Limited English proficiency independently predicted lower odds of signing consent in primary language (OR 0.35) for non-industry studies

Description #

For patients with limited English proficiency specifically, the adjusted odds of signing consent in their primary language for a non-industry-sponsored study (vs an industry-sponsored study) were OR 0.35 (95% CI 0.25–0.50, P < 0.001) relative to English-primary patients (Table 1) — the steepest of the four language-related estimates, indicating LEP patients in non-industry trials were least likely to receive a primary-language consent document.

"The odds of signing consent documents in the patient's primary language for a non-industry-sponsored study were considerably lower for patients with a primary language other than English (OR 0.38, 95% CI 0.28 to 0.52, P < 0.001) and limited English proficiency (OR 0.35, 95% CI 0.25 to 0.50, P < 0.001) compared with patients with English as their primary language." (Maria, 2023, p. 859)

Methods Context #

What? #ⓘ

The observable: the adjusted odds that an LEP patient signed consent in their primary language for a non-industry- (vs industry-) sponsored study.

"Multivariable analysis for patients with limited English proficiency signing consent documents in patient's primary language" (Maria, 2023, Table 1)

How? #ⓘ

Multivariable GEE logistic regression clustered by patient, adjusting for age, gender, race, ethnicity, histology and study type.

"After adjusting for age at consent, gender, race, ethnicity, histology and study type (observational versus interventional)" (Maria, 2023, p. 858)

Who? #ⓘ

All eligible consent events; LEP subgroup versus English-primary reference at one cancer centre, 2013–2018.

"Limited English proficiency — Reference (English primary)" (Maria, 2023, Table 1)

Other Notes #

Bivariable estimate OR 0.24 (0.18–0.32, P < 0.001; Extended Data Table 6), attenuating to 0.35 on adjustment.