Optimization of 13 C-urea breath test threshold levels for the detection of Helicobacter pylori infection in a national referral laboratory.

BACKGROUND: Threshold values for 13 C-urea breath test (13C-UBT) positivity may be affected by various sociodemographic, host, bacterial, and laboratory factors. Manufacturer recommended cutoffs for 13C-UBT assays may not be applicable in all settings. Optimizing 13C-UBT cutoffs may have profound public health ramifications. We aimed to determine the optimal threshold for 13C-UBT positivity in our population. METHODS: Consecutive test samples collected at our central laboratory from patients undergoing a first-time 13C-UBT between 1 January 2010 and 31 December 2015 were included. The difference between values at 30 minutes and at baseline (T30-T0) was expressed as delta over baseline (DOB). Cluster analysis was performed on the 13C-UBT test results to determine the optimal cutoff point with minimal interclass variance. RESULTS: Two lakhs thirty four thousand eight hundred thirty one patients (87 291 (37.2%) male, age 39.9 ± 19.9) underwent a first-time 13C-UBT, including 124 701 (53.1%) negative and 110 130 (46.9%) positive tests, using the manufacturer-recommended cutoff of 3.5 DOB. Cluster analysis determined an optimized cutoff of 2.74 DOB, representing an additional 2180 (0.93%) positive subjects who had been previously categorized as negative according to the manufacturer-specified cutoff of 3.5 DOB. Mean positive and negative DOB values were 19.54 ± 14.95 and 0.66 ± 0.51, respectively. The cutoffs for male and female subjects were 2.23 and 3.05 DOB, respectively. Threshold values for <45-year-olds, 45-60-year-olds and >60-year-olds were 2.67, 2.55, and 2.93 DOB, respectively. Of the 2180 (0.93%) patients with DOB 2.73-3.49, 289 (13.3%) performed a subsequent 13C-UBT and 140 (48.4%) remained positive when tested at 20.3 ± 14.4 months. CONCLUSIONS: Major referral laboratories should optimize threshold values for 13C-UBT positivity for their geographical location. Different cutoff values should be applied for male and female subjects.

Endoscopic findings and esophageal cancer incidence among Fanconi Anemia patients participating in an endoscopic surveillance program.

BACKGROUND AND AIMS: The primary clinical characteristics of Fanconi Anemia (FA) include typical physical features, progressive bone marrow failure, and an increased incidence of neoplasms, including esophageal carcinoma. Currently, there are no data regarding endoscopic findings or the interval time to malignancy in these patients. Data about the contribution of Human Papilloma Virus (HPV) to esophageal carcinoma is conflicting. Our objective is to document the upper gastrointestinal (GI) findings at baseline, document cancer incidence, and evaluate the role of HPV among these cancers. METHODS: We reviewed endoscopic and clinical data of FA subjects who participated in active surveillance before cancer diagnosis. Incident esophageal cancers were stained for HPV p16 protein. RESULTS: Eight FA patients were included (men 62.5%; median age at first endoscopy 20 years, median endoscopies number: 5.5). At baseline, 8/8 had endoscopic evidence for reflux esophagitis. In 3/8 the reflux esophagitis was mild and in 5/8 it was moderate or severe. During the follow up time (median time 4.5 years 2/8 developed Barrett's esophagus and 2/8 patients had incident esophageal squamous cell carcinoma during follow up, at intervals of eight and eighteen months from the previous upper endoscopy. Both cancers stained negative for HPV P16. CONCLUSIONS: FA subjects have both an extremely high risk for esophageal cancer within short intervals and a very high prevalence of reflux esophagitis with various severities. Active surveillance programs in specialized centers including annual upper endoscopies should be considered in these patients.

Video capsule endoscopy is safe and effective in suspected small bowel bleeding among left ventricular assist device recipients.

