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Importance: Evidence regarding the relative effectiveness of bariatric metabolic surgery (BMS) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) in reducing mortality and major adverse cardiovascular events (MACEs) is limited. Objective: To compare all-cause mortality and nonfatal MACEs associated with BMS vs GLP-1RAs for adults with obesity and diabetes and without known cardiovascular disease. Design, Setting, and Participants: This observational, retrospective cohort study was based on data obtained from the electronic medical records of Clalit Health Services (Clalit), the largest health care organization in Israel. The study included 6070 members aged 24 years or older, who had diabetes and obesity and no prior history of ischemic heart disease, ischemic stroke, or congestive heart failure. Patients who underwent BMS and patients who received GLP-1RAs from January 1, 2008, through December 31, 2021, were matched 1:1 by age, sex, and clinical characteristics. Follow-up ended December 31, 2022. Exposures: Initiation of BMS or GLP-1RAs. Main Outcomes and Measures: The primary outcome was all-cause mortality, assessed by multivariate Cox proportional hazards regression models. The secondary outcome was nonfatal MACEs, assessed by multivariate competing risk models. Results: The study included 3035 matched pairs of patients (total, 6070; mean [SD] age, 51.0 [9.5] years; 3938 women [64.9%]), who were followed up for a median of 6.8 years (IQR, 4.1-9.4 years). Among those with a diabetes duration of 10 years or less (2371 pairs), mortality was lower for those who underwent BMS than for those treated with GLP-1RAs (hazard ratio [HR], 0.38; 95% CI, 0.25-0.58). This association became nonsignificant when weight loss during the follow-up period was also included in the model (HR, 0.79; 95% CI, 0.43-1.48). Among patients with a duration of diabetes longer than 10 years (664 pairs), no survival advantage was demonstrated for BMS over GLP-1RA (HR, 0.65; 95% CI, 0.39-1.08). The risk for nonfatal MACEs did not differ between the treatment groups (HR, 0.74; 95% CI, 0.49-1.10 among patients with a diabetes duration of ≤10 years; HR, 1.21; 95% CI, 0.80-1.85 among patients with a diabetes duration of >10 years). Conclusions and Relevance: In this cohort study, BMS was associated with greater reduced mortality compared with first-generation GLP-1RAs among individuals with a diabetes duration of 10 years or less, mediated via greater weight loss. No differences in the risk for mortality were observed between the treatment modalities among individuals with a longer duration of diabetes, nor in the occurrence of nonfatal MACEs among all patients.
Sujet(s)
Chirurgie bariatrique , Récepteur du peptide-1 similaire au glucagon , Humains , Femelle , Mâle , Adulte d'âge moyen , Études rétrospectives , Récepteur du peptide-1 similaire au glucagon/agonistes , Chirurgie bariatrique/mortalité , Chirurgie bariatrique/méthodes , Adulte , Israël/épidémiologie , Diabète de type 2/traitement médicamenteux , Diabète de type 2/mortalité , Obésité , Hypoglycémiants/usage thérapeutique , Maladies cardiovasculaires/mortalité , Modèles des risques proportionnels ,RÉSUMÉ
OBJECTIVES: Previous research reported inconsistent results on the efficacy of molnupiravir in treating COVID-19. Moreover, efficacy was not assessed in the intended-use population (IUP), as defined by the FDA. Therefore, we aimed to evaluate the effectiveness and safety of molnupiravir for the treatment of COVID-19 in the IUP. METHODS: We performed a retrospective cohort study on all IUP in Israel's Clalit Health Services from January 16, 2022, to February 16, 2023. The effectiveness outcome was the incidence of hospitalization or death due to COVID-19, and the safety outcome was the incidence of all-cause mortality within 35 days of SARS-CoV-2 infection. Cox-proportional hazard models were used to analyse the data after 1:5 propensity-score matching. RESULTS: A total of 49 515 patients met the eligibility criteria. Of them, 3957 molnupiravir-treated patients were matched to 19 785 untreated patients. In molnupiravir-treated patients, 70 out of 3957 (5.1 per 10 000 person per day) experienced COVID-19-related hospitalization or death, compared with 699 out of 19 785 untreated patients (10.4 per 10 000 person per day); RR: 0.50 (95% CI, 0.39-0.64). All-cause mortality was also lower in the treated group, with 41 out of 3957 (3.0 per 10 000 person per day) experiencing mortality compared with 414 out of 19 785 untreated patients (6.1 per 10 000 person per day); RR: 0.50 (0.36-0.68). DISCUSSION: In a real-world cohort of IUP, molnupiravir therapy was associated with a significant reduction in hospitalizations or deaths due to COVID-19 and all-cause mortality.
