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1.
Anaerobe ; 74: 102528, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35104667

RESUMO

OBJECTIVES: Increasing incidence rates of Clostridium difficile infection (CDI) and outbreaks of emerging strains have highlighted the need for continuous monitoring and surveillance of CDI in Australia. Active surveillance captures all hospital-identified CDI cases in Western Australia (WA), where all C. difficile isolates recovered are routinely PCR ribotyped. The aim of this study was to determine incidence rates and descriptive and molecular epidemiology of CDI among patients in Perth, WA using linkage of surveillance and hospital administrative records. METHODS: All CDI cases (confirmed by tcdB PCR) from July 2012 to June 2014 captured in the Hospital Infection Surveillance WA dataset for three hospitals were linked with hospital admission records from the Patient Administration System and ribotyping data to calculate incidence rates of CDI and the distribution of various ribotypes (RTs). RESULTS: There were 381 individual cases of CDI identified among 354 hospital patients (including outpatients and ED) who experienced ≥1 CDI episode during the study period. CDI was hospital-associated in 62.7% of cases and community-associated (CA)-CDI in 31.2%. The overall incidence rate was 4.40/10,000 patient days (PD, 95% CI 3.98-4.86), females across all age groups experienced higher incidence (risk ratio 1.29, p < 0.05). The risk ratio for CA-CDI was highest (7.76, p < 0.01) for females vs males aged 15-29 years. Overall, 10.8% of cases were admitted to ICU, 15.2% had a recurrent infection and the mortality rate was 7.2%. C. difficile RT 014/020 predominated (34.9%) among 339 isolates of 71 different RTs. CONCLUSIONS: The incidence of CDI in WA is high and RT 014/020 continues to be the dominant molecular type in an otherwise diverse array of strains. High strain diversity suggests CDI cases arise from exposure to many different reservoirs.


Assuntos
Toxinas Bacterianas , Clostridioides difficile , Infecções por Clostridium , Infecção Hospitalar , Enterocolite Pseudomembranosa , Clostridioides difficile/genética , Infecções por Clostridium/epidemiologia , Infecção Hospitalar/epidemiologia , Feminino , Hospitais , Humanos , Masculino , Ribotipagem , Austrália Ocidental/epidemiologia
2.
Anaerobe ; 61: 102139, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31830597

RESUMO

This retrospective cohort study aimed to determine the incidence rates of and risk factors for recurrent Clostridioides difficile infection (rCDI) in Japan using a claims database. Inpatients of any age with ≥1 record of C. difficile infection (CDI) during the study period (January 2012-September 2016) were analyzed. We estimated the incidence rate of health care onset, health care facility associated (HO-HCFA) primary CDI and HO-HCFA rCDI for each of the first to fifth recurrences. Risk factors for the first recurrence were investigated using a univariate, and subsequently, a multivariable Cox regression model. The incidence rates (95% confidence interval [CI]) of CDI and HO-HCFA CDI were 2.43 (2.40-2.46) and 1.26 (1.24-1.28) cases per 10,000 inpatient-days, respectively. Among the 11,287 inpatients with ≥1 HO-HCFA CDI, 1424 patients had ≥1 recurrent episode (12.6% [95% CI 12.0-13.2]). The rCDI incidence rates consistently increased, with the number of recurrences ranging from 29.2 to 181.8 cases per 10,000 inpatient-days. The multivariable analysis revealed five risk factors (hazard ratio [95% CI]): age ≥65 years (vs. <65 years; 65-74 years, 1.275 [1.048-1.551]; 75-79 years, 1.612 [1.315-1.975]; ≥80 years, 2.110 [1.776-2.507]); cephalosporin use both before (vs. without cephalosporin; 1.241 [1.098-1.402]) and during the primary CDI (vs. without cephalosporin; 1.137 [1.011-1.279]); higher number of comorbidities (vs. ≤10 comorbidities; 11-14 comorbidities: 1.336 [1.131-1.580]; 15-20 comorbidities: 1.433 [1.219-1.685]; ≥21 comorbidities: 1.310 [1.099-1.561]); and gastrointestinal surgery (vs. without surgery; 0.823 [0.701-0.965]). In conclusion, CDI recurred in some Japanese patients, and the incidence rates increased with the number of recurrences. Special care is needed in patients aged ≥65 years, those with a higher number (>10) of comorbidities, and those who have received cephalosporin before or during the primary CDI.


