Prevalence of the use of oral nutritional supplements among acute inpatients at risk of malnutrition and associated patient characteristics.

AIM: To provide a snapshot of the current use of oral nutritional supplements, its association with inpatient characteristics, and with a focus on the role of nursing monitoring of food intake and implementing nutritional interventions for patients with low intake. DESIGN: Retrospective cohort study. METHODS: The study collected data from a hospital database regarding oral nutritional supplement initiation and variables of patients hospitalised in internal medicine departments, who did not receive enteral or parenteral nutrition. RESULTS: Of the 5155 admissions, 1087 fulfilled the inclusion criteria (47% female; mean age, 72.4 ± 14.6 years; mean length of stay, 14.6 ± 11.4 days). Sufficient food intake reporting was noted in 74.6% of the patients; of these 17% had decreased intake. Oral nutritional supplements and non-oral nutritional supplements groups did not differ in terms of sex, age, length of stay, Charlson Comorbidity Index, proportion of nursing reports, and absence of intake monitoring. Oral nutritional supplements were initiated in 31.9% of patients with a Malnutrition Universal Screening Tool score ≥2 and in 34.6% with decreased food intake. On multivariable analysis, hypoalbuminemia (adjusted odds ratio, 3.70), decreased food intake (adjusted odds ratio, 3.38), Malnutrition Universal Screening Tool score ≥2 (adjusted odds ratio, 2.10), and age <70 years (adjusted odds ratio, 1.56) were significantly associated with oral nutritional supplements use. CONCLUSION: The prevalence of oral nutritional intervention was suboptimal in patients at risk of malnutrition during acute hospitalisation, although decreased food intake and Malnutrition Universal Screening Tool score ≥2 independently increased the probability of oral nutritional supplements initiation. RELEVANCE IN CLINICAL PRACTICE: Understanding the clinical practice and nursing impact of care management in relation to nutritional intervention can assist in reviewing and improving patient care. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE IMPACT (ADDRESSING): This study informs clinical management and influences nursing practice standards related to assessing, monitoring, and managing malnutrition risk. IMPACT: The study impacts the quality of care for patients at risk of malnutrition. REPORTING METHOD: We adhered to the STROBE Checklist for cohort studies. PATIENT OR PUBLIC CONTRIBUTION: No Patient or Public Contribution.

Real-world effectiveness of tofacitinib in patients with rheumatoid arthritis: a prospective observational study.

OBJECTIVES: Tofacitinib is an approved treatment for rheumatoid arthritis (RA), but data on its use in the "real-world" are limited. We sought to analyse tofacitinib drug survival in the Israeli registry and compare it to other biologic agents. METHODS: We included RA patients treated with tofacitinib, etanercept, golimumab, tocilizumab, or abatacept between 2010-2019. The primary endpoint was event-free survival (EFS), defined as the time from treatment initiation to a treatment failure event from any cause (i.e., inefficacy or intolerability). EFS was compared between agents using Cox regression and Kaplan-Meier analysis, stratifying patients by treatment line. RESULTS: A total of 964 eligible treatment courses were included (tocilizumab [325], etanercept [284], abatacept [127], tofacitinib [139], and golimumab [109]). In a univariate analysis, EFS with tofacitinib in the complete cohort was similar to etanercept, golimumab, and abatacept but was lower than tocilizumab) 3-year EFS 43% vs. 53%, HR 0.65). In a multivariable analysis, tofacitinib was similar to all other drugs, except for etanercept, which was inferior (HR 1.70); advanced treatment line was also associated with greater risk for failure (HR 1.64). In a univariable analysis stratified by the treatment line, tofacitinib had similar or better drug survival than other agents in the first and second lines. In the third line and beyond, tocilizumab had a higher EFS compared to tofacitinib (HR 0.57). CONLUSIONS: Drug survival with tofacitinib is related to treatment line. Early introduction is associated with similar or better survival than other agents, whereas tocilizumab was superior in the third line or later.

The epidemiology of Staphylococcus aureus bacteraemia in Israeli children: Community- vs hospital-acquired or healthcare related infections.

