Barriers and facilitators to the use of personal information documents in health and social care settings for people living with dementia: A thematic synthesis and mapping to the COM-B framework.

INTRODUCTION: People living with dementia experience communication difficulties. Personal information documents, or healthcare passports, enable communication of information essential for the care of a person with dementia. Despite the potential for providing person-centred care, personal information documents are not ubiquitously used. The Capability Opportunity Motivation-Behaviour (COM-B) model can be used to understand factors determining individuals' behaviours. OBJECTIVES: This study aimed to identify the barriers to and facilitators of the use of healthcare passports for people living with dementia through a systematic review methodology. METHODS: A systematic search of six electronic databases was undertaken. Grey literature was searched using three databases. All study types reporting barriers to or facilitators of the use of personal information documents in the care of adults living with dementia in high-income countries were included. Study quality was assessed using the NICE Quality Appraisal Checklist. Thematic synthesis was used to develop descriptive themes, which were subsequently mapped to the COM-B framework. RESULTS: Nineteen papers were included. Themes included training, awareness, embedding the process in norms and appreciating the value of the personal information documents. A broad range of barriers and facilitators was identified within each COM-B domain. CONCLUSION: This framework provides a starting point for evidence-informed initiatives to improve the use of personal information documents in the care of people with dementia. PATIENT AND PUBLIC CONTRIBUTION: This is a review of studies and did not involve patients or the public. Review results will guide evaluation of a local personal information document, which will be designed with input from the Dementia Champions Network (includes carers and other stakeholders).

Patients' Adoption of Electronic Personal Health Records in England: Secondary Data Analysis.

BACKGROUND: In England, almost all general practices (GPs) have implemented GP online services such as electronic personal health records (ePHRs) that allow people to schedule appointments, request repeat prescriptions, and access parts of their medical records. The overall adoption rate of GP online services has been low, reaching just 28% in October 2019. In a previous study, Abd-Alrazaq et al adopted a model to assess the factors that influence patients' use of GP online services in England. According to the previous literature, the predictive power of the Abd-Alrazaq model could be improved by proposing new associations between the existing variables in the model. OBJECTIVE: This study aims to improve the predictive power of the Abd-Alrazaq model by proposing new relationships between the existing variables in the model. METHODS: The Abd-Alrazaq model was amended by proposing new direct, mediating, moderating, and moderated mediating effects. The amended model was examined using data from a previous study, which were collected by a cross-sectional survey of a convenience sample of 4 GPs in West Yorkshire, England. Structural equation modeling was used to examine the theoretical model and hypotheses. RESULTS: The new model accounted for 53% of the variance in performance expectancy (PE), 76% of the variance in behavioral intention (BI), and 49% of the variance in use behavior (UB). In addition to the significant associations found in the previous study, this study found that social influence (SI) and facilitating conditions (FCs) are associated with PE directly and BI indirectly through PE. The association between BI and UB was stronger for younger women with higher levels of education, income, and internet access. The indirect effects of effort expectancy (EE), perceived privacy and security (PPS), and SI on BI were statistically stronger for women without internet access, patients with internet access, and patients without internet access, respectively. The indirect effect of PPS on BI was stronger for patients with college education or diploma than for those with secondary school education and lower, whereas the indirect effect of EE on BI was stronger for patients with secondary school education or lower than for those with college education or a diploma. CONCLUSIONS: The predictive power of the Abd-Alrazaq model improved by virtue of new significant associations that were not examined before in the context of ePHRs. Further studies are required to validate the new model in different contexts and to improve its predictive power by proposing new variables. The influential factors found in this study should be considered to improve patients' use of ePHRs.

Metrics for Outpatient Portal Use Based on Log File Analysis: Algorithm Development.

BACKGROUND: Web-based outpatient portals help patients engage in the management of their health by allowing them to access their medical information, schedule appointments, track their medications, and communicate with their physicians and care team members. Initial studies have shown that portal adoption positively affects health outcomes; however, early studies typically relied on survey data. Using data from health portal applications, we conducted systematic assessments of patients' use of an outpatient portal to examine how patients engage with the tool. OBJECTIVE: This study aimed to document the functionality of an outpatient portal in the context of outpatient care by mining portal usage data and to provide insights into how patients use this tool. METHODS: Using audit log files from the outpatient portal associated with the electronic health record system implemented at a large multihospital academic medical center, we investigated the behavioral traces of a study population of 2607 patients who used the portal between July 2015 and February 2019. Patient portal use was defined as having an active account and having accessed any portal function more than once during the study time frame. RESULTS: Through our analysis of audit log file data of the number and type of user interactions, we developed a taxonomy of functions and actions and computed analytic metrics, including frequency and comprehensiveness of use. We additionally documented the computational steps required to diagnose artifactual data and arrive at valid usage metrics. Of the 2607 patients in our sample, 2511 were active users of the patients portal where the median number of sessions was 94 (IQR 207). Function use was comprehensive at the patient level, while each session was instead limited to the use of one specific function. Only 17.45% (78,787/451,762) of the sessions were linked to activities involving more than one portal function. CONCLUSIONS: In discussing the full methodological choices made in our analysis, we hope to promote the replicability of our study at other institutions and contribute to the establishment of best practices that can facilitate the adoption of behavioral metrics that enable the measurement of patient engagement based on the outpatient portal use.

