Potential impact of blood cholesterol guidelines on statin treatment in the U.S. population using interrupted time series analysis.

BACKGROUND: The 2013 ACC/AHA Guideline was a paradigm shift in lipid management and identified the four statin-benefit groups. Many have studied the guideline's potential impact, but few have investigated its potential long-term impact on MACE. Furthermore, most studies also ignored the confounding effect from the earlier release of generic atorvastatin in Dec 2011. METHODS: To evaluate the potential (long-term) impact of the 2013 ACC/AHA Guideline release in Nov 2013 in the U.S., we investigated the association of the 2013 ACC/AHA Guideline with the trend changes in 5-Year MACE survival and three other statin-related outcomes (statin use, optimal statin use, and statin adherence) while controlling for generic atorvastatin availability using interrupted time series analysis, called the Chow's test. Specifically, we conducted a retrospective study using U.S. nationwide de-identified claims and electronic health records from Optum Labs Database Warehouse (OLDW) to follow the trends of 5-Year MACE survival and statin-related outcomes among four statin-benefit groups that were identified in the 2013 ACC/AHA Guideline. Then, Chow's test was used to discern trend changes between generic atorvastatin availability and guideline potential impact. RESULTS: 197,021 patients were included (ASCVD: 19,060; High-LDL: 33,907; Diabetes: 138,159; High-ASCVD-Risk: 5,895). After the guideline release, the long-term trend (slope) of 5-Year MACE Survival for the Diabetes group improved significantly (P = 0.002). Optimal statin use for the ASCVD group also showed immediate improvement (intercept) and long-term positive changes (slope) after the release (P < 0.001). Statin uses did not have significant trend changes and statin adherence remained unchanged in all statin-benefit groups. Although no other statistically significant trend changes were found, overall positive trend change or no changes were observed after the 2013 ACC/AHA Guideline release. CONCLUSIONS: The 2013 ACA/AHA Guideline release is associated with trend improvements in the long-term MACE Survival for Diabetes group and optimal statin use for ASCVD group. These significant associations might indicate a potential positive long-term impact of the 2013 ACA/AHA Guideline on better health outcomes for primary prevention groups and an immediate potential impact on statin prescribing behaviors in higher-at-risk groups. However, further investigation is required to confirm the causal effect of the 2013 ACA/AHA Guideline.

Differences in provider approach to initiating and titrating guideline directed medical therapy in heart failure with reduced ejection fraction.

BACKGROUND: Despite the strong evidence supporting guideline-directed medical therapy (GDMT) in patients with heart failure with reduced ejection fraction (HFrEF), prescription rates in clinical practice are still lacking. METHODS: A survey containing 20 clinical vignettes of patients with HFrEF was answered by a national sample of 127 cardiologists and 68 internal/family medicine physicians. Each vignette had 4-5 options for adjusting GDMT and the option to make no medication changes. Survey respondents could only select one option. For analysis, responses were dichotomized to the answer of interest. RESULTS: Cardiologists were more likely to make GDMT changes than general medicine physicians (91.8% vs. 82.0%; OR 1.84 [1.07-3.19]; p = 0.020). Cardiologists were more likely to initiate beta-blockers (46.3% vs. 32.0%; OR 2.38 [1.18-4.81], p = 0.016), angiotensin receptor blocker/neprilysin inhibitor (ARNI) (63.8% vs. 48.1%; OR 1.76 [1.01-3.09], p = 0.047), and hydralazine and isosorbide dinitrate (HYD/ISDN) (38.2% vs. 23.7%; OR 2.47 [1.48-4.12], p < 0.001) compared to general medicine physicians. No differences were found in initiating angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEi/ARBs), initiating mineralocorticoid receptor antagonist (MRA), sodium-glucose transporter protein 2 (SGLT2) inhibitors, digoxin, or ivabradine. CONCLUSIONS: Our results demonstrate cardiologists were more likely to adjust GDMT than general medicine physicians. Future focus on improving GDMT prescribing should target providers other than cardiologists to improve care in patients with HFrEF.

A Quality Improvement Project to Increase Compliance With a Facility Protocol on Surgical Antimicrobial Prophylaxis.

Surgical site infections (SSIs) contribute to negative outcomes for patients and health care organizations. Compliance with clinical practice guidelines likely can help prevent SSIs. An interdisciplinary team at a regional referral center in Michigan sought to reduce SSIs by improving compliance with the facility's preoperative antibiotic selection, dosing, timing, and redosing protocol. The interventions for the quality improvement project included adding the preprocedural antibiotics and doses to the master OR schedule; holding an education session for all preoperative nurses, intraoperative nurses, and anesthesia professionals; and posting a reference guide in the preoperative and intraoperative areas. Compliance with the facility's protocol for antibiotic selection, dosing, and timing significantly improved. However, SSI rates and compliance with redosing recommendations did not change significantly. The team decided to add the antibiotic order information to the master OR schedule permanently. The team plans to consider providing education sessions on administering preprocedural antibiotics outside the OR.

Nationwide implementation of a multifaceted tailored strategy to improve uptake of standardized structured reporting in pathology: an effect and process evaluation.

BACKGROUND: Implementation strategies are aimed at improving guideline adherence. Both effect and process evaluations are conducted to provide insights into the success or failure of these strategies. In our study, we evaluate the nationwide implementation of standardized structured reporting (SSR) in pathology. METHODS: An interrupted time series analysis was conducted to evaluate the effect of a previously developed implementation strategy, which consisted of various digitally available elements, on SSR in pathology laboratories. A segmented regression analysis was performed to analyze the change in mean SSR percentages directly after the strategy introduction for pathology reporting and specific subcategories. In addition, we analyzed the change in trend in the weekly percentages after strategy introduction, also for subgroups of tumor groups, retrieval methods, and type of laboratory. The change in SSR use after the strategy introduction was determined for all pathology laboratories. We further conducted a process evaluation in which the exposure to the strategy elements was determined. Experiences of the users with all strategy elements and the remaining barriers and potential strategy elements were evaluated through an eSurvey. We also tested whether exposure to a specific element and a combination of elements resulted in a higher uptake of SSR after strategy introduction. RESULTS: There was a significant increase in an average use of SSR after the strategy introduction for reporting of gastrointestinal (p=.018) and urological (p=.003) oncological diagnoses. A significant increase was present for all oncological resections as a group (p=.007). Thirty-three out of 42 pathology laboratories increased SSR use after the strategy introduction. The "Feedback button", an option within the templates for SSR to provide feedback to the provider and one of the elements of the implementation strategy, was most frequently used by the SSR users, and effectiveness results showed that it increased average SSR use after the strategy introduction. Barriers were still present for SSR implementation. CONCLUSIONS: Nationwide SSR implementation improved for specific tumor groups and retrieval methods. The next step will be to further improve the use of SSR and, simultaneously, to further develop potential benefits of high SSR use, focusing on re-using discrete pathology data. In this way, we can facilitate proper treatment decisions in oncology.

Safely Reducing Hospitalizations for Anaphylaxis in Children Through an Evidence-Based Guideline.

BACKGROUND: Emergency department visits for anaphylaxis have increased considerably over the past few decades, especially among children. Despite this, anaphylaxis management remains highly variable and contributes to significant health care spending. On the basis of emerging evidence, in this quality improvement project we aimed to safely decrease hospitalization rates, increase the use of cetirizine, and decrease use of corticosteroids for children with anaphylaxis by December 31, 2019. METHODS: A multipronged intervention strategy including a revised evidence-based guideline was implemented at a tertiary children's teaching hospital by using the Model for Improvement. Statistical process control was used to evaluate for changes in key measures. Length of stay and unplanned return visits within 72 hours were monitored as process and balancing measures, respectively. As a national comparison, hospitalization rates were compared with other hospitals' data from the Pediatric Health Information System. RESULTS: Hospitalizations decreased significantly from 28.5% to 11.2% from preimplementation to implementation, and the balancing measure of 72-hour revisits was stable. The proportion of patients receiving cetirizine increased significantly from 4.2% to 59.7% and use of corticosteroids decreased significantly from 72.6% to 32.4% in patients without asthma. The proportion of patients meeting length of stay criteria increased from 53.3% to 59.9%. Hospitalization rates decreased nationally over time. CONCLUSIONS: We reduced hospitalizations for anaphylaxis by 17.3% without concomitant increases in revisits, demonstrating that unnecessary hospitalizations can be safely avoided. The use of a local evidence-based guideline paired with close outcome monitoring and sustained messaging and feedback to clinicians can effectively improve anaphylaxis management.

