scholarly journals The FDA MyStudies app: a reusable platform for distributed clinical trials and real-world evidence studies

JAMIA Open ◽  
2020 ◽  
Author(s):  
Zachary Wyner ◽  
Sascha Dublin ◽  
Christina Chambers ◽  
Shyam Deval ◽  
Chayim Herzig-Marx ◽  
...  
Keyword(s):  
Data Storage ◽  
Health Research ◽  
Mobile Application ◽  
Public Health Research ◽  
Patient Data ◽  
Proof Of Concept ◽  
Health Records ◽  
Secure Storage ◽  
Real World Evidence ◽  
Role Based

Abstract We developed a mobile application and secure patient data storage platform, FDA MyStudies, to address privacy, engagement, and extensibility challenges in mobile clinical research. The system extends the capabilities of the mobile frameworks Apple ResearchKit and ResearchStack through an intuitive front-end application and secure storage environment that can support health research studies. The platform supports single or multisite studies via role-based access and can be implemented within highly secure data environments. As a proof-of-concept, pregnant women participated in a descriptive study via the app in which data not routinely captured in electronic health records (EHR) were collected and linked with existing patient data to provide a more wholistic view of the patient and illustrate how patient data combined with EHR data could be used to support public health research.

scholarly journals Privacy protected text analysis in DataSHIELD

2017 ◽  
Vol 1 (1) ◽  
Author(s):  
Rebecca Wilson ◽  
Oliver Butters ◽  
Demetris Avraam ◽  
Andrew Turner ◽  
Paul Burton
Keyword(s):  
Text Analysis ◽  
Individual Patient Data ◽  
Patient Data ◽  
British Library ◽  
Free Text ◽  
Sensitive Information ◽  
Proof Of Concept ◽  
Text Data ◽  
Health Records ◽  
Different Sources

ABSTRACT ObjectivesDataSHIELD (www.datashield.ac.uk) was born of the requirement in the biomedical and social sciences to co-analyse individual patient data (microdata) from different sources, without disclosing identity or sensitive information. Under DataSHIELD, raw data never leaves the data provider and no microdata or disclosive information can be seen by the researcher. The analysis is taken to the data - not the data to the analysis. Text data can be very disclosive in the biomedical domain (patient records, GP letters etc). Similar, but different, issues are present in other domains - text could be copyrighted, or have a large IP value, making sharing impractical. ApproachBy treating text in an analogous way to individual patient data we assessed if DataSHIELD could be adapted and implemented for text analysis, and circumvent the key obstacles that currently prevent it. ResultsUsing open digitised text data held by the British Library, a DataSHIELD proof-of-concept infrastructure and prototype DataSHIELD functions for free text analysis were developed. ConclusionsWhilst it is possible to analyse free text within a DataSHIELD infrastructure, the challenge is creating generalised and resilient anti-disclosure methods for free text analysis. There are a range of biomedical and health sciences applications for DataSHIELD methods of privacy protected analysis of free text including analysis of electronic health records and analysis of qualitative data e.g. from social media.

scholarly journals Modelling Medications for Public Health Research

2016 ◽  
Vol 8 (2) ◽  
Author(s):  
Deborah Van Gaans ◽  
S Ahmed ◽  
K D'Onise ◽  
J Moyon ◽  
G Caughey ◽  
...  
Keyword(s):  
Public Health ◽  
Health Research ◽  
Public Health Research ◽  
Research Data ◽  
Data Management System ◽  
General Notion ◽  
Health Issues ◽  
Health Records ◽  
Service Community ◽  
Patient Health

Most patients with chronic disease are prescribed multiple medications, which are recorded in their personal health records. This is rich information for clinical public health researchers but also a challenge to analyse.  This paper describes the method that was undertaken within the Public Health Research Data Management System (PHReDMS) to map medication data retrieved from individual patient health records for population health researcher’s use.  The PHReDMS manages clinical, health service, community and survey research data within a secure web environment that allows for data sharing amongst researchers.  The PHReDMS is currently used by researchers to answer a broad range of questions, including monitoring of prescription patterns in different population groups and geographic areas with high incidence/prevalence of chronic renal, cardiovascular, metabolic and mental health issues.  In this paper, we present the general notion of abstraction network, a higher level network that sits above a terminology and offers compact and more easily understandable view of its content. We demonstrate the utilisation of abstraction network methodology to examine medication data from electronic medical records to allow a compact and more easily understandable view of its content.

scholarly journals Digital and Decentralized Management of Patient Data in Healthcare Using Blockchain Implementations

2021 ◽  
Vol 4 ◽  
Author(s):  
Erik Westphal ◽  
Hermann Seitz
Keyword(s):  
Data Storage ◽  
Health Sector ◽  
Patient Data ◽  
Easy Access ◽  
Access Management ◽  
Industrial Facilities ◽  
Secure Storage ◽  
Blockchain Technology ◽  
Hybrid Solutions ◽  
Basic Ideas

Blockchain solutions offer efficient approaches for trustworthy data management, especially in the medical field when storing and processing sensitive patient data. Many institutional and industrial facilities have already recognized the importance of the technology for the health sector and have also formulated basic ideas, concepts and main use cases, but concrete implementations and executions are comparatively rare. This mini review examines current research on specific blockchain implementations in healthcare that go beyond the state of concept studies or theoretical implementation ideas and describes the most promising systems based on systematic literature research. The review shows that secure storage and easy access to complete patient data is becoming increasingly important. Blockchain technology can be used as a secure, transparent and digital way to meet these needs. Hybrid solutions consisting of conventional data storage and blockchain-based access management are increasingly being developed and implemented. The automation of blockchain processes through smart contracts is also recommended. The review further reveals ambiguities in the use of permissioned and permissionless blockchain frameworks, machine learning (ML) integration as well as the question of which data should be stored in the blockchain and how this should be viewed legally. Therefore, there is still a need for further research, especially on these aspects, in order to further establish the use of blockchains in healthcare.

