Prevention of Intraoperative Awareness with Explicit Recall in an Unselected Surgical Population

Background Intraoperative awareness with explicit recall occurs in approximately 0.15% of all surgical cases. Efficacy trials based on the Bispectral Index® (BIS) monitor (Covidien, Boulder, CO) and anesthetic concentrations have focused on high-risk patients, but there are no effectiveness data applicable to an unselected surgical population. Methods We conducted a randomized controlled trial of unselected surgical patients at three hospitals of a tertiary academic medical center. Surgical cases were randomized to alerting algorithms based on either BIS values or anesthetic concentrations. The primary outcome was the incidence of definite intraoperative awareness; prespecified secondary outcomes included postanesthetic recovery variables. Results The study was terminated because of futility. At interim analysis the incidence of definite awareness was 0.12% (11/9,376) (95% CI: 0.07-0.21%) in the anesthetic concentration group and 0.08% (8/9,460) (95% CI: 0.04-0.16%) in the BIS group (P = 0.48). There was no significant difference between the two groups in terms of meeting criteria for recovery room discharge or incidence of nausea and vomiting. By post hoc secondary analysis, the BIS protocol was associated with a 4.7-fold reduction in definite or possible awareness events compared with a cohort receiving no intervention (P = 0.001; 95% CI: 1.7-13.1). Conclusion This negative trial could not detect a difference in the incidence of definite awareness or recovery variables between monitoring protocols based on either BIS values or anesthetic concentration. By post hoc analysis, a protocol based on BIS monitoring reduced the incidence of definite or possible intraoperative awareness compared with routine care.

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301. Penicillin Versus Cefazolin or Anti-staphylococcal Penicillins for Penicillin-Susceptible Staphylococcus aureus Bacteremia

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.344 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S149-S149

Author(s):

Mohammed Aldhaeefi ◽

Jeffrey Pearson ◽

Sanjat Kanjilal ◽

Brandon Dionne

Keyword(s):

Staphylococcus Aureus ◽

Blood Culture ◽

Positive Blood Culture ◽

Medical Center ◽

Academic Medical Center ◽

Similar Distribution ◽

Clinical Failure ◽

Staphylococcus Aureus Bacteremia ◽

Definitive Therapy ◽

Significant Difference

Abstract Background Staphylococcus aureus bacteremia is a significant cause of mortality. Penicillin (PCN) may have a role in the treatment of penicillin-susceptible Staphylococcus aureus (PSSA) bacteremia as it has a narrower spectrum of activity than cefazolin and is better tolerated than antistaphylococcal penicillins (ASPs). The aim of this study is to evaluate the safety and effectiveness of PCN versus cefazolin or ASPs in the treatment of PSSA bacteremia. Methods This is a single-center, retrospective study at a tertiary academic medical center. All patients with a PSSA blood culture from January 1, 2012 to September 1, 2019 were screened. Patients were excluded if they were treated with a definitive antibiotic (defined as antimicrobial therapy received 72 hours after positive blood culture) other than the study comparators, or if they received combination antibiotic therapy >72 hours from the initial positive blood culture result. The primary outcome was 60-day clinical failure, which was a composite endpoint of change in antibiotic after 72 hours of definitive therapy, recurrence of PSSA bacteremia, infection-related readmission, or all-cause mortality. Results Of 277 patients with PSSA bacteremia, 101 patients were included in the study; 62 (61%) were male and 11 (11%) had a β-lactam allergy. At baseline, 40 patients (40%) had hardware, 25 (25%) had an intravenous line, 6 (6%) were on dialysis, and 4 (4%) had active IV drug use, with similar distribution across antibiotic groups. Penicillin was the most common antibiotic used (Table 1). There was a significant difference among groups with respect to the 60-day clinical failure (log-rank p=0.019). In terms of unadjusted 60-day clinical failure, penicillin had similar outcomes to cefazolin (95% CI -0.29 to 0.104, p=0.376), however, it had statistically significant better outcomes in comparison to the ASPs, nafcillin or oxacillin (95% CI 0.023 to 0.482, p=0.031) (Table 1). Table 1. 60-day outcomes of PSSA bacteremia Conclusion Penicillin is effective and safe in the treatment of PSSA bacteremia and may be preferable to antistaphylococcal penicillins Disclosures All Authors: No reported disclosures

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Metformin and N-terminal pro B-type natriuretic peptide in type 2 diabetes patients, a post-hoc analysis of a randomized controlled trial

PLoS ONE ◽

10.1371/journal.pone.0247939 ◽

2021 ◽

Vol 16 (4) ◽

pp. e0247939

Author(s):

Wiebe M. C. Top ◽

Philippe Lehert ◽

Casper G. Schalkwijk ◽

Coen D. A. Stehouwer ◽

Adriaan Kooy

Keyword(s):

Type 2 Diabetes ◽

Cardiovascular Disease ◽

Natriuretic Peptide ◽

Treatment Effect ◽

Controlled Trial ◽

Secondary Analysis ◽

Initial Increase ◽

Post Hoc Analysis ◽

Post Hoc

Background Beyond antihyperglycemic effects, metformin may improve cardiovascular outcomes. Patients with type 2 diabetes often have an elevated plasma level of N-terminal pro B-type as a marker of (sub) clinical cardiovascular disease. We studied whether metformin was associated with a reduction in the serum level of N-terminal pro B-type natriuretic peptide (NT-proBNP) in these patients. Methods In the HOME trial 390 insulin-treated patients with type 2 diabetes were randomized to 850 mg metformin or placebo three times daily. Plasma samples were drawn at baseline, 4, 17, 30, 43 and 52 months. In a post-hoc analysis we analyzed the change in NT-proBNP in both groups. We used a longitudinal mixed model analysis adjusting for age, sex and prior cardiovascular disease. In a secondary analysis we assessed a possible immediate treatment effect post baseline. Results Metformin did not affect NT-proBNP levels over time in the primary analysis (-1% [95%CI -4;3, p = 0.62]). In the secondary analysis there was also no sustained time independent immediate treatment effect (initial increase of 17% [95%CI 4;30, p = 0.006] followed by yearly decrease of -4% [95%CI -7;0, p = 0.07]). Conclusions Metformin as compared to placebo did not affect NT-proBNP plasma levels in this 4.3-year placebo-controlled trial. Potential cardioprotective effects of metformin cannot be explained by changes in cardiac pressures or volumes to the extent reflected by NT-proBNP.

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A Controlled Trial of a Rapid Response System in an Academic Medical Center

The Joint Commission Journal on Quality and Patient Safety ◽

10.1016/s1553-7250(08)34052-5 ◽

2008 ◽

Vol 34 (7) ◽

pp. 417-425 ◽

Cited By ~ 16

Author(s):

Jeffrey M. Rothschild ◽

Seth Woolf ◽

Kathleen M. Finn ◽

Mark W. Friedberg ◽

Cindy Lemay ◽

...

Keyword(s):

Medical Center ◽

Controlled Trial ◽

Academic Medical Center ◽

Rapid Response ◽

Rapid Response System ◽

Response System ◽

Academic Medical

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Reducing Preventable Readmissions in a Neurosurgical Patient Population at an Academic Medical Center

Neurosurgery ◽

10.1093/neuros/nyz310_434 ◽

2019 ◽

Vol 66 (Supplement_1) ◽

Author(s):

Shayan Moosa ◽

Lindsay Bowerman ◽

Ellen Smith ◽

Mindy Bryant ◽

Natalie Krovetz ◽

...

