Patient-centered Data Research Articles

Unpacking Data From Adult Day Centers in Order to Realize Their Untapped Potential in Dementia Care

Adult day centers (ADCs) in the United States represent a vital, but commonly overlooked, resource for dementia care among community-dwelling older adults. However, the severity of dementia in ADC users, their medical complexity, the supports offered to them, and health outcomes associated with adult day services among persons living with dementia is poorly understood. This is in part due to a lack of standardized data collection in this industry. In this symposium, we present the most current research on these issues, as well as strategies to improve data collection across ADCs to strengthen care. The symposium begins with analysis of data from the state of California that identifies patterns of chronic conditions in ADC users with dementia that are associated with emergency department visits and hospitalizations. We then examine data from the Centers for Disease Control, comparing dementia specialized ADCs and their participants to non-specializing ADCs. We compare the extent to which states with ADC programs require collection of patient centered reported outcomes on persons with dementia. Finally, we explore an innovative collaboration between researchers and community partners to simplify data collection in these centers. Our findings suggest that persons with dementia in ADCs are an extremely complex population and that some ADCs are better suited than others to meet their extensive needs. Additional patient-centered data collection can be supported with widely available software, and has the potential to demonstrate the effectiveness of ADCs, aid in program development, and help leverage funding opportunities.

Hyperledger Healthchain: Patient-Centric IPFS-Based Storage of Health Records

Blockchain-based electronic health system growth is hindered by privacy, confidentiality, and security. By protecting against them, this research aims to develop cybersecurity measurement approaches to ensure the security and privacy of patient information using blockchain technology in healthcare. Blockchains need huge resources to store big data. This paper presents an innovative solution, namely patient-centric healthcare data management (PCHDM). It comprises the following: (i) in an on-chain health record database, hashes of health records are stored as health record chains in Hyperledger fabric, and (ii) off-chain solutions that encrypt actual health data and store it securely over the interplanetary file system (IPFS) which is the decentralized cloud storage system that ensures scalability, confidentiality, and resolves the problem of blockchain data storage. A security smart contract hosted through container technology with Byzantine Fault Tolerance consensus ensures patient privacy by verifying patient preferences before sharing health records. The Distributed Ledger technology performance is tested under hyper ledger caliper benchmarks in terms of transaction latency, resource utilization, and transaction per second. The model provides stakeholders with increased confidence in collaborating and sharing their health records.

Heart Watch Study: protocol for a pragmatic randomised controlled trial

IntroductionPersonal digital devices that provide health information, such as the Apple Watch, have developed an increasing array of cardiopulmonary tracking features which have received regulatory clearance and are directly marketed...

A Novel Methodology for Building Longitudinal, Patient-Centric Real World Datasets in Hemophilia A

A Novel Methodology for Building Longitudinal, Patient-Centric Real World Datasets in Hemophilia A

Characterizing Mild and Moderate Hemophilia A Patients in the Real World: A Patient-Centric Approach

Characterizing Mild and Moderate Hemophilia A Patients in the Real World: A Patient-Centric Approach

Efficient capture of high-quality real-world data on treatments for glaucoma: the Fight Glaucoma Blindness! Registry

ObjectiveTo describe the development and implementation of a web-based high-quality data collection tool to track the outcomes of glaucoma treatments in routine practice.Methods and analysisThis is a prospective observational registry...

Which Priorities Should Guide Palliative Surgical Research?

Research priorities in surgical palliative care should go beyond generating data from traditional surgical morbidity or mortality metrics. Surgical researchers can seek to better understand care management complexities of surgical patients with serious illnesses in order to gather high-quality, patient-centered data; improve surgical patients' experiences; and motivate surgical palliative care as a field.

Development of PRO-PMs assessing symptoms following completion of curative-intent chemotherapy.

