Design and evaluation of a wireless electronic health records system for field care in mass casualty settings.

BACKGROUND: There is growing interest in the use of technology to enhance the tracking and quality of clinical information available for patients in disaster settings. This paper describes the design and evaluation of the Wireless Internet Information System for Medical Response in Disasters (WIISARD). MATERIALS AND METHODS: WIISARD combined advanced networking technology with electronic triage tags that reported victims' position and recorded medical information, with wireless pulse-oximeters that monitored patient vital signs, and a wireless electronic medical record (EMR) for disaster care. The EMR system included WiFi handheld devices with barcode scanners (used by front-line responders) and computer tablets with role-tailored software (used by managers of the triage, treatment, transport and medical communications teams). An additional software system provided situational awareness for the incident commander. The WIISARD system was evaluated in a large-scale simulation exercise designed for training first responders. A randomized trial was overlaid on this exercise with 100 simulated victims, 50 in a control pathway (paper-based), and 50 in completely electronic WIISARD pathway. All patients in the electronic pathway were cared for within the WIISARD system without paper-based workarounds. RESULTS: WIISARD reduced the rate of the missing and/or duplicated patient identifiers (0% vs 47%, p<0.001). The total time of the field was nearly identical (38:20 vs 38:23, IQR 26:53-1:05:32 vs 18:55-57:22). CONCLUSION: Overall, the results of WIISARD show that wireless EMR systems for care of the victims of disasters would be complex to develop but potentially feasible to build and deploy, and likely to improve the quality of information available for the delivery of care during disasters.

IMPACT4: a framework for rapid, modular construction of web-based patient decision support systems and preference measurement tools.

To support the rapid creation of software systems that provide patients with decision support and measure patients' preferences, we have develop a framework called iMPACT4. The framework, which combines XML and Flash, has rich client-side state navigation control capabilities, reusable components, cross-platform compatibility, and facilitated access for persons with disabilities. It has many of the advanced navigation capabilities of complex server controlled web software while retaining an architecture that allows automated generation of web sites similar to our previous software system iMPACT3.

iMPACT3: Internet-based development and administration of utility elicitation protocols.

iMPACT3 (Internet Multimedia Preference Assessment Instrument Construction Tool, version 3) is a software development environment that helps researchers build Internet-capable multimedia utility elicitation software programs. The program is a free, openly accessible Web site (http.// preferences.ucsd.edu/impact3/asp). To develop a utility elicitation software program using iMPACT3, a researcher selects modular protocol components from a library and custom tailors the components to the details of his or her research protocol. iMPACT3 builds a Web site implementing the protocol and downloads it to the researcher's computer. In a study of 75 HIV-infected patients, an iMPACT3-generated protocol showed substantial evidence of construct validity and good internal consistency (logic error rates of 4% to 10% and procedural invariance error rates of 10% to 28%, depending on the elicitation method) but only fair 3- to 6-week test-retest reliability (intraclass correlation coefficient= 0.42 to 0.55). Further work may be needed on specific utility assessment procedures, but this study's results confirm iMPACT3's feasibility in facilitating the collection of health state utility data.

Can utility-weighted health-related quality-of-life estimates capture health effects of quality improvement for depression?

BACKGROUND: Utility methods that are responsive to changes in desirable outcomes are needed for cost-effectiveness (CE) analyses and to help in decisions about resource allocation. OBJECTIVES: Evaluated is the responsiveness of different methods that assign utility weights to subsets of SF-36 items to average improvements in health resulting from quality improvement (QI) interventions for depression. DESIGN: A group level, randomized, control trial in 46 primary care clinics in six managed care organizations. Clinics were randomized to one of two QI interventions or usual care. SUBJECTS: One thousand one hundred thirty-six patients with current depressive symptoms and either 12-month, lifetime, or no depressive disorder identified through screening 27,332 consecutive patients. MEASURES: Utility weighted SF-12 or SF-36 measures, probable depression, and physical and mental health-related quality of life scores. RESULTS: Several utility-weighted measures showed increases in utility values for patients in one of the interventions, relative to usual care, that paralleled the improved health effects for depression and emotional well being. However, QALY gains were small. Directly elicited utility values showed a paradoxical result of lower utility during the first year of the study for intervention patients relative to controls. CONCLUSIONS: The results raise concerns about the use of direct single-item utility measures or utility measures derived from generic health status measures in effectiveness studies for depression. Choice of measure may lead to different conclusions about the benefit and CE of treatment. Utility measures that capture the mental health and non-health outcomes associated with treatment for depression are needed.

