scholarly journals Digital Health Applications for Pharmacogenetic Clinical Trials

Genes ◽  
2020 ◽  
Vol 11 (11) ◽  
pp. 1261
Author(s):  
Hetanshi Naik ◽  
Latha Palaniappan ◽  
Euan A. Ashley ◽  
Stuart A. Scott
Keyword(s):  
Clinical Trials ◽  
Trial Design ◽  
Digital Health ◽  
Clinical Care ◽  
Vital Signs ◽  
Medication Administration ◽  
Therapeutic Interventions ◽  
Participant Engagement ◽  
Patient Reported ◽  
Health Related

Digital health (DH) is the use of digital technologies and data analytics to understand health-related behaviors and enhance personalized clinical care. DH is increasingly being used in clinical trials, and an important field that could potentially benefit from incorporating DH into trial design is pharmacogenetics. Prospective pharmacogenetic trials typically compare a standard care arm to a pharmacogenetic-guided therapeutic arm. These trials often require large sample sizes, are challenging to recruit into, lack patient diversity, and can have complicated workflows to deliver therapeutic interventions to both investigators and patients. Importantly, the use of DH technologies could mitigate these challenges and improve pharmacogenetic trial design and operation. Some DH use cases include (1) automatic electronic health record-based patient screening and recruitment; (2) interactive websites for participant engagement; (3) home- and tele-health visits for patient convenience (e.g., samples for lab tests, physical exams, medication administration); (4) healthcare apps to collect patient-reported outcomes, adverse events and concomitant medications, and to deliver therapeutic information to patients; and (5) wearable devices to collect vital signs, electrocardiograms, sleep quality, and other discrete clinical variables. Given that pharmacogenetic trials are inherently challenging to conduct, future pharmacogenetic utility studies should consider implementing DH technologies and trial methodologies into their design and operation.

scholarly journals Toward Patient-Centered Innovation

2020 ◽  
Vol 15 (10) ◽  
pp. 1522-1530
Author(s):  
Jennifer E. Flythe ◽  
Tandrea S. Hilliard ◽  
Kourtney Ikeler ◽  
San Keller ◽  
Debbie S. Gipson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Conceptual Framework ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Individuals with dialysis-dependent kidney failure experience considerable disease- and treatment-related decline in functional status and overall well-being. Despite these experiences, there have been few substantive technological advances in KRT in decades. As such, new federal initiatives seek to accelerate innovation. Historically, integration of patient perspectives into KRT product development has been limited. However, the US Food and Drug Administration recognizes the importance of incorporating patient perspectives into the total product life cycle (i.e., from product conception to postmarket surveillance) and encourages the consideration of patient-reported outcomes in regulatory-focused clinical trials when appropriate. Recognizing the significance of identifying patient-reported outcome measures (PROMs) that capture contemporary patient priorities, the Kidney Health Initiative, a public–private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a workgroup to (1) develop a conceptual framework for a health-related quality of life PROM; (2) identify and map existing PROMs to the conceptual framework, prioritizing them on the basis of their supporting evidence for use in the regulatory environment; and (3) describe next steps for identifying PROMs for use in regulatory clinical trials of transformative KRT devices. This paper summarizes the proposed health-related quality-of-life PROM conceptual framework, maps and prioritizes PROMs, and identifies gaps and future needs to advance the development of rigorous, meaningful PROMS for use in clinical trials of transformative KRT devices.

The Use of Patient-reported Outcomes at an Individual Level – Benefits and Challenges

2010 ◽  
Vol 06 (01) ◽  
pp. 19
Author(s):  
Agnes Czimbalmos ◽  
Andrew Bottomley ◽  
◽  
Keyword(s):  
Patient Reported Outcomes ◽  
Clinical Care ◽  
Healthcare Services ◽  
Individual Level ◽  
Patient Health Status ◽  
Hrqol Data ◽  
Patient Reported ◽  
Patient Health ◽  
Related Quality ◽  
Health Related

The aim of this article is to review the application of patient-reported outcomes (PROs) in clinical care and consider its benefits, challenges and potential improvements. Previous studies demonstrated that health-related quality of life (HRQoL) data provide information to clinicians on patient health status, QoL, symptoms and wellbeing, along with any changes in these, and helps clinicians judge the needs of patients and tailor treatments accordingly. In addition, the benefits of the application of HRQoL tools include the involvement of patients in informed decision-making in terms of their treatment or care, higher patient satisfaction with healthcare services, improved patient–clinician relationships and better communication. In many studies, health professionals have expressed their interest in using these measures but feel they need to better understand them. Despite the wide use of information-gathering questionnaires and their promising results, it is still a challenge to predict the full value of these measures in clinical care. This article addresses these major concerns.

