Screening for hepatitis C virus in a health maintenance organization.

BACKGROUND: Chronic infection with hepatitis C virus (HCV) is a major public health problem and is associated with over 10,000 deaths a year in the United States. In its early stages, HCV tends to be asymptomatic and can be detected only through screening. OBJECTIVES: To develop and validate a database risk algorithm for HCV infection using electronic data at HealthPartners, a health maintenance organization (HMO) in Minnesota. A secondary objective was to evaluate the benefit of screening health care workers for HCV. METHODS: A database risk algorithm was developed using diagnostic and procedure codes in the administrative database to identify at-risk enrollees. One thousand three hundred eighty enrollees (an at-risk sample and a control sample) and 502 health care workers participated in anonymous screening. Both descriptive statistics and logistic regression were used to examine the frequency of HCV infection, associations with risk factors, self-selection factors in participation, and concordance between the database risk algorithm and the risk profile questionnaire. RESULTS: Eleven enrollees tested positive for HCV, 9 from the at-risk sample and 2 from the control sample. All health care workers tested negative for HCV. Both lifestyle and medical risk factors were associated with positive test results for HCV. Enrollees with alcohol-drug diagnoses were less likely to participate in screening. A substantial proportion of enrollees with risk factors was identified either by the database risk algorithm or the risk profile questionnaire, but not by both. CONCLUSION: While the frequency of HCV infection was lower than previous estimates for the US population, the strong correlation with risk factors suggests that using the database risk algorithm for screening is a useful approach. Managed care plans with suitable data on their enrollee populations are in a key position to serve an important public health role in detecting asymptomatic patients who are infected with HCV.

Sepsis syndrome and associated sequelae in patients at high risk for gram-negative sepsis.

We conducted a prospective surveillance study of 80 hospitals across the United States to determine the incidence of sepsis syndrome and its associated sequelae in hospitalized patients over age 18 years who were administered antibiotics for suspected or documented gram-negative infection. A sample of 1754 hospitalized patients were followed from onset of antimicrobial therapy to discharge or death. Mortality rates (MR) varied depending on the suspected source of sepsis syndrome. For patients in whom the syndrome was associated with community-acquired urinary tract infections, mortality was 20% (relative risk [RR] = 0.51, p < 0.05), for those with trauma 20.6% (RR = 0.51, p < 0.05), and patients with nosocomial respiratory tract infections 57.1% (RR = 1.66, p < 0.05). More than two complications occurred in 65.2% of patients under age 60 years (MR 31%), 40.8% of those age 60-80 (MR 42%), and 35.6% of patients older than 80 years (MR 33.3%, p > 0.05). Various patient populations had significant differences in both the incidence of the syndrome and its complications, and consequent mortality. Perhaps morbidity as well as mortality should be used as outcomes when testing the efficacy of innovative therapies for sepsis.

Ultrafast computerized tomography of the chest in cystic fibrosis: a new scoring system.

Assessing the presence and severity of bronchiectasis (BR) and mucoid impaction (MI) of the airways in cystic fibrosis (CF) is difficult by non-invasive methods. We hypothesized that scoring ultrafast computerized tomograms (UFCT) of the chest for BR and MI could be useful in detecting early lung changes in 28 patients with CF. To do this, UFCT scores were compared to established clinical and chest X-ray (CXR) scores. Results showed that UFCT scores correlated highly with clinical (r = 0.88) and CXR (r = 0.93) scores, and several pulmonary function tests. Regression analysis indicated that BR influenced clinical and CXR scores more than MI. Both BR and MI were found in all areas of the lungs without a major propensity for one region, although there was significantly more BR in the right upper lobe than the right lower lobe. In patients with CXR score greater than or equal to 21 BR was present in 8/9 and MI in 3/9, while in those with CXR score less than 21 UFCT showed BR in 19/19 and MI in 17/19. We conclude: 1) scored UFCTs correlate well with CXR and clinical scores; 2) BR influences clinical and CXR scores more than MI; 3) UFCTs detect BR and MI in CF patients with minimal evidence of pulmonary disease; and 4) CXR scores less than 21 reflect the presence of both BR and MI.

