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June 13, 2011, Vol 171, No. 11, Pages 969-1046

Editorial

The Proof of Atherosclerosis Imaging Is in the EvidenceWhere Are the Studies?

Abstract Full Text
Arch Intern Med. 2011;171(11):976-976. doi:10.1001/archinternmed.2011.78
Original Investigation

Medical Device Recalls and the FDA Approval Process

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Arch Intern Med. 2011;171(11):1006-1011. doi:10.1001/archinternmed.2011.30
BackgroundUnlike prescription drugs, medical devices are reviewed by the US Food and Drug Administration (FDA) using 2 alternative regulatory standards: (1) premarket approval (PMA), which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device). The second standard is intended for devices that the FDA deems to involve low or moderate risk.MethodsWe analyzed the FDA's high-risk List of Device Recalls from 2005 through 2009. Using FDA data, we determined whether the recalled devices were approved by the more rigorous (PMA) process, the 510(k) process, or were exempt from FDA review.ResultsThere were 113 recalls from 2005 through 2009 that the FDA determined could cause serious health problems or death. Only 21 of the 113 devices had been approved through the PMA process (19%). Eighty were cleared through the 510(k) process (71%), and an additional 8 were exempt from any FDA regulation (7%). Cardiovascular devices comprised the largest recall category, with 35 of the high-risk recalls (31%); two-thirds were cleared by the 510(k) process (66%; n = 23). Fifty-one percent of the high-risk recalls were in 5 other device categories: general hospital, anesthesiology, clinical chemistry, neurology, or ophthalmology.ConclusionsMost medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 510(k) process or were considered so low risk that they were exempt from review (78%). These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices.

Potentially Inappropriate Medications Defined by STOPP Criteria and the Risk of Adverse Drug Events in Older Hospitalized Patients

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Arch Intern Med. 2011;171(11):1013-1019. doi:10.1001/archinternmed.2011.215

Ontario Multidetector Computed Tomographic Coronary Angiography StudyField Evaluation of Diagnostic Accuracy

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Arch Intern Med. 2011;171(11):1021-1029. doi:10.1001/archinternmed.2011.74
BackgroundComputed tomographic coronary angiography (CTCA) has gained clinical acceptance for the detection of obstructive coronary artery disease. Although single-center studies have demonstrated excellent accuracy, multicenter studies have yielded variable results. The true diagnostic accuracy of CTCA in the “real world” remains uncertain. We conducted a field evaluation comparing multidetector CTCA with invasive CA (ICA) to understand CTCA's diagnostic accuracy in a real-world setting.MethodsA multicenter cohort study of patients awaiting ICA was conducted between September 2006 and June 2009. All patients had either a low or an intermediate pretest probability for coronary artery disease and underwent CTCA and ICA within 10 days. The results of CTCA and ICA were interpreted visually by local expert observers who were blinded to all clinical data and imaging results.ResultsUsing a patient-based analysis (diameter stenosis ≥50%) of 169 patients, the sensitivity, specificity, positive predictive value, and negative predictive value were 81.3% (95% confidence interval [CI], 71.0%-89.1%), 93.3% (95% CI, 85.9%-97.5%), 91.6% (95% CI, 82.5%-96.8%), and 84.7% (95% CI, 76.0%-91.2%), respectively; the area under receiver operating characteristic curve was 0.873. The diagnostic accuracy varied across centers (P < .001), with a sensitivity, specificity, positive predictive value, and negative predictive value ranging from 50.0% to 93.2%, 92.0% to 100%, 84.6% to 100%, and 42.9% to 94.7%, respectively.ConclusionsCompared with ICA, CTCA appears to have good accuracy; however, there was variability in diagnostic accuracy across centers. Factors affecting institutional variability need to be better understood before CTCA is universally adopted. Additional real-world evaluations are needed to fully understand the impact of CTCA on clinical care.Trial Registrationclinicaltrials.gov Identifier: NCT00371891

Acid-Suppressive Medication Use and the Risk for Nosocomial Gastrointestinal Tract Bleeding

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Arch Intern Med. 2011;171(11):991-997. doi:10.1001/archinternmed.2011.14
BackgroundAcid-suppressive medications are increasingly prescribed for noncritically ill hospitalized patients, although the incidence of nosocomial gastrointestinal (GI) tract bleeding (GI bleeding) and magnitude of potential benefit from this practice are unknown. We aimed to define the incidence of nosocomial GI bleeding outside of the intensive care unit and examine the association between acid-suppressive medication use and this complication.MethodsWe conducted a pharmacoepidemiologic cohort study of patients admitted to an academic medical center from 2004 through 2007, at least 18 years of age, and hospitalized for 3 or more days. Admissions with a primary diagnosis of GI bleeding were excluded. Acid-suppressive medication use was defined as any order for a proton pump inhibitor or histamine-2-receptor antagonist. The main outcome measure was nosocomial GI bleeding. A propensity matched generalized estimating equation was used to control for confounders.ResultsThe final cohort included 78 394 admissions (median age, 56 years; 41% men). Acid-suppressive medication was ordered in 59% of admissions, and nosocomial GI bleeding occurred in 224 admissions (0.29%). After matching on the propensity score, the adjusted odds ratio for nosocomial GI bleeding in the group exposed to acid-suppressive medication relative to the unexposed group was 0.63 (95% confidence interval, 0.42-0.93). The number needed to treat to prevent 1 episode of nosocomial GI bleeding was 770.ConclusionsNosocomial GI bleeding outside of the intensive care unit was rare. Despite a protective effect of acid-suppressive medication, the number needed to treat to prevent 1 case of nosocomial GI bleeding was relatively high, supporting the recommendation against routine use of prophylactic acid-suppressive medication in noncritically ill hospitalized patients.

Proton Pump Inhibitor Use and the Antifracture Efficacy of Alendronate

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Arch Intern Med. 2011;171(11):998-1004. doi:10.1001/archinternmed.2011.20
BackgroundProton pump inhibitors (PPIs) are widely used in elderly patients and are frequently coadministered in users of oral bisphosphonates. Biologically, PPIs could affect the absorption of calcium, vitamin B12, and bisphosphonates and could affect the osteoclast proton pump, thus interacting with bisphosphonate antifracture efficacy. Moreover, PPIs themselves have been linked to osteoporotic fractures.MethodsPopulation-based, national register–based, open cohort study of 38 088 new alendronate sodium users with a mean duration of follow-up of 3.5 years. We related risk of hip fracture to recent pharmacy records of refill of prescriptions for alendronate.ResultsFor hip fractures, there was statistically significant interaction with alendronate for PPI use (P < .05). The treatment response associated with complete refill compliance to alendronate was a 39% risk reduction (hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.52-0.71; P < .001) in patients who were not PPI users, while the risk reduction in concurrent PPI users was not significant (19%; HR, 0.81; 95% CI, 0.64-1.01; P = .06). The attenuation of the risk reduction was dose and age dependent. In contrast, there was no significant impact of concurrent use of histamine H2 receptor blockers.ConclusionsConcurrent PPI use was associated with a dose-dependent loss of protection against hip fracture with alendronate in elderly patients. This is an observational study, so a formal proof of causality cannot be made, but the dose-response relationship and the lack of impact of prior PPI use provides reasonable grounds for discouraging the use of PPIs to control upper gastrointestinal tract complaints in patients treated with oral bisphosphonates.
Invited Commentary

Opportunities to Decrease Inappropriate Uses of Proton Pump InhibitorsComment on “Proton Pump Inhibitor Use and the Antifracture Efficacy of Alendronate”

Abstract Full Text
Arch Intern Med. 2011;171(11):1004-1005. doi:10.1001/archinternmed.2011.21

Medical Device Recalls: Get It Right the First TimeComment on “Medical Device Recalls and the FDA Approval Process”

Abstract Full Text
Arch Intern Med. 2011;171(11):1011-1012. doi:10.1001/archinternmed.2011.27

Medication Safety: Are We There Yet?Comment on “Potentially Inappropriate Medications Defined by STOPP Criteria and the Risk of Adverse Drug Events in Older Hospitalized Patients”

Abstract Full Text
Arch Intern Med. 2011;171(11):1019-1020. doi:10.1001/archinternmed.2011.220

Gone Fishing!: On the “Real-World” Accuracy of Computed Tomographic Coronary AngiographyComment on the “Ontario Multidetector Computed Tomographic Coronary Angiography Study”

Abstract Full Text
Arch Intern Med. 2011;171(11):1029-1031. doi:10.1001/archinternmed.2011.75

