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Technology Applications: Use of Digital Health Technology to Enable Drug Development.

ABSTRACT: PURPOSE:This pilot study developed and evaluated the feasibility, usability, and perceived satisfaction with an end-user mobile medical application and provider web portal. The two interfaces allowed for remote monitoring, provided daily guidance in the management of hypertension and diarrhea, and allowed for rapid management of adverse events during a clinical trial of olaparib and cediranib. PATIENTS AND METHODS:eCO (eCediranib/Olaparib) was designed for patient self-reported, real-time management of hypertension and diarrhea using remote monitoring. eCO links to a Bluetooth-enabled blood pressure (BP) monitor and transmits data to a secure provider web portal. eCO use was assessed for suitability, usability, and satisfaction after 4 weeks using a 17-item questionnaire. Metrics regarding patient-reported BP and diarrhea events were analyzed. RESULTS:Sixteen patients enrolled in the pilot. A total of 98.2% of expected BP values were reported: 94.2% via Bluetooth and 5.8% entered manually. Twelve patients experienced 21 BP events (systolic BP > 140 and/or diastolic BP > 90 mmHg on two consecutive readings); data from cycle 1 were comparable to the study database. Thirteen patients reported diarrhea (more than one stool per 24 hours over baseline) categorized as grade 1 or 2, which was comparable to the study database. Survey analysis showed that patients had statistically significant, positive responses to the use of the eCO application. Patients indicated eCO use made them feel more involved in their care and better connected to their health care team. The only aspect of the application that did not show a statistically significant positive response was the process of reporting diarrhea. CONCLUSION:The eCO application was designed to assist in managing acute treatment-related events most often associated with treatment discontinuation, need for drug holidays, or dose interruption. Hypertension and diarrhea events reported via eCO allowed rapid provider response and a positive overall patient experience.

SUBMITTER: Liu JF

PROVIDER: S-EPMC6874035 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Technology Applications: Use of Digital Health Technology to Enable Drug Development.

Liu Joyce F JF Lee Jung-Min JM Strock Ellie E Phillips Ruth R Mari Karine K Killiam Bill B Bonam Matthew M Milenkova Tsveta T Kohn Elise C EC Ivy S Percy SP

JCO clinical cancer informatics 20181201

<h4>Purpose</h4>This pilot study developed and evaluated the feasibility, usability, and perceived satisfaction with an end-user mobile medical application and provider web portal. The two interfaces allowed for remote monitoring, provided daily guidance in the management of hypertension and diarrhea, and allowed for rapid management of adverse events during a clinical trial of olaparib and cediranib.<h4>Patients and methods</h4>eCO (eCediranib/Olaparib) was designed for patient self-reported, r ...[more]

PMID: 30652584

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Project description:BackgroundDigital technologies (DTs) for older adults focus mainly on health care and are considered to have the potential to improve the well-being of older adults. However, adoption rates of these DTs are considered low. Although previous research has investigated possible reasons for adoption and acceptance of DT, age-based stereotypes (eg, those held by health care professionals) toward the abilities of older adults to use DTs have yet to be considered as possible barriers to adoption.ObjectiveThe aim of this study was to investigate the influencing role of ageism in the context of health care professionals attitudes toward older adults' abilities to use health care DT. A further goal was to examine if social comparison and stereotype activation affect and moderate this association.MethodsA new measurement to assess health care professionals' attitudes toward older adults using technology (ATOAUT-10) was developed and used in 2 studies. Study 1 involved the development of the ATOAUT-10 scale using a principal component analysis and further examined health care professionals' attitudes toward the use of health care DTs and correlations with ageism. Study 2 further explored the correlation between ageism and ATOAUT in an experimental design with health care professionals.ResultsIn study 1, physiotherapists (N=97) rated older adults as young as 50 years as less able to use health care DT compared to younger adults (P<.001). A multiple regression analysis revealed that higher levels of ageism, beyond other predictors, were predictive of more negative ATOAUT, (β=.36; t=3.73; P<.001). In study 2, the salience of age was manipulated. Health care professionals (N=93) were randomly assigned to rate the abilities of a young or old person to use health care DT. Old age salience moderated the correlation between ageism and ATOAUT (R2=0.19; F6,85=3.35; P=.005), such that higher levels of ageism correlated with more negative ATOAUT in the old age salient condition, but not the young condition. Stereotype activation accounted for health care professionals' attitudes more than did the experience of working with older patients or the professionals' age.ConclusionsNegative and ageist attitudes of health care professionals can potentially affect how older adults are viewed in relation to DT and consequently might influence actual use and adoption of technology-based treatment. Future studies should broaden the validation of the ATOAUT-10 scale on more diverse samples and focus on the discriminatory aspect of ageism and self-ageism of older adults. This study calls for a focus on ageism as a determinant of adoption of DT.

Project description:Innovative tools are urgently needed to accelerate the evaluation and subsequent approval of novel treatments that may slow, halt, or reverse the relentless progression of Parkinson disease (PD). Therapies that intervene early in the disease continuum are a priority for the many candidates in the drug development pipeline. There is a paucity of sensitive and objective, yet clinically interpretable, measures that can capture meaningful aspects of the disease. This poses a major challenge for the development of new therapies and is compounded by the considerable heterogeneity in clinical manifestations across patients and the fluctuating nature of many signs and symptoms of PD. Digital health technologies (DHT), such as smartphone applications, wearable sensors, and digital diaries, have the potential to address many of these gaps by enabling the objective, remote, and frequent measurement of PD signs and symptoms in natural living environments. The current climate of the COVID-19 pandemic creates a heightened sense of urgency for effective implementation of such strategies. In order for these technologies to be adopted in drug development studies, a regulatory-aligned consensus on best practices in implementing appropriate technologies, including the collection, processing, and interpretation of digital sensor data, is required. A growing number of collaborative initiatives are being launched to identify effective ways to advance the use of DHT in PD clinical trials. The Critical Path for Parkinson's Consortium of the Critical Path Institute is highlighted as a case example where stakeholders collectively engaged regulatory agencies on the effective use of DHT in PD clinical trials. Global regulatory agencies, including the US Food and Drug Administration and the European Medicines Agency, are encouraging the efficiencies of data-driven engagements through multistakeholder consortia. To this end, we review how the advancement of DHT can be most effectively achieved by aligning knowledge, expertise, and data sharing in ways that maximize efficiencies.

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Technology Applications: Use of Digital Health Technology to Enable Drug Development.

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Technology Applications: Use of Digital Health Technology to Enable Drug Development.

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