Person-days Of Follow-up Research Articles

Mortality and re-fracture rates in low trauma hip fracture.

This study aimed to estimate the incidence rate of re-fracture and all-cause mortality rate in patients with hip fractures caused by minor trauma in the first year following the event. This is a retrospective cohort study of patients over 50 years of age conducted in a referral hospital located in Tehran (Shafa-Yahyaian). Using the hospital information system (HIS), all patients hospitalized due to hip fractures caused by minor trauma during 2013-2019 were included in the study. We investigated the occurrence of death and re-fracture in all patients one year after the primary hip fracture. A total of 945 patients with hip fractures during a 307,595 person-days of follow-up, were included. The mean age of the participants was 71 years (SD = 11.19), and 533 (59%) of them were women. One hundred forty-nine deaths were identified during the first year after hip fracture, resulting in a one-year mortality rate of 17.69% (95% CI: 15.06-20.77). The one-year mortality rate was 20.06% in men and 15.88% in women. Out of all the participants, 667 answered the phone call, of which 29 cases had experienced a re-fracture in the first year (incidence rate = 5.03%, 95% CI: 3.50-7.24). The incidence rates in women and men were 6.07% and 3.65%, respectively. Patients with low-trauma hip fractures have shown a high rate of mortality in the first year. Considering the increase in the incidence of hip fractures with age, comprehensive strategies are needed to prevent fractures caused by minor trauma in the elderly population.

Redox state of human serum albumin predicts 1-year prognosis in patients with heart failure: a single center prospective cohort study

Abstract Background As chronic inflammation would be a fundamental underlying mechanism in the pathogenesis in patients with heart failure (HF), oxidative stress has a possibility to closely associate with the prognosis. However, little is known about the association of oxidative stress with the prognosis in HF patients. Purpose In this study, we assessed the association of the fraction of human mercapto-albumin [f(HMA)], an index of the redox state of human serum albumin, with prognosis in patients hospitalized for HF with the aim to find the possible biomarker available on the prediction for adverse events in HF patients. Methods A single-center prospective cohort study was conducted. In the cohort, 290 ambulate patients admitted for acute HF or exacerbation of chronic HF were registered. Of these, 182 who were successfully followed-up patients were analyzed (median age: 79 years, men: 68.3%. median follow-up: 365 days). The primary outcome was a composite of HF rehospitalization and all-cause mortality. The high-performance liquid chromatography postcolumn bromocresol green method was used to part human serum albumin into human nonmercaptalbumin (oxidized form) and human mercaptalbumin (HMA, reduced form). We divided patients into two groups by median f(HMA) level. Kaplan-Meier Curve and the Cox proportional hazards model was used to examine the significance of f(HMA) as a prognostic indicator of HF patients, adjusting for potential confounding factors. Results Median level of f(HMA) was 57.2%. During 50,965 person-days of follow-up, 52 patients (28.6%) were re-hospitalized due to HF exacerbation, and 25 patients (13.7%) died due to cardiac or noncardiac reasons. Log-rank analysis showed that a high f(HMA) group reduced adverse events (Fig. 1). In the Cox proportional hazards model, a high level of f(HMA) was associated with a reduced risk of composite outcomes (hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.39-1.07). In the subgroup analysis, high f(HMA) showed an event-reducing effect in HF rehospitalizations (HR 0.53; 95% CI 0.30-0.94), but not in all-cause mortality (HR 0.61; 95%CI 0.27-1.38). Conclusion The findings of this study support that f(HMA) could be a novel prognostic biomarker for HF patients.Fig. 1

Effectiveness of BNT162b2 mRNA vaccine third doses and previous infection in protecting against SARS-CoV-2 infections during the Delta and Omicron variant waves; the UK SIREN cohort study September 2021 to February 2022

