PERSONAL: Feasibility Study Protocol for Placebo-Controlled, Randomized n-of-1 Trials of Tamsulosin for Lower Urinary Tract Symptoms

Bauer, Scott R.; Breyer, Benjamin N.; Oni‐Orisan, Akinyemi; Steinman, Michael A.; Sim, Ida; McCulloch, Charles E.; Kenfield, Stacey A.

doi:10.3389/fdgth.2020.00007

Cited by 5 publications

(5 citation statements)

References 41 publications

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“…The participants received daily questionnaires through the mobile app at a prespecified time of their choice, and the questionnaire data from all participants were then collected in a secure cloud-based database made accessible to the research team; participants could review their own results throughout the study period. Additional study design details were previously published [9], and results pertaining to the PERSONAL pilot study itself will be published in a separate manuscript.…”

Section: Methodsmentioning

confidence: 99%

Perceptions of Older Men Using a Mobile Health App to Monitor Lower Urinary Tract Symptoms and Tamsulosin Side Effects: Mixed Methods Study

Wang¹,

Breyer²,

Lee³

et al. 2021

JMIR Hum Factors

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Background Mobile health (mHealth) apps may provide an efficient way for patients with lower urinary tract symptoms (LUTS) to log and communicate symptoms and medication side effects with their clinicians. Objective The aim of this study was to explore the perceptions of older men with LUTS after using an mHealth app to track their symptoms and tamsulosin side effects. Methods Structured phone interviews were conducted after a 2-week study piloting the daily use of a mobile app to track the severity of patient-selected LUTS and tamsulosin side effects. Quantitative and qualitative data were considered. Results All 19 (100%) pilot study participants completed the poststudy interviews. Most of the men (n=13, 68%) reported that the daily questionnaires were the right length, with 32% (n=6) reporting that the questionnaires were too short. Men with more severe symptoms were less likely to report changes in perception of health or changes in self-management; 47% (n=9) of the men reported improved awareness of symptoms and 5% (n=1) adjusted fluid intake based on the questionnaire. All of the men were willing to share app data with their clinicians. Thematic analysis of qualitative data yielded eight themes: (1) orientation (setting up app, format, symptom selection, and side-effect selection), (2) triggers (routine or habit and symptom timing), (3) daily questionnaire (reporting symptoms, reporting side effects, and tailoring), (4) technology literacy, (5) perceptions (awareness, causation or relevance, data quality, convenience, usefulness, and other apps), (6) self-management, (7) clinician engagement (communication and efficiency), and (8) improvement (reference materials, flexibility, language, management recommendations, and optimize clinician engagement). Conclusions We assessed the perceptions of men using an mHealth app to monitor and improve management of LUTS and medication side effects. LUTS management may be further optimized by tailoring the mobile app experience to meet patients’ individual needs, such as tracking a greater number of symptoms and integrating the app with clinicians’ visits. mHealth apps are likely a scalable modality to monitor symptoms and improve care of older men with LUTS. Further study is required to determine the best ways to tailor the mobile app and to communicate data to clinicians or incorporate data into the electronical medical record meaningfully.

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Section: Methodsmentioning

confidence: 99%

Perceptions of Older Men Using a Mobile Health App to Monitor Lower Urinary Tract Symptoms and Tamsulosin Side Effects: Mixed Methods Study

Wang¹,

Breyer²,

Lee³

et al. 2021

JMIR Hum Factors

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“…For example, N-of-1 trials could help quantify the potential effects of deprescribing tamsulosin for lower urinary tract symptoms. 123 N-of-1 trials could also serve as a potential strategy to address therapeutic competitionan increasingly common scenario whereby a medication that treats one condition could cause harm to another. 124 However, evidence for the efficacy and safety of N-of-1 trials, as well as their effectiveness and implementability will be needed to advance this unique strategy.…”

Section: Future Stepsmentioning

confidence: 99%

“…There are myriad use cases for such a tool. For example, N‐of‐1 trials could help quantify the potential effects of deprescribing tamsulosin for lower urinary tract symptoms 123 . N‐of‐1 trials could also serve as a potential strategy to address therapeutic competition—an increasingly common scenario whereby a medication that treats one condition could cause harm to another 124 .…”

Section: Future Stepsmentioning

confidence: 99%

N‐of‐1 trials to facilitate evidence‐based deprescribing: Rationale and case study

