Guideline-adherent Therapy Research Articles

Contributing and limiting factors to guideline-adherent therapy in senior and elderly breast cancer patients: a questionnaire-based cross-sectional study using clinical and cancer registry data in Germany

PurposeElderly cancer patients are less likely to be treated in accordance with evidence-based guideline recommendations. This study examines patient-related factors associated with deviations from guideline recommendations.MethodsUsing medical documentation and cancer registry data, we investigated the treatment courses of female breast cancer patients aged 50 and older in Germany regarding compliance with German guidelines. Participants completed a questionnaire querying factors hypothesized to be associated with guideline adherence. We conducted univariate analyses to explore the data and select variables for multivariate logistic regression to estimate adjusted odds ratios.ResultsOf 1150 participants, 206 (17.9%) were treated in deviation from guideline recommendations. Patients 70 years and older were more likely to be treated deviating from guideline recommendations than patients 50–69 years old (OR: 2.07; 95% CI: 1.52–2.80). Patients aged 50–69 years who reported that quality of life guided their treatment decision were more likely to be treated in deviation from guideline recommendations (AOR: 2.08; 95% CI: 1.11–3.92) than the elderly. In older patients, higher age was associated with an increased chance of receiving guideline-discordant care (AOR: 1.06; 95% CI: 1.01–1.11), as was depression diagnosed prior to cancer (AOR: 1.84; 95% CI: 1.00–3.40).ConclusionReasons for deviations from guideline recommendations in breast cancer patients differ by age. In decision-making concerning elderly patients, particular attention should be paid to those with pre-existing depressive disorders. Adequately addressing their needs and concerns could prevent inappropriate deviations from guideline recommendations.

An assessment of left-digit bias in the treatment of older patients with potentially curable rectal cancer

BackgroundPatient age is associated with poorer rectal cancer treatment compliance. However, it is unknown whether left-digit bias (disproportionate influence of leftmost age digit) influences this association. MethodsThe patients diagnosed with stage I–III rectal cancer between 2006 to 2017 in the National Cancer Database were identified. The association between age and receipt of guideline-adherent care was assessed using mixed-effects multivariable analyses. ResultsAmong 97,960 patients, 46.2% received guideline-adherent overall treatment and 73.3% underwent guideline-adherent surgical resection. Of those who underwent guideline-adherent surgery, 86.4% received guideline-adherent radiotherapy and 56.6% received guideline-adherent chemotherapy. After risk-adjustment, each decade increase in age was associated with 36% decreased odds of guideline-adherent therapy (odds ratio = 0.64, 95% confidence interval = 0.63–0.65). Patients aged 58 to 59 (odds ratio = 1.15, 95% confidence interval = 1.02–1.27) and 78 to 79 (odds ratio = 1.28, 95% confidence interval = 1.08–1.51) had higher odds of guideline-adherent overall treatment compared with patients aged 60 and 80, respectively. However, there were no significant differences in the receipt of guideline-adherent treatment between patients aged 60 vs 61–62 and 80 vs 81–82. ConclusionOlder patients with rectal cancer are less likely to receive guideline-adherent care, and a left-digit bias is present. Geriatric assessment-guided treatment decisions could help mitigate this bias.

Association between personalized evidence-based anticoagulation therapy and outcomes at 1-year follow-up in patients with atrial fibrillation: an analysis from the Atrial Fibrillation registry