Third doses of COVID-19 vaccines were widely deployed following primary vaccine course waning and emergence of the Omicron-variant. We investigated protection from third-dose vaccines and previous infection against SARS-CoV-2 infection during Delta-variant and Omicron-variant (BA.1 & BA.2) waves in our frequently PCR-tested cohort of healthcare-workers.Relative effectiveness of BNT162b2 third doses and infection-acquired immunity was assessed by comparing the time to PCR-confirmed infection in boosted participants with those with waned dose-2 protection (≥254 days after dose-2), by primary series vaccination type. Follow-up time was divided by dominant circulating variant: Delta 07 September 2021 to 30 November 2021, Omicron 13 December 2021 to 28 February 2022. We used a Cox regression model with adjustment/stratification for demographic characteristics and staff-type. We explored protection associated with vaccination, infection and both.We included 19,614 participants, 29% previously infected. There were 278 primary infections (4 per 10,000 person-days of follow-up) and 85 reinfections (0.8/10,000 person-days) during the Delta period and 2467 primary infections (43/10,000 person-days) and 881 reinfections (33/10,000) during the Omicron period. Relative Vaccine Effectiveness (VE) 0-2 months post-3rd dose (3rd dose) (3-doses BNT162b2) in the previously uninfected cohort against Delta infections was 63% (95% Confidence Interval (CI) 40%-77%) and was lower (35%) against Omicron infection (95% CI 21%-47%). The relative VE of 3rd dose (heterologous BNT162b2) was greater for primary course ChAdOX1 recipients, with VE 0-2 months post-3rd dose over ≥68% higher for both variants. Third-dose protection waned rapidly against Omicron, with no significant difference between two and three BNT162b2 doses observed after 4-months. Previous infection continued to provide additional protection against Omicron (67% (CI 56%-75%) 3-6 months post-infection), but this waned to about 25% after 9-months, approximately three times lower than against Delta.Infection rates surged with Omicron emergence. Third doses of BNT162b2 vaccine provided short-term protection, with rapid waning against Omicron infections. Protection associated with infections incurred before Omicron was markedly diminished against the Omicron wave. Our findings demonstrate the complexity of an evolving pandemic with potential emergence of immune-escape variants and the importance of continued monitoring.

Feasibility and acceptability pilot of video-based direct observed treatment (vDOT) for supporting antitubercular treatment in South India: a cohort study

ObjectivesThe objective of this study was to assess the feasibility and acceptability of video-based anti-tuberculosis (TB) treatment adherence support in patients with TB (PwTB) in South India.DesignAn exploratory cohort.SettingParticipants were...

High Risk of Secondary Infections Following Thrombotic Complications in Patients With COVID-19.

BackgroundThis study’s primary aim was to evaluate the impact of thrombotic complications on the development of secondary infections. The secondary aim was to compare the etiology of secondary infections in patients with and without thrombotic complications.MethodsThis was a cohort study (NCT04318366) of coronavirus disease 2019 (COVID-19) patients hospitalized at IRCCS San Raffaele Hospital between February 25 and June 30, 2020. Incidence rates (IRs) were calculated by univariable Poisson regression as the number of cases per 1000 person-days of follow-up (PDFU) with 95% confidence intervals. The cumulative incidence functions of secondary infections according to thrombotic complications were compared with Gray's method accounting for competing risk of death. A multivariable Fine-Gray model was applied to assess factors associated with risk of secondary infections.ResultsOverall, 109/904 patients had 176 secondary infections (IR, 10.0; 95% CI, 8.8–11.5; per 1000-PDFU). The IRs of secondary infections among patients with or without thrombotic complications were 15.0 (95% CI, 10.7–21.0) and 9.3 (95% CI, 7.9–11.0) per 1000-PDFU, respectively (P = .017). At multivariable analysis, thrombotic complications were associated with the development of secondary infections (subdistribution hazard ratio, 1.788; 95% CI, 1.018–3.140; P = .043). The etiology of secondary infections was similar in patients with and without thrombotic complications.ConclusionsIn patients with COVID-19, thrombotic complications were associated with a high risk of secondary infections.