INTRODUCTION:: Suspected small bowel bleeding is frequently encountered in left ventricular assist device recipients and the identification of the culprit lesion may be challenging. Data regarding the safety and yield of small bowel capsule in the investigation of suspected small bowel bleeding are limited. We aimed to evaluate the safety and efficacy of small bowel video capsule endoscopy for the investigation of suspected small bowel bleeding among left ventricular assist device recipients. METHODS:: Patients with left ventricular assist device who underwent video capsule endoscopy for the investigation of suspected small bowel bleeding were identified. Suspected small bowel bleeding was defined as the presence of overt bleeding at least 30 days following left ventricular assist device implantation with no identifiable cause in upper and lower endoscopy. RESULTS:: A total of 10 patients with left ventricular assist device associated suspected small bowel bleeding performed 12 small bowel capsule endoscopies between January 2008 and December 2015 at our tertiary medical care facility. There were no cases of capsule retention or any other serious adverse events during the exams. A significant finding was identified in 8 out of 10 patients, including 3 cases of small bowel angioectasia, 2 cases of small bowel ulcers, 1 case of cecal polyp, and 2 cases of active bleeding with no apparent bleeding source. Small bowel enteroscopy identified and treated bleeding angioectasia in the latter two cases. CONCLUSION:: Small bowel capsule endoscopy is safe and effective in the investigation of left ventricular assist device associated suspected small bowel bleeding.

The Utility of Failure Modes and Effects Analysis of Consultations in a Tertiary, Academic, Medical Center.

BACKGROUND: Failure modes and effects analysis (FMEA) is a tool used to identify potential risks in health care processes. We used the FMEA tool for improving the process of consultation in an academic medical center. METHODS: A team of 10 staff members-5 physicians, 2 quality experts, 2 organizational consultants, and 1 nurse-was established. The consultation process steps, from ordering to delivering, were computed. Failure modes were assessed for likelihood of occurrence, detection, and severity. A risk priority number (RPN) was calculated. An interventional plan was designed according to the highest RPNs. Thereafter, we compared the percentage of completed computer-based documented consultations before and after the intervention. RESULTS: The team identified 3 main categories of failure modes that reached the highest RPNs: initiation of consultation by a junior staff physician without senior approval, failure to document the consultation in the computerized patient registry, and asking for consultation on the telephone. An interventional plan was designed, including meetings to update knowledge of the consultation request process, stressing the importance of approval by a senior physician, training sessions for closing requests in the patient file, and reporting of telephone requests. The number of electronically documented consultation results and recommendations significantly increased (75%) after intervention. CONCLUSION: FMEA is an important and efficient tool for improving the consultation process in an academic medical center.

Risk of Neoplastic Progression Among Patients with an Irregular Z Line on Long-Term Follow-Up.

BACKGROUND: Barrett's esophagus (BE) is a known complication of gastroesophageal reflux disease. In a previous study, we described a high prevalence of intestinal metaplasia (IM) in patients with an irregular Z line. However, the clinical importance of this finding is unclear. GOALS: To evaluate the long-term development of BE and relevant complications in patients diagnosed with an irregular Z line, with or without IM, on routine esophago-gastro-duodenoscopy (EGD). METHODS: In our previously described cohort, 166 out of 2000 consecutive patients were diagnosed with an incidental irregular Z line. Of those with irregular Z line, 43% had IM. In this continuation study, patients' status was reassessed after a median follow-up of 70 months. Patients were divided into two groups: Patients with IM (IM-positive group) and without IM (IM-negative group). The incidence of long-term development of BE, dysplasia, and esophageal adenocarcinoma were compared between groups. RESULTS: At least one follow-up EGD was performed in 102 (61%) patients with an irregular Z line. Endoscopic evidence of BE was found in eight IM-positive patients (8/50 [16%]) and in one IM-negative patient (1/52 [1.9%]). Two (4%) IM-positive patients developed BE with low-grade dysplasia. None of the patients developed high-grade dysplasia, or esophageal adenocarcinoma. CONCLUSIONS: Patients with irregular Z line do not develop major BE complication in more than 5 years of follow-up.

Helicobacter pylori infection is positively associated with an increased BMI, irrespective of socioeconomic status and other confounders: a cohort study.