171 Background: Few patient-reported outcome performance measures (PRO-PMs) have been validated for the cancer population. The testing that has occurred mostly focuses on advanced cancers despite the fact that the majority of people with cancer are diagnosed with earlier stage disease. We developed and tested PRO-PMs to assess quality of life, pain and fatigue in adult patients completing curative-intent chemotherapy for breast, colon and non-small cell lung cancers. Our goal is to develop measures that target symptoms that impact entry into the survivorship phase. Methods: We recruited 20 diverse test sites from the Michigan Oncology Quality Collaborative (MOQC) and the Alliance of Dedicated Cancer Centers (ADCC). Test sites enrolled patients, administered surveys, and collected clinical and demographic data. A Technical Expert Panel and the Patient and Caregiver Council selected PROMs and provided testing guidance. We assessed data collection feasibility and clinician/staff/patient burden throughout the testing process. Results: PROMIS instruments were selected due to psychometric testing in the target population, public availability and acceptability to patients and test sites. 1,753 patients were enrolled between 10/1/19 – 3/31/21. The COVID public health emergency disrupted testing and resulted in lower than expected enrolled patients/completed surveys; however, adaptations led to expansions in survey administration methods. Preliminary practice-level performance results from 10 sites show variation across sites for pain interference (mean = 50.5, SD = 2.8, with a range of 44.6—54.6) and fatigue (mean 49.2, SD = 2.8, with a range of 44.6--54.3). Some test sites reported PRO implementation to be burdensome; however, most patients evaluated did not find survey completion to be burdensome. Conclusions: Next steps include testing risk adjustment variables/model, creating adjusted performance scores, reliability and validity testing. Despite the consensus goal of PRO-PMs in oncology, barriers to implementation persist and important methodologic barriers exist (e.g., ability to achieve sufficient sample size in an oncology practice; defining the most appropriate numerator calculation that reports the desired quality concept and is appropriate for the PROM being used; analytic best practices for PRO-PM adjustment/testing). This project is contributing to the knowledge base as we seek to ensure that PRO-PMs provide meaningful, actionable, patient-centered quality data with benefits that outweigh the burden of implementation.

On the Annotation of Health Care Pathways to Allow the Application of Care-Plans That Generate Data for Multiple Purposes.

Objectives: Procedural interoperability in health care requires information support and monitoring of a common work practice. Our aim was to devise an information model for a complete annotation of actions in clinical pathways that allow use of multiple plans concomitantly as several partial processes underlie any composite clinical process.Materials and Methods: The development of the information model was based on the integration of a defined protocol for clinical interoperability in the care of patients with chronic obstructive pulmonary disease and an observational study protocol for cohort characterization at the group level. In the clinical process patient reported outcome measures were included.Results: The clinical protocol and the observation study protocol were developed on the clinical level and a single plan definition was developed by merging of the protocols. The information model and a common data model that had been developed for care pathways was successfully implemented and data for the medical records and the observational study could be extracted independently. The interprofessional process support improved the communication between the stakeholders (health care professionals, clinical scientists and providers).Discussion: We successfully merged the processes and had a functionally successful pilot demonstrating a seamless appearance for the health care professionals, while at the same time it was possible to generate data that could serve quality registries and clinical research. The adopted data model was initially tested and hereby published to the public domain.Conclusion: The use of a patient centered information model and data annotation focused on the care pathway simplifies the annotation of data for different purposes and supports sharing of knowledge along the patient care path.

Collection and Reporting of Patient-reported Outcome Measures in Arthroplasty Registries: Multinational Survey and Recommendations.

Patient-reported outcome measures (PROMs) are validated questionnaires that are completed by patients. Arthroplasty registries vary in PROM collection and use. Current information about registry collection and use of PROMs is important to help improve methods of PROM data analysis, reporting, comparison, and use toward improving clinical practice. To characterize PROM collection and use by registries, we asked: (1) What is the current practice of PROM collection by arthroplasty registries that are current or former members of the International Society of Arthroplasty Registries, and are there sufficient similarities in PROM collection between registries to enable useful international comparisons that could inform the improvement of arthroplasty care? (2) How do registries differ in PROM administration and demographic, clinical, and comorbidity index variables collected for case-mix adjustment in data analysis and reporting? (3) What quality assurance methods are used for PROMs, and how are PROM results reported and used by registries? (4) What recommendations to arthroplasty registries may improve PROM reporting and facilitate international comparisons? An electronic survey was developed with questions about registry structure and collection, analysis, reporting, and use of PROM data and distributed to directors or senior administrators of 39 arthroplasty registries that were current or former members of the International Society of Arthroplasty Registries. In all, 64% (25 of 39) of registries responded and completed the survey. Missing responses from incomplete surveys were captured by contacting the registries, and up to three reminder emails were sent to nonresponding registries. Recommendations about PROM collection were drafted, revised, and approved by the International Society of Arthroplasty Registries PROMs Working Group members. Of the 25 registries that completed the survey, 15 collected generic PROMs, most frequently the EuroQol-5 Dimension survey; 16 collected joint-specific PROMs, most frequently the Knee Injury and Osteoarthritis Outcome Score and Hip Disability and Osteoarthritis Outcome Score; and 11 registries collected a satisfaction item. Most registries administered PROM questionnaires within 3 months before and 1 year after surgery. All 16 registries that collected PROM data collected patient age, sex or gender, BMI, indication for the primary arthroplasty, reason for revision arthroplasty, and a comorbidity index, most often the American Society of Anesthesiologists classification. All 16 registries performed regular auditing and reporting of data quality, and most registries reported PROM results to hospitals and linked PROM data to other data sets such as hospital, medication, billing, and emergency care databases. Recommendations for transparent reporting of PROMs were grouped into four categories: demographic and clinical, survey administration, data analysis, and results. Although registries differed in PROM collection and use, there were sufficient similarities that may enable useful data comparisons. The International Society of Arthroplasty Registries PROMs Working Group recommendations identify issues that may be important to most registries such as the need to make decisions about survey times and collection methods, as well as how to select generic and joint-specific surveys, handle missing data and attrition, report data, and ensure representativeness of the sample. By collecting PROMs, registries can provide patient-centered data to surgeons, hospitals, and national entities to improve arthroplasty care.