Association Between Type of Infertility and Live Birth in Couples With a Single Intrauterine Insemination Resulting in Pregnancy: A Propensity Score Matching Cohort Study.

BackgroundFew studies have described the relationship between the type of infertility and live birth in patients treated with intrauterine insemination (IUI). We focused on this issue and attempted to explore it.MethodsThis retrospective study enrolled 2,256 infertile patients who underwent their first IUI cycle and were subsequently diagnosed with a clinical pregnancy at Ji’an Women and Child Health Care Hospital between 2007 and 2018. Inductees were divided into primary infertility (1,680 patients) and secondary infertility groups (876 patients). Following 1:1 propensity score matching to obtain balanced data, the COX proportional hazards model, landmark analysis, and subgroup analysis were used to assess the association between infertility types and live birth rates. Subsequently, a sensitivity analysis was employed to evaluate the potential effect of unmeasured confounding on outcomes.ResultsOf the 1,486 patients who were identified as a matched cohort, 743 were in the primary infertility group and the remaining patients were in another group. A total of 1,143 patients had live births during 431,009 person-days of follow-up (average 290.0 days). Throughout the follow-up period, patients with secondary infertility demonstrated more live births than patients with primary infertility (hazard ratio [HR], 1.16; 95% confidence interval [CI], 1.04 to 1.30; P = .007). More details were observed in the landmark analysis. Live birth rates were similar in both groups within 316 days of follow-up (HR, 0.84; 95% CI, 0.62 to 1.14; P = .269), whereas the opposite was found between 316 days of follow-up and delivery day (HR, 1.19; 95% CI, 1.06 to 1.34; P = .004). This was also obtained in a subgroup analysis of patients younger than 35 years old and patients treated with natural cycles (NCs) and IUIs.ConclusionAmong the infertile patients who underwent a single natural or stimulated cycle followed by IUI and had later pregnancies, full-term young secondary infertility mothers (<35 years of age) had a greater chance of having viable babies than the primary infertility ones. The latter may get more benefits when undergoing ovarian stimulation and IUI rather than NC-IUI.

Growth Kinetics and Progression Rate of Bosniak Classification Version 2019 Class III and IV Cystic Renal Masses on Imaging Surveillance.

BACKGROUND. Active surveillance is increasingly used as first-line management for localized renal masses. Triggers for intervention primarily reflect growth kinetics, which have been poorly investigated for cystic masses defined by the Bosniak classification version 2019 (v2019). OBJECTIVE. The purpose of this study was to determine growth kinetics and incidence rates of progression of class III and IV cystic renal masses, as defined by the Bosniak classification v2019. METHODS. This retrospective study included 105 patients (68 men, 37 women; median age, 67 years) with 112 Bosniak v2019 class III or IV cystic renal masses on baseline renal mass protocol CT or MRI examinations performed from January 2005 to September 2021. Mass dimensions were measured. Progression was defined as any of the following: linear growth rate (LGR) of 5 mm/y or greater (representing the clinical guideline threshold for intervention), volume doubling time less than 1 year, T category increase, or N1 or M1 disease. Class III and IV masses were compared. Time to progression was estimated using Kaplan-Meier curve analysis. RESULTS. At baseline, 58 masses were class III and 54 were class IV. Median follow-up was 403 days. Median LGR for class III masses was 0.0 mm/y (interquartile range [IQR], -1.3 to 1.8 mm/y) and for class IV masses was 2.3 mm/y (IQR, 0.0-5.7 mm/y) (p < .001). LGR was at least 5 mm/y in four (7%) class III masses and 15 (28%) class IV masses (p = .005). Two patients, both with class IV masses, developed distant metastases. Incidence rate of progression for class III masses was 11.0 (95% CI, 4.5-22.8) and for class IV masses 73.6 (95% CI, 47.8-108.7) per 100,000 person-days of follow-up. Median time to progression was undefined for class III masses given the small number of progression events and 710 days for class IV masses. Hazard ratio of progression for class IV relative to class III masses was 5.1 (95% CI, 2.5-10.8; p < .001). CONCLUSION. During active surveillance of cystic masses evaluated using the Bosniak classification v2019, class IV masses grew faster and were more likely to progress than class III masses. CLINICAL IMPACT. In comparison with current active surveillance guidelines that treat class III and IV masses similarly, future iterations may incorporate relatively more intensive surveillance for class IV masses.

