Each individual informed consent element improved post-implementation among LEP patients (adjusted ORs 2.39-14.1)

Description #

Beyond the composite outcome, each of the three individual informed consent elements independently improved for post- vs. pre-implementation LEP patients after propensity-quintile adjustment: understanding the reasons for the procedure (adjusted OR 3.60; 95% CI, 1.52–8.56), understanding the risks (adjusted OR 2.39; 95% CI, 1.08–5.29), and having all questions answered (adjusted OR 14.1; 95% CI, 1.43–139.0) (Table 3). The "all questions answered" estimate, while significant, is extremely imprecise (CI 1.43–139.0), reflecting a near-ceiling outcome.

"For individual informed consent elements, patients in the post-implementation (vs. pre-implementation) group had statistically significantly higher odds of understanding the reasons for their procedure (adjusted odds ratio, 3.60; 95% CI, 1.52–8.56), risks of their procedure (adjusted odds ratio, 2.39; 95% CI, 1.08–5.29) and having all questions answered (adjusted odds ratio, 14.1; 95% CI, 1.43–139.0)." (Lee, 2017, p. 867)

Methods Context #

What? #ⓘ

The observables: three patient-reported informed consent elements — understanding of the reasons for the procedure, understanding of its risks, and whether all questions were answered.

"the following three central informed consent elements: patient-reported understanding of the (1) reasons for and (2) risks of the procedure and (3) having had all questions answered." (Lee, 2017, p. 865)

How? #ⓘ

Separate logistic regressions for each consent element on pre-vs-post group, adjusted for propensity-score quintiles proxying exposure to the intervention (A-0005ArtifactA-0005Initial AI draftBedside interpreter phone systemTo remove the time and availability barriers that keep clinicians from using professional interpreters in the hospital, by putting immediate, round-the-clock access to remote professional medical interpreters at every pa…).

"We calculated odds ratios for the informed consent outcomes using logistic models adjusted for propensity score quintiles" (Lee, 2017, p. 865)

Who? #ⓘ

Chinese- and Spanish-speaking hospitalized LEP patients (84 pre-, 68 post-implementation), age ≥40, awaiting or having completed an invasive procedure on the cardiovascular, general surgery, or orthopedic surgery floors of one academic medical center.

"prospectively recruited hospitalized patients from the cardiovascular, general surgery and orthopedic surgery floors who were primarily Chinese (Cantonese and Mandarin) or Spanish speaking and age ≥40" (Lee, 2017, p. 864)

Other Notes #

Unadjusted proportions for these elements are shown in Fig. 2 (reasons 77% post vs. 44% pre, p<.001; risks 57% vs. 37%, p<.05; questions answered 99% vs. 89%, p<.05).

Caveats #

• Small non-randomized pre-post observational design subject to confounding and secular trends The pre-post effect estimates come from a small, non-randomized observational study of a single academic medical center. Because assignment to the pre- vs. post-implementation groups was non-random, the data are subject to potential confounding; propensity-score adjustment can only account for measured confounders, not unmeasured ones. The authors also note that secular trends in informed consent discussions over the study period could have affected the results, though they report no other relevant interventions took place concurrently. Together these features mean the observed pre-post improvements in informed consent cannot be attributed to the intervention with certainty (the authors state causality cannot be proven).
• Outcomes rely on patient-reported comprehension and self-reported interpreter use, not objective measures The informed-consent outcomes are patient-reported comprehension — patient perception of whether they understood the reasons and risks and had their questions answered — rather than objective measures of knowledge, and the authors caution this perception may not correlate with objective knowledge (though they argue perception is itself a crucial, if imperfect, measure of whether consent was informed). Likewise, the study lacked objective measures of professional interpreter use during consent discussions and relied on patient self-report, so the interpreter-use estimates are vulnerable to recall and reporting error (compounded by missing interpreter-use data for a number of participants).