Assuntos
Clostridioides difficile , Infecções por Clostridium/epidemiologia , Infecções por Clostridium/microbiologia , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Infecções por Clostridium/tratamento farmacológico , Infecção Hospitalar/tratamento farmacológico , Infecção Hospitalar/epidemiologia , Infecção Hospitalar/microbiologia , Feminino , Humanos , Incidência , Japão/epidemiologia , Masculino , Recidiva , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco
3.
Clin Infect Dis ; 66(9): 1326-1332, 2018 04 17.
Artigo em Inglês | MEDLINE | ID: mdl-29360950

RESUMO

Background: The economic burden of Clostridium difficile infection (CDI), the leading cause of nosocomial infectious diarrhea, is not well understood. The objective of this study was to estimate the healthcare resource utilization (HCRU) and costs attributable to primary CDI and recurrent CDI (rCDI). Methods: This is a database (MarketScan) study. Patients without CDI were matched 1:1 by propensity score to those with primary CDI but no recurrences to obtain HCRU and costs attributable to primary CDI. Patients with primary CDI but no recurrences were matched 1:1 by propensity score to those with primary CDI plus 1 recurrence in order to obtain HCRU and costs attributable to rCDI. Adjusted estimates for incremental cumulative hospitalized days and healthcare costs over a 6-month follow-up period were obtained by generalized linear models with a Poisson or gamma distribution and a log link. Bootstrapping was used to obtain 95% confidence intervals (CIs). Results: A total of 55504 eligible CDI patients were identified. Approximately 25% of these CDI patients had rCDI. The cumulative hospitalized days attributable to primary CDI and rCDI over the 6-month follow-up period were 5.20 days (95% CI, 5.01-5.39) and 1.95 days (95% CI, 1.48-2.43), respectively. The healthcare costs attributable to primary CDI and rCDI over the 6-month follow-up period were $24205 (95% CI, $23436-$25013) and $10580 (95% CI, $8849-$12446), respectively. Conclusions: The HCRU and costs attributable to primary CDI and rCDI are quite substantial. It is necessary to reduce the burden of CDI, especially rCDI.


Assuntos
Infecções por Clostridium/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Recursos em Saúde/economia , Adulto , Idoso , Idoso de 80 Anos ou mais , Clostridioides difficile/isolamento & purificação , Infecções por Clostridium/epidemiologia , Efeitos Psicossociais da Doença , Infecção Hospitalar , Feminino , Recursos em Saúde/estatística & dados numéricos , Hospitalização/economia , Humanos , Masculino , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Pontuação de Propensão , Recidiva , Estudos Retrospectivos , Fatores de Risco , Estados Unidos
4.
Clin Infect Dis ; 66(3): 355-362, 2018 01 18.
Artigo em Inglês | MEDLINE | ID: mdl-29106516

RESUMO

Background: Clostridium difficile infection (CDI) is the most commonly recognized cause of recurrent diarrhea. Bezlotoxumab, administered concurrently with antibiotics directed against C. difficile (standard of care [SoC]), has been shown to reduce the recurrence of CDI, compared with SoC alone. This study aimed to assess the cost-effectiveness of bezlotoxumab administered concurrently with SoC, compared with SoC alone, in subgroups of patients at risk of recurrence of CDI. Methods: A computer-based Markov health state transition model was designed to track the natural history of patients infected with CDI. A cohort of patients entered the model with either a mild/moderate or severe CDI episode, and were treated with SoC antibiotics together with either bezlotoxumab or placebo. The cohort was followed over a lifetime horizon, and costs and utilities for the various health states were used to estimate incremental cost-effectiveness ratios (ICERs). Both deterministic and probabilistic sensitivity analyses were used to test the robustness of the results. Results: The cost-effectiveness model showed that, compared with placebo, bezlotoxumab was associated with 0.12 quality-adjusted life-years (QALYs) gained and was cost-effective in preventing CDI recurrences in the entire trial population, with an ICER of $19824/QALY gained. Compared with placebo, bezlotoxumab was also cost-effective in the subgroups of patients aged ≥65 years (ICER of $15298/QALY), immunocompromised patients (ICER of $12597/QALY), and patients with severe CDI (ICER of $21430/QALY). Conclusions: Model-based results demonstrated that bezlotoxumab was cost-effective in the prevention of recurrent CDI compared with placebo, among patients receiving SoC antibiotics for treatment of CDI.


Assuntos
Antibacterianos/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Anticorpos Neutralizantes/uso terapêutico , Infecções por Clostridium/prevenção & controle , Idoso , Antibacterianos/economia , Anticorpos Monoclonais/economia , Anticorpos Neutralizantes/economia , Anticorpos Amplamente Neutralizantes , Clostridioides difficile/efeitos dos fármacos , Infecções por Clostridium/economia , Infecções por Clostridium/mortalidade , Estudos de Coortes , Análise Custo-Benefício , Feminino , Humanos , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Anos de Vida Ajustados por Qualidade de Vida , Recidiva , Prevenção Secundária/economia , Vancomicina/economia , Vancomicina/uso terapêutico
6.
J Antimicrob Chemother ; 72(9): 2647-2656, 2017 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-28633368

RESUMO

Objectives: Data quantifying outcomes of recurrent Clostridium difficile infection (rCDI) are lacking. We sought to determine the UK hospital resource use and health-related quality of life (HRQoL) associated with rCDI hospitalizations. Patients and methods: A non-interventional study in six UK acute hospitals collected retrospective clinical and resource use data from medical records of 64 adults hospitalized for rCDI and 64 matched inpatient controls with a first episode only (f)CDI. Patients were observed from the index event (date rCDI/fCDI confirmed) for 28 days (or death, if sooner); UK-specific reference costs were applied. HRQoL was assessed prospectively in a separate cohort of 30 patients hospitalized with CDI, who completed the EQ-5D-3L questionnaire during their illness. Results: The median total management cost (post-index) was £7539 and £6294 for rCDI and fCDI, respectively (cost difference, P = 0.075); median length of stay was 21 days and 15.5 days, respectively (P = 0.269). The median cost difference between matched rCDI and fCDI cases was £689 (IQR=£1873-£3954). Subgroup analysis demonstrated the highest median costs (£8542/patient) in severe rCDI cases. CDI management costs were driven primarily by hospital length of stay, which accounted for >85% of costs in both groups. Mean EQ-5D index values were 46% lower in CDI patients compared with UK population values (0.42 and 0.78, respectively); EQ visual analogue scale scores were 38% lower (47.82 and 77.3, respectively). Conclusions: CDI has considerable impact on patients and healthcare resources. This multicentre study provides a contemporaneous estimate of the real-world UK costs associated with rCDI management, which are substantial and comparable to fCDI costs.


Assuntos
Infecções por Clostridium/economia , Infecções por Clostridium/epidemiologia , Efeitos Psicossociais da Doença , Atenção à Saúde/economia , Hospitalização/estatística & dados numéricos , Qualidade de Vida , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/uso terapêutico , Clostridioides difficile/isolamento & purificação , Infecções por Clostridium/tratamento farmacológico , Estudos de Coortes , Feminino , Recursos em Saúde/economia , Humanos , Masculino , Prontuários Médicos , Recidiva , Estudos Retrospectivos , Reino Unido/epidemiologia
7.
BMC Cancer ; 13: 519, 2013 Nov 03.
Artigo em Inglês | MEDLINE | ID: mdl-24180710

RESUMO

BACKGROUND: Given their frequency of occurrence in the United States, cancer and heart disease often coexist. For patients requiring open-heart surgery, this raises concern that the use of cardiopulmonary bypass (CPB) may cause a transient immunosuppression with the potential to promote the spread and growth of coexisting cancer cells. This study examined the association of cardiopulmonary bypass with cancer progression in a large population-based setting using linked data from several state-wide registries. METHODS: A retrospective cohort study of cancer risk, stage, and mortality in 43,347 patients who underwent coronary artery bypass graft (CABG) surgery with and without CPB in New Jersey between 1998-2004 was conducted. A competing risk analogue of the Cox proportional hazards model with propensity score adjustment and regression on the cause-specific hazard was used to compute relative risk ratios (95% confidence intervals [CIs]) for patients undergoing CABG surgery with and without CPB. RESULTS: An increased risk for overall cancer incidence (17%) and cancer-specific mortality (16% overall, 12% case fatality) was observed; yet these results did not reach statistical significance. Of 11 tumor-specific analyses, an increased risk of skin melanoma (1.66 [95% CI, 1.08-2.55: p=0.02]) and lung cancer (1.36 [95% CI, 1.02-1.81: p=0.03]) was observed for patients with pump versus off-pump open-heart surgery. No association was found with cancer stage. CONCLUSIONS: These results suggest that there may be a relationship between CPB and cancer progression. However, if real, the effect is likely modest at most. Further research may still be warranted with particular focus on skin melanoma and lung cancer which had the strongest association with CPB.


Assuntos
Ponte Cardiopulmonar/efeitos adversos , Cardiopatias/complicações , Neoplasias/complicações , Neoplasias/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Progressão da Doença , Feminino , Cardiopatias/cirurgia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Neoplasias/mortalidade , Estudos Retrospectivos , Risco
8.
Cancer ; 118(16): 4046-52, 2012 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-22180145

RESUMO

BACKGROUND: Statins are some of the most commonly prescribed medications in medical practice, and prostate cancer is the most common malignancy among men. Although there has been no consistent evidence that statins affect cancer incidence, including prostate cancer, several reports suggest they may decrease the rate of advanced prostate cancer. However, no study to date has specifically examined statin use and prostate cancer mortality. The authors conducted this population-based case-control investigation to examine this association. METHODS: This was a matched case-control study. Cases were residents of New Jersey ages 55 to 79 years who died from prostate cancer between 1997 and 2000. The cases were matched individually to population-based controls by 5-year age group and race. Medication data were obtained identically for cases and controls from blinded medical chart review. Conditional logistic regression was used to adjust for confounders. RESULTS: In total, 718 cases were identified, and cooperation was obtained from 77% of their spouses (N = 553). After a review of medical records, 387 men were eligible, and 380 were matched to a control. The unadjusted odds ratio was 0.49 (95% confidence interval, 0.34-0.70) and decreased to 0.37 (P < .0001) after adjusting for education, waist size, body mass index, comorbidities, and antihypertensive medication. There was little difference between lipophilic and hydrophilic statins, but more risk reduction was noted for high-potency statins (73%; P < .0001) compared with low-potency statins (31%; P = .32). CONCLUSIONS: Statin use was associated with substantial protection against prostate cancer death, adding to the epidemiologic evidence for an inhibitory effect on prostate cancer.