Adherence to embryo transfer guidelines in favorable-prognosis patients aged less than 35 years using autologous oocytes and in recipients using donor oocytes: a Society for Assisted Reproductive Technology Clinic Outcome Reporting System study.

OBJECTIVE: To measure the consequences of nonadherence with the 2013 American Society for Reproductive Medicine elective single embryo transfer (eSET) guidelines for favorable-prognosis patients. DESIGN: Retrospective cohort. SETTING: In vitro fertilization clinics. PATIENT(S): A total of 28,311 fresh autologous, 2,500 frozen-thawed autologous, and 3,534 fresh oocyte-donor in vitro fertilization cycles in 2014-2016 at Society for Assisted Reproductive Technology-reporting centers. INTERVENTION(S): Patients aged <35 years or using donors aged <35 years underwent first blastocyst transfer. MAIN OUTCOME MEASURE(S): Singleton birth rate, gestational age at delivery, and birth weight were compared between the eSET and non-eSET groups using the chi-square or Fisher's exact test or t-tests. RESULT(S): Among fresh transfers, 15,643 (55%) underwent eSET. Live births after non-eSETs were less likely singletons (38.0% vs. 96.5%; adjusted relative risk [aRR], 0.56) and more likely complicated by preterm delivery (55.0% vs. 20.1%; aRR, 2.39) and low birth weight (<2,500 g) (40.1% vs. 10.6%; aRR, 3.4) compared with those after eSET. Among frozen-thawed transfers, 1,439 (58%) underwent eSET. Live births after non-eSETs were less likely singletons (41.9% vs. 95.2%; aRR, 0.69; 95% confidence interval, 0.66-0.73) and more likely complicated by preterm delivery (56.4% vs. 19.5%; aRR, 2.6; 95% confidence interval, 2.2-3.1) and low birth weight (38.0% vs. 8.9%; aRR, 3.9) compared with those after eSET. Among fresh donor oocyte transfers, 1,946 (55%) underwent eSET. Live births after non-eSETs were less likely singletons (31.3% vs. 97.3%; aRR, 0.48) and more likely complicated by preterm delivery (61.1% vs. 25.7%; aRR, 2.09) and low birth weight (44.3% vs. 11.7%; aRR, 3.39) compared with those after eSET. CONCLUSION(S): Nonadherence with transfer guidelines was associated with dramatically increased multiple pregnancies, preterm births, and low birth weights.

STEP-WISE APPROACH TO THE MANAGEMENT OF SUBMACULAR HEMORRHAGE USING PNEUMATIC DISPLACEMENT AND VITRECTOMY: The Manchester Protocol.

PURPOSE: To evaluate a sequential approach of pneumatic displacement followed by vitrectomy (pars plana vitrectomy) in failed cases to deal with submacular hemorrhage (SMH) of various etiologies. METHODS: Retrospective, nonrandomized interventional case series of consecutive patients with SMH of up to 2 weeks' duration, who were treated with a stepwise approach. Step 1 involved intravitreal injection of 0.3 mL 100% C3F8 and recombinant tissue plasminogen activator 50 µg/0.1 mL. If unsuccessful, a prompt pars plana vitrectomy with subretinal recombinant tissue plasminogen activator 50 µg/0.1 mL and 20% SF6 gas tamponade was performed as a second attempt to displace the SMH. RESULTS: Thirty-one patients with SMH underwent pneumatic displacement; 24 (77.4%) had a successful outcome without further intervention. The mean presenting visual acuity of the "successful cohort" was 1.34 logMAR (20/440 Snellen), improving to 0.83 logMAR (20/135 Snellen) 1 month after treatment. Five of the seven patients with failed pneumatic displacement underwent pars plana vitrectomy with subretinal recombinant tissue plasminogen activator at an average of 5 days poststep 1, with successful SMH displacement in 3 patients, giving an overall success of 87.1% for this treatment protocol. CONCLUSION: A sequential approach of expansile gas injection followed by prompt pars plana vitrectomy, aided by recombinant tissue plasminogen activator at both steps, is a coherent, logical pathway to treat SMH with high anatomical and functional success.

Improving Hospital Infant Safe Sleep Compliance by Using Safety Prevention Bundle Methodology.

