Cost-effectiveness analysis of telotristat ethyl for treatment of carcinoid syndrome diarrhea inadequately controlled with somatostatin analogs.

AIMS: This study evaluated the cost-effectiveness of telotristat ethyl (TE) added to somatostatin analog octreotide (SSA + TE) compared to octreotide alone (SSA) in patients with carcinoid syndrome diarrhea (CSD) whose symptoms remain uncontrolled with SSA alone. MATERIALS AND METHODS: A deterministic Markov model evaluated the costs and quality-adjusted life-years (QALY) gained with SSA + TE vs SSA per a third-party US payer perspective. The model reflected clinical practice and resource use estimates based on current standards of care, with utility estimates based on similar symptoms from ulcerative colitis. Treatment efficacy was based on the phase III clinical trial of SSA + TE vs SSA alone [TELESTAR, NCT01677910]. According to TELESTAR, 44% of SSA + TE and 20% of SSA patients responded to therapy after 12 weeks. At each 4-week assessment period, SSA patients not adequately controlled received increasing doses of SSA and SSA + TE patients discontinued TE and moved to SSA only. Drug costs for adequately and not adequately controlled patients were $4,291.75 and $5,890.57 for SSA, respectively, and $9,456.07 and $5,890.57 for SSA + TE, respectively. RESULTS: The base-case analysis demonstrated lifetime QALYs of 1.67 at a cost of $495,125 for the SSA cohort and 2.33 ($590,087) for SSA + TE with an incremental QALY for SSA + TE of 0.66 for an additional $94,962. The incremental cost per QALY gained was $142,545. Sensitivity analyses demonstrated high probability (>99%) of SSA + TE being cost-effective at thresholds for rare diseases and orphan drugs of $300,000-$450,000. LIMITATIONS: The recent availability of TE precluded the incorporation of clinical and economic inputs based on real-world practice patterns. The scarcity of epidemiology and utility information for this rare condition required the use of some proxy estimates. CONCLUSIONS: This analysis demonstrated TE is a cost-effective treatment option when used on top of standard of care in CSD patients.

The effects of proton pump inhibition on patient-reported severity of dyspepsia when receiving dual anti-platelet therapy with clopidogrel and low-dose aspirin: analysis from the Clopidogrel and the Optimization of Gastrointestinal Events Trial.

BACKGROUND: Dual anti-platelet therapy with clopidogrel and low-dose aspirin increases the risk for gastrointestinal clinical events. Omeprazole has been shown to significantly reduce these events without compromising cardiovascular safety in patients treated with dual anti-platelet therapy. Whether or not omeprazole improves patient-reported outcomes is undetermined. AIM: To assess the impact of prophylactic omeprazole with background dual anti-platelet therapy on patient-reported symptoms of dyspepsia compared to placebo. METHODS: We analysed results of the Severity of Dyspepsia Assessment questionnaires collected in the Clopidogrel and the Optimization of Gastrointestinal Events Trial. RESULTS: Patient-reported outcome data from 3759 subjects were available for analysis. At 4 weeks, the mean scores of pain intensity and nonpain symptoms were lower in the omeprazole group (5.61 ± 0.17 vs. 6.40 ± 0.17, P = 0.001, and 10.61 ± 0.07 vs. 11.00 ± 0.07, P < 0.001 respectively). These differences were maintained at 24 weeks (5.91 ± 0.35 vs. 7.10 ± 0.37, P = 0.020 for pain intensity; 10.36 ± 0.12 vs. 10.93 ± 0.13, P = 0.001 for nonpain symptoms). After adjusting for covariates there were no statistically significant differences between the groups in the percent of patients with dyspepsia during follow-up. CONCLUSIONS: In addition to reducing the risk of gastrointestinal bleeding, statistically significant benefits with prophylactic omeprazole use on both pain and nonpain symptoms were evident at 4 weeks and sustained through 24 weeks. The clinical significance of these overall results is unclear, but greater in patients with pain at baseline.

A comparison of the efficacy and safety of irbesartan/HCTZ combination therapy with irbesartan and HCTZ monotherapy in the treatment of moderate hypertension.