Patient Engagement as Measured by Inpatient Portal Use: Methodology for Log File Analysis.

BACKGROUND: Inpatient portals (IPPs) have the potential to increase patient engagement and satisfaction with their health care. An IPP provides a hospitalized patient with similar functions to those found in outpatient portals, including the ability to view vital signs, laboratory results, and medication information; schedule appointments; and communicate with their providers. However, IPPs may offer additional functions such as meal planning, real-time messaging with the inpatient care team, daily schedules, and access to educational materials relevant to their specific condition. In practice, IPPs have been developed as websites and tablet apps, with hospitals providing the required technology as a component of care during the patient's stay. OBJECTIVE: This study aimed to describe how inpatients are using IPPs at the first academic medical center to implement a system-wide IPP and document the challenges and choices associated with this analytic process. METHODS: We analyzed the audit log files of IPP users hospitalized between January 2014 and January 2016. Data regarding the date/time and duration of interactions with each of the MyChart Bedside modules (eg, view lab results or medications and patient schedule) and activities (eg, messaging the provider and viewing educational videos) were captured as part of the system audit logs. The development of a construct to describe the length of time associated with a single coherent use of the tool-which we call a session-provides a foundational unit of analysis. We defined frequency as the number of sessions a patient has during a given provision day. We defined comprehensiveness in terms of the percentage of functions that an individual uses during a given provision day. RESULTS: The analytic process presented data challenges such as length of stay and tablet-provisioning factors. This study presents data visualizations to illustrate a series of data-cleaning issues. In the presence of these robust approaches to data cleaning, we present the baseline usage patterns associated with our patient panel. In addition to frequency and comprehensiveness, we present considerations of median data to mitigate the effect of outliers. CONCLUSIONS: Although other studies have published usage data associated with IPPs, most have not explicated the challenges and choices associated with the analytic approach deployed within each study. Our intent in this study was to be somewhat exhaustive in this area, in part, because replicability requires common metrics. Our hope is that future researchers in this area will avail themselves of these perspectives to engage in critical assessment moving forward.

Factors Affecting Patients' Use of Electronic Personal Health Records in England: Cross-Sectional Study.

BACKGROUND: Electronic personal health records (ePHRs) are secure Web-based tools that enable individuals to access, manage, and share their medical records. England recently introduced a nationwide ePHR called Patient Online. As with ePHRs in other countries, adoption rates of Patient Online remain low. Understanding factors affecting patients' ePHR use is important to increase adoption rates and improve the implementation success of ePHRs. OBJECTIVE: This study aimed to examine factors associated with patients' use of ePHRs in England. METHODS: The unified theory of acceptance and use of technology was adapted to the use of ePHRs. To empirically examine the adapted model, a cross-sectional survey of a convenience sample was carried out in 4 general practices in West Yorkshire, England. Factors associated with the use of ePHRs were explored using structural equation modeling. RESULTS: Of 800 eligible patients invited to take part in the survey, 624 (78.0%) returned a valid questionnaire. Behavioral intention (BI) was significantly influenced by performance expectancy (PE; beta=.57, P<.001), effort expectancy (EE; beta=.16, P<.001), and perceived privacy and security (PPS; beta=.24, P<.001). The path from social influence to BI was not significant (beta=.03, P=.18). Facilitating conditions (FC) and BI significantly influenced use behavior (UB; beta=.25, P<.001 and beta=.53, P<.001, respectively). PE significantly mediated the effect of EE and PPS on BI (beta=.19, P<.001 and beta=.28, P=.001, respectively). Age significantly moderated 3 paths: PE→BI, EE→BI, and FC→UB. Sex significantly moderated only the relationship between PE and BI. A total of 2 paths were significantly moderated by education and internet access: EE→BI and FC→UB. Income moderated the relationship between FC and UB. The adapted model accounted for 51% of the variance in PE, 76% of the variance in BI, and 48% of the variance in UB. CONCLUSIONS: This study identified the main factors that affect patients' use of ePHRs in England, which should be taken into account for the successful implementation of these systems. For example, developers of ePHRs should involve patients in the process of designing the system to consider functions and features that fit patients' preferences and skills to ensure systems are useful and easy to use. The proposed model accounted for 48% of the variance in UB, indicating the existence of other, as yet unidentified, factors that influence the adoption of ePHRs. Future studies should confirm the effect of the factors included in this model and identify additional factors.

[Legal framework for electronic medical records in the Region of the Americas: definition of domains to legislate and situation analysisEnquadramento legal para os registros eletrônicos em saúde na Região das Américas: definição de domínios para regulamentação e análise da situação]. / Marco legal para registros médicos electrónicos en la Región de las Américas: definición de dominios a legislar y análisis de situación.

