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 quantify the effect of review determinations on site participation, budget, and timeline. DESIGN:A natural experiment occurring from multiple IRBs reviewing the same protocol for a multicenter trial (May 2005 to October 2007). PARTICIPANTS:25 Veterans Affairs (VA) medical centers. MEASUREMENTS:Number of submissions, time to approval, and costs were evaluated; patient complexity, academic affiliation, size, and location (urban or rural) between participating and nonparticipating VA medical centers were compared. RESULTS:Of 25 eligible VA medical centers, 6 did not meet requirements for IRB review and 2 declined to participate. Of 17 applications, 14 were approved. The process required 115 submissions, lasted 27 months, and cost close to $170 000 in staff salaries. One IRB's concern about incentivizing a particular medication recommended by national guidelines prompted a change in our design to broaden our inclusion criteria beyond uncomplicated hypertension. The change required amending the protocol at 14 sites to preserve internal validity. The IRBs that approved the protocol classified it as minimal risk. The 12 sites that ultimately participated in the trial were more likely to be urban and academically affiliated and to care for more complex patients, which limits the external validity of the trial's findings. LIMITATION:Because data came from a single multisite trial in the VA system that uses a 2-stage review process, generalizability is limited. CONCLUSION:Complying with IRB requirements for a minimal-risk study required substantial resources and threatened the study's internal and external validity. The current review of regulatory requirements may address some of these problems.
journal_name
Ann Intern Medjournal_title
Annals of internal medicineauthors
Petersen LA,Simpson K,Sorelle R,Urech T,Chitwood SSdoi
10.7326/0003-4819-156-10-201205150-00011subject
Has Abstractpub_date
2012-05-15 00:00:00pages
728-35issue
10eissn
0003-4819issn
1539-3704pii
156/10/728journal_volume
156pub_type
杂志文章,多中心研究abstract::Anxiety commonly accompanies serious illness. However, in some patients anxiety is the primary manifestation of illness. Diagnostic criteria for these "primary" anxiety disorders have been redefined in the most recent revision of the American Psychiatric Association's Diagnostic and Statistical Manual. We discuss thes...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-100-4-558
更新日期:1984-04-01 00:00:00
abstract::Daily change of intravenous (i.v.) infusion administration sets has been recommended by the Center for Disease Control since 1973 to reduce the risk of infusion bacteremia. To evaluate this recommendation, we undertook a prospective, randomized, controlled trial that compared the rates of i.v.-associated bacteremia, i...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.7326/0003-4819-90-5-764
更新日期:1979-05-01 00:00:00
abstract:BACKGROUND:Few recent data are available on risk factors for perioperative supraventricular arrhythmia (SVA) after noncardiac surgery or on the effect of SVA on clinical outcomes. OBJECTIVE:To determine the incidence, clinical correlates, and effect on length of stay of perioperative SVA in patients having major nonca...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-129-4-199808150-00003
更新日期:1998-08-15 00:00:00
abstract:Background:The 2013 cholesterol management guidelines from the American College of Cardiology and American Heart Association (ACC/AHA) recommend lipid screening in all adults older than 20 years to identify those at increased risk for atherosclerotic cardiovascular disease (ASCVD). Statins may be considered for patient...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/M16-2052
更新日期:2017-06-20 00:00:00
abstract::In 1984, both the United Kingdom and the United States received recommendations from panels of experts specifically convened to consider the merits of Depo-Provera (depot medroxyprogesterone acetate [DMPA]) as a long-term contraceptive agent. This study compares the final reports written by these panels. We explore wh...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-106-6-886
更新日期:1987-06-01 00:00:00
abstract:OBJECTIVE:To determine the frequency of tests done in the year before elective surgery that might substitute for preoperative screening tests and to determine the frequency of test results that change from a normal value to a value likely to alter perioperative management. DESIGN:Retrospective cohort analysis of compu...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-113-12-969
更新日期:1990-12-15 00:00:00
abstract::Plasma lipids were measured in 78 uremic patients receiving either chronic peritoneal dialysis or haemodialysis. Type IV hyperlipemia was found in 60% of patients. The lipid level was not influenced by dietary habits or patient's age. Patients on chronic peritoneal dialysis had a significantly higher and more sustaine...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-85-1-29
更新日期:1976-07-01 00:00:00
abstract::In recent years there has been increasing attention to the appropriate interpretation of a clinical study. One special concern has been the difficulty inherent in interpreting studies that were not statistically significant: Was the sample size sufficient to detect a clinically important effect if, in fact, it existed...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-99-2-248
更新日期:1983-08-01 00:00:00
abstract::Nineteen patients with advanced refractory metastatic breast cancer no longer responsive to chemotherapy were treated in the first phase II efficacy trial of recombinant leukocyte A interferon (IFL-rA), a highly purified single molecular species of alpha interferon prepared by recombinant DNA methods. Patients receive...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章
doi:10.7326/0003-4819-98-5-598
更新日期:1983-05-01 00:00:00
abstract::Medically unexplained functional or somatization symptoms are somatic disorders that are not adequately explained by physical disease processes. The way in which these disorders have been understood and managed has varied over the history of medicine. However, only in the past 100 years has the "mental" explanation pr...
