Abstract:
BACKGROUND:The US Food and Drug Administration (FDA) conducts inspections of clinical investigation sites as a component of clinical trial regulation. The FDA describes the results of these inspections in the Clinical Investigator Inspection List (CLIIL). More serious violations are followed up in FDA warning letters issued to investigators. The primary objective of the current study is to qualitatively and quantitatively describe the CLIIL data and contents of FDA-issued warning letters from 2010 to 2014. METHODS:We retrospectively analyzed the CLIIL and FDA warning letters. For the CLIIL, we quantified the frequency of each violation among other data points. We compared recent data (2010-2014) to the previous 5 years (2005-2009). To analyze FDA warning letters, we developed a coding system to quantify the frequency of violations found. RESULTS:We analyzed 3637 inspections in the CLIIL database and 60 warning letters. Overall, there was a decrease or no change in all violations in the CLIIL database. The largest violation code reported was "failure to follow investigational plan" in both the 2005-2009 and 2010-2014 timeframes. Coding of FDA warning letters shows that the most common violations reported were failing to maintain accurate case histories (10.82%), enrolling ineligible subjects (8.85%), and failing to perform required tests (8.52%). CONCLUSIONS:The overall decrease in violations is encouraging. But, the high proportion of violations related to failure to follow the investigational plan is concerning as the complexity of trials increases. We conclude that more detailed information is necessary to accurately evaluate these violations. The current study provides a model for creating more granular data of violations to better inform clinical investigators and improve clinical trials.
journal_name
Anesth Analgjournal_title
Anesthesia and analgesiaauthors
Romano CA,Nair S,Delphin ESdoi
10.1213/ANE.0000000000002694subject
Has Abstractpub_date
2018-03-01 00:00:00pages
976-982issue
3eissn
0003-2999issn
1526-7598journal_volume
126pub_type
杂志文章abstract::The effect of ketamine on intraocular pressure (IOP) was studied in 10 children. Control IOP values were determined prior to induction of anesthesia, following premedication with atropine alone or in combination with pentobarbital and meperidine. After the IM injection of 8 mg/kg of ketamine, the IOP was determined at...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/00000539-197611000-00005
更新日期:1976-11-01 00:00:00
abstract:UNLABELLED:Clinical pathways are being introduced by hospitals to reduce costs and control unnecessary variation in care. We studied 766 inpatients to measure the impact of a perioperative clinical pathway for patients undergoing knee replacement surgery on hospital costs. One hundred twenty patients underwent knee rep...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1097/00000539-199805000-00012
更新日期:1998-05-01 00:00:00
abstract:UNLABELLED:To evaluate the possible effects of outpatient preoperative evaluation (OPE) for new surgical patients who will be inpatients, we conducted an observational study at a university hospital in The Netherlands. Various outcomes before and after the introduction of an OPE clinic were compared. The study populati...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1097/00000539-200203000-00030
更新日期:2002-03-01 00:00:00
abstract:BACKGROUND:Postoperative sore throat (POST) is not uncommon after general anesthesia with a supraglottic airway (SGA) device. Although it was reported that some pharmacological and nonpharmacological measures can reduce POST, because of limitations and variable success rates, we need to find a simpler and more effectiv...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章,随机对照试验
doi:10.1213/ANE.0000000000004664
更新日期:2020-12-01 00:00:00
abstract:BACKGROUND:Bilateral paravertebral block (PVB) is a suitable alternative to thoracic epidural analgesia (TEA) for abdominal surgeries. This randomized clinical trial aims to determine if PVB is noninferior to TEA in terms of analgesia after midline laparotomy. METHODS:Seventy American Society of Anesthesiologists (ASA...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章,随机对照试验
doi:10.1213/ANE.0000000000004219
更新日期:2019-09-01 00:00:00
abstract::The respiratory variations in the plethysmographic (PLET) waveform of the pulse oximeter during mechanical ventilation can be automatically quantified as the PLET variation index (PVI(®)). Like other dynamic variables, the PVI may provide useful information about fluid responsiveness but only when the patient is recei...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/ANE.0000000000000378
更新日期:2014-12-01 00:00:00
abstract:BACKGROUND:QT interval prolongation is associated with torsades des pointes (TdP), but is a poor predictor of drug torsadogenicity. Susceptibility to TdP arises from increased transmural dispersion of repolarization (TDR) across the myocardial wall, rather than QT interval prolongation per se. TDR can be measured on th...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章,随机对照试验
doi:10.1213/01.ane.0000252417.23986.6e
更新日期:2007-02-01 00:00:00
abstract:UNLABELLED:We compared the ketoprofen-propacetamol combination relative to propacetamol alone in thyroid and parathyroid surgery in terms of postoperative analgesic efficacy, bleeding, and incidence of nausea and vomiting to determine whether ketoprofen results in any benefit in this type of surgery. Patients were dist...