Goyal

Safford

Hilmer

et al. 2022

Brit J Clinical Pharma

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Deprescribing has emerged as an important aspect of patient‐centred medication management but is vastly underutilized in clinical practice. The current narrative review will describe an innovative patient‐centred approach to deprescribing—N‐of‐1 trials. N‐of‐1 trials involve multiple‐period crossover design experiments conducted within individual patients. They enable patients to compare the effects of two or more treatments or, in the case of deprescribing N‐of‐1 trials, continuation with a current treatment versus no treatment or placebo. N‐of‐1 trials are distinct from traditional between‐patient studies such as parallel‐group or crossover designs which provide an average effect across a group of patients and obscure differences between individuals. By generating data on the effect of an intervention for the individual rather than the population, N‐of‐1 trials can promote therapeutic precision. N‐of‐1 trials are a particularly appealing strategy to inform deprescribing because they can generate individual‐level evidence for deprescribing when evidence is uncertain, and can thus allay patient and physician concerns about discontinuing medications. To illustrate the use of deprescribing N‐of‐1 trials, we share a case example of an ongoing series of N‐of‐1 trials that compare maintenance versus deprescribing of beta‐blockers in patients with heart failure with preserved ejection fraction. By providing quantifiable data on patient‐reported outcomes, promoting personalized pharmacotherapy, and facilitating shared decision making, N‐of‐1 trials represent a potentially transformative strategy to address polypharmacy.

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“…Previous efforts using mobile apps to track patient-reported outcomes have informed patient-driven care and helped patients with heart failure and depression identify and self-manage potential symptom triggers [ 22 , 23 ]. If men are able and willing to track their symptoms while undergoing LUTS treatment (eg, formal n-of-1 trials or self-experimentation), their data can be used to generate individualized estimates of benefits and harms of both prescribed and self-management LUTS treatments [ 24 - 30 ]. To reduce the burden of frequent symptom assessments, we designed the PERSONAL (Placebo–Controlled, Randomized, Patient-Selected Outcomes, N-of-1 Trials) mHealth app for collecting daily LUTS severity and medication side effect data.…”

Section: Introductionmentioning

confidence: 99%

Tracking Lower Urinary Tract Symptoms and Tamsulosin Side Effects Among Older Men Using a Mobile App (PERSONAL): Feasibility and Usability Study

Lee¹,

Kenfield²,

Wang³

et al. 2021

JMIR Form Res

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Background Continuous α1a-blockade is the first-line treatment for lower urinary tract symptoms (LUTS) among older men with suspected benign prostatic hyperplasia. Variable efficacy and safety for individual men necessitate a more personalized, data-driven approach to prescribing and deprescribing tamsulosin for LUTS in older men. Objective We aim to evaluate the feasibility and usability of the PERSONAL (Placebo–Controlled, Randomized, Patient-Selected Outcomes, N-of-1 Trials) mobile app for tracking daily LUTS severity and medication side effects among older men receiving chronic tamsulosin therapy. Methods We recruited patients from the University of California, San Francisco health care system to participate in a 2-week pilot study. The primary objectives were to assess recruitment feasibility, study completion rates, frequency of symptom tracking, duration of tracking sessions, and app usability rankings measured using a follow-up survey. As secondary outcomes, we evaluated whether daily symptom tracking led to changes in LUTS severity, perceptions of tamsulosin, overall quality of life, medication adherence between baseline and follow-up surveys, and perceived app utility. Results We enrolled 19 men within 23 days, and 100% (19/19) of the participants completed the study. Each participant selected a unique combination of symptoms to track and recorded data in the PERSONAL app, with a median daily completion rate of 79% (11/14 days). The median duration of the app session was 44 (IQR 33) seconds. On a scale of 1 (strongly disagree) to 5 (strongly agree), the participants reported that the PERSONAL app was easy to use (mean 4.3, SD 1.0), that others could learn to use it quickly (mean 4.2, SD 0.9), and that they felt confident using the app (mean 4.4, SD 0.8). LUTS severity, quality of life, and medication adherence remained unchanged after the 2-week study period. Fewer men were satisfied with tamsulosin after using the app (14/19, 74% vs 17/19, 89% at baseline), although the perceived benefit from tamsulosin remained unchanged (18/19, 95% at baseline and at follow-up). In total, 58% (11/19) of the participants agreed that the PERSONAL app could help people like them manage their urinary symptoms. Conclusions This pilot study demonstrated the high feasibility and usability of the PERSONAL mobile app to track patient-selected urinary symptoms and medication side effects among older men taking tamsulosin to manage LUTS. We observed that daily symptom monitoring had no adverse effects on the secondary outcomes. This proof-of-concept study establishes a framework for future mobile app studies, such as digital n-of-1 trials, to collect comprehensive individual-level data for personalized LUTS management in older men.

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PERSONAL: Feasibility Study Protocol for Placebo-Controlled, Randomized n-of-1 Trials of Tamsulosin for Lower Urinary Tract Symptoms

Cited by 5 publications

References 41 publications

Perceptions of Older Men Using a Mobile Health App to Monitor Lower Urinary Tract Symptoms and Tamsulosin Side Effects: Mixed Methods Study

Perceptions of Older Men Using a Mobile Health App to Monitor Lower Urinary Tract Symptoms and Tamsulosin Side Effects: Mixed Methods Study

N‐of‐1 trials to facilitate evidence‐based deprescribing: Rationale and case study

Tracking Lower Urinary Tract Symptoms and Tamsulosin Side Effects Among Older Men Using a Mobile App (PERSONAL): Feasibility and Usability Study

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