Standardized classification unsuitable for spontaneous reporting: the example of osteonecrosis of the jaw

Objective: This study assessed the impact of using a standardized definition of bisphosphonate-related osteonecrosis of the jaw (BRONJ) in the analysis of a spontaneous reporting database.

Methods: All notifications of osteonecrosis of the jaw (ONJ) in the French National Pharmacovigilance Database as of 31 December 2013 were analyzed. First, we considered all reports of ONJ with bisphosphonates as BRONJ. Second, we applied the 2014 definition of BRONJ from the American Association of Oral and Maxillofacial Surgeons (AAOMS), retaining only bisphosphonates as antiresorptive medication. In the absence of any one of these criteria, or missing data, cases were not considered as BRONJ.

Results: The first analysis found 158 cases of ONJ, among which 153 were associated with bisphosphonate use. The second analysis identified only 43 cases of BRONJ (28.1%).

Conclusion: The definition of BRONJ as laid down by the AAOMS is not suitable for use in spontaneous reporting database. The use of the AAOMS definition alone should be avoided, as it leads to the exclusion of over 70% of cases. When cases of ONJ are identified, all results should be presented including confirmed and excluded cases.     

Early blood pH as an independent predictor of neurological outcome in patients with out-of-hospital cardiac arrest: A retrospective observational study

Metabolic acidosis is observed in 98% of patients with out-of-hospital cardiac arrest (OHCA). The longer the no-flow or low-flow duration, the more severe is the acidosis in these patients. This study explored whether blood pH in early stages of advanced life support (ALS) was an independent predictor of neurological prognosis in patients with OHCA.We retrospectively enrolled patients with OHCA from January 2012 to June 2018 in a single-medical tertiary hospital in Taiwan. Patients with OHCA whose blood gas analyses within 5 minutes after receiving ALS at the emergency department (ED) were enrolled. Patients younger than 20 years old, with cardiac arrest resulting from traumatic or circumstantial causes, with return of spontaneous circulation (ROSC) before ED arrival, lacking record of initial blood gas analysis, and with do-not-resuscitate orders were excluded. The primary outcome of this study was neurological status at hospital discharge.In total, 2034 patients with OHCA were enrolled. The majority were male (61.89%), and the average age was 67.8 ± 17.0 years. Witnessed OHCA was noted in 571 cases, cardiopulmonary resuscitation was performed before paramedic arrival in 512 (25.2%) cases, and a shockable rhythm was observed in 269 (13.2%). Blood pH from initial blood gas analysis remained an independent predictor of neurological outcome after multivariate regression.Blood pH at early stages of ALS was an independent prognostic factor of post-OHCA neurological outcome. Blood gas analysis on arrival at the ED may provide additional information about the prognosis of patients with OHCA.     

Transthoracic echocardiography versus transesophageal echocardiography in detecting cardiac sources of embolism

Although the yield of potential cardiac sources of embolism by echocardiography in patients with stroke and arterial embolism has been low, with the advent of transesophageal echocardiography, a renewed enthusiasm for echocardiography in these patients has developed. This article reviews the six major studies comparing transthoracic to transesophageal echocardiography in the search for potential cardiac sources of embolism. The overall yield of transesophageal echocardiography in these studies for potential cardiac sources of embolism is 43% compared to 14% by transthoracic echocardiography in a total of 367 patients. In patients without clinical cardiac disease, the yield is lower but still substantially higher by transesophageal echocardiography (24% compared to 7% by transthoracic echocardiography). For left atrial thrombus, left atrial spontaneous contrast, patent foreman ovale, and atrial septal aneurysm (ASA), transesophageal echocardiography is clearly superior than transthoracic echocardiography. Data on the detection of mitral valve prolapse and left ventricular thrombus are conflicting and neither method is clearly superior. In addition, transesophageal echocardiography identifies certain abnormalities including debris in the aorta and prosthetic strands that transthoracic echocardiography is incapable of identifying. Although transthoracic echocardiography should continue to be the initial screening modality for stroke patients, transesophageal echocardiography should be performed when surface findings are negative or equivocal in patients with likely cardioembolic stroke.     

