Testing Digital Methods of Patient-Reported Outcomes Data Collection: A prospective, cluster randomized trial to test text messaging and mobile surveys. (Preprint)

BACKGROUND The growth of mobile and digital health data collection continues to accelerate in healthcare. Patient-reported outcomes are those data points collected from patients and there is a growing body of work to use mobile and digital methods to generate these data. Multiple methods exist in using technology to gather data with mobile surveys and text messaging. There remains a gap in evaluating these methods in prospective, randomized studies. OBJECTIVE To prospectively investigate two common methods of remote patient-reported outcomes data collection. The study sought to analyze response and engagement rates through two modalities including bi-directional text messaging or mobile surveys. METHODS Prospective, block randomized trial of adult patients undergoing elective sports medicine and orthopedic procedures over 6 weeks. The primary objective was to determine if the method of digital patient engagement would impact response and completion rates. The primary outcome was response rate and total competition of patient reported outcomes questionnaires. RESULTS 127 participants were block randomized into either receiving a mobile survey (n=63) delivered as a hyperlink or were asked the same questions through an automated conversational text messaging (n=64). Gender, age, number of comorbidities, number of opioid tablets prescribed were similar across messaging arms. Overall engagement over the immediate post-operative was similar between the messaging arms. Prolonged engagement past post-operative day 4 was higher in the mobile survey arm at day 7 (95% vs. 56%). Patients with more invasive procedures showed a trend toward being responsive at day 4 as compared to non-responders. CONCLUSIONS As digital platforms become more commonly used in health care, testing the various options to engage patients to gather data is crucial to inform future care and research. We found that globally bi-directional text messaging and mobile surveys were comparable in response and engagement rates, however mobile surveys may trend toward higher response rates over longer periods of time.

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Abstract PD10-08: Baseline patient reported outcomes predict aromatase inhibitor adherence failure among women in enrolled in a randomized trial of text-messaging

10.1158/1538-7445.sabcs19-pd10-08 ◽

2020 ◽

Author(s):

Dawn L Hershman ◽

Joeseph M Unger ◽

Anna Moseley ◽

Grace C Hillyer ◽

Kathryn B. Arnold ◽

...

Keyword(s):

Randomized Trial ◽

Aromatase Inhibitor ◽

Text Messaging ◽

Patient Reported Outcomes ◽

Patient Reported

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Abstract PS9-21: Patient reported outcomes of newly diagnosed women with breast cancer enrolled in a digital health coaching program

10.1158/1538-7445.sabcs20-ps9-21 ◽

2021 ◽

Author(s):

Kelly J Brassil ◽

Bryan Fellman ◽

Brett Wisse ◽

Diana Urbauer ◽

Valerie Shelton ◽

...

Keyword(s):

Breast Cancer ◽

Patient Reported Outcomes ◽

Digital Health ◽

Health Coaching ◽

Newly Diagnosed ◽

Patient Reported

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Toxicity and Patient-Reported Outcomes of a Phase 2 Randomized Trial of Prostate and Pelvic Lymph Node Versus Prostate only Radiotherapy in Advanced Localised Prostate Cancer (PIVOTAL)

International Journal of Radiation Oncology*Biology*Physics ◽

10.1016/j.ijrobp.2018.10.003 ◽

2019 ◽

Vol 103 (3) ◽

pp. 605-617 ◽

Cited By ~ 12

Author(s):

David Dearnaley ◽

Clare L. Griffin ◽

Rebecca Lewis ◽

Philip Mayles ◽

Helen Mayles ◽

...

Keyword(s):

Prostate Cancer ◽

Lymph Node ◽

Randomized Trial ◽

Patient Reported Outcomes ◽

Pelvic Lymph Node ◽

Phase 2 ◽

Patient Reported

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PMH56 INNOVATIONS IN COMBINING PATIENT REPORTED OUTCOMES WITH COGNITIVE TESTING DATA TO STREAMLINE AND LEVERAGE REAL-TIME DATA COLLECTION

Value in Health ◽

10.1016/s1098-3015(11)72933-3 ◽

2010 ◽

Vol 13 (7) ◽

pp. A456

Author(s):

C Curry

Keyword(s):

Data Collection ◽

Real Time ◽

Patient Reported Outcomes ◽

Cognitive Testing ◽

Time Data ◽

Patient Reported ◽

Testing Data ◽

Real Time Data

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Engagement and Participant Experiences With Consumer Smartwatches for Health Research: Longitudinal, Observational Feasibility Study (Preprint)

10.2196/preprints.14368 ◽

2019 ◽

Author(s):

Anna L Beukenhorst ◽

Kelly Howells ◽

Louise Cook ◽

John McBeth ◽

Terence W O'Neill ◽

...

