Abstract:
:The U.S. Food and Drug Administration (FDA) Amendments Act of 2007 mandated that the FDA develop a system for using automated health care data to identify risks of marketed drugs and other medical products. The Observational Medical Outcomes Partnership is a public-private partnership among the FDA, academia, data owners, and the pharmaceutical industry that is responding to the need to advance the science of active medical product safety surveillance by using existing observational databases. The Observational Medical Outcomes Partnership's transparent, open innovation approach is designed to systematically and empirically study critical governance, data resource, and methodological issues and their interrelationships in establishing a viable national program of active drug safety surveillance by using observational data. This article describes the governance structure, data-access model, methods-testing approach, and technology development of this effort, as well as the work that has been initiated.
journal_name
Ann Intern Medjournal_title
Annals of internal medicineauthors
Stang PE,Ryan PB,Racoosin JA,Overhage JM,Hartzema AG,Reich C,Welebob E,Scarnecchia T,Woodcock Jdoi
10.7326/0003-4819-153-9-201011020-00010subject
Has Abstractpub_date
2010-11-02 00:00:00pages
600-6issue
9eissn
0003-4819issn
1539-3704pii
153/9/600journal_volume
153pub_type
杂志文章abstract:Background:In 1994, 40% of U.S. gun owners who had recently acquired a firearm did so without a background check. No contemporary estimates exist. Objective:To estimate the proportion of current U.S. gun owners who acquired their most recent firearm without a background check, by time since and manner of acquisition, ...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/M16-1590
更新日期:2017-02-21 00:00:00
abstract::Eighteen episodes of community-acquired bacterial pneumonia were diagnosed in 13 patients among 336 with the acquired immunodeficiency syndrome (AIDS) cared for at Memorial Sloan-Kettering Cancer Center since 1979. Bacterial pathogens isolated in 16 of 18 episodes were Haemophilus influenzae in 8, Streptococcus pneumo...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-104-1-38
更新日期:1986-01-01 00:00:00
abstract::Studies of circulating T- and B-lymphocyte rosettes were done in 20 healthy controls and 29 patients with pulmonary tuberculosis, including 18 receiving rifampin chemotherapy. Eight of the 18 patients in the rifampin group (44%) had significant suppression of their T-cell rosettes as compared with patients with tuberc...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-82-4-484
更新日期:1975-04-01 00:00:00
abstract::A patient with bladder carcinoma metastatic to lung and brain died of pneumonia. Autopsy examination showed a confluent bronchopneumonia with several small abscesses and acute pyelonephritis with abscess formation. Legionella pneumophila, serogroup 4, was isolated in pure culture from lung tissue postmortem and was al...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-93-6-835
更新日期:1980-12-01 00:00:00
abstract::The scope of recent literature on the concept of "vulnerable plaque" was reviewed by examining 463 abstracts of primary and review articles identified through MEDLINE (2003 to April 2010). Proposed definition criteria of vulnerable plaque included active inflammation, a thin cap with a large lipid core, endothelial de...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-153-6-201009210-00272
更新日期:2010-09-21 00:00:00
abstract::The coexistence of chronic idiopathic thrombocytopenic purpura and myasthenia gravis has been infrequently reported. We report another case and show the coexistence of autoantibodies to the platelet glycoprotein IIb and IIIa complex and the acetylcholine receptor. Autoantibody levels were followed during 8 weeks of tr...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-100-6-829
更新日期:1984-06-01 00:00:00
abstract:DESCRIPTION:Update of the 2005 U.S. Preventive Services Task Force (USPSTF) recommendation on screening for abdominal aortic aneurysm (AAA). METHODS:The USPSTF commissioned a systematic review that assessed the evidence on the benefits and harms of screening for AAA and strategies for managing small (3.0 to 5.4 cm) sc...
journal_title:Annals of internal medicine
pub_type: 杂志文章,实务指引
doi:10.7326/M14-1204
更新日期:2014-08-19 00:00:00
abstract:BACKGROUND:The risk for hypertension after kidney donation remains uncertain. PURPOSE:To see whether normotensive adults who donate a kidney develop higher blood pressure and risk for hypertension compared with nondonor adults acting as control participants. DATA SOURCES:MEDLINE, EMBASE, and Science Citation Index we...