BACKGROUND AND OBJECTIVES: Sudden unexpected infant death often results from unsafe sleep environments and is the leading cause of postneonatal mortality in the United States. Standardization of infant sleep environment education has been revealed to impact such deaths. This standardized approach is similar to safety prevention bundles typically used to monitor and improve health outcomes, such as those related to hospital-acquired conditions (HACs). We sought to use the HAC model to measure and improve adherence to safe sleep guidelines in an entire children's hospital. METHODS: A hospital-wide safe sleep bundle was implemented on September 15, 2017. A safe sleep performance improvement team met monthly to review data and discuss ideas for improvement through the use of iterative plan-do-study-act cycles. Audits were performed monthly from March 2017 to October 2019 and monitored safe sleep parameters. Adherence was measured and reviewed through the use of statistical process control charts (p-charts). RESULTS: Overall compliance improved from 9% to 72%. Head of bed flat increased from 62% to 93%, sleep space free of extra items increased from 52% to 81%, and caregiver education completed increased from 10% to 84%. The centerline for infant in supine position remained stable at 81%. CONCLUSIONS: Using an HAC bundle safety prevention model to improve adherence to infant safe sleep guidelines is a feasible and effective method to improve the sleep environment for infants in all areas of a children's hospital.

Appropriate number of observations for determining hand hygiene compliance among healthcare workers.

We sought to determine the minimum number of observations needed to determine hand hygiene (HH) compliance among healthcare workers. The study was conducted at a referral hospital in South Korea. We retrospectively analyzed the result of HH monitoring from January to December 2018. HH compliance was calculated by dividing the number of observed HH actions by the total number of opportunities. Optimal HH compliance rates were calculated based on adherence to the six-step technique recommended by the World Health Organization. The minimum number of required observations (n) was calculated by the following equation using overall mean value (ρ), absolute precision (d), and confidence interval (CI) (1 - α) [the equation: [Formula: see text]]. We considered ds of 5%, 10%, 20%, and 30%, with CIs of 99%, 95%, and 90%. During the study period, 8791 HH opportunities among 1168 healthcare workers were monitored. Mean HH compliance and optimal HH compliance rates were 80.3% and 59.7%, respectively. The minimum number of observations required to determine HH compliance rates ranged from 2 ([Formula: see text]: 30%, CI: 90%) to 624 ([Formula: see text]: 5%, CI: 99%), and that for optimal HH compliance ranged from 5 ([Formula: see text]: 30%, CI: 90%) to 642 ([Formula: see text]: 5%, CI: 99%). Therefore, we found that our hospital required at least five observations to determine optimal HH compliance.

Use of prophylactic pegfilgrastim for chemotherapy-induced neutropenia in the US: A review of adherence to present guidelines for usage.

Evidence-based US guidelines provide recommendations for the use of granulocyte colony-stimulating factor (G-CSF) as supportive therapy in patients with cancer receiving chemotherapy. Pegfilgrastim is recommended for FN prophylaxis in patients with non-myeloid malignancies receiving a high-risk chemotherapy regimen, or an intermediate-risk regimen if one or more risk factors are present. The guidelines highlight the patient characteristics and chemotherapy regimens for solid tumors and hematologic malignancies that may influence a patient's overall risk of FN and may benefit from pegfilgrastim support. This review aimed to evaluate how pegfilgrastim use in patients with cancer receiving myelosuppressive chemotherapy in routine clinical practice aligns with evidence-based US guidelines. Examination of the literature revealed widespread deviation in relation to under- and over-prescribing, and timing of administration in US clinical practice. Pegfilgrastim is often over-prescribed in patients receiving palliative chemotherapy and those at low risk of FN. Potential under-prescribing of pegfilgrastim was also observed. In this literature search, data that appear to support same-day administration of pegfilgrastim were from uncontrolled studies that were limited in size. Analyses of healthcare claims data clearly favored next-day use, with statistically significant increases in FN incidence among patients receiving same-day pegfilgrastim versus those treated 1-4 days post-chemotherapy. Earlier-than-recommended administration typically occurs at the physician's discretion where next-day administration might present barriers to the patient receiving supportive therapy.There is a need to ensure appropriate prescribing to optimize patient outcomes, as deviation from the guideline recommendations was associated with increased incidence of FN and hospitalization.

