Giving patients granular control of personal health information: Using an ethics ‘Points to Consider’ to inform informatics system designers

Objective: There are benefits and risks of giving patients more granular control of their personal health information in electronic health record (EHR) systems. When designing EHR systems and policies, informaticists and system developers must balance these benefits and risks. Ethical considerations should be an explicit part of this balancing. Our objective was to develop a structured ethics framework to accomplish this. Methods: We reviewed existing literature on the ethical and policy issues, developed an ethics framework called a “Points to Consider” (P2C) document, and convened a national expert panel to review and critique the P2C. Results: We developed the P2C to aid informaticists designing an advanced query tool for an electronic health record (EHR) system in Indianapolis. The P2C consists of six questions (“Points”) that frame important ethical issues, apply accepted principles of bioethics and Fair Information Practices, comment on how questions might be answered, and address implications for patient care. Discussion: The P2C is intended to clarify whatis at stake when designers try to accommodate potentially competing ethical commitments and logistical realities. The P2C was developed to guide informaticists who were designing a query tool in an existing EHR that would permit patient granular control. While consideration of ethical issues is coming to the forefront of medical informatics design and development practices, more reflection is needed to facilitate optimal collaboration between designers and ethicists. This report contributes to that discussion

Points to consider in ethically constructing patient-controlled electronic health records

Patient advocates and leaders in informatics have long proposed that patients should have greater ability to control the information in their electronic health record (EHR), including how it can be accessed by their health care providers. The value of such “granular” control, as it has been termed, has been supported prominently in an influential report by the President’s Council of Advisors on Science and Technology (PCAST). Recently, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) funded several projects to study key components of EHR systems, including exploring ways to allow granular control. This “Points to Consider” document provides an overview of the benefits, risks and challenges of granular control of EHRs; a review of the key ethical principles, values, and Fair Information Practices that ought to guide development of an EHR that accommodates granular control, and seven detailed Points to Consider to guide decision making.Award No: 90HT0054/01, a cooperative agreement program from the US Department of Health and Human Services, Office of the National Coordinator for Health IT to Indiana Health Information Technology, Inc. (IHIT) under the State HIE – Challenge Grant Program to the Indiana University School of Medicine and Regenstrief Institute, Inc

Patient Preferences in Controlling Access to Their Electronic Health Records: a Prospective Cohort Study in Primary Care

Introduction: Previous studies have measured individuals’ willingness to share personal information stored in electronic health records (EHRs) with health care providers, but none has measured preferences among patients when they are allowed to determine the parameters of provider access. Methods: Patients were given the ability to control access by doctors, nurses, and other staff in a primary care clinic to personal information stored in an EHR. Patients could restrict access to all personal data or to specific types of sensitive information, and could restrict access for a specific time period. Patients also completed a survey regarding their understanding of and opinions regarding the process. Results: Of 139 eligible patients who were approached, 105 (75.5 %) were enrolled, and preferences were collected from all 105 (100 %). Sixty patients (57 %) did not restrict access for any providers. Of the 45 patients (43 %) who chose to limit the access of at least one provider, 36 restricted access only to all personal information in the EHR, while nine restricted access of some providers to a subset of the their personal information. Thirty-four (32.3 %) patients blocked access to all personal information by all doctors, nurses, and/or other staff, 26 (24.8 %) blocked access by all doctors and/or nurses, and five (4.8 %) denied access to all doctors, nurses, and staff. Conclusions: A significant minority of patients chose to restrict access by their primary care providers to personal information contained in an EHR, and few chose to restrict access to specific types of information. More research is needed to identify patient goals and understanding of the implications when facing decisions of this sort, and to identify the impact of patient education regarding information contained in EHRs and their use in the clinical care settin

Provider Responses to Patients Controlling Access to their Electronic Health Records: A Prospective Cohort Study in Primary Care

Introduction: Applying Fair Information Practice principles to electronic health records (EHRs) requires allowing patient control over who views their data. Methods: We designed a program that captures patients’ preferences for provider access to an urban health system’s EHR. Patients could allow or restrict providers’ access to all data (diagnoses, medications, test results, reports, etc.) or only highly sensitive data (sexually transmitted infections, HIV/AIDS, drugs/alcohol, mental or reproductive health). Except for information in free-text reports, we redacted EHR data shown to providers according to patients’ preferences. Providers could “Break the Glass” to display redacted information. We prospectively studied this system in one primary care clinic, noting redactions and when users “Broke the Glass,” and surveyed providers about their experiences and opinions. Results: Eight of 9 eligible clinic physicians and all 23 clinic staff participated. All 105 patients who enrolled completed the preference program.. Providers did not know which of their patients were enrolled and nor their preferences for accessing their EHRs. During the six-month prospective study, 92 study patients (88%) returned 261 times during which providers viewed their EHRs 126 times (48%). Providers “broke the glass” 102 times, 92 times for patients not in the study and 10 times for 6 returning study patients, all of whom had restricted EHR access. Providers “broke the glass” for 6 (14%) of 43 returning study patients with redacted data vs. zero among 49 study patients without redactions (p=0.01). Although 54% of providers agreed that patients should have control over who sees their EHR information, 58% believed restricting EHR access could harm provider-patient relationships and 71% felt quality of care would suffer. Conclusions: Patients frequently preferred restricting provider access to their EHRs. Providers infrequently overrode patients’ preferences to view hidden data. Providers believed restricting EHR access would adversely impact patient care. Applying Fair Information Practice principles to EHRs will require balancing patient preferences, providers’ needs, and health care quality.This study was supported in part by grant number 90HT005 from the Office of the National Coordinator for Health Information Technology (ONC) to the Indiana Health Information Technology Corporation. The opinions expressed in this work are the authors’ and do not necessarily reflect the positions of ONC, IHIT, Eskenazi Health, Indiana University, or the Regenstrief Institute, Inc

Submaximal Oxygen Uptake Kinetics, Functional Mobility, and Physical Activity in Older Adults with Heart Failure and Reduced Ejection Fraction

Background: Submaximal oxygen uptake measures are more feasible and may better predict clinical cardiac outcomes than maximal tests in older adults with heart failure (HF). We examined relationships between maximal oxygen uptake, submaximal oxygen kinetics, functional mobility, and physical activity in older adults with HF and reduced ejection fraction. Methods: Older adults with HF and reduced ejection fraction (n = 25, age 75 ± 7 years) were compared to 25 healthy age- and gender-matched controls. Assessments included a maximal treadmill test for peak oxygen uptake (VO2peak), oxygen uptake kinetics at onset of and on recovery from a submaximal treadmill test, functional mobility testing [Get Up and Go (GUG), Comfortable Gait Speed (CGS), Unipedal Stance (US)], and self-reported physical activity (PA). Results: Compared to controls, HF had worse performance on GUG, CGS, and US, greater delays in submaximal oxygen uptake kinetics, and lower PA. In controls, VO2peak was more strongly associated with functional mobility and PA than submaximal oxygen uptake kinetics. In HF patients, submaximal oxygen uptake kinetics were similarly associated with GUG and CGS as VO2peak, but weakly associated with PA. Conclusions: Based on their mobility performance, older HF patients with reduced ejection fraction are at risk for adverse functional outcomes. In this population, submaximal oxygen uptake measures may be equivalent to VO2 peak in predicting functional mobility, and in addition to being more feasible, may provide better insight into how aerobic function relates to mobility in older adults with HF

Ice cloud formation potential by free tropospheric particles from long-range transport over the Northern Atlantic Ocean

