A Novel Digital Pill System for Medication Adherence Measurement and Reporting: A Usability Validation Study (Preprint)

2021 ◽  
Author(s):  
Susan Baumgartner ◽  
D Eric Buffkin Jr ◽  
Elise Rukavina ◽  
Jason Jones ◽  
Elizabeth Weiler ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Human Factors ◽  
Validation Study ◽  
Study Patient ◽  
Prescription Medications ◽  
Adherence Measurement ◽  
Diverse Background ◽  
System P ◽  
Patient Use ◽  
Intended Use

BACKGROUND Medication nonadherence is a costly problem that is common in clinical use and and clinical trials alike with significant adverse consequences. Digital pill systems have proven to be effective and safe solutions to the challenges of nonadherence, with documented success in improving adherence and health outcomes. OBJECTIVE This human factors validation study evaluated a novel digital pill system, the ID-CapTM System from etectRx, for usability among patient users in a simulated real-world use environment. METHODS Seventeen patients of diverse background who regularly take oral prescription medications were recruited. After training and a period of training decay, participants were asked to complete 12 patient use scenarios during which errors or difficulties were logged. Participants also were interviewed about their experience with the ID-Cap System. RESULTS In this human factors validation study, patient users completed 97% of the use scenarios successfully, and 75% of these were completed without any failures or errors. Participants found the ID-Cap System easy to use and were able to accurately and proficiently record ingestion events using the device. CONCLUSIONS Participants demonstrated the ability to safely and effectively use the ID-Cap System for its intended use. Regardless of age, educational level, or background, patients were able to use it successfully. The ID-Cap System has great potential as a useful tool for encouraging medication adherence and can be easily implemented by patient users. CLINICALTRIAL Not applicable

scholarly journals A Novel Digital Pill System for Medication Adherence Measurement and Reporting: A Usability Validation Study (Preprint)

10.2196/30786 ◽  
2021 ◽  
Author(s):  
Susan Baumgartner ◽  
D Eric Buffkin Jr ◽  
Elise Rukavina ◽  
Jason Jones ◽  
Elizabeth Weiler ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Validation Study ◽  
Adherence Measurement

scholarly journals Evaluation of the Acceptability of the Medication Event Reminder Monitor for Promoting Adherence to Multidrug-Resistant Tuberculosis Therapy in India: Qualitative Study of Patients and Healthcare Providers (Preprint)

2020 ◽  
Author(s):  
Beena E Thomas ◽  
J. Vignesh Kumar ◽  
Murugesan Periyasamy ◽  
Amit Subhash Khandewale ◽  
J. Hephzibah Mercy ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Remote Monitoring ◽  
Social Influences ◽  
Healthcare Providers ◽  
Multidrug Resistant ◽  
Performance Expectancy ◽  
Effort Expectancy ◽  
Mdr Tb ◽  
Facilitating Conditions ◽  
Patient Use

BACKGROUND Multidrug-resistant TB (MDR TB) patients face challenges adhering to medications, given that treatment is prolonged and has a high rate of adverse effects. The Medication Event Reminder Monitor (MERM) is a digital pillbox that provides daily pill-taking reminders and facilitates remote monitoring of medication adherence. OBJECTIVE We assessed the MERM’s acceptability to patients and healthcare providers (HCPs) during pilot implementation in India’s public sector MDR TB program. METHODS From October 2017 to September 2018, we conducted qualitative interviews with patients taking MDR TB therapy, who were being monitored with the MERM, and HCPs in the government program in Chennai and Mumbai. Interviews transcripts were independently coded by two researchers and analyzed to identify emergent themes. We organized findings using the unified theory of acceptance and use of technology (UTAUT), which outlines four constructs that predict technology acceptance: performance expectancy, effort expectancy, social influences, and facilitating conditions. RESULTS We interviewed 65 MDR TB patients and 10 HCPs. In patient interviews, greater acceptance of the MERM was related to perceptions that the audible and visual reminders improved medication adherence and that remote monitoring reduced the frequency of clinic visits (performance expectancy); that the device’s organization and labeling made it easier to take medications correctly (effort expectancy); that the device facilitated positive family involvement in the patient’s care (social influences); and that remote monitoring made patients feel more “cared for” by the health system (facilitating conditions). Lower patient acceptance was related to problems with the durability of the MERM’s cardboard construction and difficulties with portability and storage due to its large size (effort expectancy); concerns regarding stigma and disclosure of patients’ MDR TB diagnoses (social influences); and incorrect understanding of the MERM due to suboptimal counseling (facilitating conditions). In their interviews, HCPs reported that MERM implementation resulted in reduced in-person interactions with patients, allowing HCPs to dedicate more time to other tasks, which improved job satisfaction. CONCLUSIONS Several features of the MERM support its acceptability among MDR TB patients and HCPs, and some barriers to patient use could be addressed with improved design of the device. However, some barriers to patient use—such as disease-related stigma—are more difficult to modify and may limit its use by some MDR TB patients. Further research is needed to assess the MERM’s accuracy for measuring adherence, its effectiveness for improving treatment outcomes, and patients’ sustained use of the device in larger-scale implementation.

scholarly journals Human Factors Engineering Validation Study for a Novel 0.1 mg Epinephrine Auto-Injector

2018 ◽  
Vol 141 (2) ◽  
pp. AB154
Author(s):  
Evan Edwards ◽  
Catherine Kessler ◽  
Emily Dissinger ◽  
Naomi Cherne ◽  
Adam Shames
Keyword(s):  
Human Factors ◽  
Validation Study ◽  
Human Factors Engineering ◽  
Auto Injector

scholarly journals Development and Initial Validation of the Communication About Medication by Providers–Parent Scale (CAMP-P)

2019 ◽  
Vol 6 ◽  
pp. 2333794X1985798 ◽  
Author(s):  
Eva Igler ◽  
Ellen Sejkora ◽  
Rachel Greenley ◽  
Jill Plevinsky ◽  
Lindsey Bugno ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Parent Perceptions ◽  
Medication Administration ◽  
Provider Communication ◽  
Prescription Medications ◽  
Divergent Validity ◽  
Medical Providers ◽  
Initial Validation ◽  
Convergent And Divergent Validity ◽  
Good Internal Consistency

This study evaluated the psychometric properties of the Communication about Medication by Providers–Parent Scale (CAMP-P), a 24-item measure of communication relevant to medication adherence between parents and medical providers. Parents of youth (ages 2-7 years) who had received a prescription within the last 12 months completed online surveys regarding demographic and appointment variables, and child’s recent prescription medications, and they completed the newly developed CAMP-P. Exploratory factor analysis of CAMP-P identified 20 items about provider communication corresponding to 3 distinct scales: medication administration strategies, encouraging communication, and addressing barriers to medication taking. Factor scales were related to appointment variables, such as length of time spent discussing medications. The CAMP-P demonstrated good internal consistency and convergent and divergent validity. The CAMP-P is a novel, validated measure of parent perceptions of medication communication and can be utilized to evaluate parent-provider communication on pediatric medication adherence in clinical and research settings.

scholarly journals Human Factors/Ergonomics Work System Analysis of Patient Work: State of the Science and Future Directions

2020 ◽  
Author(s):  
Nicole E Werner ◽  
Siddarth Ponnala ◽  
Nadia Doutcheva ◽  
Richard J Holden
Keyword(s):  
Human Factors ◽  
Systems Engineering ◽  
System Analysis ◽  
The United States ◽  
Empirical Literature ◽  
Study Patient ◽  
Study Objective ◽  
Work System ◽  
System Models ◽  
Patient Work

Abstract Purpose To demonstrate the use and value of the Human Factors/Ergonomics-based Systems Engineering Initiative for Patient Safety (SEIPS) family of work system models for studying and improving patient work. Data Sources : We conducted a review of the published empirical literature applying the SEIPS family of work system models for patient work. Study Selection Included studies had to: apply one of the SEIPS family of work system models to study patient work; be published in a peer-reviewed journal in English; and include analysis of data. We identified 16 articles that met our inclusion criteria. Data Extraction For each study we extracted: settings and situations in which models were applied; research design; study methods; model(s) used; type and number of study participants; study objective(s); whether the study included an intervention; specific aspects of the model used; knowledge generated about patient work; and benefits of using the models. Results of data synthesis Our analysis revealed that a majority of studies were conducted in the United States, used qualitative or mixed methods, and employed a variety of data collection techniques to study adult patient populations with chronic illness and their informal caregivers and healthcare providers performing patient work in the home and clinical setting. The studies resulted in a variety of useful products, demonstrating several benefits of using the models. Conclusion Our review has demonstrated the value of using the SEIPS family of work systems models to study and improve patient and family contributions to health-related work.

