Quality of informed consent documents among US. hospitals: a cross-sectional study.

ABSTRACT:

Objective

To determine whether informed consent for surgical procedures performed in US hospitals meet a minimum standard of quality, we developed and tested a quality measure of informed consent documents.

Design

Retrospective observational study of informed consent documents.

Setting

25 US hospitals, diverse in size and geographical region.

Cohort

Among Medicare fee-for-service patients undergoing elective procedures in participating hospitals, we assessed the informed consent documents associated with these procedures. We aimed to review 100 qualifying procedures per hospital; the selected sample was representative of the procedure types performed at each hospital.

Primary outcome

The outcome was hospital quality of informed consent documents, assesse

SUBMITTER: Spatz ES 

PROVIDER: S-EPMC7247389 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature