A mobile health application for patients eligible for statin therapy: app development and qualitative feedback on design and usability.

BACKGROUND: Cardiovascular disease is the leading cause of death in the United States (US). Despite the well-recognized efficacy of statins, statin discontinuation rates remain high. Statin intolerance is a major cause of statin discontinuation. To accurately diagnose statin intolerance, healthcare professionals must distinguish between statin-associated and non-statin-associated muscle symptoms, because many muscle symptoms can be unrelated to statin therapy. Patients' feedback on muscle-related symptoms would help providers make decisions about statin treatment. Given the potential benefits and feasibility of existing apps for cardiovascular disease (CVD) management and the unmet need for an app specifically addressing statin intolerance management, the objectives of the study were 1) to describe the developmental process of a novel app designed for patients who are eligible for statin therapy to lower the risk of CVD; 2) to explore healthcare providers' feedback of the app; and 3) to explore patients' app usage experience. METHODS: The app was developed by an interdisciplinary team. Healthcare provider participants and patient participants were recruited in the study. Providers were interviewed to provide their feedback about the app based on screenshots of the app. Patients were interviewed after a 30 days of app usage. RESULTS: The basic features of the app included symptom logging, vitals tracking, patient education, and push notifications. Overall, both parties provided positive feedback about the app. Areas to be improved mentioned by both parties included: the pain question asked in symptom tracking and the patient education section. Both parties agreed that it was essential to add the trend report of the logged symptoms. CONCLUSIONS: The results indicated that providers were willing to use patient-reported data for disease management and perceived that the app had the potential to facilitate doctor-patient communication. Results also indicated that user engagement is the key to the success of app efficacy. To promote app engagement, app features should be tailored to individual patient's needs and goals. In the future, after it is upgraded, we plan to test the app usability and feasibility among a more diverse sample.

Development of a distributed international patient data registry for hairy cell leukemia.

Hairy cell leukemia (HCL) is a rare lymphoproliferative disorder, comprising only 2% of all leukemias. The Hairy Cell Leukemia Foundation (HCLF) has developed a patient data registry to enable investigators to better study the clinical features, treatment outcomes, and complications of patients with HCL. This system utilizes a centralized registry architecture. Patients are enrolled at HCL Centers of Excellence (COE) or via a web-based portal. All data are de-identified, which reduces regulatory burden and increases opportunities for data access and re-use. To date, 579 patients have been enrolled in the registry. Efforts are underway to engage additional COE's to expand access to patients across the globe. This international PDR will enable researchers to study outcomes in HCL in ways not previously possible due to the rarity of the disease and will serve as a platform for future prospective research.

Patient-driven research: Initial results from a prospective health-related quality of life study performed at the request of patients living with hairy cell leukemia.

A diagnosis of leukemia can have a profound effect on patients' health-related quality of life (HRQoL), however this has not been measured prospectively in patients with hairy cell leukemia (HCL). At the request of patients living with HCL who had identified this gap in knowledge about the disease, we conducted a longitudinal study of HRQoL among patients enrolled in the HCL Patient Data Registry (PDR). From September 1, 2018 to September 1, 2020, 165 patients were enrolled in the study and completed the baseline survey. The Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) was used to measure patients' HRQoL. Results show that newly diagnosed HCL patients reported the lowest HRQoL, followed by patients in relapse and those on "watch and wait." Factors associated with higher (better) FACT-Leu total scores in the multivariable analysis included older age, higher social support, and greater physical activity. These same factors were associated with lower levels of fatigue. In rare diseases where it is difficult to perform large prospective studies, patient/researcher collaborations are critical for the identification of studies that are of importance to patients and their families in order to maximize the benefits of the research and improve the lives of patients living with HCL.

Usability and Workflow Evaluation of "RhEumAtic Disease activitY" (READY). A Mobile Application for Rheumatology Patients and Providers.

BACKGROUND: RhEumAtic Disease activitY (READY) is a mobile health (mHealth) application that aims to create a shared platform integrating data from both patients and physicians, with a particular emphasis on arthritis disease activity. METHODS: We made READY available on an iPad and pilot implemented it at a rheumatology outpatient clinic. We conducted 1) a usability evaluation study to explore patients' and physicians' interactions with READY, and 2) a time motion study (TMS) to observe the clinical workflow before and after the implementation. RESULTS: A total of 33 patients and 15 physicians participated in the usability evaluation. We found usability problems in navigation, data entry, pain assessment, documentation, and instructions along with error messages. Despite these issues, 25 (75,76%) patients reported they liked READY. Physicians provided mixed feedback because they were concerned about the impact of READY on clinical workflow. Six physicians participated in the TMS. We observed 47 patient visits (44.72 hours) in the pre-implementation phase, and 42 patient visits (37.82 hours) in the post-implementation phase. We found that patients spent more time on READY than paper (4.39mins vs. 2.26mins), but overall, READY did not delay the workflow (pre = 52.08 mins vs. post = 45.46 mins). This time difference may be compensated with READY eliminating a workflow step for the staff. CONCLUSION: Patients preferred READY to paper documents. Many found it easier to input information because of the larger font size and the ease of 'tapping' rather than writing-out or circling answers. Even though patients spent more time on READY than using paper documents, the longer usage of READY was mainly due to when troubleshooting was needed. Most patients did not have problems after receiving initial support from the staff. This study not only enabled improvements to the software but also serves as good reference for other researchers or institutional decision makers who are interested in implementing such a technology.