OBJECTIVES: Define a legal framework for electronic medical records (EMRs) and determine the degree to which the countries of the Region of the Americas are prepared in this regard. METHODS: The methodology consisted of two phases. In the first, a Delphi methodology was used to develop a questionnaire and define the framework and legal domains applicable to EMRs. In the second, the questionnaire was completed in each country. This included identifying national experts and the data collection process. RESULTS: Information was collected from a total of 21 countries regarding their situation with respect to legislation on EMRs in the following domains: 1) specific legislation on EMRs; 2) protection of patients' data and secondary use of the data; 3) legislation related to the actions of health professionals; 4) regulation on EMRs and the role of patients; and 5) health standards and EMR promotion programs. CONCLUSIONS: There has been progress in the Region with respect to new legislation covering the main areas related to EMRs (for example, protection of sensitive data and use of digital signatures). However, it is necessary to continue to address issues such as access to and updating of information in EMRs. This study contributes information on the essential components of legislation on EMRs, and reports on the situation in the Region of the Americas.

OBJETIVOS: Definir um enquadramento legal para os registros eletrônicos em saúde (RES) e identificar o grau de preparação dos países da Região das Américas neste sentido. MÉTODOS: A metodologia do estudo foi dividida em duas fases. Na primeira fase, foi usado o método Delphi para elaborar o questionário e definir o enquadramento e os domínios legais para RES. Na segunda fase, foi realizada a pesquisa por país, com a identificação de dados referentes nacionais e processo de coleta de dados. RESULTADOS: Ao todo, foram obtidos dados de 21 países sobre os aspectos legais e RES distribuídos nos seguintes domínios: 1) legislação específica para RES, 2) proteção dos dados dos pacientes e uso secundário da informação, 3) legislação relacionada à atuação dos profissionais da saúde, 4) regulamentação dos RES e papel dos pacientes e 5) padrões em saúde e programas de promoção dos RES. CONCLUSÕES: Houve progresso na Região quanto à promulgação de leis que abrangem os principais domínios dos RES (p. ex., proteção de dados sensíveis ou o uso de assinatura digital). Porém, alguns aspectos precisam ser reforçados, como o acesso e a atualização das informações nos registros. Este estudo contribui ao descrever os aspectos básicos da regulamentação e informar a situação dos RES na Região das Américas.

Analysis of College Students' Personal Health Information Activities: Online Survey.

BACKGROUND: With abundant personal health information at hand, individuals are faced with a critical challenge in evaluating the informational value of health care records to keep useful information and discard that which is determined useless. Young, healthy college students who were previously dependents of adult parents or caregivers are less likely to be concerned with disease management. Personal health information management (PHIM) is a special case of personal information management (PIM) that is associated with multiple interactions among varying stakeholders and systems. However, there has been limited evidence to understand informational or behavioral underpinning of the college students' PHIM activities, which can influence their health in general throughout their lifetime. OBJECTIVE: This study aimed to investigate demographic and academic profiles of college students with relevance to PHIM activities. Next, we sought to construct major PHIM-related activity components and perceptions among college students. Finally, we sought to discover major factors predicting core PHIM activities among college students we sampled. METHODS: A Web survey was administered to collect responses about PHIM behaviors and perceptions among college students from the University of Kentucky from January through March 2017. A total of 1408 college students were included in the analysis. PHIM perceptions, demographics, and academic variations were used as independent variables to predict diverse PHIM activities using a principal component analysis (PCA) and hierarchical regression analyses (SPSS v.24, IBM Corp, Armonk, NY, USA). RESULTS: Majority of the participants were female (956/1408, 67.90%), and the age distribution of this population included an adequate representation of college students of all ages. The most preferred health information resources were family (612/1408, 43.47%), health care professionals (366/1408, 26.00%), friends (27/1408, 1.91%), and the internet (157/1408, 11.15%). Organizational or curatorial activities such as Arranging, Labeling, Categorizing, and Discarding were rated low (average=3.21, average=3.02, average=2.52, and average=2.42, respectively). The PCA results suggested 3 components from perception factors labeled as follows: Assistance (alpha=.85), Awareness (alpha=.716), and Difficulty (alpha=.558). Overall, the Demographics and Academics variables were not significant in predicting dependent variables such as Labeling, Categorizing, Health Education Materials, and Discarding, whereas they were significant for other outcome variables such as Sharing, Collecting, Knowing, Insurance Information, Using, and Owning. CONCLUSIONS: College years are a significant time for students to learn decision-making skills for maintaining information, a key aspect of health records, as well as for educators to provide appropriate educational and decision aids in the environment of learning as independent adults. Our study will contribute to better understand knowledge about specific skills and perceptions for college students' practice of effective PHIM throughout their lives.

Using scenarios and personas to enhance the effectiveness of heuristic usability evaluations for older adults and their care team.

