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עמוד בית
Thu, 13.06.24

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November 2014
Ori Lev PhD and Bracha Rager-Zisman PhD

Emerging and re-emerging infections cause huge concern among public health workers and international and national bodies such as the World Health Organization (WHO) and the U.S. National Institutes of Health (NIH). Indeed, scientists around the world express the view that despite the danger, research on these emerging virulent pathogens is crucial and must continue. While most of the studies underway are targeted at improving and protecting public health, some studies bear potentially serious risks resulting from misuse. These studies are defined as dual-use research (DUR) of concern, where it is not evident that the benefits outweigh the risks. The H5N1 controversy has pushed various governments to institute new policies to govern such research. We describe the regulations that govern this emerging field of research in the United States and Israel, two countries that have taken leading stands on these issues. We suggest that the existing policies are able to mitigate many of the risks that this research encapsulates, yet more work is required – especially on the global level.

September 2014
Menachem Rottem MD and Adham Egbarya BSc

Background: The efficacy of subcutaneous immunotherapy for the treatment of allergic rhinitis, allergic conjunctivitis, allergic asthma and stinging insect hypersensitivity has been demonstrated in several studies.

Objectives: To investigate the effectiveness and side effects of immunotherapy in Israel and the relationship between local and systemic side effects.

Methods: This retrospective study was based on patient records and a computerized database for drug dispensing over a 5 year period. Success was rated as partial or complete. Side effects were classified as local or systemic. Systemic side effects were further classified according to severity, as mild (cutaneous), moderate (respiratory symptoms), or severe (cardiovascular).

Results: Of the 135 patients on aero-allergen immunotherapy who reached maintenance, 120 (88.9%) exhibited complete or partial improvement and 15 (11.1%) did not improve. All of the 44 patients on hymenoptera immunotherapy reached effective maintenance doses. The mean percent side effects calculated per treatment (injection) were 2.49 for local and 1.58 for a systemic reaction during the build-up phase, and 1.13 and 1.12 during the maintenance phase, respectively. Rates of systemic reactions were 1.3% for cutaneous, 1.14% for respiratory and 0.97% for cardiovascular reactions during the build-up phase, and 1.11%, 0.53%, and 0.51% during the maintenance phase, respectively. The odds of systemic reactions were significantly higher in patients with local reactions both in the build-up phase (P = 0.03) and in the maintenance phase (P = 0.0003). The number of annual medications dispensed per patient decreased from 31.5 to 26.0 during the first year after reaching maintenance, and to 22.5 in the second year. Pharmaceutical costs were 67% lower 1 year after the start of the maintenance phase, compared to the year before the start of immunotherapy, and 63% lower in the second year (P = NS).

Conclusions: Immunotherapy was effective and safe. Recognizing the benefits and safety of immunotherapy is necessary for physicians and health authorities in order to provide better care for allergic patients.

May 2014
Yael Zenziper BPharm, Daniel Kurnik MD, Noa Markovits MD, Amitai Ziv MD MHA, Ari Shamiss MD MPA, Hillel Halkin MD and Ronen Loebstein MD

Background: Prescription errors are common in hospitalized patients and result in significant morbidity, mortality and costs. Electronic prescriptions with computerized physician order entry systems (CPOE) and integrated computerized decision support systems (CDSS providing online alerts) reduce prescription errors by approximately 50%. However, the introduction of CDSS is often met by opposition due to the flood of alerts, and most prescribers eventually ignore even crucial alerts (“alert fatigue”). 

Objectives: To describe the implementation and customization of a commercial CDSS (SafeRx®) for electronic prescribing in Internal Medicine departments at a tertiary care center, with the purpose of improving comprehensibility and substantially reducing the number of alerts to minimize alert fatigue. 

Methods: A multidisciplinary expert committee was authorized by the hospital administration to customize the CDSS according to the needs of six internal medicine departments at Sheba Medical Center. We assessed volume of prescriptions and alert types during the period February–August 2012 using the statistical functions provided by the CDSS. 

Results: A mean of 339 ± 13 patients per month per department received 11.2 ± 0.5 prescriptions per patient, 30.1% of which triggered one or more CDSS alerts, most commonly drug-drug interactions (43.2%) and dosing alerts (38.3%). The review committee silenced or modified 3981 alerts, enhancing comprehensibility, and providing dosing instructions adjusted to the patient’s renal function and recommendations for follow-up. 

Conclusions: The large volume of drug prescriptions in internal medicine departments is associated with a significant rate of potential prescription errors. To ensure its effectiveness and minimize alert fatigue, continuous customization of the CDSS to the specific needs of particular departments is required.

 

January 2014
Mona Boaz, Alexander Bermant, Tiberiu Ezri, Dror Lakstein, Yitzhak Berlovich, Iris Laniado RN and Zeev Feldbrin
Background: Surgical adverse events are errors that emerge during perioperative patient care. The World Health Organization recently published “Guidelines for Safe Surgery.”

Objectives: To estimate the effect of implementation of a safety checklist in an orthopedic surgical department.


Methods: We conducted a single-center cross-sectional study to compare the incidence of complications prior to and following implementation of the Guidelines for Safe Surgery checklist. The medical records of all consecutive adult patients admitted to the orthopedics department at Wolfson Medical Center during the period 1 July 2008 to 1 January 2009 (control group) and from 1 January 2009 to 1 July 2009 (study group) were reviewed. The occurrences of all complications were compared between the two groups.

Results: The records of 760 patients (380 in each group) hospitalized during this 12 month period were analyzed. Postoperative fever occurred in 5.3% vs. 10.6% of patients with and without the checklist respectively (P = 0.008). Significantly more patients received only postoperative prophylactic antibiotics rather than both pre-and postoperative antibiotic treatment prior to implementation of the checklist (3.2% vs. 0%, P = 0.004). In addition, a statistically non-significant 34% decrease in the rate of surgical wound infection was also detected in the checklist group. In a logistic regression model of postoperative fever, the checklist emerged as a significant independent predictor of this outcome: odds ratio 0.53, 95% confidence interval 0.29–0.96, P = 0.037.

Conclusion: A significant reduction in postoperative fever after the implementation of the surgical safety checklist was found. It is possible that the improved usage of preoperative prophylactic antibiotics may explain the reduction in postoperative fever.

November 2013
I. Strauss, T. Jonas-Kimchi, Z. Lidar MD, D. Buchbut, N. Shtraus, B. W. Corn and A. A. Kanner, T. Wolak, E. Aliev, B. Rogachev, Y. Baumfeld, C. Cafri,, M. Abu-Shakra and Victor Novack.
 Background: Contrast-induced nephropathy (CIN) is one of the major causes of new-onset renal failure in hospitalized patients. Although renin-angiotensin-aldosterone system (RAAS) blocking agents are widely used among patients requiring contrast studies, data on the effect of these agents on the development of CIN are sparse and inconsistent.  

Objectives: To evaluate in a randomized control trial whether uninterrupted administration of angiotensin II (AngII) blockade medications influence estimated glomerular filtration rate (eGFR) in patients undergoing non-emergent coronary angiography.

Methods: Patients receiving treatment with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACE-I/ARB) were recruited consecutively. The enrolled subjects were randomized into three groups at a 1:1:1 ratio: group A (ACE/ARB stopped 24 hours prior to the procedure and restarted immediately after the procedure), group B (ACE/ARB stopped 24 hours prior to the procedure and restarted 24 hours after the procedure), and group C (ACE/ARB continued throughout the study period). Plasma creatinine was measured and eGFR was calculated according to the Cockroft-Gault equation before and 48 hours after the coronary angiography. The primary endpoint was a change in eGFR at 48 hours.

Results: Groups A, B and C comprised 30, 31 and 33 patients respectively. The mean age of the study population was 65 ± 12 years and 67% were males. Fifty percent of the subjects had diabetes mellitus. The primary endpoint analysis showed that at 48 hours after the procedure there was no difference in ΔeGFR between groups A and C (4.25 ± 12.19 vs. 4.65 ± 11.76, P = 0.90) and groups B and C (3.72 ± 17.42 vs. 4.65 ± 11.76, P = 0.82). In post-hoc analysis the patients were clustered according to the following groups: medical alternation (group A and B) versus control (group C) and to baseline eGFR ≥ 60 ml/min vs. eGFR < 60 ml/min. In patients with baseline eGFR < 60 ml/min the ΔeGFR (baseline eGFR-eGFR 48 hours post-angiography) was significantly different between the intervention vs. control group (median 5.61 vs. median -2.19, P = 0.03 respectively). While in patients with baseline eGFR ≥ 60 ml/min there was no significant difference in ΔeGFR between the intervention and control groups.

Conclusions: ACE-I and ARB can safely be used before and after coronary angiography in patients with eGFR ≥ 60 ml/min. 

January 2013
L. Ashkenazi-Hoffnung, P. Merlob, B. Stahl and G. Klinger
 Background: Diclectin (pyridoxine 10 mg and doxylamine 10 mg) has traditionally been used to treat nausea and vomiting of pregnancy (NVP); however, this drug is unavailable in many countries.

Objectives: To evaluate the efficacy and safety of a simple bi-daily treatment regimen with the combination of pyridoxine (50 mg twice daily) and doxylamine (25–50 mg) as an alternative treatment for NVP.