journal_title:Anesthesia and analgesia
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1097/00000539-200104000-00047
更新日期:2001-04-01 00:00:00
abstract::As most of us are aware, almost every facet of our society is becoming, for better or worse, progressively more technology-dependent. Technological advancement has made autonomous systems, also known as robots, an integral part of our life in several fields, including medicine. The application of robots in anesthesia ...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章,评审
doi:10.1213/ANE.0000000000004646
更新日期:2020-05-01 00:00:00
abstract:BACKGROUND:We determined the sensitivity of motor responses evoked by stimulating catheters in determining catheter-nerve contact using ultrasonography as reference. METHODS:Femoral nerves were contacted using stimulating catheters under ultrasonography scanning in 25 patients. The output current was increased from it...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/ANE.0b013e31822c9887
更新日期:2011-11-01 00:00:00
abstract:UNLABELLED:The transient hyperemic response (THR) in the middle cerebral artery (MCA) after the release of brief compression of the ipsilateral common carotid artery has been used to study cerebral autoregulation. We conducted the present study to evaluate the reliability of THR to detect changes in cerebral autoregula...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1097/00000539-199810000-00018
更新日期:1998-10-01 00:00:00
abstract:BACKGROUND:Central poststroke pain (CPSP) is a disabling morbidity occurring in 8%-14% of patients with stroke. It is infrequently recognized and difficult to manage. OBJECTIVE:We systematically reviewed the pathophysiology and treatment of CPSP. METHODS:We conducted a Medline search using the key words "central post...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章,评审
doi:10.1213/ane.0b013e31819d644c
更新日期:2009-05-01 00:00:00
abstract::This study documented gastric fluid acidity in ambulatory surgical patients 30-120 min after they had taken a 300-mg tablet of ranitidine, as changes specific to this relatively brief dose-to-sampling interval previously had not been delineated. At 20-120 min before outpatient surgery, ranitidine was given with 15 mL ...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/00000539-199112000-00018
更新日期:1991-12-01 00:00:00
abstract:BACKGROUND:The bispectral index (BIS) monitor has been available for clinical use for >20 years and has had an immense impact on academic activity in Anesthesiology, with >3000 articles referencing the bispectral index. Despite attempts to infer its algorithms by external observation, its operation has nevertheless rem...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/ANE.0000000000005220
更新日期:2020-12-01 00:00:00
abstract::Ocular microtremor (OMT) is a fine physiologic tremor of the eye related to neuronal activity in the reticular formation of the brainstem. The frequency of OMT is suppressed by propofol and sevoflurane and predicts the response to command at emergence from anesthesia. Previous studies have relied on post hoc computer ...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章,多中心研究
doi:10.1213/01.ANE.0000133145.98702.C0
更新日期:2004-09-01 00:00:00
abstract:BACKGROUND:The cerebral perfusion pressure that denotes the lower limit of cerebral blood flow autoregulation (LLA) is generally considered to be equivalent for reductions in arterial blood pressure (ABP) or increases in intracranial pressure (ICP). However, the effect of decreasing ABP at different levels of ICP has n...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/ane.0b013e3181964848
更新日期:2009-04-01 00:00:00
abstract::Patients receiving metoprolol before cardiac revascularization surgery were randomly divided into those in whom metoprolol was discontinued before the operation (N = 10) and those in whom metoprolol was continued up to the time of operation (N = 10). Cardiovascular responses to neuroleptanesthesia and sternotomy were ...
