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      Using digital tools in clinical, health and social care research: a mixed-methods study of UK stakeholders

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          Abstract

          Objective

          The COVID-19 pandemic accelerated changes to clinical research methodology, with clinical studies being carried out via online/remote means. This mixed-methods study aimed to identify which digital tools are currently used across all stages of clinical research by stakeholders in clinical, health and social care research and investigate their experience using digital tools.

          Design

          Two online surveys followed by semistructured interviews were conducted. Interviews were audiorecorded, transcribed and analysed thematically.

          Setting, participants

          To explore the digital tools used since the pandemic, survey participants (researchers and related staff (n=41), research and development staff (n=25)), needed to have worked on clinical, health or social care research studies over the past 2 years (2020–2022) in an employing organisation based in the West Midlands region of England (due to funding from a regional clinical research network (CRN)). Survey participants had the opportunity to participate in an online qualitative interview to explore their experiences of digital tools in greater depth (n=8).

          Results

          Six themes were identified in the qualitative interviews: ‘definition of a digital tool in clinical research’; ‘impact of the COVID-19 pandemic’; ‘perceived benefits/drawbacks of digital tools’; ‘selection of a digital tool’; ‘barriers and overcoming barriers’ and ‘future digital tool use’. The context of each theme is discussed, based on the interview results.

          Conclusions

          Findings demonstrate how digital tools are becoming embedded in clinical research, as well as the breadth of tools used across different research stages. The majority of participants viewed the tools positively, noting their ability to enhance research efficiency. Several considerations were highlighted; concerns about digital exclusion; need for collaboration with digital expertise/clinical staff, research on tool effectiveness and recommendations to aid future tool selection. There is a need for the development of resources to help optimise the selection and use of appropriate digital tools for clinical research staff and participants.

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          Most cited references21

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          Using thematic analysis in psychology

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            Digitizing clinical trials

            Clinical trials are a fundamental tool used to evaluate the efficacy and safety of new drugs and medical devices and other health system interventions. The traditional clinical trials system acts as a quality funnel for the development and implementation of new drugs, devices and health system interventions. The concept of a “digital clinical trial” involves leveraging digital technology to improve participant access, engagement, trial-related measurements, and/or interventions, enable concealed randomized intervention allocation, and has the potential to transform clinical trials and to lower their cost. In April 2019, the US National Institutes of Health (NIH) and the National Science Foundation (NSF) held a workshop bringing together experts in clinical trials, digital technology, and digital analytics to discuss strategies to implement the use of digital technologies in clinical trials while considering potential challenges. This position paper builds on this workshop to describe the current state of the art for digital clinical trials including (1) defining and outlining the composition and elements of digital trials; (2) describing recruitment and retention using digital technology; (3) outlining data collection elements including mobile health, wearable technologies, application programming interfaces (APIs), digital transmission of data, and consideration of regulatory oversight and guidance for data security, privacy, and remotely provided informed consent; (4) elucidating digital analytics and data science approaches leveraging artificial intelligence and machine learning algorithms; and (5) setting future priorities and strategies that should be addressed to successfully harness digital methods and the myriad benefits of such technologies for clinical research.
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              Disparities in Health Care and the Digital Divide

              Purpose of Review Disparities in health outcomes are a well documented and worrisome part of our health care system. These disparities persist in spite of, and are occasionally exacerbated by, new technologies that are intended to improve health care. This results in a “digital divide” in which populations that have poorer health outcomes continue to have poorer health outcomes despite technological improvements. Recent Findings In many ways, the digitical divide is already shrinking via improved access to internet and technology/process improvements. For example, people with schizophrenia, PTSD, and bipolar disorder have had their care successfully augmented by new technology. However, problems persist- being impoverished, female, and black all correlate with decreased probability of completing a telehealth visit, and millions of americans have insufficient internet access to complete telehealth visits. Summary We must continue to utilize new technology in health care to improve outcomes, but we must also be wary to ensure those outcomes are equitable across different populations.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2024
                3 April 2024
                : 14
                : 4
                : e076613
                Affiliations
                [1 ] departmentWMG , Ringgold_2707University of Warwick , Coventry, UK
                [2 ] departmentSchool of Engineering , University of Birmingham , Birmingham, UK
                [3 ] National Institute for Health Research Clinical Research Network West Midlands , Birmingham, UK
                [4 ] The Royal Wolverhampton NHS Trust , Wolverhampton, UK
                [5 ] departmentWarwick Medical School , Ringgold_2707University of Warwick , Coventry, UK
                [6 ] departmentSchool of Sport, Exercise and Rehabilitation Sciences , University of Birmingham , Birmingham, UK
                Author notes
                [Correspondence to ] Dr Mark T Elliott; m.elliott.3@ 123456bham.ac.uk
                Author information
                http://orcid.org/0000-0003-2945-157X
                http://orcid.org/0000-0001-5473-135X
                http://orcid.org/0000-0001-6351-1340
                http://orcid.org/0000-0003-4000-0198
                Article
                bmjopen-2023-076613
                10.1136/bmjopen-2023-076613
                11146398
                38569710
                0381111e-5afe-4687-8ab1-3a531dce7590
                © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/.

                History
                : 12 June 2023
                : 08 February 2024
                Funding
                Funded by: National Institute for Health and Care Research, Clinical Research Network West Midlands Improvement and Innovation Strategic Funding;
                Award ID: NA
                Categories
                Research Methods
                1506
                1730
                Original research
                Custom metadata
                unlocked

                Medicine
                clinical trial,qualitative research,telemedicine
                Medicine
                clinical trial, qualitative research, telemedicine

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