Patient acceptability and usability of a self-administered electronic patient-reported outcome assessment in HIV care: relationship with health behaviors and outcomes.

We assessed acceptability/usability of tablet-based patient-reported outcome (PRO) assessments among patients in HIV care, and relationships with health outcomes using a modified Acceptability E-Scale (AES) within a self-administered PRO assessment. Using multivariable linear regression, we measured associations between patient characteristics and continuous combined AES score. Among 786 patients (median age=48; 91% male; 49% white; 17% Spanish-speaking) overall mean score was 26/30 points (SD: 4.4). Mean scores per dimension (max 5, 1=lowest acceptability, 5=highest): ease of use 4.7, understandability 4.7, time burden 4.3, overall satisfaction 4.3, helpfulness describing symptoms/behaviors 4.2, and enjoyability 3.8. Higher overall score was associated with race/ethnicity (+1.3 points/African-American patients (95%CI:0.3-2.3); +1.6 points/Latino patients (95%CI:0.9-2.3) compared to white patients). Patients completing PROs in Spanish scored +2.4 points on average (95%CI:1.6-3.3). Higher acceptability was associated with better quality of life (0.3 points (95%CI:0.2-0.5)) and adherence (0.4 points (95%CI:0.2-0.6)). Lower acceptability was associated with: higher depression symptoms (-0.9 points (95%CI:-1.4 to -0.4)); recent illicit opioid use (-2.0 points (95%CI:-3.9 to -0.2)); multiple recent sex partners (-0.8 points (95%CI:-1.5 to -0.1)). While patients endorsing depression symptoms, recent opioid use, condomless sex, or multiple sex partners found PROs less acceptable, overall, patients found the assessments highly acceptable and easy to use.

A Comparison of Adherence Timeframes Using Missed Dose Items and Their Associations with Viral Load in Routine Clinical Care: Is Longer Better?

Questions remain regarding optimal timeframes for asking about adherence in clinical care. We compared 4-, 7-, 14-, 30-, and 60-day timeframe missed dose items with viral load levels among 1099 patients on antiretroviral therapy in routine care. We conducted logistic and linear regression analyses examining associations between different timeframes and viral load using Bayesian model averaging (BMA). We conducted sensitivity analyses with subgroups at increased risk for suboptimal adherence (e.g. patients with depression, substance use). The 14-day timeframe had the largest mean difference in adherence levels among those with detectable and undetectable viral loads. BMA estimates suggested the 14-day timeframe was strongest overall and for most subgroups although findings differed somewhat for hazardous alcohol users and those with current depression. Adherence measured by all missed dose timeframes correlated with viral load. Adherence calculated from intermediate timeframes (e.g. 14-day) appeared best able to capture adherence behavior as measured by viral load.

Provider perceptions of the value of same-day, electronic patient-reported measures for use in clinical HIV care.

Strong evidence suggests that patient-reported outcomes (PROs) aid in managing chronic conditions, reduce omissions in care, and improve patient-provider communication. However, provider acceptability of PROs and their use in clinical HIV care is not well known. We interviewed providers (n = 27) from four geographically diverse HIV and community care clinics in the US that have integrated PROs into routine HIV care, querying perceived value, challenges, and use of PRO data. Perceived benefits included the ability of PROs to identify less-observable behaviors and conditions, particularly suicidal ideation, depression, and substance use; usefulness in agenda setting prior to a visit; and reduction of social desirability bias in patient-provider communication. Challenges included initial flow integration issues and ease of interpretation of PRO feedback. Providers value same-day, electronic patient-reported measures for use in clinical HIV care with the condition that PROs are (1) tailored to be the most clinically relevant to their population; (2) well integrated into clinic flow; and (3) easy to interpret, highlighting chief patient concerns and changes over time.

Lessons learned from the design and implementation of myocardial infarction adjudication tailored for HIV clinical cohorts.

We developed, implemented, and evaluated a myocardial infarction (MI) adjudication protocol for cohort research of human immunodeficiency virus. Potential events were identified through the centralized Centers for AIDS Research Network of Integrated Clinical Systems data repository using MI diagnoses and/or cardiac enzyme laboratory results (1995-2012). Sites assembled de-identified packets, including physician notes and results from electrocardiograms, procedures, and laboratory tests. Information pertaining to the specific antiretroviral medications used was redacted for blinded review. Two experts reviewed each packet, and a third review was conducted if discrepancies occurred. Reviewers categorized probable/definite MIs as primary or secondary and identified secondary causes of MIs. The positive predictive value and sensitivity for each identification/ascertainment method were calculated. Of the 1,119 potential events that were adjudicated, 294 (26%) were definite/probable MIs. Almost as many secondary (48%) as primary (52%) MIs occurred, often as the result of sepsis or cocaine use. Of the patients with adjudicated definite/probable MIs, 78% had elevated troponin concentrations (positive predictive value = 57%, 95% confidence interval: 52, 62); however, only 44% had clinical diagnoses of MI (positive predictive value = 45%, 95% confidence interval: 39, 51). We found that central adjudication is crucial and that clinical diagnoses alone are insufficient for ascertainment of MI. Over half of the events ultimately determined to be MIs were not identified by clinical diagnoses. Adjudication protocols used in traditional cardiovascular disease cohorts facilitate cross-cohort comparisons but do not address issues such as identifying secondary MIs that may be common in persons with human immunodeficiency virus.

