Narrative review of telemedicine applications in decentralized research

Abstract Telemedicine enables critical human communication and interaction between researchers and participants in decentralized research studies. There is a need to better understand the overall scope of telemedicine applications in clinical research as the basis for further research. This narrative, nonsystematic review of the literature sought to review and discuss applications of telemedicine, in the form of synchronous videoconferencing, in clinical research. We searched PubMed to identify relevant literature published between January 1, 2013, and June 30, 2023. Two independent screeners assessed titles and abstracts for inclusion, followed by single-reviewer full-text screening, and we organized the literature into core themes through consensus discussion. We screened 1044 publications for inclusion. Forty-eight publications met our inclusion and exclusion criteria. We identified six core themes to serve as the structure for the narrative review: infrastructure and training, recruitment, informed consent, assessment, monitoring, and engagement. Telemedicine applications span all stages of clinical research from initial planning and recruitment to informed consent and data collection. While the evidence base for using telemedicine in clinical research is not well-developed, existing evidence suggests that telemedicine is a potentially powerful tool in clinical research.

[1]  R. Dmochowski,et al.  Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder , 2023, BMC Urology.

[2]  M. Katz,et al.  Meeting Trial Participants Where They Are: Decentralized Clinical Trials as a Patient-Centered Paradigm for Enhancing Accrual and Diversity in Surgical and Multidisciplinary Trials in Oncology. , 2023, JCO oncology practice.

[3]  N. Smyth,et al.  ‘Imposter participants’ in online qualitative research, a new and increasing threat to data integrity? , 2023, Health expectations : an international journal of public participation in health care and health policy.

[4]  C. Ng,et al.  Electronic informed consent criteria for research ethics review: a scoping review , 2022, BMC Medical Ethics.

[5]  Darci J. Harland,et al.  Imposter Participants: Overcoming Methodological Challenges Related to Balancing Participant Privacy with Data Quality When Using Online Recruitment and Data Collection , 2022, The Qualitative Report.

[6]  James R. Roberts,et al.  Conducting a pediatric randomized clinical trial during a pandemic: A shift to virtual procedures , 2022, Journal of Clinical and Translational Science.

[7]  H. Gardarsdottir,et al.  Which decentralised trial activities are reported in clinical trial protocols of drug trials initiated in 2019–2020? A cross-sectional study in ClinicalTrials.gov , 2022, BMJ Open.

[8]  M. Fleury,et al.  Association of Remote Technology Use and Other Decentralization Tools With Patient Likelihood to Enroll in Cancer Clinical Trials , 2022, JAMA network open.

[9]  M. Turakhia,et al.  Pandemic-proof recruitment and engagement in a fully decentralized trial in atrial fibrillation patients (DeTAP) , 2022, npj Digital Medicine.

[10]  Brandon M. Welch,et al.  Providers’ Perspectives on Telemental Health Usage After the COVID-19 Pandemic: Retrospective Analysis , 2022, JMIR formative research.

[11]  Denise H. Daudelin,et al.  Participant and research team perspectives on the conduct of a remote therapeutic COVID-19 clinical trial: A mixed methods approach , 2022, Journal of Clinical and Translational Science.

[12]  Anne Nyholm Gaarskjær,et al.  Participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent: A parallel-group pilot study among Danish citizens , 2022, Contemporary clinical trials communications.

[13]  Carmina G. Valle,et al.  Recruitment of young adult cancer survivors into a randomized controlled trial of an mHealth physical activity intervention , 2022, Trials.

[14]  Julia Shaver The State of Telehealth Before and After the COVID-19 Pandemic , 2022, Primary Care: Clinics in Office Practice.

[15]  J. Pugmire,et al.  Deployment of an End-to-End Remote, Digitalized Clinical Study Protocol in COVID-19: Process Evaluation , 2022, JMIR formative research.

[16]  G. Bloomfield,et al.  Inclusion and diversity in clinical trials: Actionable steps to drive lasting change. , 2022, Contemporary clinical trials.

[17]  I. Boutron,et al.  Patients’ Perspectives on Transforming Clinical Trial Participation: Large Online Vignette-based Survey , 2022, Journal of medical Internet research.

[18]  L. Simmons,et al.  From hybrid to fully remote clinical trial amidst the COVID-19 pandemic: Strategies to promote recruitment, retention, and engagement in a randomized mHealth trial , 2022, Digital health.

