Direct-Spanish care raised primary-endpoint general satisfaction over interpreter services (4.45 vs 4.09) in an RCT

Description #

In this randomized trial of Spanish-speaking cancer patients with LEP, the prespecified primary endpoint — the composite general-satisfaction score from the PSQ survey immediately after the initial consultation — was significantly higher for patients cared for directly in Spanish than for those cared for via professional interpreter services (mean composite scores 4.45 vs 4.09; P = .007) (Fig. 2A). Patients in the direct-Spanish arm also more frequently gave top ratings (5 of 5) for general satisfaction (63% vs 25%; P = .001) (Fig. 2B).

"The primary endpoint of the composite general satisfaction score from the survey conducted immediately after the initial consultation was higher for the direct-Spanish arm compared with the interpretive services arm (mean composite scores of 4.45 vs 4.09, respectively; P = .007) (Fig. 2A)." (Seible, 2021, p. 859)

"Patients in the direct-Spanish arm reported top ratings (5 out of 5) with composite general satisfaction more frequently than the interpretive services arm (63% vs 25%; P = .001) (Fig. 2B)." (Seible, 2021, p. 859)

Methods Context #

What? #ⓘ

The observable: composite general-satisfaction score (PSQ Short Form) recorded immediately after the initial consultation — the prespecified primary endpoint.

"The primary endpoint was prespecified as the general satisfaction composite score from the PSQ survey conducted immediately after the initial consultation." (Seible, 2021, p. 858)

How? #ⓘ

Randomized 1:1 (blocked randomization) to direct-Spanish vs interpreter-services arms, with the same 2 bilingual physicians used in both arms; satisfaction compared with Wilcoxon rank-sum tests, P < .05 significant; powered for a 6% increase in satisfaction.

"Patients were randomly assigned 1:1 using a blocked randomization approach with randomly selected block sizes." (Seible, 2021, p. 857)

Who? #ⓘ

83 adult Spanish-language-preferring cancer patients (≥18 y, not incarcerated) referred for radiation therapy at a community radiation oncology clinic in Chula Vista, CA; 40 randomized to interpretive services and 43 to direct Spanish; all analyzed.

"Of the 102 patients approached about the study, 83 (81.4%) agreed to participate, enrolled in the study, and were randomly assigned. This included 40 patients in the interpretive services arm and 43 in the direct-Spanish arm." (Seible, 2021, p. 859)

Other Notes #

This is the first RCT to directly compare direct language-concordant care with interpreter-based care in a clinical setting (Seible, 2021, p. 858).

Caveats #

• HOLA interpreter arm used bilingual physicians speaking English, which may not represent a typical interpreter encounter To provide an internal control, the same 2 bilingual physicians delivered both arms — meaning the interpreter-services arm consisted of bilingual physicians speaking English through an interpreter. The authors note this may not represent an average interpreter-based encounter, since a non-bilingual physician might face greater communication challenges than a bilingual one even when both use translation. This could bias the comparison toward the null (understating the true direct-Spanish advantage over typical interpreter care).
• HOLA studied only Spanish-preferring patients, so findings may not extend to other languages or cultural groups The study focused on a single LEP group — patients identifying Spanish as their preferred language. The authors caution that whether the findings extend to other languages or to different ethnic or cultural groups is unknown and deserves further study.
• HOLA findings come from one community subspecialty clinic with only 2 bilingual physicians, limiting generalizability The trial's data were generated at a single community radiation oncology subspecialty clinic, using specifically video and telephonic interpreter services, and delivered by only 2 bilingual physicians. The authors note this makes it difficult to know whether the satisfaction and communication-content findings generalize to other clinical settings, interpreter modalities, or providers.
• HOLA was necessarily unblinded, so awareness of arm allocation could have introduced bias Because the communication modality cannot be hidden, the trial was necessarily conducted unblinded. The authors acknowledge that patients' and physicians' awareness of study-arm allocation could have introduced bias into the patient-reported satisfaction outcomes.
• HOLA's small sample raises possibility of arm heterogeneity influencing the findings The trial enrolled a small number of participants (83 total; 40 vs 43 per arm), which introduces the possibility of heterogeneity between study arms. Although observed patient characteristics did not statistically differ between groups, the authors note that unmeasured differences in participants could potentially influence the findings.