Despite the importance of incorporating patient reported outcomes (PROs) into clinical trials, capture is inadequate. The most recent evidence of this comes from a recent study performed by Pugh et al, which demonstrated that specific populations are getting left behind.1
The investigators examined PRO capture across 10 NRG Oncology clinical trials and found that approximately one-quarter of patients (24.7%) decline to participate in PROs, and that nearly two-thirds (62.2%) declined electronic PRO capture. What was novel, and quite concerning, was the fact that racial/ethnic minorities and patients with less education were less likely to consent to PROs. Furthermore, racial/ethnic minorities, older patients, and current smokers were less likely to consent to electronic PRO capture.
The disparities in PRO capture uncovered by the authors are concerning for many reasons. First, the populations identified have worse access to clinical trials at baseline.2 Older patients are often explicitly excluded from trials on the basis of age. Racial/ethnic minorities, current smokers, and patients with less formal education experience de facto exclusion due to structural racism and other forms of structural inequity.3
For example, residential segregation and insurance disparities prohibit many of these populations from accessing facilities that perform trials. Even when trials are accessible, downstream effects of discrimination (eg, disparities in comorbidities, finances,4 and social support) deter participation.
Additionally, discordance between PROs and clinician reports could be more severe for racial/ethnic minority patients. Racially discordant patient-physician relationships are of shorter duration and lower patient-related quality.5 Black patients experience poorer communication quality and information-giving compared with White patients.6 Data also show that medical trainees hold false beliefs about racial differences in pain tolerance.7 This raises concerns about whether clinician reports are even less likely to reflect the experiences of racial/ethnic minority patients. Disparities in PRO capture may, therefore, magnify existing disparities in clinical trial access and data quality.
Disparities in electronic PRO capture, specifically, highlight important concerns. Electronic PRO capture may increase efficiency and accuracy, and facilitate real-time toxicity mitigation. Reliance on paper PRO capture may therefore disproportionately harm institutions that are already under-resourced. If trial funding allocations are not adjusted for these disparities, institutions with less electronic PRO capture may be expected to spend more time on data collection and entry without adequate resources to do so. Given their payor mix, these institutions may already have fewer resources to compensate for the additional manpower required. Additionally, given the impaired accuracy of paper vs electronic PRO collection, data quality may suffer for these populations.