AIM: Incidences of Staphylococcus aureus bacteraemia (SAB) in Israeli children are unknown. The characteristics of SAB in children have not been evaluated. METHODS: SAB from children aged ≤18 years old, admitted to a tertiary hospital in Israel during 2002-2015, were included. The proportional rate of SAB was calculated per 1000 admissions. SAB were classified as community acquired (CA), hospital acquired (HA) and healthcare related (HCR). Patients' characteristics, antibiotic susceptibility and outcomes were assessed in each group. RESULTS: The rate of SAB was stable, 1.48 per 1000 admissions. HA, CA and HCR-SAB comprised 53%, 25% and 22%, respectively. Only 27/185 (14.6%) were caused by methicillin-resistant S aureus (MRSA): 22%, 6% and 5% of HA, CA and HCR-SAB, respectively. Central venous catheter, recent surgery, immunodeficiency and age <6 years were the main risk factors for HA and HCR-SAB (adjusted OR: 68.9, 7.5, 5.8 and 5.5, respectively). Treatment duration for CA was >21 days: and for HA and HCR, 14-20 days. All-cause in-hospital mortality and 30-day mortality were documented in 10 (5%) and 3 (2%) episodes, respectively. CONCLUSION: The rate of SAB; the proportions of CA, HA and HCR-SAB; and the proportion of MRSA was stable over the years. MRSA was mainly in HA-SAB. Thirty-day mortality was rare.

The association between serum magnesium levels and community-acquired pneumonia 30-day mortality.

BACKGROUND: Community acquired pneumonia (CAP) is a common illness affecting hundreds of millions worldwide. Few studies have investigated the relationship between serum magnesium levels and outcomes of these patients. We aimed to study the association between serum magnesium levels and 30-day mortality among patients with CAP. METHODS: Retrospective overview of patients hospitalized with CAP between January 1, 2010 and December 31, 2016. Participants were analyzed retrospectively in order to identify the risk factors for a primary endpoint of 30-day mortality. Normal levels of magnesium levels in our laboratory varies between 1.35 and 2.4 mg/dl. RESULTS: 3851 patients were included in our cohort. Age > 75 years, blood urea nitrogen (BUN) > 20 mg/dl, hypoalbuminemia, and abnormal levels of magnesium were all associated with increased risk of 30-day mortality. Normal magnesium levels were associated with the lowest mortality rate (14.7%). Notably, within the normal levels, high normal magnesium levels (2-2.4 mg/dl) were correlated with higher mortality rates (30.3%) as compared to levels that ranged between 1.35-2 mg/dl (12.9%). Hypomagnesemia and hypermagnesemia were both associated with excess of 30-day mortality, 18.4 and 50%, respectively. CONCLUSION: Hypomagnesemia and hypermagnesemia on admission were associated with an increased rate of 30-day mortality among adult patients hospitalized with CAP. Interestingly, magnesium levels within the upper normal limits were associated with higher mortality.

Prevalence of Iron Deficiency and Iron Deficiency Anemia in Strenuously Training Male Army Recruits.

OBJECTIVES: The objectives of our study were to determine the effect of strenuous physical training on the prevalence of iron deficiency anemia (IDA), iron deficiency (ID) with normal hemoglobin (Hb), and anemia without ID. METHODS: Our study was a prospective observational study. We followed 115 healthy male recruits in the Israel Defense Forces elite units during 15 months of training. Blood samples were collected at recruitment and at 6-, 9- and 15-month follow-ups. RESULTS: Upon recruitment, anemia (Hb < 14 g/dL), ID, and ID anemia (IDA) were diagnosed in 28, 31, and 9% of individuals, respectively. Sixty-three subjects (54%) were followed for 6 months; 9 of them (14%) developed new-onset IDA. Among them, the prevalence of anemia rose from 19 to 52%, and ID from 33 to 35%. At the 15-month follow-up, 29% had developed new-onset IDA and 65% showed evidence of ID. CONCLUSION: We report a high prevalence of anemia, ID, and IDA among young healthy males participating in prolonged strenuous training programs. These findings can be partly explained by the physiological changes associated with strenuous physical activity. Further investigations aiming to develop specific diagnostic guidelines for this unique population are warranted.

The cultural expression of spiritual distress in Israel.