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Comparative evidence for the effects of bariatric metabolic surgery (BMS) and glucagon-like peptide-1 receptor agonists (GLP-1RA) on cardiovascular outcomes is limited. Here, in an observational, retrospective cohort study, we compared the incidence of congestive heart failure (CHF) in adults living with obesity and diabetes without history of CHF (primary CHF) treated with BMS versus GLP-1RA. The population cohort comprised members of Clalit Health Services with no prior history of ischemic heart disease, ischemic stroke or CHF. During the time period of 2008-2021, patients who underwent their first BMS were matched 1:1 with patients who initiated treatment with GLP-1RA, based on clinical characteristics. The study included 2,205 matched pairs of patients (64.5% female), followed for a median of 6.6 years and up to 12 years. Primary incidence of CHF occurred in 26 (1.2%) patients treated with BMS and in 90 patients treated with GLP-1RA (4.1%) (adjusted hazard ratio 0.43, 95% confidence interval 0.27-0.68). Further adjustment for weight reduction did not significantly diminish this association (hazard ratio adjusted for weight reduction 0.48, 95% confidence interval 0.28-0.82), indicating that the differential effect was not mediated through the relative advantage of BMS in maximal weight reduction. In this study, BMS was associated with a stronger reduction in primary incidence of CHF compared with treatment with GLP-1RA. With the increasing use of highly potent next-generation GLP-1RAs, further comparative long-term studies are warranted.
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Prior studies found reduced incidences of cardiovascular diagnoses and treatments in the initial phase of the COVID-19 pandemic. However, these studies included a limited number of outcomes and did not consider pre-pandemic trends. This study aimed to describe trends in the incidence of cardiovascular diagnoses and treatments over the years 2012-2021 in Israel and to compare the two years of the COVID-19 period with the preceding 8 years. In this retrospective, population-based study, carried out within Clalit Health Services, the incidence rates of cardiovascular outcomes were calculated for individuals aged ≥ 25 (~2.7 million adults per year) during the first (Y1, 3/2020-2/2021) and second (Y2, 3/2021-2/2022) years of COVID-19 and the 8 years prior (3/2012-2/2020). Declines were observed in Y1 compared to 2019 in all diagnoses and treatments: STEMI (-16.3%; 95% CI: -16.6, -16.1), non-STEMI (-16.4%; -16.6, -16.2), AF (-14.1%; -14.2, -14.0), CHF (-7.8%; -7.9, -7.7), CVA (-5.0%; -5.0, -4.9), catheterization (-64.7%; -65.2, -64.2), CABG (-77.7%; -79.2, -76.2), ablation (-21.2%; -22.0, -20.4), pacemaker implantation (-39.3%; -40.7, -37.9), and defibrillator insertion (-12.5%; -13.1, -12.0). Compared with expected rates based on pre-pandemic trends, observed rates were within expected ranges (CHF, CVA, and ablation), less than expected (STEMI, non-STEMI, AF, catheterization, CABG, and pacemaker insertion), or more than expected (defibrillator insertion). In Y2, STEMI, catheterization, and CABG returned to expected rates; non-STEMI and AF were lower than expected; and CHF, CVA, ablation, and pacemaker and defibrillator implantations were higher than expected. Several cardiovascular diagnoses and treatment trends were interrupted by COVID-19. The long-term consequences of these changes should be considered by health policymakers.
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OBJECTIVES: The global supply of vaccines against mpox (previously called monkeypox virus infection) was significantly lower than the demand. Therefore, evidence-based vaccine prioritization criteria, based on risk assessment were needed. Our objective was therefore to identify the characteristics of individuals at the highest risk for mpox. METHODS: This population-based cohort study included all Clalit Health Services (CHS) subjects assumed to be at risk for mpox. The eligibility criteria for inclusion were determined based on known characteristics of people with infection worldwide and insights of lesbian, gay, bisexual, transgender, queer+ (LGBTQ+) -specialized CHS clinicians. Cox hazards models were used to identify the risk factors for mpox within the study cohort. The study commenced on 6 June 2022, the date of the first known mpox in CHS members, until 31 July 2022, when the mpox vaccination campaign started. RESULTS: A total of 8088 individuals of 4.7 million CHS members (0.18%) were identified according to the study inclusion criteria. Of those, 69 (0.85%) developed infection during the study period. Risk factors for mpox were birth in 1980 or later (hazard ratio, 5.04; 95% CI, 2.11-12.02), history of syphilis (2.62; 1.58-4.35), registration to primary healthcare clinics in the Tel Aviv district (2.82; 1.44-5.54), HIV-pre-exposure prophylaxis medication use (3.96; 2.14-7.31), PDE5 inhibitors use (2.92; 1.77-4.84), and recent sexually transmitted infections (STIs) within the last 18 months (2.27; 1.35-3.82). No infections were observed in individuals with none of the factors. Individuals with three or more risk factors had a 20.30-fold (10.39-39.69) higher risk for mpox compared with those with 0-2, with 85.5% (75.0-92.8%) sensitivity and 77.8% (76.9-78.7%) specificity. DISCUSSION: Weighting individuals' risk levels based on validated risk factors against vaccine availability can assist health systems in the equitable prioritization of vaccine allocation in various future outbreaks, given supply-demand gaps.