Abstract Background The guideline treatments based on a relatively broad set of enrollment criteria inhibits the personalized evidence-based approach. Personalized evidence-based medicine (EBM) involves the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specific treatment. Objective We report the 1-year follow-up data of the Atrial Fibrillation Registry, focusing on the relationship between personalized EBM and guideline-adherent anticoagulation therapy use and the occurrence of major clinical adverse events. Methods 2683 patients at high risk for stroke and 1-year follow-up were enrolled in study. The primary endpoint was the percentage of guideline-based and personalized EBM recommendations acted on by clinicians. Secondary endpoints include the following: outcomes for all-cause mortality, thromboembolism (TE), bleeding, and the composite endpoints. Results From 2683 patients, 1971 (73.5%) EMR were guideline adherent and only 824 (30.7%) of them were personalized EBM anticoagulation therapy adherent, whilst 712 (26.5%) were non-guideline adherent and 1147 (42.8%) were guideline adherent but non-personalized EBM adherent. The composite endpoint of cardiovascular death, any TE or bleeding was significantly lower in personalized EBM adherent patients during 1-year follow-up (P=0.02). The endpoint of all cause death and any TE is increased by >20% by guideline adherent but non-personalized EBM adherent treatment [hazard ratio (HR) 1.254 (95% CI 0.931; 1.689)] and >80% non-guideline adherent and non-personalized EBM adherent treatment [HR 1.892 (95% CI 1.359; 2.635)]. For the composite endpoint of cardiovascular death, any TE or bleeding, guideline adherent but non-personalized EBM adherent treatment increased risk by >40% [HR 1.454 (95% CI 1.037; 2.040)], and non-guideline adherent and non-personalized EBM adherent treatment by >110% [HR 2.113 (95% CI 1.453; 3.074)]. Conclusion Personalized EBM anticoagulation management is associated with significantly better outcomes, including those related to the composite endpoint of cardiovascular death, any TE or bleeding in high-risk patients. Funding Acknowledgement Type of funding sources: None.

Abstract PO-231: Development and evaluation of a theory-based, multilevel intervention to improve the delivery of timely, guideline-adherent adjuvant therapy for patients with head and neck cancer

Abstract Background: Delays initiating guideline-adherent postoperative radiation therapy (PORT) in head and neck squamous cell carcinoma (HNSCC) occur in more than 50% of patients and are key drivers of excess mortality and racial disparities in survival. Theory-based multilevel interventions to address delays and racial disparities in timely PORT have not been described and effective interventions to improve timely, equitable PORT are lacking. Purpose: This study aims to describe the development of NDURE (Navigation for Disparities and Untimely Radiation Therapy), a novel theory- based, multilevel intervention to decrease delays starting PORT and evaluate its feasibility, acceptability, and preliminary clinical efficacy. Methods: An intervention mapping approach was used to develop NDURE. Consecutive patients with locally- advanced HNSCC undergoing surgery and PORT were enrolled into a single-arm clinical trial. Results: NDURE targets the determinants of timely, guideline-adherent PORT through the following core functions: 1) patient education, 2) standardization of the process for initiating the discussion of PORT, 3) PORT care plans, 4) provider role definition, 5) referral tracking and follow-up, and 6) transportation assistance. NDURE was feasible, as judged by trial accrual (88% overall; 100% for African Americans) and dropout (n=0). 100% of patients reported moderate/strong agreement that NDURE helped solve challenges starting PORT; 86% were highly likely to recommend NDURE. The rate of timely, guideline-adherent PORT was 86% overall and 100% for African Americans. Conclusions: NDURE is a novel, theory-based, multilevel intervention targeting determinants of timely PORT among HNSCC patients. NDURE is feasible, acceptable, and has potential to improve the timely, equitable, guideline-adherent PORT. These results support conducting a randomized controlled trial to test NDURE’s clinical efficacy. clinicaltrials.gov number NCT04030130 Citation Format: Evan M. Graboyes, Katherine R. Sterba, Hong Li, Graham Warren, Anthony J. Alberg, Elizabeth A. Calhoun, Brian Nussenbaum, Jessica McCay, Courtney H. Marsh, David M. Neskey, John Kaczmar, Anand K. Sharma, Jennifer Harper, Terry A. Day, Chanita Hughes Halbert. Development and evaluation of a theory-based, multilevel intervention to improve the delivery of timely, guideline-adherent adjuvant therapy for patients with head and neck cancer [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-231.

Treatment of Clostridioides difficile Infection and Non-compliance with Treatment Guidelines in Adults in 10 US Geographical Locations, 2013-2015.