Educating health professionals: a hepatitis C educational program in a health maintenance organization.

OBJECTIVE: To describe the components of and staff reaction to an educational outreach program about hepatitis C (HCV) at a managed care organization in Minnesota. PROJECT PROTOCOL: Educational programs for primary care clinicians consisted of lunch-and-learn sessions conducted in 2 phases. In phase 1 (1997-1998), educational programs were offered in 4 clinics; in phase 2 (1999), these programs were offered to a larger number of clinics. There was a structured, 2-stage recruitment process, and the protocol included multiple contacts that involved sending educational materials to participants several weeks before the program. A development team, comprised of key health maintenance organization (HMO) stakeholders, provided consultation. EVALUATION: The initiative reached more than 1000 healthcare professionals, including 150 physicians. The educational programs received very high ratings, and pre- and posttests documented significant improvement in knowledge about HCV. CONCLUSIONS: This successful educational initiative had 5 key elements: (1) value to healthcare staff (i.e., importance of the topic and quality of the programs); (2) incentives (i.e., convenience, free lunch, and continuing medical education/continuing education unit credits); (3) repeated exposures (i.e., multiple opportunities for learning, both oral and written); (4) commitment by key stakeholders at the HMO and the clinics; and (5) an exceptionally well-organized implementation plan.

Further observations on the role of IgE-mediated hypersensitivity in recurrent otitis media with effusion.

One hundred young patients with recurrent otitis media with effusion (OME) were evaluated for IgE-mediated hypersensitivity by critical analysis of history, physical findings, skin testing for selected antigen, laboratory determination of total IgE, and radioallergosorbent testing (RAST) for six inhalant and two food allergens. The patients could be divided into allergic rhinitis and nonallergic groups. Allergic rhinitis patients had higher total IgE in their serum, and middle ear effusion (MEE). IgE was elevated in 16 of 35 allergic patients. In 8 of these 16 (23% of the allergic group), the IgE/mg protein was higher in the MEE than in the corresponding serum, suggesting local production of IgE. Nasal IgE was substantially increased in the allergic patients; however, in many patients there was no correlation between the corresponding MEE IgE and elevated nasal IgE, suggesting that local production of nasal and middle ear IgE is independent. We conclude that IgE-mediated allergic reactions may play a role in the pathogenesis of OME in about 23% of young allergic patients.

Self-management skills for cooperative care in asthma.

The increases in morbidity and mortality rates from asthma over the last decade may be attributable in part to delayed and ineffective action on the part of patients and parents. Providing information about this disorder and educating patients, families, and communities in asthma self-management and cooperative-care skills may help reverse these trends. Such programs are designed to complement the traditional health care system and include instruction about the pathophysiology of asthma, ways to recognize and treat symptoms, adverse drug effects, and the need for professional assistance. In this article are outlined seven exemplary asthma self-care programs available to physicians and other health care providers.

Are bioelectric impedance measurements valid in patients with cystic fibrosis?

This pilot study compared the use of bioelectric impedance analysis (BIA), a rapid, portable, and painless method of measuring body composition, to isotope dilution in patients with and without cystic fibrosis (CF). Many methods exist for measuring body composition but these measures can be difficult to use in the clinical setting. BIA has been validated as a tool for nutritional assessment in healthy adults, but it must be validated in patient populations with specific disease-related nutritional problems, such as CF. Ten ambulatory patients with CF were selected along with ten controls matched for age, sex, and body mass index (BMI; wt/ht2). Total body water (TBW) was determined using isotoperatio mass spectrometry on urine specimens before and after patients consumed 0.2 g/kg deuterium-rich water. BIA was performed using a tetrapolar technique; 500 microA of current at 50 kHz was introduced and the voltage drop measured. Seven men and three women were studied in each group. Median age was 27 (range, 18-39) and median BMI was 19.2 (range, 16.7-30.1) in CF adults. Median age was 27.5 (range, 15-43) and median BMI was 20.7 (range, 19.4-31.6) in controls. The resistance index (RI; ht2/resistance) correlated strongly with TBW in patients with CF (r = 0.88; y = 0.482x + 11.138; p < 0.05) as well as in controls (r = 0.87; y = 0.661x + 1.299; p < 0.05). We conclude that BIA is a rapid, portable, and painless method for measuring body composition that correlates well with the deuterium-dilution method.(ABSTRACT TRUNCATED AT 250 WORDS)

In vivo effects of theophylline on diaphragm, bicep, and quadricep strength and fatigability.

Aminophylline has been demonstrated to increase in vitro contractility in skeletal muscle, including diaphragm. In vivo studies report significant increases in diaphragm contractility in patients with chronic obstructive pulmonary disease but only small increases in control subjects. The present study determined the effects of aminophylline on strength and fatigability in the diaphragm, the biceps brachii, and the quadriceps of normal individuals. Seven healthy subjects were tested with placebo and drug conditions on separate days in a randomized, double-blind fashion. Mean theophylline levels of 15 +/- 2 mg/L SD were maintained by constant intravenous infusion. Strength of the diaphragm was measured as maximum inspiratory pressure. Strength of the biceps and quadriceps were measured isometrically during arm flexion (90 degrees) and leg extension (115 degrees) against an electronic load cell. Fatigue was measured as the decrease in tension during a 30-second contraction and during a 6-minute period of alternating 5-second maximal contraction and 5-second rest. Therapeutic levels of theophylline had no effect on strength or fatigability during a maximal contraction in any muscle group studied.

Fluorescence polarization immunoassay for theophylline modified for use with dried blood spots on filter paper.

We used dried blood spots successfully as alternative specimens for quantifying concentrations of theophylline in the circulation by a modified fluorescence polarization immunoassay (FPIA) with the Abbott TDx instrument. The method described is simple, rapid, and acceptably precise. More importantly, it can provide results comparable with those of the conventional serum assay. Results for 64 pairs of dried blood spots (y) and serum (x) specimens analyzed by the respective FPIA methods yielded the following regression parameters: y = 0.94x + 0.71, r = 0.988, and Sxy = 0.92. A major advantage of FPIA is that it requires only basic laboratory skills. When coupled with the use of dried blood spots, this system can be effective in remote theophylline monitoring, particularly suited for domiciliary care.

Delivering clinical preventive services is a systems problem.

A steadily increasing number of research trials and prevention advocates are identifying the practice environment as the main source of both problems and solutions to the improved delivery of clinical preventive services. Although these sources are correctly focusing on office systems as solutions, there is a tendency to focus on only parts of a system and to relate this to just one or a few related preventive services. However, the effort required to set up and maintain an office system makes it difficult to justify doing so for a single clinical activity. The process and system thinking of Continuous Quality Improvement (CQI) theory suggests that there may be both efficiency and effectiveness advantages to the concept of all clinical preventive services being served by a single system with many interrelated component processes. Such a system should be usable for all age groups. This system and its literature base are described. The feasibility of applying this concept is being tested in a randomized controlled trial in 44 primary care clinics in Minnesota and Wisconsin.

Multicentre evaluation of disposable visual measuring device to assay theophylline from capillary blood sample.

A device using enzyme immunochromatography to indicate visually theophylline concentration in a small capillary blood sample was evaluated for precision and accuracy at four hospitals. Preliminary studies indicated sensitivity as low as 2.5 micrograms/ml, and accuracy and precision matched those in test samples ranging from 5 to 30 micrograms/ml. Absence of theophylline was also reliably detected. Paired samples of capillary and venous blood from 214 patients were used to compare this method with four standard laboratory assays. Correlations with the standard assays were 0.93-0.97, slopes 1.00-1.27, and y intercepts -1.91-0.46. The within-run coefficients of variation on twenty replicate patient sample analyses at the four hospitals were 5.1-9.7% and between-run coefficients of variation on a 15.9 microgram/ml control 5.7-9.4%. This disposable device for theophylline monitoring, which can be done within 15 min at the patient's side without instruments, is sufficiently accurate to replace laboratory analysis for routine therapeutic drug monitoring.