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Orthopoxvirose simienne , Femelle , Humains , Études de cohortes , Études rétrospectives , Appréciation des risques , Facteurs de risqueRÉSUMÉ
The recent global outbreak of the monkeypox (mpox) virus in humans was declared a public health emergency by the World Health Organization in July 2022. The smallpox and mpox vaccine (JYNNEOS; Modified Vaccinia Ankara-Bavarian Nordic; MVA-BN), provided as a two-dose regimen, is currently the primary vaccine utilized against mpox. However, the efficacy of MVA-BN against mpox has never been demonstrated in clinical trials to date. Due to the limited supply of vaccines, the World Health Organization has recommended prioritizing the vaccination of high-risk groups. We evaluated the real-world effectiveness of a single, subcutaneous dose of MVA-BN in this observational, retrospective cohort study, which included the analysis of electronic health records of all members of Clalit Health Services eligible for the vaccine on 31 July 2022. We used a Cox proportional hazards regression model with time-dependent covariates to estimate the association between vaccination and mpox while adjusting for sociodemographic and clinical risk factors. In an analysis of 2,054 male individuals who met vaccine eligibility criteria, 1,037 (50%) were vaccinated during the study recruitment period and completed at least 90 d of follow-up. During the study period, 5 and 16 infections were confirmed in vaccinated and unvaccinated individuals, respectively. The adjusted vaccine effectiveness was estimated at 86% (95% confidence interval, 59-95%). Our results suggest that a single dose of subcutaneous MVA-BN in this high-risk cohort is associated with a significantly lower risk of MPXV infection.
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Orthopoxvirose simienne , Vaccin antivariolique , Humains , Mâle , Orthopoxvirose simienne/prévention et contrôle , Études rétrospectives , Vaccin antivariolique/effets indésirables , Virus de la vaccineRÉSUMÉ
BACKGROUND: The oral protease inhibitor nirmatrelvir has shown substantial efficacy in high-risk, unvaccinated patients infected with the B.1.617.2 (delta) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Data regarding the effectiveness of nirmatrelvir in preventing severe coronavirus disease 2019 (Covid-19) outcomes from the B.1.1.529 (omicron) variant are limited. METHODS: We obtained data for all members of Clalit Health Services who were 40 years of age or older at the start of the study period and were assessed as being eligible to receive nirmatrelvir therapy during the omicron surge. A Cox proportional-hazards regression model with time-dependent covariates was used to estimate the association of nirmatrelvir treatment with hospitalization and death due to Covid-19, with adjustment for sociodemographic factors, coexisting conditions, and previous SARS-CoV-2 immunity status. RESULTS: A total of 109,254 patients met the eligibility criteria, of whom 3902 (4%) received nirmatrelvir during the study period. Among patients 65 years of age or older, the rate of hospitalization due to Covid-19 was 14.7 cases per 100,000 person-days among treated patients as compared with 58.9 cases per 100,000 person-days among untreated patients (adjusted hazard ratio, 0.27; 95% confidence interval [CI], 0.15 to 0.49). The adjusted hazard ratio for death due to Covid-19 was 0.21 (95% CI, 0.05 to 0.82). Among patients 40 to 64 years of age, the rate of hospitalization due to Covid-19 was 15.2 cases per 100,000 person-days among treated patients and 15.8 cases per 100,000 person-days among untreated patients (adjusted hazard ratio, 0.74; 95% CI, 0.35 to 1.58). The adjusted hazard ratio for death due to Covid-19 was 1.32 (95% CI, 0.16 to 10.75). CONCLUSIONS: Among patients 65 years of age or older, the rates of hospitalization and death due to Covid-19 were significantly lower among those who received nirmatrelvir than among those who did not. No evidence of benefit was found in younger adults.