CORR Insights®: Is Uncontrolled Diabetes Mellitus Associated with Incidence of Complications After Posterior Instrumented Lumbar Fusion? A National Claims Database Analysis.

CORR Insights®: Is Uncontrolled Diabetes Mellitus Associated with Incidence of Complications After Posterior Instrumented Lumbar Fusion? A National Claims Database Analysis.

A Blockchain-Based Healthcare Platform for Secure Personalised Data Sharing.

To facilitate personalised healthcare provision across Europe, we envision solutions that enable the secure integration and sharing of medical health records. These solutions should address privacy concerns, such as granular access control to personal data, establishing what should be accessible when and by whom, whilst complying with collective regulatory frameworks such as the European General Data Protection Regulation (GDPR) and adhering to international standards on how to manage information security. The proposed healthcare system design integrates technologies such as blockchain and scalable data lakes with adequate system routines to guarantee the secure access of confidential data. In this paper, we present the essential architectural components for the secure integration of medical records in a blockchain-based platform. We present a patient-centric data retrieval approach which incorporates a structured format to compose access rules.

Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivate for root coverage: 5-year results of an RCT using 3D digital measurement technology for volumetric comparison of soft tissue changes.

Comparison of the clinical efficacy (digitally volumetric, aesthetic, patient-centred outcomes) of tunnel technique (TUN) with subepithelial connective tissue graft (CTG) versus coronally advanced flap (CAF) with enamel matrix derivate (EMD) 5years after gingival recession therapy. In 18 patients contributing 36 RT1 recessions, study models were collected at baseline and follow-ups. Optical scans assessed recessions computer-assisted [recession depth, recession reduction (RECred), complete root coverage (CRC), percentage of root coverage (RC), pointwise (pTHK) and mean areal (aTHK) marginal soft tissue thickness]. Root coverage aesthetic Score (RES) was used for aesthetic evaluation and visual analogue scales for patient-centred data collection applied. Sixty months after surgery, 50.0% (TUN+CTG) and 0.0% (CAF+EMD) of sites showed CRC (p=0.0118), 82.2% (TUN+CTG) and 32.0% (CAF+EMD) achieved RC, respectively (p=0.0023). CTG achieved significantly better RECred (TUN+CTG: 1.75±0.74mm; CAF+EMD: 0.50±0.39mm; p=0.0009) and aTHK (TUN+CTG: 0.95±0.41mm; CAF+EMD: 0.26±0.28mm; p=0.0013). RES showed superior outcomes (p=0.0533) for TUN+CTG (6.86±2.31) compared to CAF+EMD (4.63±1.99). The study failed to find significant differences related to patient-centred outcomes (TUN+CTG: 8.30±2.21; CAF+EMD: 7.50±1.51; p=0.1136). Five years after treatment, CTG resulted in better clinical and aesthetic outcomes than CAF+EMD. Increased THK was associated with improved outcomes for RECred and RC.

Determinants of Longitudinal Adherence in Smartphone-Based Self-Tracking for Chronic Health Conditions

The use of interactive mobile and wearable technologies for understanding and managing health conditions is a growing area of interest for patients, health professionals and researchers. Self-tracking technologies such as smartphone apps and wearable devices for measuring symptoms and behaviours generate a wealth of patient-centric data with the potential to support clinical decision making. However, the utility of self-tracking technologies for providing insight into patients' conditions is impacted by poor adherence with data logging. This paper explores factors associated with adherence in smartphone-based tracking, drawing on two studies of patients living with axial spondyloarthritis (axSpA), a chronic rheumatological condition. In Study 1, 184 axSpA patients used the uMotif health tracking smartphone app for a period of up to 593 days. In Study 2, 108 axSpA patients completed a survey about their experience of using self-tracking technologies. We identify six significant correlates of self-tracking adherence, providing insight into the determinants of tracking behaviour. Specifically, our data provides evidence that adherence correlates with the age of the user, the types of tracking devices that are being used (smartphone OS and physical activity tracker), preferences for types of data to record, the timing of interactions with a self-tracking app, and the reported symptom severity of the user. We discuss how these factors may have implications for those designing, deploying or using mobile and wearable tracking technologies to support monitoring and management of chronic diseases.