This prospective, double-blind, parallel-group study randomized patients with moderate hypertension (seated systolic blood pressure (SeSBP) 160-179 mm Hg when seated diastolic blood pressure (SeDBP) <110 mm Hg; or SeDBP 100-109 mm Hg when SeSBP <180 mm Hg) 3:1:1 to treatment with irbesartan 300 mg/hydrochlorothiazide (HCTZ) 25 mg combination therapy (n=328), irbesartan 300 mg monotherapy (n=106) or HCTZ monotherapy 25 mg (n=104). Treatment was initiated at half dose, with forced titration to full dose after two weeks followed by ten further weeks' treatment. The primary efficacy variable was the mean reduction in SeSBP from baseline to week 8. Baseline characteristics were similar between groups, with mean baseline blood pressure approximately 162/98 mm Hg; the mean age was 55 years. At week 8 there was a reduction in SeSBP of 27.1 mm Hg with irbesartan/HCTZ, compared with 22.1 mm Hg with irbesartan monotherapy (P=0.0016) and 15.7 mm Hg with HCTZ (P<0.0001). Both the rate of decline and the total degree of decline achieved were greatest with irbesartan/HCTZ and least with HCTZ. A significantly greater percentage of patients reached a treatment goal of SeSBP <140 mm Hg and SeDBP <90 mm Hg by week 8 with irbesartan/HCTZ (53.4%), compared with irbesartan (40.6%; P=0.0254) and HCTZ (20.2%; P<0.0001) alone. Treatment was well tolerated in all three-treatment groups with a slight increase in adverse events in the combination therapy group. In conclusion, irbesartan/HCTZ (300/25 mg) is well tolerated and achieves rapid and sustained reductions in both systolic blood pressure and diastolic blood pressure in patients with moderate hypertension.

[Adherence to guidelines in CHF therapy in Germany]. / Leitliniengerechte Herzinsuffizienzbehandlung in Deutschland -- Ergebnisse der MAHLER-Studie.

BACKGROUND AND OBJECTIVE: The MAHLER survey examined the impact of the European guidelines for the treatment of chronic heart failure (CHF). Especially, the trial addressed the question whether adherence to treatment guidelines leads to a reduction in the rate of CHF and cardiovascular (CV) hospitalization. The present sub-study presents the Germany specific data of the MAHLER study and compares the results with the results in other European countries. PATIENTS AND METHOD: The gobal adherence index (GAI) shows the proportion of correctly prescribed heart failure medications per patient. Class adherence indicators for angiotensin-converting enzyme (AC)-inhibitors, beta-blockers, spironolactone, diuretics and cardiac glycosides and general adherence indicators (GAI3 adherence to first three classes of heart failure medications, GAI5 adherence to five classes) were constructed. In the German sub-study, 251 patient were included, who were seen by 21 cardiologists in private practice (mean age 68,6 + 10,4 years; 173 man, 78 woman; 158 NYHA II; 91 NYHA III, 2 NYHA IV). RESULTS: Mean adherence to CHF therapy guidelines was 63 % for GAI3, 62 % for GAI5. Compared to the other MAHLER-study countries, Germany was on place two and three concerning GAI3 and GAI5, respectively. Strong adherence to treatment guidelines in Germany led to a reduction of CHF and CV hospitalization rate by 40 % (p < 0.033). Thus, the German data confirm the results of the international study indicating that a good GAI3 performance is an independent predictor of time to hospitalization. Hitherto, the relative risk for hospitalization was higher for CHF patients in Germany than for patients in all other European countries. CONCLUSIONS: In Germany like in other European countries, guideline adherence for CHF therapy leads to a reduction in hospitalization rate.

A clinically meaningful difference was generated for a performance measure of recovery from hip fracture.

BACKGROUND AND OBJECTIVE: The Lower Extremity Gain Scale (LEGS) is a performance measure of tasks that are often impaired in hip fracture patients. This study was designed to determine a clinically meaningful difference in LEGS. METHODS: The population was 139 female patients (age >65 years) admitted to Baltimore hospitals. Recovery levels were estimated by fitting trajectory curves for the cohort for the 12 months post fracture. The clinically meaningful difference was evaluated using an anchor-based approach, examining the relationship between the LEGS recovery level and age. A second, distribution-based method used an effect size of .20. RESULTS: According to our model, a difference of 5 years in age corresponded to a difference of 1.6-3.6 points in LEGS scores. The standard deviation for LEGS at 12 months was 8.0; thus, Cohen's effect size of 0.2 would equate to a difference of 1.6 points. CONCLUSION: This suggests that a clinically meaningful difference in the LEGS scores for a population in this age range would be 2-3 points.

Assessment of the association between blood pressure control and health care resource use.

BACKGROUND: Several studies have reported increased health care resource use among hypertensive patients with uncontrolled blood pressure (BP). OBJECTIVE: The purpose of this study was to investigate the relationship between BP control and health care resource use. METHODS: Data were obtained from the Caring for Hypertension on Initiation: Costs and Effectiveness (CHOICE) study, a multicenter feasibility study of actual physician and patient behavior and clinical outcomes in a naturalistic setting. Adult patients with newly diagnosed hypertension were randomized to either Group 1 (treatment with diuretics or beta-blockers) or Group 2 (treatment with calcium channel blockers or angiotensin-converting enzyme inhibitors) and followed for 5 +/- 1 months. Physicians practiced standard care while documenting medications, BP measurements, and health care resource use for their patients. A subsequent analysis evaluating the relationship between BP and physician visits was performed for the whole population and for a subpopulation of patients with at least 4 months of follow-up data. Cox regression was used to model time to next visit. RESULTS: A total of 512 patients with newly diagnosed hypertension were followed: 399 had follow-up data for at least 4 months. Baseline demographic characteristics were similar in the 2 groups. Kaplan-Meier curves and a log-rank test showed that the time to next visit for patients with uncontrolled BP was significantly shorter than for patients whose BP was controlled (P < 0.05). On average, patients with uncontrolled BP (> or = 140/90 mm Hg) had follow-up office visits approximately 13 days earlier than patients with controlled BP (< 140/90 mm Hg). This association remained significant after adjustment for repeated measures, and after exclusion of the first return visit. Cox regression analysis showed that higher systolic and diastolic BP measurements were significantly associated with a shorter time to next visit, after adjustment for age and sex. Total estimated costs during the study period were $170 per patient for medications and $283 per patient for office visits. CONCLUSIONS: In the CHOICE study, higher BP was associated with a shorter time to next visit. Office visits were the main cost driver in the short-term management of hypertension.

The challenge of controlling systolic blood pressure: data from the National Health and Nutrition Examination Survey (NHANES III), 1988--1994.

Clinicians tend to focus on diastolic blood pressure (DBP), rather than systolic blood pressure (SBP), to identify and treat hypertension. The authors used data from the National Health and Nutrition Examination Survey (NHANES III, 1988--1994) Mobile Examination Center to examine the distributions of SBP and DBP in treated and untreated individuals with hypertension. We identified the percentage of the hypertensive population with SBP controlled to less than 140 mm Hg and the percentage with DBP controlled to less than 90 mm Hg, stratified by treatment status, gender, race, and ethnicity. Individuals were classified as having hypertension if they had SBP of more than 140 mm Hg or DBP of more than 90 mm Hg, or if they were taking medication for hypertension. A weighted analysis was performed to project the results to the entire U.S. population from 1988--1994; these totals were further estimated for the year 2000 by extrapolation. For men, women, whites, African Americans, and Hispanics, SBP control rates were uniformly poorer than DBP control rates. The difference persisted when subgroups were categorized according to treatment status. The disparity in SBP and DBP control rates was especially great for women: only 50% of treated white women with hypertension had SBP control, but 92% had DBP control. The prevalence of isolated systolic hypertension was greater than 50% among all individuals with hypertension in the 55--60-year age group and increased with age thereafter. A greater emphasis on SBP is needed to improve population blood pressure control. (c)2001 Le Jacq Communications, Inc.

A health perception score predicts cardiac events in patients with heart failure: results from the IMPRESS trial.

BACKGROUND: New York Heart Association (NYHA) class and treadmill exercise test variables are widely used for estimating prognosis and measuring the outcomes of treatment in patients with heart failure, but they do not take patients' perceptions into account. METHODS AND RESULTS: Five hundred forty-five patients enrolled in a multicenter 24-week comparison of the effects of omapatrilat and lisinopril on functional capacity in patients with heart failure reported a visual analog scale (VAS) score of their overall health perception at week 12 of the study. A total of 27 first events, defined as death or worsening heart failure (hospitalization, emergency room visit, or study discontinuation), occurred in the subsequent 12 weeks. The mean (+/-SD) health perception scores were 0.43 +/- 0.31 and 0.68 +/- 0.20 in patients with and without events, respectively (P =.0006). The risk ratio (RR) for an event associated with a decile change in the health perception score was 0.74 (95% confidence interval [CI], 0.61-0.88; P =.001). The RR was unaltered by adjustment for demographic variables, treadmill time, and NYHA functional class. Although the week 12 NYHA functional class was predictive of events (RR = 2.1; 95% CI, 1.2-4.6; P =.04), treadmill time was not (RR = 0.87; 95% CI, 0.73-1.03; P = 0.11). CONCLUSIONS: A patient-reported measure of perceived health predicts events in patients with heart failure.

