Comparison of computerized surveillance and manual chart review for adverse events.
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ABSTRACT: Objective
To understand how the source of information affects different adverse event (AE) surveillance methods.Design
Retrospective analysis of inpatient adverse drug events (ADEs) and hospital-associated infections (HAIs) detected by either a computerized surveillance system (CSS) or manual chart review (MCR).Measurement
Descriptive analysis of events detected using the two methods by type of AE, type of information about the AE, and sources of the information.Results
CSS detected more HAIs than MCR (92% vs 34%); however, a similar number of ADEs was detected by both systems (52% vs 51%). The agreement between systems was greater for HAIs than ADEs (26% vs 3%). The CSS missed events that did not have information in coded format or that were described only in physician narratives. The MCR detected events missed by CSS using information in physician narratives. Discharge summaries were more likely to contain information about AEs than any other type of physician narrative, followed by emergency department reports for HAIs and general consult notes for ADEs. Some ADEs found by MCR were detected by CSS but not verified by a clinician.Limitations
Inability to distinguish between CSS false positives and suspected AEs for cases in which the clinician did not document their assessment in the CSS.Conclusion
The effect that information source has on different surveillance methods depends on the type of AE. Integrating information from physician narratives with CSS using natural language processing would improve the detection of ADEs more than HAIs.
SUBMITTER: Tinoco A
PROVIDER: S-EPMC3128408 | biostudies-literature | 2011 Jul-Aug
REPOSITORIES: biostudies-literature
Publications
Comparison of computerized surveillance and manual chart review for adverse events.
Tinoco Aldo A Evans R Scott RS Staes Catherine J CJ Lloyd James F JF Rothschild Jeffrey M JM Haug Peter J PJ
Journal of the American Medical Informatics Association : JAMIA 20110701 4
<h4>Objective</h4>To understand how the source of information affects different adverse event (AE) surveillance methods.<h4>Design</h4>Retrospective analysis of inpatient adverse drug events (ADEs) and hospital-associated infections (HAIs) detected by either a computerized surveillance system (CSS) or manual chart review (MCR).<h4>Measurement</h4>Descriptive analysis of events detected using the two methods by type of AE, type of information about the AE, and sources of the information.<h4>Resul ...[more]
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Project description:ObjectivesThe objectives of this study were to document the incidence rate and types of adverse events (AEs) among home care (HC) clients in Canada; identify factors contributing to these AEs; and determine to what extent evidence of completion of incident reports were documented in charts where AEs were found.MethodsThis was a retrospective cohort study based on expert chart review of a random sample of 1200 charts of clients discharged in fiscal year 2009-2010 from publicly funded HC programmes in Manitoba, Quebec and Nova Scotia, Canada.ResultsThe results show that 4.2% (95% CI 3.0% to 5.4%) of HC patients discharged in a 12-month period experienced an AE. Adjusting to account for clients with lengths of stay in HC of less than 1 year, the AE incidence rate per client-year was 10.1% (95% CI 8.4% to 11.8%); 56% of AEs were judged preventable. The most frequent AEs were injuries from falls, wound infections, psychosocial, behavioural or mental health problems and adverse outcomes from medication errors. More comorbid conditions (OR 1.15; 95% CI 1.05 to 1.26) and a lower instrumental activities of daily living score (OR 1.54; 95% CI 1.16 to 2.04) were associated with a higher risk of experiencing an AE. Clients' decisions or actions contributed to 48.4% of AEs, informal caregivers 20.4% of AEs, and healthcare personnel 46.2% of AEs. Only 17.3% of charts with an AE contained documentation that indicated an incident report was completed, while 4.8% of charts without an AE had such documentation.ConclusionsClient safety is an important issue in HC, as it is in institutionalised care. HC includes the planned delivery of self-care by clients and care provision by family, friends and other individuals often described as 'informal' caregivers. As clients and these caregivers can contribute to the occurrence of AEs, their involvement in the delivery of healthcare interventions at home must be considered when planning strategies to improve HC safety.