Rapid diagnosis of spontaneous bacterial peritonitis with leukocyte esterase reagent strips in a European and in an American center

BACKGROUND: Timely diagnosis and treatment of spontaneous bacterial peritonitis (SBP) are essential to survival. The purpose of the present paper was to evaluate leukocyte esterase reagent strips (Nephur-Test and MultistixSG10) in the bedside diagnosis of SBP. METHODS: Patients with cirrhotic ascites were prospectively included in France (center 1) and in the USA (center 2). Paracenteses were performed on admission and repeated as indicated. Bedside reagent strip testing was performed on the ascitic fluid and compared to manual cell count with differential and ascitic fluid culture. In center 1, the Nephur-Test was tested in all cases, with dual testing with MultistixSG10 in a subgroup. In center 2, all cases had dual testing. Spontaneous bacterial peritonitis was defined as a polymorphonuclear ascites count > or =250/microL. RESULTS: A total of 184 samples was obtained in 76 patients. Center 1 included 151 samples from 53 patients. Seven samples had SBP, obtained in six patients. Center 2 included 33 samples from 23 patients. Six samples had SBP, obtained in five patients. The sensitivity, specificity, positive and negative predictive value of the reagent strips were as follows. Center 1/Nephur-Test: 86%, 100%, 100%, 99%; center 1/MultistixSG10: 100%, 100%, 100%, 100%; center 2/Nephur-Test: 100%, 92.5%, 75%, 100%; center 2/MultistixSG10: 83%, 96%, 83%, 96%. CONCLUSION: Leukocyte esterase reagent strips may provide a rapid bedside diagnosis of SBP.     

Expression of FK506-binding protein 52 (FKBP52) in chorionic villi with early recurrent spontaneous abortion

Objective: To investigate the mRNA and protein expression of FK506-binding protein 52 (FKBP52) in the chorionic villi of patients with recurrent spontaneous abortion (RSA) and normal women during early pregnancy.

Methods: Fresh chorionic villus tissues were collected from 60 subjects. A total of 30 patients with a history of RSA were enrolled into the RSA group and 30 normal pregnant women were enrolled into the control group. The FKBP52 mRNA expression levels in chorionic villi of the RSA patients and healthy controls were measured via semiquantitative RT-PCR. The protein distribution and expression levels of FKBP52 in chorionic villi were analyzed through immunohistochemistry (IHC). The correlation between FKBP52 expression and RSA was analyzed.

Results: We demonstrated that FKBP52 mRNA is expressed in chorionic villi samples of normal pregnancy and RSA. RSA patients exhibited significantly lower FKBP52 gene expression levels compared with those in normal pregnancies (p?<?0.05). FKBP52 immunoreactivity in chorionic villi was mainly observed in trophoblast cell cytoplasm. The FKBP52 protein expression levels in the chorionic villi of RSA patients was significantly lower than in normal women during pregnancy (p?<?0.05).

Conclusions: FKBP52 protein levels were decreased in the chorionic villi of RSA patients, which indicate that the decrease in FKBP52 may be associated with RSA. The low FKBP52 mRNA expression level, which is consistent with the IHC result, may affect embryonic development and even lead to abortion. FKBP52 may be involved in the pathogenesis of RSA and new therapies that increase the FKBP52 expression may help treat RSA.     

Impact of amniotic fluid “sludge” on the risk of preterm delivery

Objective: To evaluate the impact of amniotic fluid “sludge” (AFS) on the risk of preterm delivery and to describe the effect of antibiotic treatment in that situation.

Methods: Case–control study including singleton pregnancies with or without AFS, between 15–32 weeks of gestation. Factors associated with preterm delivery before 32 weeks, 34 weeks and 37 weeks were evaluated with univariate and multivariate logistic regression. Since all women with AFS in this study were treated with antibiotics, a historical comparison was performed with similar patients with AFS found before 2007 and not treated with antibiotics.

Results: AFS was observed in 90/1220 patients (7.4%). AFS was associated with shorter cervical length, greater body mass index, cervical cerclage and preterm birth before 28 weeks. However, after adjustment, AFS did not remain associated with preterm delivery before 32 or 34 weeks. The historical comparison suggested that azithromycin could significantly reduce the risk of preterm delivery before 34 weeks (odds ratio: 0.2; 95% CI: 0.04–0.92).