Keyword(s):

High Risk ◽

Patient Population ◽

Medical Center ◽

Academic Medical Center ◽

Readmission Rates ◽

Academic Medical ◽

Neurosurgical Patient ◽

Neurosurgical Patients ◽

Significant Difference

Abstract INTRODUCTION Hospital readmissions are extremely costly in terms of time and resources and negatively impact patient safety and satisfaction. In this study, we performed a Pareto analysis of 30-day readmissions in a neurosurgical patient population in order to identify patients at high-risk for readmission. Using this information, we implemented a new practice parameter with the goal of reducing preventable readmissions. METHODS Patient characteristics and causes for readmission were prospectively collected for all neurosurgical patients readmitted to an academic medical center within 30 d of discharge between July and October 2018. A program was then initiated where postoperative neurosurgical spine patients were contacted by phone at standardized intervals before their 2-wk follow-up appointment, with the purpose of more quickly addressing surgical concerns and/or coordinating care for general medical issues. Finally, 30-d readmission rates were compared between the initial 4-mo period and January 2019 through April 2019. RESULTS Prior to intervention, the largest group of readmitted patients included those who had undergone recent spinal surgery (16/47, 34%). Among spine readmissions during this time, 47% were readmitted before their two-week follow-up appointment, 67% lived over 50 miles from the medical center, and 40% were Medicare-insured. There was a statistically significant difference in the mean rate of spine readmissions per month in the periods before (7.0%) and after (3.0%) the program onset (P = .029, 57% decline). The total number of surgically and medically related spine readmissions decreased between the pre- and postintervention periods from 10 to 3 (70%) and 3 to 1 (67%), respectively. CONCLUSION Our data suggests that a large number of neurosurgical readmissions may be prevented by the simple process of early follow-up and consistent communication via telephone. Readmission rates may be further reduced by standardizing the coordination of postoperative general medical follow-up and providing thorough wound care teaching for high-risk patients.

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2424. Shedding of Viable Clostridiodes difficile in Patients Admitted to a Medical Intensive Care Unit

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz360.2102 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S837-S838

Author(s):

Vincent B Young ◽

Micah Keidan ◽

Rachel D Yelin ◽

Thelma E Dangana ◽

Pamela B Bell ◽

...

Keyword(s):

Intensive Care ◽

Medical Center ◽

Academic Medical Center ◽

Secondary Analysis ◽

Icu Patients ◽

Specific Pcr ◽

Patient Admissions ◽

Academic Medical ◽

Healthcare Associated ◽

Record Review

Abstract Background Hospitalized patients are at risk of colonization with a range of healthcare-associated bacterial pathogens, including C. difficile. In patients admitted to intensive care units (ICUs), in whom C. difficile infection (CDI) is associated with increased morbidity and mortality. To understand the risk for acquisition of C. difficile and development of CDI, we monitored ICU patients daily for shedding of C. difficile by culture. Methods We conducted a secondary analysis of daily rectal/fecal swab samples collected from medical ICU patients of a 720-bed academic medical center in Chicago, IL. Selective culture for C. difficile was performed on swab samples from patients who had 2 or more samples obtained using selective media. Confirmation of putative C. difficile isolates was done by specific PCR assays for the 16S rRNA-encoding gene and the toxin genes tcdA, tcdB, cdtA and cdtB. Clinical testing for CDI was performed using the Xpert® C. difficile PCR assay (Cepheid). Clinical and demographic metadata were collected at bedside and by electronic medical record review. Results Culture was attempted on 2106 swab samples from 451 patients (486 ICU admissions) (Figure 1). A mean of 4.33 samples was obtained from each patient. C. difficile was isolated from 211 (10%) samples from 79 patients (Table 1). The first sample was positive by culture for 48 (9.9%) of patient admissions to the ICU. 31 (6.4%) patients who were initially negative by culture had a subsequent sample from which C. difficile was isolated. Persistence of culture-positivity varied from patient to patient (Figure 2). Of 80 patients who were tested for CDI based on physician suspicion, 12 patients had a positive Cepheid PCR test; 9 had diarrhea and were treated for CDI. Conclusion Surveillance for shedding of C. difficile by daily culture reveals that patients admitted to the ICU can shed the pathogen intermittently without attributable disease. This can be in the form patients who are admitted carrying the organism as well as those who appear to acquire the organism during their stay. It is unclear whether patient or microbiome factors underlie the differences seen in patterns of shedding. Furthermore, intermittent shedding may reflect multiple episodes of exposure to C. difficile spores and asymptomatic shedding without stable colonization. Disclosures All authors: No reported disclosures.