| S-EPMC3888609 | biostudies-literature
Project description:Evidence suggests that fasting, during which only water is consumed, results in potentially health promoting physiological effects. However, peer-reviewed research assessing the safety of water-only fasting is lacking. To address this, we conducted a chart review to describe adverse events (AEs) that occurred during medically supervised, water-only fasting.Electronic charts from patient visits to a residential medical facility from 2006 to 2011 were reviewed. Patients who were at least 21 years of age and water-only fasted for ?2 consecutive days with a refeeding period equal to half of the fast length were included. Out of 2539 charts, 768 visits met our inclusion and exclusion criteria. AEs were abstracted from chart notes and classified according to CTCAE (v4.03) and MedDRA (v12.1) terminology. Descriptive analysis of AEs is reported.During the protocol period, the highest grade AE (HGAE) in 555 visits was a grade 2 event or lower, in 212 visits it was a grade 3 event, in 1 visit it was a grade 4 event, and there were no grade 5 events. There were 2 (0.002%) visits with a serious adverse event (SAE). The majority of AEs identified were mild (n?=?4490, 75%) in nature and known reactions to fasting.To our knowledge, this is the most comprehensive analysis of AEs experienced during medically supervised, water-only fasting conducted to date. Overall, our data indicate that the majority of AEs experienced were mild to moderate and known reactions to fasting. This suggests that the protocol used in this study can be safely implemented in a medical setting with minimal risk of a SAE.
| S-EPMC5819235 | biostudies-literature
Project description:IntroductionAdverse events are a major cause of patient harm in the hospitalised setting. Low-income and middle-income countries account for a disproportionate share of the global burden of adverse events. However, patient safety research is still centred around high-income countries and high-resource health systems. The methods and data produced from these efforts are ill-suited to low-income and middle-income systems due to the social and technical differences between these settings. We aim to use our pilot-tested, locally developed methodology to estimate the frequency and characteristics of adverse events in hospitalised patients in a lower-middle-income country to inform patient safety policies and initiatives.Methods and analysisThis multi-centre study will employ a two-step chart review methodology to identify adverse events in a representative sample of patients admitted at five hospitals between 1 January 2019 and 31 December 2019. The first step will include assessing patient files against a list of triggers to detect adverse events and the second step will involve an in-depth review of the events to capture pertinent characteristics. The triggers have been adapted from validated tools used in other studies. The reviewing team will be trained on the use of research tools and operational definitions to ensure that data are collected uniformly. The main outcome of interest is the rate at which adverse events occur in hospitalised patients. Further analysis will look to identify and quantify associations between the main outcome of interest and a variety of variables such as patient age and gender using tests of independence and regression techniques.Ethics and disseminationThis study protocol has been approved by the Ethics Review Committee at Aga Khan University (Reference number: 2023-6324-24566). The findings of this study will be published in a peer-reviewed journal and disseminated to the public through national and international conferences, workshops, websites and social media.