Survival status and predictors of mortality among traumatic brain injury patients in an Ethiopian hospital: A retrospective cohort study.

IntroductionTraumatic brain injury is a major global public health problem causing substantial mortality among the adult population. Hence, this study aimed to determine the predictors of mortality among adult traumatic brain injury patients in Felegehiwot Comprehensive Specialized Hospital in Northwest Ethiopia during 2020.MethodsA retrospective cohort study was conducted at Felegehiwot Comprehensive Specialized Hospital using anonymized patient data obtained from chart review. Descriptive statistics were used to summarise the patient characteristics. The Kaplan–Meier survival curve and log-rank test were used to test for differences in survival status among groups. The Cox proportional hazards regression model was used at the 5% level of significance to determine the net effect of each explanatory variable on time to death.ResultsIn total, 338 patients aged ≥15 years and diagnosed with traumatic brain injury were included in the analysis. Among these patients, 103 (30.45%) died, giving a crude death rate of 25.53 per 1000 (95% CI: 21.05–30.98) person-days of follow-up. The overall median survival time was 44 days. The independent predictors of mortality after diagnosis of traumatic brain injury were admission Glasgow coma scale score ≤ 8 (adjusted hazard ratio (AHR): 4.85; 95% confidence interval (CI): 1.73–13.62), bilateral non-reactive pupils at admission (AHR: 2.00 (95% CI: 1.10–3.71), elevated systolic blood pressure at admission (AHR: 0.31; 95% CI:0.11–0.86), elevated diastolic blood pressure at admission (AHR: 3.54; 95% CI: 1.33–9.43), and haematoma evacuation (AHR: 0.42; 95% CI: 0.16–0.90).DiscussionThe Survival status of traumatic brain injury patients was relatively low in this study. Glasgow coma scale score, bilateral non-reactive pupils, and elevated blood pressure were significant predictors of mortality. Further prospective follow-up studies that include residence and occupation are recommended.

Available bleeding scoring systems poorly predict major bleeding in the acute phase of pulmonary embolism

Abstract Background Bleeding prediction scores may help to guide acute management of patients with pulmonary embolism (PE). However, existing scoring systems have not been validated for in-hospital assessment. We aimed to compare 6 available bleeding scores, in a real-life cohort for the prediction of major in-hospital bleeding. Methods We recorded in-hospital characteristics of 2,754 PE patients included in a prospective observational multicenter cohort study contributing 18,028 person-days of follow-up. We assessed the VTE-BLEED, RIETE, ORBIT, HEMORRA2HAGES, ATRIA, and HAS-BLED scores at baseline. ISTH-defined bleeding events were independently adjudicated. The accuracy of the scores for the prediction of in-hospital bleeding was evaluated and compared. Results We observed 82 first in-hospital major bleeding events (3.0% (95% CI, 2.4–3.7)). Overall, the predictive power of bleeding scores was poor, with a C index ranging from 0.57 to 0.69 (Figure 1). The RIETE score had the numerically highest model fit and best discriminatory capacity, but without reaching statistical significance versus the ORBIT, HEMORR2HAGES, and ATRIA scores. The VTE-BLEED and HAS-BLED scores had significantly lower C indices, integrated discrimination improvement, and net reclassification improvement compared to the four others. Conclusion Currently available scoring systems have insufficient accuracy for the prediction of in-hospital major bleeding in patients with acute PE. The development of acute-PE-specific risk scores is needed to optimally target patients that warrant bleeding-prevention strategies. Funding Acknowledgement Type of funding sources: None. Figure 1