Sujet(s)
Antiviraux , Traitements médicamenteux de la COVID-19 , COVID-19 , Lactames , Leucine , Nitriles , Proline , Adulte , Sujet âgé , Antiviraux/usage thérapeutique , COVID-19/virologie , Hospitalisation , Humains , Lactames/usage thérapeutique , Leucine/usage thérapeutique , Adulte d'âge moyen , Nitriles/usage thérapeutique , Proline/usage thérapeutique , SARS-CoV-2 , Résultat thérapeutiqueRÉSUMÉ
BACKGROUND: A substantial drop in emergency department (ED) visit volume was previously demonstrated at the onset of the COVID-19 pandemic. OBJECTIVE: To examine changes in the number of non-COVID adult ED visits and their associated 30-day mortality during 14 months of the pandemic in Israel. METHODS: This is a retrospective cohort study including 1,285,270 adult ED visits between 1st March, 2018 and 30th April, 2021 to the internal and surgical EDS in eight general hospitals of the largest healthcare organization in Israel. The 14 months of the pandemic period (March 2020-April 2021) were divided into seven periods according to dates of the three lockdowns. Exposure to each of these periods was compared to the parallel period during the two previous years. March 2020-April 2021 was compared to the parallel periods in 2018 and 2019. RESULTS: During the pandemic period, the largest decline in ED visits (44.6% and 50.9% for internal and surgical EDs, respectively) and the highest excess 30-day mortality following an ED visit (internal EDs Adjusted OR (ORadj), 1.49; 95% CI, 1.34-1.66 and surgical EDs: ORadj 1.50; CI, 1.16-1.94) were 95%, observed during the first lockdown. Both gradually levelled-off subsequently until near-normalization was reached in March-April 2021 for both parameters. CONCLUSIONS: A substantial decline in non-COVID ED visits and excess mortality at the beginning of the pandemic, are probably the results of social distancing restrictions alongside patients' fear of exposure to COVID-19, which gradually moderated thereafter, until near normalization was reached after 14 months. Gradual return to pre-pandemic ED utilization patterns were noticed as the population and the healthcare system acclimatize to life alongside COVID.
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COVID-19 , Pandémies , Adulte , COVID-19/épidémiologie , Contrôle des maladies transmissibles , Service hospitalier d'urgences , Humains , Israël/épidémiologie , Études rétrospectivesRÉSUMÉ
BACKGROUND: The COVID-19 pandemic has had diverse effects on population health and psychology in relation to non-COVID-19 diseases, as well as on COVID-19 infection. Fewer patients with acute myocardial infarction (AMI) sought medical attention during the first lockdown of the pandemic. METHODS AND RESULTS: We conducted a retrospective cohort study of Clalit Health Services patients treated in multiple hospitals for AMI. We examined the numbers and characteristics of the patients and 30-day mortality during three 5-week phases of the first wave of the COVID-19 pandemic in Israel: pre-lockdown (N = 702), lockdown (N = 584), and lockdown-lift (N = 669). We compared data for the same period in 2018 and 2019. We stratified the data by ST-elevation myocardial infarction (STEMI) and non-STEMI. AMI hospitalizations during the lockdown were 17% lower than in the pre-lockdown period (rate ratio-0.83, 95% CI 0.74-0.93), and 22% and 31% lower than in the corresponding periods in 2018 and 2019, respectively. The reduction was mainly attributed to non-STEMI hospitalizations (26% lower than the pre-lockdown period in 2020). Hospitalizations due to both STEMI and non-STEMI were moderately reduced during the post-lockdown period compared to the corresponding periods in 2018 and 2019. Thirty-day mortality rate was similar for all the periods assessed. CONCLUSIONS: The number of hospitalized patients with AMI during the first COVID-19 lockdown and post-lockdown periods was significantly reduced, without significant changes in 30-day mortality rates.
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COVID-19 , Infarctus du myocarde , Infarctus du myocarde sans sus-décalage du segment ST , Intervention coronarienne percutanée , Infarctus du myocarde avec sus-décalage du segment ST , COVID-19/épidémiologie , Contrôle des maladies transmissibles , Hospitalisation , Humains , Infarctus du myocarde/diagnostic , Infarctus du myocarde/épidémiologie , Infarctus du myocarde/thérapie , Pandémies , Études rétrospectives , Infarctus du myocarde avec sus-décalage du segment ST/diagnostic , Infarctus du myocarde avec sus-décalage du segment ST/épidémiologie , Infarctus du myocarde avec sus-décalage du segment ST/thérapie , Isolement socialRÉSUMÉ
OBJECTIVES: We aimed to examine clinical data and baseline blood test results as potential predictive biomarkers for benefit from nivolumab, in advanced non-small cell lung cancer patients (NSCLC). MATERIALS AND METHODS: A chart review was performed of 108 advanced NSCLC patients who commenced treatment with nivolumab between 2015-6 at three Israeli cancer centers, and for whom laboratory tests results were available. Data collected included sex, age, ECOG-PS, histology and number of previous lines of treatment. Baseline blood test results collected: absolute lymphocyte and neutrophil count (ANC), white blood cells (WBC), hemoglobin, platelets, albumin and lactate dehydrogenase (LDH). Neutrophil to Lymphocyte Ratio and 'derived NLR' (dNLR = (ANC/[WBC-ANC])) were calculated. Disease control at six months (DC6) was defined as any tumor shrinkage or stable disease during the first six months of nivolumab treatment. The association between clinical/laboratory variables and survival was tested with a Cox proportional hazard model. Data cut-off occurred in November 2019. RESULTS: 35 patients (32.4%) achieved DC6. Median overall survival (OS) of entire study population was 5.4 months. Four year survival rate was 16%. Achievement of DC6 strongly correlated with longer OS (HR 0.12, 95% C.I. 0.07-0.21, p<0.001). In univariate and multivariate analysis, dNLR, albumin and LDH correlated significantly with OS. No variables correlated significantly with DC6 in multivariate analysis. Based on albumin and LDH, we produced a score called CLAS (combined LDH and albumin score), including four prognostic groups of patients. Patients having low albumin and high LDH had the worst prognosis. CONCLUSION: In real-life setting, long-term efficacy of nivolumab in advanced line treatment of NSCLC is consistent with clinical trials. Response or stability of disease during first six months of treatment is associated with prolonged survival. We propose a novel score (CLAS) that may be useful for predicting outcome in nivolumab-treated NSCLC patients, but further validation is required.