A CQI intervention to change the care of depression: a controlled study.

CONTEXT: Although new strategies for managing depression in primary care (e.g., nurse telephone calls, collaborative care) have been shown to be effective, no models are available for their systematic implementation in the "real world." OBJECTIVE: To test whether a continuous quality improvement (CQI) intervention could be used to implement systems in primary care clinics to improve the care and outcomes for patients diagnosed with depression. DESIGN: Before-after study with concurrent controls. INTERVENTION: A multidisciplinary team from the three intervention clinics developed and implemented a graded set of five care management options, ranging from watchful waiting (nurse telephone call in 4 to 6 weeks) to mental health management, which clinicians could order for their patients with depression. SETTING: 9 primary care clinics in greater Minneapolis-St. Paul, Minnesota. PATIENTS: Outpatients 18 years of age and older whose primary care clinic visit included an International Classification of Diseases, 9th revision, code for depression and who completed baseline and 3-month follow-up surveys before and after the intervention. MAIN OUTCOME MEASURES: Measures of process of care (follow-up depression visits to physician, mental health visits, follow-up telephone calls) and outcomes of care (improved depression symptoms over 3 months, satisfaction with care). RESULTS: Although the CQI team appeared to function well, only 30 of the 257 patients identified from depression-coded visits for this study were referred to the new system during the 3-month evaluation period. In both the intervention and control clinics, follow-up visits, mental health referrals, and follow-up telephone calls did not improve significantly from the preintervention levels of about 0.5 for a primary care visit, 0.4 for a mental health visit, or 0.1 for a follow-up phone call per person. The same was true of patient outcomes: The proportion of patients in the intervention and control clinics who had improved depression symptoms and those who were very satisfied with their depression care did not change significantly from the preintervention levels of 43% and 26%, respectively. CONCLUSIONS: Our attempt to improve the primary care management of depression failed because physicians used the new order system so infrequently. Whether a greater leadership commitment to change or a different improvement process would alter our findings is an open question.

The clinical evaluation of new drugs for sepsis. A prospective study design based on survival analysis.

OBJECTIVE: To develop a survival model and severity assessment method to estimate the 28-day mortality risk for patients with sepsis syndrome entering phase 2 and 3 drug evaluations. DESIGN: Retrospective analysis of intensive care unit admissions with sepsis syndrome by means of log-normal regression to identify risk factors for 28-day mortality. Prospective application of the model to patients with gram-negative infection meeting sepsis syndrome criteria from separate data collection (validation group). PATIENTS: A total of 58,737 intensive care unit admissions at 107 hospitals in the United States and Western Europe screened to yield 1195 patients meeting entry criteria for the sepsis syndrome study for the original model; 295 hospitalized patients with gram-negative infection meeting criteria for sepsis syndrome for validation. MAIN OUTCOME MEASURES: Survival time and mortality at 28 days after fulfillment of the sepsis syndrome criteria. RESULTS: Acute physiologic abnormalities were the most important prognostic factors influencing outcome (82% of total chi 2). Specific disease resulting in intensive care unit admission and the time the patient was in the hospital and intensive care unit before qualification were also independent risks, as were age and a clinical history of cirrhosis. The model's overall classification accuracy was a Somers' Dyx of .52 (rank correlation between predicted risk and 28-day mortality) (receiver operating characteristic area, 0.76), with equal accuracy (Dyx = .59; receiver operating characteristic area, 0.80) in the independent group of patients. CONCLUSIONS: We created an accurate independent estimate for 28-day mortality risk for patients with sepsis syndrome (severe sepsis). This estimate could improve the evaluation of new drugs by investigating whether the drug's benefit varies by patient risk and then determining the amount of benefit for individual patients.