BACKGROUND: Although spiritual distress is present across cultures, the ways in which patients experience it vary between cultures. Our goal was to examine the cultural expression and key indicators of spiritual distress in Israel. METHODS: We conducted a structured interview of 202 oncology outpatients in a cross-sectional study. Self-diagnosis of spiritual distress, which is a demonstrated gold standard for identifying its presence, was compared with the Facit-Sp-12 and a number of other items (from the Spiritual Injury Scale and newly developed Israeli items) hypothesized as Israeli cultural expressions of spiritual distress, demographic and medical data, and patient desire to receive spiritual care. RESULTS: Significant variation was found between Israeli cultural expression of spiritual distress and that found in studies from other countries. Key expressions of spiritual distress in this study included lack of inner peace, grief, and an inability to accept what is happening. Items related to faith were not significant, and loss of meaning showed mixed results. Patients requesting spiritual care were more likely to be in spiritual distress. No demographic or medical data correlated with spiritual distress. CONCLUSIONS: Specially designed interventions to reduce spiritual distress should address the expressions of the distress specific to that culture. Studies of the efficacy of spiritual care can examine the extent of spiritual distress in general or of its specific cultural expressions.

Modification of initial therapy in early and advanced Hodgkin lymphoma, based on interim PET/CT is beneficial: a prospective multicentre trial of 355 patients.

This multicentre study evaluated 5-year progression-free (PFS) and overall survival (OS) in early and advanced Hodgkin lymphoma (HL), where therapy was individualized based on initial prognostic factors and positron emission tomography-computed tomography performed after two cycles (PET-2). Between September 2006 and August 2013, 359 patients aged 18-60 years, were recruited in nine Israeli centres. Early-HL patients initially received ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) ×2. Depending on initial unfavourable prognostic features, PET-2-positive patients received additional ABVD followed by involved-site radiotherapy (ISRT). Patients with negative PET-2 and favourable disease received ISRT or ABVD ×2; those with unfavourable disease received ABVD ×2 with ISRT or, alternatively, ABVD ×4. Advanced-HL patients initially received ABVD ×2 or escalated BEACOPP (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, prednisone; EB) ×2 based on their international prognostic score (≤2 or ≥3). PET-2-negative patients further received ABVD ×4; PET-2-positive patients received EB ×4 and ISRT to residual masses. With a median follow-up of 55 (13-119) months, 5-year PFS was 91% and 69% for PET-2-negative and positive early-HL, respectively; 5-year OS was 100% and 95%, respectively. For advanced-HL, the PFS was 81% and 68%, respectively (P = 0·08); 5-year OS was 98% and 91%, respectively. PET-2 positivity is associated with inferior prognosis in early-HL, even with additional ABVD and ISRT. Advanced-HL patients benefit from therapy escalation following positive PET-2. EB can be safely de-escalated to ABVD in PET-2-negative patients.

Biopsy of breast cancer metastases: patient characteristics and survival.

BACKGROUND: Discordance in hormone receptors (HR) and human epidermal growth factor receptor 2 (HER2) status between primary tumors and metastatic sites for breast cancer is well established. However, it is uncertain which patient-related factors lead to biopsy when metastases are suspected and whether having a biopsy impacts survival. METHODS: The medical charts of metastatic breast cancer (MBC) patients diagnosed January 2000-August 2014 were retrospectively reviewed. A biopsy was defined as a procedure where tissue was obtained and assessed for both HR and HER2. Both bivariate and multivariate analyses were performed to assess patient characteristics related to biopsy and whether having a biopsy was associated with improved survival. RESULTS: Of 409 patients suspected of having MBC, 165 (40%) had a biopsy, and 34% of these had discordant HR or HER2 status when compared to the initial diagnosis. In multivariate analysis, having a biopsy was associated with: recurrence in years 2010-2014, disease-free interval of > =3 years, stage 0-IIA at presentation, suspected locoregional recurrence, being HR+/HER2-, or missing HR/HER2 at diagnosis. A similar multivariate analysis revealed that having a biopsy was associated with improved survival (HR = 0.67, p = 0.002). The association of biopsy and improved survival was noted in specific subgroups: patients with missing HR and HER2 data at initial diagnosis (p = 0.001), those without metastases in liver, lung or brain (p = 0.001), and being younger than 70 years old at recurrence (p < 0.001). CONCLUSIONS: Specific clinical factors were associated with biopsy at the time of suspected recurrence. Having a biopsy was associated with reduced mortality.

Hypothyroxinemia and Risk for Transient Tachypnea of Newborn.

Transient tachypnea of newborn is associated with hypothyroxinemia in animals via decreased stimulation of beta-adrenergic receptors and Na-K-ATPase activity. In 26 549 term neonates, serum total thyroxine <14 ug/dL, male sex, and elective cesarean delivery were significantly associated with greater risk for transient tachypnea of newborn.

