A pragmatic randomized trial comparing tablet computer informed consent to traditional paper-based methods for an osteoporosis study.

ABSTRACT:

Objective

Methods to improve informed consent efficiency and effectiveness are needed for pragmatic clinical trials. We compared informed consent using a tablet computer to a paper approach to assess comprehension and satisfaction of patients and clinic staff for a future osteoporosis clinical trial.

Methods

Nine community-based practices identified and recruited patients to compare the informed consent processes (tablet vs. paper) in a mock osteoporosis clinical trial. The tablet informed consent included an animation summarizing the trial, complete informed consent document, and questions to assess and reinforce comprehension of the study. Participants were women age ≥55 years with ≥1 year of alendronate use. We surveyed participants to assess comprehension and satisfactio

SUBMITTER: Warriner AH 

PROVIDER: S-EPMC5935867 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature