The Nature and Severity of Adverse Events in Select Outpatient Surgical Procedures in the Veterans Health Administration.
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ABSTRACT: Background
Research on adverse events (AEs) in outpatient surgery has been limited. As part of a Veterans Health Administration (VA) project on AE surveillance, we chart-reviewed selected outpatient surgical cases to characterize the nature and severity of AEs.Methods
We abstracted financial year 2012-2015 VA outpatient surgery cases selected with high (n = 1185) and low (n = 1072) likelihood of an AE based on postoperative health care utilization. The abstraction tool included established AE definitions and validated harm and severity scales.Results
We found AEs in 608 high-likelihood (51%) and 126 low-likelihood outpatient surgical procedures (12%). Among 1010 unique AEs, the most common were wound issues (n = 261, 26%), urinary retention (23%), and urinary tract infections (12%). While 63% of all AEs involved minimal harm, 28% required hospitalization, and 9% were severely harmful including 8 AEs requiring intervention to sustain life and 2 deaths. Overall, 102 AEs (10%) required, at minimum, a repeat surgery to treat.Conclusions
Among VA outpatient surgical procedures selected based on likelihood of an AE, nearly 40% of identified events carried more than minimal patient harm, undermining the claim that outpatient surgery is relatively safe. Prevalent and preventable AEs such as wound dehiscence and urinary retention may be useful targets for quality improvement.
SUBMITTER: Mull HJ
PROVIDER: S-EPMC8445237 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe incidence of adverse events with noncardiac procedures (NCP) after the use of drug eluting stents (DES) is not well studied. We sought to determine the incidence and temporal trends of adverse events in patients undergoing NCP after coronary DES.MethodsWe performed a retrospective review of patients receiving DES during percutaneous coronary intervention (PCI) in the Lexington VAMC between January 1, 2004 and December 31, 2010 to determine the circumstances and the results of their NCP.ResultsWe identified 1,092 patients who underwent at least one PCI with DES who were followed for at least 3 years. Of those, 452 patients (41%) had a NCP at a median of 534 days after PCI with 1,081 procedures (894 low-, 160 Intermediate-, and 27 high-risk) performed. Clinically relevant NCP-related complications were defined as significant bleeding or stent thrombosis and occurred in 13 individuals (nine perioperative bleeding and four probable/possible stent thrombosis including two mortalities). Five adverse events occurred within the first year at a rate of 0.014 event/patient-year. During the remainder of follow-up (up to 9 years), eight events were documented at a rate of 0.0004 event/patient-years. During the first year of follow-up, there was no significant increase in risk of recurrent myocardial infarction (MI) or target vessel revascularization (TVR) in patients undergoing NCP but higher risk of all-cause mortality in those who did not undergo NCP. However, in patients who underwent NCP, there was a statistically significant increase in myocardial infarction (MI), target vessel revascularization (TVR), and rehospitalization for cardiac reasons compared with those without NCP during long term follow-up (median of 5.6 years).ConclusionNCP after DES requiring management of DAT are relatively common among veterans following PCI using DES. The risk of bleeding and stent thrombosis is concentrated in the first year but remains very low.
| S-EPMC4476539 | biostudies-literature
Project description:ObjectiveDevelop and validate a surveillance model to identify outpatient surgical adverse events (AEs) based on previously developed electronic triggers.Data sourcesVeterans Health Administration's Corporate Data Warehouse.Study designSix surgical AE triggers, including postoperative emergency room visits and hospitalizations, were applied to FY2012-2014 outpatient surgeries (n = 744,355). We randomly sampled trigger-flagged and unflagged cases for nurse chart review to document AEs and measured positive predictive value (PPV) for triggers. Next, we used chart review data to iteratively estimate multilevel logistic regression models to predict the probability of an AE, starting with the six triggers and adding in patient, procedure, and facility characteristics to improve model fit. We validated the final model by applying the coefficients to FY2015 outpatient surgery data (n = 256,690) and reviewing charts for cases at high and moderate probability of an AE.Principal findingsOf 1,730 FY2012-2014 reviewed surgeries, 350 had an AE (20 percent). The final surveillance model c-statistic was 0.81. In FY2015 surgeries with >0.8 predicted probability of an AE (n = 405, 0.15 percent), PPV was 85 percent; in surgeries with a 0.4-0.5 predicted probability of an AE, PPV was 38 percent.ConclusionsThe surveillance model performed well, accurately identifying outpatient surgeries with a high probability of an AE.