Utility elicitation using single-item questions compared with a computerized interview.

BACKGROUND: The use of a simpler procedure for the measurement of utilities could affect primarily the variance or both the mean and the variance of measurements. In the former case, simpler methods would be useful for population studies of preferences; however, in the latter, their use for such studies might be problematic. PURPOSE: The purpose of this study was to compare the results of utility elicitation using single-item questions to computer elicitation using the Ping-Pong search procedure. METHODS: In a convenience sample of 149 primary care patients with symptoms of depression, the authors measured and compared standard gamble (SG) utilities elicited using a single-item "open question" to SG elicitations performed using a computerized interview procedure. Elicitations were performed 1 to 2 weeks apart to minimize memory effects. RESULTS: More than 90% of persons with utilities of 1.0 to the single-item standard gamble had utilities of less than 1.0 on the computer SG instrument. Consistent with this finding, the mean utilities were lower in computer interviews (0.80 vs. 0.90; P < 0.0001 for differences). Within subjects, utility measures had only a fair degree of correlation (r = 0.54). CONCLUSIONS: Use of single-item questions to elicit utilities resulted in less precise estimates of utilities that were upwardly biased relative to those elicited using a more complex search procedure.

Acceptability of computerized visual analog scale, time trade-off and standard gamble rating methods in patients and the public.

One technique to enhance patient participation in clinical decision making is formal measurement of preferences and values. Three commonly applied methods are a visual analog scale(VAS), the standard gamble(SG), and the time trade-off(TTO). We studied participants subjective experience using computer implementations these methods using scale we call the VIBE (for Value Instrument Battery--Evaluation) that measures four aspects of user acceptance (clarity, difficulty, reasonableness, and comfort level) Studies were performed in two groups: patients with HIV infection (n=75) and a convenience sample of the general public(n=640). In the patient study, VIBE scores appeared reliable (Cronbach s alpha of 0.739, 0.826, and 0.716, for VAS, SG, and TTO ratings, respectively.) Patients acceptance of the VAS the highest, followed by the TTO and the SG method (p<0.05 for all comparisons). Despite significant enhancements in computer software for measuring SG preferences, observed differences in acceptance between SG and VAS methods were replicated in the general public study (p<0.0001 for differences). The results suggest developers of clinical decision support systems should use VAS and TTO rating methods where these methods are theoretically appropriate.

What is the next step in patient decision support?

Patient decision support systems have a promising role in the delivery of health care. However, the best approach for further development of these systems is a matter of speculation. To help chart a course for further development of decision support systems, we consider the four traditional roles that patients play in the medical decision making process, the limitations that patients face in participating in each role and describe how contemporary systems address can facilitate successful decision making for each role. Because patients have a diversity of preferences for the role they play in decision making, we believe that the critical research question is how to make decision support systems robust enough to support a patient's desired role, whatever that role might be. By directing research in decision support systems in this fashion, we believe that they will achieve a larger patient audience and have increased value in the delivery of clinical care.

Differences in health values among patients, family members, and providers for outcomes in schizophrenia.

OBJECTIVE: The objectives of this study were to determine whether there are important differences in how patients, family members, and health care providers (HCPs) value health outcomes in schizophrenia and to assess the degree to which such differences, if they exist, could adversely affect clinical and policy decision making. METHODS: Participants viewed videotaped depictions of simulated patients with mild and moderate symptoms of schizophrenia, with and without a common adverse drug effect (pseudoparkinsonism), and then provided standard gamble and visual analog scale ratings of desirability of these states. SUBJECTS: A convenience sample of unrelated patients (n = 148), family members of patients (n = 91), and HCPs (nurses, psychologists, doctors of pharmacy, and doctors of medicine; n = 99) was drawn from geographically and clinically diverse environments. RESULTS: Patients' and family members' utilities for health states averaged 0.1 to 0.15 units higher than those of HCPs (P <0.002 for differences between groups, ANOVA for multiple observations). The disutility of adverse drug effects was less for health professionals than patients and family members (P = 0.008). Health professionals tended to prefer states with mild symptoms with extrapyramidal side effects to states with moderate symptoms. Patients and family members found these states equally preferable (P <0.007 for differences between groups). CONCLUSIONS: There are systematic differences in values for health outcomes between patients and HCPs with regard to states with adverse effects of antipsychotic drugs. Family members of patients in general had values that were more similar to those of patients than were those of health professionals. The results emphasize the importance of participation by patients (or family member proxies) in clinical decision making and guideline development.