Keyword(s):

Data Collection ◽

Knee Osteoarthritis ◽

Patient Reported Outcomes ◽

Health Data ◽

Self Report ◽

Sensor Data ◽

Battery Life ◽

Activity Data ◽

Technical Problems ◽

Patient Reported

BACKGROUND Wearables provide opportunities for frequent health data collection and symptom monitoring. The feasibility of using consumer cellular smartwatches to provide information both on symptoms and contemporary sensor data has not yet been investigated. OBJECTIVE This study aimed to investigate the feasibility and acceptability of using cellular smartwatches to capture multiple patient-reported outcomes per day alongside continuous physical activity data over a 3-month period in people living with knee osteoarthritis (OA). METHODS For the KOALAP (Knee OsteoArthritis: Linking Activity and Pain) study, a novel cellular smartwatch app for health data collection was developed. Participants (age ≥50 years; self-diagnosed knee OA) received a smartwatch (Huawei Watch 2) with the KOALAP app. When worn, the watch collected sensor data and prompted participants to self-report outcomes multiple times per day. Participants were invited for a baseline and follow-up interview to discuss their motivations and experiences. Engagement with the watch was measured using daily watch wear time and the percentage completion of watch questions. Interview transcripts were analyzed using grounded thematic analysis. RESULTS A total of 26 people participated in the study. Good use and engagement were observed over 3 months: most participants wore the watch on 75% (68/90) of days or more, for a median of 11 hours. The number of active participants declined over the study duration, especially in the final week. Among participants who remained active, neither watch time nor question completion percentage declined over time. Participants were mainly motivated to learn about their symptoms and enjoyed the self-tracking aspects of the watch. Barriers to full engagement were battery life limitations, technical problems, and unfulfilled expectations of the watch. Participants reported that they would have liked to report symptoms more than 4 or 5 times per day. CONCLUSIONS This study shows that capture of patient-reported outcomes multiple times per day with linked sensor data from a smartwatch is feasible over at least a 3-month period. INTERNATIONAL REGISTERED REPORT RR2-10.2196/10238

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Asymptomatic population reference values for three knee patient-reported outcomes measures: evaluation of an electronic data collection system and implications for future international, multi-centre cohort studies

Archives of Orthopaedic and Trauma Surgery ◽

10.1007/s00402-018-2874-4 ◽

2018 ◽

Vol 138 (5) ◽

pp. 611-621 ◽

Cited By ~ 2

Author(s):

James M. McLean ◽

Oscar Brumby-Rendell ◽

Ryan Lisle ◽

Jacob Brazier ◽

Kieran Dunn ◽

...

Keyword(s):

Data Collection ◽

Cohort Studies ◽

Reference Values ◽

Patient Reported Outcomes ◽

Collection System ◽

Electronic Data ◽

Data Collection System ◽

Electronic Data Collection ◽

Outcomes Measures ◽

Patient Reported

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Digital health application for real-time patient-reported outcomes during prostate radiotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.2_suppl.157 ◽

2016 ◽

Vol 34 (2_suppl) ◽

pp. 157-157 ◽

Cited By ~ 2

Author(s):

Daniel Xiao Yang ◽

Jackson Thea ◽

Yi An ◽

James B. Yu

Keyword(s):

Quality Of Life ◽

Real Time ◽

Mobile Applications ◽

Mobile Application ◽

Patient Reported Outcomes ◽

Digital Health ◽

Prostate Radiotherapy ◽

Patient Reported

157 Background: The use of digital health technology, including mobile applications, in the clinical setting is becoming increasingly more prevalent. Such technology is currently being explored as clinical research tools. While the side effects of prostate radiotherapy are well documented after treatment, there remains a paucity of data on patient-reported outcomes and changes in quality of life (QOL) during the treatment period. Therefore, mobile applications represent a practical platform to enable patient reporting in real-time during prostate radiotherapy. Methods: Using an existing open source code framework (Apple ResearchKit), we developed a novel mobile application that enables prostate cancer patients to report, either during or immediately following daily radiation treatment, changes in urinary, bowel, sexual, and hormonal QOL domains. The mobile application utilizes validated questions from the Expanded Prostate Index Composite for Clinical Practice (EPIC-CP) Survey, and allows for survey responses to be tracked over time throughout the treatment period and at routine follow up. Results: For the initial phase of our study, we are currently piloting the mobile application at a single institution with a goal of accruing 50 patients. Study results will be compared to data from traditional surveys, which are available at follow-up but impracticable for real-time symptom reporting. By ASCO 2016 Genitourinary Cancers Symposium, we plan to begin the second phase of our study where any patient can enroll online through a mobile software distribution platform (Apple App Store). Conclusions: We demonstrate the feasibility of using a mobile application to enable patients to report quality of life changes in real-time during prostate radiotherapy. Moreover, our application facilitates clinical trials where patient data collection can be automated and completed at scale. Future prospective studies are planned to evaluate validity of clinical trial data gathered through such methodology.

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