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Project description:Patients at elevated cardiovascular risk are prone to perioperative cardiovascular complications, like myocardial injury after non-cardiac surgery (MINS). We have demonstrated in a mouse model of atherosclerosis that perioperative stress leads to an increase in plaque volume and higher plaque vulnerability. Regulatory T cells (Tregs) play a pivotal role in development and destabilization of atherosclerotic plaques. For this exploratory post-hoc analysis we identified 40 patients recruited into a prospective perioperative biomarker study, who within the inclusion period underwent sequential open vascular surgery. On the basis of protein markers measured in the biomarker study, we evaluated the perioperative inflammatory response in patients' plasma before and after index surgery as well as before and after a second surgical procedure. We also analyzed available immunohistochemistry samples to describe plaque vulnerability in patients who underwent bilateral carotid endarterectomy (CEA) in two subsequent surgical procedures. Finally, we assessed if MINS was associated with sequential surgery. The inflammatory response of both surgeries was characterized by postoperative increases of interleukin-6,-10, Pentraxin 3 and C-reactive protein with no clear-cut difference between the two time points of surgery. Plaques from CEA extracted during the second surgery contained less Tregs, as measured by Foxp3 staining, than plaques from the first intervention. The 2nd surgical procedure was associated with MINS. In conclusion, we provide descriptive evidence that sequential surgical procedures involve repeat inflammation, and we hypothesize that elevated rates of cardiovascular complications after the second procedure could be related to reduced levels of intraplaque Tregs, a finding that deserves confirmatory testing and mechanistic exploration in future populations.
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Project description:BACKGROUND:Drug-related adverse events (AEs) are reported to be common amongst patients receiving outpatient parenteral antimicrobial therapy (OPAT). However, comparative data regarding intravenous (iv) catheter-related AEs are lacking. OBJECTIVES:To compare drug- and iv catheter-related AEs from a large UK OPAT centre. PATIENTS AND METHODS:We reviewed 544 OPAT episodes [median (IQR) age: 57 (39-71) years, 60% male, 13% with diabetes] with a median (IQR) duration of 7 (2-18) days. Clinically significant drug- and iv catheter-related AEs were calculated as a percentage of OPAT episodes with an AE and also as AEs per 1000 iv drug/catheter days. RESULTS:Drug-related AEs complicated 13 (2.4%) OPAT episodes at 1.7 (95% CI 0.9-2.9) per 1000 drug days. Catheter-related AEs occurred more frequently, complicating 32 (5.9%) episodes at 5.7 (95% CI 4.2-7.9) per 1000 iv catheter days (χ2 test for difference in AE rate: P < 0.001). Non-radiologically guided midline catheters were associated with the most frequent AEs (n = 23) at 15.6 (95% CI 10.3-23.4) per 1000 iv catheter days compared with other types of iv catheters (HR 8.4, 95% CI 2.4-51.9, P < 0.004), and self-administration was associated with a higher rate of catheter-related AEs at 12.0 (95% CI 6.0-23.9) per 1000 iv catheter days (HR 4.15, 95% CI 1.7-9.1, P = 0.007). CONCLUSIONS:Clinically significant iv catheter-related AEs occurred more frequently than drug-related AEs, especially when using non-radiologically guided midline catheters. Regular review of the need for iv therapy and switching to oral antimicrobials when appropriate is likely to minimize OPAT-related AEs.
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Project description:BackgroundThe 2014 Veterans Access, Choice and Accountability Act was intended to improve Veterans' access to timely health care by expanding their options to receive community care (CC) paid for by the Veterans Health Administration (VA). Although CC could particularly benefit rural Veterans, we know little about rural Veterans' experiences with CC.ObjectiveThe objective of this study was to compare rural Veterans' experiences with CC and VA outpatient health care services to those of urban Veterans and examine changes over time.Research designRetrospective, cross-sectional study using data from the Survey of Healthcare Experiences of Patients (SHEP) and VA Corporate Data Warehouse. Subjects: All Veterans who responded to the SHEP survey in Fiscal Year (FY) 16 or FY19.MeasuresOutcomes were 4 measures of care experience (Access, Communication, Coordination, and Provider Rating). Independent variables included care setting (CC/VA), rural/urban status, and demographic and clinical characteristics.ResultsCompared with urban Veterans, rural Veterans rated CC the same (for specialty care) or better (for primary care). Rural Veterans reported worse experiences in CC versus VA, except for specialty care Access. Rural Veterans' care experiences improved between FY16 and FY19 in both CC and VA, with greater improvements in CC.ConclusionsRural Veterans' reported comparable or better experiences in CC compared with urban Veterans, but rural Veterans' CC experiences still lagged behind their experiences in VA for primary care. As growing numbers of Veterans use CC, VA should ensure that rural and urban Veterans' experiences with CC are at least comparable to their experiences with VA care.
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Project description:BackgroundTestosterone supplementation has been shown to increase muscle mass and strength in healthy older men. The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied.MethodsCommunity-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter (3.5 to 12.1 nmol per liter) or a free serum testosterone level of less than 50 pg per milliliter (173 pmol per liter) were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group.ResultsA total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load.ConclusionsIn this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy. (ClinicalTrials.gov number, NCT00240981.)