journal_title:Annals of internal medicine
pub_type: 杂志文章,meta分析,评审
doi:10.7326/0003-4819-145-3-200608010-00006
更新日期:2006-08-01 00:00:00
abstract::Hyperamylasemia, which has been reported in patients with the eating disorders anorexia nervosa and bulimia, generally has been thought to result from pancreatitis. To evaluate the mechanisms of hyperamylasemia, we measured amylase, lipase, and isoamylase activity in 17 consecutive patients admitted to the eating diso...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-106-1-50
更新日期:1987-01-01 00:00:00
abstract:OBJECTIVE:To determine the most effective and safe dose of enoxaparin to prevent deep venous thrombosis in high-risk surgical patients. DESIGN:A double-blind, randomized, multicenter clinical trial. SETTING:Private, university, and government hospitals in the United States. PATIENTS:572 patients having elective hip ...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.7326/0003-4819-121-2-199407150-00001
更新日期:1994-07-15 00:00:00
abstract:OBJECTIVE:To determine the rate of use of prophylaxis for venous thromboembolism in high-risk hospital patients. DESIGN:A retrospective medical record review. SETTING:A community-wide study in 16 short-stay hospitals in central Massachusetts. PATIENTS:A total of 2017 patients with multiple risk factors for venous th...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-591
更新日期:1991-10-15 00:00:00
abstract:PURPOSE:To examine studies of normal colon and colorectal cancer for evidence that the location of the primary tumor proximal or distal to the splenic flexure of the colon may determine distinct genetic categories of this disease. DATA IDENTIFICATION:Studies were identified through a manual search of journals, through...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-113-10-779
更新日期:1990-11-15 00:00:00
abstract:BACKGROUND:The Department of Health and Human Services recently called for public comment on human subjects research protections. OBJECTIVE:To assess variability in reviews across institutional review boards (IRBs) for a multisite, minimal-risk trial of financial incentives for evidence-based hypertension care and to ...
journal_title:Annals of internal medicine
pub_type: 杂志文章,多中心研究
doi:10.7326/0003-4819-156-10-201205150-00011
更新日期:2012-05-15 00:00:00
abstract:BACKGROUND:The clinical significance of asymptomatic deep venous thrombosis that develops after joint arthroplasty and the value of screening tests to detect thrombi are uncertain. OBJECTIVES:To determine 1) the rate of symptomatic deep venous thrombosis or pulmonary embolism occurring after hospitalization for joint ...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.7326/0003-4819-127-6-199709150-00004
更新日期:1997-09-15 00:00:00
abstract::Thirty-nine cases of Legionnaires' disease in a 16-month period were identified in visitors to and residents of Bloomington, Indiana. Thirty-five patients had spent at least one night at the Indiana Memorial Union in the 2 weeks before becoming ill. Five of 32 sporadic cases nationwide between 1 January and 31 March 1...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-90-4-587
更新日期:1979-04-01 00:00:00
abstract:BACKGROUND:Lateral epicondylitis is a common condition for which botulinum toxin has been reported to have a therapeutic role in uncontrolled studies. OBJECTIVE:To determine if an injection of botulinum toxin is more effective than placebo for reducing pain in adults with lateral epicondylitis. DESIGN:Randomized, dou...
journal_title:Annals of internal medicine
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.7326/0003-4819-143-11-200512060-00007
更新日期:2005-12-06 00:00:00
abstract:STUDY OBJECTIVE:To evaluate the tolerance and safety of oral dextran sulfate (UA001), a potent in-vitro inhibitor of human immunodeficiency virus (HIV) in patients with the acquired immunodeficiency syndrome (AIDS) and AIDS-related complex. DESIGN:Unblinded, dose-escalation 8-week trial. SETTING:An AIDS outpatient cl...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-110-3-183
更新日期:1989-02-01 00:00:00
abstract:BACKGROUND:Injection insulin therapy is not readily accepted by patients and many health care providers; therefore, less invasive options for insulin therapy are desirable. PURPOSE:To examine the efficacy, safety, and patient acceptability of inhaled insulin therapy in nonpregnant adults with diabetes mellitus. DATA ...