A Methodology for Mapping the Patient Journey for Noncommunicable Diseases in Low- and Middle-Income Countries.

Noncommunicable diseases (NCDs) are responsible for 71% of all worldwide mortality each year, and have an exceptionally large impact in low- and middle-income countries (LMICs). However, there is often a lack of local data from these countries to inform practice and policy improvements. Generating locally contextualized evidence base for NCDs that can help identify gaps, aid decision-making and improve patient care in LMICs needs an innovative approach. The approach used in Mapping the Patient Journey Towards Actionable Beyond the Pill Solutions (MAPS) is designed to quantitatively map different stages of the patient journey in four critical NCDs, ie, hypertension, dyslipidemia, depression, and pain (chronic and neuropathic) across selected LMICs in Africa, the Middle East, South East Asia, and Latin America. The key touchpoints along the patient journey include awareness, screening, diagnosis, treatment, adherence, and control or remission. MAPS employs an evidence mapping methodology that follows a three-step semi-systematic review: 1) systematic peer-reviewed database search; 2) unstructured searches of local or real-world data; and 3) expert opinion. Evidence generation and visualization is based on locally validated and deduplicated data published over the last 10 years. This approach will be the first to provide quantitative mapping of the different stages of the patient journey for selected NCDs in LMICs. By focusing on local, patient-centric data, the goal of the MAPS initiative is to address and prioritize local research and knowledge gaps, then contribute to evidence-based, high-quality, and affordable advances in the management of NCDs in LMICs. This will ultimately improve patient outcomes and contribute towards the achievement of global NCD targets.

Blockchain-Based Distributed Patient-Centric Image Management System

In recent years, many researchers have focused on developing a feasible solution for storing and exchanging medical images in the field of health care. Current practices are deployed on cloud-based centralized data centers, which increase maintenance costs, require massive storage space, and raise privacy concerns about sharing information over a network. Therefore, it is important to design a framework to enable sharing and storing of big medical data efficiently within a trustless environment. In the present paper, we propose a novel proof-of-concept design for a distributed patient-centric image management (PCIM) system that is aimed to ensure safety and control of patient private data without using a centralized infrastructure. In this system, we employed an emerging Ethereum blockchain and a distributed file system technology called Inter-Planetary File System (IPFS). Then, we implemented an Ethereum smart contract called the patient-centric access control protocol to enable a distributed and trustworthy access control policy. IPFS provides the means for decentralized storage of medical images with global accessibility. We describe how the PCIM system architecture facilitates the distributed and secured patient-centric data access across multiple entities such as hospitals, patients, and image requestors. Finally, we deployed a smart contract prototype on an Ethereum testnet blockchain and evaluated the proposed framework within the Windows environment. The evaluation results demonstrated that the proposed scheme is efficient and feasible.

PPM1 Development of a DATA Infrastructure That Combines Top-Tier Danish Registry DATA with Real-World DATA, to Create More Complete Personalized Medical DATA, While Allowing for Commercialization While Upholding Gdpr Legislation

Creating a patient-centric health data infrastructure that successfully combines superior Danish registry data with data from patients’ apps and wearables. Thus, generating personalized medical data, while upholding strict ethical and GDPR guidelines, creating value for patients through targeted medical solutions, improved ability for commercial leverage and accessible health data overview. The Hedax and OSCAR projects bring together the relevant Danish consortiums to collaborate on bridging the political and technical gap between the personal app & wearable data, Danish health data, and GDPR. The project partners have developed the technology to process Danish health registry data, e.g. economic, statistical, geo-demographic data, private data (with consent from the user) from smart devices, medical devices, insurance claim data, pseudonymized CPR registry data, and genome data. The data sources are connected to a Personal Data Store (PDS) and a virtual platform for a GDPR compliant, encrypted analysis. The outcome is a patient-centric health data infrastructure that is GDPR compliant while commercializing the extracted combination of high-quality Danish health registry data and real-world data. The result will be enhanced patient health data insights, integrated clinical pathways, personalized medicine for citizens, access to 3rd party data for healthcare providers, a GDPR data hotel, sandbox, and enhanced access to enriched health data for clinical trials and research-based innovation. Hedax & OSCAR’s new health data infrastructure that combines registry data with apps & wearables paves the way for a level of medical data integration yet to be seen on the world market and promises a wealth of societal and commercial benefits.

