Personalized Feedback for Personalized Trials: Construction of Summary Reports for Participants in a Series of Personalized Trials for Chronic Lower Back Pain

D’Angelo, Stefani; Ahn, Heejoon; Miller, Danielle; Monane, Rachel; Butler, Mark J.

doi:10.1162/99608f92.d5b57784

Cited by 9 publications

(8 citation statements)

References 24 publications

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“…Participants are encouraged to seek a medical professional's opinion if they have any questions or concerns about the data displayed in their report. A similar version of the participant report in a series of personalized trials for chronic lower back pain is described and displayed in further detail elsewhere [48].…”

Section: Participant Reportmentioning

confidence: 99%

A Series of Remote Melatonin Supplement Interventions for Poor Sleep: Protocol for a Feasibility Pilot Study for a Series of Personalized (N-of-1) Trials

Butler¹,

D’Angelo²,

Perrin³

et al. 2023

JMIR Res Protoc

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Background Poor sleep, defined as short-duration or poor-quality sleep, is a frequently reported condition with many deleterious effects including poorer cognitive functioning, increased accidents, and poorer health. Melatonin has been shown to be an efficacious treatment to manage symptoms of poor sleep. However, the treatment effects of melatonin on sleep can vary greatly between participants. Personalized, or N-of-1, trial designs represent a method for identifying the best treatment for individual participants. Although using N-of-1 trials of melatonin to treat poor sleep is possible, the feasibility, acceptability, and effectiveness of N-of-1 trials using melatonin are unknown. Using the National Institutes of Health Stage Model for Behavioral Intervention Development, a stage IB (intervention refinement, modification, and adaptation and pilot testing) design appeared to be needed to address these feasibility questions. Objective This trial series evaluates the feasibility, acceptability, and effectiveness of a series of personalized interventions for remote delivery of melatonin dose (3 and 0.5 mg) versus placebo supplements for self-reported poor sleep among 60 participants. The goal of this study is to provide valuable information about implementing remote N-of-1 randomized controlled trials to improve poor sleep. Methods Participants will complete a 2-week baseline followed by six 2-week alternating intervention periods of 3 mg of melatonin, 0.5 mg of melatonin, and placebo. Participants will be randomly assigned to 2 intervention orders. The feasibility and acceptability of the personalized trial approach will be determined with participants’ ratings of usability and satisfaction with the remote, personalized intervention delivery system. The effectiveness of the intervention will be measured using participants’ self-reported sleep quality and duration and Fitbit tracker–measured sleep duration and efficiency. Additional measures will include ecological momentary assessment measures of fatigue, stress, pain, mood, concentration, and confidence as well as measures of participant adherence to the intervention, use of the Fitbit tracker, and survey data collection. Results As of the submission of this protocol, recruitment for this National Institutes of Health stage IB personalized trial series is approximately 78.3% complete (47/60). We expect recruitment and data collection to be finalized by June 2023. Conclusions Evaluating the feasibility, acceptability, and effectiveness of a series of personalized interventions of melatonin will address the longer term aim of this program of research—is integrating N-of-1 trials useful patient care? The personalized trial series results will be published in a peer-reviewed journal and will follow the CONSORT (Consolidated Standards of Reporting Trials) extension for N-of-1 trials (CENT 2015) reporting guidelines. This trial series was approved by the Northwell Health institutional review board. Trial Registration ClinicalTrials.gov NCT05349188; https://www.clinicaltrials.gov/study/NCT05349188 International Registered Report Identifier (IRRID) DERR1-10.2196/45313

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Section: Participant Reportmentioning

confidence: 99%

A Series of Remote Melatonin Supplement Interventions for Poor Sleep: Protocol for a Feasibility Pilot Study for a Series of Personalized (N-of-1) Trials

Butler¹,

D’Angelo²,

Perrin³

et al. 2023

JMIR Res Protoc

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“…Personalized trials are becoming more commonplace with recent examples including studying fatigue, depression, and back pain. [21][22][23] The objective of this study was to assess the feasibility and acceptability of a randomized personalized trial that serially delivered four BCTs, one for each 2-week period, to promote low-intensity PA (walking) in middle-aged and older adults. Wearable technology and smartphone messaging were employed to facilitate completely remote delivery of the study.…”