journal_title:Annals of internal medicine
pub_type: 历史文章,杂志文章,评审
doi:10.7326/0003-4819-134-9_part_2-200105011-00018
更新日期:2001-05-01 00:00:00
abstract:BACKGROUND:The appropriate duration of therapy for catheter-associated Staphylococcus aureus bacteremia is controversial. Conventional practice dictates that all patients receive prolonged courses of intravenous antibiotics. Some clinicians recommend abbreviated therapeutic courses, but an alternate approach involves p...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-130-10-199905180-00004
更新日期:1999-05-18 00:00:00
abstract:BACKGROUND:Elevated blood pressure (BP) is the largest contributing risk factor to all-cause and cardiovascular mortality. PURPOSE:To update a systematic review on the benefits and harms of screening for high BP in adults and to summarize evidence on rescreening intervals and diagnostic and predictive accuracy of diff...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/M14-1539
更新日期:2015-02-03 00:00:00
abstract::To standardize the cutoff points of serum cortisol values in the evaluation of Cushing's syndrome during a low- and high-dose dexamethasone suppression test, daily serum cortisol measurements (0800 hours and 1600 hours) and urinary 17-hydroxycorticosteroids were compared (Study A). Forty-seven subjects were studied (1...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-97-1-21
更新日期:1982-07-01 00:00:00
abstract:BACKGROUND:Ear involvement is not unusual in autoimmune diseases, but few data on this problem in the Sjögren syndrome are available. OBJECTIVES:To determine whether the incidence of hearing loss is increased in patients with the Sjögren syndrome and to determine what factors might be involved in the pathogenesis of S...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-126-6-199703150-00005
更新日期:1997-03-15 00:00:00
abstract:OBJECTIVE:To compare the effects of atenolol and nifedipine on mood and cognitive function in elderly hypertensive patients. DESIGN:Randomized, double-blind, crossover trial. PATIENTS:Thirty-one elderly volunteers (7 women and 4 men) 60 to 81 years of age with mild to moderate hypertension were recruited from the gen...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.7326/0003-4819-116-8-615
更新日期:1992-04-15 00:00:00
abstract:BACKGROUND:A sensitive and acceptable screening regimen for women at high risk for breast cancer is essential. Contrast-enhanced magnetic resonance imaging (MRI) of the breast is highly sensitive for diagnosis of breast cancer but has variable specificity. PURPOSE:To summarize the sensitivity, specificity, likelihood ...
journal_title:Annals of internal medicine
pub_type: 杂志文章,meta分析,评审
doi:10.7326/0003-4819-148-9-200805060-00007
更新日期:2008-05-06 00:00:00
abstract::Relapsing polychondritis, an uncommon, chronic, multisystem disorder characterized by recurrent episodes of inflammation of cartilaginous tissues, can be life-threatening, debilitating, and difficult to diagnose. This review is based on the authors' experience with 36 patients with relapsing polychondritis who were fo...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-129-2-199807150-00011
更新日期:1998-07-15 00:00:00
abstract:BACKGROUND:Bed alarm systems intended to prevent hospital falls have not been formally evaluated. OBJECTIVE:To investigate whether an intervention aimed at increasing bed alarm use decreases hospital falls and related events. DESIGN:Pair-matched, cluster randomized trial over 18 months. Nursing units were allocated b...
journal_title:Annals of internal medicine
pub_type: 杂志文章,随机对照试验
doi:10.7326/0003-4819-157-10-201211200-00005
更新日期:2012-11-20 00:00:00
abstract:Background:Iron chelation therapy (ICT) in patients with lower-risk myelodysplastic syndromes (MDS) has not been evaluated in randomized studies. Objective:To evaluate event-free survival (EFS) and safety of ICT in iron-overloaded patients with low- or intermediate-1-risk MDS. Design:Multicenter, randomized, double-b...