Infectious Diseases Society of America/Society for Healthcare Epidemiology of America (IDSA/SHEA) guidelines describe recommended therapy for Clostridioides difficile infection (CDI). To describe CDI treatment and, among those with severe CDI, determine predictors of adherence to the 2010 IDSA/SHEA treatment guidelines. We analyzed 2013-2015 CDI treatment data collected through the Centers for Disease Control and Prevention's Emerging Infections Program. Generalized linear mixed models were used to identify predictors of guideline-adherent therapy. A CDI case was defined as a positive stool specimen in a person aged ≥ 18 years without a positive test in the prior 8 weeks; severe CDI cases were defined as having a white blood cell count ≥ 15,000 cells/μl. Prescribing and predictors of guideline-adherent CDI therapy for severe disease. Of 18,243 cases, 14,257 (78%) were treated with metronidazole, 7683 (42%) with vancomycin, and 313 (2%) with fidaxomicin. The median duration of therapy was 14 (interquartile range, 11-15) days. Severe CDI was identified in 3250 (18%) cases; of 3121 with treatment data available, 1480 (47%) were prescribed guideline-adherent therapy. Among severe CDI cases, hospital admission (adjusted odds ratio [aOR] 2.48; 95% confidence interval [CI] 1.90, 3.24), age ≥ 65 years (aOR 1.37; 95% CI 1.10, 1.71), Charlson comorbidity index ≥ 3 (aOR 1.27; 95% CI 1.04, 1.55), immunosuppressive therapy (aOR 1.21; 95% CI 1.02, 1.42), and inflammatory bowel disease (aOR 1.56; 95% CI 1.13, 2.17) were associated with being prescribed guideline-adherent therapy. Provider adherence to the 2010 treatment guidelines for severe CDI was low. Although the updated 2017 CDI guidelines, which expand the use of oral vancomycin for all CDI, might improve adherence by removing the need to apply severity criteria, other efforts to improve adherence are likely needed, including educating providers and addressing barriers to prescribing guideline-adherent therapy, particularly in outpatient settings.

Antibiotic Use and Respiratory Pathogens in Adults With Sickle Cell Disease and Acute Chest Syndrome.

Background: Acute chest syndrome (ACS) is an acute complication of sickle cell disease (SCD). Historically, the most common pathogens were Chlamydophila pneumoniae, Mycoplasma pneumoniae, and respiratory syncytial virus. Pediatric patients receiving guideline-adherent therapy experienced fewer ACS-related and all-cause 30-day readmissions compared with those receiving nonadherent therapy. This has not been evaluated in adults. Objectives: The primary objectives were to characterize antibiotic use and pathogens. The secondary objective was to assess the occurrence of readmissions associated with guideline-adherent and clinically appropriate treatment compared with regimens that did not meet those criteria. Methods: A retrospective cohort analysis was conducted for adults with SCD hospitalized between August 1, 2014, and July 31, 2017, with pneumonia (PNA) or ACS. The study was approved by the institutional review board. Results: A total of 139 patients with 255 hospitalizations were reviewed. Among 41 respiratory cultures, 3 organisms were isolated: Cryptococcus neoformans, Pseudomonas aeruginosa, and budding yeast. Respiratory panels were collected on 121 admissions, with 17 positive for 1 virus; all were negative for Chlamydophila pneumoniae and M pneumoniae. There were significantly more ACS-/PNA-related 7-day readmissions from patients on guideline-adherent regimens compared with nonadherent regimens (3.7% vs 0%; P = 0.04). Conclusion and Relevance: These findings challenge existing knowledge regarding the most common pathogens in adults with SCD with ACS or PNA. Routine inclusion of a macrolide may not be necessary. Future studies focused on pathogen characterization with standardized assessment are necessary to determine appropriate empirical therapy in this population.

Oncologist volume and outcomes in older adults diagnosed with diffuse large B cell lymphoma

Although provider-level volume is frequently associated with outcomes in cancers requiring complex surgeries, whether similar relations exist for cancers treated primarily with systemic therapy is unknown. Using a population-based cohort analysis of older adults diagnosed with diffuse large B cell lymphoma (DLBCL) during the years 2004-2011, we evaluated the association between oncologist volume and 4 clinical outcomes (receipt of any chemotherapy, receipt of an anthracycline-containing or equivalent regimen, early hospitalization, and overall survival). Our primary explanatory variable was lymphoma treatment volume, defined as the number of patients with newly diagnosed lymphoma for which an oncologist initiated therapy during a 12-month look-back period from each incident DLBCL case. We identified 8247 Medicare beneficiaries who were newly diagnosed with DLBCL. Chemotherapy was administered to 6202 (75.2%) beneficiaries, and 71.4% of cytotoxic regimens contained an anthracycline. Beneficiaries who were treated by higher-volume oncologists had increased odds of receiving chemotherapy (adjusted odds ratio [aOR], 1.45; 95% confidence interval [CI], 1.24-1.70; P <.001) and of receiving an anthracycline-containing regimen (aOR, 1.26; 95% CI, 1.06-1.50; P = .009). Receiving care from a higher-volume provider was also associated with decreased hospitalization (aOR, 0.80; 95% CI, 0.69-0.95; P = .007) and improved survival (adjusted hazard ratio, 0.85; 95% CI, 0.79-0.92; P < .001). In older adults diagnosed with DLBCL, receiving care from a provider with more experience treating lymphoma patients was associated with receipt of guideline-adherent therapy, reduced hospitalizations, and improved survival. Clinical volume may be an important factor in providing high-quality cancer care in the modern era.