Assuntos
Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Neoplasias da Próstata/mortalidade , Idoso , Estudos de Casos e Controles , Etnicidade , Humanos , Masculino , Pessoa de Meia-Idade , Risco
9.
Stat Med ; 31(19): 2055-67, 2012 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-22415966

RESUMO

It is well-known that both frequentist and Bayesian clinical trial designs have their own advantages and disadvantages. To have better properties inherited from these two types of designs, we developed a Bayesian-frequentist two-stage single-arm phase II clinical trial design. This design allows both early acceptance and rejection of the null hypothesis ( H(0) ). The measures (for example probability of trial early termination, expected sample size, etc.) of the design properties under both frequentist and Bayesian settings are derived. Moreover, under the Bayesian setting, the upper and lower boundaries are determined with predictive probability of trial success outcome. Given a beta prior and a sample size for stage I, based on the marginal distribution of the responses at stage I, we derived Bayesian Type I and Type II error rates. By controlling both frequentist and Bayesian error rates, the Bayesian-frequentist two-stage design has special features compared with other two-stage designs.


Assuntos
Teorema de Bayes , Ensaios Clínicos Fase II como Assunto/estatística & dados numéricos , Projetos de Pesquisa , Tamanho da Amostra , Viés , Distribuição Binomial , Ensaios Clínicos Fase II como Assunto/normas , Interpretação Estatística de Dados , Relação Dose-Resposta a Droga , Determinação de Ponto Final , Humanos , Modelos Estatísticos
10.
Infect Dis Ther ; 11(1): 187-199, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34731456

RESUMO

INTRODUCTION: Colistin is used to treat severe antibiotic-resistant Gram-negative infections (GNIs). With the rise of antibiotic resistance, colistin has been used increasingly as a 'last-line' therapy for multidrug-resistant GNIs. We evaluated the incidence of acute kidney injury (AKI) and mortality among patients receiving colistin or one of the new ß-lactam/ß-lactamase inhibitors (ßL + ßLI) (ceftazidime/avibactam, ceftolozane/tazobactam, or meropenem/vaborbactam). METHODS: This retrospective cohort study used data from the Premier Healthcare Database. The cohort included propensity score-matched adults with an inpatient stay between January 2016 and December 2018. Patients given both colistin and BL + BLI as treatment for ≥ 72 h were excluded. AKI was defined as acute renal failure or dialysis during hospitalization with antibiotic administration. Propensity score matching was used to control for selection bias and confounding. Logistic regression evaluated associations between treatment, AKI, and in-hospital mortality. RESULTS: The total number of patients in the matched cohorts were 256 in each. Overall, 23.8% and 13.3% of patients receiving colistin or new ßL + ßLI agents, respectively, experienced AKI during hospitalization (p = 0.002); odds of AKI for colistin were 3.0 (95% CI 1.71, 5.21). Following propensity score-matching, patients without baseline renal disease experienced AKI during hospitalization to a higher degree in the colistin group compared to the ßL + ßLI group (17.1% vs. 6.8%); colistin use was associated with 3.7 times higher odds (95% CI 1.84, 7.42) of AKI compared to ßL + ßLI agents. The odds of mortality in patients on colistin developing AKI were more than three times that of patients receiving a BL + BLI agent who developed AKI. Among patients receiving colistin, incident AKI was associated with 6.1 times higher odds (95% CI 2.53, 14.71) of mortality. CONCLUSIONS: Patients receiving colistin for GNIs had significantly higher odds of AKI and mortality than those receiving ßL + ßLI.

11.
Adv Ther ; 39(9): 4169-4188, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35836089

RESUMO

INTRODUCTION: Lusutrombopag is an oral thrombopoietin receptor agonist (TPO-RA). Clinical trials have shown lusutrombopag's efficacy in reducing need for preoperative platelet transfusion in patients with chronic liver disease (CLD) and severe thrombocytopenia. This analysis assessed efficacy and safety of lusutrombopag in patients with severe thrombocytopenia and CLD undergoing planned invasive procedures. METHODS: An electronic database search (through 1 December 2020) identified three randomised, placebo-controlled, double-blind clinical trials comparing lusutrombopag with placebo in patients with CLD and platelet count below 50 × 109/L scheduled to undergo a procedure with a perioperative bleeding risk. A random-effects meta-analysis examined treatment effect, with Cochrane Collaboration's tool assessing risk of bias. RESULTS: The meta-analysis included 343 (lusutrombopag 3 mg, n = 173; placebo, n = 170) patients. More patients met the criteria for treatment response (platelet count at least 50 × 109/L and increase of at least 20 × 109/L from baseline anytime during the study) with lusutrombopag versus placebo (risk ratio [RR] 6.39; 95% confidence interval [CI] 3.69, 11.07; p < 0.0001). The primary efficacy outcome, proportion of patients requiring no platelet transfusion and no rescue therapy for bleeding for at least 7 days post procedure, was achieved by more patients treated with lusutrombopag versus placebo (RR 3.42; 95% CI 1.86, 6.26; p = 0.0001). The risk of any bleeding event was significantly lower with lusutrombopag compared to placebo (RR 0.55; 95% CI 0.32, 0.95; p = 0.03); conversely, thrombosis event rates were similar between lusutrombopag and placebo (RR 0.79; 95% CI 0.19, 3.24; p = 0.74). CONCLUSION: This meta-analysis showed that treatment of severe thrombocytopenia with lusutrombopag in patients with CLD prior to a planned invasive procedure was efficacious and safe in increasing platelet counts, avoiding the need for platelet transfusions, and reducing risk of bleeding, thereby enhancing the certainty of evidence supporting the efficacy and safety of lusutrombopag.


