Albert W. Wu

Methods to Explain the Clinical Significance of Health Status Measures

One can classify ways to establish the interpretability of quality-of-life measures as anchor based or distribution based. Anchor-based measures require an independent standard or anchor that is itself interpretable and at least moderately correlated with the instrument being explored. One can further classify anchor-based approaches into population-focused and individual-focused measures. Population-focused approaches are analogous to construct validation and rely on multiple anchors that frame an individuals response in terms of the entire population (eg, a group of patients with a score of 40 has a mortality of 20%). Anchors for population-based approaches include status on a single item, diagnosis, symptoms, disease severity, and response to treatment. Individual-focused approaches are analogous to criterion validation. These methods, which rely on a single anchor and establish a minimum important difference in change in score, require 2 steps. The first step establishes the smallest change in score that patients consider, on average, to be important (the minimum important difference). The second step estimates the proportion of patients who have achieved that minimum important difference. Anchors for the individual-focused approach include global ratings of change within patients and global ratings of differences between patients. Distribution-based methods rely on expressing an effect in terms of the underlying distribution of results. Investigators may express effects in terms of between-person standard deviation units, within-person standard deviation units, and the standard error of measurement. No single approach to interpretability is perfect. Use of multiple strategies is likely to enhance the interpretability of any particular instrument.

Noncardiac Comorbidity Increases Preventable Hospitalizations and Mortality Among Medicare Beneficiaries With Chronic Heart Failure

OBJECTIVES We studied the impact of noncardiac comorbidity on potentially preventable hospitalizations and mortality in elderly patients with chronic heart failure (CHF). BACKGROUND Chronic HF disproportionately affects older individuals, who typically have extensive comorbidity. However, little is known about how noncardiac comorbidity complicates care in these patients. METHODS This was a cross-sectional study of 122,630 individuals age >/=65 years with CHF identified through a 5% random sample of all U.S. Medicare beneficiaries. We assessed the relationship of the 20 most common noncardiac comorbidities to one-year potentially preventable hospitalizations and total mortality. Preventable hospitalizations were determined by admissions for ambulatory care sensitive conditions using predefined criteria. RESULTS Sixty-five percent of the sample had at least one hospitalization, of which 50% were potentially preventable. Exacerbations of CHF accounted for 55% of potentially preventable hospitalizations. Nearly 40% of patients with CHF had >/=5 noncardiac comorbidities, and this group accounted for 81% of the total inpatient hospital days experienced by all CHF patients. The risk of hospitalization and potentially preventable hospitalization strongly increased with the number of chronic conditions (both p < 0.0001). After controlling for demographic factors and other diagnoses, comorbidities that were associated consistently with notably higher risks for CHF-preventable and all-cause preventable hospitalizations, and mortality, included chronic obstructive pulmonary disease/bronchiectasis, renal failure, diabetes, depression, and other lower respiratory diseases (all p < 0.01). CONCLUSIONS Noncardiac comorbidities are highly prevalent in older patients with CHF and strongly associate with adverse clinical outcomes. Cardiologists and other providers routinely caring for older patients with CHF may improve outcomes in this high-risk population by better recognizing non-CHF conditions, which may complicate traditional CHF management strategies.

Self-reported symptoms and medication side effects influence Adherence to highly active antiretroviral therapy in persons with HIV infection

Objectives: To identify variables predictive of nonadherence to highly active antiretroviral therapy (HAART) and to assess whether self‐reported symptoms or medication side effects are related to adherence. Design: Cross‐sectional multicenter study Adherence Italian Cohort Naive Antiretrovirals [AdICONA] within the Italian Cohort Naive Antiretrovirals (ICONA). Methods: Participants receiving HAART completed a 16‐item self‐administered questionnaire to assess nonadherence in the last 3 days as well as the type and intensity of 24 common HIV‐ and HAART‐related symptoms experienced during the last 4 weeks. Results: From May 1999 to March 2000, 358 persons were enrolled: 22% reported nonadherence and were less likely to have HIV RNA <500 copies/ml (odds ratio = 0.51; 95% confidence interval: 0.31‐0.85). Frequency of moderate/severe symptoms or medication side effects in nonadherent participants ranged from 3.6% to 30%. On univariate analysis, nausea, anxiety, confusion, vision problems, anorexia, insomnia, taste perversion, and abnormal fat distribution were significantly associated with nonadherence. Nonadherent persons had a higher mean overall symptom score (12.3 ± 9.2 versus 8.1 ± 6.6; p < .001) and mean medication side effect score (2.9 ± 2.7 versus 1.9 ± 1.9; p < .001) when compared with adherent participants. In the multivariate analysis, nausea (p = .003); anxiety (p = .006); younger age (p = .007); unemployment (p < .001); not recalling name, color, and timing of drugs (p = .009); running out of pills between visits (p = .002); and being too busy (p = .03) were independently associated with nonadherence in the last 3 days. Conclusions: In addition to patient characteristics, medication‐related variables, and reasons for nonadherence, patient‐reported symptoms and medication side effects were significantly associated with adherence to HAART.