Interhospital Transfer Delays Anticoagulation Reversal in Warfarin-Associated Intracranial Hemorrhage

IntroductionIntracranial hemorrhage (ICH) is a complication of warfarin-associated anticoagulation resulting in significant morbidity and mortality. The purpose of this study was to assess whether interhospital transfer delays the administration of 4-factor prothrombin complex concentrate to patients with warfarin-associated ICH. Materials and MethodsThis was a retrospective cohort study of all patients presenting to a 60,000 visit academic ED between August 2013 and July 2017 requiring emergent anticoagulation reversal for warfarin-associated ICH. Patients were divided into 2 cohorts: (1) transfer patients who arrived at the academic center after receiving care in a local community hospital and (2) control patients who presented directly to the academic center ED. The primary outcome was time to administration of 4-factor prothrombin complex concentrate. Secondary outcomes included hematoma expansion, guideline-adherent vitamin K administration (10mg IV), intensive care unit and hospital length of stay, disposition at discharge, and in-hospital mortality. ResultsThis study included 203 patients (177 transfer patients, 26 control). The median time to arrival in transfer patients was 186 minutes (IQR 145-242). The median time to administration of guideline-adherent therapy in transfer patients was 296 minutes, compared to 119 minutes in patients who were not transferred (median difference= −176, 95% confidence interval −143 to −208, P ≤ .001). Delay in anticoagulation reversal did not result in hematoma expansion, intensive care unit and hospital length of stay, discharge disposition, or in-hospital mortality. ConclusionsPatients requiring interhospital transfer experienced significant delays in guideline-adherent anticoagulation reversal for warfarin-associated ICH, but this delay was not associated with worse outcomes.

Oral Anticoagulation Therapy in Atrial Fibrillation Patients Managed in the Emergency Department Compared to Cardiology Outpatient: Opportunities for Improved Outcomes

Recent registry data suggests oral anticoagulation (OAC) usage remains suboptimal in atrial fibrillation (AF) patients. The aim of our study was to determine if rates of appropriate use of OAC in individuals with AF differs between the emergency department (ED) and cardiac outpatient clinic (CO). This was a retrospective study of consecutive AF patients over a 12-month period. Data from clinical records, discharge summaries and outpatient letters were independently reviewed by two investigators. Appropriateness of OAC was assessed according to the CHA2DS2-VASc score. Of 455 unique ED presentations with AF as a primary diagnosis, 115 patients who were treated and discharged from the ED were included. These were compared to 259 consecutively managed AF patients from the CO. Inappropriate OAC was significantly higher in the ED compared to the CO group (65 vs. 18%, p<0.001). Treatment in the ED was a significant multivariate predictor of inappropriate OAC (odds ratio 8.2 [4.8-17.7], p<0.001). This patient level data highlights that significant opportunity exists to improve disparities in the use of guideline adherent therapy in the ED compared to CO. There is an urgent need for protocol-driven treatment in the ED or streamlined early follow-up in a specialised AF clinic to address this treatment gap.

Adherence to Treatment Guidelines for Clostridium difficile Infections in the Intensive Care Unit

