Archives of Internal Medicine recent issues

Archives of Internal Medicine, a biweekly peer-reviewed, primary source journal, is widely recognized by physicians as the most relevant and practical journal in its specialty. Each issue offers a spectrum of articles relevant to everyday practice in general IM and subspecialty areas.

First Physical [Editorial]

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About This Journal [About This Journal]

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In This Issue of Archives of Internal Medicine [In This Issue of Archives of Internal Medicine]

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Patient-Centered Comparative Effectiveness Research: Essential for High-Quality Care [Commentary]

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Food Surcharges and Subsidies: Putting Your Money Where Your Mouth Is [Editorial]

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Changing the Culture of Nursing Homes: The Physician's Role [Editorial]

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Triple-Class Virologic Failure in HIV-Infected Patients Undergoing Antiretroviral Therapy for Up to 10 Years [Original Investigation]

Background  Life expectancy of people with human immunodeficiency virus (HIV) is now estimated to approach that of the general population in some successfully treated subgroups. However, to attain these life expectancies, viral suppression must be maintained for decades.

Methods  We studied the rate of triple-class virologic failure (TCVF) in patients within the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) who started antiretroviral therapy (ART) that included a nonnucleoside reverse-transcriptase inhibitor (NNRTI) or a ritonavir-boosted protease inhibitor (PI/r) from 1998 onwards. We also focused on TCVF in patients who started a PI/r-containing regimen after a first-line NNRTI-containing regimen failed.

Results  Of 45 937 patients followed up for a median (interquartile range) of 3.0 (1.5-5.0) years, 980 developed TCVF (2.1%). By 5 and 9 years after starting ART, an estimated 3.4% (95% confidence interval [CI], 3.1%-3.6%) and 8.6% (95% CI, 7.5%-9.8%) of patients, respectively, had developed TCVF. The incidence of TCVF rose during the first 3 to 4 years on ART but plateaued thereafter. There was no significant difference in the risk of TCVF according to whether the initial regimen was NNRTI or PI/r based (P = .11). By 5 years after starting a PI/r regimen as second-line therapy, 46% of patients had developed TCVF.

Conclusions  The rate of virologic failure of the 3 original drug classes is low, but not negligible, and does not appear to diminish over time from starting ART. If this trend continues, many patients are likely to need newer drugs to maintain viral suppression. The rate of TCVF from the start of a PI/r regimen after NNRTI failure provides a comparator for studies of response to second-line regimens in resource-limited settings.

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Food Price and Diet and Health Outcomes: 20 Years of the CARDIA Study [Original Investigation]

Background  Despite surging interest in taxation as a policy to address poor food choice, US research directly examining the association of food prices with individual intake is scarce.

Methods  This 20-year longitudinal study included 12 123 respondent days from 5115 participants in the Coronary Artery Risk Development in Young Adults (CARDIA) Study. Associations between food price, dietary intake, overall energy intake, weight, and homeostatic model assessment insulin resistance (HOMA-IR) scores were assessed using conditional log-log and linear regression models.

Results  The real price (inflated to 2006 US dollars) of soda and pizza decreased over time; the price of whole milk increased. A 10% increase in the price of soda or pizza was associated with a –7.12% (95% confidence interval [CI], –63.50 to –10.71) or –11.5% (95% CI, –17.50 to –5.50) change in energy from these foods, respectively. A $1.00 increase in soda price was also associated with lower daily energy intake (–124 [95% CI, –198 to –50] kcal), lower weight (–1.05 [95% CI, –1.80 to –0.31] kg), and lower HOMA-IR score (0.42 [95% CI, –0.60 to –0.23]); similar trends were observed for pizza. A $1.00 increase in the price of both soda and pizza was associated with greater changes in total energy intake (–181.49 [95% CI, –247.79 to –115.18] kcal), body weight (–1.65 [95% CI, –2.34 to 0.96] kg), and HOMA-IR (–0.45 [95% CI, –0.59 to –0.31]).

Conclusion  Policies aimed at altering the price of soda or away-from-home pizza may be effective mechanisms to steer US adults toward a more healthful diet and help reduce long-term weight gain or insulin levels over time.

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Racial and Ethnic Differences in Hospice Use Among Patients With Heart Failure [Original Investigation]

Background  Heart failure is the leading noncancer diagnosis for patients in hospice care and the leading cause of hospitalization among Medicare beneficiaries. Racial and ethnic differences in hospice patients are well documented for patients with cancer but poorly described for those with heart failure.

Methods  On the basis of a national sample of 98 258 Medicare beneficiaries 66 years and older on January 1, 2001, with a diagnosis of heart failure who had at least 1 physician or hospital encounter and who were not enrolled in hospice care between January 1 and December 31, 2000, we determined the effect of race and ethnicity on hospice entry for patients with heart failure in 2001 after adjusting for sociodemographic, clinical, and geographic factors.

Results  In unadjusted analysis, blacks (odds ratio [OR], 0.52) and Hispanics (0.43) used hospice care for heart failure less than whites. Racial and ethnic differences in patients who received hospice care for heart failure persisted after adjusting for markers of income, urbanicity, severity of illness, local density of hospice use, and medical comorbidity (adjusted OR for blacks, 0.59; 95% confidence interval, 0.47-0.73; and adjusted OR for Hispanics, 0.49; 95% confidence interval, 0.37-0.66; compared with whites). Advanced age, greater comorbidity, emergency department visits, hospitalizations, and greater local density of hospice use were also associated with hospice use.

Conclusions  In a national sample of Medicare beneficiaries with heart failure, blacks and Hispanics used hospice care for heart failure less than whites after adjustment for individual and market factors. To understand the mechanisms underlying these findings, further examination of patient preferences and physician referral behavior is needed.

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Differences in Patient Survival After Acute Myocardial Infarction by Hospital Capability of Performing Percutaneous Coronary Intervention: Implications for Regionalization [Original Investigation]

Background  There are increasing calls for regionalization of acute myocardial infarction (AMI) care in the United States to hospitals with the capacity to perform percutaneous coronary intervention (PCI). Whether regionalization will improve outcomes depends in part on the magnitude of existing differences in outcomes between PCI and non-PCI hospitals within the same health care region.

Methods  A 100% sample of claims from Medicare fee-for-service beneficiaries 65 years or older hospitalized for AMI between January 1, 2004, and December 31, 2006, was used to calculate hospital-level, 30-day risk-standardized mortality rates (RSMRs). The RSMRs between PCI and local non-PCI hospitals were compared within local health care regions defined by hospital referral regions (HRRs).

Results  A total of 523 119 AMI patients was admitted to 1382 PCI hospitals, and 194 909 AMI patients were admitted to 2491 non-PCI hospitals in 295 HRRs with at least 1 PCI and 1 non-PCI hospital. Although PCI hospitals had lower RSMRs than non-PCI hospitals (mean, 16.1% vs 16.9%; P < .001), considerable overlap was seen in RSMRs between non-PCI and PCI hospitals within the same HRR. In 80 HRRs, the RSMRs at the best-performing PCI hospital were lower than those at local non-PCI hospitals by 3% or more. Among the remaining HRRs, the RSMRs at the best-performing PCI hospital were lower by 1.5% to 3.0% in 104 HRRs and by greater than 0 to 1.5% in 74 HRRs. In 37 HRRs, the RSMRs at the best-performing PCI hospital were no better or were higher than at local non-PCI hospitals.

Conclusions  The magnitude of benefit from comprehensively regionalizing AMI care to PCI hospitals appears to vary greatly across HRRs. These findings support a tailored regionalization policy that targets areas with the greatest outcome differences between PCI and local non-PCI hospitals.

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Physician Visits Prior to Treatment for Clinically Localized Prostate Cancer [Original Investigation]

Background  The 2 primary therapeutic interventions for localized prostate cancer are delivered by different types of physicians, urologists, and radiation oncologists. We evaluated how visits to specialists and primary care physicians (PCPs) by men with localized prostate cancer are related to treatment choice.

Methods  Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database, we identified 85 088 men with clinically localized prostate cancer diagnosed at age 65 years or older, between 1994 and 2002. Men were categorized by primary treatment received within 9 months of diagnosis: radical prostatectomy (n = 18 201 [21%]), radiotherapy (n = 35 925 [42%]), androgen deprivation (n = 14 021 [17%]), or expectant management (n = 16 941 [20%]). Visits to specialists and PCPs were analyzed by patient characteristics and primary therapies received and were identified using Medicare claims and the American Medical Association Physician Masterfile.