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Anticoagulants/usage thérapeutique , Fibrillation auriculaire/traitement médicamenteux , Dabigatran/usage thérapeutique , Pyrazoles/usage thérapeutique , Pyridones/usage thérapeutique , Rivaroxaban/usage thérapeutique , Administration par voie orale , Adulte , Sujet âgé , Sujet âgé de 80 ans ou plus , Anticoagulants/administration et posologie , Fibrillation auriculaire/complications , Fibrillation auriculaire/épidémiologie , Dabigatran/administration et posologie , Femelle , Humains , Israël/épidémiologie , Mâle , Adulte d'âge moyen , Pyrazoles/administration et posologie , Pyridones/administration et posologie , Rivaroxaban/administration et posologie , Accident vasculaire cérébral/épidémiologie , Accident vasculaire cérébral/prévention et contrôleRÉSUMÉ
BACKGOUND: Randomized controlled trials (RCTs) have shown that dabigatran, rivaroxaban and warfarin cause similar bleeding rates. METHODS: We performed a retrospective population-based cohort study to determine the incidence of bleeding in patients with atrial fibrillation (AF) beginning dabigatran, rivaroxaban or warfarin. Consecutive patients initiating anticoagulation for AF during a 3year period were identified using a computerized database. Patients who bled and required hospitalization underwent chart review. Bleeding incidences were calculated per 100 patient-years of treatment. RESULTS: 18,249 patients were included: 9564 (52.4%) received warfarin, 5976 (32.7%) dabigatran, and 2709 (14.8%) rivaroxaban. Bleeding incidences were 3.9 (95% CI, 3.6-4.4) in warfarin-treated patients, 4.2 (95% CI, 3.7-4.7) in dabigatran patients, and 4.1 (95% CI, 3.0-5.3) in rivaroxaban patients. Intracranial hemorrhage (ICH) rates were 0.71 (95% CI, 0.56-0.90) for warfarin, 0.4 (95% CI, 0.18-0.87) for dabigatran, and 0.27 (95%CI, 0.10-0.80) for rivaroxaban. GI hemorrhage rates were 1.88 (95%CI, 1.62-2.20) for warfarin, 2.98 (95% CI, 2.4-3.5) for dabigatran and 2.39 (95%CI, 1.6-3.5) for rivaroxaban. CONCLUSIONS: We demonstrate similar bleeding rates with both dabigatran 150mg and 110mg and rivaroxaban compared to warfarin.
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Anticoagulants/effets indésirables , Fibrillation auriculaire/traitement médicamenteux , Dabigatran/effets indésirables , Hémorragie gastro-intestinale/mortalité , Hémorragies intracrâniennes/mortalité , Rivaroxaban/effets indésirables , Warfarine/effets indésirables , Adulte , Sujet âgé , Sujet âgé de 80 ans ou plus , Anticoagulants/administration et posologie , Dabigatran/administration et posologie , Bases de données factuelles , Femelle , Hémorragie gastro-intestinale/induit chimiquement , Humains , Incidence , Hémorragies intracrâniennes/induit chimiquement , Israël , Mâle , Adulte d'âge moyen , Modèles des risques proportionnels , Études rétrospectives , Rivaroxaban/administration et posologie , Accident vasculaire cérébral/prévention et contrôle , Warfarine/administration et posologieRÉSUMÉ
BACKGROUND: Opioids are considered a cornerstone in the treatment of pain. They are rarely used in almost half of the countries of the world, especially in children. OBJECTIVE: The aim of this study was to assess opioid use over a ten-year study period from 2001-2010, among children 0-18 years old who are members of Clalit Health Services (CHS), the largest HMO in Israel METHODS: Data on the purchase of opioids, authorized for use in Israel, was obtained from the computerized databases of CHS. In addition, the patient's demographic details and cancer morbidity were also extracted. The data was analyzed after all the doses of all opioids consumed (fentanyl patch, oxycodone, methadone, hydromorphone, oral transmucosal fentanyl) were converted into oral morphine equivalents (OME). RESULTS: In all, 1,098 children purchased at least one opioid prescription during the study period. Of them, 27.3% had a diagnosis of cancer and 55.5% were female. A 42% decrease in total annual OME (mg) purchased, from 209,443 mg to 122,048 mg, was observed from 2001 to 2010. There was no specific pattern or trend in the annual number of pediatric and adolescent patients who purchased at least one opioid drug during the study period. In 86.5% of the cases, children with a non-cancer cause of pain purchased opioids for only one month. CONCLUSIONS: There is a low and inconsistent rate of opioid consumption among pediatric and adolescent members of the CHS. Further study is needed to explore the reasons for this low opioid consumption rate in this population group.