Introduction: The incidence of Clostridium difficile infections (CDI) in intensive care unit (ICU) patients is about 4%. Several studies have looked at patient outcomes based on adherence to SHEA-IDSA guidelines for treatment of CDI in general patient populations. However, there is a paucity of data regarding the effect of these guidelines in an ICU population. The goal of this study is to assess the impact of guideline adherent therapy (GAT) vs. guideline non-adherent therapy (non-GAT) on outcomes of ICU patients diagnosed with CDI. We measured CDI cure, all-cause mortality, mortality from CDI, and hospital length of stay. Methods: In this retrospective study we reviewed 400 patients admitted to an ICU at a tertiary care center and diagnosed with CDI, between January 2010 and December 2016 (Figure 1). We extracted patient demographics, comorbidities, concomitant therapies, CDI severity, CDI antibiotic regimen, and clinical outcomes. Comparisons between GAT and non-GAT patients were made using Kruskal-Wallis and Fisher's exact tests as appropriate.FigureResults: 360 patients were included in the final analysis, of which only 58 (16.1%) received GAT. We did not find a significant difference in guideline adherence based on disease severity (Table 1). GAT cured 72.4% of patients with CDI vs 55.3% of patients treated with non-GAT (p=0.023).The GAT group had longer median hospital stays compared to the non-GAT group (32.5 [interquartile range 23.2 - 48.0] days vs. 27.0 [16.0 - 44.0] days respectively, p=0.028). We found no significant difference in CDI-related or all-cause mortality. Outcomes were also analyzed for undertreated vs. overtreated patients, within the non-GAT group (Table 2).Table: Table. Guideline adherence based on clinical stateTable: Table. Outcomes based on guideline adherence and overtreatment vs. undertreatmentConclusion: Patients who received GAT had a higher cure rate. However, the majority of critically ill patients in this study received non-GAT. Unlike prior studies in the general population, we did not observe a difference in mortality based on guideline adherence. Paradoxically, patients whom received GAT were hospitalized longer. Data for CDI treatment is stronger for the general patient population with mild or moderate disease than for critically ill patients. Despite current guidelines, ICU patients often require treatment decisions based on patient characteristics and expert experience. Future prospective studies are warranted to determine optimal antibiotic regimens for critically ill patients with CDI as well as factors contributing to divergence from current recommendations in this population.

Association of Guideline-Adherent Antibiotic Treatment With Readmission of Children With Sickle Cell Disease Hospitalized With Acute Chest Syndrome

Acute chest syndrome (ACS) is a common, serious complication of sickle cell disease (SCD) and a leading cause of hospitalization and death in both children and adults with SCD. Little is known about the effectiveness of guideline-recommended antibiotic regimens for the care of children hospitalized with ACS. To use a large, national database to describe patterns of antibiotic use for children with SCD hospitalized for ACS and to determine whether receipt of guideline-adherent antibiotics was associated with lower readmission rates. Retrospective cohort study including 14 480 hospitalizations in 7178 children (age 0-22 years) with a discharge diagnosis of SCD and either ACS or pneumonia. Information was obtained from 41 children's hospitals submitting data to the Pediatric Health Information System from January 1, 2010, to December 31, 2016. National Heart, Lung, and Blood Institute guideline-adherent (macrolide with parenteral cephalosporin) vs non-guideline-adherent antibiotic regimens. Acute chest syndrome-related and all-cause 7- and 30-day readmissions. Of the 14 480 hospitalizations, 6562 (45.3%) were in girls; median (interquartile range) age was 9 (4-14) years. Guideline-adherent antibiotics were provided in 10 654 of 14 480 hospitalizations for ACS (73.6%). Hospitalizations were most likely to include guideline-adherent antibiotics for children aged 5 to 9 years (3230 of 4047 [79.8%]) and declined to the lowest level for children 19 to 22 years (697 of 1088 [64.1%]). Between-hospital variation in antibiotic regimens was wide, with use of guideline-adherent antibiotics ranging from 24% to 90%. Children treated with guideline-adherent antibiotics had lower 30-day ACS-related (odds ratio [OR], 0.71; 95% CI, 0.50-1.00) and all-cause (OR, 0.50; 95% CI, 0.39-0.64) readmission rates vs children who received other regimens (cephalosporin and macrolide vs neither drug class). Current approaches to antibiotic treatment in children with ACS vary widely, but guideline-adherent therapy appears to result in fewer readmissions compared with non-guideline-adherent therapy. Efforts to increase the dissemination and implementation of SCD treatment guidelines are warranted as is comparative effectiveness research to strengthen the underlying evidence base.

