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Gastrointestinal Endoscopy Oct 2011Studies suggest that advancing age is an independent risk factor for experiencing adverse events during colonoscopy. Yet many of these studies are limited by small... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Studies suggest that advancing age is an independent risk factor for experiencing adverse events during colonoscopy. Yet many of these studies are limited by small sample sizes and/or marked variation in reported outcomes.
OBJECTIVE
To determine the incidence rates for specific adverse events in elderly patients undergoing colonoscopy and calculate incidence rate ratios for selected comparison groups.
SETTING AND PATIENTS
Elderly patients undergoing colonoscopy.
DESIGN
Systematic review and meta-analysis.
MAIN OUTCOME MEASUREMENTS
Perforation, bleeding, cardiovascular (CV)/pulmonary complications, and mortality.
RESULTS
Our literature search yielded 3328 articles, of which 20 studies met our inclusion criteria. Pooled incidence rates for adverse events (per 1000 colonoscopies) in patients 65 years of age and older were 26.0 (95% CI, 25.0-27.0) for cumulative GI adverse events, 1.0 (95% CI, 0.9-1.5) for perforation, 6.3 (95% CI, 5.7-7.0) for GI bleeding, 19.1 (95% CI, 18.0-20.3) for CV/pulmonary complications, and 1.0 (95% CI, 0.7-2.2) for mortality. Among octogenarians, adverse events (per 1000 colonoscopies) were as follows: cumulative GI adverse event rate of 34.9 (95% CI, 31.9-38.0), perforation rate of 1.5 (95% CI, 1.1-1.9), GI bleeding rate of 2.4 (95% CI, 1.1-4.6), CV/pulmonary complication rate of 28.9 (95% CI, 26.2-31.8), and mortality rate of 0.5 (95% CI, 0.06-1.9). Patients 80 years of age and older experienced higher rates of cumulative GI adverse events (incidence rate ratio 1.7; 95% CI, 1.5-1.9) and had a greater risk of perforation (incidence rate ratio 1.6, 95% CI, 1.2-2.1) compared with younger patients (younger than 80 years of age). There was an increased trend toward higher rates of GI bleeding and CV/pulmonary complications in octogenarians but neither was statistically significant.
LIMITATIONS
Heterogeneity of studies included and not all complications related to colonoscopy were captured.
CONCLUSIONS
Elderly patients, especially octogenarians, appear to have a higher risk of complications during and after colonoscopy. These data should inform clinical decision making, the consent process, public health policy, and comparative effectiveness analyses.
Topics: Aged; Aged, 80 and over; Cardiovascular Diseases; Colonoscopy; Gastrointestinal Hemorrhage; Humans; Intestinal Perforation; Respiration Disorders
PubMed: 21951478
DOI: 10.1016/j.gie.2011.06.023 -
BMJ Open Aug 2016Record review is the most used method to quantify patient safety. We systematically reviewed the reliability and validity of adverse event detection with record review. (Review)
Review
OBJECTIVES
Record review is the most used method to quantify patient safety. We systematically reviewed the reliability and validity of adverse event detection with record review.
DESIGN
A systematic review of the literature.
METHODS
We searched PubMed, EMBASE, CINAHL, PsycINFO and the Cochrane Library and from their inception through February 2015. We included all studies that aimed to describe the reliability and/or validity of record review. Two reviewers conducted data extraction. We pooled κ values (κ) and analysed the differences in subgroups according to number of reviewers, reviewer experience and training level, adjusted for the prevalence of adverse events.
RESULTS
In 25 studies, the psychometric data of the Global Trigger Tool (GTT) and the Harvard Medical Practice Study (HMPS) were reported and 24 studies were included for statistical pooling. The inter-rater reliability of the GTT and HMPS showed a pooled κ of 0.65 and 0.55, respectively. The inter-rater agreement was statistically significantly higher when the group of reviewers within a study consisted of a maximum five reviewers. We found no studies reporting on the validity of the GTT and HMPS.
CONCLUSIONS
The reliability of record review is moderate to substantial and improved when a small group of reviewers carried out record review. The validity of the record review method has never been evaluated, while clinical data registries, autopsy or direct observations of patient care are potential reference methods that can be used to test concurrent validity.
Topics: Analysis of Variance; Humans; Medical Errors; Medical Records; Observer Variation; Patient Safety; Safety Management
PubMed: 27550650
DOI: 10.1136/bmjopen-2016-011078 -
The Cochrane Database of Systematic... Feb 2018Fibromyalgia is a chronic widespread pain condition affecting millions of people worldwide. Current pharmacotherapies are often ineffective and poorly tolerated.... (Review)
Review
BACKGROUND
Fibromyalgia is a chronic widespread pain condition affecting millions of people worldwide. Current pharmacotherapies are often ineffective and poorly tolerated. Combining different agents could provide superior pain relief and possibly also fewer side effects.
OBJECTIVES
To assess the efficacy, safety, and tolerability of combination pharmacotherapy compared to monotherapy or placebo, or both, for the treatment of fibromyalgia pain in adults.
SEARCH METHODS
We searched CENTRAL, MEDLINE, and Embase to September 2017. We also searched reference lists of other reviews and trials registries.
SELECTION CRITERIA
Double-blind, randomised controlled trials comparing combinations of two or more drugs to placebo or other comparators, or both, for the treatment of fibromyalgia pain.
DATA COLLECTION AND ANALYSIS
From all studies, we extracted data on: participant-reported pain relief of 30% or 50% or greater; patient global impression of clinical change (PGIC) much or very much improved or very much improved; any other pain-related outcome of improvement; withdrawals (lack of efficacy, adverse events), participants experiencing any adverse event, serious adverse events, and specific adverse events (e.g. somnolence and dizziness). The primary comparison was between combination and one or all single-agent comparators. We also assessed the evidence using GRADE and created a 'Summary of findings' table.
MAIN RESULTS
We identified 16 studies with 1474 participants. Three studies combined a non-steroidal anti-inflammatory drug (NSAID) with a benzodiazepine (306 participants); two combined amitriptyline with fluoxetine (89 participants); two combined amitriptyline with a different agent (92 participants); two combined melatonin with an antidepressant (164 participants); one combined carisoprodol, paracetamol (acetaminophen), and caffeine (58 participants); one combined tramadol and paracetamol (acetaminophen) (315 participants); one combined malic acid and magnesium (24 participants); one combined a monoamine oxidase inhibitor with 5-hydroxytryptophan (200 participants); and one combined pregabalin with duloxetine (41 participants). Six studies compared the combination of multiple agents with each component alone and with inactive placebo; three studies compared combination pharmacotherapy with each individual component but did not include an inactive placebo group; two studies compared the combination of two agents with only one of the agents alone; and three studies compared the combination of two or more agents only with inactive placebo.Heterogeneity among studies in terms of class of agents evaluated, specific combinations used, outcomes reported, and doses given prevented any meta-analysis. None of the combinations of drugs found provided sufficient data for analysis compared with placebo or other comparators for our preferred outcomes. We therefore provide a narrative description of results. There was no or inadequate evidence in any comparison for primary and secondary outcomes. Two studies only reported any primary outcomes of interest (patient-reported pain relief of 30%, or 50%, or greater). For each 'Risk of bias' item, only half or fewer of studies had unequivocal low risk of bias. Small size and selective reporting were common as high risk of bias.Our GRADE assessment was therefore very low for primary outcomes of pain relief of 30% or 50% or greater, PGIC much or very much improved or very much improved, any pain-related outcome, participants experiencing any adverse event, any serious adverse event, or withdrawing because of an adverse event.Three studies found some evidence that combination pharmacotherapy reduced pain compared to monotherapy; these trials tested three different combinations: melatonin and amitriptyline, fluoxetine and amitriptyline, and pregabalin and duloxetine. Adverse events experienced by participants were not serious, and where they were reported (in 12 out of 16 studies), all participants experienced them, regardless of treatment. Common adverse events were nausea, dizziness, somnolence, and headache.
AUTHORS' CONCLUSIONS
There are few, large, high-quality trials comparing combination pharmacotherapy with monotherapy for fibromyalgia, consequently limiting evidence to support or refute the use of combination pharmacotherapy for fibromyalgia.
