LEP patients signed consent in a non-primary language in 65.9% of non-industry vs 31.9% of industry events

Description #

For patients with limited English proficiency who signed consent, the proportion signing in a language different from their primary language was 65.9% in non-industry-sponsored studies versus 31.9% in industry-sponsored studies, P < 0.001 (Fig. 4b). Equivalently, only 34.1% signed in their primary language in non-industry studies versus 68.1% in industry studies. Restricting to studies without any translated documents gave 64.9% vs 30.6% (P < 0.001).

"For patients with limited English proficiency, rates were 31.9% versus 65.9%, respectively (P < 0.001) (Fig. 4)." (Maria, 2023, p. 858)

Methods Context #

What? #ⓘ

The observable: among consent events for LEP patients, the proportion signed in a language other than the patient's primary language, by sponsor type.

"Grey bars indicate the proportion of consent events for which patients signed consent documents in a language different than primary in industry-sponsored versus non-industry-sponsored studies (31.9% versus 65.9%, P < 0.001)." (Maria, 2023, Fig. 4)

How? #ⓘ

Retrospective review of the consent language of each signed document; proportions compared with GEE logistic regression clustered by patient.

"Logistic regression models with generalized estimating equations clustered by patient unique identifier compared the proportions above." (Maria, 2023, Fig. 4)

Who? #ⓘ

Consent events for LEP patients who signed consent (industry n = 307; non-industry n = 174, per Fig. 4b bar totals) at one cancer centre, 2013–2018.

"Consent events for patients with limited English proficiency" (Maria, 2023, Fig. 4b)

Other Notes #

The direction is the mirror image of the industry advantage: LEP patients in non-industry trials were roughly twice as likely to have to sign a consent document they could not fully read.