| S-EPMC10711861 | biostudies-literature
Project description:ImportanceConventional approaches for tracking postoperative adverse events requires manual medical record review, thus limiting the scalability of such efforts.ObjectiveTo determine if a surveillance system using computerized provider order entry (CPOE) events for selected medications as well as laboratory, microbiologic, and radiologic orders can decrease the manual medical record review burden for surveillance of postoperative complications.Design, setting, and participantsThis cohort study reviewed the medical records of 21 775 patients who underwent surgical procedures at a university-based tertiary referral center (University of Utah, Salt Lake City) from July 1, 2007, to August 31, 2017. Patients were included if their case was selected for review by a surgical clinical reviewer as part of the National Surgical Quality Improvement Program. Patients were excluded if they had incomplete follow-up data.Main outcomes and measuresThirty-day postoperative occurrences of superficial surgical site infection, deep surgical site infection, organ space surgical site infection, urinary tract infection, pneumonia, sepsis, septic shock, deep vein thrombosis requiring therapy, and pulmonary embolism, as defined by the National Surgical Quality Improvement Program. A logistic regression model was developed for each postoperative complication using CPOE features as predictors on a development set, and performance was measured on a holdout internal validation set. The models were internally validated using bootstrapping with 10 000 replications to determine the sensitivity, specificity, positive predictive value, and negative predictive value of CPOE-based surveillance system.ResultsThe study included 21 775 patients who underwent surgical procedures. Among these patients, 11 855 (54.4%) were women and 9920 (45.6%) were men, with a mean (SD) age of 51.7 (16.8) years. Overall, the prevalence of postoperative complications was low, ranging from 0.2% (pulmonary embolism) to 2.6% (superficial surgical site infection). Use of CPOE events to detect patients who experienced at least 1 complication had a sensitivity of 74.8% (95% CI, 71.1%-78.4%), specificity of 86.8% (95% CI, 85.5%-88.3%), positive predictive value of 33.8% (95% CI, 31.2%-36.4%), negative predictive value of 97.5% (95% CI, 97.1%-97.8%), and area under the curve of 0.808 (95% CI, 0.791-0.824). The negative predictive value for individual complications ranged from 98.7% to 100%. Use of CPOE events to screen for adverse events was estimated to diminish the burden of manual medical record review by 55.4% to 90.3%. A CPOE-based surveillance system performed well for both inpatient and outpatient procedures.Conclusions and relevanceA CPOE-based surveillance of postoperative complications has high negative predictive value, which demonstrates that this approach can augment the currently used, resource-intensive manual medical record review process.
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Project description:ImportanceSafety surveillance of vaccines against COVID-19 is critical to ensure safety, maintain trust, and inform policy.ObjectivesTo monitor 23 serious outcomes weekly, using comprehensive health records on a diverse population.Design, setting, and participantsThis study represents an interim analysis of safety surveillance data from Vaccine Safety Datalink. The 10 162 227 vaccine-eligible members of 8 participating US health plans were monitored with administrative data updated weekly and supplemented with medical record review for selected outcomes from December 14, 2020, through June 26, 2021.ExposuresReceipt of BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) COVID-19 vaccination, with a risk interval of 21 days for individuals after vaccine dose 1 or 2 compared with an interval of 22 to 42 days for similar individuals after vaccine dose 1 or 2.Main outcomes and measuresIncidence of serious outcomes, including acute myocardial infarction, Bell palsy, cerebral venous sinus thrombosis, Guillain-Barré syndrome, myocarditis/pericarditis, pulmonary embolism, stroke, and thrombosis with thrombocytopenia syndrome. Incidence of events that occurred among vaccine recipients 1 to 21 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. For a signal, a 1-sided P < .0048 was required to keep type I error below .05 during 2 years of weekly analyses. For 4 additional outcomes, including anaphylaxis, only descriptive analyses were conducted.ResultsA total of 11 845 128 doses of mRNA vaccines (57% BNT162b2; 6 175 813 first doses and 5 669 315 second doses) were administered to 6.2 million individuals (mean age, 49 years; 54% female individuals). The incidence of events per 1 000 000 person-years during the risk vs comparison intervals for ischemic stroke was 1612 vs 1781 (RR, 0.97; 95% CI, 0.87-1.08); for appendicitis, 1179 vs 1345 (RR, 0.82; 95% CI, 0.73-0.93); and for acute myocardial infarction, 935 vs 1030 (RR, 1.02; 95% CI, 0.89-1.18). No vaccine-outcome association met the prespecified requirement for a signal. Incidence of confirmed anaphylaxis was 4.8 (95% CI, 3.2-6.9) per million doses of BNT162b2 and 5.1 (95% CI, 3.3-7.6) per million doses of mRNA-1273.Conclusions and relevanceIn interim analyses of surveillance of mRNA COVID-19 vaccines, incidence of selected serious outcomes was not significantly higher 1 to 21 days postvaccination compared with 22 to 42 days postvaccination. While CIs were wide for many outcomes, surveillance is ongoing.
