Abstract
Background Although systemic lupus erythematosus (SLE) disproportionately affects minority racial groups, they are significantly under-represented in clinical trials. This produces underpowered conclusions in race-based sub-group analyses. The decision to participate in clinical research is complex. Primary care providers (PCPs) have the ability to introduce the idea of clinical trials and to refer to specialists who participate in clinical trials. We evaluated SLE knowledge and implicit bias in clinical research participation in both PCPs and lupus patients.
Methods Lupus patients and PCPs completed a pre-test consisting of knowledge and belief questions followed by an educational program about lupus, clinical research, and human subjects protections. The same questions were repeated as part of the post-test. Responses to knowledge questions were analyzed by Fishers exact test for between group (patients vs. PCPs) comparisons or McNemars test for within group (pre-test vs. post-test) comparisons. Belief questions were scored on a Likert scale and analyzed by Mann-Whitney or Wilcoxon matched pairs for between group and within group comparisons.
Results 55 providers and 32 lupus patients completed the questionnaires and educational program. Knowledge topics included 1) triggers of SLE, 2) lupus racial differences, and 3) informed consent. There was a statistically significant difference between PCPs and patients on the pre-test informed consent topic (PCP 46% correct and patient 15%, p=0.0005). Post-test results were similar between groups. The education program resulted in improvement in knowledge scores for PCPs (Q1 42% to 85%, p<0.001; Q2 56% to 91%, p<0.0001; Q3 84% to 87%, p=0.5) and patients (Q1 38% to 84%, p=0.0003; Q2 56% to 75%, p=0.1; Q3 47% to 72% p=0.01). Topics of clinical trial belief questions included perceived risks of trials, differing racial background between provider and patient, education level needed for trial participation, and perceived effect of poverty on protocol compliance. The final topic demonstrated the greatest incongruence between PCPs and patients (figure 1).
Perceived Impact of Poverty and Study Protocol Adherence. A) Primary care providers were asked to respond to the following statement Indigent patients are less likely to comply with a study protocol before and after the educational program and had a shift towards increased disagreement (median [interquartile range], Pre 4 [2, 5] and Post 3 [2, 5], p=0.024). B) Similarly lupus patients were asked to respond to I think people who are poor or have less education are less likely to correctly follow the instructions they are given during a research study with a majority of responses disagreeing which remained stable after the program (Pre 2 [1, 4] and Post 1.5 [1, 4.75], p=0.72). Significant differences in responses between providers and patients were noted both before the program (p=0.0037) and after the program (p=0.0088). The shift in providers response towards disagreement after the program was not large enough to result in post-test responses similar to the patients.
Conclusions Beliefs about race, education, and poverty may impact referral to clinical trial centers and clinical trial participation. More than a third of PCPs believe that indigent people are poor candidates for clinical trials. Despite a shift away from this attitude following an educational program, providers remained much more likely than lupus patients to hold this opinion.
Funding Source(s): HHS-OMH-CPI-MP-17-002-1