Evidence for reliability, validity and usefulness of the Medical Outcomes Study HIV Health Survey (MOS-HIV)

The Medical Outcomes Study HIV Health Survey (MOS-HIV) is a brief, comprehensive measure of health-related quality of life (HRQoL) used extensively in human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS). The 35-item questionnaire includes ten dimensions (health perceptions, pain, physical, role, social and cognitive functioning, mental health, energy, health distress and quality of life (QoL)) and takes approximately 5 minutes to complete. Subscales are scored on a 0–100 scale (a higher score indicates better health) and physical and mental health summary scores can be generated. The MOS-HIV has been shown to be internally consistent, correlate with concurrent measures of health, discriminate between distinct groups, predict future outcomes and be responsive to changes over time. Limited experience suggests acceptable reliability and validity in women, injecting drug users and African–American and lower socioeconomic status patients. The MOS-HIV is available in 14 languages and has been included as a secondary outcome measure in numerous clinical trials for all stages of disease. In several studies it has detected significant differences between treatments; in some cases concordant with conventional end-points and, in others, discordant. The interpretation of scores is facilitated by an explanation in terms meaningful to the intended audience. Research is needed to compare the MOS-HIV to other strategies for HRQoL assessment in early HIV disease.

To tell the truth: ethical and practical issues in disclosing medical mistakes to patients.

While moonlighting in an emergency room, a resident physician evaluated a 35-year-old woman who was 6 months pregnant and complaining of a headache. The physician diagnosed a “mixed tension/sinus headache.” The patient returned to the ER 3 days later with an intracerebral bleed, presumably related to eclampsia, and died.

Pain and satisfaction with pain control in seriously ill hospitalized adults: Findings from the SUPPORT research investigations

OBJECTIVES To evaluate the pain experience of seriously ill hospitalized patients and their satisfaction with control of pain during hospitalization. To understand the relationship of level of pain and dissatisfaction with pain control to demographic, psychological, and illness-related variables. DESIGN Prospective, cohort study. SETTING Five teaching hospitals. PATIENTS Patients for whom interviews were available about pain (n = 5,176) from a total of 9,105 patients in the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT). INTERVENTIONS None. MEASUREMENTS AND MAIN RESULTS Patients were interviewed after study enrollment about their experiences with pain. When patients could not be interviewed due to illness, we used surrogate (usually a family member) responses calibrated to patient responses (from the subset of interviews with both patient and surrogate responses). Ordinal logistic regression was used to study the association of variables with level of pain and satisfaction with its control. Nearly 50% of patients reported pain. Nearly 15% reported extremely severe pain or moderately severe pain occurring at least half of the time, and nearly 15% of those patients with pain were dissatisfied with its control. After adjustment for confounding variables, older and sicker patients reported less pain, while patients with more dependencies in activities of daily living, more comorbid conditions, more depression, more anxiety, and poor quality of life reported more pain. Patients with colon cancer reported more pain than patients in other disease categories. Levels of reported pain varied among the five hospitals and also by physician specialty. After adjustment for confounding variables, dissatisfaction with pain control was more likely among patients with more severe pain, greater anxiety, depression, and alteration of mental status, and lower reported income; dissatisfaction with pain control also varied among study hospitals and by physician specialty. CONCLUSIONS Pain is common among severely ill hospitalized patients. The most important variables associated with pain and satisfaction with pain control were patient demographics and those variables that reflected the acute illness. Pain and satisfaction with pain control varied significantly among study sites, even after adjustment for many potential confounders. Better pain management strategies are needed for patients with the serious and common illnesses studied in SUPPORT.

Health-related quality of life in patients with human immunodeficiency virus infection in the United States: results from the HIV cost and services utilization study

