Discussion
lymphedema, PCD, BCRL, pain
LYMPHEDEMA, SAID
Our study findings indicate that the text reminders did not improve treatment compliance because the BCRL patients were already highly treatment compliant. Overall, there were significant improvements in mean weight and BMI at the 30-day visit and in arm girth at the 60-day visit. There were significant improvements in several lymphedema-specific QOL and symptom severity measures and 30- and/or 60-day follow-ups and the SF-36 pain domain score was significantly improved at both the 30- and 60-day follow-ups.Because we did not find any differences in compliance by the randomized study groups for the primary endpoint, the data were pooled and outcomes evaluated by compliance status (complete vs partial compliance). There were no differences between compliance groups for weight, BMI, and SF-36 scores, and LYMQOL-ARM scores except the functional domain. Compared to the partially compliant group, the fully compliant group experienced significantly greater improvements in arm girth, LYMQOL-ARM functional domain score, and in the LSIDS-A overall, soft-tissue sensation, and neurological sensation scores. Although even partial compliance is beneficial, these findings support the effort to encourage full treatment compliance among BCRL patients in order obtain the optimal benefits the therapy offers.The strengths of this study include the randomized assignment and comparison of participants who received or did not receive text reminders for treatment compliance. Additionally, we measured compliance through data automatically received from the PCD device, mitigating recall issues of patient-reported compliance. We also included comparisons of validated patient-reported outcomes to evaluate changes in quality of life and symptomology related to treatment compliance.One obvious limitation of the study is the small sample size. This study was designed as a small feasibility study to further inform additional studies in the future. Additionally, there is the potential for selection bias since all study participants were required to have the capability to receive text messages at their treatment location. This requirement effectively eliminated any patients who had limited internet or phone accessibility issues. Although we were interested to see if there were any differences in outcomes across racial and ethnic variables, our population was predominantly White, making it difficult to meaningfully assess for the presence of health disparities among those who met eligibility criteria. That said, we did see a trend toward higher rates of full compliance among Black study participants compared with White participants. Larger studies with more diverse populations may help to delineate if any equity issues exist with access to and compliance with PCD therapy.Finally, in hindsight, the selection of the BCRL population was not the most effective group on which to test this technology since the population is already highly compliant without receiving reminders. Future studies in other populations of patients with lymphedema may demonstrate different results.