Guideline adherence and clinical outcome in vulnerable and healthy breast cancer patients: Results of a prospective cross-sectional study in Germany.

e18132 Background: In 2003 the German Cancer Society and the German Society for Breast Disease introduced a number of Quality Indicators (QIs) to improve standards of breast cancer care. Although QIs should be based on clinical evidence, evidence for important subpopulations (i.e. vulnerable patients) is often limited. In this prospective cross-sectional study we assessed conformity and non-conformity of guidelines and their impact on clinical outcome in a real-world setting. Methods: This prospective analysis included patients with primary breast cancer. Patients with stage IV and recurrent breast cancer were excluded. Data was collected from 2012-2016 in six certified breast care centers using a personal questionnaire and data from the patients' medical records. Guideline adherence to a set of 11 QIs was explored. Overall survival (OS) and disease free survival (DFS) were correlated with fulfillment of QIs and tumor characteristics. Results: Survival analysis was conducted in 2390 patients with a median follow-up of 16 months. 88 (4%) patients had a recurrent disease. 31 (1.3%) patients died of breast cancer. Tumor stage, grading, Her2- and hormone receptor status and Ki-67 correlated with DFS and OS. 1725/1907 patients (90.5%) received a guideline adherent treatment. The most prevalent reasons for non-conformity were old age (24.7%) and/or comorbidity (20.9%). Breast cancer specific DFS and OS were not significantly different between patients treated adherent or not adherent to the guidelines. In contrast, survival analysis of death other than breast cancer showed a significantly worse OS (p = 0.006) for patients not treated according to guideline recommendation. Conclusions: Conformity of clinical guidelines was observed in the majority of patients including healthy and vulnerable patients. These patients tended to have a longer breast cancer specific survival. Patients who were not considered suitable for guideline-adherent therapy died more often from other medical reasons rather than from breast cancer. In our study 10% of the patients had a limited life expectancy due to old age and co-morbidities with no assumed benefit from guideline adherence.

Guideline-adherent therapy for stroke prevention in atrial fibrillation in different health care settings: Results from RAMSES study

ObjectiveNo studies have been conducted in Turkey to compare the quality of stroke prevention therapies provided in different healthcare settings in patients with atrial fibrillation (AF). Therefore, we aimed to evaluate possible differences between secondary (SH) and tertiary hospital (TH) settings in the effectiveness of implementing AF treatment strategies. MethodsBaseline characteristics of 6273 patients with non-valvular AF enrolled in the RAMSES (ReAl-life Multicentre Survey Evaluating Stroke Prevention Strategies in Turkey) study were compared. ResultsOf the study population, 3312 (52.8%) patients were treated in THs and 2961 (47.2%) patients were treated in SHs. Patients treated in the SH setting were older (70.8±9.8 vs. 68.7±11.4years, p<0.001), had a lower socioeconomic status, had a higher CHA2DS2VASc and HASBLED scores (3.4±1.4 vs. 3.1±1.7, p<0.001 and 1.7±1.0 vs. 1.6±1.1, p<0.001 respectively), and had more comorbidities than patients treated in THs. Inappropriate oral anticoagulant use was more prevalent in SHs than THs (31.4% vs. 25.6%, p<0.001). When over- and undertreatment rates were compared among hospital types, overtreatment was more prevalent in THs (7.6% vs. 0.9%, p<0.001) while undertreatment was more common in SHs (30.5% vs. 17.9%, p<0.001). ConclusionThis study demonstrates the marked disparity between patient groups with AF presenting at SHs and THs. The use of guideline-recommended therapy is not adequate in either type of centre, overtreatment was more prevalent in THs and undertreatment was more prevalent in SHs.

Sepsis recognition in the emergency department - impact on quality of care and outcome?

BackgroundAppropriate and timely recognition of sepsis is a prerequisite for starting goal-directed therapy bundles. We analyzed the appropriateness of sepsis recognition and documentation with regard to adequacy of therapy and outcome in an internal medicine emergency department (ED).MethodsThis study included 487 consecutive patients ≥18 years of age who presented to a university hospital ED during a 4-week period. Clinical, laboratory, and follow-up data were acquired independently from documentation by ED physicians. The study team independently rated quality of sepsis classification (American College of Chest Physicians/Society of Critical Care Medicine definitions), diagnostic workup, and guideline-adherent therapy in the ED.ResultsOf 487 included patients, 110 presented because of infection. Of those, 54 patients matched sepsis criteria, including 20 with organ damage and thus severe sepsis, as rated by the study team. Sepsis was not recognized in 32 of these 54 cases (59%). Multivariate binary logistic regression analysis revealed that higher systolic blood pressure (p <0.05), the ability to stand (p <0.01) and a low number of documented vital signs in the ED discharge letter (p < 0.05) were independent predictors of missed sepsis. Surprisingly, adequate detection of the septic focus (81 vs. 93%, p = 0.17), appropriate fluid administration (86 vs. 87%, p = 0.39), and guideline-adherent antibiotic regimen (95 vs. 100%, p = 0.42) did not differ between cases of recognized and unrecognized sepsis, respectively. Non-recognition affected neither death-censored length of hospital stay (median 7.63 d vs. 7.13 d, p = 0.42) nor a combined endpoint of death or ICU admission to (9 vs. 12%, p = 0.55).ConclusionsNon-recognition of sepsis in ED patients with serious infections who formally meet organizational sepsis definitions seems to have no deleterious impact on initial therapy adequacy.Electronic supplementary materialThe online version of this article (doi:10.1186/s12873-017-0122-9) contains supplementary material, which is available to authorized users.