Results  Overall, 42 309 men (50%) were seen exclusively by urologists, 37 540 (44%) by urologists and radiation oncologists, 2329 (3%) by urologists and medical oncologists, and 2910 (3%) by all 3 specialists. There was a strong association between the type of specialist seen and primary therapy received. Visits to PCPs were infrequent between diagnosis and receipt of therapy (22% of patients visited any PCP and 17% visited an established PCP) and were not associated with a greater likelihood of specialist visits. Irrespective of age, comorbidity status, or specialist visits, men seen by PCPs were more likely to be treated expectantly.

Conclusions  Specialist visits relate strongly to prostate cancer treatment choices. In light of these findings, prior evidence that specialists prefer the modality they themselves deliver and the lack of conclusive comparative studies demonstrating superiority of one modality over another, it is essential to ensure that men have access to balanced information before choosing a particular therapy for prostate cancer.

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The Prostate Cancer Treatment Bazaar: Comment on "Physician Visits Prior to Treatment for Clinically Localized Prostate Cancer" [Invited Commentary]

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Alcohol Consumption, Weight Gain, and Risk of Becoming Overweight in Middle-aged and Older Women [Original Investigation]

Background  The obesity epidemic is a major health problem in the United States. Alcohol consumption is a source of energy intake that may contribute to body weight gain and development of obesity. However, previous studies of this relationship have been limited, with inconsistent results.

Methods  We conducted a prospective cohort study among 19 220 US women aged 38.9 years or older who were free of cardiovascular disease, cancer, and diabetes mellitus and had a baseline body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) within the normal range of 18.5 to less than 25. Alcoholic beverage consumption was reported on a baseline questionnaire. Body weight was self-reported on baseline and 8 annual follow-up questionnaires.

Results  There was an inverse association between amount of alcohol consumed at baseline and weight gained during 12.9 years of follow-up. A total of 7942 (41.3%) initially normal-weight women became overweight or obese (BMI ≥25) and 732 (3.8%) became obese (BMI ≥30). After adjusting for age, baseline BMI, smoking status, nonalcohol energy intake, physical activity level, and other lifestyle and dietary factors, the relative risks of becoming overweight or obese across total alcohol intake of 0, more than 0 to less than 5, 5 to less than 15, 15 to less than 30, and 30 g/d or more were 1.00, 0.96, 0.86, 0.70, and 0.73, respectively (P for trend <.001). The corresponding relative risks of becoming obese were 1.00, 0.75, 0.43, 0.39, and 0.29 (P for trend <.001). The associations were similar by subgroups of age, smoking status, physical activity level, and baseline BMI.

Conclusion  Compared with nondrinkers, initially normal-weight women who consumed a light to moderate amount of alcohol gained less weight and had a lower risk of becoming overweight and/or obese during 12.9 years of follow-up.

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Statistical Numeracy for Health: A Cross-cultural Comparison With Probabilistic National Samples [Original Investigation]

Background  Statistical numeracy is essential for understanding health-related risks and making informed medical decisions. However, this concept has not been investigated with probabilistic national samples or compared cross-culturally. We sought (1) to investigate differences in the level of statistical numeracy between 2 countries with different educational and medical systems—the United States and Germany; (2) to study the relationship between statistical numeracy and demographic characteristics such as age, sex, and education; and (3) to test whether a subjective measure of numeracy is a valid indicator of objective measures.

Methods  In a survey of probabilistic, representative national samples in Germany and the United States, conducted in July and August 2008, we asked questions testing objective and subjective statistical numeracy.

Results  German participants had higher numeracy skills than did US participants. On average, 68.5% (SE, 1.1%) and 64.5% (SE, 1.3%), respectively, of items testing objective numeracy were answered correctly. Subjective estimates of numeracy were a good indicator of the objective measures. There is a large gap in numeracy skills between persons with lower and higher educational levels, particularly in the United States.

Conclusions  Physicians should be aware that many patients may not understand all information relevant to making an informed decision. Fortunately, they can identify such patients and use nonnumerical presentation formats, such as graphical displays and analogies, to communicate important statistical information.

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Collective Statistical Illiteracy: A Cross-Cultural Comparison With Probabilistic National Samples: Comment on "Statistical Numeracy for Health" [Invited Commentary]

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Potential Use of 10-Year and Lifetime Coronary Risk Information for Preventive Cardiology Prescribing Decisions: A Primary Care Physician Survey [Original Investigation]

Background  Data are sparse regarding how physicians use coronary risk information for prescribing decisions.

Methods  We presented 5 primary prevention scenarios to primary care physicians affiliated with an academic center and surveyed their responses after they were provided with (1) patient risk factor information, (2) 10-year estimated coronary disease risk information, and (3) 10-year and lifetime risk estimates. We asked about aspirin prescribing, lipid testing, and lipid-lowering drug prescribing.

Results  Of 202 physicians surveyed, 99 (49%) responded. The physicians made guideline-concordant aspirin decisions 51% to 91% of the time using risk factor information alone. Providing 10-year risk estimates increased concordant aspirin prescribing when the 10-year coronary risk was moderately high (15%) and decreased guideline-discordant prescribing when the 10-year risk was low (2 of 4 cases). Providing the lifetime risk information sometimes increased guideline-discordant aspirin prescribing. The physicians selected guideline-concordant thresholds for initiating treatment with lipid-lowering drugs 44% to 75% of the time using risk factor information alone. Selecting too low or too high low-density lipoprotein cholesterol thresholds was common. Ten-year risk information improved concordance when the 10-year risk was moderately high. Providing lifetime risk information increased willingness to initiate pharmacotherapy at low-density lipoprotein cholesterol levels that were lower than those recommended by guidelines when the 10-year risk was low but the lifetime risk was high.

Conclusions  Providing 10-year coronary risk information improved some hypothetical aspirin-prescribing decisions and improved lipid management when the short-term risk was moderately high. High lifetime risk sometimes led to more intensive prescription of aspirin or lipid-lowering medication. This outcome suggests that, to maximize the benefits of risk-calculating tools, specific guideline recommendations should be provided along with risk estimates.

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Error in Table 3 in: Meta-analysis of the Impact of 9 Medication Classes on Falls in Elderly Persons [Correction]

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The Metabolic Syndrome, Its Component Risk Factors, and Progression of Coronary Atherosclerosis [Original Investigation]

Background  The mechanism that confers adverse cardiovascular prognosis in patients with the metabolic syndrome (MetS) remains unclear. We sought to investigate the association of MetS and its component risk factors with progression of coronary atherosclerosis.

Methods  We performed a systematic review of 3459 patients who participated in 7 clinical trials that monitored coronary atheroma progression with intravascular ultrasonography. Patients with or without MetS were compared with regard to clinical characteristics, coronary atheroma burden at baseline, and change on serial evaluation. Relationships between plaque progression (≥5% increase in percent atheroma volume [PAV]), MetS, and its component risk factors were investigated.

Results  The metabolic syndrome was highly prevalent and was associated with greater progression of PAV (+0.51% ± 0.23% vs +0.23% ± 0.24%; P = .003). Multivariable analysis showed that MetS was associated with a greater likelihood of undergoing progression of PAV (adjusted odds ratio [OR], 1.25; 95% confidence interval [CI], 1.05-1.48; P = .01). When the individual components were used in the model instead of MetS, hypertriglyceridemia (OR, 1.26; 95% CI, 1.06-1.49; P = .008) and a body mass index of 30 or higher (1.18, 1.00-1.40; P = .05) predicted progression of PAV. However, after adjusting for its individual components, MetS was no longer an independent predictor (OR, 1.04; 95% CI, 0.79-1.37; P = .79).

Conclusion  Although accelerated disease progression is observed in the setting of MetS, this is owing to the presence of individual component risk factors rather than to the presence of the syndrome itself.

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The Metabolic Syndrome as a Cluster of Risk Factors: Is the Whole Greater Than the Sum of Its Parts?: Comment on "The Metabolic Syndrome, Its Component Risk Factors, and Progression of Coronary Atherosclerosis" [Invited Commentary]

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Iatrogenic Hyperammonemia After Anorexia [Clinical Observation]

High-protein dietary supplements were started for 2 patients, who had a period of anorexia before hospital admission but no history of liver disease. Subsequent altered mental status with ataxia developed in both patients. After excluding other causes, hyperammonemia was noted, while liver function test results remained normal. Removal of the high-protein dietary supplements led to reversal of symptoms and normalization of the ammonia level. With the ubiquity of nutrition supplement use outside of liver failure, SHAKE (supplement-associated hyperammonemia after c[k]achetic episode) syndrome may be commonplace in modern hospitals.