Assuntos
Anemia , Hepatopatias , Trombocitopenia , Anemia/tratamento farmacológico , Doença Crônica , Cinamatos/efeitos adversos , Hemorragia/tratamento farmacológico , Humanos , Hepatopatias/complicações , Hepatopatias/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto , Tiazóis/efeitos adversos , Trombocitopenia/complicações , Trombocitopenia/tratamento farmacológico
12.
N Engl J Med ; 356(11): 1099-109, 2007 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-17360988

RESUMO

BACKGROUND: Management of acute myocardial infarction requires urgent diagnostic and therapeutic procedures, which may not be uniformly available throughout the week. METHODS: We examined differences in mortality between patients admitted on weekends and those admitted on weekdays for a first acute myocardial infarction, using the Myocardial Infarction Data Acquisition System. All such admissions in New Jersey from 1987 to 2002 (231,164) were included and grouped in 4-year intervals. RESULTS: There were no significant differences in demographic characteristics, coexisting conditions, or infarction site between patients admitted on weekends and those admitted on weekdays. However, patients admitted on weekends were less likely to undergo invasive cardiac procedures, especially on the first and second days of hospitalization (P<0.001). In the interval from 1999 to 2002 (59,786 admissions), mortality at 30 days was significantly higher for patients admitted on weekends (12.9% vs. 12.0%, P=0.006). The difference became significant the day after admission (3.3% vs. 2.7%, P<0.001) and persisted at 1 year (1% absolute difference in mortality). The difference in mortality at 30 days remained significant after adjustment for demographic characteristics, coexisting conditions, and site of infarction (hazard ratio, 1.048; 95% confidence interval [CI], 1.022 to 1.076; P<0.001), but it became nonsignificant after additional adjustment for invasive cardiac procedures (hazard ratio, 1.023; 95% CI, 0.997 to 1.049; P=0.09). CONCLUSIONS: For patients with myocardial infarction, admission on weekends is associated with higher mortality and lower use of invasive cardiac procedures. Our findings suggest that the higher mortality on weekends is mediated in part by the lower rate of invasive procedures, and we speculate that better access to care on weekends could improve the outcome for patients with acute myocardial infarction.


Assuntos
Infarto do Miocárdio/mortalidade , Avaliação de Processos e Resultados em Cuidados de Saúde , Admissão do Paciente , Idoso , Angioplastia Coronária com Balão/estatística & dados numéricos , Cateterismo Cardíaco/estatística & dados numéricos , Ponte de Artéria Coronária/estatística & dados numéricos , Feminino , Mortalidade Hospitalar , Humanos , Tempo de Internação , Masculino , Infarto do Miocárdio/terapia , Fatores de Tempo
13.
Open Forum Infect Dis ; 7(4): ofaa097, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32363211

RESUMO

BACKGROUND: Bezlotoxumab is approved for prevention of recurrence of Clostridioides difficile infection (CDI) in adults receiving standard of care (SoC) therapy based on findings from MODIFY clinical trials. However, utilization practices and validation of trial results in the real world are limited. METHODS: Records of patients receiving bezlotoxumab between April 2017 and December 2018 across 34 infusion centers in the United States were retrospectively reviewed. Recurrent CDI (rCDI), defined as diarrhea lasting ≥2 days resulting in treatment, was assessed 90 days postbezlotoxumab. RESULTS: The study cohort included 200 patients (median age, 70 years; 66% female; median Charlson comorbidity index, 5), of whom 86% (n = 173) had prior CDI episodes and 79% (n = 158) had ≥2 risk factors for rCDI. SoC antibiotics included vancomycin (n = 137, 68%), fidaxomicin (n = 60, 30%), and metronidazole (n = 3, 2%). Median time from C. difficile stool test to bezlotoxumab and initiation of SoC to bezlotoxumab were 15 days and 11 days, respectively. Within 90 days, 31 of 195 patients (15.9%) experienced rCDI, which corresponds to a success rate of 84.1%. Patients with ≥2 CDI recurrences prebezlotoxumab had a higher risk of subsequent rCDI compared with those with 1 recurrence or primary CDI (hazard ratio, 2.77; 95% confidence interval, 1.14-6.76; P = .025). CONCLUSIONS: This real-world multicenter study demonstrated successful prevention of rCDI with bezlotoxumab comparable to clinical trial results regardless of type of SoC and timing of infusion. Multiple prior CDI recurrences were associated with a higher risk of subsequent rCDI, supporting the use of bezlotoxumab earlier in the disease course.

