Primary-language-other-than-English patients were 8.1% of consent events in industry vs 4.4% in non-industry cancer trials

Description #

Patients whose primary language was other than English accounted for a smaller share of consent events in non-industry-sponsored studies (4.4%) than in industry-sponsored studies (8.1%), P < 0.001 (Fig. 3a). This is the broader-denominator counterpart to the LEP-specific comparison, and was similar when restricted to interventional studies (Extended Data Fig. 1a: 8.2% vs 4.0%).

"Patients with a primary language other than English represented 8.1% of consent events in industry-sponsored studies versus 4.4% in studies not sponsored by industry (P < 0.001) (Fig. 3)." (Maria, 2023, p. 857)

Methods Context #

What? #ⓘ

The observable: the proportion of consent events for patients recorded as having a primary language other than English, by study sponsor type.

"Of the remaining 742 consent events, the patient met the definition for limited English proficiency in 481 consent events (64.8%)." (Maria, 2023, p. 856)

How? #ⓘ

Retrospective single-centre analysis; proportions compared with generalized-estimating-equation logistic regression clustered by patient.

"Logistic regression models with generalized estimating equations clustered by patient unique identifier compared the proportions above." (Maria, 2023, Fig. 3)

Who? #ⓘ

12,082 consent events (9,213 patients) at one academic cancer centre, 2013–2018; 742 events were for patients with a primary language other than English.

"Nearly half of consent events (n = 5,738) were for industry-sponsored studies (Extended Data Table 3)." (Maria, 2023, p. 856)

Other Notes #

"Primary language other than English" is the superset that includes LEP; a patient with a non-English primary language was classified LEP only if interpreter need was documented.

Caveats #

• Retrospective single-centre EHR-based cohort that cannot establish causation (Maria 2023) The associations come from a retrospective, single-centre analysis built on electronic health record and clinical-trials-database data at one academic cancer centre. A retrospective design cannot prove causation; the single-centre setting limits generalizability (sensitivities around patient health information, study-related data, and regulatory differences make cross-centre replication difficult); and key variables were captured retrospectively and may be inaccurate — Medi-Cal insurance status is dynamic and may not reflect status at the consent event, and language information may not be documented accurately in the EHR. The authors argue that consistent associations across analyses support the hypothesis, but the estimates remain observational.
• Only patients who signed consent were analysed, so barriers to any participation are unmeasured (Maria 2023) The analysis only includes patients who actually signed a consent document, so patients who were never approached or who declined — and the upstream barriers that kept them out of any study entirely (delays waiting for translated documents, staff untrained in consenting LEP patients) — are not captured. Because consent documents are typically translated only after a prospective participant is identified, the observed disparity may understate the true under-representation of LEP patients, and analyses of translated-document impact are subject to reverse causation.