William B. Lober

Implementing Syndromic Surveillance: A Practical Guide Informed by the Early Experience

Syndromic surveillance refers to methods relying on detection of individual and population health indicators that are discernible before confirmed diagnoses are made. In particular, prior to the laboratory confirmation of an infectious disease, ill persons may exhibit behavioral patterns, symptoms, signs, or laboratory findings that can be tracked through a variety of data sources. Syndromic surveillance systems are being developed locally, regionally, and nationally. The efforts have been largely directed at facilitating the early detection of a covert bioterrorist attack, but the technology may also be useful for general public health, clinical medicine, quality improvement, patient safety, and research. This report, authored by developers and methodologists involved in the design and deployment of the first wave of syndromic surveillance systems, is intended to serve as a guide for informaticians, public health managers, and practitioners who are currently planning deployment of such systems in their regions.

Enhancing Patient-Provider Communication With the Electronic Self-Report Assessment for Cancer: A Randomized Trial

PURPOSE Although patient-reported cancer symptoms and quality-of-life issues (SQLIs) have been promoted as essential to a comprehensive assessment, efficient and efficacious methods have not been widely tested in clinical settings. The purpose of this trial was to determine the effect of the Electronic Self-Report Assessment-Cancer (ESRA-C) on the likelihood of SQLIs discussed between clinicians and patients with cancer in ambulatory clinic visits. Secondary objectives included comparison of visit duration between groups and usefulness of the ESRA-C as reported by clinicians. PATIENTS AND METHODS This randomized controlled trial was conducted in 660 patients with various cancer diagnoses and stages at two institutions of a comprehensive cancer center. Patient-reported SQLIs were automatically displayed on a graphical summary and provided to the clinical team before an on-treatment visit (n = 327); in the control group, no summary was provided (n = 333). SQLIs were scored for level of severity or distress. One on-treatment clinic visit was audio recorded for each participant and then scored for discussion of each SQLI. We hypothesized that problematic SQLIs would be discussed more often when the intervention was delivered to the clinicians. RESULTS The likelihood of SQLIs being discussed differed by randomized group and depended on whether an SQLI was first reported as problematic (P = .032). Clinic visits were similar with regard to duration between groups, and clinicians reported the summary as useful. CONCLUSION The ESRA-C is the first electronic self-report application to increase discussion of SQLIs in a US randomized clinical trial.

Cohort profile: the Centers for AIDS Research Network of Integrated Clinical Systems

Highly active antiretroviral therapy (HAART) delays disease progression and death. However, the treatments incompletely control HIV replication, only partially restore immune function, have significant shortand long-term toxicities, and eventually fail in many patients with consequent development of HIV drug resistance. Thus, there is increasing need for information to guide HIV-infected patients and their providers in making decisions regarding optimal use of antiretroviral therapies. Although clinical trials provide valuable information about efficacy and side effects of antiretroviral treatment, they have limited size, duration and power to detect effects on clinical outcomes, focusing instead on surrogate endpoints such as virologic failure, treatment discontinuation or composite outcome measures. Outside the clinical trial setting, there is tremendous heterogeneity among HIV-infected patients. The prevalence and impact of important health conditions such as hepatitis C virus (HCV) co-infection, mental illness and substance abuse likely contribute to increased toxicity and decreased clinical effectiveness of HAART regimens among the broader spectrum of patients treated in routine care. Cohorts with significant diversity in HIV disease severity, comorbidities and demographic distributions are required to provide information regarding long-term outcomes and complications of HIV infection in the modern HAART era. The Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) was created to better define the relationship between patient and treatment factors and long-term clinical outcomes among HIV-infected patients in the HAART era. The CFARs are a national network of centres of excellence for HIV care and research established by the National Institutes of Health (NIH) whose mission is to support a multi-disciplinary environment for basic, clinical, epidemiologic, behavioural and translational research in the prevention, detection and treatment of HIV infection and AIDS. There are 19 CFARs located at academic and research institutions throughout the United States. The objective of the CNICS project is to integrate clinical data from the large and diverse population of HIV-infected persons receiving care at CFAR sites to investigate questions related to HIV disease management that cannot be readily addressed through traditional randomized controlled clinical trials and other cohort studies. Investigators with expertise in basic, clinical, translational and epidemiologic research, in addition to medical informatics, are collaborating on the CNICS project. The potential to build a comprehensive clinical data repository for HIV disease was greatly advanced by the work of CFAR investigators at the participating CNICS sites who had instituted point-of-care electronic medical record systems (EMRs) with the dual purpose of providing real-time clinical information to facilitate the delivery of HIV care and capturing standardized clinical data to support populationbased HIV research. The initial four CNICS sites were Case Western Reserve University, University of * Corresponding author. Center for AIDS Research, University of Washington, 325 9th Ave, MS 359931, Seattle, WA 98104, USA. E-mail: kitahata@u.washington.edu 1 Department of Medicine, University of Washington, Seattle, 98195, USA. 2 Department of Medicine, Case Western Reserve University, Cleveland, 44106, USA. 3 Department of Medicine, University of California, San Diego, 92110, USA. 4 Department of Medicine, Harvard University, Boston, 02115, USA. 5 Department of Medicine, Johns Hopkins University, Baltimore, 21218, USA. 6 Department of Medicine, University of Alabama, Birmingham, 35209, USA. 7 Department of Medicine, University of California, San Francisco, 94143, USA. Published by Oxford University Press on behalf of the International Epidemiological Association

Roundtable on bioterrorism detection: information system-based surveillance.