Treatment of Carbapenem-Resistant Acinetobacter baumannii Ventilator-Associated Pneumonia: Retrospective Comparison Between Intravenous Colistin and Intravenous Ampicillin-Sulbactam.

Carbapenem-resistant Acinetobacter baumannii has been increasingly reported as the causative agent of ventilator-associated pneumonia (VAP) among patients in the intensive care units. However, there are insufficient data to guide the appropriate treatment for such infection. Our aim was to compare the outcome of carbapenem-resistant A. baumannii VAP treated with colistin or with ampicillin-sulbactam. We conducted a retrospective study of patients diagnosed with carbapenem-resistant A. baumannii VAP during 2008 and 2009. Clinical and microbiologic cure rates, 30-day mortality, and change in renal function were compared between patients treated with colistin versus those treated with ampicillin-sulbactam. The association between treatment and mortality was examined through multivariable logistic regression analysis. Of the 98 patients diagnosed with carbapenem-resistant A. baumannii VAP, 66 were treated with colistin and 32 with ampicillin-sulbactam. Baseline characteristics of patients were similar, except for a longer intensive care unit stay and lower creatinine clearance test before VAP diagnosis among patients treated with colistin. Clinical cure rates were similar in the 2 groups. In the colistin group, microbiologic failure rates were higher at 7 days [16/33 (48%) vs. 3/17 (18%); P = 0.03]; patients had a more significant elevation in creatinine (+0.2 ± 1.0 mg/dL vs. -0.3 ± 1.1 mg/dL; P = 0.021), and treatment was associated with an increased 30-day mortality (adjusted-odds ratio, 6.5; 95% confidence interval, 1.348-31.342; P = 0.02). In conclusion, patients treated with colistin or ampicillin-sulbactam had similar clinical cure rates. However, colistin was associated with higher rates of microbiologic failure, reduction in renal function, and an increased 30-day mortality. A prospective study comparing high-dose colistin and ampicillin-sulbactam for the treatment of carbapenem-resistant A. baumannii VAP is warranted.

Do Wound Cultures Give Information About the Microbiology of Blood Cultures in Severe Burn Patients?

BACKGROUND: Blood stream infection (BSI) and the subsequent development of sepsis are among the most common infection complications occurring in severe burn patients. This study was designed to evaluate the relationship between the burn wound flora and BSI pathogens. METHODS: Documentation of all bacterial and fungal wound and blood isolates from severe burn patients hospitalized in the burn unit and intensive care unit was obtained from medical records retrieved retrospectively from a computerized, hospital-wide database over a 13-year period. All data were recorded in relation to the Ryan score. RESULTS: Of 195 severe burn patients, 88 had at least 1 BSI episode. Transmission of the same pathogen from wound to blood was documented in 30% of the patients, with a rising BSI frequency as the Ryan score increased. There were a total of 263 bacteremic episodes in 88 study patients, 44% of blood isolates were documented previously in wound cultures, and transmission of the same pathogen from wound to blood was noted in 65% of bacteremic patients. CONCLUSIONS: When there is clinical suspicion of sepsis, appropriate empirical systemic antibiotic therapy should be broad spectrum and should rely on the susceptibility of the organisms from recent cultures of the burn wound surface, until the blood cultures results are completed.

The effect of complementary and alternative medicine on quality of life, depression, anxiety, and fatigue levels among cancer patients during active oncology treatment: phase II study.

BACKGROUND: During the past decade, there has been growing interest in complementary and alternative medicine (CAM) among cancer patients and it is being integrated more frequently within conventional cancer centers. The long-term effect of mind-body therapies on quality of life (QoL), depression, anxiety, and fatigue was tested prospectively in this study. PATIENTS AND METHODS: Cancer patients who received six weekly sessions of CAM during their oncological treatments participated in the study. The Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI) and QoL-EORTC-C30 were completed during the intervention and follow-up period. RESULTS: Over a two-year period, 163 patients entered the study, 135 of whom completed all six CAM sessions. An improvement was demonstrated in the median of BFI from 4.8 to 3.9 (p < 0.001), HADS-Anxiety from 8 to 7 (p < 0.001) and HADS-Depression from 7 to 6 (p < 0.001) after 12 weeks. In addition, the median of global QoL improved from 50 to 67 (p < 0.001), and a significant improvement was noticed in several parameters on the functioning and symptoms scales of the QoL-EORTC-C30. CONCLUSION: Cancer patients who completed six weekly sessions of CAM improved significantly on measured outcomes, regardless of their demographic characteristics.

