Informed consent, shared-decision making and a reasonable patient's wishes based on a cross-sectional, national survey in the USA using a hypothetical scenario

Abstract

Objective: In approximately half the states in the USA, and more recently in the UK, informed consent is legally defined as what a reasonable patient would wish to know. Our objective was to discern the information needs of a hospitalised, 'reasonable patient' during the informed-consent process.

Design: We performed a cross-sectional study to develop a survey instrument and better define 'reasonable person' in relation to informed consent in a hypothetical scenario where an invasive procedure may be an option.

Setting: A 10-question survey was administered from April 19 through 22 October 2018 to three groups: student nurses (n=76), health professions educators (n=63) and a US national population (n=1067).

Primary and secondary outcome measures: The primary outcome measure was the average intensity, on a 5-point scale, by which survey groups wished to have each of 10 questions answered. The secondary outcome was to discern relationships between survey demographics and the intensity by which participants wanted an answer.

Results: Despite substantial demographic differences in the nursing-student group and health-professions-educator group, the average intensity scores were within 0.2 units on nine of 10 questions. The national survey revealed a strong desire to have an answer to each question (range 3.98-4.60 units). It showed that women desired answers more than men and older adults desired answers more than younger adults.

Conclusions: Based on responses to 10 survey questions regarding wishes of people in a situation where an invasive procedure may be necessary, the vast majority want an answer to each question. They wanted to know about all treatment options, risky drugs, decision aids, who will perform the procedure, and the cost. They wanted their advocate present, periodic review of their medical record, a full day to review documents and expected outcomes and restrictions after the procedure.

Keywords: informed consent; overuse of procedures; reasonable patient; shared-decision making.

Figure 1

National intensity scores above 4.0 versus question number for gender differences in the national survey. Responses came from 497 males and 570 females.

Figure 2

National intensity scores above 4.0 versus question number for age differences in the national survey. Responses came from 297, 230, 343 and 197 people in the four respective age groups.