Unannounced telephone-based pill counts: a valid and feasible method for monitoring adherence.

Phone-based unannounced pill counts to measure medication adherence are much more practical and less expensive than home-based unannounced pill counts, but their validity has not been widely assessed. We examined the validity of phone versus home-based pill counts using a simplified protocol streamlined for studies embedded in clinical care settings. A total of 100 paired counts were used to compare concordance between unannounced phone and home-based pill counts using interclass correlations. Discrepancy analyses using χ(2) tests compared demographic and clinical characteristics across patients who were concordant between phone and home-based pill counts and patients who were not concordant. Concordance was high for phone-based and home-based unannounced total pill counts, as well as individual medication counts and calculated adherence. This study demonstrates that a simplified phone-based pill count protocol can be implemented among patients from a routine clinical care setting and is a feasible means of monitoring medication adherence.

Development and usability testing of a web-based cancer symptom and quality-of-life support intervention.

The feasibility and acceptability of computerized screening and patient-reported outcome measures have been demonstrated in the literature. However, patient-centered management of health information entails two challenges: gathering and presenting data using "patient-tailored" methods and supporting "patient-control" of health information. The design and development of many symptom and quality-of-life information systems have not included opportunities for systematically collecting and analyzing user input. As part of a larger clinical trial, the Electronic Self-Report Assessment for Cancer-II project, participatory design approaches were used to build and test new features and interfaces for patient/caregiver users. The research questions centered on patient/caregiver preferences with regard to the following: (a) content, (b) user interface needs, (c) patient-oriented summary, and (d) patient-controlled sharing of information with family, caregivers, and clinicians. Mixed methods were used with an emphasis on qualitative approaches; focus groups and individual usability tests were the primary research methods. Focus group data were content analyzed, while individual usability sessions were assessed with both qualitative and quantitative methods. We identified 12 key patient/caregiver preferences through focus groups with 6 participants. We implemented seven of these preferences during the iterative design process. We deferred development for some of the preferences due to resource constraints. During individual usability testing (n = 8), we were able to identify 65 usability issues ranging from minor user confusion to critical errors that blocked task completion. The participatory development model that we used led to features and design revisions that were patient centered. We are currently evaluating new approaches for the application interface and for future research pathways. We encourage other researchers to adopt user-centered design approaches when building patient-centered technologies.

Integrating a web-based, patient-administered assessment into primary care for HIV-infected adults.

Providers routinely under diagnose at risk behaviors and outcomes, including depression, suicidal ideation, substance abuse, and poor medication adherence. To address this, we developed a web-based, self-administered patient-reported assessment tool and integrated it into routine primary care for HIV-infected adults. Printed results were delivered to providers and social workers immediately prior to patient appointments. The assessment included brief, validated instruments measuring clinically relevant domains including depression, substance use, medication adherence, and HIV transmission risk behaviors. Utilizing the Institute for Healthcare Improvement's Plan-Do-Study-Act (PDSA) approach to quality improvement, we addressed issues with clinic flow, technology, scheduling, and delivery of assessment results with the support of all levels of clinic staff. We found web-based patient-reported assessments to be a feasible tool that can be integrated into a busy multi-provider HIV primary care clinic. These assessments may improve provider recognition of key patient behaviors and outcomes. Critical factors for successful integration of such assessments into clinical care include: strong top-level /ort from clinic management, provider understanding of patient-reported assessments as a valuable clinical tool, tailoring the assessment to meet provider needs, communication among clinic staff to address flow issues, timeliness of delivery, and sound technological resources.

Integrating public health applications with commercial EMRs.

At HIMSS 2007, we demonstrated how three processes of public health agencies could be facilitated through use of a prototype health information exchange, satisfying the AHIC biosurveillance use case.

Barriers to the use of a personal health record by an elderly population.

Personal health records(PHRs) are proposed as a strategy to make health care delivery increasingly patient-centered. Yet little work has been done in understanding the workflows of patients in their own homes, or influence of access, cognitive, physical, or literacy barriers on workflow and outcomes of using health records. Many populations may require assistance in using PHRs to improve their health out-comes. We studied PHR use by an elderly and disabled population and describe those barriers encountered by our patients.

Distributed health assessment and intervention research software framework.