BACKGROUND: Data on the association of Helicobacter pylori infection and BMI are conflicting. The fact that both H. pylori infection and BMI are associated with low socioeconomic status (SES) makes this relationship difficult to characterize. MATERIALS AND METHODS: We aimed to evaluate the association between BMI and H. pylori infection after adjusting for multiple covariates. We analyzed a cohort of 235 107 individuals aged 18 years or older, who performed a C urease breath test (C-UBT), from 2007 to 2014. Data on BMI, age, sex, SES, ethnicity, and medications were extracted from a nationwide population-based database. BMIs were classified according to the WHO recommendations: underweight (<18.5 kg/m), normal weight (18.5-24.9 kg/m), overweight (25-29.9 kg/m), obese class I (30-34.9 kg/m), and obese class II or more (>35 kg/m). STUDY RESULTS: The positivity rate for H. pylori among underweight, normal weight, overweight, and obese class I and class II or more was 55.6, 58.5, 63.0, 64.5, and 65.5%, respectively (P<0.001, Plinear trend 0.007). The association between BMI and H. pylori infection was significant across all SES, sex, ethnicity, and age categories. After adjusting for age, sex, ethnicity, and SES, being overweight and obese class I and class II or more were associated significantly with H. pylori positivity: odds ratio 1.13 [95% confidence interval (CI): 1.11-1.15], 1.14 (95% CI: 1.11-1.17), and 1.15 (95% CI: 1.11-1.19), respectively, P value less than 0.001 for all. CONCLUSION: Among individuals who were referred to a C-UBT by primary care physician, after adjusting for multiple covariates including SES, we found a positive association between H. pylori infection and an increased BMI.

Smoking increases the likelihood of Helicobacter pylori treatment failure.

BACKGROUND AND AIMS: Data regarding the impact of smoking on the success of Helicobacter pylori (H. pylori) eradication are conflicting, partially due to the fact that sociodemographic status is associated with both smoking and H. pylori treatment success. We aimed to assess the effect of smoking on H. pylori eradication rates after controlling for sociodemographic confounders. METHODS: Included were subjects aged 15 years or older, with a first time positive C13-urea breath test (C13-UBT) between 2007 to 2014, who underwent a second C13-UBT after receiving clarithromycin-based triple therapy. Data regarding age, gender, socioeconomic status (SES), smoking (current smokers or "never smoked"), and drug use were extracted from the Clalit health maintenance organization database. RESULTS: Out of 120,914 subjects with a positive first time C13-UBT, 50,836 (42.0%) underwent a second C13-UBT test. After excluding former smokers, 48,130 remained who were eligible for analysis. The mean age was 44.3±18.2years, 69.2% were females, 87.8% were Jewish and 12.2% Arabs, 25.5% were current smokers. The overall eradication failure rates were 33.3%: 34.8% in current smokers and 32.8% in subjects who never smoked. In a multivariate analysis, eradication failure was positively associated with current smoking (Odds Ratio {OR} 1.15, 95% CI 1.10-1.20, p<0.001), female gender (OR 1.20, 95% CI 1.14-1.25, p<0.001) and a low socioeconomic status (OR 1.24, 95% CI 1.17-1.31, p<0.001). CONCLUSIONS: After controlling for socio-demographic confounders, smoking was found to significantly increase the likelihood of unsuccessful first-line treatment for H. pylori infection.

Acute care for exercise-induced hyperthermia to avoid adverse outcome from exertional heat stroke.

INTRODUCTION: Exertional heat stroke (EHS) is a major concern in military trainees performing intense physical exercise, with substantial morbidity rates. Prehospital diagnosis of EHS is essentially clinical. Thus, soldiers, command personnel, and medical staff are taught to recognize this injury and immediately begin aggressive treatment to prevent further deterioration. PATIENTS AND METHODS: During 2007, 5 otherwise healthy Israeli Defense Forces (IDF) soldiers were diagnosed with EHS while performing strenuous exercise. They were treated vigorously according to the IDF EHS-treatment protocol and were referred to the emergency department. RESULTS: On arrival at the emergency department, physical examination including rectal temperature was unremarkable in all soldiers. Blood and urine workup showed near-normal values. No other medical conditions that could have explained the clinical presentation were found. All soldiers were discharged shortly afterward, with no further consequences. A heat-tolerance test was performed several weeks after the event and was interpreted as normal. All soldiers returned to active service. CONCLUSION: Because the initial clinical findings were very suggestive of EHS and because no other condition could have explained the prehospital transient hyperthermia, we suggest that these soldiers were correctly diagnosed with EHS, and we propose that rapid vigorous cooling prevented further deterioration and complications. We suggest calling this condition aborted heat stroke.