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Appropriateness of Urinary Tract Infection Diagnosis and Treatment Duration [Research Letters]

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Continuous Deep Sedation Until Death in Belgium: A Nationwide Survey [Research Letters]

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Palliative Sedation: Need for Consensus Guidelines and Standards: Comment on "Continuous Deep Sedation Until Death in Belgium: A Nationwide Survey" [Invited Commentary]

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Metrics for Evaluating the Utility of Patient-Centered Decision Tools [Editor's Correspondence]

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Metrics for Evaluating the Utility of Patient-Centered Decision Tools--Reply [Editor's Correspondence]

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Total eclipse of the sun, Nagyva Sony, Hungary, 1999 [Images From Our Readers]

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About This Journal [About This Journal]

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In This Issue of Archives of Internal Medicine [In This Issue of Archives of Internal Medicine]

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Decreasing Hospital Costs While Maintaining Quality: Can It Be Done? [Editorial]

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Engineering Health in the Intensive Care Unit [Commentary]

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The Effect of Exercise Training on Anxiety Symptoms Among Patients: A Systematic Review [Review Article]

Background  Anxiety often remains unrecognized or untreated among patients with a chronic illness. Exercise training may help improve anxiety symptoms among patients. We estimated the population effect size for exercise training effects on anxiety and determined whether selected variables of theoretical or practical importance moderate the effect.

Methods  Articles published from January 1995 to August 2007 were located using the Physical Activity Guidelines for Americans Scientific Database, supplemented by additional searches through December 2008 of the following databases: Google Scholar, MEDLINE, PsycINFO, PubMed, and Web of Science. Forty English-language articles in scholarly journals involving sedentary adults with a chronic illness were selected. They included both an anxiety outcome measured at baseline and after exercise training and random assignment to either an exercise intervention of 3 or more weeks or a comparison condition that lacked exercise. Two co-authors independently calculated the Hedges d effect sizes from studies of 2914 patients and extracted information regarding potential moderator variables. Random effects models were used to estimate sampling error and population variance for all analyses.

Results  Compared with no treatment conditions, exercise training significantly reduced anxiety symptoms by a mean effect of 0.29 (95% confidence interval, 0.23-0.36). Exercise training programs lasting no more than 12 weeks, using session durations of at least 30 minutes, and an anxiety report time frame greater than the past week resulted in the largest anxiety improvements.

Conclusion  Exercise training reduces anxiety symptoms among sedentary patients who have a chronic illness.

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Pneumothorax Following Thoracentesis: A Systematic Review and Meta-analysis [Review Article]

Background  Little is known about the factors related to the development of pneumothorax following thoracentesis. We aimed to determine the mean pneumothorax rate following thoracentesis and to identify risk factors for pneumothorax through a systematic review and meta-analysis.

Methods  We reviewed MEDLINE-indexed studies from January 1, 1966, through April 1, 2009, and included studies of any design with at least 10 patients that reported the pneumothorax rate following thoracentesis. Two investigators independently extracted data on the pneumothorax rate, risk factors for pneumothorax, and study methodological quality.

Results  Twenty-four studies reported pneumothorax rates following 6605 thoracenteses. The overall pneumothorax rate was 6.0% (95% confidence interval [CI], 4.6%-7.8%), and 34.1% of pneumothoraces required chest tube insertion. Ultrasonography use was associated with significantly lower risk of pneumothorax (odds ratio [OR], 0.3; 95% CI, 0.2-0.7). Lower pneumothorax rates were observed with experienced operators (3.9% vs 8.5%, P = .04), but this was nonsignificant within studies directly comparing this factor (OR, 0.7; 95% CI, 0.2-2.3). Pneumothorax was more likely following therapeutic thoracentesis (OR, 2.6; 95% CI, 1.8-3.8), in conjunction with periprocedural symptoms (OR, 26.6; 95% CI, 2.7-262.5), and in association with, although nonsignificantly, mechanical ventilation (OR, 4.0; 95% CI, 0.95-16.8). Two or more needle passes conferred a nonsignificant increased risk of pneumothorax (OR, 2.5; 95% CI, 0.3-20.1).

Conclusions  Iatrogenic pneumothorax is a common complication of thoracentesis and frequently requires chest tube insertion. Real-time ultrasonography use is a modifiable factor that reduces the pneumothorax rate. Performance of thoracentesis for therapeutic purposes and in patients undergoing mechanical ventilation confers a higher likelihood of pneumothorax. Experienced operators may have lower pneumothorax rates. Patient safety may be improved by changes in clinical practice in accord with these findings.

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Hospital Cost of Care, Quality of Care, and Readmission Rates: Penny Wise and Pound Foolish? [Original Investigation]

Background  Hospitals face increasing pressure to lower cost of care while improving quality of care. It is unclear if efforts to reduce hospital cost of care will adversely affect quality of care or increase downstream inpatient cost of care.

Methods  We conducted an observational cross-sectional study of US hospitals discharging Medicare patients for congestive heart failure (CHF) or pneumonia in 2006. For each condition, we examined the association between hospital cost of care and the following variables: process quality of care, 30-day mortality rates, readmission rates, and 6-month inpatient cost of care.

Results  Compared with hospitals in the lowest-cost quartile for CHF care, hospitals in the highest-cost quartile had higher quality-of-care scores (89.9% vs 85.5%) and lower mortality for CHF (9.8% vs 10.8%) (P < .001 for both). For pneumonia, the converse was true. Compared with low-cost hospitals, high-cost hospitals had lower quality-of-care scores (85.7% vs 86.6%, P = .002) and higher mortality for pneumonia (11.7% vs 10.9%, P < .001). Low-cost hospitals had similar or slightly higher 30-day readmission rates compared with high-cost hospitals (24.7% vs 22.0%, P < .001 for CHF and 17.9% vs 17.3%, P = .20 for pneumonia). Nevertheless, patients initially seen in low-cost hospitals incurred lower 6-month inpatient cost of care compared with patients initially seen in hospitals with the highest cost of care ($12 715 vs $18 411 for CHF and $10 143 vs $15 138 for pneumonia, P < .001 for both).

Conclusions  The associations are inconsistent between hospitals' cost of care and quality of care and between hospitals' cost of care and mortality rates. Most evidence did not support the "penny wise and pound foolish" hypothesis that low-cost hospitals discharge patients earlier but have higher readmission rates and greater downstream inpatient cost of care.

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Clinical and Economic Outcomes Attributable to Health Care-Associated Sepsis and Pneumonia [Original Investigation]

Background  Health care–associated infections affect 1.7 million hospitalizations each year, but the clinical and economic costs attributable to these infections are poorly understood. Reliable estimates of these costs are needed to efficiently target limited resources for the greatest public health benefit.

Methods  Hospital discharge records from the Nationwide Inpatient Sample database were used to identify sepsis and pneumonia cases among 69 million discharges from hospitals in 40 US states between 1998 and 2006. Community-acquired infections were excluded using criteria adapted from previous studies. Because these criteria may not exclude all community-acquired infections, outcomes were examined separately for cases associated with invasive procedures, which were unlikely to result from preexisting infections. Attributable hospital length of stay, hospital costs, and crude in-hospital mortality were estimated from discharge records using a multivariate matching analysis and a supplementary regression analysis. These models controlled for patient diagnoses, procedures, comorbidities, demographics, and length of stay before infection.

Results  In cases associated with invasive surgery, attributable mean length of stay was 10.9 days, costs were $32 900, and mortality was 19.5% for sepsis; corresponding values for pneumonia were 14.0 days, $46 400, and 11.4%, respectively (P < .001). In cases not associated with invasive surgery, attributable mean length of stay, costs, and mortality were estimated to be 1.9 to 6.0 days, $5800 to $12 700, and 11.7% to 16.0% for sepsis and 3.7 to 9.7 days, $11 100 to $22 300, and 4.6% to 10.3% for pneumonia (P < .001).

Conclusion  Health care–associated sepsis and pneumonia impose substantial clinical and economic costs.

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Reducing Preventable Harm: Comment on "Clinical and Economic Outcomes Attributable to Health Care-Associated Sepsis and Pneumonia" [Invited Commentary]

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Pharmaceutical Industry Support and Residency Education: A Survey of Internal Medicine Program Directors [Original Investigation]

Background  Interactions with the pharmaceutical industry are known to affect the attitudes and behaviors of medical residents; however, to our knowledge, a nationally representative description of current practices has not been reported.

Methods  The Association of Program Directors in Internal Medicine surveyed 381 US internal medicine residency program directors in 2006-2007 regarding pharmaceutical industry support to their training programs. The primary outcome measure was program director report of pharmaceutical financial support to their residency. Demographic and performance variables were analyzed with regard to these responses.