scholarly journals The Impact of the Timing of Health-Related Quality of Life Assessments on the Actual Results in Glioma Patients: A Randomized Prospective Study

Cancers ◽  
2020 ◽  
Vol 12 (8) ◽  
pp. 2172
Author(s):  
Marthe C.M. Peeters ◽  
Hanneke Zwinkels ◽  
Johan A.F. Koekkoek ◽  
Maaike J. Vos ◽  
Linda Dirven ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Care ◽  
Depression Scale ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
The Impact ◽  
Hrqol Scale

Background: The aim of this study was to explore the impact of the timing of Health-Related Quality of Life (HRQoL) measurements in clinical care on the obtained HRQoL scores in glioma patients, and the association with feelings of anxiety or depression. Methods: Patients completed the European Organisation for Research and Treatment of Cancer (EORTC)’s Quality of Life Questionnaires (QLQ-C30 and QLQ-BN20), and the Hospital Anxiety and Depression Scale (HADS) twice. All patients completed the first measurement on the day of the Magnetic Resonance Imaging (MRI) scan (t = 0), but the second measurement (t = 1) depended on randomization; Group 1 (n = 49) completed the questionnaires before and Group 2 (n = 51) after the consultation with the physician. Results: median HRQoL scale scores on t0/t1 and change scores were comparable between the two groups. Between 8–58% of patients changed to a clinically relevant extent (i.e., ≥10 points) on the evaluated HRQoL scales in about one-week time, in both directions, with only 3% of patients remaining stable in all scales. Patients with a stable role functioning had a lower HADS anxiety change score. The HADS depression score was not associated with a change in HRQoL. Conclusions: Measuring HRQoL before or after the consultation did not impact HRQoL scores on a group level. However, most patients reported a clinically relevant difference in at least one HRQoL scale between the two time points. These findings highlight the importance of standardized moments of HRQoL assessments, or patient-reported outcomes in general, during treatment and follow-up in clinical trials.

scholarly journals Patient Reported Outcomes in Large Vessel Vasculitides

2021 ◽  
Vol 23 (2) ◽  
Author(s):  
Joanna Robson ◽  
Sarah Mackie ◽  
Catherine Hill
Keyword(s):  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Systemic Vasculitis ◽  
Clinical Care ◽  
Large Vessel Vasculitis ◽  
Large Vessel ◽  
Patient Reported ◽  
The Impact ◽  
Large Vessel Vasculitides ◽  
Disease Specific

Abstract Purpose of Review The goal of this paper is to review current and future uses of patient-reported outcomes in large vessel vasculitis. The large vessel vasculitides comprise Giant Cell Arteritis and Takayasu arteritis; both are types of systemic vasculitis which affect the larger blood vessels. Patient-reported outcomes (PROs) capture the impact of these diseases on health-related quality of life. Recent Findings Generic PROs such as the SF-36 are currently used to compare HRQOL of people with GCA and TAK within clinical trials and observational studies and to make comparisons with the general population and HRQoL in other diseases. The development of a disease-specific PRO for GCA is currently underway. Beyond clinical trials, there is much interest in the use of PROs within routine clinical care, particularly E-PROs for remote use. Summary Further work will be needed to complete the development of disease-specific PROs for people with large vessel vasculitis and to establish feasibility, acceptability, and utility of E-PROs.

scholarly journals The Use of Wearables in Clinical Trials During Cancer Treatment: Systematic Review (Preprint)

2020 ◽  
Author(s):  
Ulrikke Lyng Beauchamp ◽  
Helle Pappot ◽  
Cecilie Holländer-Mieritz
Keyword(s):  
Physical Activity ◽  
Clinical Trials ◽  
Cancer Treatment ◽  
Controlled Trial ◽  
Severe Disease ◽  
Vital Signs ◽  
Sensor Data ◽  
Special Focus ◽  
Oncological Treatment ◽  
Patient Reported