The DHAIR software system is a database-driven, web-based survey platform. It implements the delivery of survey instruments in packaged assessments, creation and editing of those assessments, researcher access to the results of the survey application, and a flexible authorization framework.

Feasibility of data exchange with a Patient-centered Health Record.

A patient-centered health record is a personal health record that is patient-owned, patient-managed, and that represents the health information important to patients in the ways they prefer to represent it. The Patient-centered Health Record (PcHR) was developed to address these needs. Integration with traditional electronic health records adds significant value, and we used a national showcase to demonstrate the feasibility of exchanging health information through document level interoperability with commercial enterprise clinical systems.

Patient-centered design for a personal health record system.

Our objective for this project was to design a user interface (UI) for a patient-centered personal health record system that models how patients view their health information. We assessed user needs, examined how patients label and categorize health information, and evaluated two user interfaces that we designed for the Patient-Centered Health Record (PcHR) system. Our design process focused on discovering useful content and ensuring that the UI was intuitive, easy to use, and helpful for users.

User-driven design of a computerized rounding and sign-out application.

Clinical information systems depend on close integration to workflow for success. We describe a method for user-driven design that guided our development of a computerized rounding and sign-out system. The resulting system supported clinical workflow sufficiently well that it spontaneously attracted new users, required no training, and is currently used by 95% of the house staff at two academic medical centers.

Developing a relational XML schema for sharing HIV clinical data.

Access to multi-site clinical data regarding treatment and outcomes of HIV-infected patients in routine care is required to support clinical research to improve the treatment of HIV. As part of the NIAID-funded CFAR Network of Integrated Clinical Systems (CNICS), we have developed a relational XML Schema to extend the existing observational research repository and to integrate real-time clinical information from electronic medical records (EMRs) at six Centers for AIDS Research (CFAR) into the repository. The schema will aid the expansion of the research repository beyond the initial sites, and the development process may facilitate the use of multi-site repositories to study other chronic diseases.

Acceptability of an Internet treatment decision support program for men with prostate cancer.

We have implemented a customized Internet decision support system designed to engage men in the decision-making process for the management of localized prostate cancer. The system is delivered to patients in the patient education room of the UWMC Prostate Oncology Center. The system interactively guides the patient through a series of surveys, and delivers multi-media interaction modeling and decision support output, both of which are customized for the patient's preferences. The system is currently implemented on an open source platform.

National Pharmaceutical Stockpile drill analysis using XML data collection on wireless Java phones.

This study describes an informatics effort to track subjects through a National Pharmaceutical Stockpile (NPS) distribution drill. The drill took place in Seattle on 1/24/2002. Washington and the State Department of Health are among the first in the nation to stage a NPS drill testing the distribution of medications to mock patients, thereby testing the treatment capacity of the plan given a post-anthrax exposure scenario. The goal of the Public Health Informatics Group at the University of Washington (www.phig.washington.edu) was to use informatics approaches to monitor subject numbers and elapsed time. This study compares accuracy of time measurements using a mobile phone Java application to traditional paper recording in a live drill of the NPS. Pearson correlation = 1.0 in 2 of 3 stations. Differences in last station measurements can be explained by delay in recording of the exit time. We discuss development of the application itself and lessons learned. (MeSH Bioterrorism, Informatics, Public Health)

Communicable disease case entry using PDAs and public wireless networks.

Concerns about detecting and responding to attacks with biowarfare agents have resulted in the development of deployable case reporting systems, e.g. RSVP. We implement a proof of concept web-based information system to be used securely from personal digital assistants over public wireless networks, by public health field workers for routine and emergent case reporting. The system collects data for a local health jurisdiction, provides content- and event-based notification, and forwards case reports to the Colorado State communicable disease reporting system (CEDRS). We believe this demonstrates a useful integration of portable and web-based technologies with public health practice.

IML: An image markup language.

Image Markup Language is an extensible markup language (XML) schema used to describe both image metadata and annotations. It describes both data pertaining to an entire image, and data that are tied to specific regions or features of the image. Developed for a specific domain in Medical Education, this pa-per describes extensions to take advantage of the Dublin Core metadata standard, and of an XML schema for vector graphics representation. We have developed a prototype system of open source tools implementing an authoring system, a client system, and an image annotation database which can be queried though the Web.

Loxosceles arizonica bite associated with shock.

Envenomation by the brown recluse spider (Loxosceles reclusa) is associated with shock, significant hemolysis, renal insufficiency, and disseminated intravascular coagulation (DIC). Shock has never been associated with envenomation by L arizonica, a related species indigenous to Arizona, southern California, and northwestern Mexico. We report the case of a 13-year-old girl, bitten by a specimen of L arizonica (the spider was identified by an entomologist), in whom shock and a typical cutaneous lesion developed. She did not experience renal insufficiency or disseminated intravascular coagulation. Infectious causes of shock were excluded. She recovered completely with supportive care.