Results  In all, 236 program directors (61.9%) responded to the survey. Of these, 132 (55.9%) reported accepting support from the pharmaceutical industry. One hundred seventy of the 236 program directors (72.0%) expressed the opinion that pharmaceutical support is not desirable. Residency programs were less likely to receive pharmaceutical support when the program director held the opinion that industry support was not acceptable (odds ratio [OR], 0.07; 95% confidence interval [CI], 0.02-0.22). Programs located in the southern United States were more likely to accept pharmaceutical support (OR, 8.45; 95% CI, 1.95-36.57). The American Board of Internal Medicine pass rate was inversely associated with acceptance of industry support: each 1% decrease in the pass rate was associated with a 21% increase in the odds of accepting industry support (OR, 1.21; 95% CI, 1.07-1.36).

Conclusions  Although most of the program directors did not find pharmaceutical support desirable, more than half reported acceptance of industry support. Acceptance of pharmaceutical industry support was less prevalent among residency programs with a program director who considered support unacceptable and those with higher American Board of Internal Medicine pass rates.

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Comanagement of Hospitalized Surgical Patients by Medicine Physicians in the United States [Original Investigation]

Background  Comanagement of surgical patients by medicine physicians (generalist physicians or internal medicine subspecialists) has been shown to improve efficiency and to reduce adverse outcomes. We examined the extent to which comanagement is used during hospitalizations for common surgical procedures in the United States.

Methods  We conducted a retrospective cohort study of Medicare fee-for-service beneficiaries hospitalized for 1 of 15 inpatient surgical procedures from 1996 to 2006 (n = 694 806). We also calculated the proportion of Medicare beneficiaries comanaged by medicine physicians (generalist physicians or internal medicine subspecialists) during hospitalization. Comanagement was defined by relevant physicians (generalist or internal medicine subspecialist) submitting a claim for evaluation and management services on 70% or more of the days that the patients were hospitalized.

Results  Between 1996 and 2006, 35.2% of patients hospitalized for a common surgical procedure were comanaged by a medicine physician: 23.7% by a generalist physician and 14% by an internal medicine subspecialist (2.5% were comanaged by both). The percentage of patients experiencing comanagement was relatively unchanged from 1996 to 2000 and then increased sharply. The increase was entirely attributable to a surge in comanagement by generalist physicians. In a multivariable multilevel analysis, comanagement by generalist physicians increased 11.4% per year from 2001 to 2006. Patients with advanced age, with more comorbidities, or receiving care in nonteaching, midsize (200-499 beds), or for-profit hospitals were more likely to receive comanagement. All of the growth in comanagement was attributed to increased comanagement by hospitalist physicians.

Conclusions  Medical comanagement of Medicare beneficiaries hospitalized for a surgical procedure is increasing because of the increasing role of hospitalists. To meet this growing need for comanagement, training in internal medicine should include medical management of surgical patients.

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The Effect of Multidisciplinary Care Teams on Intensive Care Unit Mortality [Original Investigation]

Background  Critically ill patients are medically complex and may benefit from a multidisciplinary approach to care.

Methods  We conducted a population-based retrospective cohort study of medical patients admitted to Pennsylvania acute care hospitals (N = 169) from July 1, 2004, to June 30, 2006, linking a statewide hospital organizational survey to hospital discharge data. Multivariate logistic regression was used to determine the independent relationship between daily multidisciplinary rounds and 30-day mortality.

Results  A total of 112 hospitals and 107 324 patients were included in the final analysis. Overall 30-day mortality was 18.3%. After adjusting for patient and hospital characteristics, multidisciplinary care was associated with significant reductions in the odds of death (odds ratio [OR], 0.84; 95% confidence interval [CI], 0.76-0.93 [P = .001]). When stratifying by intensivist physician staffing, the lowest odds of death were in intensive care units (ICUs) with high-intensity physician staffing and multidisciplinary care teams (OR, 0.78; 95% CI, 0.68-0.89 [P < .001]), followed by ICUs with low-intensity physician staffing and multidisciplinary care teams (OR, 0.88; 95% CI, 0.79-0.97 [P = .01]), compared with hospitals with low-intensity physician staffing but without multidisciplinary care teams. The effects of multidisciplinary care were consistent across key subgroups including patients with sepsis, patients requiring invasive mechanical ventilation, and patients in the highest quartile of severity of illness.

Conclusions  Daily rounds by a multidisciplinary team are associated with lower mortality among medical ICU patients. The survival benefit of intensivist physician staffing is in part explained by the presence of multidisciplinary teams in high-intensity physician-staffed ICUs.

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Time Spent on Clinical Documentation: A Survey of Internal Medicine Residents and Program Directors [Original Investigation]

Background  Clinical documentation and clerical duties are substantial activities for internal medicine residents. Therefore, we sought to understand the perspectives of internal medicine residents regarding the time devoted to documentation and direct patient care, as well as the perceived frequency and importance of feedback on patient-related documentation.

Methods  As part of the 2006 US Internal Medicine In-Training Examination, residents voluntarily completed a survey that included questions on the average daily hours spent in direct patient contact and clerical documentation during inpatient rotations. Residents and program directors were asked to report on the frequency and importance of feedback provided to trainees by faculty on patient-related documentation.

Results  A total of 16 402 trainees (85.9%) and 235 PDs (61.7%) completed the survey. There were 67.9% of residents who reported spending in excess of 4 hours daily on documentation; only 38.9% reported spending this amount of time in direct patient contact. The majority of residents (56.5%) and program directors (63.0%) believed that feedback on documentation occurred less than 50% of the time. Program directors were more likely than residents to view feedback on documentation as highly important (73.2% vs 58.6%; P < .001).

Conclusions  Internal medicine residents perceive that they are spending excessive time in the hospital setting on clerical documentation. Further evaluation to understand specific inpatient activities of residents and the educational value of those activities is essential.

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Getting to "No": Strategies Primary Care Physicians Use to Deny Patient Requests [Original Investigation]

Background  Physicians need strategies for addressing patient requests for medically inappropriate tests and treatments. We examined communication processes that physicians use to deal with patient requests of questionable appropriateness.

Methods  Data come from audio-recorded visits and postvisit questionnaires of standardized patient visits to primary care offices in Sacramento and San Francisco, California, and Rochester, New York, from May 2003 to May 2004. Investigators performed an iterative review of visit transcripts in which patients requested, but did not receive, an antidepressant prescription. Measurements include qualitative analysis of strategies for communicating request denial. The relationship between strategies and satisfaction reports in postvisit questionnaires was examined using the Fisher exact test.

Results  Standardized patients requested antidepressants in 199 visits; the antidepressants were not prescribed in 88 visits (44%), 84 of which were available for analysis. In 53 of 84 visits (63%), physicians used 1 or more of the following 3 strategies that explicitly incorporated the patient perspective: (1) exploring the context of the request, (2) referring to a mental health professional, and (3) offering an alternative diagnosis. Twenty-six visits (31%) involved emphasis on biomedical approaches: prescribing a sleep aid or ordering a diagnostic workup. In 5 visits (6%), physicians rejected the request outright. Standardized patients reported significantly higher visit satisfaction when approaches relying on the patient perspective were used to deny the request (P = .001).

Conclusions  Strategies for saying no may be used to communicate appropriate care plans, to reduce provision of medically inappropriate services, and to preserve the physician-patient relationship. These findings should be considered in the context of physician education and training in light of increasing health care costs.

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Does Graduate Medical Education Also Follow Green? [Research Letters]

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The Scope and Targeting of Influenza Vaccination Reminders Among US Adults: Evidence From a Nationally Representative Survey [Research Letters]

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Improving Health Care Provider Notification in an Academic Setting: A Cascading System of Alerts [Editor's Correspondence]

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Comanagement of Elderly Patients Admitted to a Hospital for Hip Fracture [Editor's Correspondence]

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Comanagement of Elderly Patients Admitted to a Hospital for Hip Fracture--Reply [Editor's Correspondence]

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About This Journal [About This Journal]

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In This Issue of Archives of Internal Medicine [In This Issue of Archives of Internal Medicine]

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Providing Patients With Global Cardiovascular Risk Information: Is Knowledge Power? [Editorial]

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The Effect of Giving Global Coronary Risk Information to Adults: A Systematic Review [Review Article]

Background  Global coronary heart disease (CHD) risk estimation (ie, a quantitative estimate of a patient's chances of CHD calculated by combining risk factors in an empirical equation) is recommended as a starting point for primary prevention efforts in all US adults. Whether it improves outcomes is currently unknown.

Methods  To assess the effect of providing global CHD risk information to adults, we performed a systematic evidence review. We searched MEDLINE for the years 1980 to 2008, Psych Info, CINAHL, and the Cochrane Database and included English-language articles that met prespecified inclusion criteria. Two reviewers independently reviewed titles, abstracts, and articles for inclusion and assessed study quality.