OP544 Appraising Variation In Health Technology Assessment Of Novel Immuno-Oncology Medicines In Australia, Canada, France, And The United Kingdom

IntroductionDemonstrating the value of medicines through health technology assessment (HTA) systems is becoming increasingly complex. Innovative therapies – such as immuno-oncology (IO) agents – are testing limits of methodological approaches in markets with established HTA systems. The objective of this study is to understand how requirements, approaches, and decision-making differ between select HTA agencies with a focus on specific PD-1/PD-L1 (programmed death receptor-1/programmed death-ligand 1) agents and cancer indications, and to describe how this variation impacts patient access. To achieve this objective, we conducted a detailed HTA dossier review for several recently launched IO products across Australia (AU), Canada (CA), France (FR), and the United Kingdom (UK).MethodsContent experts reviewed HTA dossiers for pembrolizumab, nivolumab, and atezolizumab for non-small cell lung cancer (NSCLC) first-line monotherapy, NSCLC combination therapy, and adjuvant melanoma. A systematic analytic framework was developed to understand best-practice methodology across systems. Information on submitted data, patient/expert input, and access decisions were extracted; key themes were identified and refined through workshop discussion, and probed further through blinded primary research with eight individuals with current or recent experience of HTA systems.ResultsWe identified six major elements of variation impacting decision-making: evidentiary expectations for biomarkers, use/impact of patient-centered data; use/impact of real-world data, acceptance of surrogate endpoints, approaches for clinical data extrapolation, and accepted time horizons. Considerable variation in time to access was observed; for pembrolizumab (NSCLC first-line monotherapy), time from product registration to HTA decision ranged from 42 (CA) to 487 (AU) days; time from registration to listing ranged from 189 (CA) to 605 (AU) days.ConclusionsEvaluated HTA systems demonstrate a large degree of variability in approaches to decision-making for novel IO medicines; resultant access decisions and time to access are also highly variable. Inconsistency between systems and duplication of effort when assessing similar clinical/economic data could be contributing to limited or delayed patient access; the relationship merits further exploration. Assessed HTA systems are currently undergoing process revisions but expert input suggests that this is not expected to reduce variation, and could further increase complexity. The influence of parallel scientific advice programs between HTA agencies and regulatory bodies in reducing variation must also be determined.

Isabl Platform, a digital biobank for processing multimodal patient data

BackgroundThe widespread adoption of high throughput technologies has democratized data generation. However, data processing in accordance with best practices remains challenging and the data capital often becomes siloed. This presents an opportunity to consolidate data assets into digital biobanks—ecosystems of readily accessible, structured, and annotated datasets that can be dynamically queried and analysed.ResultsWe present Isabl, a customizable plug-and-play platform for the processing of multimodal patient-centric data. Isabl's architecture consists of a relational database (Isabl DB), a command line client (Isabl CLI), a RESTful API (Isabl API) and a frontend web application (Isabl Web). Isabl supports automated deployment of user-validated pipelines across the entire data capital. A full audit trail is maintained to secure data provenance, governance and ensuring reproducibility of findings.ConclusionsAs a digital biobank, Isabl supports continuous data utilization and automated meta analyses at scale, and serves as a catalyst for research innovation, new discoveries, and clinical translation.

Integrating Healthcare Data for Enhanced Citizen-Centred Care and Analytics.

The potential of healthcare systems worldwide is expanding as new medical devices and data sources are regularly presented to healthcare providers which could be used to personalise, improve and revise treatments further. However, there is presently a large gap between the data collected, the systems that store the data, and any ability to perform big data analytics to combinations of such data. This paper suggests a novel approach to integrate data from multiple sources and formats, by providing a uniform structure to the data in a healthcare data lake with multiple zones reflecting how refined the data is: from raw to curated when ready to be consumed or used for analysis. The integration further requires solutions that can be proven to be secure, such as patient-centric data sharing agreements (smart contracts) on a blockchain, and novel privacy-preserving methods for extracting metadata from data sources, originally derived from partially-structured or from completely unstructured data. Work presented here is being developed as part of an EU project with the ultimate aim to develop solutions for integrating healthcare data for enhanced citizen-centred care and analytics across Europe.