The Optimal Timing of Smoking Cessation Before SurgeryComment on “Smoking Cessation Shortly Before Surgery and Postoperative Complications”

Abstract Full Text
Arch Intern Med. 2011;171(11):989-990. doi:10.1001/archinternmed.2011.88
Review Article

Influence of Noninvasive Cardiovascular Imaging in Primary PreventionSystematic Review and Meta-analysis of Randomized Trials

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Arch Intern Med. 2011;171(11):977-982. doi:10.1001/archinternmed.2011.69
BackgroundDespite extensive use in practice, the impact of noninvasive cardiovascular imaging in primary prevention remains unclear.MethodsWe searched for randomized trials that compared imaging with usual care and reported any of the following outcomes in a primary prevention setting: medication prescribing, lifestyle modification (including diet, exercise, or smoking cessation), angiography, or revascularization.ResultsSeven trials were included. Trials screened patients for inducible myocardial ischemia (2 trials), coronary calcification (3 trials), carotid atherosclerosis (1 trial), or left ventricular hypertrophy (1 trial). Imaging had no effect on medication prescribing overall (odds ratio [OR], 1.01; 95% confidence interval [CI], 0.76-1.33) or on provision of lipid-modifying agents (OR, 1.08; 95% CI, 0.58-2.01), antihypertensive drugs (OR, 1.05; 95% CI, 0.75-1.47), or antiplatelet agents (OR, 1.05; 95% CI, 0.84-1.32). Similarly, no effect was seen on dietary improvement (OR, 0.78; 95% CI, 0.22-2.85), physical activity (0.02 vs −0.08 point change for imaging vs control on a 5-point scale; P = .23), or smoking cessation (OR, 2.24; 95% CI, 0.97-5.19). Imaging was not associated with invasive angiography (OR, 1.26; 95% CI, 0.89-1.79).ConclusionsWe found limited evidence suggesting that noninvasive cardiovascular imaging alters primary prevention efforts. However, given the imprecision of these results, further high-quality studies are needed.

Stopping Smoking Shortly Before Surgery and Postoperative ComplicationsA Systematic Review and Meta-analysis

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Arch Intern Med. 2011;171(11):983-989. doi:10.1001/archinternmed.2011.97
ObjectiveTo examine existing smoking studies that compare surgical patients who have recently quit smoking with those who continue to smoke to provide an evidence-based recommendation for front-line staff. Concerns have been expressed that stopping smoking within 8 weeks before surgery may be detrimental to postoperative outcomes. This has generated considerable uncertainty even in health care systems that consider smoking cessation advice in the hospital setting an important priority. Smokers who stop smoking shortly before surgery (recent quitters) have been reported to have worse surgical outcomes than early quitters, but this may indicate only that recent quitting is less beneficial than early quitting, not that it is risky.DesignSystematic review with meta-analysis.Data SourcesBritish Nursing Index (BNI), The Cochrane Library database, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, Medline, PsycINFO to May 2010, and reference lists of included studies.Study SelectionStudies were included that allow a comparison of postoperative complications in patients undergoing any type of surgery who stopped smoking within 8 weeks prior to surgery and those who continued to smoke.Data ExtractionTwo reviewers independently screened potential studies and assessed their methodologic quality. Data were entered into 3 separate meta-analyses that considered all available studies, studies with a low risk of bias that validated self-reported abstinence (to assess possible benefits), and studies of pulmonary complications only (to assess possible risks). Results were combined by using a random-effects model, and heterogeneity was evaluated by using the I2 statistic.ResultsNine studies met the inclusion criteria. One found a beneficial effect of recent quitting compared with continuing smoking, and none identified any detrimental effects. In meta-analyses, quitting smoking within 8 weeks before surgery was not associated with an increase or decrease in overall postoperative complications for all available studies (relative risk [RR], 0.78; 95% confidence interval [CI], 0.57-1.07), for a group of 3 studies with high-quality scores (RR, 0.57; 95% CI, 0.16-2.01), or for a group of 4 studies that specifically evaluated pulmonary complications (RR, 1.18; 95% CI, 0.95-1.46).ConclusionsExisting data indicate that the concern that stopping smoking only a few weeks prior to surgery might worsen clinical outcomes is unfounded. Further larger studies would be useful to arrive at a more robust conclusion. Patients should be advised to stop smoking as early as possible, but there is no evidence to suggest that health professionals should not be advising smokers to quit at any time prior to surgery.
Challenges in Clinical Electrocardiography