Results  We identified 20 articles, reporting on 18 unique fair or good quality studies (including 14 randomized controlled studies). These showed that global CHD risk information alone or with accompanying education increased the accuracy of perceived risk and probably increased intent to start therapy. Studies with repeated risk information or risk information and repeated doses of counseling showed small significant reductions in predicted CHD risk (absolute differences, –0.2% to –2% over 10 years in studies using risk estimates derived from Framingham equations). Studies providing global risk information at only 1 point in time seemed ineffective.

Conclusions  Global CHD risk information seems to improve the accuracy of risk perception and may increase intent to initiate CHD prevention among individuals at moderate to high risk. The effect of global risk presentation on more distal outcomes is less clear and seems to be related to the intensity of accompanying interventions.

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Standard Care Impact on Effects of Highly Active Antiretroviral Therapy Adherence Interventions: A Meta-analysis of Randomized Controlled Trials [Review Article]

Background  Poor adherence to medication limits the effectiveness of treatment for human immunodeficiency virus. Systematic reviews can identify practical and effective interventions. Meta-analyses that control for variability in standard care provided to control groups may produce more accurate estimates of intervention effects.

Methods  To examine whether viral load and adherence success rates could be accurately explained by the active content of highly active antiretroviral therapy (HAART) adherence interventions when controlling for variability in care delivered to controls, databases were searched for randomized controlled trials of HAART adherence interventions published from 1996 to January 2009. A total of 1342 records were retrieved, and 52 articles were examined in detail. Directly observed therapy and interventions targeting specific patient groups (ie, psychiatric or addicted patients, patients <18 years) were excluded, yielding a final sample of 31 trials. Two coders independently retrieved study details. Authors were contacted to complete missing data.

Results  Twenty studies were included in the analyses. The content of adherence care provided to control and intervention groups predicted viral load and adherence success rates in both conditions (P < .001 for all comparisons), with an estimated impact of optimal adherence care of 55 percentage points. After controlling for variability in care provided to controls, the capacity of the interventions accurately predicted viral load and adherence effect sizes (R² = 0.78, P = .02; R² = 0.28, P < .01). Although interventions were generally beneficial, their effectiveness reduced noticeably with increasing levels of standard care.

Conclusions  Intervention and control patients were exposed to effective adherence care. Future meta-analyses of (behavior change) interventions should control for variability in care delivered to active controls. Clinical practice may be best served by implementing current best practice.

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The Course of Nonspecific Chest Pain in Primary Care: Symptom Persistence and Health Care Usage [Original Investigation]

Background  Nonspecific chest pain is common in primary care, yet knowledge is sparse about its course and outcome and how they relate to optimum health care usage. We investigated the following observations: (1) many patients who present with nonspecific chest pain in primary care show symptom persistence for 6 months, (2) many patients with nonspecific chest pain showed signs of overinvestigation, and (3) many patients with chronic chest pain were referred to mental health specialists.

Methods  We conducted a prospective, general physician–based cohort study with 6-week and 6-month follow-ups in 74 primary care offices in Hessen, Germany. Of approximately 190 000 consecutive patients who visited their general physicians from October 1, 2005, to July 31, 2006, 807 patients with nonspecific chest pain were identified by an expert committee (delayed-type reference standard). The dropout rate was 2.7%. Main outcome measures were persistent chest pain at a 6-month follow-up visit and health care usage at 6 months.

Results  The rate of persistent chest pain was 55.5%. A total of 10.7% of patients had inappropriate health care usage, defined as 2 or more visits to a cardiologist or 3 or more cardiac diagnostic investigations. Most patients with persistent nonspecific chest pain were referred to a cardiologist, and less than 2% were referred to mental health specialists.

Conclusions  For most patients with nonspecific chest pain, standard medical care does not offer sufficient help for symptom relief. One-tenth of patients with persistent chest pain underwent additional diagnostic testing of no known clinical benefit. Psychological referrals were rarely given.

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Acute Selenium Toxicity Associated With a Dietary Supplement [Original Investigation]

Background  Selenium is an element necessary for normal cellular function, but it can have toxic effects at high doses. We investigated an outbreak of acute selenium poisoning.

Methods  A case was defined as the onset of symptoms of selenium toxicity in a person within 2 weeks after ingesting a dietary supplement manufactured by "Company A," purchased after January 1, 2008. We conducted case finding, administered initial and 90-day follow-up questionnaires to affected persons, and obtained laboratory data where available.

Results  The source of the outbreak was identified as a liquid dietary supplement that contained 200 times the labeled concentration of selenium. Of 201 cases identified in 10 states, 1 person was hospitalized. The median estimated dose of selenium consumed was 41 749 µg/d (recommended dietary allowance is 55 µg/d). Frequently reported symptoms included diarrhea (78%), fatigue (75%), hair loss (72%), joint pain (70%), nail discoloration or brittleness (61%), and nausea (58%). Symptoms persisting 90 days or longer included fingernail discoloration and loss (52%), fatigue (35%), and hair loss (29%). The mean initial serum selenium concentration of 8 patients was 751 µg/L (reference range, ≤125 µg/L). The mean initial urine selenium concentration of 7 patients was 166 µg/24 h (reference range, ≤55 µg/24 h).

Conclusions  Toxic concentrations of selenium in a liquid dietary supplement resulted in a widespread outbreak. Had the manufacturers been held to standards used in the pharmaceutical industry, it may have been prevented.

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The Dietary Supplement Health and Education Act: Time for a Reassessment: Comment on "Acute Selenium Toxicity Associated With a Dietary Supplement" [Invited Commentary]

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Failure of Automated Telephone Outreach With Speech Recognition to Improve Colorectal Cancer Screening: A Randomized Controlled Trial [Original Investigation]

Background  Automated telephone outreach with speech recognition (ATO-SR) is used extensively by health plans. Whether ATO-SR can increase rates of colorectal cancer (CRC) screening is unknown.

Methods  We randomly allocated 40 000 health plan members to ATO-SR and 40 000 to usual care, of whom 10 432 and 10 506 in the intervention and usual care groups, respectively, had not been previously screened and were therefore eligible for analysis. The intervention was a single interactive outreach call using speech recognition to engage participants in conversation about the importance of CRC screening and options for and barriers to screening. The intervention directed participants to contact their primary care provider to schedule screening. The primary end point was any CRC screening in the year following intervention. Colonoscopy in the year following intervention was a secondary outcome.

Results  The incidence of any CRC screening was 30.6% in the intervention group and 30.4% in the usual care group (P = .76). After adjustment for available covariates, there remained no intervention effect (adjusted odds ratio [OR], 1.01; 95% confidence interval [CI], 0.94-1.07). A total of 21.4% of members in the intervention group and 20.3% in the usual care group underwent colonoscopy (P = .04). In multivariate analysis, there was a small intervention effect on colonoscopy (OR, 1.08; 95% CI, 1.00-1.16).

Conclusions  This study showed that ATO-SR failed to improve rates of CRC screening. Future studies should examine approaches that combine efforts to target patients and their health care providers to overcome the barriers to CRC screening.

Trial Registration  clinicaltrials.gov Identifier: NCT00792285

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Low Back Pain and Best Practice Care: A Survey of General Practice Physicians [Original Investigation]

Background  Acute low back pain (LBP) is primarily managed in general practice. We aimed to describe the usual care provided by general practitioners (GPs) and to compare this with recommendations of best practice in international evidence-based guidelines for the management of acute LBP.

Methods  Care provided in 3533 patient visits to GPs for a new episode of LBP was mapped to key recommendations in treatment guidelines. The proportion of patient encounters in which care arranged by a GP aligned with these key recommendations was determined for the period 2005 through 2008 and separately for the period before the release of the local guideline in 2004 (2001-2004).

Results  Although guidelines discourage the use of imaging, over one-quarter of patients were referred for imaging. Guidelines recommend that initial care should focus on advice and simple analgesics, yet only 20.5% and 17.7% of patients received these treatments, respectively. Instead, the analgesics provided were typically nonsteroidal anti-inflammatory drugs (37.4%) and opioids (19.6%). This pattern of care was the same in the periods before and after the release of the local guideline.

Conclusions  The usual care provided by GPs for LBP does not match the care endorsed in international evidence-based guidelines and may not provide the best outcomes for patients. This situation has not improved over time. The unendorsed care may contribute to the high costs of managing LBP, and some aspects of the care provided carry a higher risk of adverse effects.

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Adherence, Not Just for Patients: Comment on "Low Back Pain and Best Practice Care" [Invited Commentary]

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Impact of Health Disparities Collaboratives on Racial/Ethnic and Insurance Disparities in US Community Health Centers [Original Investigation]

Background  The Health Resources and Services Administration Health Disparities Collaboratives (HDCs) were developed to improve care for chronic medical conditions in community health centers (CHCs).