scholarly journals Third Party Certification of Agri-Food Supply Chain Using Smart Contracts and Blockchain Tokens

Sensors ◽  
2021 ◽  
Vol 21 (16) ◽  
pp. 5307
Author(s):  
Ricardo Borges dos Santos ◽  
Nunzio Marco Torrisi ◽  
Rodrigo Palucci Pantoni
Keyword(s):  
Supply Chain ◽  
Mobile Application ◽  
Consumer Behaviour ◽  
Economic Incentives ◽  
Third Party ◽  
Smart Contracts ◽  
Proof Of Concept ◽  
Socially Responsible ◽  
The Public ◽  
Blockchain Technology

Every consumer’s buying decision at the supermarket influences food brands to make first party claims of sustainability and socially responsible farming methods on their agro-product labels. Fine wines are often subject to counterfeit along the supply chain to the consumer. This paper presents a method for efficient unrestricted publicity to third party certification (TPC) of plant agricultural products, starting at harvest, using smart contracts and blockchain tokens. The method is capable of providing economic incentives to the actors along the supply chain. A proof-of-concept using a modified Ethereum IGR token set of smart contracts using the ERC-1155 standard NFTs was deployed on the Rinkeby test net and evaluated. The main findings include (a) allowing immediate access to TPC by the public for any desired authority by using token smart contracts. (b) Food safety can be enhanced through TPC visible to consumers through mobile application and blockchain technology, thus reducing counterfeiting and green washing. (c) The framework is structured and maintained because participants obtain economical incentives thus leveraging it´s practical usage. In summary, this implementation of TPC broadcasting through tokens can improve transparency and sustainable conscientious consumer behaviour, thus enabling a more trustworthy supply chain transparency.

scholarly journals Utility of routinely collected electronic health records data to support effectiveness evaluations in inflammatory bowel disease: a pilot study of tofacitinib

2021 ◽  
Vol 28 (1) ◽  
pp. e100337
Author(s):  
Vivek Ashok Rudrapatna ◽  
Benjamin Scott Glicksberg ◽  
Atul Janardhan Butte
Keyword(s):  
Inflammatory Bowel Disease ◽  
Pilot Study ◽  
Disease Activity ◽  
Real World ◽  
Bowel Disease ◽  
P Value ◽  
Health Records ◽  
Real World Evidence ◽  
Inflammatory Bowel

ObjectivesElectronic health records (EHR) are receiving growing attention from regulators, biopharmaceuticals and payors as a potential source of real-world evidence. However, their suitability for the study of diseases with complex activity measures is unclear. We sought to evaluate the use of EHR data for estimating treatment effectiveness in inflammatory bowel disease (IBD), using tofacitinib as a use case.MethodsRecords from the University of California, San Francisco (6/2012 to 4/2019) were queried to identify tofacitinib-treated IBD patients. Disease activity variables at baseline and follow-up were manually abstracted according to a preregistered protocol. The proportion of patients meeting the endpoints of recent randomised trials in ulcerative colitis (UC) and Crohn’s disease (CD) was assessed.Results86 patients initiated tofacitinib. Baseline characteristics of the real-world and trial cohorts were similar, except for universal failure of tumour necrosis factor inhibitors in the former. 54% (UC) and 62% (CD) of patients had complete capture of disease activity at baseline (month −6 to 0), while only 32% (UC) and 69% (CD) of patients had complete follow-up data (month 2 to 8). Using data imputation, we estimated the proportion achieving the trial primary endpoints as being similar to the published estimates for both UC (16%, p value=0.5) and CD (38%, p-value=0.8).Discussion/ConclusionThis pilot study reproduced trial-based estimates of tofacitinib efficacy despite its use in a different cohort but revealed substantial missingness in routinely collected data. Future work is needed to strengthen EHR data and enable real-world evidence in complex diseases like IBD.

scholarly journals Utilizing asynchronous email interviews for health research: overview of benefits and drawbacks

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Michelle Amri ◽  
Christina Angelakis ◽  
Dilani Logan
Keyword(s):  
Public Health ◽  
Data Collection ◽  
Data Quality ◽  
Health Research ◽  
Geographic Location ◽  
Public Health Research ◽  
Data Accuracy ◽  
Global Public Health ◽  
Snowball Sampling ◽  
Face To Face

Abstract Objective Through collating observations from various studies and complementing these findings with one author’s study, a detailed overview of the benefits and drawbacks of asynchronous email interviewing is provided. Through this overview, it is evident there is great potential for asynchronous email interviews in the broad field of health, particularly for studies drawing on expertise from participants in academia or professional settings, those across varied geographical settings (i.e. potential for global public health research), and/or in circumstances when face-to-face interactions are not possible (e.g. COVID-19). Results Benefits of asynchronous email interviewing and additional considerations for researchers are discussed around: (i) access transcending geographic location and during restricted face-to-face communications; (ii) feasibility and cost; (iii) sampling and inclusion of diverse participants; (iv) facilitating snowball sampling and increased transparency; (v) data collection with working professionals; (vi) anonymity; (vii) verification of participants; (viii) data quality and enhanced data accuracy; and (ix) overcoming language barriers. Similarly, potential drawbacks of asynchronous email interviews are also discussed with suggested remedies, which centre around: (i) time; (ii) participant verification and confidentiality; (iii) technology and sampling concerns; (iv) data quality and availability; and (v) need for enhanced clarity and precision.

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