A new approach for measuring quality of care for women with hypertension.

BACKGROUND: Guidelines for care of hypertensive patients have proliferated recently, yet quality assessment remains difficult in the absence of well-defined measurement systems. Existing systems have not always linked process measures to blood pressure outcomes. METHODS: A quality measurement system was developed and tested on hypertensive women in a West Coast health plan. An expert panel selected clinically detailed, evidence-explicit indicators using a modified Delphi method. Thirteen indicators (1 screening, 5 diagnostic, 5 treatment, and 2 follow-up indicators) were selected by this process. Trained nurses used a laptop-based tool to abstract data from medical records for the most recent 2 years of care. RESULTS: Of 15 004 eligible patients with hypertensive and other chronic disease codes, 613 patients were sampled, all eligible for the screening indicator. Of these, 234 women with an average blood pressure of 140/90 mm Hg or more, or a documented diagnosis of hypertension, were studied for the remaining indicators. The average woman received 64% of the recommended care. Most patients did not receive adequate initial history, physical examination, or laboratory tests. Only 37% of hypertensive women with persistent elevations to more than 160/90 mm Hg had changes in therapy or lifestyle recommended. The average adherence proportion to all indicators was lower in patients with uncontrolled blood pressure (>140/90 mm Hg) than in those with controlled blood pressure (54% vs 73%; P<.001). CONCLUSIONS: Quality of hypertensive care falls short of indicators based on randomized controlled trials and national guidelines. Poor performance in essential care processes is associated with poor blood pressure control.

Impact of poorly controlled hypertension on healthcare resource utilization and cost.

OBJECTIVE: To examine the relation between blood pressure (BP) control and utilization and cost of healthcare resources. STUDY DESIGN: A retrospective database study of managed care patients in New Mexico from January 1, 1996, to December 31, 1997. PATIENTS AND METHODS: We stratified 1000 hypertensive patients into categories based on average and maximum BP. Antihypertensive medication use and cost, number of physician visits, and interval between hypertension-related physician visits were determined. RESULTS: Medication costs increased progressively across all BP categories from lowest to highest, and higher average systolic BP (SBP) was significantly correlated with increased cost (P < .001). There were significant correlations between higher maximum BP and greater number of hypertension-related physician visits (P < .001). Mean number of visits for BP groups was 5.5 for patients with a maximum diastolic BP (DBP) < 85 mm Hg and 10.0 for those with a maximum DBP > or = 100 mm Hg (P < .001). Patients with a maximum SBP > or = 180 mm Hg averaged 9.7 visits, whereas those with a maximum SBP < 120 mm Hg averaged 4.1 visits (P < .001). Both SBP and DBP were significantly correlated with time to next visit (P < .001). Mean visit intervals ranged from 44 days for patients with an SBP < 85 mm Hg to 25 days for those with an SBP > or = 180 mm Hg (P < .001). A similar association was found between DBP and visit interval. CONCLUSIONS: Poor control of hypertension is associated with higher drug costs and more physician visits. Aggressive treatment might help reduce managed care costs and resource utilization.

Predominance of isolated systolic hypertension among middle-aged and elderly US hypertensives: analysis based on National Health and Nutrition Examination Survey (NHANES) III.

The purpose of the present study was to examine patterns of systolic and diastolic hypertension by age in the nationally representative National Health and Nutrition Examination Survey (NHANES) III and to determine when treatment and control efforts should be recommended. Percentage distribution of 3 blood pressure subtypes (isolated systolic hypertension, combined systolic/diastolic hypertension, and isolated diastolic hypertension) was categorized for uncontrolled hypertension (untreated and inadequately treated) in 2 age groups (ages <50 and >/=50 years). Overall, isolated systolic hypertension was the most frequent subtype of uncontrolled hypertension (65%). Most subjects with hypertension (74%) were >/=50 years of age, and of this untreated older group, nearly all (94%) were accurately staged by systolic blood pressure alone, in contrast to subjects in the untreated younger group, who were best staged by diastolic blood pressure. Furthermore, most subjects (80%) in the older untreated and the inadequately treated groups had isolated systolic hypertension and required a greater reduction in systolic blood pressure than in the younger groups (-13.3 and -16.5 mm Hg versus -6.8 and -6.1 mm Hg, respectively; P:=0.0001) to attain a systolic blood pressure treatment goal of <140 mm Hg. Contrary to previous perceptions, isolated systolic hypertension was the majority subtype of uncontrolled hypertension in subjects of ages 50 to 59 years, comprised 87% frequency for subjects in the sixth decade of life, and required greater reduction in systolic blood pressure in these subjects to reach treatment goal compared with subjects in the younger group. Better awareness of this middle-aged and older high-risk group and more aggressive antihypertensive therapy are necessary to address this treatment gap.