Treatment of Acute Coronary Syndrome by Telemedically Supported Paramedics Compared With Physician-Based Treatment: A Prospective, Interventional, Multicenter Trial

BackgroundPrehospital treatment of acute coronary syndrome (ACS) in German emergency medical services (EMSs) is reserved for EMS physicians due to legal issues.ObjectiveThe objective of this prospective, interventional, multicenter trial was to evaluate the quality of telemedically-delegated therapy and the possible complications in patients with ACS.MethodsAfter approval by the ethics committee and trial registration, a one-year study phase was started in August 2012 with 5 ambulances, telemedically equipped and staffed with paramedics, in 4 German EMS districts. The paramedics could contact an EMS-physician–staffed telemedicine center. After initiation of an audio connection, real-time data transmission was automatically established. If required, 12-lead electrocardiogram (ECG) and still pictures could be sent. Video was streamed from inside each ambulance. All drugs, including opioids, were delegated to the paramedics based on standardized, predefined algorithms. To compare telemedically-delegated medication and treatment in ACS cases with regular EMS missions, a matched pair analysis with historical controls was performed.ResultsTeleconsultation was performed on 150 patients having a cardiovascular emergency. In 39 cases, teleconsultation was started due to suspected ACS. No case had a medical complication. Correct handling of 12-lead ECG was performed equally between the groups (study group, n=38 vs control group, n=39, P>.99). There were no differences in correct handling of intravenous administration of acetylsalicylic acid, heparin, or morphine between both the groups (study group vs control group): acetylsalicylic acid, n=31 vs n=33, P=.73; unfractionated heparin, n=34 vs n=33, P>.99; morphine, n=29 vs n=27, P=.50. The correct handling of oxygen administration was significantly higher in the study group (n=29 vs n=18, P=.007).ConclusionsTelemedical delegation of guideline conform medication and therapy by paramedics in patients with ACS and was found to be feasible and safe. The quality of guideline-adherent therapy was not significantly different in both the groups except for the correct administration of oxygen, which was significantly higher in the study group.Trial RegistrationClinicaltrials.gov NCT01644006; http://clinicaltrials.gov/ct2/show/NCT01644006 (Archived by WebCite at http://www.webcitation.org/6mPam3eDy).

'Real-world' atrial fibrillation management in Europe: observations from the 2-year follow-up of the EURObservational Research Programme-Atrial Fibrillation General Registry Pilot Phase.

Atrial fibrillation (AF) is commonly associated with a high risk of stroke, thromboembolism, and mortality. The 1-year follow-up of the EURObservational Research Programme-Atrial Fibrillation (EORP-AF) Pilot Registry demonstrated a high mortality but good outcomes with European Society of Cardiology guideline-adherent therapy. Whether these 'real-world' observations on patients managed by European cardiologists extend to 2 years remains uncertain. In this report from the EORP-AF General Registry Pilot Phase, we provide data on the 2-year follow-up outcomes. Consistent with the 1-year follow-up report, only a small proportion of patients were symptomatic (24.9%), with minor differences between the different AF subtypes. Persistence of oral anticoagulant (OAC) therapy remains high at 2-years, with ∼80% of patients treated with OAC. The prescribing rates of non-vitamin K antagonist oral anticoagulants are progressively increasing (13.7% at 2 years). Rate and rhythm control approaches remained consistent across the entire follow-up observation. Overall mortality rates remained high, with 5.0% of patients dead during the 2-year follow-up, mostly due to cardiovascular causes (61.8%). Atrial fibrillation readmissions were frequent, particularly related to arrhythmias and heart failure. On multivariate analyses, any cardiovascular reason for admission rather than AF was significantly associated with increased mortality during the 2-year follow-up. In this 2-year follow-up report from EORP-AF, mortality rates with AF remain high from cardiovascular causes, despite the high prevalent use of OAC. Improved management strategies to reduce major adverse outcomes in AF patients are needed.