OBJECTIVE: Using heuristics to evaluate user experience is a common methodology for human-computer interaction studies. One challenge of this method is the inability to tailor results towards specific end-user needs. This manuscript reports on a method that uses validated scenarios and personas of older adults and care team members to enhance heuristics evaluations of the usability of commercially available personal health records for homebound older adults. MATERIALS AND METHODS: Our work extends the Chisnell and Redish heuristic evaluation methodology by using a protocol that relies on multiple expert reviews of each system. It further standardizes the heuristic evaluation process through the incorporation of task-based scenarios. RESULTS: We were able to use the modified version of the Chisnell and Redish heuristic evaluation methodology to identify potential usability challenges of two commercially available personal health record systems. This allowed us to: (1) identify potential usability challenges for specific types of users, (2) describe improvements that would be valuable to all end-users of the system, and (3) better understand how the interactions of different users may vary within a single personal health record. CONCLUSIONS: The methodology described in this paper may help designers of consumer health information technology tools, such as personal health records, understand the needs of diverse end-user populations. Such methods may be particularly helpful when designing systems for populations that are difficult to recruit for end-user evaluations through traditional methods.

Importance-Performance Analysis of Personal Health Records in Taiwan: A Web-Based Survey.

BACKGROUND: Empowering personal health records (PHRs) provides basic human right, awareness, and intention for health promotion. As health care delivery changes toward patient-centered services, PHRs become an indispensable platform for consumers and providers. Recently, the government introduced "My health bank," a Web-based electronic medical records (EMRs) repository for consumers. However, it is not yet a PHR. To date, we do not have a platform that can let patients manage their own PHR. OBJECTIVE: This study creates a vision of a value-added platform for personal health data analysis and manages their health record based on the contents of the "My health bank." This study aimed to examine consumer expectation regarding PHR, using the importance-performance analysis. The purpose of this study was to explore consumer perception regarding this type of a platform: it would try to identify the key success factors and important aspects by using the importance-performance analysis, and give some suggestions for future development based on it. METHODS: This is a cross-sectional study conducted in Taiwan. Web-based invitation to participate in this study was distributed through Facebook. Respondents were asked to watch an introductory movie regarding PHR before filling in the questionnaire. The questionnaire was focused on 2 aspects, including (1) system functions, and (2) system design and security and privacy. The questionnaire would employ 12 and 7 questions respectively. The questionnaire was designed following 5-points Likert scale ranging from 1 ("disagree strongly") to 5 ("Agree strongly"). Afterwards, the questionnaire data was sorted using IBM SPSS Statistics 21 for descriptive statistics and the importance-performance analysis. RESULTS: This research received 350 valid questionnaires. Most respondents were female (219 of 350 participants, 62.6%), 21-30 years old (238 of 350 participants, 68.0%), with a university degree (228 of 350 participants, 65.1%). They were still students (195 out of 350 participants, 56.6%), with a monthly income of less than NT $30,000 (230 of 350 participants, 65.7%), and living in the North Taiwan (236 of 350 participants, 67.4%), with a good self-identified health status (171 of 350 participants, 48.9%). After performing the importance-performance analysis, we found the following: (1) instead of complex functions, people just want to have a platform that can let them integrate and manage their medical visit, health examination, and life behavior records; (2) they do not care whether their PHR is shared with others; and (3) most of the participants think the system security design is not important, but they also do not feel satisfied with the current security design. CONCLUSIONS: Overall, the issues receiving the most user attention were the system functions, circulation, integrity, ease of use, and continuity of the PHRs, data security, and privacy protection.

Patient Use of Electronic Prescription Refill and Secure Messaging and Its Association With Undetectable HIV Viral Load: A Retrospective Cohort Study.

BACKGROUND: Electronic personal health records (PHRs) can support patient self-management of chronic conditions. Managing human immunodeficiency virus (HIV) viral load, through taking antiretroviral therapy (ART) is crucial to long term survival of persons with HIV. Many persons with HIV have difficulty adhering to their ART over long periods of time. PHRs contribute to chronic disease self-care and may help persons with HIV remain adherent to ART. Proportionally veterans with HIV are among the most active users of the US Department of Veterans Affairs (VA) PHR, called My HealtheVet. Little is known about whether the use of the PHR is associated with improved HIV outcomes in this population. OBJECTIVE: The objective of this study was to investigate whether there are associations between the use of PHR tools (electronic prescription refill and secure messaging [SM] with providers) and HIV viral load in US veterans. METHODS: We conducted a retrospective cohort study using data from the VA's electronic health record (EHR) and the PHR. We identified veterans in VA care from 2009-2012 who had HIV and who used the PHR. We examined which ones had achieved the positive outcome of suppressed HIV viral load, and whether achievement of this outcome was associated with electronic prescription refill or SM. From 18,913 veterans with HIV, there were 3374 who both had a detectable viral load in 2009 and who had had a follow-up viral load test in 2012. To assess relationships between electronic prescription refill and viral control, and SM and viral control, we fit a series of multivariable generalized estimating equation models, accounting for clustering in VA facilities. We adjusted for patient demographic and clinical characteristics associated with portal use. In the initial models, the predictor variables were included in dichotomous format. Subsequently, to evaluate a potential dose-effect, the predictor variables were included as ordinal variables. RESULTS: Among our sample of 3374 veterans with HIV who received VA care from 2009-2012, those who had transitioned from detectable HIV viral load in 2009 to undetectable viral load in 2012 tended to be older (P=.004), more likely to be white (P<.001), and less likely to have a substance use disorder, problem alcohol use, or psychosis (P=.006, P=.03, P=.004, respectively). There was a statistically significant positive association between use of electronic prescription refill and change in HIV viral load status from 2009-2012, from detectable to undetectable (OR 1.36, CI 1.11-1.66). There was a similar association between SM use and viral load status, but without achieving statistical significance (OR 1.28, CI 0.89-1.85). Analyses did not demonstrate a dose-response of prescription refill or SM use for change in viral load. CONCLUSIONS: PHR use, specifically use of electronic prescription refill, was associated with greater control of HIV. Additional studies are needed to understand the mechanisms by which this may be occurring.