Trends of stress fracture prevalence among Israel Defense Forces basic trainees.

Stress fractures (SFs) are a common type of overuse injury encountered in training soldiers. High rates of SF may cause a tremendous negative effect on the military unit capability to perform its missions. In this study, we reviewed the medical registry of Israel Defense Forces (IDF) soldiers assigned to combat basic training programs between the years 1998 and 2007. SF rates among IDF combat basic trainees were as high as 20% in several companies during the first years of the study. Amendments in training programs were targeted to fit the different capability and the qualifications required from combat soldiers. As a result, a steady decline of SF rates was observed, with a yearly average of 5% in the later years of the study. Increasing awareness of both medical and commanding personnel to SF and their prevention led to the gradual decline in their frequency observed in IDF basic training programs during recent years.

Changing trends of peritonsillar abscess.

OBJECTIVE: This retrospective, cohort study aims to assess the changing characteristics of peritonsillar abscess (PTA). METHOD: Data were obtained from PTA patient records admitted to a secondary hospital over a 10-year period. RESULTS: A total of 427 patients, aged 31.6 +/- 15.2 years (range, 3-91), were treated for PTA, reflecting an incidence of 0.9/10 000/y. Forty-seven (11%) patients had more than one episode. There was no sex, seasonal, or side predominance. Thirteen (3%) patients developed complications. One hundred four (24.4%) patients were 40 years or older, had a longer hospital stay, and were prone to complications. One hundred two (23.8%) patients did not have an anteceding pharyngotonsillitis. Smoking was more common among patients with PTA as compared with the general population and was associated with more complications. A total of 283 (66.2%) patients developed PTA in spite of prior antibiotic therapy; 51.1% of smokers that received prior antibiotics had a higher incidence of Streptococcus viridans isolates. CONCLUSION: Peritonsillar abscess may have changed its characteristics: affecting more older patients having a worse and longer course and PTA evolvement without anteceding tonsillitis or in spite of a prior adequate antibiotic therapy. Smoking may be a predisposing factor.

Eager blood donor.

Blood donor questionnaire is an integral component of blood safety, designed to identify and disqualify donors who do not fit certain criteria. One of the criteria is the time interval between 2 consecutive donations because repeated blood donors are exposed to adverse effects of frequent donations. We describe a 19-year-old healthy Israeli Defense Forces male soldier who has been detected by the Israeli National Blood Services only after his fifth voluntary blood donation within 12 weeks. The soldier was asymptomatic, yet blood examination revealed iron deficiency anemia with a low ferritin level. This case demonstrates the limitations of blood donation processing, which fortunately ended with no substantial morbidity. We discuss the possible obstacles in that process.

Intersex patients in military service.

The term "intersex" describes a variety of medical conditions in which sex determination is atypical. One of its most severe forms is an inadequate response to androgens due to mutations in the androgen receptor gene, which may manifest as a complete androgen insensitivity syndrome (CAIS). In this form of intersex condition, genetically male individuals do not form masculine genitalia, but have a female phenotype. Officially, Israel Defense Forces policy does not prohibit intersex patients' draft. However, it is uncommon to encounter intersex patients in the military setting. In this report, we describe a case of a combat Israeli Defense Forces female soldier, whose CAIS diagnosis was not reported to the military health authorities before her recruitment, but was revealed only during active service. Medical and other professional issues were discreetly handled, permitting her to successfully fulfill her 2 years of duty service. Although CAIS is a rare entity, it should be appropriately addressed in medical, psychological, social, and command aspects in the unique military setting. Our recommendation is to allow intersex patients military service, but not in combat units.