Estimation of utilities for the effects of depression from the SF-12.

BACKGROUND: Utilities for health conditions, including major depressive disorder, have a theoretical relationship to health-related quality of life (HRQOL). Because of the complexity of utility measurement and the existence of large numbers of completed studies with HRQOL data but not utility data, it would be desirable to be able to estimate utilities from measurements of HRQOL. OBJECTIVE: The objective of this study was to estimate utility for remission in major depression by use of information on associated variation in Short Form 12 (SF-12) scores. DESIGN: A mapping function for SF-12 scores (based on a 6-health-state model with patient-weighted preferences) was applied to longitudinal data from a large naturalistic study to estimate changes in utilities. SUBJECTS: Preference ratings for states were performed in a convenience sample of depressed primary care patients (n = 140). Outcomes were evaluated in patients in the Course of Depression Study (n = 295) with a DSM III diagnosis of depression at the onset of the study. MEASURES: From clinical interview data, differences in utilities and global physical and mental health-related quality of life at 1- and 2-year follow-up were compared for patients who did and did not experience remission as determined by the Course of Depression Interview. RESULTS: Remission of depression resulted in health status improvement, as measured by the SF-12, equivalent to a gain of 0.11 quality-adjusted life-years over 2 years. CONCLUSIONS: Utilities for changes in health status, associated with a clinical change in depression, can be modeled from the SF-12 scales, which results in utilities within the range of estimates described in the literature.

Comparison of preferences for health outcomes in schizophrenia among stakeholder groups.

BACKGROUND: To determine the effectiveness of psychiatric interventions for use in cost-effectiveness analysis, we assessed the feasibility of using a multimedia computer survey to study preferences (utilities) for health outcomes among persons with schizophrenia, family members of persons with schizophrenia, health professionals, and the public. METHODS: We developed videos depicting two patterns of mental health impairment in schizophrenia, both with and without pseudo-parkinsonism side-effects. These descriptions were integrated into a computer program that measured preferences using two psychometric methods: (1) standard gamble and (2) a visual analog scale. This program was used to compare preferences among potential stakeholder groups. RESULTS: 20 persons with schizophrenia, 11 family members, 20 healthy volunteers and 14 health professionals participated in the computerized interview. All but one subject completed the survey. The correlation among ratings of various states was high (r=0.7-0.95) and ratings were internally consistent in 89% of participants. There were significant differences in values between groups for health states (p=0.024) and in values for the effects of pseudo-parkinsonism on quality of life (p<0.001). Persons with schizophrenia valued the disease states more highly and placed more significance than did other groups on the effects of pseudo-parkinsonism on quality of life. CONCLUSIONS: Computer-based multimedia techniques can offer a feasible and valid approach to measure preferences for outcomes in schizophrenia. The study found significant differences in preferences among stakeholder groups for schizophrenia outcomes. Further work is needed to clarify how these differences affect clinical decision-making and policies for health resource allocation.

The effects of patient sex and race on medical students' ratings of quality of life.