Consumer Adoption of Personal Health Record Systems: A Self-Determination Theory Perspective.

BACKGROUND: Personal Health Records (PHR) systems provide individuals with access and control over their health information and consequently can support individuals in becoming active participants, rather than passive recipients, in their own care process. In spite of numerous benefits suggested for consumers' utilizing PHR systems, research has shown that such systems are not yet widely adopted or well known to consumers. Bearing in mind the potential benefits of PHRs to consumers and their potential interest in these systems-and that similar to any other type of information system, adoption is a prerequisite for realizing the potential benefits of PHR systems-research is needed to understand how to enhance the adoption rates for PHR systems. OBJECTIVE: This research seeks to understand how individuals' intentions to adopt PHR systems are affected by their self-determination in managing their own health-the extent of their ability to take an active role in managing their own health. As such, this research aims to develop and empirically validate a theoretical model that explains PHR systems adoption by the general public through the integration of theories from the information systems and psychology literatures. METHODS: This research employs a cross-sectional survey method targeted at the Canadian general public without any prior experience in using PHR systems. A partial least squares approach to structural equation modeling was used to validate the proposed research model of this study (N=159). RESULTS: Individuals with higher levels of ability to manage their own health (self-determination) are more likely to adopt PHR systems since they have more positive perceptions regarding the use of such systems. Further, such self-determination is fueled by autonomy support from consumers' physicians as well as the consumers' personality trait of autonomy orientation. CONCLUSIONS: This study advances our theoretical understanding of PHR systems adoption. It also contributes to practice by providing insightful implications for designing, promoting, and facilitating the use of PHR systems among consumers.

Impact of an Electronic Health Record-Integrated Personal Health Record on Patient Participation in Health Care: Development and Randomized Controlled Trial of MyHealthKeeper.

BACKGROUND: Personal health record (PHR)-based health care management systems can improve patient engagement and data-driven medical diagnosis in a clinical setting. OBJECTIVE: The purpose of this study was (1) to demonstrate the development of an electronic health record (EHR)-tethered PHR app named MyHealthKeeper, which can retrieve data from a wearable device and deliver these data to a hospital EHR system, and (2) to study the effectiveness of a PHR data-driven clinical intervention with clinical trial results. METHODS: To improve the conventional EHR-tethered PHR, we ascertained clinicians' unmet needs regarding PHR functionality and the data frequently used in the field through a cocreation workshop. We incorporated the requirements into the system design and architecture of the MyHealthKeeper PHR module. We constructed the app and validated the effectiveness of the PHR module by conducting a 4-week clinical trial. We used a commercially available activity tracker (Misfit) to collect individual physical activity data, and developed the MyHealthKeeper mobile phone app to record participants' patterns of daily food intake and activity logs. We randomly assigned 80 participants to either the PHR-based intervention group (n=51) or the control group (n=29). All of the study participants completed a paper-based survey, a laboratory test, a physical examination, and an opinion interview. During the 4-week study period, we collected health-related mobile data, and study participants visited the outpatient clinic twice and received PHR-based clinical diagnosis and recommendations. RESULTS: A total of 68 participants (44 in the intervention group and 24 in the control group) completed the study. The PHR intervention group showed significantly higher weight loss than the control group (mean 1.4 kg, 95% CI 0.9-1.9; P<.001) at the final week (week 4). In addition, triglyceride levels were significantly lower by the end of the study period (mean 2.59 mmol/L, 95% CI 17.6-75.8; P=.002). CONCLUSIONS: We developed an innovative EHR-tethered PHR system that allowed clinicians and patients to share lifelog data. This study shows the effectiveness of a patient-managed and clinician-guided health tracker system and its potential to improve patient clinical profiles. TRIAL REGISTRATION: ClinicalTrials.gov NCT03200119; https://clinicaltrials.gov/ct2/show/NCT03200119 (Archived by WebCite at http://www.webcitation.org/6v01HaCdd).

Patient Health Record Systems Scope and Functionalities: Literature Review and Future Directions.