Comparison of Routine Replacement With Clinically Indicated Replacement of Peripheral Intravenous Catheters.

Importance: Peripheral intravenous catheters (PVCs) are the most frequently used indwelling devices in hospitals worldwide. Peripheral intravenous catheter bloodstream infections (PVC-BSIs) are rare, but severe and preventable, adverse events. Objective: To investigate the incidence of PVC-BSIs after changing the policy of routine PVC replacement every 96 hours to clinically indicated replacement. Design, Setting, and Participants: This institution-wide, observational cohort study evaluated all patients hospitalized at a large university-affiliated hospital with 10 sites in Western Switzerland with a PVC insertion between January 1, 2016, and February 29, 2020. Exposures: Peripheral intravenous catheters were routinely replaced every 96 hours until March 31, 2018 (baseline period). Between April 1, 2018, and October 15, 2019, PVCs were replaced if clinically indicated (intervention period). From October 16, 2019, PVCs were again routinely replaced every 96 hours (reversion period). Main Outcomes and Measures: The PVC-BSI rates and PVC-BSI incidence rate ratios (IRRs) during each period. Results: A total of 412 631 PVCs with documented catheter duration were included (164 331 patients; median [interquartile range] patient age, 51 [33-72] years; 88 928 [54.1%] female): 241 432 PVCs at baseline, 130 779 at intervention, and 40 420 at reversion. Eleven PVC-BSIs were observed during the baseline period, 46 during the intervention, and 4 during the reversion period. Although the monthly number of PVC-days remained stable during all study periods, the number of monthly inserted PVCs decreased during the intervention period. The number of PVCs still in place more than 4 or more than 7 days was higher during the intervention period compared with the baseline and reversion periods. A significantly increased IRR of PVC-BSIs was observed for the intervention period (IRR, 7.20; 95% CI, 3.65-14.22; P < .001) compared with baseline, whereas during the reversion period there was no significant increase (IRR, 1.35; 95% CI, 0.30 6.17; P = .69). Conclusions and Relevance: The results of this cohort study using a large, prospective surveillance database suggest that replacement of PVCs only when clinically indicated may be associated with an increased risk of PVC-BSI compared with routine replacement. Even if PVC-associated BSI is a rare event, the use of PVCs in most patients makes this outcome relevant.

SARS-CoV-2 screening of asymptomatic health care workers: experience of a General hospital.

Health care workers (HCWs) are at major risk to be infected by SARS-CoV-2 and transmit the virus to the patients. Furthermore, travels are a major factor in the diffusion of the virus. We report our experience regarding the screening of asymptomatic HCWs returning from holidays, following the issue of a national guideline on 08/20/2020. The organization of the occupational health department and the clinical laboratory was adapted in order to start the screening on August, 24, 2020. All HCWs tested for SARS-CoV-2 the week before and 4 weeks after the implementation of the screening were included. The mean number of tests was analyzed per working day and working week. Overall, 502 (31.4%) HCWs were tested for SARS-CoV-2 during the study period. The mean number of HCWs tested per working day was 27.1. HCWs accounted for 36.9% (n = 167) and 11.2% (n = 84) of the tests performed in the 1st and the 4th week following the implementation of the guidelines. The number of tests performed each week in HCWs increased by at least 20-fold after the implementation of the guidelines. No asymptomatic HCW was tested positive. Screening of asymptomatic HCWs was poorly effective in the context of low circulation of the virus. We suggest giving priority to infection prevention and control measures and screening of symptomatic subjects and asymptomatic contacts.

Evaluation of reporting quality of randomized controlled trials in patients with COVID-19 using the CONSORT statement.

OBJECTIVE: To evaluate the reporting quality of randomized controlled trials (RCTs) regarding patients with COVID-19 and analyse the influence factors. METHODS: PubMed, Embase, Web of Science and the Cochrane Library databases were searched to collect RCTs regarding patients with COVID-19. The retrieval time was from the inception to December 1, 2020. The CONSORT 2010 statement was used to evaluate the overall reporting quality of these RCTs. RESULTS: 53 RCTs were included. The study showed that the average reporting rate for 37 items in CONSORT checklist was 53.85% with mean overall adherence score of 13.02±3.546 (ranged: 7 to 22). The multivariate linear regression analysis showed the overall adherence score to the CONSORT guideline was associated with journal impact factor (P = 0.006), and endorsement of CONSORT statement (P = 0.014). CONCLUSION: Although many RCTs of COVID-19 have been published in different journals, the overall reporting quality of these articles was suboptimal, it can not provide valid evidence for clinical decision-making and systematic reviews. Therefore, more journals should endorse the CONSORT statement, authors should strictly follow the relevant provisions of the CONSORT guideline when reporting articles. Future RCTs should particularly focus on improvement of detailed reporting in allocation concealment, blinding and estimation of sample size.