journal_title:Annals of internal medicine
pub_type: 杂志文章,meta分析
doi:10.7326/0003-4819-145-9-200611070-00009
更新日期:2006-11-07 00:00:00
abstract::A 20-year follow-up evaluation of young men with fixed and reproducible orthostatic proteinuria showed no evidence of progressive renal disease. Follow-up information was obtained on 43 of the original 64 patients and detailed information was secured on 36. All had normal renal function and only six patients continued...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-97-4-516
更新日期:1982-10-01 00:00:00
abstract::A 42-year-old woman developed goitrous hypothyroidism while receiving ethionamide for treatment of an atypical mycobacterial infection. Five weeks after discontinuation of ethionamide therapy, thyroid function had returned to normal. The goitrogenic effect was studied in vitro by incubating ethionamide in various conc...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-100-6-837
更新日期:1984-06-01 00:00:00
abstract:BACKGROUND:The fecal immunochemical test (FIT) is a common method for colorectal cancer (CRC) screening, yet its acceptability and performance over several rounds of annual testing are largely unknown. OBJECTIVE:To assess FIT performance characteristics over 4 rounds of annual screening. DESIGN:Retrospective cohort s...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/M15-0983
更新日期:2016-04-05 00:00:00
abstract::A 17-year-old girl with a clinical diagnosis of adult-type juvenile rheumatoid arthritis developed a severe hepatotoxic reaction to 3.6 g of aspirin per day. This was associated with a microangiopathic anemia and transient congestive cardiac failure. She responded well to steroids, and when all laboratory test finding...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-86-2-183
更新日期:1977-02-01 00:00:00
abstract:DESCRIPTION:The Women's Preventive Services Initiative (WPSI), a national coalition of women's health professional organizations and patient representatives, developed a recommendation on screening for anxiety in adolescent and adult women to improve detection; achieve earlier diagnosis and treatment; and improve healt...
journal_title:Annals of internal medicine
pub_type: 杂志文章,实务指引
doi:10.7326/M20-0580
更新日期:2020-07-07 00:00:00
abstract::We studied D-penicillamine toxicity in 259 patients with systemic sclerosis treated since 1972. The average daily dose of 635 mg was given for a mean of 1.8 years. Of patients with systemic sclerosis, 47% has side effects from D-penicillamine treatment, similar to the 56% of 807 patients with rheumatoid arthritis in s...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-104-5-699
更新日期:1986-05-01 00:00:00
abstract::Bacteremia caused by rapidly growing mycobacteria are usually due to Mycobacterium fortuitum or M. chelonei. Other rapidly growing mycobacteria generally are considered to be nonpathogenic. We report the case of a patient with bacteremia due to an unidentified, rapidly growing, scotochromogenic mycobacteria that was d...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-99-4-475
更新日期:1983-10-01 00:00:00
abstract:STUDY OBJECTIVE:To assess the effects of dopamine, which has an inotropic effect on the myocardium and increases renal and splanchnic blood flow, on diaphragmatic contraction. DESIGN AND PATIENTS:We studied the changes in transdiaphragmatic pressure during electrical bilateral supramaximal stimulation of the phrenic n...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-110-1-17
更新日期:1989-01-01 00:00:00
abstract::The new knowledge of the regulation of cell growth and the genetic and biochemical changes that lead to malignancy have created many new opportunities for cancer drug discovery. These new targets include oncogenes, growth factors and their receptors, signal transduction pathways, and cell differentiation signals. Atte...
journal_title:Annals of internal medicine
pub_type: 评论,杂志文章,评审
doi:10.7326/0003-4819-118-8-199304150-00011
更新日期:1993-04-15 00:00:00
abstract:BACKGROUND:Aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) are anti-inflammatory but have been linked in some studies to Crohn disease (CD) and ulcerative colitis (UC). OBJECTIVE:To assess the association between aspirin and NSAID use and incident CD and UC. DESIGN:Prospective cohort study. SETTING:Nurses'...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-156-5-201203060-00007
更新日期:2012-03-06 00:00:00
abstract:BACKGROUND:The pandemic potential of influenza A (H5N1) virus is a prominent public health concern of the 21st century. OBJECTIVE:To estimate the effectiveness and cost-effectiveness of alternative pandemic (H5N1) mitigation and response strategies. DESIGN:Compartmental epidemic model in conjunction with a Markov mod...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-151-12-200912150-00156
更新日期:2009-12-15 00:00:00
abstract:BACKGROUND:Current magnetic resonance techniques generate high signal from venous blood and show thrombi as filling defects. Magnetic resonance direct thrombus imaging (MRDTI) directly visualizes acute thrombus. OBJECTIVE:To determine the accuracy of MRDTI for diagnosis of acute symptomatic deep venous thrombosis (DVT...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章
doi:10.7326/0003-4819-136-2-200201150-00006
更新日期:2002-01-15 00:00:00