Topics: 5-Hydroxytryptophan; Acetaminophen; Adult; Amitriptyline; Anti-Inflammatory Agents, Non-Steroidal; Antidepressive Agents; Benzodiazepines; Carisoprodol; Drug Therapy, Combination; Duloxetine Hydrochloride; Fibromyalgia; Fluoxetine; Humans; Magnesium; Malates; Melatonin; Monoamine Oxidase Inhibitors; Muscle Relaxants, Central; Pregabalin; Randomized Controlled Trials as Topic
PubMed: 29457627
DOI: 10.1002/14651858.CD010585.pub2 -
The Cochrane Database of Systematic... Jul 2015Milnacipran is a serotonin-norepinephrine reuptake inhibitor (SNRI) that is sometimes used to treat chronic neuropathic pain and fibromyalgia. This is an update of an... (Review)
Review
BACKGROUND
Milnacipran is a serotonin-norepinephrine reuptake inhibitor (SNRI) that is sometimes used to treat chronic neuropathic pain and fibromyalgia. This is an update of an earlier review of milnacipran for neuropathic pain and fibromyalgia in adults originally published in The Cochrane Library Issue 3, 2012. We split that review so that this one looked only at neuropathic pain, and a separate review looks at fibromyalgia.
OBJECTIVES
To assess the analgesic efficacy and associated adverse events of milnacipran for chronic neuropathic pain in adults.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE to 23 February 2015, together with reference lists of retrieved papers and reviews.
SELECTION CRITERIA
We included randomised, double-blind studies of eight weeks' duration or longer, comparing milnacipran with placebo or another active treatment in chronic neuropathic pain.
DATA COLLECTION AND ANALYSIS
Two review authors independently searched for studies, extracted efficacy and adverse event data, and examined issues of study quality. We did not carry out any analysis.
MAIN RESULTS
We included a single study of 40 participants with chronic low back pain with a neuropathic component. It found no difference in pain scores between milnacipran 100 mg to 200 mg daily or placebo after six weeks (very low quality evidence). Adverse event rates were similar between treatments, with too few data to draw conclusions (very low quality evidence).
AUTHORS' CONCLUSIONS
There was no evidence to support the use of milnacipran to treat neuropathic pain conditions.
Topics: Adult; Analgesics; Back Pain; Chronic Pain; Cyclopropanes; Fibromyalgia; Humans; Milnacipran; Neuralgia; Randomized Controlled Trials as Topic; Selective Serotonin Reuptake Inhibitors
PubMed: 26148202
DOI: 10.1002/14651858.CD011789 -
Vaccine Nov 2015In 2013, the WHO Strategic Advisory Group of Experts on Immunization (SAGE) requested WHO to develop a process and a plan to move the maternal immunization agenda... (Review)
Review
In 2013, the WHO Strategic Advisory Group of Experts on Immunization (SAGE) requested WHO to develop a process and a plan to move the maternal immunization agenda forward in support of an increased alignment of data safety evidence, public health needs, and regulatory processes. A key challenge identified was the continued need for harmonization of maternal adverse event following immunization (AEFI) research and surveillance efforts within developing and developed country contexts. We conducted a systematic review as a preliminary step in the development of standardized AEFI definitions for use in maternal and neonatal clinical trials, post-licensure surveillance, and other vaccine studies. We documented the current extent and nature of variability in AEFI definitions and adverse event reporting among 74 maternal immunization studies, which reported a total of 240 different types of adverse events. Forty-nine studies provided explicit AEFI case definitions describing 35 separate types of AEFIs. We identified variability in how AEFIs were determined to be present, in how AEFI definitions were applied, and in the ways that AEFIs were reported. Definitions for key maternal/neonatal AEFIs differed on four discrete attributes: overall level of detail, physiological and temporal boundaries and cut-offs, severity strata, and standards used. Our findings suggest that investigators may proactively address these inconsistencies through comprehensive and consistent reporting of AEFI definitions and outcomes in future publications. In addition, efforts to develop standardized AEFI definitions should generate definitions of sufficient detail and consistency of language to avoid the ambiguities we identified in reviewed articles, while remaining practically applicable given the constraints of low-resource contexts such as limited diagnostic capacity and high patient throughput.
