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Opinion Editorial with institutional review board approval (eg, based on rou- to assess patient screening or service use interventions rather tinely available clinical or administrative data). This ap- than drugs or devices. proach puts no burden on the participants and is similar to ob- In summary, Gabbard et al ethically and pragmatically servational studies, which do not typically obtain individual implemented Zelen’s design to document an intervention that informed consent. It is also more cost-effective to only obtain increased ACP use. Their ACP pathway appears to be repro- consent from those in the experimental group. ducible, scalable, and potentially economical. Engaging Notably, nearly half of the patients who were random- patients in ACP and obtaining appropriate reimbursement al- ized to the intervention arm declined study participation. We lows health care professionals to sustainably deliver high- would expect about the same or a higher rate of decline had quality, patient-centered care. The notable difference be- the control group been approached, which is the crux of the tween documentation and billing rates in the intervention ethical concern: should the control patients have explicitly pro- group highlights the continuing need to improve ACP work- vided consent? In this instance, the control group
JAMA Internal Medicine – American Medical Association
Published: Mar 15, 2021
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