Kevin Weinfurt

© 2020 Elsevier Inc. Patient-reported health data provide information for pragmatic clinical trials that may not be readily available from electronic health records or administrative claims data. In this report, we present key considerations for collecting patient-reported health information in pragmatic clinical trials, which are informed by best practices from patient-reported outcome research. We focus on question design and administration via electronic data collection platforms with respect to 3 types of patient-reported health data: medication use, utilization of health care services, and comorbid conditions. We summarize key scientific literature on the accuracy of these patient-reported data compared with electronic health record data. We discuss question design in detail, specifically defining the concept to be measured, patient understanding of the concept, recall periods of the question, and patient willingness to report. In addition, we discuss approaches for question administration and data collection platforms, which are key aspects of successful patient-reported data collection.

AIMS: Bother attributed to lower urinary tract symptoms (LUTS) drives care-seeking and treatment aggressiveness. The longitudinal relationship of LUTS severity and bother in a care-seeking cohort, however, is not well understood. We aim to conduct a longitudinal evaluation of LUTS severity and bother and identify characteristics of patients with discordant LUTS bother relative to severity. METHODS: Men and women with LUTS seeking care at six US tertiary care centers enrolled in the symptoms of lower urinary tract dysfunction research network study. Patients reporting at least one urinary symptom based on the LUTS Tool were prospectively enrolled from June 2015 to January 2017. Correlations were used to assess the relationship between LUTS severity and bother. Discordance scores (ie, the difference between bother and severity) were used to classify patients with high and low bother. Patients were classified as having high or low bother phenotypes if scores were one standard deviation above or below zero, respectively. Repeated measures multinomial logistic regression evaluated characteristics associated with high and low bother phenotypes. RESULTS: LUTS severity and bother were at least moderately correlated for all symptom items and highly correlated for 13 out of 21 items. Correlations were highest for urgency, and lowest for daytime frequency and urinary incontinence. Odds of being in high bother phenotype were lowest at 3 and 12 months (3 months vs baseline odds ratio [OR] = 0.71, 95% confidence ninterval [CI] = 0.54-0.94; 12 months vs baseline OR = 0.66, 95% CI = 0.48-0.91), and highest for those who endorsed all urgency questions (OR = 3.65, 95% CI = 2.17-6.13). Odds of being in the low bother phenotype were lowest for patients who endorsed all urgency items (OR = 0.33, 95% CI = 0.26-0.42), and all frequency items (OR = 0.68, 95% CI = 0.53-0.88). CONCLUSIONS: LUTS severity and bother correlate highly and measurement of both in clinical practice is likely redundant. There are patient factors associated with discordance which may justify additional evaluation.

© 2020 Wiley Periodicals LLC Aims: Measurement of self-reported lower urinary tract symptoms (LUTS) typically uses a recall period, for example, “In the past 30 days….” Compared to averaged daily reports, 30-day recall is generally unbiased, but recall bias varies by item. We examined the associations between personal characteristics (eg, age, symptom bother) and 30-day recall of LUTS using items from the Symptoms of Lower Urinary Tract Dysfunction Research Network Comprehensive Assessment of Self-reported Urinary Symptoms questionnaire. Methods: Participants (127 women and 127 men) were recruited from 6 US tertiary care sites. They completed daily assessments for 30 days and a 30-day recall assessment at the end of the study month. For each of the 18 tested items, representing 10 LUTS, the average of the participant's daily responses was modeled as a function of their 30-day recall, the personal characteristic, and the interaction between the 30-day recall and the characteristic in separate general linear regression models, adjusted for sex. Results: Nine items representing 7 LUTS exhibited under- or overreporting (recall bias) for at least 25% of participants. Bias was associated with personal characteristics for six LUTS. Underreporting of incontinence was associated with older age, lower anxiety, and negative affect; overreporting of other LUTS was associated with, symptom bother, symptom variability, anxiety, and depression. Conclusions: We identified under- or overreporting that was associated with personal characteristics for six common LUTS. Some cues (eg, less bother and lower anxiety) were related to recall bias in an unexpected direction. Thus, providers should exercise caution when making judgments about the accuracy of a patient's symptom recall based on patient demographic and psychosocial characteristics.