BACKGROUND Interest in the use of wearables in medical care is increasing. Wearables can be used to monitor different variables, such as vital signs and physical activity. A crucial point for using wearables in oncology is if patients already under the burden of severe disease and oncological treatment can accept and adhere to the device. At present, there are no specific recommendations for the use of wearables in oncology, and little research has examined the purpose of using wearables in oncology. OBJECTIVE The purpose of this review is to explore the use of wearables in clinical trials during cancer treatment, with a special focus on adherence. METHODS PubMed and EMBASE databases were searched prior and up to October 3, 2019, with no limitation in the date of publication. The search strategy was aimed at studies using wearables for monitoring adult patients with cancer during active antineoplastic treatment. Studies were screened independently by 2 reviewers by title and abstract, selected for inclusion and exclusion, and the full-text was assessed for eligibility. Data on study design, type of wearable used, primary outcome, adherence, and device outcome were extracted. Results were presented descriptively. RESULTS Our systematic search identified 1269 studies, of which 25 studies met our inclusion criteria. The types of cancer represented in the studies were breast (7/25), gastrointestinal (4/25), lung (4/25), and gynecologic (1/25); 9 studies had multiple types of cancer. Oncologic treatment was primarily chemotherapy (17/25). The study-type distribution was pilot/feasibility study (12/25), observational study (10/25), and randomized controlled trial (3/25). The median sample size was 40 patients (range 7-180). All studies used a wearable with an accelerometer. Adherence varied across studies, from 60%-100% for patients wearing the wearable/evaluable sensor data and 45%-94% for evaluable days, but was differently measured and reported. Of the 25 studies, the most frequent duration for planned monitoring with a wearable was 8-30 days (13/25). Topics for wearable outcomes were physical activity (19/25), circadian rhythm (8/25), sleep (6/25), and skin temperature (1/25). Patient-reported outcomes (PRO) were used in 17 studies; of the 17 PRO studies, only 9 studies reported correlations between the wearable outcome and the PRO. CONCLUSIONS We found that definitions of outcome measures and adherence varied across studies, and limited consensus among studies existed on which variables to monitor during treatment. Less heterogeneity, better consensus in terms of the use of wearables, and established standards for the definitions of wearable outcomes and adherence would improve comparisons of outcomes from studies using wearables. Adherence, and the definition of such, seems crucial to conclude on data from wearable studies in oncology. Additionally, research using advanced wearable devices and active use of the data are encouraged to further explore the potential of wearables in oncology during treatment. Particularly, randomized clinical studies are warranted to create consensus on when and how to implement in oncological practice.

scholarly journals Implementation of a fully remote randomized clinical trial with cardiac monitoring

2021 ◽  
Vol 1 (1) ◽  
Author(s):  
Jacob J. Mayfield ◽  
Neal A. Chatterjee ◽  
Peter A. Noseworthy ◽  
Jeanne E. Poole ◽  
Michael J. Ackerman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Randomized Clinical Trial ◽  
Digital Health ◽  
Vital Signs ◽  
Safety Monitoring ◽  
Cardiac Monitoring ◽  
Health Technologies ◽  
Infectious Risk ◽  
Consumer Device

Abstract Background The coronavirus disease 2019 (COVID-19) pandemic has challenged researchers performing clinical trials to develop innovative approaches to mitigate infectious risk while maintaining rigorous safety monitoring. Methods In this report we describe the implementation of a novel exclusively remote randomized clinical trial (ClinicalTrials.gov NCT04354428) of hydroxychloroquine and azithromycin for the treatment of the SARS-CoV-2–mediated COVID-19 disease which included cardiovascular safety monitoring. All study activities were conducted remotely. Self-collected vital signs (temperature, respiratory rate, heart rate, and oxygen saturation) and electrocardiographic (ECG) measurements were transmitted digitally to investigators while mid-nasal swabs for SARS-CoV-2 testing were shipped. ECG collection relied on a consumer device (KardiaMobile 6L, AliveCor Inc.) that recorded and transmitted six-lead ECGs via participants’ internet-enabled devices to a central core laboratory, which measured and reported QTc intervals that were then used to monitor safety. Results Two hundred and thirty-one participants uploaded 3245 ECGs. Mean daily adherence to the ECG protocol was 85.2% and was similar to the survey and mid-nasal swab elements of the study. Adherence rates did not differ by age or sex assigned at birth and were high across all reported race and ethnicities. QTc prolongation meeting criteria for an adverse event occurred in 28 (12.1%) participants, with 2 occurring in the placebo group, 19 in the hydroxychloroquine group, and 7 in the hydroxychloroquine + azithromycin group. Conclusions Our report demonstrates that digital health technologies can be leveraged to conduct rigorous, safe, and entirely remote clinical trials.