Methods: A prospective case-controlled observational study of mother-infant pairs was conducted between February 2008 and December 2010. All women who contacted the Beilinson Teratology Information Service (BELTIS) regarding treatment of NVP were eligible for inclusion. Using data on NVP severity, treatment efficacy and outcomes, we compared the two groups of women: those treated with the combination of pyridoxine and doxylamine (treatment group, n=29) and those treated with metoclopramide (control group, n=29).

Results: Moderate to severe symptoms were present in 97% of the treatment group women vs. 69% of control group women (P < 0.01). Despite increased symptom severity in the treatment group, the combination regimen was efficacious: 20/29 (69%) vs. 18/25 (72%) in the treatment vs. control women respectively (P = 0.65). There were no congenital anomalies in the treatment group. Follow-up was normal for all infants.

Conclusions: Bi-daily combination therapy with pyridoxine and doxylamine for NVP is safe, has comparable efficacy to metoclopramide, and is a treatment alternative in countries where Diclectin is not available. Despite symptoms warranting counseling by a teratology information service, more than a third of women do not take the suggested treatment.

 

October 2010
T. Bergman-Levy, A. Bleich, M. Kotler and Y. Melamed

The courts have recently become increasingly involved in the administration of compulsory psychiatric services in Israel. Data reveal a gradual increase in the rate of court-ordered hospitalizations according to Section 15 of the Law for the Treatment of the Mentally Ill. This paper examines the implications of this trend, particularly the issues of security and safety in psychiatric hospitalization. We present highlights from extensive British experience, focusing on the implications on forensic psychiatry in Israel. We review the development of the hierarchy of security in the British psychiatric services, beginning in the early 1970s with the establishment of the Butler Committee that determined a hierarchy of three levels of security for the treatment of patients, culminating with the establishment of principles for the operation of medium security units in Britain (Read Committee, 1991). These developments were the basis for the forensic psychiatric services in Britain. We discuss the relevance of the British experience to the situation in Israel while examining the current status of mental health facilities in Israel. In our opinion, a safe and suitable environment is a necessary condition for a treatment setting. The establishment of medium security units or forensic psychiatry departments within a mental health facility will enable the concentration and classification of court-ordered admissions and will enable systemic flexibility and capacity for better treatment, commensurate with patient needs.

July 2010
O. Halshtok, O. Goitein, R. Abu Sham'a, H. Granit, M. Glikson and E. Konen
Background: Until recently, cardiac pacemakers and implantable cardioverter defibrillators were considered an absolute contraindication for magnetic resonance imaging. Given the significant increase in implanting such devices, these contraindications will preclude MRI scanning in a large patient population. Several recent reports have addressed the safety and feasibility of MRI in the presence of cardiac implantable devices.

Objectives: To summarize our experience with MRI scanning in the presence of pacemakers and implantable cardioverter defibrillators.

Methods: Eighteen patients (15 males and 3 females, median 59) were scanned using a 1.5 T MRI scanner. A clinical discussion was held to verify the absolute medical necessity of the study before performing the scan. Scan supervision included device interrogation and programming beforehand, patient monitoring during, and device interrogation and reprogramming after the scan. Full resuscitation equipment was available outside the MRI suite.

Results: Thirty-four scans were performed, and all but one were of diagnostic quality. Anatomic regions included the brain (N=26), cervical spine (N=2), lumbar spine (N=1), cardiac (N=2), abdomen (N=1), abdomen and pelvis (N=1) and pelvis (N=1). None of the patients reported any side effects and no life-threatening events occurred during or following the scans. Five cases of device spontaneous reversion to backup mode were recorded (four in the same patient). Device replacement was not required in any patient.

Conclusions: In this small cohort of patients MRI scanning in the presence of cardiac implantable devices was safe. MRI in these patients is feasible although not recommended for routine scans. Scans should be considered on a case-to-case basis and performed in a dedicated specialized setup.

 

February 2009
C. Stein-Zamir, E. Tallen-Gozani, N. Abramson, H. Shoob, R. Yishai, V. Agmon, A. Reisfeld, L. Valinsky and E. Marva

Background: Foodborne Salmonella enterica outbreaks constitute both a threat to public health and an economic burden worldwide.

Objectives: To characterize the pathogen(s) involved and possible source of infection of an outbreak of acute gastroenteritis in a banqueting hall in Jerusalem.

Methods: We conducted interviews of guests and employees of the banqueting hall, and analyzed food items, samples from work surfaces and stool cultures.

Results: Of 770 persons participating in three events on 3 consecutive days at a single banqueting hall, 124 were interviewed and 75 reported symptoms. Salmonella enterica, serovar Enteritidis, phage type C-8, was isolated from: 10 stool cultures (eight guests, one symptomatic employee and one asymptomatic employee) and a sample of a mayonnaise-based egg salad. Pulsed-field gel electrophoresis[c1]  of the isolates revealed an identical pattern in the outbreak isolates, different from SE C-8 controls. A culture-positive, asymptomatic employee was linked to all three events. After a closure order, allowing for cleaning of the banqueting hall, revision of food preparation procedures and staff instruction on hygiene, the banqueting hall was reopened with no subsequent outbreaks.