BACKGROUND: A new generation of user-centric information systems is emerging in health care as patient health record (PHR) systems. These systems create a platform supporting the new vision of health services that empowers patients and enables patient-provider communication, with the goal of improving health outcomes and reducing costs. This evolution has generated new sets of data and capabilities, providing opportunities and challenges at the user, system, and industry levels. OBJECTIVE: The objective of our study was to assess PHR data types and functionalities through a review of the literature to inform the health care informatics community, and to provide recommendations for PHR design, research, and practice. METHODS: We conducted a review of the literature to assess PHR data types and functionalities. We searched PubMed, Embase, and MEDLINE databases from 1966 to 2015 for studies of PHRs, resulting in 1822 articles, from which we selected a total of 106 articles for a detailed review of PHR data content. RESULTS: We present several key findings related to the scope and functionalities in PHR systems. We also present a functional taxonomy and chronological analysis of PHR data types and functionalities, to improve understanding and provide insights for future directions. Functional taxonomy analysis of the extracted data revealed the presence of new PHR data sources such as tracking devices and data types such as time-series data. Chronological data analysis showed an evolution of PHR system functionalities over time, from simple data access to data modification and, more recently, automated assessment, prediction, and recommendation. CONCLUSIONS: Efforts are needed to improve (1) PHR data quality through patient-centered user interface design and standardized patient-generated data guidelines, (2) data integrity through consolidation of various types and sources, (3) PHR functionality through application of new data analytics methods, and (4) metrics to evaluate clinical outcomes associated with automated PHR system use, and costs associated with PHR data storage and analytics.

Overcoming Clinical Inertia: A Randomized Clinical Trial of a Telehealth Remote Monitoring Intervention Using Paired Glucose Testing in Adults With Type 2 Diabetes.

BACKGROUND: Type 2 diabetes mellitus is a worldwide challenge. Practice guidelines promote structured self-monitoring of blood glucose (SMBG) for informing health care providers about glycemic control and providing patient feedback to increase knowledge, self-efficacy, and behavior change. Paired glucose testing­pairs of glucose results obtained before and after a meal or physical activity­is a method of structured SMBG. However, frequent access to glucose data to interpret values and recommend actions is challenging. A complete feedback loop­data collection and interpretation combined with feedback to modify treatment­has been associated with improved outcomes, yet there remains limited integration of SMBG feedback in diabetes management. Incorporating telehealth remote monitoring and asynchronous electronic health record (EHR) feedback from certified diabetes educators (CDEs)­specialists in glucose pattern management­employ the complete feedback loop to improve outcomes. OBJECTIVE: The purpose of this study was to evaluate a telehealth remote monitoring intervention using paired glucose testing and asynchronous data analysis in adults with type 2 diabetes. The primary aim was change in glycated hemoglobin (A(1c))­a measure of overall glucose management­between groups after 6 months. The secondary aims were change in self-reported Summary of Diabetes Self-Care Activities (SDSCA), Diabetes Empowerment Scale, and Diabetes Knowledge Test. METHODS: A 2-group randomized clinical trial was conducted comparing usual care to telehealth remote monitoring with paired glucose testing and asynchronous virtual visits. Participants were aged 30-70 years, not using insulin with A1c levels between 7.5% and 10.9% (58-96 mmol/mol). The telehealth remote monitoring tablet computer transmitted glucose data and facilitated a complete feedback loop to educate participants, analyze actionable glucose data, and provide feedback. Data from paired glucose testing were analyzed asynchronously using computer-assisted pattern analysis and were shared with patients via the EHR weekly. CDEs called participants monthly to discuss paired glucose testing trends and treatment changes. Separate mixed-effects models were used to analyze data. RESULTS: Participants (N=90) were primarily white (64%, 56/87), mean age 58 (SD 11) years, mean body mass index 34.1 (SD 6.7) kg/m2, with diabetes for mean 8.2 (SD 5.4) years, and a mean A(1c) of 8.3% (SD 1.1; 67 mmol/mol). Both groups lowered A(1c) with an estimated average decrease of 0.70 percentage points in usual care group and 1.11 percentage points in the treatment group with a significant difference of 0.41 percentage points at 6 months (SE 0.08, t159=-2.87, P=.005). Change in medication (SE 0.21, t157=-3.37, P=.009) was significantly associated with lower A(1c) level. The treatment group significantly improved on the SDSCA subscales carbohydrate spacing (P=.04), monitoring glucose (P=.001), and foot care (P=.02). CONCLUSIONS: An eHealth model incorporating a complete feedback loop with telehealth remote monitoring and paired glucose testing with asynchronous data analysis significantly improved A(1c) levels compared to usual care. TRIAL REGISTRATION: Clinicaltrials.gov NCT01715649; https://www.clinicaltrials.gov/ct2/show/NCT01715649 (Archived by WebCite at http://www.webcitation.org/6ZinLl8D0).

Patient online access to medical records in general practice: Perceived effects after one year follow-up.