14.
Cancer Epidemiol Biomarkers Prev ; 17(9): 2467-72, 2008 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-18768517

RESUMO

Studies suggest inverse associations between obesity and prostate-specific antigen (PSA). However, there is little evidence whether factors related to obesity, including lifestyle (diet and physical activity) and physiologic factors (insulin resistance and metabolic syndrome), influence PSA. We used dietary, physical activity, and serum PSA, insulin, glucose, and lipid data for men >40 years from the National Health and Nutrition Examination Survey (2001-2004; N = 2,548). Energy, fat, and carbohydrate intakes were estimated from a 24-hour dietary recall. Men were considered as having metabolic syndrome based on the Adult Treatment Panel III criteria. Leisure-time physical activity and doctor-diagnosed hypertension were self-reported. Body mass index was calculated from measured weight and height. We computed the geometric mean PSA (ng/mL), adjusted for age, race, and body mass index, by tertile of energy, fat, and carbohydrate intake and level of physical activity, and among men with and without insulin resistance and metabolic syndrome in the whole population and by race. The geometric mean PSA (95% confidence interval) among men in the lowest tertile of energy was 1.05 (0.97-1.1) relative to 0.85 (0.8-0.9) in the highest tertile (P = 0.0002) in the whole population. The PSA concentrations were lower among overweight men with higher versus lower energy intake (P = 0.001). The PSA concentrations in men with insulin resistance was lower [0.87 (0.8-0.9)] relative to men without insulin resistance [0.98 (0.9-1.1)] at P = 0.04. All associations were in similar directions within racial subgroups. No associations were observed between the other lifestyle and physiologic factors. Additional studies are required to confirm these results and to investigate the potential mechanisms that may explain these relationships.


Assuntos
Estilo de Vida , Síndrome Metabólica/sangue , Obesidade/sangue , Antígeno Prostático Específico/sangue , Adulto , Idoso , Glicemia/análise , Dieta , Humanos , Insulina/sangue , Resistência à Insulina , Lipídeos/sangue , Masculino , Síndrome Metabólica/epidemiologia , Pessoa de Meia-Idade , Atividade Motora , Inquéritos Nutricionais , Obesidade/epidemiologia , Estados Unidos
15.
J Gen Intern Med ; 23(3): 248-53, 2008 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-18172740

RESUMO

BACKGROUND: There is no available evidence from randomized trials that early detection of prostate cancer improves health outcomes, but the prostate-specific antigen (PSA) test is commonly used to screen men for prostate cancer. OBJECTIVE: The objective of the study is to see if screening with PSA decreases mortality from prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: This is a case-control study using one-to-one matching on race, age, and time of availability of exposure to PSA screening. Decedents, 380, from New Jersey Vital Statistics 1997 to 2000 inclusive, 55-79 years of age at diagnosis were matched to living controls without metastatic prostate cancer. Medical records were obtained from all providers, and we abstracted information about PSA tests from 1989 to the time of diagnosis in each index case. MEASUREMENTS: Measurements consist of a comparison of screening (yes, no) between cases and controls. Measure of association was the odds ratio. RESULTS: Eligible cases were diagnosed each year from 1989 to 1999 with the median year being 1993. PSA screening was evident in 23.2-29.2% of cases and 21.8-26.1% of controls depending on the screening criteria. The unadjusted, matched odds ratio for dying of prostate cancer if ever screened was 1.09 (95% CI 0.76 to 1.60) for the most restrictive criteria and 1.19 (95% CI, 0.85 to 1.66) for the least restrictive. Adjustment for comorbidity and education level made no significant differences in these values. There were no significant interactions by age or race. CONCLUSIONS: PSA screening using an ever/never tabulation for tests from 1989 until 2000 did not protect New Jersey men from prostate cancer mortality.


Assuntos
Programas de Rastreamento/normas , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/mortalidade , Neoplasias da Próstata/prevenção & controle , Fatores Etários , Idoso , Estudos de Casos e Controles , Intervalos de Confiança , Humanos , Masculino , Programas de Rastreamento/tendências , Pessoa de Meia-Idade , New Jersey , Razão de Chances , Probabilidade , Neoplasias da Próstata/sangue , Valores de Referência , Estudos Retrospectivos , Medição de Risco , Sensibilidade e Especificidade , Análise de Sobrevida
16.
Medicine (Baltimore) ; 97(36): e12212, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30200134