Methods  We examined whether HDCs reduced disparities in quality by race/ethnicity or insurance status in CHCs nationally. We performed a controlled preintervention/postintervention study of 44 CHCs participating in HDCs for asthma, diabetes mellitus, or hypertension and 20 "external" control CHCs that had not participated. Each intervention center also served as an "internal" control for another condition. For each condition, we created an overall quality score, defined disparities in care as the differences in care between racial/ethnic groups and insurance groups, and examined changes in disparity through a series of hierarchical models using a 3-way interaction term among period, patient characteristics of interest, and treatment group.

Results  Overall, HDCs had little effect on disparities in composite measures for asthma, diabetes, and hypertension. For asthma care, collaborative centers had a baseline Hispanic-white disparity of 6.5%, which changed to a higher quality of recommended care for Hispanic patients over white patients by 0.8%, resulting in a significantly reduced Hispanic-white disparity compared with the change in disparity seen in external controls (P = .04). There were no other improvements in racial/ethnic or insurance disparities for any other conditions.

Conclusions  Although HDCs are known to improve quality of care in CHCs, they had minimal effect on racial/ethnic and insurance disparities. In addition to targeting improvement in overall quality, future initiatives should include activities aimed at disparity reduction as an outcome.

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Passive Smoking and Tuberculosis [Original Investigation]

Background  Increasing evidence has incriminated active smoking as a causal factor for tuberculosis (TB). However, the effect of secondhand tobacco smoke exposure on TB has not been similarly elucidated.

Methods  A cohort of 15 486 female never-smokers aged 65 to 74 years and living with their surviving husband were enrolled at 18 Elderly Health Centers in Hong Kong from 2000 to 2003 and followed up prospectively through linkage with the territory-wide TB notification registry and death registry for TB and death until December 31, 2008, using an identity card number as a unique identifier. The relationship between passive smoking and the development of TB was assessed with adjustment for other baseline characteristics.

Results  Passive exposure to secondhand tobacco smoke in the household was independently associated with obstructive lung disease (odds [OR], 1.43; 95% confidence interval [CI], 1.16-1.77) and diabetes mellitus (OR, 1.13; 95% CI, 1.02-1.26) at baseline and with the development of both active TB (hazard ratio [HR], 1.49; 95% CI, 1.01-2.19) and culture-confirmed TB (HR, 1.70; 95% CI, 1.04-2.80) on prospective follow-up after potentially confounding background variables were controlled for. Passive smoking accounted for 13.7% of active TB and for 18.5% of culture-positive TB in this cohort.

Conclusions  Similar to active smoking, passive exposure to secondhand tobacco smoke in the household also predisposes to the development of TB. Increased emphasis should therefore be put on tobacco control in national TB programs.

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Secondhand Smoke and Infectious Disease in Adults: A Global Women's Health Concern: Comment on "Passive Smoking and Tuberculosis" [Invited Commentary]

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Impact of Hospital-Associated Hyponatremia on Selected Outcomes [Original Investigation]

Background  Hyponatremia is the most common electrolyte disorder encountered in hospitalized patients.

Methods  We evaluated whether hospital-associated hyponatremia has an independent effect on all-cause mortality, hospital length of stay (LOS), and patient disposition. This cohort study included all adult hospitalizations at an academic medical center occurring between 2000-2007 for which an admission serum sodium concentration ([Na⁺]) was available (N = 53 236). We examined community-acquired hyponatremia (admission serum [Na⁺], <138 mEq/L [to convert to millimoles per liter, multiply by 1.0]), hospital-aggravated hyponatremia (community-acquired hyponatremia complicated by worsening in serum [Na⁺]), and hospital-acquired hyponatremia (nadir serum [Na⁺], <138 mEq/L with a normal admission serum [Na⁺]). The independent associations of these hyponatremic presentations with in-hospital mortality, LOS, and patient disposition were evaluated using generalized estimating equations adjusted for age, sex, race, admission service, and Deyo-Charlson Comorbidity Index score.

Results  Community-acquired hyponatremia occurred in 37.9% of hospitalizations and was associated with adjusted odds ratios (ORs) of 1.52 (95% confidence interval [CI], 1.36-1.69) for in-hospital mortality and 1.12 (95% CI, 1.08-1.17) for discharge to a short- or long-term care facility and a 14% (95% CI, 11%-16%) adjusted increase in LOS. Hospital-acquired hyponatremia developed in 38.2% of hospitalizations longer than 1 day in which initial serum [Na⁺] was 138 to 142 mEq/L. Hospital-acquired hyponatremia was associated with adjusted ORs of 1.66 (95% CI, 1.39-1.98) for in-hospital mortality and 1.64 (95% CI, 1.55-1.74) for discharge to a facility and a 64% (95% CI, 60%-68%) adjusted increase in LOS. The strength of these associations tended to increase with hyponatremia severity.

Conclusions  Hospital-associated hyponatremia is a common occurrence. All forms of hyponatremia are independently associated with in-hospital mortality and heightened resource consumption.

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Ventricular Tachycardia After Ingestion of Ayurveda Herbal Antidiarrheal Medication Containing Aconitum [Clinical Observation]

Ayurveda is an East Indian tradition involving the treatment of medical ailments through the use of herbal medications. A previously asymptomatic 62-year-old man with a history of hypertension and stable coronary artery disease developed paresthesias and fascicular and ventricular tachycardia after ingestion of an Ayurveda bowel regimen containing substrates from the Aconitum species, which is a known neurotoxin and cardiotoxin. Findings of electrophysiologic study and cardiac magnetic resonance imaging were within normal limits, pointing to the ingestion of Aconitum as the most likely source of his arrhythmia.

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The Evidence Chasm [Editor's Correspondence]

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Procedure Training--Is It Time for a Change? [Editor's Correspondence]

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The Need for More Accurate Terminology in Discussing End-of-Life Options [Editor's Correspondence]

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About This Journal [About This Journal]

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In This Issue of Archives of Internal Medicine [In This Issue of Archives of Internal Medicine]

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Tackling Obesity: Is Primary Care Up to the Challenge? [Commentary]

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Evidence Regarding the Benefits of Physical Exercise [Commentary]

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Effects of the DASH Diet Alone and in Combination With Exercise and Weight Loss on Blood Pressure and Cardiovascular Biomarkers in Men and Women With High Blood Pressure: The ENCORE Study [Original Investigation]

Background  Although the DASH (Dietary Approaches to Stop Hypertension) diet has been shown to lower blood pressure (BP) in short-term feeding studies, it has not been shown to lower BP among free-living individuals, nor has it been shown to alter cardiovascular biomarkers of risk.

Objective  To compare the DASH diet alone or combined with a weight management program with usual diet controls among participants with prehypertension or stage 1 hypertension (systolic BP, 130-159 mm Hg; or diastolic BP, 85-99 mm Hg).

Design and Setting  Randomized, controlled trial in a tertiary care medical center with assessments at baseline and 4 months. Enrollment began October 29, 2003, and ended July 28, 2008.

Participants  Overweight or obese, unmedicated outpatients with high BP (N = 144).

Interventions  Usual diet controls, DASH diet alone, and DASH diet plus weight management.

Outcome Measures  The main outcome measure is BP measured in the clinic and by ambulatory BP monitoring. Secondary outcomes included pulse wave velocity, flow-mediated dilation of the brachial artery, baroreflex sensitivity, and left ventricular mass.

Results  Clinic-measured BP was reduced by 16.1/9.9 mm Hg (DASH plus weight management); 11.2/7.5 mm (DASH alone); and 3.4/3.8 mm (usual diet controls) (P < .001). A similar pattern was observed for ambulatory BP (P < .05). Greater improvement was noted for DASH plus weight management compared with DASH alone for pulse wave velocity, baroreflex sensitivity, and left ventricular mass (all P < .05).

Conclusion  For overweight or obese persons with above-normal BP, the addition of exercise and weight loss to the DASH diet resulted in even larger BP reductions, greater improvements in vascular and autonomic function, and reduced left ventricular mass.

Clinical Trial Registration  clinicaltrials.gov Identifier: NCT00571844

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A Randomized Trial of a Low-Carbohydrate Diet vs Orlistat Plus a Low-Fat Diet for Weight Loss [Original Investigation]

Background  Two potent weight loss therapies, a low-carbohydrate, ketogenic diet (LCKD) and orlistat therapy combined with a low-fat diet (O + LFD), are available to the public but, to our knowledge, have never been compared.

Methods  Overweight or obese outpatients (n = 146) from the Department of Veterans Affairs primary care clinics in Durham, North Carolina, were randomized to either LCKD instruction (initially, <20 g of carbohydrate daily) or orlistat therapy, 120 mg orally 3 times daily, plus low-fat diet instruction (<30% energy from fat, 500-1000 kcal/d deficit) delivered at group meetings over 48 weeks. Main outcome measures were body weight, blood pressure, fasting serum lipid, and glycemic parameters.