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Project description:BackgroundIt has become widely accepted that whenever animals are used in scientific procedures, the 3Rs principle of replacement, reduction and refinement described by William Russell and Rex Burch should be adhered to. Animals should be replaced with non-sentient alternatives if possible, the number of animals used should be reduced and experimental procedures should be refined to minimise pain, suffering and distress. Administration of analgesic agents to animals undergoing surgical procedures is a refinement used to alleviate pain. In this study, a structured literature review was carried out to examine current trends in analgesic administration to rabbits undergoing experimental surgical procedures.Results128 papers from 51 peer-reviewed journals were selected for inclusion in this review. Reporting administration of systemic analgesia to rabbits in peer-reviewed scientific papers increased significantly from 16% to 50% between 1995-1997 and 2005-2007 (P < 0.001). Papers that reported ethical approval were more likely than papers that did not specify approval to report systemic analgesic administration (P < 0.001). When systemic analgesics were administered, buprenorphine was the most frequently used agent and non-steroidal anti-inflammatory drugs were used less frequently than opioids in both time periods.ConclusionsAlthough this review provides evidence that systemic analgesic administration to rabbits undergoing surgical procedures is increasing, rabbits do not always receive analgesia when they undergo experimental surgery. Other practices in rabbit perioperative care that could be improved, highlighted by this survey include: 1) changing the timing of analgesic administration by giving systemic analgesics pre- or perioperatively rather than only postoperatively, 2) using multimodal analgesia when pain is likely to be moderate to severe and 3) increasing the use of non-steroidal anti-inflammatory drugs and use of other techniques such as epidural analgesia particularly for orthopaedic procedures.
| S-EPMC3058034 | biostudies-literature
Project description:ObjectiveTo examine differences in use of Veterans Health Administration (VA) and Medicare outpatient services by VA primary care patients.Data sources/study settingVA administrative and Medicare claims data from 2001 to 2004.Study designRetrospective cohort study of outpatient service use by 8,964 community-based and 6,556 hospital-based VA primary care patients.Principal findingsA significant proportion of VA patients used Medicare-reimbursed primary care (>30 percent) and specialty care (>60 percent), but not mental health care (3-4 percent). Community-based patients had 17 percent fewer VA primary care visits (p<.001), 9 percent more Medicare-reimbursed visits (p<.001), and 6 percent fewer total visits (p<.05) than hospital-based patients. Community-based patients had 22 percent fewer VA specialty care visits (p<.0001) and 21 percent more Medicare-reimbursed specialty care visits (p<.0001) than hospital-based patients, but no difference in total visits (p=.80).ConclusionsMedicare-eligible VA primary care patients followed over 4 consecutive years used significant primary care and specialty care outside of VA. Community-based patients offset decreased VA use with increased service use paid by Medicare, suggesting that increasing access to VA primary care via community clinics may fragment veteran care in unintended ways. Coordination of care between VA and non-VA providers and health care systems is essential to improve the quality and continuity of care.
| S-EPMC2965504 | biostudies-literature
Project description:ImportanceThe US Department of Veterans Affairs (VA) Veterans Choice Program (VCP) expanded health care access to community settings outside the VA for eligible patients. Little is known about the effect of VCP on access to surgery and postoperative outcomes. Since its initiation, care coordination issues, which are often associated with adverse postoperative outcomes, have been reported. Research findings on the association of VCP and postoperative outcomes are limited to only a few select procedures and have been mixed, potentially due to bias from unmeasured confounding.ObjectiveTo investigate the association of the VCP with access to surgery and postoperative outcomes using a nonrandomized controlled regression discontinuity design (RDD) to reduce the impact of unmeasured confounders.Design, setting, and participantsThis was a nonrandomized RDD study of the Veterans Health Administration (VHA). Participants included veterans enrolled in the VHA who required surgery between October 1, 2014, and June 1, 2019.InterventionsThe VCP, which expanded access to VA-paid community care for eligible veterans living 40 miles or more from their closest VA hospital.Main outcomes and measuresPostoperative emergency department visits, inpatient readmissions, and mortality at 30 and 90 days.ResultsA total of 615 473 unique surgical procedures among 498 427 patients (mean [SD] age, 63.0 [12.9] years; 450 366 male [90.4%]) were identified. Overall, 94 783 procedures (15.4%) were paid by the VHA, and the proportion of VHA-paid procedures varied by procedure type. Patients who underwent VA-paid procedures were more likely to be women (9209 [12.7%] vs men, 38 771 [9.1%]), White race (VA paid, 54 544 [74.4%] vs VA provided, 310 077 [73.0%]), and younger than 65 years (VA paid, 36 054 [49.1%] vs 229 411 [46.0%] VA provided), with a significantly lower comorbidity burden (mean [SD], 1.8 [2.2] vs 2.6 [2.7]). The nonrandomized RDD revealed that VCP was associated with a slight increase of 0.03 in the proportion of VA-paid surgical procedures among eligible veterans (95% CI, 0.01-0.05; P = .01). However, there was no difference in postoperative mortality, readmissions, or emergency department visits.Conclusions and relevanceExpanded access to health care in the VHA was associated with a shift in the performance of surgical procedures in the private sector but had no measurable association with surgical outcomes. These findings may assuage concerns of worsened patient outcomes resulting from care coordination issues when care is expanded outside of a single health care system, although it remains unclear whether these additional procedures were appropriate or improved patient outcomes.
| S-EPMC9558067 | biostudies-literature