Corticosteroids for Hospitalized Community-Acquired Pneumonia — Time to Change Practice?

As many as 20% of patients with community-acquired pneumonia (CAP) worsen despite guideline-adherent antimicrobial therapy. Systemic corticosteroids might reduce cytokine and inflammatory responses that can lead to some CAP treatment failures. In 2015, researchers published two new randomized, controlled trials in which systemic corticosteroids were evaluated in hospitalized CAP patients. A Spanish trial of 120 patients with severe CAP who received steroids showed that these patients were significantly less likely to experience a multicomponent treatment-failure endpoint that included both adverse clinical outcomes (mechanical ventilation, …

A Feather in the CAP: Steroids for Community-Acquired Pneumonia

As many as 20% of patients with community-acquired pneumonia (CAP) worsen despite guideline-adherent antimicrobial therapy; in fact, some cases are

Dokumentation von Antibiotic Stewardship (ABS)-Interventionen im Rahmen infektiologischer Visiten

Proactive audit of antibiotic use ensures quality of prescribing and can improve outcome in patients with infections. A rational, individualized therapy is being defined in interdisciplinary cooperation on the basis of clinical, laboratory, radiological and microbiological examination findings. By fostering targeted antibiotic therapy proactive audit reduces adverse effects and contributes to drug therapy safety and subsequently to patient safety. A proactive audit of antibiotic use is performed weekly on four intensive care units at the University Hospital Dresden by a infectious disease specialist a pharmacist and the attending physicians. Patient-related therapy adjustments were systematically documented over a 4-month period; antibiotic use before and after audit as well as ABS strategies (de-escalation, oral switch, duration of treatment, dose and administration optimization) were analyzed. Both targeted therapy and interventions regarding the duration of treatment led to a reduction in the prescribing of broad spectrum antibiotics by 20%. Routine interdisciplinary proactive audit of antibiotic use with intervention and feedback increases guideline-adherent therapy and process quality.

Guideline-adherent therapy in patients with acute coronary syndromes. The EPICOR registry in Germany.

Representative data on the current management of patients with acute coronary syndromes (ACS) are of high interest. The EPICOR registry aimed to prospectively collect such real-life data with particular focus on antithrombotic drug utilization and outcomes. As part of the international prospective EPICOR registry, 29 hospitals in Germany documented 296 patients with ST-elevation myocardial infarction (STEMI)-ACS and 333 with unstable angina or non-STEMI (NSTEMI)-ACS surviving the hospital phase. The statistical analysis was performed in a descriptive manner. The ClinicalTrials.gov identifier is NCT01171404. The mean age of patients was 62 ± 13years, and 77.4 % were men. Treatment with antithrombotic agents was initiated in the prehospital phase in 50.7 % of STEMI and 33.3 % of NSTEMI patients. During the hospital stay (median 7.0days), cardiac catheterization was performed in 97.6 %, percutaneous coronary intervention in 85.6 %, thrombolysis in 4.6 %, and coronary bypass surgery in 2.7 % patients. The use of acetylic salicylic acid (ASA) was reported in 95.6 % vs. 96.1 %, clopidogrel in 60.8 % vs. 73.0 %, prasugrel in 45.6 % vs. 22.5 %, any GP IIb/IIIa inhibitor in 52.4 % vs. 18.9 % [any dual combination of ASA+(clopidogrel/prasugrel)in 94.0 vs. 91.0 %], statins in 94.6 % vs. 92.2 %, beta blockers in 96.3 % vs. 94.6 %, and ACE-I/ARB in 91.6 % vs. 87.7 % of STEMI vs. NSTEMI patients, respectively. Combined use of the five drug classes recommended in the guidelines-ASA, P2Y12 antagonists, statin, beta blocker, and ACE-I/ARB-was reported in 81.1 % vs. 69.4 % of STEMI vs. NSTEMI patients, respectively. In Germany a high proportion of patients with ACS are treated according to current guidelines, receiving primary revascularization as well as antithrombotic drugs and other agents for prevention of secondary events; associated bleeding complications were less frequent as compared with published registries.