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Tolerability of a probiotic in subjects with a history of methicillin-resistant Staphylococcus aureus colonisation

Beneficial Microbes ◽

10.3920/bm2013.0062 ◽

2014 ◽

Vol 5 (4) ◽

pp. 389-395 ◽

Cited By ~ 5

Author(s):

S. Warrack ◽

P. Panjikar ◽

M. Duster ◽

N. Safdar

Keyword(s):

Staphylococcus Aureus ◽

Methicillin Resistant Staphylococcus Aureus ◽

Medical Center ◽

Controlled Trial ◽

Academic Medical Center ◽

Resistant Bacteria ◽

Public Health Importance ◽

Methicillin Resistant ◽

History Of ◽

Study Population

Methicillin-resistant Staphylococcus aureus (MRSA) is a pathogen of major public health importance. Colonisation precedes infection; thus reducing MRSA carriage may be of benefit for reducing infection. Probiotics represent a novel approach to reducing MRSA carriage. We undertook a pilot feasibility randomised controlled trial of the tolerability and acceptability of probiotics for reducing nasal and intestinal carriage of MRSA. In addition, subjects were screened for vancomycin-resistant enterocococci (VRE). Subjects with a history of MRSA were recruited from a large, academic medical center and randomised to take either a placebo or probiotic (Lactobacillus rhamnosus HN001). Subjects returned to the clinic after four weeks for further testing to determine adherence to the probiotic regimen and colonisation of MRSA. 48 subjects were enrolled and randomised. Nearly 25% were transplant recipients and 30% had diabetes. The probiotic was well tolerated in the study population though minor side effects, such as nausea and bloating, were observed. A majority of the subjects randomised to HN001 had good adherence to the regimen. At the four week time point among subjects randomised to the probiotic, MRSA was detected in 67 and 50% of subjects colonised in the nares and the gastrointestinal tract, respectively. Three subjects who initially tested positive for VRE were negative after four weeks of probiotic exposure. Probiotics were well tolerated in our study population of largely immunocompromised subjects with multiple comorbidities. Adherence to the intervention was good. Probiotics should be studied further for their potential to reduce colonisation by multidrug resistant bacteria.

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Shed-MEDS: pilot of a patient-centered deprescribing framework reduces medications in hospitalized older adults being transferred to inpatient postacute care

Therapeutic Advances in Drug Safety ◽

10.1177/2042098618781524 ◽

2018 ◽

Vol 9 (9) ◽

pp. 523-533 ◽

Cited By ~ 9

Author(s):

Alec W. Petersen ◽

Avantika S. Shah ◽

Sandra F. Simmons ◽

Matthew S. Shotwell ◽

J. Mary Lou Jacobsen ◽

...

Keyword(s):

Older Adults ◽

Usual Care ◽

Medical Center ◽

Academic Medical Center ◽

The United States ◽

Patient Centered ◽

Convenience Sample ◽

Point Reduction ◽

Significant Difference ◽

Hospitalized Older Adults

Background: Polypharmacy is common in hospitalized older adults. Deprescribing interventions are not well described in the acute-care setting. The objective of this study was to describe a hospital-based, patient-centered deprescribing protocol (Shed-MEDS) and report pilot results. Methods: This was a pilot study set in one academic medical center in the United States. Participants consisted of a convenience sample of 40 Medicare-eligible, hospitalized patients with at least five prescribed medications. A deprescribing protocol (Shed-MEDS) was implemented among 20 intervention and 20 usual care control patients during their hospital stay. The primary outcome was the total number of medications deprescribed from hospital enrollment. Deprescribed was defined as medication termination or dose reduction. Enrollment medications reflected all prehospital medications and active in-hospital medications. Baseline characteristics and outcomes were compared between the intervention and usual care groups using simple logistic or linear regression for categorical and continuous measures, respectively. Results: There was no significant difference between groups in mean age, sex or Charlson comorbidity index. The intervention and control groups had a comparable number of medications at enrollment, 25.2 (±6.3) and 23.4 (±3.8), respectively. The number of prehospital medications in each group was 13.3 (±4.6) and 15.3 (±4.6), respectively. The Shed-MEDS protocol compared with usual care significantly increased the mean number of deprescribed medications at hospital discharge and reduced the total medication burden by 11.6 versus 9.1 ( p = 0.032) medications. The deprescribing intervention was associated with a difference of 4.6 [95% confidence interval (CI) 2.5–6.7, p < 0.001] in deprescribed medications and a 0.5 point reduction (95% CI −0.01 to 1.1) in the drug burden index. Conclusions: A hospital-based, patient-centered deprescribing intervention is feasible and may reduce the medication burden in older adults.