Conclusions: AFS, treated with azithromycin, was associated with a higher risk of prematurity, but not independently after adjustment for cervical length and second trimester vaginal bleeding. Further studies need to evaluate the effect of antibiotics in pregnancies with AFS.     

Gender differences in acute coronary syndromes: focus on the women with ACS without an obstructing culprit lesion

Introduction: The etiologies of acute coronary syndromes (ACS) in women expand beyond the traditional paradigm of obstructive epicardial atherosclerotic disease and plaque rupture. Fundamental differences in pathobiology and presentation can partially explain the gender disparity in ACS diagnosis and management, but there is also much we do not know about the spectrum of coronary artery disease in women.

Areas covered: This review seeks to explain some key differences between men and women in terms of risk factors, pathophysiology, and clinical presentations, as well as identify areas where more data are needed, focusing on women presenting with ACS but without a culprit lesion to explain their presentation. Literature search was undertaken with PubMed and Google Scholar.

Expert commentary: Women with acute coronary syndromes but without plaque rupture or obstructive epicardial atherosclerosis can be difficult to diagnose and manage. Improving care in this underdiagnosed and undertreated population will require early identification of at risk patients, development of better diagnostic strategies, and standardized implementation of guideline-based therapies.     

Predicting long-term outcomes after cardiac arrest by using serum neutrophil gelatinase-associated lipocalin

Objectives

Neutrophil gelatinase-associated lipocalin (NGAL) is secreted by various tissues in pathologic states. Previous studies reported that post-cardiac arrest serum NGAL levels correlate with short-term neurologic outcomes and survival. The aim of this study was to examine the associations between NGAL levels post-cardiac arrest and long-term outcomes and survival.

Texting-Based Reporting of Adverse Drug Reactions to Ensure Patient Safety: A Feasibility Study

Background

Paper-based adverse drug reaction (ADR) reporting has been in practice for more than 6 decades. Health professionals remain the primary source of reports, while the value of patients’ reporting is yet unclear. With the increasing popularity of using electronic gadgets in health, it is expected that the electronic transmission of reports will become the norm within a few years.

Objective

The aims of this study are to investigate whether short messaging service or texting can provide an alternative or supplemental method for ADR reporting given the increasing role of mobile phones in health care monitoring; to determine the usefulness of texting in addition to paper-based reporting of ADRs by resident physicians; and to describe the barriers to ADR reporting and estimate the cost for setting up and maintaining a texting-computer reporting system.

Methods

This was a pre-post cross-sectional study that measured the number of ADRs texted by 51 resident physicians for 12 months from the Department of Obstetrics and Gynecology and the Department of Adult Medicine of a tertiary government hospital in Manila, Philippines, with 1350-bed capacity. Reports were captured by a texting-computer reporting system. Prior to its implementation, key informant interview and focus group discussion were conducted. Baseline information and practice on the existing paper-based reporting system were culled from the records of the hospital’s Pharmacy and Therapeutics Committee. A postintervention survey questionnaire was administered at the end of 12 months.

Results

Only 3 ADRs were texted by 51 resident physicians in 12 months (reporting rate 3/51 or 6%). By contrast, 240 ADRs from the paper-based reporting system from 848 resident physicians of the study hospital were collected and tabulated (reporting rate 240/848 or 28.3%). Texting ADRs was not efficient because of power interruption, competition with the existing paper-based reporting system, and unforeseen expiration of prepaid text loads/credits. The 3 ADRs texted were a report of vivid dreams and nightmares, a report of disturbing dreams and memory lapses, both of which were due to montelukast use, and a report of hepatitis from an isoniazid/rifampicin fixed-dose combination. Nineteen of 51 resident physicians (37%) registered in the reporting system responded to the postintervention survey. The most common reasons for not reporting ADRs were no adverse reaction identified 11/19 (58%) and restrictive reporting syntax 4/19 (21%). All doctors preferred a free form of reporting. The direct cost of the texting-based reporting system was calculated to be US $5581.40 and the indirect cost was US $9989.40. The total cost for texting-based ADR reporting system for 12 months was US $15,570.79.

Conclusions

Reporting of ADRs via texting could be lower compared with an existing ADR paper-based system. Problems of Internet connectivity, reporting syntax, and expiration and reliability of text loads/credits should be addressed while implementing a text-based ADR reporting system in a developing country.