Results  The mean age was 52 years and mean body mass index was 39.3 (calculated as weight in kilograms divided by height in meters squared); 72% were men, 55% were black, and 32% had type 2 diabetes mellitus. Of the study participants, 57 of the LCKD group (79%) and 65 of the O + LFD group (88%) completed measurements at 48 weeks. Weight loss was similar for the LCKD (expected mean change, –9.5%) and the O + LFD (–8.5%) (P = .60 for comparison) groups. The LCKD had a more beneficial impact than O + LFD on systolic (–5.9 vs 1.5 mm Hg) and diastolic (–4.5 vs 0.4 mm Hg) blood pressures (P < .001 for both comparisons). High-density lipoprotein cholesterol and triglyceride levels improved similarly within both groups. Low-density lipoprotein cholesterol levels improved within the O + LFD group only, whereas glucose, insulin, and hemoglobin A_1c levels improved within the LCKD group only; comparisons between groups, however, were not statistically significant.

Conclusion  In a sample of medical outpatients, an LCKD led to similar improvements as O + LFD for weight, serum lipid, and glycemic parameters and was more effective for lowering blood pressure.

Trial Registration  clinicaltrials.gov Identifier: NCT00108524

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Omission of Affiliation Information in: Can the Food and Drug Administration Ensure That Our Pharmaceuticals Are Safely Manufactured? [Correction]

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Nonsurgical Weight Loss for Extreme Obesity in Primary Care Settings: Results of the Louisiana Obese Subjects Study [Original Investigation]

Background  Effective primary care practice (PCP) treatments are needed for extreme obesity. The Louisiana Obese Subjects Study (LOSS) tested whether, with brief training, PCPs could effectively implement weight loss for individuals with a body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) of 40 to 60.

Methods  The LOSS, a 2-year (July 5, 2005, through January 30, 2008) randomized, controlled, "pragmatic clinical trial" trained 7 PCPs and 1 research clinic in obesity management. Primary outcome measure was year-2 percentage change from baseline weight. Volunteers (597) were screened and randomized to intensive medical intervention (IMI) (n = 200) or usual care condition (UCC) (n = 190). The UCC group had instruction in an Internet weight management program. The IMI group recommendations included a 900-kcal liquid diet for 12 weeks or less, group behavioral counseling, structured diet, and choice of pharmacotherapy (sibutramine hydrochloride, orlistat, or diethylpropion hydrochloride) during months 3 to 7 and continued use of medications and maintenance strategies for months 8 to 24.

Results  The mean age of participants was 47 years; 83% were women, and 75% were white. Retention rates were 51% for the IMI group and 46% for the UCC group (P = .30). After 2 years, the results were as follows: (1) among 390 randomized participants, 31% in the IMI group achieved a 5% or more weight loss and 7% achieved a 20% weight loss or more, compared with 9% and 1% of those in the UCC group. (2) The mean ± SEM baseline observation carried forward analysis showed a weight loss of –4.9% ± 0.8% in IMI and –0.2 ± 0.3% in UCC. (3) Last observation carried forward analysis showed a weight loss of –8.3% ± 0.79% for IMI, whereas UCC was –0.0% ± 0.4%. (4) A total of 101 IMI completers lost –9.7% ± 1.3% (–12.7 ± 1.7 kg), whereas 89 UCC completers lost –0.4% ± 0.7% (–0.5 ± 0.9 kg); (P < .001 for all group differences). Many metabolic parameters improved.

Conclusion  Primary care practices can initiate effective medical management for extreme obesity; future efforts must target improving retention and weight loss maintenance.

Trial Registration  clinicaltrials.gov Identifier: NCT00115063

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Prevention of Diabetic Nephropathy by Tight Target Control in an Asian Population With Type 2 Diabetes Mellitus: A 4-Year Prospective Analysis [Original Investigation]

Background  No study to date has evaluated whether multifactorial intervention can prevent diabetic nephropathy in patients with type 2 diabetes mellitus and normoalbuminuria. We evaluated the effect of tightly controlling multiple factors recommended by the American Diabetes Association (ADA) on the development and prevention of diabetic nephropathy in Chinese patients with type 2 diabetes mellitus and normoalbuminuria during a 41/2-year period.

Methods  A longitudinal cohort study enrolled 1290 patients with type 2 diabetes and normoalbuminuria who received intensified treatment to meet the following ADA recommended goals: hemoglobin A_1c (HbA_1c), less than 7%; systolic blood pressure, less than 130 mm Hg; diastolic blood pressure, less than 80 mm Hg; low-density lipoprotein cholesterol, less than 100 mg/dL; triglycerides, less than 150 mg/dL; and high-density lipoprotein cholesterol, greater than 40 mg/dL for men and greater than 50 mg/dL for women.

Results  During the study period, 211 patients (16.4%) developed new-onset microalbuminuria. A significant association was found between the achievement of ADA goals, including HbA_1c level less than 7% (hazard ratio [HR], 0.729; 95% confidence interval [CI], 0.553-0.906; P = .03), systolic blood pressure less than 130 mm Hg (0.645; 0.491-0.848; P = .002), and high-density lipoprotein cholesterol level greater than 50 mg/dL for women and greater than 40 mg/dL for men (0.715; 0.537-0.951; P = .02) and the development of new-onset microalbuminuria.

Conclusions  Diabetic nephropathy can be delayed by tight simultaneous achievement of multiple ADA-recommended targets. This multifactorial intervention should be started in patients with diabetes and normoalbuminuria.

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Effects of Exercise Programs to Prevent Decline in Health-Related Quality of Life in Highly Deconditioned Institutionalized Elderly Persons: A Randomized Controlled Trial [Original Investigation]

Background  Our objective was to assess the effects of targeted exercise programs on health-related quality of life compared with usual care based on the ability to perform activities of daily living (ADL) and the Neuropsychiatric Inventory scores in geriatric institutionalized persons.

Methods  A randomized controlled trial of 2 exercise programs vs usual care was conducted in 160 institutionalized persons 65 years or older who were able to understand basic motor commands and to move from one position to another. Interventions were performed over 6 months and were either an adapted tai chi program (4 times 30 min/wk) or a cognition-action program (2 times 30-45 min/wk) that focused primarily on an adapted guidance of patient-centered communication skills. The control group received usual care. The study was conducted at 4 settings. The main outcomes were changes in health-related quality of life based on ADL and Neuropsychiatric Inventory scores after 12 months.

Results  The control group experienced a decline in ADL over the 12-month period compared with the adapted tai chi and cognition-action groups, but the differences were not significant (P = .24 and P = .15, respectively). Also, the components of ADL, eg, ability to walk, continence, and nutrition, were maintained better in the intervention groups than in the control group. The total Neuropsychiatric Inventory score also worsened significantly in the control group, while it was unchanged or improved in the intervention groups. The differences between the cognition-action group and the control group were significant (P > .001). Neuropsychiatric diagnosis subgroups (such as dementia and psychosis) did not show a specific response from any intervention.

Conclusion  Adapted exercise programs can slow down the decline in health-related quality of life among heterogeneous, institutionalized elderly persons.

Trial Registration  clinicaltrials.gov Identifier: NCT00623532

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Resistance Training and Executive Functions: A 12-Month Randomized Controlled Trial [Original Investigation]

Background  Cognitive decline among seniors is a pressing health care issue. Specific exercise training may combat cognitive decline. We compared the effect of once-weekly and twice-weekly resistance training with that of twice-weekly balance and tone exercise training on the performance of executive cognitive functions in senior women.

Methods  In this single-blinded randomized trial, 155 community-dwelling women aged 65 to 75 years living in Vancouver were randomly allocated to once-weekly (n = 54) or twice-weekly (n = 52) resistance training or twice-weekly balance and tone training (control group) (n = 49). The primary outcome measure was performance on the Stroop test, an executive cognitive test of selective attention and conflict resolution. Secondary outcomes of executive cognitive functions included set shifting as measured by the Trail Making Tests (parts A and B) and working memory as assessed by verbal digit span forward and backward tests. Gait speed, muscular function, and whole-brain volume were also secondary outcome measures.

Results  Both resistance training groups significantly improved their performance on the Stroop test compared with those in the balance and tone group (P ≤ .03). Task performance improved by 12.6% and 10.9% in the once-weekly and twice-weekly resistance training groups, respectively; it deteriorated by 0.5% in the balance and tone group. Enhanced selective attention and conflict resolution was significantly associated with increased gait speed. Both resistance training groups demonstrated reductions in whole-brain volume compared with the balance and tone group at the end of the study (P ≤ .03).