The Influence of the Availability Heuristic on Physicians in the Emergency Department.

STUDY OBJECTIVE: Heuristics, or rules of thumb, are hypothesized to influence the care physicians deliver. One such heuristic is the availability heuristic, under which assessments of an event's likelihood are affected by how easily the event comes to mind. We examined whether the availability heuristic influences physician testing in a common, high-risk clinical scenario: assessing patients with shortness of breath for the risk of pulmonary embolism. METHODS: We performed an event study from 2011 to 2018 of emergency physicians caring for patients presenting with shortness of breath to 104 Veterans Affairs (VA) hospitals. Our measures were physician rates of pulmonary embolism testing (D-dimer and/or computed tomography scan) for subsequent patients after having a patient visit with a pulmonary embolism discharge diagnosis, hypothesizing that physician rates of pulmonary embolism testing would increase after having a recent patient visit with a pulmonary embolism diagnosis due to the availability heuristic. RESULTS: The sample included 7,370 emergency physicians who had 416,720 patient visits for shortness of breath. The mean rate of pulmonary embolism testing was 9.0%. For physicians who had a recent patient visit with a pulmonary embolism diagnosis, their rate of pulmonary embolism testing for subsequent patients increased by 1.4 percentage points (95% confidence interval 0.42 to 2.34) in the 10 days after, which is approximately 15% relative to the mean rate of pulmonary embolism testing. We failed to find statistically significant changes in rates of pulmonary embolism testing in the subsequent 50 days following these first 10 days. CONCLUSION: After having a recent patient visit with a pulmonary embolism diagnosis, physicians increase their rates of pulmonary embolism testing for subsequent patients, but this increase does not persist. These results provide large-scale evidence that the availability heuristic may play a role in complex testing decisions.

Mixed methods study evaluating the implementation of the WHO hand hygiene strategy focusing on alcohol based handrub and training among health care workers in Faranah, Guinea.

INTRODUCTION: The most frequent adverse health events in healthcare worldwide are healthcare-associated infection. Despite ongoing implementation of the WHO multimodal Hand Hygiene (HH) Improvement Strategy, healthcare-associated infection rate continues to be twofold higher in low- than in high-income countries. This study focused on continued evaluation of HH compliance and knowledge. The mixed method approach, with inclusion of patients and care-givers, provided insight into challenges and facilitators of the WHO HH Improvement Strategy, and highlighted improvement points. METHODS: An uncontrolled, before-and-after intervention, mixed methods study in Faranah Regional Hospital was conducted from December 2017 to August 2019. The intervention implemented the WHO HH Strategy including HH training for healthcare workers (HCWs), and the relaunch of the local production of alcohol-based handrub (ABHR). A baseline assessment of HH knowledge, perception and compliance of HCWs was done prior to the intervention and compared to two follow-up assessments. The second follow-up assessment was complemented by a qualitative component. RESULTS: Overall compliance six months post-intervention was 45.1% and significantly higher than baseline but significantly lower than in first follow-up. Knowledge showed similar patterns of improvement and waning. The perception survey demonstrated high appreciation of the intervention, such as local production of ABHR. HCW's were concerned about overconsuming of ABHR, however simultaneous quantitative measurements showed that consumption in fact was 36% of the estimated amount needed for sufficient HH compliance. Potential fields for improvement identified by HCWs to enhance sustainability were permanent ABHR availability, having a dedicated person with ownership over continuous simulation HH trainings including simulations to improve technique. CONCLUSION: The study shows that the WHO multimodal HH strategy has a positive effect on HCW compliance and knowledge. Improvement points identified by local staff like sensitization on appropriate ABHR amount per HH action should be considered for sustainable HH improvement.