During the 2001 AMIA Annual Symposium, the Anesthesia, Critical Care, and Emergency Medicine Working Group hosted the Roundtable on Bioterrorism Detection. Sixty-four people attended the roundtable discussion, during which several researchers discussed public health surveillance systems designed to enhance early detection of bioterrorism events. These systems make secondary use of existing clinical, laboratory, paramedical, and pharmacy data or facilitate electronic case reporting by clinicians. This paper combines case reports of six existing systems with discussion of some common techniques and approaches. The purpose of the roundtable discussion was to foster communication among researchers and promote progress by 1) sharing information about systems, including origins, current capabilities, stages of deployment, and architectures; 2) sharing lessons learned during the development and implementation of systems; and 3) exploring cooperation projects, including the sharing of software and data. A mailing list server for these ongoing efforts may be found at http://bt.cirg.washington.edu.

Challenges to Using an Electronic Personal Health Record by a Low-income Elderly Population

Background Electronic personal health records (PHRs) are increasingly recognized and used as a tool to address various challenges stemming from the scattered and incompatible personal health information that exists in the contemporary US health care system. Although activity around PHR development and deployment has increased in recent years, little has been reported regarding the use and utility of PHRs among low-income and/or elderly populations. Objective The aim was to assess the use and utility of PHRs in a low-income, elderly population. Methods We deployed a Web-based, institution-neutral PHR system, the Personal Health Information Management System (PHIMS), in a federally funded housing facility for low-income and elderly residents. We assessed use and user satisfaction through system logs, questionnaire surveys, and user group meetings. Results Over the 33-month study period, 70 residents participated; this number was reduced to 44 by the end of the study. Although the PHIMS was available for free and personal assistance and computers with Internet connection were provided without any cost to residents, only 13% (44/330) of the eligible residents used the system, and system usage was limited. Almost one half of the users (47%, 33/70) used the PHIMS only on a single day. Use was also highly correlated with the availability of in-person assistance; 77% of user activities occurred while the assistance was available. Residents’ ability to use the PHR system was limited by poor computer and Internet skills, technophobia, low health literacy, and limited physical/cognitive abilities. Among the 44 PHIMS users, 14 (32%) responded to the questionnaire. In this selected subgroup of survey participants, the majority (82%, 9/11) used the PHIMS three times or more and reported that it improved the quality of overall health care they received. Conclusions Our findings suggest that those who can benefit the most from a PHR system may be the least able to use it. Disparities in access to and use of computers, the Internet, and PHRs may exacerbate health care inequality in the future.

Depression screening using the Patient Health Questionnaire-9 administered on a touch screen computer

Objective: To (1) evaluate the feasibility of touch screen depression screening in cancer patients using the Patient Health Questionnaire‐9 (PHQ‐9), (2) evaluate the construct validity of the PHQ‐9 using the touch screen modality, and (3) examine the prevalence and severity of depression using this screening modality.

Routine Collection of Patient-Reported Outcomes in an HIV Clinic Setting:The First 100 Patients

BACKGROUND Information from patient-reported outcomes (PROs) can enhance patient-provider communication and facilitate clinical research. However, there are barriers to collecting PROs within a clinic. Recent technological advances may help overcome these barriers. We examined the feasibility of using a web-based application on tablet PCs with touch screens to collect PROs in a busy, multi-provider, outpatient HIV clinical care setting. METHODS Patients presenting for routine care were asked to complete a touch-screen-based assessment containing 62 to 111 items depending on patient responses. The assessment included instruments measuring body morphology abnormalities, depression, symptom burden, medication adherence, drug/alcohol/tobacco use, and health-related quality of life. RESULTS Of 136 patients approached to participate in the study, 106 patients (78%) completed the assessment, 6 (4%) started but did not complete it, and 24 (18%) refused. Of those who completed the assessment, the mean age was 48 years, and 29% reported a history of injection drug use. The median time to complete the assessment was 12 minutes. The prevalence of lipoatrophy was 51%, the prevalence of lipohypertrophy was 69%, and the prevalence of moderate or severe depression was 51%. We found that 25% of those receiving highly active antiretroviral therapy noted missing a dose of their antiretroviral medications in the prior 4 days. CONCLUSIONS Collection of PROs using touch-screen-based, internet technology was feasible in a busy HIV clinic. We found a high prevalence of body morphology abnormalities, depression, and poor adherence. Touch-screen-based collection of PROs is a promising tool to facilitate research and clinical care.