Topics: Disease Transmission, Infectious; Drug-Related Side Effects and Adverse Reactions; Female; Global Health; Humans; Immunization; Infant, Newborn; Pregnancy; Pregnancy Complications, Infectious; Product Surveillance, Postmarketing; Vaccines; World Health Organization
PubMed: 26413879
DOI: 10.1016/j.vaccine.2015.08.043 -
European Journal of Cardio-thoracic... Aug 2017The aim of the current study was to estimate adverse event rates while awaiting myocardial revascularization and review criteria for prioritizing patients. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
The aim of the current study was to estimate adverse event rates while awaiting myocardial revascularization and review criteria for prioritizing patients.
METHODS
A PubMed search was performed on 19 January 2015, to identify English-language, original, observational studies reporting adverse events while awaiting coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). Rates of death, non-fatal myocardial infarction (MI) and emergency revascularization were calculated as occurrence rates per 1000 patient-weeks and pooled using random-effects models.
RESULTS
The search yielded 1323 articles, of which 22 were included with 66 410 patients and 607 675 patient-weeks on the wait list. When awaiting CABG, rates per 1000 patient-weeks were 1.1 [95% confidence interval 0.9-1.3] for death, 1.0 [0.6-1.6] for non-fatal MI and 1.8 [0.8-4.1] for emergency revascularization. Subgroup analyses demonstrated consistent outcomes, and sensitivity analyses demonstrated comparable event rates with low heterogeneity. Higher urgency of revascularization was based primarily on angiographic complexity, angina severity, left ventricular dysfunction and symptoms on stress testing, and such patients with a semi-urgent status had a higher risk of death than patients awaiting elective revascularization (risk ratio at least 2.8). Individual studies identified angina severity and left ventricular dysfunction as most important predictors of death when awaiting CABG. Adverse rates per 1000 patient-weeks for patients awaiting PCI were 0.1 [95% confidence interval 0.0-0.4] for death, 0.4 [0.1-1.2] for non-fatal MI and 0.7 [0.4-1.4] for emergency revascularization but were based on only a few old studies.
CONCLUSIONS
Rates of death, non-fatal MI and emergency revascularization when awaiting myocardial revascularization are infrequent but higher in specific patients. Countries that not yet have treatment recommendations related to waiting times should consider introducing a maximum to limit adverse events, particularly when awaiting CABG.
Topics: Aged; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Percutaneous Coronary Intervention; Time-to-Treatment; Waiting Lists
PubMed: 28472484
DOI: 10.1093/ejcts/ezx115 -
Neurosurgery Sep 2023Focused ultrasound (FUS-T) and stereotactic radiosurgery thalamotomy (SRS-T) targeting the ventral intermediate nucleus are effective incisionless surgeries for... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Focused ultrasound (FUS-T) and stereotactic radiosurgery thalamotomy (SRS-T) targeting the ventral intermediate nucleus are effective incisionless surgeries for essential tremor (ET). However, their efficacy for tremor reduction and, importantly, adverse event incidence have not been directly compared.
OBJECTIVE
To present a comprehensive systematic review with network meta-analysis examining both efficacy and adverse events (AEs) of FUS-T vs SRS-T for treating medically refractory ET.
METHODS
We conducted a systematic review and network meta-analysis according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, using the PubMed and Embase databases. We included all primary FUS-T/SRS-T studies with approximately 1-year follow-up, with unilateral Fahn-Tolosa-Marin Tremor Rating Scale or Clinical Rating Scale for Tremor scores prethalamotomy/post-thalamotomy and/or AEs. The primary efficacy outcome was Fahn-Tolosa-Marin Tremor Rating Scale A+B score reduction. AEs were reported as an estimated incidence.
RESULTS
Fifteen studies of 464 patients and 3 studies of 62 patients met inclusion criteria for FUS-T/SRS-T efficacy comparison, respectively. Network meta-analysis demonstrated similar tremor reduction between modalities (absolute tremor reduction: FUS-T: -11.6 (95% CI: -13.3, -9.9); SRS-T: -10.3 (95% CI: -14.2, -6.0). FUS-T had a greater 1-year adverse event rate, particularly imbalance and gait disturbances (10.5%) and sensory disturbances (8.3%). Contralateral hemiparesis (2.7%) often accompanied by speech impairment (2.4%) were most common after SRS-T. There was no correlation between efficacy and lesion volume.