scholarly journals PRM29 Translation and Validation Study of Morisky Medication Adherence Scale (MMAS): The Urdu Version

2011 ◽  
Vol 14 (7) ◽  
pp. A426
Author(s):  
F. Saleem ◽  
M.A. Hassali ◽  
A.A. Shafie ◽  
H.K. Al-Qazaz ◽  
M. Atif ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Validation Study ◽  
Morisky Medication Adherence Scale ◽  
Adherence Scale ◽  
Translation And Validation

scholarly journals Human factors validation study of 3 mg sumatriptan autoinjector, for migraine patients

2016 ◽  
pp. 131 ◽  
Author(s):  
Anthony Andre ◽  
Elimor Brand-Schieber ◽  
Sagar Munjal ◽  
Rajesh Kumar ◽  
Will Valladao ◽  
...  
Keyword(s):  
Human Factors ◽  
Validation Study

Human Factors Engineering Simulation Methodology

1986 ◽  
Vol 30 (13) ◽  
pp. 1306-1310 ◽  
Author(s):  
Brett A. Storey
Keyword(s):  
Human Factors ◽  
Dynamic Simulation ◽  
Human Factors Engineering ◽  
Human Engineering ◽  
Simulation Research ◽  
Test And Evaluation ◽  
Simulation Techniques ◽  
Simulation Evaluation ◽  
Evaluation Techniques ◽  
Intended Use

This report describes a methodology of simulation research which is designed to accomplish requirements of a human factors engineering simulation, plan. This approach, accompanied by detailed test plans and schedules will fulfill the data item DI-H-7052 (Human Engineering Dynamic Simulation Plan) for intended use of dynamic simulation techniques in support of human engineering analysis, design support and test and evaluation. This methodology will cover the need for dynamic simulation, evaluation techniques, procedures and guidelines, and the behavioral, subjective and physiological methods recommended for use in human engineering evaluations.

Evaluation of early clinical experience of a novel prognostic proteomics prostate cancer biopsy test.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 88-88 ◽  
Author(s):  
Sibgat Choudhury ◽  
Bruce J. Trock ◽  
Rene Benson Skone ◽  
Julie Nardone ◽  
James Dunyak ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Score ◽  
Validation Study ◽  
Prostate Tumor ◽  
Risk Scores ◽  
P Value ◽  
Score Distribution ◽  
Aggressive Disease ◽  
Tumor Pathology ◽  
Intended Use

88 Background: Standard clinical and pathological parameters derived from diagnostic biopsy are insufficient to accurately assess final prostate tumor pathology of patients with biopsy Gleason grades 3+3 or 3+4. We developed a novel assay (ProMark) that performs quantitative measurements of 8 protein markers from prostate biopsy FFPE sections. In the validation study, assay risk scores were strongly predictive of final prostate tumor pathology with a C-stat of 0.69 (95%CI = 0.63 – 0.76) (p<0.0001). By design, the train-test (N=381) and validation (N=274) studies were enrichment studies, with a higher % of aggressive disease than in the intended use population. Here we study 293 needle biopsy cases that have come to our CLIA lab for ProMark testing over a four month period. The objective of this study is to establish the ProMark score distribution for these ‘real world’ clinical use patients, and to confirm that this distribution matches our clinical validation study. Methods: To establish prevalence of aggressive disease in the intended use population, we used the Institutional Urology Prostate Cancer Database at Johns Hopkins. Among 9,305 men with biopsy Gleason 3+3 or 3+4 and prostatectomy from 2004-2014 the distribution of favorable (GS<4+3 & organ confined) and unfavorable (GS≥4+3 or non-organ confined) based on surgical pathology is 73.1% vs. 26.9%. The adjusted risk score distribution from the validation trial (N=274) is then compared to the CLIA lab samples (N=293), based on cumulative distributions and binomial confidence intervals. Results: Comparison of the risk score distribution of early clinical data with the population-adjusted validation score distribution shows good agreement based on 95% CIs. Table shows expected and measured frequencies in Low, Intermediate and High risk categories. The K-S test for comparison of distributions has p-value=0.44, supporting equivalence of distribution. Conclusions: The results of our study show that early clinical practice closely matches expectations from controlled clinical studies. [Table: see text]

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