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Association of Patients’ Characteristics with Acupuncture Treatment Outcomes in Treating Bell’s Palsy: Results from a Randomised Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2019/6073484 ◽

2019 ◽

Vol 2019 ◽

pp. 1-7

Author(s):

Xianjun Xiao ◽

Qianhua Zheng ◽

Yunzhou Shi ◽

Leixiao Zhang ◽

Ling Zhao ◽

...

Keyword(s):

Acupuncture Treatment ◽

Controlled Trial ◽

Secondary Analysis ◽

Complete Recovery ◽

Bell’S Palsy ◽

Acute Stage ◽

Chorda Tympani ◽

Bell's Palsy ◽

Significant Difference ◽

Multicenter Randomized Controlled Trial

Background. Acupuncture has been found to be effective for treating Bell’s palsy (BP). However, which class of BP patients will have a better response to acupuncture remains uncertain and requires investigation. Methods. We performed a secondary analysis of a multicenter, randomized, controlled trial. BP patients were randomly divided into five acupuncture treatment groups. The degree of facial nerve recovery was assessed according to the House–Brackmann grading system (HB grade). Grade I was defined as complete recovery (CR), and grades II–VI were defined as incomplete recovery (IR). The relevant patient characteristics were collected and compared between CR and IR groups by univariate and logistic regression analyses. Results. Eight-hundred twenty-six subjects were analyzed. Among these, 698 (85%) subjects had a good prognosis. No significant difference in the effectiveness of the five treatments was observed (all P>0.05). The likelihood of IR increased by 2.2% with each one-year increase in age (odds ratio (OR) 1.022, 95% confidence interval (CI) 1.005–1.038; P=0.009). The likelihood of IR increased by 9% with each kg/m2 increase in BMI (OR 1.090, 95% CI 1.019–1.165; P=0.012). The likelihood of IR at the recovery stage was higher than that at the acute stage (OR 7.996, 95% CI 4.570–13.991; P<0.001), and the likelihood of IR of patients with lesions at or above the chorda tympani was higher than that of patients with lesions below the chorda tympani (OR 1.989, 95% CI 1.256–3.150; P=0.003). The likelihood of IR increased by 281.7% with each unit increase in the HB grade (OR 2.817, 95% CI 2.113–3.756; P<0.001). Conclusions. Younger patients at the acute stage of the disease with low BMIs, low initial HB grades, and lesions below the chorda tympani were more likely to respond to acupuncture.

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Radiofrequency Ablation vs Electrocautery Blinded Randomized Trial: Impact on Clinically Meaningful Outcomes

Otolaryngology ◽

10.1177/0194599820964737 ◽

2020 ◽

pp. 019459982096473

Author(s):

Aaron J. Prussin ◽

Eric Babajanian ◽

Marc Error ◽

J. Fredrik Grimmer ◽

Jessica Ku ◽

...

