Influence of a Prospective Multicenter Clinical Trial on Adherence to Imaging Acquisition and Office Visit Follow-Up After Kidney Stone Surgery: A Bi-Institutional Experience

Introduction: Participation in a clinical trial has been shown to influence medical adherence. We compared postoperative imaging completion and office visit attendance between patients enrolled in the Pediatric KIDney Stone (PKIDS) Trial and those who were not at two participating institutions. We hypothesized that study enrollment would improve adherence to postoperative follow-up. Methods: A retrospective review of patients (8–21 years) undergoing kidney stone surgery during the PKIDS study period was performed at two geographically different PKIDS institutions. Medical records were reviewed for completed imaging and follow-up office visits. The primary outcome was postoperative imaging acquisition within 8 weeks of surgery in alignment with the PKIDS protocol. Secondary outcomes included imaging acquisition by 16 weeks and postoperative office visit attendance by 8 and 16 weeks. Multivariable logistic regression assessed factors influencing adherence. Results: A total of 181 patients were included: 120 PKIDS vs 61 non-PKIDS. 51.9% of patients completed imaging at 8 weeks. PKIDS enrollment was not associated with imaging acquisition at 8 weeks or any secondary outcomes on univariate or multivariable analyses. A higher national Area Deprivation Index percentile (i.e., higher neighborhood-level deprivation) was associated with lower imaging acquisition on multivariable analysis (Odds ratio [OR] 0.98, 95% confidence interval [CI]: 0.97–0.99, p = 0.03). Conversely, private insurance was associated with higher attainment of imaging (OR 2.36, 95% CI: 1.09–5.12, p = 0.03) and office visit attendance within 16 weeks (OR: 3.08, 95% CI: 1.42–6.69, p < 0.01). There were no variables associated with 8-week postoperative office visits. Conclusions: PKIDS trial enrollment was not associated with increased adherence to postoperative follow-up in two geographically different PKIDS sites. This study supports the generalizability of the PKIDS study to non-PKIDS participants and future use of the PKIDS dataset to examine determinants of postoperative care in pediatric kidney stone disease.