Association between interactive voice response adherence and subject retention in a randomized controlled trial

作者：Gatehouse Christopher S; Tennen Howard A; Feinn Richard S; Abu Hasaballah Khamis S; Lalla Rajesh V^*

来源：Contemporary Clinical Trials, 2012, 33(4): 589-592.

DOI：10.1016/j.cct.2012.03.011

• Interactive voice response
• IVR
• Interactive voice response systems
• IVRS
• Retention
• Compliance
• Clinical research

Introduction: Interactive voice response (IVR) technology uses the telephone to collect patient reports. This study examined whether IVR adherence during a year-long clinical trial was related to subject retention in the trial. %26lt;br%26gt;Methods: As part of a randomized, double-blind, placebo-controlled study of daily multivitamin supplementation for recurrent aphthous stomatitis, 160 study participants were asked to make 1 weekly IVR call for the one-year study duration. %26lt;br%26gt;Results: The 114 subjects who completed the study made 90.5% of their expected number of IVR calls, as compared to 55.7% of expected calls made by the 46 subjects who withdrew prematurely (p%26lt;0.001). Subjects who successfully completed the study were also more likely to initiate their IVR calls as compared to subjects who withdrew from the study (p%26lt;0.001). A multivariable model incorporating different adherence variables was able to successfully predict retention status of more than 80% of subjects. IVR adherence during the first few weeks of study participation was strongly predictive of subsequent retention and successful completion of this one-year study. %26lt;br%26gt;Discussion: Subjects who withdrew prematurely had more missing data than study completers, even after accounting for period of study participation, potentially introducing bias into IVR results. Sub-optimal adherence to weekly IVR might provide an early signal of subsequent premature withdrawal in clinical trials. IVR adherence could be used as a screening tool during a trial period, to identify subjects most likely to stay on long clinical trials. %26lt;br%26gt;Conclusion: IVR adherence may be useful in anticipating retention in long-term clinical studies.

• 出版日期2012-7