Using digital technologies in clinical trials: Current and future applications

Rosa, Carmen La; Marsch, Lisa A.; Winstanley, Erin L.; Brunner, Meg; Campbell, Aimee N.C.

doi:10.1016/j.cct.2020.106219

Cited by 49 publications

(51 citation statements)

References 76 publications

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“…To provide an overview of prior work exploring challenges experienced in traditional and digital health care research and software development projects, we present each of the main themes and descriptors of challenges identified alongside similar research findings from others (Table 1). We included 10 publications [64][65][66][67][68][69][70][71][72][73] Limited access to project personnel with the relevant expertise and knowledge [9,25,37,68] Identifying and recruiting study personnel with the necessary expertise and experience to design and set up the feasibility study • Poor retention of personnel [69] • Time needed to train personnel [9,25] External constraints • • Time taken for ethical and regulatory approval from public authorities [69,70] Uncertainties regarding time taken for tasks to be completed by contracted personnel outside of the research team and time taken for public authorities to make decisions and provide approvals…”

Section: Comparison With Prior Workmentioning

confidence: 99%

“…Adaptations needed to allow digital tools to be used in research [25,36] Changing intervention requirements, elements of the study protocol, and associated study documentation…”

Section: • •mentioning

confidence: 99%

“…Lack of understanding of requirement complexity [68] Planning and scheduling [23,25,37,38] One interesting challenge was identified in relation to the group decision-making process affecting the study timeframe. Research concerning cultural expectations and decision-making indicates that, within the Swedish culture, there are high expectations for shared authority and decision-making between managers and personnel [64].…”

Section: • •mentioning

confidence: 99%

“…The Portal is designed to deliver internet-administered cognitive behavioral therapy interventions and support the execution of study procedures, for example, randomization, web-based informed consent, and data collection [ 23 ]. Digital technologies (eg, technologies using the internet) are facilitating the delivery of health care worldwide [ 24 , 25 ]. Indeed, internet-administered interventions have been posited as a solution to the global mental health crisis and to help overcome significant barriers to treatment access (eg, geographical and resource barriers) [ 26 ].…”

Section: Introductionmentioning

confidence: 99%

“…Furthermore, digital technologies are being increasingly incorporated into the design and execution of health care research, for example, to facilitate recruitment, enhance retention, and collect data [ 24 , 25 , 32 , 33 ]. The use of digital technologies in health care research has intensified during the COVID-19 pandemic in an attempt to continue health care research in the absence of in-person contact [ 34 ].…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Conducting Digital Health Care Research: Document Analysis of Challenges Experienced During Intervention Development and Feasibility Study Setup of an Internet-Administered Intervention for Parents of Children Treated for Cancer

Woodford¹,

Karlsson²,

Hagström³

et al. 2021

JMIR Form Res

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Background The design and conduct of research to develop, test, and evaluate complex health care interventions is challenging. Although the existing literature describes key challenges associated with the design and conduct of definitive (evaluation) trials, there is a lack of information concerning specific challenges associated with the intervention development phase and setup of feasibility studies. In particular, the literature is scarce concerning the challenges associated with conducting digital health care research, such as research on internet-administered interventions and research using digital features to support the execution of study procedures (eg, recruitment, consent, retention, and data collection and management). This study is conducted in the context of the intervention development and feasibility study setup phases of an internet-administered, guided, low-intensity cognitive behavioral therapy–based intervention for parents of children previously treated for cancer. Objective The aim of this study is to explore the challenges experienced during the development phase of the internet-administered intervention and digital features to support the execution of the study procedures and a feasibility study setup. Methods To explore the key challenges experienced, we conducted a document analysis of written records from all study meetings held by the research team (meeting minutes) between June 7, 2018, and January 10, 2020, guided by a thematic analysis approach. Furthermore, discussion groups with members of the research team were held to develop a more detailed understanding of the key challenges experienced. Methods and results are reported in accordance with the relevant items from the Standards for Reporting Qualitative Research checklist. Results Six main themes were identified: decision-making and communication, expertise, external constraints, flexibility, planning and scheduling, and technical constraints. Conclusions Significant challenges were experienced during the intervention development and setup phases of the feasibility study. Implications are discussed to inform future design, conduct, and planning of internet-administered intervention development and feasibility studies, especially within the context of digital health care research.

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Section: Comparison With Prior Workmentioning

confidence: 99%

“…Adaptations needed to allow digital tools to be used in research [25,36] Changing intervention requirements, elements of the study protocol, and associated study documentation…”

Section: • •mentioning

confidence: 99%

Section: • •mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Conducting Digital Health Care Research: Document Analysis of Challenges Experienced During Intervention Development and Feasibility Study Setup of an Internet-Administered Intervention for Parents of Children Treated for Cancer

Woodford¹,

Karlsson²,

Hagström³

et al. 2021

JMIR Form Res

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show abstract

Statistical analysis of actigraphy data with generalised additive models

Lisi,

Abellan

2023

Pharmaceutical Statistics

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There is a growing interest in the use of physical activity data in clinical studies, particularly in diseases that limit mobility in patients. High‐frequency data collected with digital sensors are typically summarised into actigraphy features aggregated at epoch level (e.g., by minute). The statistical analysis of such volume of data is not straightforward. The general trend is to derive metrics, capturing specific aspects of physical activity, that condense (say) a week worth of data into a single numerical value. Here we propose to analyse the entire time‐series data using Generalised Additive Models (GAMs). GAMs are semi‐parametric models that allow inclusion of both parametric and non‐parametric terms in the linear predictor. The latter are smooth terms (e.g., splines) and, in the context of actigraphy minute‐by‐minute data analysis, they can be used to assess daily patterns of physical activity. This in turn can be used to better understand changes over time in longitudinal studies as well as to compare treatment groups. We illustrate the application of GAMs in two clinical studies where actigraphy data was collected: a non‐drug, single‐arm study in patients with amyotrophic lateral sclerosis, and a physical‐activity sub‐study included in a phase 2b clinical trial in patients with chronic obstructive pulmonary disease.

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Automatic detection of early osteonecrosis of the femoral head from various hip pathologies using deep convolutional neural network: a multi-centre study

Shen

Shi

et al. 2023

International Orthopaedics (SICOT)

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Using digital technologies in clinical trials: Current and future applications

Cited by 49 publications

References 76 publications

Conducting Digital Health Care Research: Document Analysis of Challenges Experienced During Intervention Development and Feasibility Study Setup of an Internet-Administered Intervention for Parents of Children Treated for Cancer

Conducting Digital Health Care Research: Document Analysis of Challenges Experienced During Intervention Development and Feasibility Study Setup of an Internet-Administered Intervention for Parents of Children Treated for Cancer

Statistical analysis of actigraphy data with generalised additive models

Automatic detection of early osteonecrosis of the femoral head from various hip pathologies using deep convolutional neural network: a multi-centre study

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