Primed to comply: Individual participant data sharing statements on ClinicalTrials.gov.

In June 2017, the International Committee of Medical Journal Editors (ICMJE) announced a requirement that authors reporting the results of clinical trials to journals that follow ICMJE recommendations must include an individual participant data (IPD) sharing statement with manuscripts submitted after 01 July 2018. Additionally, all new clinical trials for which enrollment began on or after 01 January 2019 must include a data sharing statement in the trial's publicly posted registration. This study sought to understand whether IPD sharing statements of clinical trials first registered on ClinicalTrials.gov before 01 January 2019 reflected comprehension of the expectations and a willingness to share. To establish baseline characteristics for the prevalence and quality of IPD sharing statements, we examined IPD sharing statements among 2,040 clinical trials first posted on ClinicalTrials.gov between 01 January 2018 and 06 June 2018. Two independent coders further analyzed the quality of the IPD sharing statements of trials whose registration records indicated the intent to share IPD. The vast majority of trials included in this study did not indicate an intent to share IPD (n = 1,928; 94.5%). Among the trials that did commit to sharing IPD (n = 112, 5.5%), significant variability existed in the content and structure of IPD sharing statements. The results of this study suggest that successful compliance with the IPD sharing statement requirements of the ICMJE will require further clarification, enhanced education, and outreach to investigators.

Agents of empathy: How medical interpreters bridge sociocultural gaps in genomic sequencing disclosures with Spanish-speaking families.

OBJECTIVES: To describe how linguistic tools used by interpreters during return of genomic sequencing results may have impacted communication with Spanish-speaking families, and to discuss the implications for the role of medical interpreters. METHODS: Using discourse analysis, we identified and categorized the various ways hospital-based interpreters adapted clinicians' language in 37 audio-recorded sessions in which Spanish-speaking parents participating in a clinical trial received their child's genomic sequencing results from English-speaking clinicians. RESULTS: We found that interpreters adapted clinicians' statements using five empathic linguistic tools: contextualization, encouragement, checking comprehension, endearment, and softening. Interpreters used an average of four linguistic tools per session, with contextualization and encouragement being the most frequently used. CONCLUSIONS: Interpreters used empathic linguistic tools to alter clinicians' statements when communicating genomic information to Spanish-speaking families. Our findings demonstrate the critical role of interpreters as cultural mediators and facilitators of understanding for Spanish-speaking families. PRACTICE IMPLICATIONS: This study expands upon the definition of clinical empathy in interpreter-mediated sessions. Our findings suggest that revisions of standards of medical interpretation practice may be warranted regarding interpreters' ability to adapt clinicians' language in a culturally sensitive manner during interpretation.

Portero versus portador: Spanish interpretation of genomic terminology during whole exome sequencing results disclosure.

AIM: Describe modifications to technical genomic terminology made by interpreters during disclosure of whole exome sequencing (WES) results. PATIENTS & METHODS: Using discourse analysis, we identified and categorized interpretations of genomic terminology in 42 disclosure sessions where Spanish-speaking parents received their child's WES results either from a clinician using a medical interpreter, or directly from a bilingual physician. RESULTS: Overall, 76% of genomic terms were interpreted accordantly, 11% were misinterpreted and 13% were omitted. Misinterpretations made by interpreters and bilingual physicians included using literal and nonmedical terminology to interpret genomic concepts. CONCLUSION: Modifications to genomic terminology made during interpretation highlight the need to standardize bilingual genomic lexicons. We recommend Spanish terms that can be used to refer to genomic concepts.