RESUMO

Recurrent Clostridium difficile infection (rCDI) requiring rehospitalization contributes to poor outcomes, which may differ between patients hospitalized with versus for it.We performed a multicenter retrospective cohort study of rehospitalized adults surviving initial CDI hospitalization. Hospital mortality, length of stay (LOS), 30-day readmission, and mean gap between hospital costs and Diagnosis Related Group (DRG) reimbursement served as outcomes.Among the 25.7% (n = 99,175) survivors requiring rehospitalization, 36,504 (36.8%) had rCDI (14,005 [38.4%] principal diagnosis rCDI [PrCDI]). Compared with non-CDI, PrCDI, and secondary diagnosis rCDI [SrCDI] carried lower risk of death (PrCDI odds ratio [OR] 0.52; 95% confidence interval [CI] 0.46, 0.58; SrCDI OR 0.80; 95% CI 0.75, 0.85) and 30-day readmission (PrCDI OR 0.84; 95% CI 0.80, 0.88; SrCDI OR 0.97; 95% CI 0.94, 1.01), and excess LOS (PrCDI 1.8 days; 95% CI 1.7, 2.0; SrCDI 1.4 days; 95% CI 1.3, 1.5), and costs (PrCDI $1399; 95% CI $858, $1939; SrCDI $2809; 95% CI $2307, $3311). Mean gap between hospital costs and DRG reimbursements was highest in SrCDI ($13,803).A rehospitalization within 60-days of an initial CDI hospitalization occurs in approximately 25% of all survivors, 1/3 with rCDI. SrCDI carries worse outcomes than PrCDI. The potential loss of revenue incurred by the hospital is nearly 3-fold higher for SrCDI than PrCDI.


Assuntos
Infecções por Clostridium/diagnóstico , Infecções por Clostridium/terapia , Readmissão do Paciente , Adolescente , Adulto , Idoso , Infecções por Clostridium/economia , Infecções por Clostridium/mortalidade , Feminino , Seguimentos , Custos de Cuidados de Saúde , Mortalidade Hospitalar , Humanos , Tempo de Internação/economia , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente/economia , Estudos Retrospectivos , Estados Unidos , Adulto Jovem
17.
Open Forum Infect Dis ; 5(11): ofy218, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30460321

RESUMO

BACKGROUND: Patients with recurrent Clostridium difficile infection (rCDI) are more likely to have a hospital readmission and spend increased time in inpatient settings compared with patients with primary CDI. MODIFY I and II demonstrated that bezlotoxumab significantly reduced rCDI vs placebo. A post hoc within-trial analysis assessed whether bezlotoxumab was associated with a reduction in cumulative inpatient-days. METHODS: Data were pooled from the MODIFY trials to estimate the cumulative hospitalized days summed over the 84-day follow-up period. We adjusted inpatient use data from pooled MODIFY I and II for survival and censoring to estimate 84-day cumulative inpatient-days, overall and for subgroups. Treatment effects were obtained using recycled predictions based on trial protocol and rCDI risk, and 95% confidence intervals were obtained using 1000 bootstrap replicates. RESULTS: Mean cumulative inpatient-days were greater in the placebo arm (14.1 days) vs the bezlotoxumab arm (12.1 days) in the overall population. The mean difference between treatment groups was 2.1 days (95% confidence interval, -0.4 to -3.7). This was consistent in participants with risk factors for rCDI: age ≥65 years, compromised immunity, severe CDI, prior CDI, and ribotype 027/078/244 infection. As the number of risk factors increased, bezlotoxumab resulted in greater reductions in the number of inpatient-days compared with placebo (difference: -1.2 days, -2.3 days, -2.5 days, and -3.0 days for 0, 1, 2, and ≥3 risk factors, respectively). CONCLUSIONS: Bezlotoxumab was associated with a reduction in cumulative inpatient-days, suggesting that treatment with bezlotoxumab may substantially reduce rCDI-associated health care resource use. Trial registrations. MODIFY I (MK-3415A-001, NCT01241552) and II (MK-3415A-002, NCT01513239).

18.
J Gen Intern Med ; 22(1): 80-5, 2007 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-17351844

RESUMO

BACKGROUND: Today's medical students are being educated at a time when there are no evidence-based guidelines for prostate cancer screening. OBJECTIVE: To examine medical students' knowledge and beliefs concerning prostate cancer screening and specific determinants for their beliefs. DESIGN, SETTING, AND PARTICIPANTS: One thousand six hundred and forty four students were sampled at 20 medical schools using a web-based, cross-sectional survey. MAIN OUTCOME MEASURES: Basic knowledge and beliefs about prostate cancer testing, epidemiology, and therapy were ascertained. RESULTS: Four of 8 knowledge items were answered incorrectly by 50% or more of students. Seven of 8 students believe that early diagnosis from screening can improve survival from prostate cancer. Second- and third-year students were more likely than fourth-year students to believe that the digital rectal exam (DRE) and the prostate-specific antigen test were accurate, adjusted odds ratio (AOR) 1.8; 95% confidence interval (CI), 1.2 to 2.7 and 1.7; 1.3 to 2.2 for second and third years, respectively, for the DRE. Black and Hispanic students were no more likely than white students to agree that early screening diagnosis improves survival, but blacks were more likely to agree with screening black or Hispanic men (AOR 7.8; 95% CI, 5.3 to 11.4 and 3.2; 2.2 to 4.7, respectively). More knowledgeable students were less likely to believe in the benefit of early detection and the accuracy of the prostate-specific antigen (AOR 0.3; 95%CI, 0.2 to 0.5). CONCLUSIONS: Medical students generally are very optimistic about the benefits of screening for prostate cancer. Increased knowledge about prostate cancer is associated with a more conservative view of screening. Other predictors are independent of this knowledge.