Is elevated red cell distribution width a prognostic predictor in adult patients with community acquired pneumonia?

BACKGROUND: Community acquired pneumonia (CAP) is a major cause of morbidity and mortality. We recently demonstrated that among young patients (<60 years old) with CAP, elevated red blood cell distribution width (RDW) level on admission was associated with significant higher rates of mortality and severe morbidity. We aimed to investigate the prognostic predictive value of RDW among CAP patients in general population of internal wards. METHODS: The cohort included patients of 18 years old or older who were diagnosed with CAP (defined as pneumonia identified 48 hours or less from hospitalization) between January 1, 2005 and December 31, 2010. Patients were retrospectively analyzed for risk factors for a primary endpoint of 90-day mortality. Secondary endpoint was defined as complicated hospitalization (defined as at least one of the following: In- hospital mortality, length of stay of at least 10 days or ICU admission). Binary logistic regression analysis was used for the calculation of the odds ratios (OR) and p values in univariate and multivariate analysis to identify association between patient characteristic, 90-day mortality and complicated hospitalization. RESULTS: The cohort included 3815 patients. In univariate analysis, patients with co-morbid conditions tended to have a complicated course of CAP. In multivariate regression analysis, variables associated with an increased risk of 90-day mortality included age > 70 years, high Charlson comorbidity index (>2), Hb < 10 mg/dl, Na <130 meq/l, blood urea nitrogen (BUN) >30 mg/dl, systolic blood pressure < 90 mmHg and elevated RDW >15%. Variables associated with complicated hospitalization included high Charlson comorbidity index, BUN > 30 mg/dl, hemoglobin < 10 g/dl, heart rate >124 bpm, systolic blood pressure < 90 mmHg and elevated RDW. Mortality rate and complicated hospitalization were significantly higher among patients with increased RDW regardless of the white blood cell count or hemoglobin levels. CONCLUSIONS: Elevated RDW levels on admission are associated with significant higher rates of mortality and severe morbidity in adult patients with CAP. RDW as a prognostic marker was unrelated with hemoglobin levels, WBC count, age or Charlson score.

Evaluation of prevalence of food intake monitoring during acute hospitalization and its association with malnutrition screening scores of inpatients who were not considered for enteral or parenteral nutrition.

OBJECTIVES: Malnutrition risk can be recognized by nurses using screening tools and food intake monitoring. We measured the prevalence of food intake reporting and its association with malnutrition screening scores or other patient characteristics. METHODS: This retrospective cohort study collected hospital database information regarding patients aged ≥18 y who were hospitalized for ≥ 7 consecutive days and were orally fed or had medical records that no tube feeding or parenteral nutrition had been administered. Data were collected and statistically analyzed focusing on food intake reporting, Malnutrition Universal Screening Tool (MUST) scores, oral nutritional intervention, and other secondary characteristics. RESULTS: Out of 5155 patients admitted to two internal medicine departments over 1 y (July 1, 2018, through August 31, 2019), 1087 fulfilled the inclusion criteria with a mean age of 72.4 ± 14.6 y; of these, 74.6% had sufficient food intake reports. No food intake was reported for one-third of patients with MUST scores ≥ 2. There were no differences between the groups of patients with and without reported food intake with regard to MUST scores, sex, mean albumin level, comorbidity, length of stay, all-cause in-hospital mortality, hospital-acquired pressure injury, or the rate of oral nutritional intervention. MUST scores ≥ 2 were not significantly associated with intake reporting. Increased probability of having food intake reported was found in patients ages ≥70 y (adjusted odds ratio = 1.36; P = 0.036 [95% CI, 1.02-1.82]) and those who had Norton scores ≤ 13 (adjusted odds ratio = 1.60; P = 0.013 [95% CI, 1.10-2.31]). However, the model had a weak predictive efficacy (area under the curve = 0.577; P < 0.0001 [95% CI, 0.538-0.616]). CONCLUSIONS: More adherence to food intake monitoring guidelines is needed.

Absence of oral nutritional support in low food intake inpatients is associated with an increased risk of hospital-acquired pressure injury.