journal_title:Anesthesia and analgesia
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1983-04-01 00:00:00
abstract:BACKGROUND:Several data suggest that both opioid and N-methyl-d-aspartate (NMDA) receptors are localized at the peripheral level, and drugs acting on these receptors may produce antinociception after topical administration; however, the antinociceptive effect of endogenous ligands at these receptors is poorly clarified...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/ane.0b013e3181b21c5e
更新日期:2009-10-01 00:00:00
abstract::In a prospective, randomized, double-blind study, we investigated whether epinephrine increased the efficacy of levobupivacaine and sufentanil during epidural labor analgesia. Seventy term parturients received an epidural injection of levobupivacaine 0.125% and sufentanil 0.75 microg/mL with or without 1:800,000 epine...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1213/01.ane.0000221038.46094.c0
更新日期:2006-07-01 00:00:00
abstract::Mice continuously exposed to 50% nitrous oxide for 2 weeks or more become tolerant to nitrous oxide, as measured by an 8% to 19% increase in their nitrous oxide ED50 (the dose required to abolish the righting reflex in 50% of the animals). Control mice tolerant to nitrous oxide were given intraperitoneal injections of...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:
更新日期:1981-03-01 00:00:00
abstract:BACKGROUND:The rate of neuraxial analgesia during labor in France is one of the highest among high-income countries: 77% of vaginal deliveries in 2010. In this context, the question of how women's preferences for delivering without neuraxial analgesia relate to actual use is of interest. Our objective was to study the ...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/ANE.0000000000000832
更新日期:2015-09-01 00:00:00
abstract:UNLABELLED:Despite their contribution to overall perioperative treatment of patients, anesthesiologists often remain in anonymity. We evaluated the impact of business cards on physician recognition after general anesthesia. Using a questionnaire, 441 patients were interviewed for recall of the anesthesiologist's name, ...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1097/00000539-200111000-00045
更新日期:2001-11-01 00:00:00
abstract::Agreement between estimated fibrinogen concentration via thromboelastography and traditional assays is not established in the parturient. We therefore recruited 56 parturients and performed Clauss and functional fibrinogen level (FLEV) tests. Mean difference of measurements was 36.8 mg/dL (95% CI, 21.8-51.9) with a st...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/ANE.0000000000003301
更新日期:2019-09-01 00:00:00
abstract::Tracheal temperature--the temperature of the tracheal wall--is believed to reflect the core temperature. The trachea reacts quickly to temperature changes because it is surrounded by various large arteries and veins. Using the blood temperature from the cardiopulmonary bypass (CPB) and the jugular vein temperature as ...
journal_title:Anesthesia and analgesia
pub_type: 临床试验,杂志文章
doi:10.1213/00000539-199304000-00020
更新日期:1993-04-01 00:00:00
abstract:BACKGROUND:Propofol-evoked injection site pain is not observed with fospropofol. We hypothesized that unlike propofol, fospropofol does not activate the irritant receptor, transient receptor potential 1 (TRPA1). METHODS:We tested the hypothesis using electrophysiology and behavioral studies. RESULTS:Our data demonstr...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/ANE.0b013e318258b9db
更新日期:2012-10-01 00:00:00
abstract:BACKGROUND:Lung isolation with bronchial blockers is a well-described and accepted procedure, often described for use during the management of massive hemoptysis. Recommendations for balloon inflation are sparse, with some advocating for saline whereas other suggest air, including the manufacturers. We sought to evalua...
journal_title:Anesthesia and analgesia
pub_type: 临床试验,杂志文章
doi:10.1213/ANE.0000000000004397
更新日期:2019-12-01 00:00:00
abstract:UNLABELLED:Neuronal baseline K(+) channels were activated by several volatile anesthetics. Whole-cell recordings from cultured cerebellar granule neurons of 7-day-old male Sprague-Dawley rats showed outward-rectifying K(+) currents with a conductance of approximately 1.1 +/- 0.3 nS (n = 20) at positive potentials. The ...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/01.ane.0000055365.31940.0a
更新日期:2003-05-01 00:00:00
abstract::Acute fatty liver of pregnancy (AFLP) is a late gestational complication with biochemical similarities to the inherited disorders of mitochondrial fatty acid oxidation and clinical similarities to fulminant hepatic failure. The following case illustrates our perioperative management of this rarely encountered disorder...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1097/00000539-200105000-00036
更新日期:2001-05-01 00:00:00
abstract:BACKGROUND:Cell-free hemoglobin (Hb) forms in stored red blood cells (RBCs) as a result of hemolysis. Studies suggest that this cell-free Hb may decrease nitric oxide (NO) bioavailability, potentially leading to endothelial dysfunction, vascular injury, and multiorgan dysfunction after transfusion. We tested the hypoth...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/ANE.0000000000001392
更新日期:2016-08-01 00:00:00
abstract::We report a case of a 75-yr-old female patient in whom motor deficits and paresthesias occurred after lumbar epidural analgesia. These symptoms were eventually found to be due to a tethered cord syndrome. An epidural catheter was inserted for analgesia after colon surgery. The postoperative course was characterized by...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/01.ane.0000120387.09339.d1
更新日期:2004-07-01 00:00:00