Sustained Ventricular Fibrillation in a Conscious Patient

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Arch Intern Med. 2011;171(11):973-973. doi:10.1001/archinternmed.2011.235

Sustained Ventricular Fibrillation in a Conscious Patient—Discussion

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Arch Intern Med. 2011;171(11):974-975. doi:10.1001/archinternmed.2011.236
Images From Our Readers

If these stones could teach humans humanity

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Arch Intern Med. 2011;171(11):1005-1005. doi:10.1001/archinternmed.2011.229

Harvard Yard, Boston, Massachusetts

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Arch Intern Med. 2011;171(11):1046-1046. doi:10.1001/archinternmed.2011.228
Research Letters

Inappropriate Medications in Elderly ICU Survivors: Where to Intervene?

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Arch Intern Med. 2011;171(11):1032-1034. doi:10.1001/archinternmed.2011.233

Nonmedical Use of Opioid Analgesics Obtained Directly From Physicians: Prevalence and Correlates

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Arch Intern Med. 2011;171(11):1034-1036. doi:10.1001/archinternmed.2011.217

Effect of Computerized Physician Order Entry on Radiologic Examination Order Indication Quality

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Arch Intern Med. 2011;171(11):1036-1038. doi:10.1001/archinternmed.2011.234

Resident Time Spent in Clinical and Educational Activities at Home: Implications for Duty Hours

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Arch Intern Med. 2011;171(11):1038-1039. doi:10.1001/archinternmed.2011.218
Editor's Correspondence

Lack of Cardiovascular Disease Among Old Order Amish With Familial Defective Apolipoprotein B

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Arch Intern Med. 2011;171(11):1039-1040. doi:10.1001/archinternmed.2011.238

Lack of Cardiovascular Disease Among Old Order Amish With Familial Defective Apolipoprotein B—Reply

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Arch Intern Med. 2011;171(11):1039-1040. doi:10.1001/archinternmed.2011.239

Depression and Type 2 Diabetes Mellitus: A Call to Explore the Common Cause Hypothesis

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Arch Intern Med. 2011;171(11):1040-1041. doi:10.1001/archinternmed.2011.221

Low Serum 25-Hydroxyvitamin D Levels and the Bidirectional Association Between Depression and Type 2 Diabetes Mellitus in Women

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Arch Intern Med. 2011;171(11):1041-1042. doi:10.1001/archinternmed.2011.222

Low Serum 25-Hydroxyvitamin D Levels and the Bidirectional Association Between Depression and Type 2 Diabetes Mellitus in Women—Reply

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Arch Intern Med. 2011;171(11):1041-1042. doi:10.1001/archinternmed.2011.223

Levels of Evidence Needed for Changing Indications, Contraindications, and Food and Drug Administration Labeling: The Case of Metformin

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Arch Intern Med. 2011;171(11):1042-1043. doi:10.1001/archinternmed.2011.224

Levels of Evidence Needed for Changing Indications, Contraindications, and Food and Drug Administration Labeling: The Case of Metformin—Reply

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Arch Intern Med. 2011;171(11):1042-1043. doi:10.1001/archinternmed.2011.225

Inverse Association Between Duration of Use of Acid-Suppressive Medications and Fracture Risk

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Arch Intern Med. 2011;171(11):1044-1044. doi:10.1001/archinternmed.2011.226

Inverse Association Between Duration of Use of Acid-Suppressive Medications and Fracture Risk—Reply

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Arch Intern Med. 2011;171(11):1044-1044. doi:10.1001/archinternmed.2011.227

FDA Recalls Not as Alarming as They Seem

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Arch Intern Med. 2011;171(11):1044-1046. doi:10.1001/archinternmed.2011.242

FDA Recalls Not as Alarming as They Seem—Reply

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Arch Intern Med. 2011;171(11):1044-1046. doi:10.1001/archinternmed.2011.243
In This Issue of Archives of Internal Medicine

In This Issue of Archives of Internal Medicine

Abstract Full Text
Arch Intern Med. 2011;171(11):971-971. doi:10.1001/archinternmed.2011.214
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