PURPOSE To measure health-related quality of life among adult patients with human immunodeficiency virus (HIV) disease; to compare the health-related quality of life of adults with HIV with that of the general population and with patients with other chronic conditions; and to determine the associations of demographic variables and disease severity with health-related quality of life. SUBJECTS AND METHODS We studied 2,864 HIV-infected adults participating in the HIV Cost and Services Utilization Study, a probability sample of adults with HIV receiving health care in the contiguous United States (excluding military hospitals, prisons, or emergency rooms). A battery of 28 items covering eight domains of health (physical functioning, emotional well-being, role functioning, pain, general health perceptions, social functioning, energy, disability days) was administered. The eight domains were combined into physical and mental health summary scores. SF-36 physical functioning and emotional well-being scales were compared with the US general population and patients with other chronic diseases on a 0 to 100 scale. RESULTS Physical functioning was about the same for adults with asymptomatic HIV disease as for the US population [mean (+/- SD) of 92+/-16 versus 90+/-17) but was much worse for those with symptomatic HIV disease (76+/-28) or who met criteria for the acquired immunodeficiency syndrome (AIDS; 58+/-31). Patients with AIDS had worse physical functioning than those with other chronic diseases (epilepsy, gastroesophageal reflux disease, clinically localized prostate cancer, clinical depression, diabetes) for which comparable data were available. Emotional well-being was comparable among patients with various stages of HIV disease (asymptomatic, 62+/-9; symptomatic, 59+/-11; AIDS, 59+/-11), but was significantly worse than the general population and patients with other chronic diseases except depression. In multivariate analyses, HIV-related symptoms were strongly associated with physical and mental health, whereas race, sex, health insurance status, disease stage, and CD4 count were at most weakly associated with physical and mental health. CONCLUSIONS There is substantial morbidity associated with HIV disease in adults. The variability in health-related quality of life according to disease progression is relevant for health policy and allocation of resources, and merits the attention of clinicians who treat patients with HIV disease.

Development and validation of a self-completed HIV symptom index.

Traditional, open-ended provider questions regarding patient symptoms are insensitive. Better methods are needed to measure symptoms for clinical management, patient-oriented research, and adverse drug-event reporting. Our objective was to develop and initially validate a brief, self-reported HIV symptom index tailored to patients exposed to multidrug antiretroviral therapies and protease inhibitors, and to compare the new index to existing symptom measures. The research design was a multistage design including quantitative review of existing literature, qualitative and quantitative analyses of pilot data, and quantitative analyses of a prospective sample. Statistical analyses include frequencies, chi-square tests for significance, linear and logistic regression. The subjects were from a multisite convenience sample (n = 73) within the AIDS Clinical Trials Group and a prospective sample from the Cleveland Veterans Affairs Medical Center (n = 115). Measures were patient-reported symptoms and health-related quality of life, physician-assessed disease severity, CD4 cell count, and HIV-1 RNA viral quantification. A 20-item, self-completed HIV symptom index was developed based upon prior reports of symptom frequency and bother and expert opinion. When compared with prior measures the index included more frequent and bothersome symptoms, yet was easier to use (self-report rather than provider interview). The index required less than 5 minutes to complete, achieved excellent completion rates, and was thought comprehensive and comprehensible in a convenience sample. It was further tested in a prospective sample of patients and demonstrated strong associations with physical and mental health summary scores and with disease severity. These associations were independent of CD4 cell count and HIV-1 RNA viral quantification. This 20-item HIV symptom index has demonstrated construct validity, and offers a simple and rational approach to measuring HIV symptoms for clinical management, patient-oriented research, and adverse drug reporting.

Incidents relating to the intra-hospital transfer of critically ill patients. An analysis of the reports submitted to the Australian Incident Monitoring Study in Intensive Care.

ObjectiveTransportation of critically ill patients within the hospital poses important risks. We sought to identify causes, outcomes and contributing factors associated with intra-hospital transport.DesignCross-sectional case review.SettingIncident reports submitted to the Australian Incident Monitoring Study in Intensive Care (AIMS-ICU).Measurement and main resultsBetween 1993 and 1999, 176 reports were submitted describing 191 incidents. Seventy-five reports (39%) identified equipment problems, relating prominently to battery/power supply, transport ventilator and monitor function, access to patient elevators and intubation equipment. Hundred sixteen reports (61%) identified patient/staff management issues including poor communication, inadequate monitoring, incorrect set-up of equipment, artificial airway malpositioning and incorrect positioning of patients. Serious adverse outcomes occurred in 55 reports (31%) including major physiological derangement (15%), patient/relative dissatisfaction (7%), prolonged hospital stay (4%), physical/psychological injury (3%) and death (2%). Of 900 contributing factors identified, 46% were system-based and 54% human-based. Communication problems, inadequate protocols, in-servicing/training and equipment were prominent equipment-related incidents. Errors of problem recognition and judgement, failure to follow protocols, inadequate patient preparation, haste and inattention were common management-related incidents. Rechecking the patient and equipment, skilled assistance and prior experience were important factors limiting harm.ConclusionsIntra-hospital transport poses an important risk to ICU patients. The adequate provision of highly qualified staff, specially designed and well maintained equipment, as well as continuous monitoring are essential to avoid/mitigate these incidents. Professional societies and local units should adopt guidelines/protocols for intra-hospital transportation. Monitoring of incidents should aid in the continuous improvement in patient safety.

The relationship between a dementia diagnosis, chronic illness, medicare expenditures, and hospital use

Objectives: To determine whether dementia increases medical expenditures, the probability of hospitalization, and potentially preventable hospitalization, controlling for variables including age and comorbidity.