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Analgésiques morphiniques/usage thérapeutique , Tumeurs/complications , Douleur/traitement médicamenteux , Adolescent , Analgésiques morphiniques/administration et posologie , Enfant , Enfant d'âge préscolaire , Bases de données factuelles , Femelle , Humains , Nourrisson , Israël , Mâle , Douleur/étiologieRÉSUMÉ
BACKGROUND: After a decade of extensive use, the actual contribution of bevacizumab in first-line treatment of metastatic colorectal cancer (mCRC) is still unclear. OBJECTIVE: To evaluate 'real-life' outcomes of patients with mCRC before and after the introduction of bevacizumab to standard mCRC first-line practice. METHODS: Using the computerized administrative database of Clalit Health Services' (CHS), Israel's largest health care provider, we retrospectively compared two cohorts (n = 1739): (A) all CHS' patients diagnosed with mCRC between January 2000 and December 2004 that received first-line irinotecan or oxaliplatin-based combination chemotherapy (before bevacizumab was introduced) (n = 1052), and (B) all patients that started first-line irinotecan or oxaliplatin combination chemotherapy together with bevacizumab between September 2006 and December 2009 (after bevacizumab was fully reimbursed in Israel for mCRC first-line therapy) (n = 687). The primary endpoint was overall survival (OS) and secondary endpoints were first-line progression-free survival (PFS) and metastatectomy rates. RESULTS: Median OS was longer in Cohort B than in Cohort A [23.0 months vs.15.0, adjusted hazard ratio (HR), 0.75]. Secondary outcomes were also better; PFS of 14.0 months vs. 9.8 in the earlier period (HR, 0.75) and metastatectomy rate of 8.1% versus 3.9%. The longer OS in Cohort B was preserved even after controlling for latter-line epidermal growth factor receptor (EGFR) inhibitor use (HR = 0.77). CONCLUSION: In this analysis, OS, PFS and metastatectomy rates of first-line treatment of mCRC were significantly higher in the later period of the study. These results, derived from 'real-life' practice, suggest that the use of bevacizumab, among other alterations in the clinical management of mCRC between the two periods, might have had a significant contribution to these outcomes, and may therefore support the current practice of adding bevacizumab to first-line treatment of mCRC.
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Inhibiteurs de l'angiogenèse/administration et posologie , Anticorps monoclonaux humanisés/administration et posologie , Protocoles de polychimiothérapie antinéoplasique/usage thérapeutique , Tumeurs colorectales/traitement médicamenteux , Bévacizumab , Camptothécine/administration et posologie , Camptothécine/analogues et dérivés , Études de cohortes , Tumeurs colorectales/vascularisation , Tumeurs colorectales/mortalité , Tumeurs colorectales/anatomopathologie , Survie sans rechute , Récepteurs ErbB/antagonistes et inhibiteurs , Femelle , Humains , Irinotécan , Israël/épidémiologie , Mâle , Métastasectomie , Adulte d'âge moyen , Composés organiques du platine/administration et posologie , Oxaliplatine , Études rétrospectivesRÉSUMÉ
BACKGROUND: Opioids are considered a cornerstone in the treatment of cancer pain. OBJECTIVES: To assess opioid use during a 6 year period (2001-2006) among cancer patients served by Clalit Health Services, the largest health management organization in Israel. METHODS: Purchasing data of opioids authorized for use in Israel were obtained from the computerized databases of Clalit for the period 2001-2006. Patients' demographic and cancer morbidity data were extracted. The data were analyzed by translating the purchased opioids (fentanyl patch, oxycodone, buprenorphine, methadone, hydromorphone) to oral morphine equivalents (OME). RESULTS: During the study period 182,066 Clalit members were diagnosed with cancer; 58,443 (32.1%) of them died and 31,628 (17.3%) purchased opioids at least once. In 2001, 7.5% of Clalit cancer patients purchased opioids at least once within 5 years of the initial diagnosis. Between 2002 and 2006 this percentage increased consistently, reaching 9.9% in 2006. The average daily dose of opioids increased from 104.1 mg OME in the year 2001 to 115.2 mg OME in 2006 (11% increase). The average duration of opioid purchasing was 5.0 +/- 8.3 months (range 1-84 months, median 2). During the study period 19,426 cancer patients who purchased opioids at least once died; only 14.3% (3274) were still alive 2 years after their first opioid prescription. CONCLUSIONS: Opioid purchasing increased during the study period, especially during the final months of life. Children (0-18 years old) and elderly male patients (> or = 65 years) began opioid treatment later compared to other age groups. Only a few patients had an opioid early enough to relieve their pain.
