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Desirability and feasibility of wireless electronic monitoring of medications in clinical trials.

ABSTRACT: Medication nonadherence is a vexing problem in health care necessitating patients and health professionals' efforts to prevent, minimize, or reverse it. Research participants' inconsistent medication taking obscures treatment efficacy and adds costs to biomedical research. Electronic monitoring devices (EMDs), like the Medication Event Monitoring System (MEMS), have grown in sophistication, providing precise, timely insights into individuals' medication-taking patterns across clinical populations. This article reports on the desirability and feasibility study of using a wireless EMD in clinical research to promote adherence to clinical regimens and research protocols. Nonadherence in transplant patients has been linked to late acute rejection and graft loss. High levels of adherence (97.7 %) were documented for six renal transplant recipients for a mean of 6 months (M?=?196.1?±?71.2 days) who indicated acceptance of the technology. MEMS data confirmed the feasibility of using wireless EMDs to monitor medication use. Monitoring provides greater assurance that research studies reflect the biological impact of medications and provide a basis for targeting adherence enhancement efforts within research investigations.

SUBMITTER: Robiner WN

PROVIDER: S-EPMC4537458 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Desirability and feasibility of wireless electronic monitoring of medications in clinical trials.

Robiner William N WN Flaherty Nancy N Fossum Thyra A TA Nevins Thomas E TE

Translational behavioral medicine 20150901 3

Medication nonadherence is a vexing problem in health care necessitating patients and health professionals' efforts to prevent, minimize, or reverse it. Research participants' inconsistent medication taking obscures treatment efficacy and adds costs to biomedical research. Electronic monitoring devices (EMDs), like the Medication Event Monitoring System (MEMS), have grown in sophistication, providing precise, timely insights into individuals' medication-taking patterns across clinical population ...[more]

PMID: 26327934

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Project description:BackgroundThere are currently several concerns about the ways in which people are recruited to participate in randomised controlled trials, the low acceptance rates among people invited to participate, and the experiences of trial participants. An information resource about on-going clinical trials designed for potential and current participants could help overcome some of these problems.MethodsWe carried out a scoping exercise to explore the desirability and feasibility of establishing such a resource. We sought the views of a range of people including people who were considering taking part in a trial, current trial participants, people who had been asked but refused to participate in a trial, consumer group representatives and researchers who design and conduct trials.ResultsThere was broad-based support for the concept of a centralised information resource for members of the public about on-going and recently completed clinical trials. Such an information resource could be based on a database containing standardised information for each trial relating to the purpose of the trial; the interventions being compared; the implications of participation for participants; and features indicative of scientific quality and ethical probity. The usefulness of the database could be enhanced if its search facility could allow people to enter criteria such as a disease and geographic area and be presented with all the trials relevant to them, and if optional display formats could allow them to view information in varying levels of detail. Access via the Internet was considered desirable, with complementary supported access via health information services. The development of such a resource is technically feasible, but the collation of the required information would take a significant investment of resources.ConclusionA centralised participant oriented information resource about clinical trials could serve several purposes. A more detailed investigation of its feasibility and exploration of its potential impacts are required.

Project description:Publication of a report from the Institute of Medicine in 2000 showing that a vaccine against cytomegalovirus (CMV) would likely be cost saving was very influential and encouraged the clinical evaluation of candidate vaccines. The major objective of a CMV vaccination program would be to reduce disease caused by congenital CMV infection, which is the leading viral cause of sensorineural hearing loss and neurodevelopmental delay. CMV has challenges as a vaccine target because it is a herpesvirus, it persists lifelong despite host immunity, infected individuals can be reinfected with new strains, overt disease occurs in those with immature or impaired immune systems and persons with this infection do not usually report symptoms. Nevertheless, natural immunity against CMV provides some protection against infection and disease, natural history studies have defined the serological and molecular biological techniques needed for endpoints in future clinical trials of vaccines and CMV is not highly communicable, suggesting that it may not be necessary to achieve very high levels of population immunity through vaccination in order to affect transmission. Three phase 2 CMV vaccine studies have been completed in the last 3 years and all report encouraging outcomes. A key international meeting was organized by the Food and Drug Administration in January 2012 at which interested parties from regulatory bodies, industry and academia discussed and prioritised designs for phase 2 and phase 3 clinical trials. Vaccines able to prevent primary infection with CMV and to boost the immune response of those already infected are desirable. The major target populations for a CMV vaccine include women of childbearing age and adolescents. Toddlers represent another potential population, since an effect of vaccine in this age group could potentially decrease transmission to adults. In addition, prospective recipients of transplants and patients with AIDS would be expected to benefit.

Project description:ObjectivesTo design an electronic questionnaire for symptom monitoring and to evaluate the feasibility, usability and acceptability when applied to patients with metastatic lung cancer.SettingSingle-centre feasibility study.ParticipantsPatients with stage IV lung cancer in antineoplastic treatment.InterventionsThis study describes the first three phases of a complex intervention design: phase 1, development of the intervention; phase 2, feasibility testing and phase 3, evaluation of the intervention. In phase 1, items were selected for the questionnaire and adjusted following patient interviews. In phase 2, patients completed the electronic questionnaire weekly during a 3-week feasibility test. In case of symptom deterioration, a nurse was notified with the aim to contact the patient. In phase 3, patients evaluated phase 2 by paper questionnaires, and interviews were conducted with the participating nurses.Primary outcome measuresThe study outcomes: phase 1, usability and relevance; phase 2, recruitment rate, compliance and threshold functionality and phase 3, usability, acceptability and relevance.ResultsIn phase 1, a questionnaire was designed and reviewed by patients (n=8). The interviews revealed high usability and relevance of the intervention.For phases 2 and 3, 20 of 29 approached patients (69%) responded to the questionnaire on a weekly basis. Two patients did not complete any questionnaires (compliance 90%). The remaining 18 patients completed 65 of a total of 72 possible questionnaires (7 missed, 93% completed). Reported symptoms led to a phone call from a nurse in 30% of the responses.The patients reported high usability and acceptability of questionnaire and software. The substance of the telephonic conversations was relevant, and the study set-up was logistically acceptable.ConclusionsAn electronic questionnaire designed for symptom monitoring revealed high usability, acceptability and relevance in the target population. In conclusion, the study set-up was considered feasible for a randomised controlled trial.Trial registration numberNCT03529851.

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Desirability and feasibility of wireless electronic monitoring of medications in clinical trials.

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Desirability and feasibility of wireless electronic monitoring of medications in clinical trials.

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