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Project description:Computerized physician order entry (CPOE) with clinical decision support (CDS) has been promoted as an effective strategy to prevent the development of a drug injury defined as an adverse drug event (ADE).To systematically review studies evaluating the effects of CPOE with CDS on the development of an ADE as an outcome measure.PUBMED versions of MEDLINE (from inception through March 2007) were searched to identify relevant studies. Reference lists of included studies were also searched.We searched for original investigations, randomized and nonrandomized clinical trials, and observational studies that evaluated the effect of CPOE with CDS on the rates of ADEs. The studies identified were assessed to determine the type of computer system used, drug categories being evaluated, types of ADEs measured, and clinical outcomes assessed.Of the 543 citations identified, 10 studies met our inclusion criteria. These studies were grouped into categories based on their setting: hospital or ambulatory; no studies related to the long-term care setting were identified. CPOE with CDS contributed to a statistically significant (P < or = .05) decrease in ADEs in 5 (50.0%) of the 10 studies. Four studies (40.0%) reported a nonstatistically significant reduction in ADE rates, and 1 study (10.0%) demonstrated no change in ADE rates.Few studies have measured the effect of CPOE with CDS on the rates of ADEs, and none were randomized controlled trials. Further research is needed to evaluate the efficacy of CPOE with CDS across the various clinical settings.
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Project description:ObjectivesHalf of prescription drugs commonly given to children lack product labeling on pediatric safety, efficacy, and dosing. Two drugs most widely used off-label in pediatrics are azithromycin and fentanyl. We sought to determine the risk of serious adverse events (SAEs) when oral azithromycin or intravenous/intramuscular fentanyl are used off-label compared to on-label in pediatric intensive care units (ICUs).Study designSix pediatric hospitals participated in a retrospective chart review of patients administered oral azithromycin (n = 241) or intravenous/intramuscular fentanyl (n = 367) between January 5, 2013 and December 26, 2014. Outcomes were SAEs by drug and labeling status: off-label compared to on-label by Food and Drug Administration (FDA)-approved age and/or indication. Statistical analysis was performed using logistic regression to estimate odds ratios (ORs) and Cox regression to estimate hazard ratios (HRs).ResultsTwenty-one (9%) children receiving azithromycin experienced SAEs. Off-label use of azithromycin was not associated with a higher risk of SAE (OR 0.87, 95% CI 0.27-2.71, p = 0.81). Ninety-five (26%) children receiving fentanyl experienced SAEs. Fentanyl off-label use by both age and indication was not associated with a higher risk of overall SAEs compared to on-label use (OR 1.99, 95% CI 0.94-4.19, p = 0.07). However, the risk of the SAE respiratory depression was significantly greater when fentanyl was used off-label by both age and indication (OR 5.05, 95% CI 1.08-23.56, p = 0.044). Results based on HRs were similar.ConclusionsAzithromycin off-label use in pediatric ICUs does not appear to be associated with an increased risk of SAEs. Off-label use of fentanyl appears to be more frequently associated with respiratory depression when used off-label by both age and indication in pediatric ICUs. Prospective studies should be undertaken to assess the safety and efficacy of fentanyl in the pediatric population so that data can be added to the FDA labeling.
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Project description:The PrePex medical male circumcision (MMC) device is relatively easy to place and remove with some training. PrePex has been evaluated in several countries to assess feasibility and acceptability. However, several studies have reported pain associated with removal.To assess safety of PrePex and whether analgesia administered prior to removal reduces pain experienced by participants.A multi-site non-randomized, prospective cohort study in which adult (18-45 years old) males requesting PrePex device male circumcision, were enrolled in six South African clinics from July 2014 to March 2015. Participants were routinely provided with analgesia shortly after the surveillance commenced following a protocol review. Analgesia regimen for device removal depended on medication availability at clinics.Of 1023 enrolled participants who had PrePex placed, 98% (1004) had the device removed at a study clinic. Their median age was 25 (IQR: 21-30) years. HIV sero-positivity was 3.6% (37/1023). Nurses placed and removed half of all devices. Adverse events were experienced by 2.4% (25/1023) of participants; 15 required surgical intervention: device displacement (5/14), early removals (3/14), self-removals (5/14) and insufficient skin removed (2/14). Majority (792: 79%) of participants received analgesia. Most received either paracetamol-codeine (33%), lidocaine (29%) or EMLA and Oral Combination (28%). A lower proportion of participants who received any analgesia (except for lidocaine) prior to PrePex removal experienced severe pain compared to those who received no analgesia (16.6% vs. 29%: p = 0.0001).Reported adverse events during this PrePex active surveillance were similar to previous reports and to those of surgical circumcision. Pain medication provided prior to removal is effective at decreasing severe pain during PrePex device removal.
