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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
  1. John T James1,
  2. Darwin Jay Eakins2,
  3. Robert R Scully3
  1. 1 CEO, Patient Safety America, Houston, Texas, USA
  2. 2 University of Kansas, Lawrence, Kansas, USA
  3. 3 Private Collaborator, Houston, Texas, USA
  1. Correspondence to Dr John T James; john.t.james{at}earthlink.net

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.

  • informed consent
  • shared-decision making
  • reasonable patient
  • overuse of procedures

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors JTJ conceived the study and developed the questions. DJE formed the survey instrument to suit each of the situations where questions were to be presented to a survey audience. JTJ and RRS analysed the data. JTJ wrote most of the paper in close consultation with coauthors. All authors agreed to be accountable for accuracy of the work.

  • Funding The study was supported by Patient Safety America, Houston, Texas, USA. A donation (US$1400) from Dr James to support the SurveyMonkey platform provided the funds required. His roles are given below in the Author’s contribution section.

  • Competing interests Dr James founded Patient Safety America as a no-budget organisation dedicated to educating people about problems in the US healthcare industry. He serves as its unpaid CEO and leader. He has no conflicts of interest, advocating only for improved care.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available in a public, open access repository. National survey data at: http://patientsafetyamerica.com/survey-data/ Health-Professions-Educator survey at: https://www.surveymonkey.com/results/SM-DQJDBBQ7L/ Nursing-student survey available at: https://www.surveymonkey.com/results/SM-5F2SX9W3V/ Available ‘Supplementary files’ include the research proposal, 2 forms of the survey, and 6 statistical analysis files.

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