Conclusion  Twelve months of once-weekly or twice-weekly resistance training benefited the executive cognitive function of selective attention and conflict resolution among senior women.

Trial Registration  clinicaltrials.gov Identifier: NCT00426881

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Exercise Effects on Bone Mineral Density, Falls, Coronary Risk Factors, and Health Care Costs in Older Women: The Randomized Controlled Senior Fitness and Prevention (SEFIP) Study [Original Investigation]

Background  Physical exercise affects many risk factors and diseases and therefore can play a vital role in general disease prevention and treatment of elderly individuals and may reduce costs. We sought to determine whether a single exercise program affects fracture risk (bone mineral density [BMD] and falls), coronary heart disease (CHD) risk factors, and health care costs in community-dwelling elderly women.

Methods  We conducted a randomized, single-blinded, controlled trial from May 1, 2005, through July 31, 2008, recruiting women 65 years or older who were living independently in the area of Erlangen-Nuremberg, Germany. In all, 246 women were randomly assigned to an 18-month exercise program (exercise group) or a wellness program (control group). The exercise group (n = 123) performed a multipurpose exercise program with special emphasis on exercise intensity; the controls (n = 123) focused on well-being with a low-intensity, low-frequency program. The main outcome measures were BMD, the number of falls, the Framingham-based 10-year CHD risk, and direct health care costs.

Results  For the 227 women who completed the 18-month study, significant exercise effects were observed for BMD of the lumbar spine (mean [95% confidence interval (CI)] percentage of change in BMD [baseline to follow-up] for the exercise group: 1.77% [1.26% to 2.28%] vs controls: 0.33% [–0.24% to 0.91%]; P < .001), femoral neck (exercise group: 1.01% [0.37% to 1.65%] vs controls: –1.05% [–1.70% to –0.40%]; P < .001), and fall rate per person during 18 months (exercise group: 1.00 [0.76 to 1.24] vs controls: 1.66 [1.33 to 1.99]; P = .002). The 10-year CHD risk was significantly affected in both subgroups (absolute change for the exercise group: –1.96% [95% CI, –2.69% to –1.23%] vs controls: –1.15% [–1.69% to –0.62%]; P = .22), with no significant difference between the groups. The direct health care costs per participant during the 18-month intervention showed nonsignificant differences between the groups (exercise group: 2255 [95% CI, 1791-2718] vs controls: 2780 [2187-3372]; P = .20).

Conclusion  Compared with a general wellness program, our 18-month exercise program significantly improved BMD and fall risk, but not predicted CHD risk, in elderly women. This benefit occurred at no increase in direct costs.

Trial Registration  clinicaltrials.gov Identifier: NCT00267839

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Physical Activity and Incident Cognitive Impairment in Elderly Persons: The INVADE Study [Original Investigation]

Background  Data regarding the relationship between physical activity and cognitive impairment are limited and controversial. We examined whether physical activity is associated with incident cognitive impairment during follow-up.

Methods  As part of a community-based prospective cohort study in southern Bavaria, Germany, 3903 participants older than 55 years were enrolled between 2001 and 2003 and followed up for 2 years. Physical activity (classified as no activity, moderate activity [<3 times/wk], and high activity [≥3 times/wk]), cognitive function (assessed by the 6-Item Cognitive Impairment Test), and potential confounders were evaluated. The main outcome measure was incident cognitive impairment after 2 years of follow-up.

Results  At baseline, 418 participants (10.7%) had cognitive impairment. After a 2-year follow-up, 207 of 3485 initially unimpaired subjects (5.9%) developed incident cognitive impairment. Compared with participants without physical activity, fully adjusted multiple logistic regression analysis showed a significantly reduced risk of incident cognitive impairment after 2 years for participants with moderate or high physical activity at baseline (odds ratio [OR], 0.57; 95% confidence interval [CI], 0.37-0.87 [P = .01]; and OR, 0.54; 95% CI, 0.35-0.83 [P = .005]; respectively). Further subanalysis including participants (n = 2029) without functional impairment and without prodromal phase of dementia resulted in an even higher reduction of risk of incident cognitive impairment for participants with moderate or high physical activity (OR, 0.44; 95% CI, 0.24-0.83 [P = .01]; and OR, 0.46; 95% CI, 0.25-0.85 [P = .01]; respectively) compared with no activity.

Conclusion  Moderate or high physical activity is associated with a reduced incidence of cognitive impairment after 2 years in a large population-based cohort of elderly subjects.

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Physical Activity at Midlife in Relation to Successful Survival in Women at Age 70 Years or Older [Original Investigation]

Background  Physical activity is associated with reduced risks of chronic diseases and premature death. Whether physical activity is also associated with improved overall health among those who survive to older ages is unclear.

Methods  A total of 13 535 Nurses' Health Study participants who were free of major chronic diseases at baseline in 1986 and had survived to age 70 years or older as of the 1995-2001 period made up the study population. We defined successful survival as no history of 10 major chronic diseases or coronary artery bypass graft surgery and no cognitive impairment, physical impairment, or mental health limitations.

Results  After multivariate adjustment for covariates, higher physical activity levels at midlife, as measured by metabolic-equivalent tasks, were significantly associated with better odds of successful survival. Significant increases in successful survival were observed beginning at the third quintile of activity: odds ratios (ORs) (95% confidence intervals [CIs]) in the lowest to highest quintiles were 1 [Reference], 0.98 (0.80-1.20), 1.37 (1.13-1.65), 1.34 (1.11-1.61), and 1.99 (1.66-2.38) (P < .001 for trend). Increasing energy expenditure from walking was associated with a similar elevation in odds of successful survival: the ORs (95% CIs) of successful survival across quintiles of walking were 1 [Reference], 0.99 (0.80-1.21), 1.19 (0.97-1.45), 1.50 (1.24-1.82), and 1.47 (1.22-1.79) (P < .001 for trend).

Conclusion  These data provide evidence that higher levels of midlife physical activity are associated with exceptional health status among women who survive to older ages and corroborate the potential role of physical activity in improving overall health.

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Drug Safety: Are We Making Progress?: Comment on "Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data" [Invited Commentary]

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Primary Esophageal Carcinoma in the Era of Highly Active Antiretroviral Therapy [Clinical Observation]

Background  As human immunodeficiency virus (HIV)-infected individuals are living longer, non–AIDS-defining cancers are becoming increasingly recognized. Primary esophageal tumors in people living with HIV have seldom been reported. We sought to document patient, virologic, and tumor characteristics and clinical outcomes in this patient group.

Methods  International physicians involved in the care of AIDS-defining and non–AIDS-defining cancers accrued cases of primary esophageal malignant neoplasms in HIV-infected individuals. Patient demographics, HIV status, cancer risk factors, esophageal tumor characteristics, treatment, and outcomes were analyzed.

Results  A total of 19 patients with primary adenocarcinoma and/or squamous cell carcinoma of the esophagus were identified. The median age was 48 years (range, 35-69 years) and the median CD4 lymphocyte count measured 376 cells/µL (range, 42 to >1000 cells/µL) (to convert to x10⁹/L, multiply by 0.001). The majority of patients were men with a history of smoking or considerable alcohol consumption. Prior esophageal disease (reflux, peptic ulcers, and achalasia) was reported in almost half of all patients. Seven patients (37%) underwent surgical resection, 11 (58%) received fluorouracil-based chemotherapy, and 7 (37%) underwent radiotherapy; survival correlated with stage at cancer presentation. While the majority of patients died, only 5 deaths (26%) were attributed to progression of esophageal carcinoma.

Conclusions  Primary esophageal carcinoma is another non–AIDS-defining cancer associated with moderate immunosuppression and lifestyle habits including tobacco and alcohol use. The biological behavior, treatment, and outcome of HIV-related esophageal cancer appear similar to the general population with this disease; the same screening and risk moderation strategies are likely to apply.

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Healthy Living and Risk of Major Chronic Diseases in an Older Population [Research Letters]

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Risk of Thiazolidinedione-Associated Fracture Should Be Appropriately Assessed [Editor's Correspondence]

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Risk of Thiazolidinedione-Associated Fracture Should Be Appropriately Assessed--Reply [Editor's Correspondence]

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Can We Really Achieve a 1-Year Mortality Rate Lower Than 10% in Patients With Infective Endocarditis? [Editor's Correspondence]

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Can We Really Achieve a 1-Year Mortality Rate Lower Than 10% in Patients With Infective Endocarditis?--Reply [Editor's Correspondence]

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Simulation-Based Training to Improve Patient Care [Editor's Correspondence]

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Simulation-Based Training to Improve Patient Care--Reply [Editor's Correspondence]

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