[19]  T. MacDonald,et al.  A systematic review of methods used to conduct decentralised clinical trials , 2021, British journal of clinical pharmacology.

[20]  J. Tabernero,et al.  The impact of COVID-19 on cancer care and oncology clinical research: an experts’ perspective , 2021, ESMO Open.

[21]  C. Tanner,et al.  Recruitment for Remote Decentralized Studies in Parkinson’s Disease , 2021, Journal of Parkinson's disease.

[22]  T. MacDonald,et al.  Learning from remote decentralised clinical trial experiences: A qualitative analysis of interviews with trial personnel, patient representatives and other stakeholders , 2021, British journal of clinical pharmacology.

[23]  A. Dispenzieri,et al.  Increased Utilization of Virtual Visits and Electronic Approaches in Clinical Research During the COVID-19 Pandemic and Thereafter , 2021, Mayo Clinic Proceedings.

[24]  A. Tozzi,et al.  Impact of telemedicine on health outcomes in children with medical complexity: an integrative review , 2021, European Journal of Pediatrics.

[25]  M. McDonough,et al.  Protocol: A cluster randomized controlled trial of a mobile application to support physical activity maintenance after an exercise oncology program. , 2021, Contemporary clinical trials.

[26]  Sandeep Lahiry,et al.  Digital clinical trial: A new norm in clinical research , 2021, Perspectives in clinical research.

[27]  T. Moulin,et al.  Simulation-Based Teaching of Telemedicine for Future Users of Teleconsultation and Tele-Expertise: Feasibility Study , 2021, JMIR medical education.

[28]  Liran Chen,et al.  The impact of COVID-19 on the clinical trial , 2021, PloS one.

[29]  Kyle Possemato,et al.  Expanding access to psychosocial research studies during the COVID-19 pandemic through virtual modalities. , 2021, Families, systems & health : the journal of collaborative family healthcare.

[30]  R. Playle,et al.  Lifestyle, Exercise and Activity Package for People living with Progressive Multiple Sclerosis (LEAP-MS): adaptions during the COVID-19 pandemic and remote delivery for improved efficiency , 2021, Trials.

[31]  E. Dorsey,et al.  Improving Access to Care: Telemedicine Across Medical Domains. , 2021, Annual review of public health.

[32]  C. Barrios,et al.  Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420) , 2021, JCO Global Oncology.

[33]  J. Ligibel,et al.  Lessons learned from the delivery of virtual integrative oncology interventions in clinical practice and research during the COVID-19 pandemic , 2021, Supportive Care in Cancer.

[34]  S. Cummings Clinical Trials Without Clinical Sites. , 2021, JAMA internal medicine.

[35]  A. Marelli,et al.  CHILD-BRIGHT READYorNot Brain-Based Disabilities Trial: protocol of a randomised controlled trial (RCT) investigating the effectiveness of a patient-facing e-health intervention designed to enhance healthcare transition readiness in youth , 2021, BMJ Open.

[36]  R. Thota,et al.  Barriers and Facilitators to Telemedicine: Can You Hear Me Now? , 2021, American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting.

[37]  L. Veilleux,et al.  Using Telerehabilitation to Deliver a Home Exercise Program to Youth With Arthrogryposis: Single Cohort Pilot Study , 2021, Journal of medical Internet research.

[38]  Jamie L. Adams,et al.  Design of a virtual longitudinal observational study in Parkinson’s disease (AT‐HOME PD) , 2020, Annals of clinical and translational neurology.

[39]  S. Reisner,et al.  Telemedicine and Inequities in Health Care Access: The Example of Transgender Health. , 2020, Transgender health.

[40]  G. Baiocchi,et al.  Telemedicine and cancer research during the COVID‐19 pandemic , 2020, Journal of surgical oncology.

[41]  I. Ray-Coquard,et al.  Clinical research disruption in the post-COVID-19 era: will the pandemic lead to change? , 2020, ESMO Open.

[42]  J. Mariani,et al.  Digital Clinical Trials for Substance Use Disorders in the Age of Covid-19 , 2020, Journal of addiction medicine.

[43]  H. Abrams,et al.  Curricular needs for training telemedicine physicians: A scoping review , 2020, Medical teacher.

[44]  T. Herzog,et al.  COVID‐19 pandemic and impact on cancer clinical trials: An academic medical center perspective , 2020, Cancer medicine.