scholarly journals Digital Health Apps in the Clinical Care of Inflammatory Bowel Disease: Scoping Review

10.2196/14630 ◽  
2019 ◽  
Vol 21 (8) ◽  
pp. e14630 ◽  
Author(s):  
Andrew Lukas Yin ◽  
David Hachuel ◽  
John P Pollak ◽  
Ellen J Scherl ◽  
Deborah Estrin
Keyword(s):  
Inflammatory Bowel Disease ◽  
Mobile Health ◽  
Bowel Disease ◽  
Digital Health ◽  
Clinical Care ◽  
Mobile App ◽  
Health Apps ◽  
Patient Reported ◽  
Inflammatory Bowel

Background Digital health is poised to transform health care and redefine personalized health. As Internet and mobile phone usage increases, as technology develops new ways to collect data, and as clinical guidelines change, all areas of medicine face new challenges and opportunities. Inflammatory bowel disease (IBD) is one of many chronic diseases that may benefit from these advances in digital health. This review intends to lay a foundation for clinicians and technologists to understand future directions and opportunities together. Objective This review covers mobile health apps that have been used in IBD, how they have fit into a clinical care framework, and the challenges that clinicians and technologists face in approaching future opportunities. Methods We searched PubMed, Scopus, and ClinicalTrials.gov to identify mobile apps that have been studied and were published in the literature from January 1, 2010, to April 19, 2019. The search terms were (“mobile health” OR “eHealth” OR “digital health” OR “smart phone” OR “mobile app” OR “mobile applications” OR “mHealth” OR “smartphones”) AND (“IBD” OR “Inflammatory bowel disease” OR “Crohn's Disease” (CD) OR “Ulcerative Colitis” (UC) OR “UC” OR “CD”), followed by further analysis of citations from the results. We searched the Apple iTunes app store to identify a limited selection of commercial apps to include for discussion. Results A total of 68 articles met the inclusion criteria. A total of 11 digital health apps were identified in the literature and 4 commercial apps were selected to be described in this review. While most apps have some educational component, the majority of apps focus on eliciting patient-reported outcomes related to disease activity, and a few are for treatment management. Significant benefits have been seen in trials relating to education, quality of life, quality of care, treatment adherence, and medication management. No studies have reported a negative impact on any of the above. There are mixed results in terms of effects on office visits and follow-up. Conclusions While studies have shown that digital health can fit into, complement, and improve the standard clinical care of patients with IBD, there is a need for further validation and improvement, from both a clinical and patient perspective. Exploring new research methods, like microrandomized trials, may allow for more implementation of technology and rapid advancement of knowledge. New technologies that can objectively and seamlessly capture remote data, as well as complement the clinical shift from symptom-based to inflammation-based care, will help the clinical and health technology communities to understand the full potential of digital health in the care of IBD and other chronic illnesses.

Lessons Learned in the Assessment of Health-Related Quality of Life: Selected Examples From the National Cancer Institute of Canada Clinical Trials Group

2007 ◽  
Vol 25 (32) ◽  
pp. 5078-5081 ◽  
Author(s):  
Michael Brundage ◽  
David Osoba ◽  
Andrea Bezjak ◽  
Dongsheng Tu ◽  
Michael Palmer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
National Cancer Institute ◽  
Lessons Learned ◽  
Quality Data ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

In this article, we provide a brief historical review of the development of patient-reported outcome measurement, analysis, and reporting in clinical trials of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG). In doing so, we examine selected lessons learned in furthering the quality of these data and their application to clinical practice. We conclude that sequential institution of key policies within the NCIC CTG and the development of a collective philosophy within the group has enabled the routine incorporation of health-related quality of life into clinical trial protocols according to robust scientific principles; that collection of quality data is possible in a variety of circumstances (although not universally so); that patient-reported data on subjective experiences is likely to be more reliable and valid than conventional toxicity information; and that simple analyses that report group trends as well as individual patient response rates are preferred.

Sign in / Sign up

Export Citation Format

Share Document