Conclusions: It is often difficult to pinpoint the source of infection in S. enterica outbreaks. Using molecular subtyping methods, a link was confirmed between patients, a food handler, (presumably a carrier) and a food item – all showing an identical specific Salmonella enterica serovar Enteritidis. Testing asymptomatic as well as symptomatic food handlers in outbreak investigations is imperative. Pre- and post-hiring screening might be considered as preventive measures; hygiene and sanitation education are essential.





 [c1]OK




 
December 2008
Y. Zeldin, Z. Weiler, E. Magen, L. Tiosano, M. I. Kidon

Background: Subcutaneous allergen immunotherapy is effective in treating allergic airway disease. Disadvantages include immediate local and systemic adverse reactions and poor compliance.

Objectives: To obtain real-life efficacy and safety data through a prospective observational study of SIT[1] in the allergist's office.

Methods: We prospectively collected data from all patients with a diagnosis of allergic rhinitis and/or asthma and a specific immunoglobulin E-mediated sensitization to one or more aeroallergens who began SIT during the 2 year period 1 January 2005 to 31 December 2006. As part of the routine immunotherapy care patients were asked to complete a disease activity questionnaire before and yearly during the treatment. The primary outcome measure was the combined rhinitis and asthma symptoms scores. Data from patients completing at least 1 year of immunotherapy were analyzed.

Results: Altogether, 133 enrolled patients with a mean age of 22.7 years completed at least 1 year of SIT. The allergic rhinitis and asthma disease activity score decreased from a mean of 8.1 to 3.3 (rhinitis) and from 4.8 to 2.4 (asthma) on a 10 cm visual analogue scale after 1 year of SIT (P < 0.001 for all comparisons). Rhinitis medication use in all patients and asthma medication use in asthmatics decreased significantly. Mild local adverse reactions were almost universal. There were 11 patients (8%) who developed 14 immediate systemic, mild to moderate reactions. All reactions were successfully treated in the clinic; none required additional observation or hospitalization.

Conclusions: In the hands of experienced allergists subcutaneous allergy immunotherapy is a safe and efficacious option for patients with allergic rhinitis and asthma. 






[1] SIT = subcutaneous allergen immunotherapy


October 2008
A. Roguin, S. Abadi, E. Ghersin, A. Engel, R. Beyar and S. Rispler

Background: Multi-detector computed tomography has advanced enormously and now enables non-invasive evaluation of coronary arteries as well as cardiac anatomy, function and perfusion. However, the role of cardiac MDCT[1] is not yet determined in the medical community and, consequently, many clinically unnecessary scans are performed solely on a self-referral basis.

Objectives: To prospectively evaluate the role of a cardiologist consultation and recommendation prior to the scan, and the influence on the diagnostic yield of cardiac MDCT.

Methods: In our center, a CT service was initiated, but with the prerequisite approval of a cardiologist before performance of the CT. Each individual who wanted and was willing to pay for a cardiac CT was interviewed by an experienced cardiologist who determined whether cardiac MDCT was the most appropriate next test in the cardiovascular evaluation. Subjects were classified into three groups: a) those with a normal or no prior stress test, no typical symptoms and no significant risk factors of coronary artery disease were recommended to perform a stress test or to remain under close clinical follow-up without MDCT; b) those with an equivocal stress test, atypical symptoms and/or significant risk factors were allowed to have cardiac MDCT; and c) those with positive stress test or clinically highly suspected CAD[2] were advised to go directly to invasive coronary angiography. CT findings were categorized as normal CAD (normal calcium score and no narrowings), < 50% and > 50% CAD.

Results: A total of 254 people were interviewed, and in only 39 cases did the cardiologist approve the CT. However, 61 of the 215, despite our recommendation not to undergo CT, decided to have the scan. Assessment of the 100 cases that underwent MDCT showed a statistically significant better discrimination of significant CAD, according to the cardiologist’s recommendation: MDCT not recommended in 3/54 (6%) vs. MDCT recommended in 12/39 (31%) vs. recommended invasive coronary angiography in 4/7 (57%) (P < 0.001).

Conclusions: Detection of coronary calcification, as well as MDCT angiography can provide clinically useful information if applied to suitable patient groups. It is foreseeable that MDCT angiography will become part of the routine workup in some subsets of patients with suspected CAD. Selection of patients undergoing MDCT scans by a cardiologist improves the ability of the test to stratify patients, preventing unnecessary scans in both high and low risk patients






[1] MDCT = multi-detector computed tomography

[2] CAD = coronary artery disease


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