Article Figures & Data
Figures
- Figure 1.
CONSORT flow diagram of participant randomization, allocation, follow-up, and analysis.
CONSORT = Consolidated Standards of Reporting Trials
- Figure 2A.
Primary outcomes: satisfaction with decision and subjective understanding.
- Figure 2B.
Secondary outcomes: objective knowledge, perceived voluntariness, and trust in medical researchers.
Notes: Values for all outcomes represent means by e-consent study arm by follow-up assessment time point based on descriptive analyses of study data. Numbers of participants for all outcomes were 734 at immediate follow-up, 624 at 1-week follow-up, and 510 at 6-month follow-up. Numbers of participants for at each follow-up by e-consent group are shown in Figure 1.
Tables
Characteristic Standard (n = 243) Interactive (n = 248) Trust-Enhanced (n = 243) Total (n = 734) P Value Age, a, mean (SD), y 46.3 (16.8) 45.2 (15.3) 45.4 (16.0) 45.5 (16.0) 0.716 Sex, No. (%) 0.486 Female 161 (66.3) 168 (67.7) 173 (71.2) 502 (68.4) Male 82 (33.7) 80 (32.3) 70 (28.8) 232 (31.6) Race, No. (%) 0.309 White 123 (50.6) 115 (46.4) 100 (41.2) 338 (46.0) Black or African American 96 (39.5) 109 (44.0) 113 (46.5) 318 (43.3) Asian 3 (1.2) 3 (1.2) 9 (3.7) 15 (2.0) American Indian or Alaska Native 1 (0.4) 2 (0.8) 1 (0.4) 4 (0.5) Native Hawaiian or Pacific Islander 0 (0.0) 1 (0.4) 1 (0.4) 2 (0.3) Other single race 10 (4.1) 9 (3.6) 7 (2.9) 26 (3.5) Multiple race 10 (4.1) 9 (3.6) 12 (4.9) 31 (4.2) Ethnicity, No. (%) 0.402 Hispanic or Latinx 25 (10.3) 24 (9.7) 17 (7.0) 66 (9.0) Not Hispanic or Latinx 218 (89.7) 224 (90.3) 226 (93.0) 668 (91.0) Education, No. (%) 0.127 Less than high school 23 (9.5) 20 (8.1) 29 (11.9) 72 (9.8) High school graduate or GED 85 (35.0) 98 (39.5) 66 (27.2) 249 (33.9) Some college 77 (31.7) 68 (27.4) 89 (36.6) 234 (31.9) Bachelor’s degree 37 (15.2) 38 (15.3) 31 (12.8) 106 (14.4) Master’s, professional, or doctorate degree 21 (8.6) 24 (9.7) 28 (11.5) 73 (9.9) Note: Differences between conditions were assessed using ANOVA for age and χ2 tests for all other variables.
e-consent = electronic consent; GED = general education development
↵a n = 732 for age due to missing data.
- Table 2.
Adjusted Difference in Outcomes for Trust-Enhanced e-Consent Compared With the Standard and Interactive e-Consents at 6-Month Follow-Up
Outcomes Interactive vs Standard, B (SE) P Value Trust-Enhanced vs Standard, B (SE) P Value Trust-Enhanced vs Interactive, B (SE) P Value Satisfaction with decision 0.43 (0.09) P <.001 0.87 (0.09) P <.001 0.43 (0.07) P <.001 Subjective understanding 18.04 (2.58) P <.001 32.19 (2.64) P <.001 14.09 (2.42) P <.001 Objective knowledge 1.21 (0.18) P <.001 2.12 (0.18) P <.001 0.92 (0.16) P <.001 Perceived voluntariness 0.81 (0.66) P = .22 3.97 (0.64) P <.001 3.18 (0.68) P <.001 Trust in medical researchers 6.63 (0.91) P <.001 12.50 (0.95) P <.001 5.90 (0.90) P <.001 B = regression coefficient; e-consent = electronic consent; SE = standard error.
Notes: Multivariate results represent data from 732 unique participants with 1 to 3 observations per participant due to attrition. Two participants were excluded because of missing data for age. All models include controls for participant age, sex, race, ethnicity, education, version, and time point (full model estimates available in supplemental materials, https://www.AnnFamMed.org/content/19/1/16/suppl/DC1/). Effect estimates and associated SE represent the interaction of e-consent version (standard, interactive, and trust-enhanced) with time point (6 months).
Supplemental Figures
Supplemental Figures
Files in this Data Supplement:
- Supplemental data: Figures - PDF file
The Article in Brief
An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine
Elizabeth H. Golembiewski , and colleagues
Background Patients are sometimes asked to share their personal health information for research purposes. Informed consent and trust are critical components in a patient's decision to participate in research. Researchers at the University of Florida conducted a three-arm randomized controlled trial to compare the effects on patient experiences of three electronic consent (e-consent) designs that asked them to share PHI for research purposes. Participants were randomized to a standard e-consent form (standard); an e-consent that contained standard information plus hyperlinks to additional interactive details (interactive); or an e-consent that contained standard information, interactive hyperlinks, and factual messages about data protections and researcher training (trust-enhanced).
What This Study Found Researchers found no differences in preferences at one-week follow up. However, after six months, participants expressed the most satisfaction and subjective understanding with the trust-enhanced e-consent.
Implications
- Research institutions should consider developing and further validating e-consents that deliver information interactively, beyond that which is required by federal regulations, including facts that may enhance patient-informed consent and trust in research.
In this issue
Jump to section
Related Articles
Cited By...
- No citing articles found.