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/M19-0916
更新日期:2020-04-21 00:00:00
abstract::A recent, widely publicized meta-analysis of 42 clinical trials concluded that rosiglitazone was associated with an approximately 43% increased risk for myocardial infarction and an approximately 64% increased risk for cardiovascular death. The sensitivity of these conclusions to several methodological choices was not...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-147-8-200710160-00182
更新日期:2007-10-16 00:00:00
abstract::Prospective data at Framingham and elsewhere have shown conclusively that risk of coronary heart disease in persons younger than age 50 is strikingly related to the serum total cholesterol level. Within so-called normal limits risk has been found to mount over a five-fold range. The impact has been found to be augment...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-90-1-85
更新日期:1979-01-01 00:00:00
abstract:DESCRIPTION:Update of the 2004 U.S. Preventive Services Task Force (USPSTF) recommendation statement on screening for bladder cancer. METHODS:The USPSTF performed a targeted literature search for new evidence on the benefits and harms of screening, the accuracy of primary care-feasible screening tests, and the benefit...
journal_title:Annals of internal medicine
pub_type: 杂志文章,实务指引
doi:10.7326/0003-4819-155-4-201108160-00008
更新日期:2011-08-16 00:00:00
abstract::In September 1978, cases of hepatitis B in two patients treated by the same dentist led to investigation of a dental practice in Baltimore, Maryland. The dentist had had acute hepatitis B in June 1978 and had remained positive for hepatitis B surface antigen and hepatitis B e antigen over the ensuing 6 months. He had ...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-95-2-133
更新日期:1981-08-01 00:00:00
abstract:BACKGROUND:When deep venous thrombosis is suspected, objective testing is required to confirm or refute the diagnosis. OBJECTIVE:To determine whether the combination of a low clinical suspicion and a normal D -dimer result rules out deep venous thrombosis. DESIGN:Prospective cohort study. SETTING:Three tertiary care...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-135-2-200107170-00011
更新日期:2001-07-17 00:00:00
abstract::Type 2 diabetes mellitus is a metabolic disease of carbohydrate metabolism. However, it should also be considered a vascular disease because diabetic patients have a strong predilection for atherosclerosis. With the increasing prevalence and earlier age at onset of diabetes, the projected effect of diabetes on cardiov...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-139-10-200311180-00010
更新日期:2003-11-18 00:00:00
abstract:OBJECTIVE:To describe the effects of human immunodeficiency virus (HIV) infection on the serologic manifestations and response to treatment of syphilis in intravenous drug users. DESIGN:Cohort study of intravenous drug users. SETTING:Medical clinic in a hospital-based methadone maintenance treatment program in New Yo...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-118-5-199303010-00005
更新日期:1993-03-01 00:00:00
abstract::It is hypothesized that peritoneal fluid might be used as an alternative vehicle for monitoring the clinical chemistry of patients on peritoneal dialyses and save these patients the venesection and resultant blood loss. Peritoneal fluid was obtained before 47.2% of 106 dialysis treatments and compared with simultaneou...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-89-1-67
更新日期:1978-07-01 00:00:00
abstract:Background:Older adults with acute myocardial infarction (AMI) have higher prevalence of functional impairments, including deficits in cognition, strength, and sensory domains, than their younger counterparts. Objective:To develop and evaluate the prognostic utility of a risk model for 6-month post-AMI mortality in ol...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/M19-0974
更新日期:2020-01-07 00:00:00
abstract::Reversible cerebral vasoconstriction syndromes (RCVS) comprise a group of diverse conditions, all characterized by reversible multifocal narrowing of the cerebral arteries heralded by sudden (thunderclap), severe headaches with or without associated neurologic deficits. Reversible cerebral vasoconstriction syndromes a...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-146-1-200701020-00007
更新日期:2007-01-02 00:00:00
abstract::Hearing loss is highly prevalent and may significantly affect how we age. Although the population is aging, relatively few adults receive treatment for hearing loss. Internists are a critical partner to audiologists and otolaryngologists in caring for the adult population with hearing loss. This review provides a prim...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/AITC202012010
更新日期:2020-12-01 00:00:00