Cost per millimeter of mercury lowering is a measure of economic value for antihypertensive agents.

The use of pharmacoeconomic analyses to evaluate the appropriateness of treatment regimens is increasing rapidly. Trials that study the efficacy of antihypertensive agents do not often measure long-term cardiovascular morbidity and mortality, so complementary methods are needed to evaluate the cost-effectiveness of these agents. One method is to compare agents on the basis of their costs and blood pressure-lowering efficacy, producing a ratio of cost per millimeter of mercury lowering, or cost/mm Hg. This provides a simple, transparent method with which to evaluate the cost-effectiveness of antihypertensive agents. It also allows the cost-effectiveness of a blood pressure treatment to be assessed in terms of ambulatory blood pressure data. The use of cost/mm Hg requires assumptions that tolerability of agents is comparable and that blood pressure lowering is a valid surrogate for cardiovascular risk reduction. Given the emergence of new treatments that have differences in blood pressure efficacy, cost/mm Hg is likely to become increasingly used as an indicator of economic value.

Headache in mild-to-moderate hypertension and its reduction by irbesartan therapy.

BACKGROUND: Although it is generally acknowledged to be a problem in severe hypertension, headache has not been consistently associated with mild-to-moderate hypertension. PATIENTS AND METHODS: In 7 randomized, double-blind, placebo-controlled trials, which included 2,673 patients with mild-to-moderate hypertension (defined as seated diastolic blood pressure of 95-110 mm Hg), patients were randomized to receive once-daily treatment with irbesartan, an angiotensin II receptor blocker (n= 1,987), or placebo (n=686). The data were pooled and analyzed retrospectively to determine whether the level of hypertension was associated with headache and whether antihypertensive therapy reduced the incidence of headache. RESULTS: Factors found to be predictive of headache incidence were diastolic blood pressure, sex (female), and age (<50 years). In comparison with placebo, the use of irbesartan was associated with a significant reduction in the incidence of headache (P=.003). CONCLUSIONS: These data suggest that mild-to-moderate hypertension is not asymptomatic and that the incidence of headache can be reduced by antihypertensive treatment with a favorable adverse effect profile.

The cardiovascular event reduction tool (CERT)--a simplified cardiac risk prediction model developed from the West of Scotland Coronary Prevention Study (WOSCOPS).

The clinical decision to treat hypercholesterolemia is premised on an awareness of patient risk, and cardiac risk prediction models offer a practical means of determining such risk. However, these models are based on observational cohorts where estimates of the treatment benefit are largely inferred. The West of Scotland Coronary Prevention Study (WOSCOPS) provides an opportunity to develop a risk-benefit prediction model from the actual observed primary event reduction seen in the trial. Five-year Cox model risk estimates were derived from all WOSCOPS subjects (n = 6,595 men, aged 45 to 64 years old at baseline) using factors previously shown to be predictive of definite fatal coronary heart disease or nonfatal myocardial infarction. Model risk factors included age, diastolic blood pressure, total cholesterol/ high-density lipoprotein ratio (TC/HDL), current smoking, diabetes, family history of fatal coronary heart disease, nitrate use or angina, and treatment (placebo/ 40-mg pravastatin). All risk factors were expressed as categorical variables to facilitate risk assessment. Risk estimates were incorporated into a simple, hand-held slide rule or risk tool. Risk estimates were identified for 5-year age bands (45 to 65 years), 4 categories of TC/HDL ratio (<5.5, 5.5 to <6.5, 6.5 to <7.5, > or = 7.5), 2 levels of diastolic blood pressure (<90, > or = 90 mm Hg), from 0 to 3 additional risk factors (current smoking, diabetes, family history of premature fatal coronary heart disease, nitrate use or angina), and pravastatin treatment. Five-year risk estimates ranged from 2% in very low-risk subjects to 61% in the very high-risk subjects. Risk reduction due to pravastatin treatment averaged 31%. Thus, the Cardiovascular Event Reduction Tool (CERT) is a risk prediction model derived from the WOSCOPS trial. Its use will help physicians identify patients who will benefit from cholesterol reduction.

Neural networks in outcomes research.