PURPOSE: Although previous studies have examined race and sex differences in health care, few studies have investigated the possible role of physician bias. We evaluated the influence of race and sex on medical students' perceptions of patients' symptoms to determine if there are differences in these perceptions early in medical training. SUBJECTS AND METHODS: One-hundred sixty-four medical students were randomly assigned to view a video of a black female or white male actor portraying patients with identical symptoms of angina. We evaluated students' perceptions of the actors' health state (based on their assessment of quality of life) using a visual analog scale and a standard rating technique, as well as the type of chest pain diagnosis. RESULTS: Students assigned a lower value (indicating a less desirable health state) to the black woman than to the white man with identical symptoms [visual scale (mean +/- SD): 72 +/- 13 vs 67 +/- 12, P <0.02; standard gamble: 87 +/- 10 vs 80 +/- 15, P < 0.001). Nonminority students reported higher mean values for the white male patient (standard gamble: 89 +/- 8 vs 81 +/- 14 for the black female patient), whereas minority students' assessments did not differ by patient. Male students assigned a slightly lower value to the black female patient (standard gamble: 76 +/- 16 vs 87 +/- 10 for the white male patient). Students were less likely to characterize the black female patient's symptoms as angina (46% vs 74% for the white male patient, P = 0.001). CONCLUSIONS: The way that medical students perceive patient symptoms appears to be affected by nonmedical factors.

The risks of multimedia methods: effects of actor's race and gender on preferences for health states.

OBJECTIVE: While the use of multimedia methods in medical education and decision support can facilitate learning, it also has certain hazards. One potential hazard is the inadvertent triggering of racial and gender bias by the appearance of actors or patients in presentations. The authors hypothesized that race and gender affect preferences. To explore this issue they studied the effects of actors' race and gender on preference ratings for health states that include symptoms of schizophrenia. DESIGN: A convenience sample of patients with schizophrenia, family members of patients, and health professionals was used. Participants were randomly assigned to rate two health states, one portrayed by either a man of mixed race (Hispanic-black) or a white man and the second portrayed by either a white woman or a white man. MEASUREMENTS: Visual analog scale (VAS) and standard gamble ratings of health state preferences for health states that include symptoms of mild and moderate schizophrenia. RESULTS: Studies of the effects of the race of the actor (n = 114) revealed that racial mismatch between the actor and the participant affected the participant's preferences for health states. Ratings were lower when racial groups differed (mean difference, 0.098 for visual analog scale ratings and 0.053 lower in standard gamble, P = 0.006 for interactions between the race of the subject and the actor). In studies of the effects of a female actress on ratings (n = 117), we found no evidence of a corresponding interaction between the gender of the actor and the study participant. Rather, an interaction between actor's gender and method of assessment was observed. Standard gamble ratings (difference between means, 0.151), but not visual analog scale ratings (difference, 0.005), were markedly higher when the state was portrayed by the actress (P = 0.003 for interactions between actor's gender and method of preference assessment). Differential effects on standard gamble ratings suggest that an actor's gender may influence the willingness of viewers to gamble to gain health benefits (or risk attitude). CONCLUSIONS: Educators and researchers considering the use of multimedia methods for decision support need to be aware of the potential for the race and gender of patients or actors to influence preferences for health states and thus, potentially, medical decisions.

The reliability and internal consistency of an Internet-capable computer program for measuring utilities.

OBJECTIVE: The purpose of this study was to assess the reliability and internal consistency of measurements of utilities performed with a computer program (iMPACT2) designed for Internet surveys and Internet patient decision-support systems. METHODS: We implemented the Internet Multimedia Preference Assessor Construction Tool, version 2 (iMPACT2) program using the combination of a web server, HTML files, and a web-accessible database. The program randomized subjects, screened their responses for missing data and failures of internal consistency, assisted patients with resolving certain inconsistencies, and, upon a subject's completion of the protocol, provided a report of results to the research assistant administering the program. To validate the iMPACT2 program, we recruited 60 healthy community volunteers and elicited preferences in a research-lab setting using a visual analog scale (VAS) and the standard gamble (SG) for subject's current health and three hypothetical states. For purposes of comparison, we also administered a Short Form-12 (SF-12) health-assessment questionnaire. Subjects used the computer software on two occasions separated by 2-4 weeks of time. RESULTS: Visual analog scale and standard gamble ratings for subjects' current health were reliable (intraclass correlation coefficient (ICC) of 0.82 and 0.84 (two outliers excluded -0.60 without exclusions), respectively) were comparable with the reliability of the Physical and Mental Component scales of the SF-12 (ICCs of 0.84 and 0.75, respectively). Subjects could easily discriminate between hypothetical states (D scores 0.74 for SG and 0.90 for VAS), and 94% had a completely internally consistent ordering of preference ratings for states. CONCLUSIONS: iMPACT2 produces measurements of standard gamble utilities that are reliable and have a high degree of internal consistency. Procedures for assessment of utilities developed for desktop computer programs can be translated to software designed for the Internet, facilitating the use of utilities and endpoints in clinical trials and development of web-based decision-support applications for patients. However, further testing, including direct comparisons with traditional interviewer administered utility elicitation protocols, is needed.

