Methods
erectile dysfunction
SIDE EFFECT, ERECTILE DYSFUNCTION
The aim of this study was to implement a large-scale AE-PRO data collection and response system and evaluate how it affected treatment continuation and quality of care delivered on a DTC platform. This system's development was initiated in response to patient chart audits conducted by the care quality and safety team. These audits uncovered that certain patients were experiencing manageable side effects early in their treatment, leading them to discontinue it prematurely. Many of the remaining patients adjusted medication at the one-year follow-up visit included in usual care. Together, the quality and safety team and a technical infrastructure project team identified the need to proactively reach out to patients about side effect experiences earlier in the treatment course.We used iterative Plan-Do-Study-Act (PDSA) cycles, a common quality improvement (QI) framework. The first PDSA cycle involved four steps: 1) the design of the data collection tool; 2) the pilot deployment of the tool to a randomly selected group of new patients; 3) the systematic assessment of whether the collection of AE-related PROs within the first few weeks of treatment would lead to better treatment outcomes; and, 4) the rollout of the tool platform-wide. The second cycle involved implementing a new intervention to assist providers in managing the increase in side effects reporting after the rollout of the form. This intervention entailed developing suggested messaging for providers to counsel patients around the most common mild (or combination of mild) side effects. Integrity of the data was maintained and checked by data analysts and members of the quality and safety team throughout the process of both cycles. Generalizability to healthcare settings external to the DTC platform was not evaluated. Age and geographic region but not sex were reported as descriptive demographic characteristics because the nature of the study population – those receiving care for erectile dysfunction – meant that the population consisted exclusively of male patients. States were categorized into geographic regions consistent with US Census Bureau designations, which can be seen in the Additional file 