Neural networks (NNs) are being used in the areas of prediction and classification of outcomes in medicine--areas in which regression models have traditionally been used. In this report, we summarize the steps in developing and testing an NN. Through applications in clinical research, we present several examples of NN development and evaluation. Through these applications we show that the performance of the NNs matched or exceeded the performance of traditional methods. We then discuss the advantages and disadvantages of NN models in comparison to traditional regression methods.

Supraclavicular masses: results of a series of 309 cases biopsied by fine needle aspiration.

BACKGROUND: The purpose of this study was to determine the current distribution of diseases resulting in supraclavicular swelling or lymphadenopathy as diagnosed by fine needle aspiration (FNA) biopsy. METHODS: Supraclavicular aspirates in this retrospective 5-year study from a large public hospital were classified as neoplastic, infectious, inflammatory, reactive, and nondiagnostic. RESULTS: Malignancy was present in 55% of the 309 aspirates (47% metastatic, 8% lymphoma). Age was most predictive of malignancy (32% for age < or =41 years, 68% for age >40 years). Lymphoma occurred equally in both groups, but the lymphoma:metastasis ratio was much higher in younger patients (1:1.6 for age < or =41 years versus 1:11 for age >40 years). Ethnic origin was related to tumor type, metastatic uterine cervical carcinoma being most frequent in Hispanics, and lymphoma in Caucasians. Primary oropharyngeal sites were unusual; most malignancies originated in the lung, breast, or cervix. Left or right side did not discriminate for either the presence or type of tumor. The 43 aspirates from human immunodeficiency virus (HIV) positive (+) patients were predominantly inflammatory, infectious, or reactive; lymphoma was infrequent (7%). Overall, 39 patients had mycobacterial infection; aspirate smears or culture were positive in 19. Three other FNAs grew Staphylococcus aureus and one stained for Cryptococcus. Aspirates were not informative in 24 cases (8%). The sensitivity of FNA for malignancy was 97%, specificity was 98%, and positive predictive value 98%. CONCLUSION: Aspiration biopsy is an excellent diagnostic tool for supraclavicular masses. Patients over 40 years old are likely to have metastatic malignancy, from breast, lung, or infradiaphragmatic sites. Aspirates with inflammation and those from HIV+ patients should undergo extensive culture.

Fine needle aspiration diagnosis of mycobacterial lymphadenitis. Sensitivity and predictive value in the United States.

OBJECTIVE: Fine needle aspiration (FNA) has proven valuable in diagnosing tuberculous lymphadenitis in countries with endemic mycobacterial infection (MI). Its role in developed countries, where sensitivity and positive predictive value are likely to be lower, has not been adequately explored. STUDY DESIGN: This retrospective, five-year study from a public hospital in the United States examined the predictiveness of 238 nodal FNAs in patients with MI; 59% of patients were also HIV+. RESULTS: Diagnostic results (stainable acid-fast bacilli or positive culture) were present in nearly half the aspirates; sensitivity was 46%, specificity 100%, positive predictive value (PPV) 100% and negative predictive value (NPV) 94%. If granulomatous inflammation (GI) was also considered a positive result, sensitivity increased to 53%; false positive cases of GI reduced PPV to 80%, while specificity (98%) and NPV (95%) changed little. Considered alone, GI had the lowest sensitivity (25%) and PPV (65%). CONCLUSION: FNA was useful in this U.S. population with MI, identifying almost half the affected patients. However, nondiagnostic results, such as granulomatous inflammation, should be interpreted with caution.

Cytologic features of mycobacterial pleuritis: logistic regression and statistical analysis of a blinded, case-controlled study.

Tuberculous pleural effusions are characterized by lymphocytosis; the significance of mesothelial cells is uncertain, as are the cytologic features in concurrent human immunodeficiency virus (HIV) infection. This blinded study compared 38 culture-positive pleural fluids (6 HIV+) with 38 controls from benign exudative processes. Logistic regression analysis selected mature lymphocytes as most predictive of positive culture, and mesothelial cells and eosinophils as negative predictors. Mesothelial cells were scant (< 10% of nucleated cells) in 36/38 cases with mycobacteria (sensitivity 95%); if these cell were > 10%, tuberculosis was virtually ruled out in HIV- patients. Specificity was maximized (82%) when mesothelial cells < 10% were combined with lymphocytes > 50%; positive predictive value with this combination was 76%, but was raised to 96% if moderate/marked cellularity was also identified. Among tuberculosis cases, reactive mesothelial cells differentiated HIV+ from HIV- patients; there was no other significant difference.