Clustering and the design of preference-assessment surveys in healthcare.

OBJECTIVE: To show cluster analysis as a potentially useful tool in defining common outcomes empirically and in facilitating the assessment of preferences for health states. DATA SOURCES: A survey of 224 patients with ventricular arrhythmias treated at Kaiser Permanente of Northern California. STUDY DESIGN/METHODS: Physical functioning was measured using the Duke Activity Status Index (DASI), and mental status and vitality using the Medical Outcomes Study Short Form-36 items (SF-36). A "k-means" clustering algorithm was used to identify prototypical health states, in which patients in the same cluster shared similar responses to items in the survey. PRINCIPAL FINDINGS: The clustering algorithm yielded four prototypical health states. Cluster 1 (21 percent of patients) was characterized by high scores on physical functioning, vitality, and mental health. Cluster 2 (33 percent of patients) had low physical function but high scores on vitality and mental health. Cluster 3 (29 percent of patients) had low physical function and low vitality but preserved mental health. Cluster 4 (17 percent of patients) had low scores on all scales. These clusters served as the basis of written descriptions of the health states. CONCLUSIONS: Employing a clustering algorithm to analyze health status survey data enables researchers to gain a data-driven, concise summary of the experiences of patients.

Effects on preferences of violations of procedural invariance.

BACKGROUND: In studies of health preferences, utilities for hypothetical health states cannot always be successfully measured. One marker for unsuccessful measurement is violation of "procedural invariance": when the ranking of two health states varies across assessment procedures. Using preference values based on unsuccessful measurement may result in misinterpretation of patients' attitudes about health. OBJECTIVE: The authors sought to determine whether people who violated procedural invariance had different preferences than people who satisfied it. METHODS: They performed secondary analyses of three completed studies that used the same two assessment procedures, identifying participants who violated procedural invariance and comparing the mean standard gamble (SG) and visual analog scale (VAS) scores of violators and satisfiers. PARTICIPANTS: Experiment 1, 30 healthy volunteers and 30 patients with cardiac arrhythmias; experiment 2, 139 patients with depressive illness; experiment 3, 98 family members of patients with schizophrenia. RESULTS: Rates of violation of procedural invariance ranged from 16% to 32%. Violation of procedural invariance was not associated with age, education level, race, or gender. Subjects with violations of procedural invariance had, in general, less ability to discriminate among states and less reliable VAS and SG measurements, and sometimes had different mean SG and VAS values. CONCLUSIONS: Violation of procedural invariance of preferences across scaling methods may be a signal for failure of the measurement process. Researchers should test for procedural invariance and consider reporting data separately for satisfiers and violators.

Use of meta-analytic results to facilitate shared decision making.

OBJECTIVES: Describe and evaluate an Internet-based approach to patient decision support using mathematical models that predict the probability of successful treatment on the basis of meta-analytic summaries of the mean and standard deviation of symptom response. DESIGN: An Internet-based decision support tool was developed to help patients with benign prostatic hypertrophy (BPH) determine whether they wanted to use alpha blockers. The Internet site incorporates a meta-analytic model of the results of randomized trials of the alpha blocker terazosin. The site describes alternative treatments for BPH and potential adverse effects of alpha blockers. The site then measures patients' current symptoms and desired level of symptom reduction. In response, the site computes and displays the probability of a patient's achieving his objective by means of terazosin or placebo treatment. SETTING: Self-identified BPH patients accessing the site over the Internet. MAIN OUTCOME MEASURES: Patients' perceptions of the usefulness of information. RESULTS: Over a three-month period, 191 patients who were over 50 years of age and who reported that they have BPH used the decision support tool. Respondents had a mean American Urological Association (AUA) score of 18.8 and a desired drop in symptoms of 10.1 AUA points. Patients had a 40 percent chance of achieving treatment goals with terazosin and a 20 percent chance with placebo. Patients found the information useful (93 percent), and most (71 percent) believed this type of information should be discussed before prescribing medications. CONCLUSIONS: Interactive meta-analytic summary models of the effects of pharmacologic treatments can help patients determine whether a treatment offers sufficient benefits to offset its risks.