OBJECTIVE: Online access to medical records is expected to foster patient empowerment and patient-centred healthcare. However, data on actual experienced effects remain limited. We aimed to examine the development of effects patients perceive from online access. METHODS: A nationwide online survey (N = 1769) evaluated Dutch patients' use of online access and beliefs about its effects on 16 outcomes at baseline and one-year follow-up. Analyses of Variance (ANOVA) were used to examine within-person belief changes across three user groups: patients who 1) used online access before the study, 2) started use during the study, and 3) did not use it at all. RESULTS: There was a small decline in five beliefs around online access facilitating patient empowerment and participation in participants who started using online access during the study compared to at least one other user group. Most changes in beliefs did not differ between groups. CONCLUSION: No evidence of benefits from online access was found. The findings might indicate inadequacies in the current system of online access. Possibly, the benefits of online access are contingent upon portal improvements and changes in documentation practices. PRACTICE IMPLICATION: Records need to be easily accessible and comprehensible for patients. Consultation practices should enable patient participation.

[Use of Electronic Medical Records for Research: New Ethical Challenges and Possible Solutions]. / Uso dos Registos Clínicos Eletrónicos para Investigação: Novos Desafios Éticos e Soluções Possíveis.

Some clinicians feel that Ethics Committees act as a blockade to observational clinical studies. In the case of retrospective studies some have tried to solve this problem by reducing this sensitive data to simple administrative data in the hands of the government. Others see the new European General Data Protection Regulation 2016/679 (European Union) as being more liberal than the Portuguese Law nº 21/2014, April 16th (Clinical Research Law). Both solutions presume participant consent from his / her silence, even if nobody truly tried to specifically inform him / her. Such views do collide with the guarantees of protection of patient's ethical rights. In this article we propose an ethical alternative to those positions.

Alguns investigadores entendem que as Comissões de Ética para a Saúde são um bloqueio aos estudos clínicos observacionais. No que toca aos estudos retrospetivos há quem proponha resolver este problema tratando os Dados Pessoais de Saúde como dados administrativos simples na posse do Estado e há quem interprete o novo Regulamento Geral de Proteção de Dados (União Europeia) 2016/679 de forma menos garantista que a Lei nº 21/2014, de 16 de abril (sobre a Investigação Clínica), resultando em ambos os casos na presunção que o silêncio do participante constitui consentimento, mesmo se ninguém tentar sequer informá-lo do novo usodos seus dados. Estas soluções colidem com garantias éticas de proteção dos direitos dos doentes. Propomos uma alternativa ética a estas propostas.

Consumer-Mediated Data Exchange for Research: Current State of US Law, Technology, and Trust.

A compendium of US laws and regulations offers increasingly strong support for the concept that researchers can acquire the electronic health record data that their studies need directly from the study participants using technologies and processes called consumer-mediated data exchange. This data acquisition method is particularly valuable for studies that need complete longitudinal electronic records for all their study participants who individually and collectively receive care from multiple providers in the United States. In such studies, it is logistically infeasible for the researcher to receive necessary data directly from each provider, including providers who may not have the capability, capacity, or interest in supporting research. This paper is a tutorial to inform the researcher who faces these data acquisition challenges about the opportunities offered by consumer-mediated data exchange. It outlines 2 approaches and reviews the current state of provider- and consumer-facing technologies that are necessary to support each approach. For one approach, the technology is developed and estimated to be widely available but could raise trust concerns among research organizations or their institutional review boards because of the current state of US law applicable to consumer-facing technologies. For the other approach, which does not elicit the same trust concerns, the necessary technology is emerging and a pilot is underway. After reading this paper, the researcher who has not been following these developments should have a good understanding of the legal, regulatory, technology, and trust issues surrounding consumer-mediated data exchange for research, with an awareness of what is potentially possible now, what is not possible now, and what could change in the future. The researcher interested in trying consumer-mediated data exchange will also be able to anticipate and respond to an anticipated barrier: the trust concerns that their own organizations could raise.

Determinants and outcomes of patient access to medical records: Systematic review of systematic reviews.

BACKGROUND: Patient access to electronic health records (EHRs) is associated with several determinants and outcomes, which are interrelated. However, individual studies and the reviews summarizing them have only addressed particular aspects, such as policy, usability or health outcomes of adoption. Therefore, no comprehensive overview exists. Additionally, reviews used different theoretical frameworks, which makes results difficult to compare. OBJECTIVE: We aimed to systematically review recent systematic reviews on determinants and outcomes of patient access to EHRs to create a comprehensive overview and inform policy-makers and EHR implementers about the available literature, and to identify knowledge gaps in the literature reviews. METHODS: We searched MEDLINE, EMBASE and PsycINFO for systematic reviews on patient portals, personal health records, and patient access to records that addressed determinants and outcomes of adoption. We synthesized the results from these reviews into the Clinical Adoption Framework (CAF), by mapping quotes from the reviews to categories and dimensions of the CAF, starting with the most recent ones until saturation of the CAF had been reached. The risk of bias in the reviews was assessed using the AMSTAR2 checklist. RESULTS: We included nineteen reviews from 8871 records that were retrieved until February 19th, 2018. The reviews had a median of 4 (IQR: 4-4) critical flaws according to the AMSTAR2 checklist. The reviews contained a total of 1054 quotes that were mapped to the CAF. All reviews reported on the dimension 'People' that can affect adoption (e.g. personal characteristics such as age) and the dimension 'HIS use' (health information system use). Most reviews reported the dimensions 'Organisation', 'Implementation', HIS 'System quality', and outcomes of HIS use. However, gaps in knowledge might exist on macro-level determinants and outcomes, such as healthcare standards, funding, and incentives, because few reviews addressed these aspects. CONCLUSIONS: No review covered all aspects of the CAF and there was a large variety in aspects that were addressed, but all dimensions of the CAF were addressed by at least two reviews. Although reviews had critical flaws according to the AMSTAR2 checklist, almost half of the reviews did use methods to assess bias in primary studies. Implementers can use the synthesized results from this study as a reference for implementation and development when taking quality restrictions into account. Researchers should address the risk of bias in primary studies in future reviews and use a framework such as CAF to make results more comparable and reusable.