Keyword(s):

Radiofrequency Ablation ◽

Adverse Events ◽

Medical Center ◽

Academic Medical Center ◽

Normal Activity ◽

Inclusion Criteria ◽

Pain Scores ◽

Significant Difference ◽

Monopolar Electrocautery ◽

Daily Pain

Objective To analyze patients’ return to normal activity, pain scores, narcotic use, and adverse events after undergoing tonsillectomy or adenotonsillectomy with monopolar electrocautery or radiofrequency ablation. Study Design Randomized double-blinded clinical trial based on prospective parallel design. Setting Academic medical center and tertiary children’s hospital between March 2018 and July 2019. Methods Inclusion criteria included patients aged ≥3 years with surgical indication of recurrent tonsillitis or airway obstruction/sleep-disordered breathing. Patients were randomly assigned to monopolar electrocautery or radiofrequency ablation. Patients were blinded to treatment assignment. Survey questions answered via text or email were collected daily until postoperative day 15. The primary outcome was the patient’s return to normal activity. Secondary outcomes included daily pain score, total amount of postoperative narcotic use, and adverse events. Results Of the 236 patients who met inclusion criteria and were randomly assigned to radiofrequency ablation or monopolar electrocautery, 230 completed the study (radiofrequency ablation, n = 112; monopolar electrocautery, n = 118). There was no statistically significant difference between the groups in the number of days for return to normal activity ( P = .89), daily pain scores over 15 postoperative days ( P = .46), postoperative narcotic use ( P = .61), or return to hospital for any reason ( P = .60), including bleeding as an adverse event ( P = .13). Conclusions As one of the largest randomized controlled trials examining instrumentation in tonsillectomy, our data do not show a difference between monopolar electrocautery and radiofrequency ablation with regard to return to normal activity, daily pain scores, total postoperative narcotic use, or adverse events.

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Contamination and washing of cloth masks and risk of infection among hospital health workers in Vietnam: a post hoc analysis of a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-042045 ◽

2020 ◽

Vol 10 (9) ◽

pp. e042045

Author(s):

Chandini Raina MacIntyre ◽

Tham Chi Dung ◽

Abrar Ahmad Chughtai ◽

Holly Seale ◽

Bayzidur Rahman

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Poor Performance ◽

Full Time ◽

Risk Of Infection ◽

Viral Contamination ◽

Post Hoc Analysis ◽

Significant Difference ◽

Randomised Controlled ◽

Post Hoc

BackgroundIn a previous randomised controlled trial (RCT) in hospital healthcare workers (HCWs), cloth masks resulted in a higher risk of respiratory infections compared with medical masks. This was the only published RCT of cloth masks at the time of the COVID-19 pandemic.ObjectiveTo do a post hoc analysis of unpublished data on mask washing and mask contamination from the original RCT to further understand poor performance of the two-layered cotton cloth mask used by HCWs in that RCT.Setting14 secondary-level/tertiary-level hospitals in Hanoi, Vietnam.ParticipantsA subgroup of 607 HCWs aged ≥18 years working full time in selected high-risk wards, who used a two-layered cloth mask and were part of a randomised controlled clinical trial comparing medical masks and cloth masks.InterventionWashing method for cloth masks (self-washing or hospital laundry). A substudy of contamination of a sample of 15 cloth and medical masks was also conducted.Outcome measureInfection rate over 4 weeks of follow up and viral contamination of masks tested by multiplex PCR.ResultsViral contamination with rhinovirus was identified on both used medical and cloth masks. Most HCW (77% of daily washing) self-washed their masks by hand. The risk of infection was more than double among HCW self-washing their masks compared with the hospital laundry (HR 2.04 (95% CI 1.03 to 4.00); p=0.04). There was no significant difference in infection between HCW who wore cloth masks washed in the hospital laundry compared with medical masks (p=0.5).ConclusionsUsing self-reported method of washing, we showed double the risk of infection with seasonal respiratory viruses if masks were self-washed by hand by HCWs. The majority of HCWs in the study reported hand-washing their mask themselves. This could explain the poor performance of two layered cloth masks, if the self-washing was inadequate. Cloth masks washed in the hospital laundry were as protective as medical masks. Both cloth and medical masks were contaminated, but only cloth masks were reused in the study, reiterating the importance of daily washing of reusable cloth masks using proper method. A well-washed cloth mask can be as protective as a medical mask.Trial resgistration numberACTRN12610000887077.

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