Sujet(s)
Analgésiques morphiniques/usage thérapeutique , Ordonnances médicamenteuses/statistiques et données numériques , Tumeurs/complications , Douleur rebelle/traitement médicamenteux , Douleur rebelle/étiologie , Adolescent , Adulte , Sujet âgé , Analgésiques morphiniques/administration et posologie , Femelle , Humains , Israël , Mâle , Adulte d'âge moyen , Types de pratiques des médecins/statistiques et données numériques , Résultat thérapeutiqueRÉSUMÉ
BACKGROUND: The study goal was to assess indices of continuity of care in the primary care setting and their association with health outcomes and healthcare services utilization, given the reported importance of continuity regarding quality of care and healthcare utilization. METHODS: The study included a random sample of enrollees from Clalit Health Services 19 years-of-age or older who visited their primary care clinic at least three times in 2009. Indices of continuity of care were computed, including the Usual Provider Index (UPC), Modified Modified Continuity Index (MMCI), Continuity of Care Index (COC), and Sequential Continuity (SECON). Quality measures of preventive medicine and healthcare services utilization and their costs were assessed as outcomes. RESULTS: 1,713 randomly sampled patients were included in the study (mean age: 48.9 ± 19.2, 42% males). Continuity of care indices were: UPC: 0.75; MMCI: 0.81; COC: 0.67; SECON: 0.70. After controlling for patient characteristics in a multivariate analysis, a statistically significant association was found between higher values of UPC, COC, and SECON and a decrease in the number and cost of ED visits. Higher MMCI values were associated with a greater number and higher costs of medical consultation visits. Continuity of care indices were associated with BMI measurements, and inversely associated with blood pressure measurements. No association was found with other quality indicators, e.g., screening tests for cancer. CONCLUSIONS: Several continuity of care indices were associated with decreased number and costs of ED visits. There were both positive and negative associations of continuity of care indices with different aspects of healthcare utilization. The relatively small effects of continuity might be due to the consistently high levels of continuity in Clalit Health Services.
RÉSUMÉ
BACKGROUND: Introduction of new private, voluntary immunizations often results in low vaccine uptake among certain sub-groups within the population. Revealing factors associated with underimmunization is crucial in vaccine endorsement and distribution. OBJECTIVE: Our goal was to investigate the effect of child's birth order on private voluntary varicella vaccination. METHODS: A nested case-control study was conducted on a cohort of 110,902 Israeli children under the age of 5 years. We compared social and demographic factors of immunized and unimmunized participants. Logistic regression models were built to examine the association between birth order and vaccination, controlling for child's age, gender, country of birth, ethnicity, parents' country of birth, area of residence, and socioeconomic status (SES). RESULTS: Ethnicity had the highest association with varicella immunization status. The odds of vaccination in the general Jewish and Ultra-Orthodox Jewish populations were 25.55- (95%CI:20.13;32.42) and 15.04- (95%CI:10.18;22.22) times the odds in Arab population, respectively. Child's birth order was inversely related to vaccination status and presented a nonlinear exposure-response relationship. This relationship was maintained in different ethnicity and SES groups. Child's birth order was associated with vaccination differently in large (> 3 siblings) and small to average-sized sibships (≤ 3 siblings). Other parameters associated with vaccination were child's and parents' country of origin, area of residence and SES. CONCLUSIONS: Birth order is an independent risk factor for underimmunization, associated with child's vaccination status beyond economic, social, and demographic parental characteristics.