Electronic Self-Report Assessment for Cancer and Self-Care Support: Results of a Multicenter Randomized Trial

PURPOSE The purpose of this trial was to evaluate the effect of a Web-based, self-report assessment and educational intervention on symptom distress during cancer therapy. PATIENTS AND METHODS A total of 752 ambulatory adult participants were randomly assigned to symptom/quality-of-life (SxQOL) screening at four time points (control) versus screening, targeted education, communication coaching, and the opportunity to track/graph SxQOL over time (intervention). A summary of the participant-reported data was delivered to clinicians at each time point in both groups. All participants used the assessment before a new therapeutic regimen, at 3 to 6 weeks and 6 to 8 weeks later, completing the final assessment at the end of therapy. Change in Symptom Distress Scale-15 (SDS-15) score from pretreatment to end of study was compared using analysis of covariance and regression analysis adjusting for selected variables. RESULTS We detected a significant difference between study groups in mean SDS-15 score change from baseline to end of study: 1.27 (standard deviation [SD], 6.7) in the control group (higher distress) versus -0.04 (SD, 5.8) in the intervention group (lower distress). SDS-15 score was reduced by an estimated 1.21 (95% CI, 0.23 to 2.20; P = .02) in the intervention group. Baseline SDS-15 score (P < .001) and clinical service (P = .01) were predictive. Multivariable analyses suggested an interaction between age and study group (P = .06); in subset analysis, the benefit of intervention was strongest in those age > 50 years (P = .002). CONCLUSION Web-based self-care support and communication coaching added to SxQOL screening reduced symptom distress in a multicenter sample of participants with various diagnoses during and after active cancer treatment. Participants age > 50 years, in particular, may have benefited from the intervention.

Consumer Empowerment in Health Care Amid the Internet and Social Media

OBJECTIVES Consumer empowerment in health and rapid change in health information and communication technologies have their roots in broader social trends. This article reviews the activities at the intersection of consumer empowerment and technology. DATA SOURCES Technical reports, white papers, books, journal articles, and Web sites. CONCLUSION Social trends are visible in the integration of information and communication technologies into health care, in both searching for and sharing information on the Internet, in the use of social media to create new types of interactions with family, providers, and peers, and in the e-patient, who integrates these new roles and new technologies. IMPLICATIONS FOR NURSING PRACTICE Changes in both patients and technology will impact oncology nursing practice as new, patient-centered, interactions emerge.

Computerized symptom and quality-of-life assessment for patients with cancer part I: development and pilot testing.

PURPOSE/OBJECTIVES To develop and test an innovative computerized symptom and quality-of-life (QOL) assessment for patients with cancer who are evaluated for and treated with radiation therapy. DESIGN Descriptive, longitudinal prototype development and cross-sectional clinical data. SETTING Department of radiation oncology in an urban, academic medical center. SAMPLE 101 outpatients who were evaluated for radiation therapy, able to communicate in English (or through one of many interpreters available at the University of Washington), and competent to understand the study information and give informed consent. Six clinicians caring for the patients in the sample were enrolled. METHODS Iterative prototype development was conducted using a standing focus group of clinicians. The software was developed based on survey markup language and implemented in a wireless, Web-based format. Patient participants completed the computerized assessment prior to consultation with the radiation physician. Graphical output pages with flagged areas of symptom distress or troublesome QOL issues were made available to consulting physicians and nurses. MAIN RESEARCH VARIABLES Pain intensity, symptoms, QOL, and demographics. INSTRUMENTS Computerized versions of a 0 to 10 Pain Intensity Numerical Scale (PINS), Symptom Distress Scale, and Short Form-8. FINDINGS Focus group recommendations included clinician priorities of brevity, flexibility, and simplicity for both input interface and output and that the assessment output contain color graphic display. Patient participants included 45 women and 56 men with a mean age of 52.7 years (SD = 13.8). Fewer than half of the participants (40%) reported using a computer on a regular basis (weekly or daily). Completion time averaged 7.8 minutes (SD = 3.7). Moderate to high levels of distress were reported more often for fatigue, pain, and emotional issues than for other symptoms or concerns. CONCLUSIONS Computerized assessment of cancer symptoms and QOL is technically possible and feasible in an ambulatory cancer clinic. A wireless, Web-based system facilitates access to results and data entry and retrieval. The symptom and QOL profiles of these patients new to radiation therapy were comparable to other samples of outpatients with cancer. IMPLICATIONS FOR NURSING The ability to capture an easily interpreted illustration of a patients symptom and QOL experience in less than 10 minutes is a potentially useful adjunct to traditional face-to-face interviewing. Ultimately, electronic patient-generated data could produce automated red flags directed to the most appropriate clinicians (e.g., nurse, pain specialist, social worker, nutritionist) for further evaluation. Such system enhancement could greatly facilitate oncology nurses coordination role in caring for complex patients with cancer.