BACKGROUND & AIMS: Hospital-acquired pressure injury (HAPI) incidence is a common burden in hospitals. Decreased food intake leading to malnutrition compromises body tissues involved in pressure injury occurrence. However, most tools for predicting pressure injuries do not include daily food intake monitoring nor consider further nutritional interventions. This study aimed to investigate clinical practices for food intake monitoring and its association with predicting HAPI risk, together with Norton Scale use, and whether the initiation or absence of oral nutritional supplements (ONS), separately from other nutritional interventions, was associated with HAPI incidence in low food intake inpatients, who consumed less than 50% of requirements. METHODS: This observational cohort study covered a one-year period (08/2018-07/2019). Demographic and clinical data were extracted from computerized files of patients hospitalized ≥7 days, aged ≥60 years, and who ate orally. Patients receiving enteral or parenteral nutrition were excluded. Differences were studied between groups without and with HAPI grade ≥2. Subgroups divided by Norton Scale and intake, Norton Scale and albumin levels, food intake and initiation (or not) of any nutritional intervention versus ONS only, were examined for the consistency of association with HAPI. RESULTS: Of the 5155 admissions during the study period, 895 patients fulfilled the inclusion criteria: 48% female, mean age 77.6 ± 9.1 years, 11% with MUST score ≥2. Nutritional intake was reported in 76% of patients, of them 22% had low food intake, and 9% of the study group developed HAPI grade ≥2. Regarding HAPI incidence, no differences were found between groups divided by MUST scores. Independent risk factors significantly associated with HAPI were Norton <14, albumin levels <3 g/dl, and low food intake. Not providing ONS in low food intake patients had an adjusted 3.49-fold (95%CI 1.57-7.75) increase in HAPI risk (6-fold for non-adjusted relative risk). CONCLUSION: Failure to initiate ONS as part of nutritional support in low food intake patients is associated with high HAPI risk in these patients. Consequently, monitoring of daily food intake for identifying low intake patients should be integrated into routinely used tools such as the Norton Scale, and adherence to nutritional protocols should be addressed.

The presence of a bulky mediastinal mass of 7 cm or greater in diameter confers an adverse prognosis to patients with advanced Hodgkin lymphoma in case of negative interim PET/CT.

In the PET-adapted therapy era, a bulky mediastinal mass (BMM) is not considered a risk factor in patients with advanced-stage Hodgkin lymphoma (HL). The current retrospective study aimed to estimate the prognostic significance of BMM presence and size for disease-free survival (DFS) and determine the most accurate mass size cutoff (among 5 cm, 7 cm, 10 cm) to predict inferior DFS in such patients. The study included 196 advanced-HL patients treated at Rambam (n = 121) and Memorial Sloan Kettering Cancer Center (n = 75) between 2002 and 2016. At a median follow-up of 66.5 (1-222) months, 36 relapses occurred. In multivariate analysis, only the cutoff of 7 cm predicted inferior DFS and PFS (p < 0.007 and <0.038, respectively) in interim PET/CT (PET-2) negative (79%) patients. This study identifies the BMM size cutoff of 7 cm in any plane as most precise in predicting adverse prognosis in PET-2-negative patients with advanced-stage HL. More aggressive initial chemotherapy than ABVD improves such prognosis.

High Body Mass Index is Associated with Shorter Retention of Tumor Necrosis Factor-Alpha Blocker Treatment in Rheumatoid Arthritis.

PURPOSE: To evaluate the association between body mass index (BMI) and tumor necrosis factor α (TNF-α) blockers retention in patients with rheumatoid arthritis (RA). PATIENTS AND METHODS: This prospective cohort study analyzed data about patients with RA who initiated TNF blockers from the Israeli registry of inflammatory diseases from 2011 to 2019. Patients were grouped by BMI: normal (BMI <24.9 kg/m2), overweight (BMI 25-29.9 kg/m2), obese (BMI 30-34.9 kg/m2) and morbid obese (BMI ≥35 kg/m2). Treatment cessation due to inefficacy was defined as an "event" and therapy with a drug above 3 months was defined as a "course." Kaplan-Meier survival curve was used to describe drug survival. Event-free survival was calculated using Cox regression with a hazard ratio and confidence interval of 95%. RESULTS: The final analysis included 521 RA patients (80% females) treated with etanercept, infliximab, adalimumab or golimumab. Eight hundred and eighteen treatment initiations were included in the final analysis, 334 (41%) in the normal weight group, 261 (32%) in the overweight, 144 (17%) in the obese and 79 (10%) in the morbid obesity group. Three hundred and twenty-six (40%) treatment initiations were with etanercept, 215 (26%) with adalimumab 197 (24%) with infliximab, and 80 (10%) with golimumab. BMI was inversely associated with drug survival. Morbid obese patients were more likely to discontinue treatment compared with normal weight patients HR 2.28 (95% CI 1.67-3.10, p<0.01). This association remained significant for each drug type (except for golimumab) in a subgroup analysis. Adalimumab switch rate was higher compared to etanercept with HR =1.51 (95% CI 1.20-1.91, p<0.01), no other significant differences were noted between the other drugs. CONCLUSION: Morbid obese RA patients have lower TNF-α blocker retention compared to normal weight patients.

