestational age or required prolonged newborn intensive care unit stay were excluded from analyses. PRIMARY MEASUREMENTS: Predictors: validated two-question Hunger Vital Sign™ food insecurity screener; outcomes: extent of NAS pharmacological treatment and length of hospital stay (LOS) for NAS. FINDINGS: Of the mother-infant dyads, 61 (81%) infants were treated pharmacologically for NAS. Mean hospital LOS was 19.9 (standard deviation = 9.4) days. Maternal food insecurity (n = 43, 57.3%) was associated with infant NAS pharmacological treatment in logistic regression analyses individually adjusted for prenatal: maternal depression [adjusted odds ratios (aOR) = 3.69 (95% confidence intervals (CI) = 1.02-13.43, P = 0.05)] and methadone agonist treatment [aOR = 4.17 (95% CI = 1.05-16.50, P = 0.04)]. Associations of food insecurity and LOS were inconclusive regardless of covariate control (P > 0.05). CONCLUSION: Among women receiving opioid agonist treatment, prenatal food insecurity appears to be associated with increased risk for neonatal abstinence syndrome pharmacological treatment.