Long-range transported free tropospheric particles can play a significant role on heterogeneous ice nucleation. Using optical and electron microscopy we examine the physicochemical characteristics of ice nucleating particles (INPs). Particles were collected on substrates from the free troposphere at the remote Pico Mountain Observatory in the Azores Islands, after long-range transport and aging over the Atlantic Ocean. We investigate four specific events to study the ice formation potential by the collected particles with different ages and transport patterns. We use single-particle analysis, as well as bulk analysis to characterize particle populations. Both analyses show substantial differences in particle composition between samples from the four events; in addition, single-particle microscopy analysis indicates that most particles are coated by organic material. The identified INPs contained mixtures of dust, aged sea salt and soot, and organic material acquired either at the source or during transport. The temperature and relative humidity (RH) at which ice formed, varied only by 5% between samples, despite differences in particle composition, sources, and transport patterns. We hypothesize that this small variation in the onset RH may be due to the coating material on the particles. This study underscores and motivates the need to further investigate how long-range transported and atmospherically aged free tropospheric particles impact ice cloud formatio

Sacral nerve stimulation allows for decreased antegrade continence enema use in children with severe constipation.

BackgroundSacral nerve stimulation (SNS) can be beneficial for children with constipation, but no studies have focused on children with constipation severe enough to require antegrade continence enemas (ACEs). Our objective was to evaluate the efficacy of SNS in children with constipation treated with ACE.MethodsUsing a prospective patient registry, we identified patients <21years old who were receiving ACE prior to SNS placement. We compared ACE/laxative usage, PedsQL Gastrointestinal Symptom Scale (GSS), Fecal Incontinence Quality of Life Scale (FIQL), Fecal Incontinence Severity Index (FISI), and Vancouver Dysfunctional Elimination Syndrome Score (DES) at baseline and progressive follow-up time intervals.ResultsTwenty-two patients (55% male, median 12years) were included. Median ACE frequency decreased from 7 per week at baseline to 1 per week at 12months (p<0.0001). Ten children (45%) had their cecostomy/appendicostomy closed. Laxative use, GSS, FIQL, and DES did not change. FISI improved over the first 12months with statistical significance reached only at 6months (p=0.02). Six (27%) children experienced complications after SNS that required further surgery.ConclusionsIn children with severe constipation dependent on ACE, SNS led to a steady decrease in ACE usage with nearly half of patients receiving cecostomy/appendicostomy closure within 2years.Level of evidenceIV

Multidrug-Resistant Tuberculosis in Patients without HIV Infection

BACKGROUND Investigations of outbreaks of multidrug-resistant tuberculosis have found low rates of treatment response and very high mortality, and they have mainly involved patients with advanced human immunodeficiency virus (HIV) infection. For patients without HIV infection, one study reported an overall rate of response to treatment of 56 percent, and the mortality from tuberculosis was 22 percent. We investigated treatment response and mortality rates in 26 HIV-negative patients in New York with multidrug-resistant tuberculosis. METHODS We obtained detailed data from seven teaching hospitals in New York City on patients with multidrug-resistant tuberculosis--defined as tuberculosis resistant at least to isoniazid and rifampin--who were HIV-negative on serologic testing. Lengths of times from diagnosis to the initiation of appropriate therapy and from the initiation of appropriate therapy to conversion to negative cultures were assessed. Therapeutic responses were evaluated by both microbiologic and clinical criteria. RESULTS Between March 1991 and September 1994, 26 HIV-negative patients were identified and treated. Of the 25 patients for whom adequate data were available for analysis, 24 (96 percent) had clinical responses; all 17 patients for whom data on microbiologic response were available had such a response. The median times from diagnosis to the initiation of appropriate therapy and from the initiation of therapy to culture conversion were 44 days (range, 0 to 181) and 69 days (range, 2 to 705), respectively. Side effects requiring the discontinuation of medication occurred in 4 of 23 patients (17 percent) who were treated with second-line antituberculosis medications. The median follow-up for the 23 patients who responded and who received appropriate therapy was 91 weeks (range, 41 to 225). CONCLUSIONS In this report from New York City, HIV-negative patients with multidrug-resistant tuberculosis, contrary to previous reports, responded well to appropriate chemotherapy, both clinically and microbiologically