Health values and prospect theory.

Health values are important components of medical decisions. Experimental data suggest that people value health in complex and dynamic ways. Prospect theory is a descriptive theory of choice that may accurately characterize how people assign values to health states. The authors first provide background on prospect theory and how it can be applied to health values. Next, they review the relevant health research and find mixed support for prospect theory. Last, they discuss implications of prospect theory for cost-effectiveness analysis. The application of prospect theory to health deserves further research because it may help clarify the link between health and values.

Associations between health status and utilities implications for policy.

BACKGROUND: If shape of a person's utility function is associated with his health status, as is predicted by Prospect Theory, the use of utilities from the healthy could result in 'de facto' discrimination against the sick. OBJECTIVES: To determine if patients' utilities for hypothetical states and for their current health were associated with their health status. DESIGN: A cross-sectional study of the health and values of patients with depressive illnesses. SETTING: Patients from three large primary care practices with various medical illnesses complicated by symptoms of depression. MEASURES: Short-Form 12 health status measurements, standard gamble, and visual analog scale preference measurements for patients' current health and for three hypothetical states. RESULTS: One hundred and forty nine patients enrolled in the study and 139 patients completed the survey. Utilities for the best and worst states were similar across different levels of health status; however, standard gamble utilities for intermediate health states were higher for patients in poorer health than patients in better health (P = 0.019,) suggesting utility functions with radically different shapes. Utilities for patients' current health were also associated with their health status. Patients in poor health tended to overvalue their current health relative to the most similar hypothetical state; whereas, patients in good health tended undervalue their current health state (P = 0.036). CONCLUSIONS: In patients with depressive illnesses, there were significant interactions between health and values, that were consistent with the predictions of Prospect Theory, and that could result in systematic under valuation of the health effects of treatments that primarily benefit more severely patients ill.

Using administrative data to compare the relative effectiveness of amlodipine vs nifedipine CC.

OBJECTIVE: To describe an approach for using claims data to compare the effectiveness of 2 similar drugs used for similar indications within a health maintenance organization. STUDY DESIGN: A database study comparing the effectiveness of amlodipine and nifedipine CC in the initial treatment of hypertension. PATIENTS AND METHODS: The claims records of Pennsylvania Medicaid patients between 18 and 64 years of age with continuous eligibility in 1994 were studied. Pharmacy, hospital, and outpatient claims data were merged, and adult patients receiving the target drugs for the specified indication were identified. The effectiveness of the 2 agents used were compared based on the concept that a change in dispensed medication suggested either an adverse event or lack of effectiveness. Adherence rates, adverse events, and pharmacy and nonpharmacy costs associated with the 2 agents were also compared. RESULTS: Patients receiving amlodipine and nifedipine CC as initial treatment for hypertension had similar demographic characteristics and numbers of comorbid conditions. More patients started on nifedipine CC switched to another calcium channel blocker (15.8% for nifedipine CC vs 10.3% for amlodipine). More patients started on amlodipine switched to another class of antihypertensive agent (13.2% for amlodipine vs 7.3% for nifedipine CC). Patients in both groups received adjunctive antihypertensive drugs at a similar frequency (35% for nifedipine CC vs 42%, for amlodipine). Rates of adherence were similar. In adherent patients, there was no difference in rates of reported adverse events. The nonpharmacy costs were similar between groups. Patients in the amlodipine group also had a trend toward higher overall pharmacy charges (all medications) and higher charges for antihypertensive medications other than the study drugs ($302 vs $188, P = .054). CONCLUSIONS: Claims data are often the best available evidence for comparing the effectiveness of pharmaceuticals in real clinical practice. While these comparisons have inherent limitations, the accuracy of the assessment can be maximized by limiting the assessment to agents with the same specific indications. Other important elements include comparison of crossover rates to other pharmaceuticals in the same class; rates of addition of other pharmaceuticals in the same class, adherence, adverse events, and overall healthcare charges.