Assuntos
Atitude do Pessoal de Saúde , Competência Clínica , Programas de Rastreamento , Neoplasias da Próstata/prevenção & controle , Estudantes de Medicina , Estudos Transversais , Diagnóstico Precoce , Feminino , Humanos , Masculino , Exame Físico , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/diagnóstico , Grupos Raciais , Inquéritos e Questionários , Estados Unidos
19.
Infect Control Hosp Epidemiol ; 38(1): 45-52, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-27760583

RESUMO

BACKGROUND Considerable efforts have been dedicated to developing strategies to prevent and treat recurrent Clostridium difficile infection (rCDI); however, evidence of the impact of rCDI on patient healthcare utilization and outcomes is limited. OBJECTIVE To compare healthcare utilization and 1-year mortality among adults who had rCDI, nonrecurrent CDI, or no CDI. METHODS We performed a nested case-control study among adult Kaiser Foundation Health Plan members from September 1, 2001, through December 31, 2013. We identified CDI through the presence of a positive laboratory test result and divided patients into 3 groups: patients with rCDI, defined as CDI in the 14-57 days after initial CDI; patients with nonrecurrent CDI; and patients who never had CDI. We conducted 3 matched comparisons: (1) rCDI vs no CDI; (2) rCDI vs nonrecurrent CDI; (3) nonrecurrent CDI vs no CDI. We followed patients for 1 year and compared healthcare utilization between groups, after matching patients on age, sex, and comorbidity. RESULTS We found that patients with rCDI consistently have substantially higher levels of healthcare utilization in various settings and greater 1-year mortality risk than both patients who had nonrecurrent CDI and patients who never had CDI. CONCLUSIONS Patients who develop an initial CDI are generally characterized by excess underlying, severe illness and utilization. However, patients with rCDI experience even greater adverse consequences of their disease than patients who do not experience rCDI. Our results further support the need for continued emphasis on identifying and using novel approaches to prevent and treat rCDI. Infect Control Hosp Epidemiol. 2016;1-8.


Assuntos
Infecções por Clostridium/mortalidade , Infecções por Clostridium/terapia , Serviços de Saúde/estatística & dados numéricos , Adulto , Idoso , Algoritmos , Antibacterianos/uso terapêutico , California/epidemiologia , Estudos de Casos e Controles , Clostridioides difficile , Transplante de Microbiota Fecal , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Fatores de Risco
20.
J Med Econ ; 19(1): 77-83, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26366612

RESUMO

BACKGROUND: Posaconazole is superior to fluconazole/itraconazole in preventing invasive fungal diseases (IFDs) in neutropenic patients. Whether the higher cost of posaconazole is offset by decreases in IFDs in a given institute requires cost-effective analysis encompassing the spectrum of IFDs and socioeconomic factors specific to that geographic area. METHODS: This study performed a cost-effective analysis of posaconazole prophylaxis for IFDs in an Asian teaching hospital, employing decision modeling and data of IFDs and medication costs specific to the institute, in neutropenic patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). RESULTS: In the cost-effectiveness analysis, the higher cost of posaconazole was partially offset by a reduction in the cost of treating IFDs that were prevented, resulting in an incremental cost of 125,954 Hong Kong dollars/16,148 USD per IFD avoided. Over a lifetime horizon, assuming same case fatality rate of IFDs in both groups, use of posaconazole results in 0.07 discounted life years saved. This corresponds to an incremental cost of 116,023 HKD/14,875 USD per life year saved. This incremental cost per life year saved in posaconazole prophylaxis fulfilled the World Health Organization defined threshold for cost-effectiveness. CONCLUSION: Posaconazole prophylaxis was cost-effective in Hong Kong.


Assuntos
Antifúngicos/economia , Fluconazol/economia , Itraconazol/economia , Micoses/prevenção & controle , Triazóis/economia , Antifúngicos/administração & dosagem , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Fluconazol/administração & dosagem , Hong Kong , Hospitais de Ensino , Humanos , Itraconazol/administração & dosagem , Leucemia Mieloide Aguda/complicações , Leucemia Mieloide Aguda/mortalidade , Modelos Econométricos , Micoses/etiologia , Micoses/mortalidade , Síndromes Mielodisplásicas/complicações , Síndromes Mielodisplásicas/mortalidade , Fatores Socioeconômicos , Triazóis/administração & dosagem
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