| S-EPMC5868790 | biostudies-literature
Project description:BackgroundVaccinia-associated myo/pericarditis was observed during the US smallpox vaccination (DryVax) campaign initiated in 2002. A highly-attenuated vaccinia strain, modified vaccinia Ankara (MVA) has been evaluated in clinical trials as a safer alternative to DryVax and as a vector for recombinant vaccines. Due to the lack of prospectively collected cardiac safety data, the US Food and Drug Administration required cardiac screening and surveillance in all clinical trials of MVA since 2004. Here, we report cardiac safety surveillance from 6 phase I trials of MVA vaccines.MethodsFour clinical research organizations contributed cardiac safety data using common surveillance methods in trials administering MVA or recombinant MVA vaccines to healthy participants. 'Routine cardiac investigations' (ECGs and cardiac enzymes obtained 2 weeks after injections of MVA or MVA-HIV recombinants, or placebo-controls), and 'Symptom-driven cardiac investigations' are reported. The outcome measure is the number of participants who met the CDC-case definition for vaccinia-related myo/pericarditis or who experienced cardiac adverse events from an MVA vaccine.ResultsFour hundred twenty-five study participants had post-vaccination safety data analyzed, 382 received at least one MVA-containing vaccine and 43 received placebo; 717 routine ECGs and 930 cardiac troponin assays were performed. Forty-five MVA recipients (12%) had additional cardiac testing performed; 22 for cardiac symptoms, 19 for ECG/laboratory changes, and 4 for cardiac symptoms with an ECG/laboratory change. No participant had evidence of symptomatic or asymptomatic myo/pericarditis meeting the CDC-case definition and judged to be related to an MVA vaccine.ConclusionsProspective surveillance of MVA recipients for myo/pericarditis did not detect cardiac adverse reactions in 382 study participants.Trial registrationClinicalTrials.gov NCT00082446?NCT003766090?NCT00252148?NCT00083603?NCT00301184?NCT00428337.
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Project description:Post-marketing drug surveillance for adverse drug events (ADEs) has typically relied on spontaneous reporting. Recently, regulatory agencies have turned their attention to more preemptive approaches that use existing data for surveillance. We conducted an environmental scan to identify active surveillance systems worldwide that use existing data for the detection of ADEs. We extracted data about the systems' structures, data, and functions. We synthesized the information across systems to identify common features of these systems. We identified nine active surveillance systems. Two systems are US based-the FDA Sentinel Initiative (including both the Mini-Sentinel Initiative and the Federal Partner Collaboration) and the Vaccine Safety Datalink (VSD); two are Canadian-the Canadian Network for Observational Drug Effect Studies (CNODES) and the Vaccine and Immunization Surveillance in Ontario (VISION); and two are European-the Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records and Biomedical Knowledge (EU-ADR) Alliance and the Vaccine Adverse Event Surveillance and Communication (VAESCO). Additionally, there is the Asian Pharmacoepidemiology Network (AsPEN) and the Shanghai Drug Monitoring and Evaluative System (SDMES). We identified two systems in the UK-the Vigilance and Risk Management of Medicines (VRMM) Division and the Drug Safety Research Unit (DSRU), an independent academic unit. These surveillance systems mostly use administrative claims or electronic medical records; most conduct pharmacovigilance on behalf of a regulatory agency. Either a common data model or a centralized model is used to access existing data. The systems have been built using national data alone or via partnership with other countries. However, active surveillance systems using existing data remain rare. North America and Europe have the most population coverage; with Asian countries making good advances.
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