Assessing Patient Participation Burden Based on Protocol Design Characteristics

Getz, Kenneth A.; Sethuraman, Venkat; Rine, Jessica; Peña, Yaritza; Ramanathan, Sharma; Stergiopoulos, Stella

doi:10.1007/s43441-019-00092-4

Cited by 6 publications

(5 citation statements)

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“…Frequent healthcare professional–patient interaction (e.g. once a week) is not suggested maybe due to the occurrence of participation burden and alert fatigue (Getz et al, 2019). Medium frequent interaction (e.g.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of smartphone application–based self‐management interventions in patients with type 2 diabetes: A systematic review and meta‐analysis of randomized controlled trials

Zhao

Wang

et al. 2021

Journal of Advanced Nursing

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Aims To synthesize evidences on smartphone application–based intervention and determine its effectiveness on glycaemic control, self‐management behaviours, psychological well‐being, quality of life and cardiometabolic risk factors. Design A systematic review and meta‐analysis of randomized controlled trials (RCTs). Data sources Major English and Chinese electronic databases were searched from January 2008 to January 2021, including PubMed, Web of Science, Embase, Cochrane Central Register of Controlled Trials, Google Scholar, China National Knowledge Infrastructure (CNKI), Wanfang and Sinomed. Review methods RCTs were screened and selected if they used smartphone applications to support patients in the self‐management of diabetes. Data extraction and methodological assessment were performed by two reviewers independently. Meta‐analysis was performed to pool the intervention effect on outcomes of interest using RevMan 5.3. Results Across 19 included trials involving 2585 participants, smartphone application–based interventions were associated with a clinically and statistically significant reduction of glycated haemoglobin (HbA1c). Beneficial effects were also observed in participants’ behavioural performance, especially in medication adherence. Intervention effects on psychological status, quality of life and cardiometabolic risk factors were nonsignificant. Subgroup analysis showed interactive approach with medium frequency or flexible facilitator–patient interaction induced a larger effect on HbA1c reduction. Besides, patients with baseline HbA1c ≥9% benefited more than those with HbA1c <9% from the use of smartphone applications. Conclusions Smartphone application–based diabetes self‐management intervention could optimize patients’ glycaemic control and enhance participants’ self‐management performance. Further endeavour is required to examine the long‐term effects and cost‐effectiveness of smartphone application–based intervention before promoting the adoption and dissemination of such intervention. Impact This review supports the potential of smartphone application–based intervention as effective approach to optimize glycaemic control and promote self‐management engagement among patients with type 2 diabetes. Suggestions for future research and practice are provided and discussed.

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Section: Discussionmentioning

confidence: 99%

Effectiveness of smartphone application–based self‐management interventions in patients with type 2 diabetes: A systematic review and meta‐analysis of randomized controlled trials

Zhao

Wang

et al. 2021

Journal of Advanced Nursing

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“…pt indicates patient; "Family" refers to relatives or close friends who may share in decision making; RCT, randomized controlled trial. 2 We generated 2 metrics of participation: attendance rates based on the number of ADRC study visits each participant attended divided by the number of study visits scheduled as of January 21, 2021, and (2) whether the participant had dropped out of the study. The analysis of attendance rates included only participants (N = 377) with 2 or more possible visits and included a control variable for the total number of possible visits.…”

Section: Methodsmentioning

confidence: 99%

“…Conceptual model of role of perceived participant burden in recruitment and retention. pt indicates patient; “Family” refers to relatives or close friends who may share in decision making; RCT, randomized controlled trial 2…”

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confidence: 99%

Perceptions of Research Burden and Retention Among Participants in ADRC Cohorts

Gabel

Bollinger

Knox

et al. 2022

Alzheimer Disease &Amp; Associated Disorders

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Objectives: Alzheimer disease (AD) and related dementias clinical research is associated with significant participant burden. The Perceived Research Burden Assessment (PeRBA) measures participants' perceptions of logistical, psychological, and physical burdens. The purpose of this study was to assess PeRBA's psychometric properties, perceptual sources, and behavioral consequences with participants in a multisite study of participant retention in longitudinal cohort studies of Alzheimer disease and related dementias.Design: Multicenter mixed methods.Setting: In-person or phone.

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“… 93 , 94 In one study, more complex protocols were associated with half the screen-to-completion rate, 12% longer time to first patient first visit, 73% longer time to last patient last visit, and 68% more amendments relative to less complex protocols. 95 , 96 Thus, protocols should be simplified to the extent possible, with the goal of prioritizing the ability of the trial to address its primary objective.…”

Section: Trial Phases and Treatment Groupsmentioning

confidence: 99%

“…The first step is to make the study protocol as patient-friendly as possible. 93 , 94 , 96 Investigators and sponsors are scientifically curious and generally interested in answering as many questions as possible, often resulting in excessively burdensome protocols. 93 Incorporating patient input upfront can illuminate the burden of participation in a manner that may suggest opportunities for streamlining a protocol and supporting patient engagement.…”

Section: Patient Selection Recruitment and Retentionmentioning

confidence: 99%

Design and conduct of confirmatory chronic pain clinical trials

Katz¹

2020

PR9

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The purpose of this article is to provide readers with a basis for understanding the emerging science of clinical trials and to provide a set of practical, evidence-based suggestions for designing and executing confirmatory clinical trials in a manner that minimizes measurement error. The most important step in creating a mindset of quality clinical research is to abandon the antiquated concept that clinical trials are a method for capturing data from clinical practice and shifting to a concept of the clinical trial as a measurement system, consisting of an interconnected set of processes, each of which must be in calibration for the trial to generate an accurate and reliable estimate of the efficacy (and safety) of a given treatment. The status quo of inaccurate, unreliable, and protracted clinical trials is unacceptable and unsustainable. This article gathers aspects of study design and conduct under a single broad umbrella of techniques available to improve the accuracy and reliability of confirmatory clinical trials across traditional domain boundaries.

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Assessing Patient Participation Burden Based on Protocol Design Characteristics

Cited by 6 publications

References 0 publications

Effectiveness of smartphone application–based self‐management interventions in patients with type 2 diabetes: A systematic review and meta‐analysis of randomized controlled trials

Effectiveness of smartphone application–based self‐management interventions in patients with type 2 diabetes: A systematic review and meta‐analysis of randomized controlled trials

Perceptions of Research Burden and Retention Among Participants in ADRC Cohorts

Design and conduct of confirmatory chronic pain clinical trials

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