Patients with a primary language other than English or Spanish did not have higher odds (OR 0.9) of signing consent for studies with Spanish consent at opening
Source
Maria A Velez (2023). Consent document translation expense hinders inclusive clinical trial enrolment. Nature.
Description #
A null that reveals the effect is language-specific: patients whose primary language was other than English or Spanish did not have higher odds of signing consent for studies that had a Spanish consent document available at study opening — OR 0.9 (95% CI 0.6–1.3), interval spanning 1 (Extended Data Table 4). Availability of a translated document only raised enrollment for speakers of the language that was actually translated (Spanish), not for non-English speakers in general.
"Patients with a primary language other than English or Spanish did not have higher odds of signing consent documents for studies that had Spanish consent at study opening (OR 0.9, 95% CI 0.6 to 1.3)." (Maria, 2023, p. 858)
Methods Context #
What? #ⓘ
The observable: the odds that a patient whose primary language was other than English or Spanish signed consent, comparing studies with vs without a Spanish consent document at study opening.
"Odds for patients with a primary language other than English or Spanish of signing consent to studies with a Spanish translation compared to studies without them." (Maria, 2023, Extended Data Table 4)
How? #ⓘ
GEE logistic regression clustered by patient, same study-opening subset as the Spanish-speaker analysis but for the non-Spanish, non-English subgroup.
"Odds ratios (with 95% CI) were estimated from a logistic regression model with Generalized Estimating Equations clustered by patient unique identifier." (Maria, 2023, Extended Data Table 4)
Who? #ⓘ
Patients with a primary language other than English or Spanish across studies at one cancer centre, 2013–2018.
"At study opening" (Maria, 2023, Extended Data Table 4)
Other Notes #
This is a genuine null (CI includes 1); it should oppose any claim that translated-consent availability raises enrollment for non-English speakers regardless of which language is translated, and it bounds the OR-5.7 Spanish result to language-matched availability.