[45]  David D. Odineal,et al.  Leveraging Tele-Critical Care Capabilities for Clinical Trial Consent , 2020, Critical care explorations.

[46]  C. Tanner,et al.  A Virtual Cohort Study of Individuals at Genetic Risk for Parkinson’s Disease: Study Protocol and Design , 2020, Journal of Parkinson's disease.

[47]  J. Obeid,et al.  Remote Methods for Conducting Tobacco-Focused Clinical Trials , 2020, Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco.

[48]  Robert Ellis,et al.  Remote Monitoring in Clinical Trials During the COVID‐19 Pandemic , 2020, Clinical and translational science.

[49]  Thomas R. Campion,et al.  Replacing Paper Informed Consent with Electronic Informed Consent for Research in Academic Medical Centers: A Scoping Review. , 2020, AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science.

[50]  Yue Cao,et al.  Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial , 2020, JMIR formative research.

[51]  Nehal B. Trivedi,et al.  Re-Prioritizing Digital Health and Health Literacy in Healthy People 2030 to Affect Health Equity , 2020, Health communication.

[52]  Jin-Young Choi,et al.  Risk management-based security evaluation model for telemedicine systems , 2020, BMC Medical Informatics and Decision Making.

[53]  M. Khasraw,et al.  Adapting to a Pandemic — Conducting Oncology Trials during the SARS-CoV-2 Pandemic , 2020, Clinical Cancer Research.

[54]  Rashmi Mullur,et al.  Telehealth-Based Health Coaching Increases m-Health Device Adherence and Rate of Weight Loss in Obese Participants. , 2020, Telemedicine journal and e-health : the official journal of the American Telemedicine Association.

[55]  J. Zibert,et al.  Virtual Clinical Trials: Perspectives in Dermatology , 2020, Dermatology.

[56]  C. Nelson,et al.  A telehealth approach to improving clinical trial access for infants with tuberous sclerosis complex , 2020, Journal of Neurodevelopmental Disorders.

[57]  S. Hirshfield,et al.  A randomized controlled efficacy trial of an mHealth HIV prevention intervention for sexual minority young men: MyPEEPS mobile study protocol , 2020, BMC Public Health.

[58]  Susan Persky,et al.  A Virtual Home for the Virtual Clinical Trial , 2020, Journal of medical Internet research.

[59]  Michelle Nichols,et al.  An Exploration of Useful Telemedicine-Based Resources for Clinical Research. , 2020, Telemedicine journal and e-health : the official journal of the American Telemedicine Association.

[60]  J. Magnani,et al.  New technologies, new disparities: The intersection of electronic health and digital health literacy. , 2019, International journal of cardiology.

[61]  Saif S. Khairat,et al.  Evaluating the Perceptions of Teleconsent in Urban and Rural Communities. , 2019, European journal for biomedical informatics.

[62]  V. Williamson,et al.  Oxford Video Informed Consent Tool (OxVIC): a pilot study of informed video consent in spinal surgery and preoperative patient satisfaction , 2019, BMJ Open.

[63]  Mabel Crescioni,et al.  Training on the Use of Technology to Collect Patient-Reported Outcome Data Electronically in Clinical Trials: Best Practice Recommendations from the ePRO Consortium , 2019, Therapeutic innovation & regulatory science.

[64]  C. Loo,et al.  Pilot trial of home-administered transcranial direct current stimulation for the treatment of depression. , 2019, Journal of affective disorders.

[65]  E. Paskett,et al.  Overcoming Barriers to Clinical Trial Enrollment. , 2019, American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting.

[66]  A. Dicker,et al.  Telemedicine Training in Undergraduate Medical Education: Mixed-Methods Review , 2019, JMIR medical education.

[67]  S. Mertens,et al.  SANRA—a scale for the quality assessment of narrative review articles , 2019, Research Integrity and Peer Review.

[68]  S. Steinhubl,et al.  Digital recruitment and enrollment in a remote nationwide trial of screening for undiagnosed atrial fibrillation: Lessons from the randomized, controlled mSToPS trial , 2019, Contemporary clinical trials communications.

[69]  A. Green,et al.  Clinic to in-home telemedicine reduces barriers to care for patients with MS or other neuroimmunologic conditions , 2018, Neurology: Neuroimmunology & Neuroinflammation.