Section: Introductionmentioning

confidence: 99%

“…Personalized trials are becoming more commonplace with recent examples including studying fatigue, depression, and back pain. 21 – 23 …”

Section: Introductionmentioning

confidence: 99%

Feasibility Test of Personalized (N-of-1) Trials for Increasing Middle-Aged and Older Adults’ Physical Activity

Friel,

Goodwin,

Robles

et al. 2023

Preprint

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Purpose To test the feasibility of a remotely-delivered intervention to increase low-intensity physical activity (walking) in middle-aged and older adults. Design This study used a Personalized (N-of-1) trial design. Setting This study took place at a major healthcare system from November 2021 to February 2022. Subjects Sixty adults (45–75 years, 92% female, 80% white) were recruited. Intervention A 10-week study comprising a 2-week baseline, followed by four 2-week periods where 4 Behavior Change Techniques (BCTs) - self-monitoring, goal setting, action planning and feedback - were delivered one at a time in random order. Measures Activity was measured by a Fitbit, and intervention components delivered by email/text. Average daily steps were compared between baseline and intervention. Participants completed satisfaction items derived from the System Usability Scale and reported attitudes and opinions about personalized trials. Results Participants rated personalized trial components as feasible and acceptable. Changes in steps between baseline and intervention were not significant, but a large heterogeneity of treatment effects existed, suggesting some participants significantly increased walking while others significantly decreased. Conclusions Our intervention was well-accepted but use of BCTs delivered individually did not result in a significant increase in steps. Feasibility and heterogeneity of treatment effects support adopting a personalized trial approach to optimize intervention results.

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“…Importantly, this issue concludes with use cases of personalized trials that range from presentation of results to patients, medication side-effect testing, lower back pain management, and multimorbidity disease management (D'Angelo et al, 2022;Howard et al, 2022;Butler et al, 2022;.…”

Section: Introducing the Special Issue On Advances In Personalized Tr...mentioning

confidence: 99%

“…Best practices for reporting, ethics, and conduct of personalized trials comprise the next section ( Porcino & Vohra, 2022 ; Samuel & Wootton, 2022 ; and Kravitz & Duan, 2022 ). Importantly, this issue concludes with use cases of personalized trials that range from presentation of results to patients, medication side-effect testing, lower back pain management, and multimorbidity disease management ( D’Angelo et al, 2022 ; Howard et al, 2022 ; Butler et al, 2022 ; and Suls et al, 2022 ).…”

Section: Introducing the Special Issue On Advances In Personalized Tr...mentioning

confidence: 99%

Introducing Data Sciences to N-of-1 Designs, Statistics, Use-Cases, the Future, and the Moniker ‘N-of-1’ Trial

Davidson

Cheung

Friel

et al. 2022

Harvard Data Science Review

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This article, an introduction to HDSR's "Personalized (N-of-1) Trials: Methods, Applications, and Impact" special issue, describes the rationale for a primer of the methods, data types and management, designs, and use cases for personalized (N-of-1) trials. It explains that the design and implementation of personalized (N-of-1) trials is only useful if patients volunteer for research involving them and actively participate in clinical services that use them. However, 'N-of-1 trials' may be an inadequate name to enact such patient engagement. The authors briefly review what patients have reported about the 'N-of-1' label and propose a more consumerfriendly moniker for this type of research and clinical approach to improve evidence-based science.

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Personalized Feedback for Personalized Trials: Construction of Summary Reports for Participants in a Series of Personalized Trials for Chronic Lower Back Pain

Cited by 9 publications

References 24 publications

A Series of Remote Melatonin Supplement Interventions for Poor Sleep: Protocol for a Feasibility Pilot Study for a Series of Personalized (N-of-1) Trials

A Series of Remote Melatonin Supplement Interventions for Poor Sleep: Protocol for a Feasibility Pilot Study for a Series of Personalized (N-of-1) Trials

Feasibility Test of Personalized (N-of-1) Trials for Increasing Middle-Aged and Older Adults’ Physical Activity

Introducing Data Sciences to N-of-1 Designs, Statistics, Use-Cases, the Future, and the Moniker ‘N-of-1’ Trial

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