Managing Patient-Generated Health Data Through Mobile Personal Health Records: Analysis of Usage Data.

BACKGROUND: Personal health records (PHRs) and mHealth apps are considered essential tools for patient engagement. Mobile PHRs (mPHRs) can be a platform to integrate patient-generated health data (PGHD) and patients' medical information. However, in previous studies, actual usage data and PGHD from mPHRs have not been able to adequately represent patient engagement. OBJECTIVE: By analyzing 5 years' PGHD from an mPHR system developed by a tertiary hospital in South Korea, we aimed to evaluate how PGHD were managed and identify issues in PGHD management based on actual usage data. Additionally, we analyzed how to improve patient engagement with mPHRs by analyzing the actively used services and long-term usage patterns. METHODS: We gathered 5 years (December 2010 to December 2015) of log data from both hospital patients and general users of the app. We gathered data from users who entered PGHD on body weight, blood pressure (BP), blood glucose levels, 10-year cardiovascular disease (CVD) risk, metabolic syndrome risk, medication schedule, insulin, and allergy. We classified users according to whether they were patients or general users based on factors related to continuous use (≥28 days for weight, BP, and blood glucose, and ≥180 days for CVD and metabolic syndrome), and analyzed the patients' characteristics. We compared PGHD entry counts and the proportion of continuous users for each PGHD by user type. RESULTS: The total number of mPHR users was 18,265 (patients: n=16,729, 91.59%) with 3620 users having entered weight, followed by BP (n=1625), blood glucose (n=1374), CVD (n=764), metabolic syndrome (n=685), medication (n=252), insulin (n=72), and allergy (n=61). Of those 18,256 users, 3812 users had at least one PGHD measurement, of whom 175 used the PGHD functions continuously (patients: n=142, 81.14%); less than 1% of the users had used it for more than 4 years. Except for weight, BP, blood glucose, CVD, and metabolic syndrome, the number of PGHD records declined. General users' continuous use of PGHD was significantly higher than that of patients in the blood glucose (P<.001) and BP (P=.03) functions. Continuous use of PGHD in health management (BP, blood glucose, and weight) was significantly greater among older users (P<.001) and men (P<.001). In health management (BP, weight, and blood glucose), overall chronic disease and continuous use of PGHD were not statistically related (P=.08), but diabetes (P<.001) and cerebrovascular diseases (P=.03) were significant. CONCLUSIONS: Although a small portion of users managed PGHD continuously, PGHD has the potential to be useful in monitoring patient health. To realize the potential, specific groups of continuous users must be identified, and the PGHD service must target them. Further evaluations for the clinical application of PGHD, feedback regarding user interfaces, and connections with wearable devices are needed.

Patient healthcare passports in community specialist palliative care: a mixed methods study.

BACKGROUND: Patient held records need to be evaluated in palliative care settings. OBJECTIVES: To evaluate how patients, families and professionals in a specialist palliative setting use a patient held record created through close consultation with patients and carers. METHODS: A mixed methods prospective longitudinal cohort study in the UK-adult patients under community specialist palliative care nurse review or attending day hospice were given questionnaires at record introduction and after 4-6 weeks. Hospice staff completed a questionnaire and focus group after 8 months. RESULTS: From Sept 2016 to June 2017, 550 patients were screened, 347 (63.1%) were offered records and 259 accepted (74.6%). 238 accepted a research pack, 105 returned questionnaire 1 (44.1% response rate) and 26 returned questionnaire 2 (24.8% of initial respondents). Questionnaire 1 (patients): 40% found it burdensome repeating information, and almost 70% were interested in a record to reduce this. Questionnaire 2 (patients): 74% found the record easy to use, but few (4, 15.4%) used it regularly. Over 60% stated the record was useful and would recommend it to others, despite not using it themselves. Professionals indicated that it was mainly patients and relatives who used the record, not non-palliative professionals. CONCLUSIONS: While initial uptake of the record was high, use appeared low. While people saw real value in the record for others, they did not generally use it themselves. This evaluation demonstrates that patient held records are unlikely to be used by palliative care patients even though they see value in the concept.