CONCLUSION
Our systematic review found similar efficacy between FUS-T and SRS-T for ET, with trend toward higher efficacy yet greater adverse event incidence with FUS-T. Smaller lesion volumes could mitigate FUS-T off-target effects for greater safety.
Topics: Humans; Essential Tremor; Magnetic Resonance Imaging; Radiosurgery; Thalamus; Treatment Outcome; Tremor; Ultrasonic Surgical Procedures; Network Meta-Analysis
PubMed: 37010324
DOI: 10.1227/neu.0000000000002462 -
Hemodialysis International.... Jan 2023We conducted a systematic review of studies investigating lock solutions for use in non-tunneled hemodialysis catheters.
BACKGROUND
We conducted a systematic review of studies investigating lock solutions for use in non-tunneled hemodialysis catheters.
METHODS
We searched PubMed and Cochrane databases from inception to June 11, 2021. Study inclusion criteria were: randomized trial or observational study, adults (>18 years), with acute kidney injury (AKI); and temporary non-tunneled catheters. We recorded bleeding events, catheter dysfunction and complications.
RESULTS
Of 649 studies identified, 6 were included (4 randomized, 1 non-randomized trial, 1 retrospective cohort study; sample sizes 78-1496 patients). Citrate was compared to heparin in 4 studies, to saline in 1, and ethanol versus saline in 1. Event-free survival of non-tunneled catheters did not differ between groups. Catheter-related infections and adverse events were less frequent with citrate locks, but reached statistical significance in only two studies.
CONCLUSION
Existing data are too heterogeneous to enable recommending one type of catheter lock over any other for non-tunneled hemodialysis catheters.
Topics: Adult; Humans; Retrospective Studies; Central Venous Catheters; Renal Dialysis; Catheterization; Heparin; Catheter-Related Infections; Citric Acid; Citrates; Catheters, Indwelling; Observational Studies as Topic
PubMed: 36203330
DOI: 10.1111/hdi.13047 -
Journal of the American Veterinary... Nov 2016OBJECTIVE To evaluate methods used to ascertain, define, and report adverse events (AEs) in companion animal clinical trials involving cancer treatment. DESIGN... (Review)
Review
OBJECTIVE To evaluate methods used to ascertain, define, and report adverse events (AEs) in companion animal clinical trials involving cancer treatment. DESIGN Systematic review. SAMPLE English-language articles describing prospective clinical trials involving dogs and cats with naturally occurring cancer published in peer-reviewed journals between 2008 and 2014. PROCEDURES Reports were identified via MEDLINE and CAB database searches combined with a hand-searching strategy. General article characteristics were abstracted and summarized. Data for AE reporting were collected with a 14-item checklist adapted from the 2004 CONSORT extension for reporting harms. Study characteristics associated with the AE reporting checklist score were identified by means of linear regression analysis. RESULTS 168 articles with data for 6,132 animals were included. Standardized terminology was significantly more likely to be used to describe AEs for trials that included chemotherapy (92/115 [80.0%]) than for trials that did not (16/53 [30.2%]). Median AE reporting checklist score was 5 out of 14 (range, 0 to 12). Poorly reported items included methods and time frame of AE ascertainment, AE data analysis, and reasons for treatment discontinuation and death. Trials with industry funding, a single-arm design, and treatment with chemotherapy were associated with a significantly higher quality of AE reporting. CONCLUSIONS AND CLINICAL RELEVANCE Reporting of adverse events in veterinary clinical trials evaluating cancer treatment was selective and heterogeneous. Harms associated with cancer treatments could be underestimated because of suboptimal collection and reporting of AE data. Findings supported the adoption of a higher standard for AE surveillance and reporting in veterinary patients.
Topics: Animals; Antineoplastic Agents; Clinical Trials as Topic; Drug-Related Side Effects and Adverse Reactions; Neoplasms; Pets
PubMed: 27767430
DOI: 10.2460/javma.249.9.1079