Analyzing Medical Research Results Based on Synthetic Data and Their Relation to Real Data Results: Systematic Comparison From Five Observational Studies.

BACKGROUND: Privacy restrictions limit access to protected patient-derived health information for research purposes. Consequently, data anonymization is required to allow researchers data access for initial analysis before granting institutional review board approval. A system installed and activated at our institution enables synthetic data generation that mimics data from real electronic medical records, wherein only fictitious patients are listed. OBJECTIVE: This paper aimed to validate the results obtained when analyzing synthetic structured data for medical research. A comprehensive validation process concerning meaningful clinical questions and various types of data was conducted to assess the accuracy and precision of statistical estimates derived from synthetic patient data. METHODS: A cross-hospital project was conducted to validate results obtained from synthetic data produced for five contemporary studies on various topics. For each study, results derived from synthetic data were compared with those based on real data. In addition, repeatedly generated synthetic datasets were used to estimate the bias and stability of results obtained from synthetic data. RESULTS: This study demonstrated that results derived from synthetic data were predictive of results from real data. When the number of patients was large relative to the number of variables used, highly accurate and strongly consistent results were observed between synthetic and real data. For studies based on smaller populations that accounted for confounders and modifiers by multivariate models, predictions were of moderate accuracy, yet clear trends were correctly observed. CONCLUSIONS: The use of synthetic structured data provides a close estimate to real data results and is thus a powerful tool in shaping research hypotheses and accessing estimated analyses, without risking patient privacy. Synthetic data enable broad access to data (eg, for out-of-organization researchers), and rapid, safe, and repeatable analysis of data in hospitals or other health organizations where patient privacy is a primary value.

Blood urea nitrogen variation upon admission and at discharge in patients with heart failure.

AIMS: Heart failure (HF) is one of the leading causes for hospitalization and mortality. After first admission with acute decompensated HF, some patients are in high risk for short-term and long-term mortality. These patients should be identified, closely followed up, and treated. It has been observed that blood urea nitrogen (BUN) on admission is a predictive marker for short-term mortality. Recently, it has been shown that higher BUN levels on discharge are also a bad prognostic predictor. However, the prognostic value of BUN alteration during hospital stay was not investigated; therefore, we aimed to investigate the effect of BUN variation during hospitalization on mortality. METHODS AND RESULTS: A retrospective study included patients with first hospitalization with the primary diagnosis of HF. The patients were divided into four groups on the basis of the values of BUN on admission and discharge, respectively: normal-normal, elevated-normal, normal-elevated, and elevated-elevated. Four thousand seven hundred sixty-eight patients were included; 2567 were male (53.8%); the mean age was 74.7 ± 12.7 years. The 90 day mortality rate in the normal-normal group was 7% lower than that in the elevated-normal (14.6%) and normal-elevated (19.3%) groups; P value < 0.01. The 90 day mortality in the elevated-elevated group (28.8%) was significantly higher than that in the other groups; P < 0.001. During the 36 month follow-up, these results are maintained. While sub-dividing BUN levels into <30, 30-39, and >40 mg/dL, higher BUN levels correlated with higher 90 day mortality rate regardless of creatinine levels, brain natriuretic peptide, or age. Moreover, BUN on admission and on discharge correlated better with mortality than did creatinine and glomerular filtration rate at the same points. CONCLUSIONS: The BUN both on admission and on discharge is a prognostic predictor in patients with HF; however, patients with elevated levels both on admission and on discharge have the worst prognosis. Moreover, worsening or lack of improvement in BUN during hospitalization is a worse prognostic predictor. To the best of our knowledge, this is the first trial to discuss the BUN change during hospitalization in HF.