Sujet(s)
Rang de naissance , Vaccin contre la varicelle/administration et posologie , Connaissances, attitudes et pratiques en santé , Immunisation/méthodes , Immunisation/statistiques et données numériques , Études cas-témoins , Vaccin contre la varicelle/immunologie , Enfant d'âge préscolaire , Études de cohortes , Femelle , Humains , Nourrisson , Nouveau-né , Israël , Mâle , Modèles statistiquesRÉSUMÉ
OBJECTIVE: The objective of this study was to assess opioid use during 7 years (2000-2006) among Clalit Health Services (CHS) members. DESIGN: Purchasing data of opioids authorized for use in Israel were obtained from the computerized databases of CHS. Patient demographics and cancer morbidity were also extracted. The data were analyzed by converting the purchased opioids to oral morphine equivalents (OMEs). SETTING: CHS is the largest health maintenance organization in Israel (3,774,600) and insures almost 54% of the Israeli population. PATIENTS: All CHS members who purchased an opioid at least once during the 7-year study period (2000-2006). INTERVENTION: There were no interventions in this study. OUTCOME MEASURES: The outcome measures of this study were total OME purchased per year, OME (mg) per capita/per year, and OME (mg) daily dose. RESULTS: There were 119,562 patients who purchased an opioid at least once (3.2% of CHS population). Of them, 57.4% were women, 69.0% aged 65 years and above (average age 56.05 years +/- 26.7), 7.7% purchased opioids for more than 12 months, and 81.3% purchased opioids for only 1-4 months. A 96% increase in total OME purchased was found between 2000 and 2006 (from 56.4 kg to 110.6 kg). The annual OME purchased per capita increased from 15.7 mg in the year 2000 to 29.3 mg in 2006. The total number of patients who received at least one opioid prescription increased by 60%, while the growth in total number of CHS members was smaller (4.8%). CONCLUSIONS: There is a growing use of opioids at CHS during the 7-year period, a potential indicator of the progress made in improving accessibility and availability of opioids in our health care organization in Israel.
Sujet(s)
Analgésie/méthodes , Analgésie/statistiques et données numériques , Analgésiques morphiniques/usage thérapeutique , Health Maintenance Organizations (USA)/statistiques et données numériques , Centres antidouleur/statistiques et données numériques , Douleur rebelle/traitement médicamenteux , Adulte , Sujet âgé , Sujet âgé de 80 ans ou plus , Femelle , Accessibilité des services de santé , Humains , Israël , Mâle , Adulte d'âge moyen , Tumeurs/complications , , Douleur postopératoire/traitement médicamenteux , Ordonnances/statistiques et données numériques , Qualité des soins de santé/statistiques et données numériques , Facteurs tempsRÉSUMÉ
CONTEXT: Because clinical manifestations of thyroid disorders are variable and subtle in children and adolescents, thyroid function tests are often repeated in patients with nonspecific symptoms. OBJECTIVES: The objective of the study was to determine the natural history of initial abnormal TSH and define populations at greater risk for developing a subsequent thyroid dysfunction. METHODS: A total of 121,052 of 1.043 million outpatients aged 0.5-16 yr insured by the Clalit Health Medical Organization had a TSH determination in 2002 and follow-up to 2007. Extracted from the Clalit Health Medical Organization database were their demographic data, referral diagnoses, and laboratory results (TSH, free T(4), thyroid antibodies). Excluded were patients with overt hypothyroidism or hyperthyroidism on initial testing. RESULTS: Results of 96.5% of initial serum TSH concentrations were normal (0.35-5.5 mIU/liter), 0.2% were low (<0.35 mIU/liter), 2.9% elevated (>5.5 to
Sujet(s)
Tests de la fonction thyroïdienne/statistiques et données numériques , Glande thyroide/physiologie , Adolescent , Enfant , Enfant d'âge préscolaire , Études de cohortes , Femelle , Études de suivi , Humains , Immunoglobulines thyréostimulantes/sang , Nourrisson , Mâle , Valeur prédictive des tests , Risque , Maladies de la thyroïde/diagnostic , Maladies de la thyroïde/épidémiologie , Thyréostimuline/sang , Thyroxine/sangRÉSUMÉ
OBJECTIVES: Foreign body aspiration (FBA) is a life-threatening event in children. The gold standard for diagnosis is bronchoscopy, but there is no consensus regarding indications for the procedure. The aim of this study was to formulate a predictive model for assessing the probability of FBA in suspected cases as an aid in the decision to perform diagnostic bronchoscopy. METHODS: The files of 150 patients who underwent bronchoscopy for suspected FBA at our center between 1996 and 2004 were reviewed for medical history, physical examination, and radiologic studies. The findings were analyzed by logistic regression. RESULTS: Using the file data, we formulated a predictive model wherein each parameter received a numeric coefficient representing its significance in evaluating suspected FBA. The most significant parameters were age 10 to 24 months, foreign body in the child's mouth and severe respiratory complaints during the choking episode, hypoxemia, dyspnea or stridor following the acute event, unilateral signs on lung auscultation, abnormal tracheal radiogram, unilateral infiltrate or atelectasis, and local hyperinflation or obstructive emphysema on chest radiogram. CONCLUSIONS: In our predictive model, every case of suspected FBA can be assigned a score based on the specific parameters present, which is then entered into a probability formula to determine the likelihood of a positive diagnosis. This model may serve as a useful tool for deciding on the use of bronchoscopy in all children with suspected FBA.