[70]  N. Colombo,et al.  Building clinical trials around patients: Evaluation and comparison of decentralized and conventional site models in patients with low back pain , 2018, Contemporary clinical trials communications.

[71]  B. Caulfield,et al.  The Burden of a Remote Trial in a Nursing Home Setting: Qualitative Study , 2018, Journal of medical Internet research.

[72]  J. Kim,et al.  Patient-centered recruitment and retention for a randomized controlled study , 2018, Trials.

[73]  Grant D. Huang,et al.  Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative. , 2018, Contemporary clinical trials.

[74]  A. Leiter,et al.  Telemedicine-Enabled Clinical Trial of Metformin in Patients With Prostate Cancer. , 2017, JCO clinical cancer informatics.

[75]  A. Feldman Welcome to your Journal of Clinical and Translational Science , 2017, Journal of Clinical and Translational Science.

[76]  S Edirippulige,et al.  Education and training to support the use of clinical telehealth: A review of the literature , 2017, Journal of telemedicine and telecare.

[77]  Sadiq Naveed,et al.  How to Conduct a Systematic Review: A Narrative Literature Review , 2016, Cureus.

[78]  Matthew Brooks,et al.  Evaluating barriers to adopting telemedicine worldwide: A systematic review , 2016, Journal of telemedicine and telecare.

[79]  Jennifer A. Byrne Improving the peer review of narrative literature reviews , 2016, Research Integrity and Peer Review.

[80]  S. Salvi,et al.  Challenges in recruitment and retention of clinical trial subjects , 2016, Perspectives in clinical research.

[81]  K. Harland,et al.  Telemedicine Provides Noninferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial. , 2016, Academic emergency medicine : official journal of the Society for Academic Emergency Medicine.

[82]  O. Nov,et al.  Social Annotation Valence: The Impact on Online Informed Consent Beliefs and Behavior , 2016, Journal of medical Internet research.

[83]  Fernando A Wilson,et al.  Does telemedicine improve treatment outcomes for diabetes? A meta-analysis of results from 55 randomized controlled trials. , 2016, Diabetes research and clinical practice.

[84]  Leslie Lenert,et al.  Teleconsent: A novel approach to obtain informed consent for research , 2016, Contemporary clinical trials communications.

[85]  Jeannie S. Huang,et al.  Clinical trial management of participant recruitment, enrollment, engagement, and retention in the SMART study using a Marketing and Information Technology (MARKIT) model. , 2015, Contemporary clinical trials.

[86]  Denzil A. Harris,et al.  Novel methods and technologies for 21st-century clinical trials: a review. , 2015, JAMA neurology.

[87]  M. Wallin,et al.  Remote cognitive assessments for patients with multiple sclerosis: a feasibility study , 2015, Multiple sclerosis.

[88]  J. Kvedar,et al.  Privacy and Security Concerns in Telehealth. , 2014, The virtual mentor : VM.

[89]  E Ray Dorsey,et al.  Virtual house calls for Parkinson disease (Connect.Parkinson): study protocol for a randomized, controlled trial , 2014, Trials.

[90]  Dongwen Wang,et al.  Willingness of Parkinson's disease patients to participate in research using internet-based technology. , 2012, Telemedicine journal and e-health : the official journal of the American Telemedicine Association.

[91]  C. Fisher,et al.  Clinical research nursing: a critical resource in the national research enterprise. , 2012, Nursing outlook.

[92]  G. Kitas,et al.  Writing a narrative biomedical review: considerations for authors, peer reviewers, and editors , 2011, Rheumatology International.

[93]  John Fulcher,et al.  Consent Mechanisms for Electronic Health Record Systems: A Simple Yet Unresolved Issue , 2007, Journal of Medical Systems.

[94]  Robert Kevin Grigsby,et al.  Federal Policy for the Protection of Human Subjects , 1993, Research on social work practice.

[95]  J. Xiao,et al.  Disparities in the Uptake of Telemedicine and Implications for Clinical Trial Enrollment in Patients With Breast Cancer , 2022 .

[96]  Saif S. Khairat,et al.  Assessing the Satisfaction of Citizens Using Teleconsent in Clinical Research , 2018, MIE.

[97]  P. Dasgupta,et al.  Video Consent: a Pilot Study of Informed Consent in Laparoscopic Urology and Its Impact on Patient Satisfaction , 2006, JSLS : Journal of the Society of Laparoendoscopic Surgeons.