The initial impact of a national BNT162b2 mRNA COVID-19 vaccine rollout

ObjectiveThis study examined the initial impact of a national BNT162b2 vaccine rollout on SARS-CoV-2 infections in Qatar. MethodsAll individuals who had completed ≥14 days of follow-up by 16 March 2021 after receiving the BNT162b2 vaccine were included. This study calculated incidence rates (IR) and their 95% confidence intervals (CI) during days 1–7, 8–14, 15–21, 22–28, and >28 days post-vaccination. Poisson regression was used to calculate incidence rate ratios (IRR) relative to the first 7-day post-vaccination period. ResultsA total of 199,219 individuals with 6,521,124 person-days of follow-up were included. SARS-CoV-2 infection was confirmed in 1877 (0.9%), of which 489 (26.1%) were asymptomatic and 123 (6.6%) required oxygen support. The median time from first vaccination to SARS-CoV-2 confirmation was 11.9 days (IQR 7.7–18.2). Compared with the first 7-day post-vaccination period, SARS-CoV-2 infections were lower by 65.8–84.7% during 15–21, 22–28, and >28 days (P < 0.001 for each). For severe COVID-19, the incidence rates were 75.7–93.3% lower during the corresponding time periods (P < 0.001 for each). ConclusionThe results were consistent with an early protective effect of BNT162b2 vaccine against all degrees of SARS-CoV-2 severity.

Contemporary Outcomes after Durable Left Ventricular Assist Device Explantation in Patients with Evidence of Cardiac Recovery

<h3>Purpose</h3> In patients with durable left ventricular assist devices, cardiac recovery allowing device explanation is a rare and poorly understood phenomenon. The aim of this study was to describe the clinical features and outcomes of patients with cardiac recovery who underwent LVAD explantation or decommission with no formal recovery protocol at two large academic medical centers. <h3>Methods</h3> We identified all patients with nonischemic cardiomyopathy (NICM) with a continuous flow durable LVAD implanted at two centers through 2017 who had evidence of cardiac recovery as determined by a multidisciplinary assessment of cardiac surgeons and heart failure specialists, and underwent either explant of the LVAD or its decommission (turned off but left in-situ). Clinical, laboratory, echocardiographic features, and outcomes were analyzed. <h3>Results</h3> Twenty individuals met entry criteria. Indications for LVAD explant/decommission included pump thrombosis (45%, N=9/20), driveline infection (30%, N=6/20), or cardiac recovery without concurrent LVAD complication (25%, N=5/20). The average age at LVAD explant/decommission was 41±13 years and the median duration of support was 656 (265-1,089) days. The average left ventricular ejection fraction (LVEF) was 13±4% at implant, 45±11% at explant/decommission, and 32±18% at last-follow-up. There were 4 deaths (3 within 369 days) and 5 LVAD reimplantations (4 within 16 days and 1 at 62 days) over 12,986 person-days of follow-up after explant/decommission. Only 15% of the total cohort (N=3/20) had sustained LVEF recovery (Figure). <h3>Conclusion</h3> A minority of patients with NICM who had evidence of cardiac recovery allowing LVAD explant/decommission maintained their improved function. In nearly one-half of patients, regression in cardiac function was catastrophic and resulted in death or required reimplantation of a durable LVAD. These observations highlight the need to better define predictors allowing safe withdrawal of durable LVAD support.

Assessing additive effects of air pollutants on mortality rate in Massachusetts

BackgroundWe previously found additive effects of long- and short-term exposures to fine particulate matter (PM2.5), ozone (O3), and nitrogen dioxide (NO2) on all-cause mortality rate using a generalized propensity score (GPS) adjustment approach. The study addressed an important question of how many early deaths were caused by each exposure. However, the study was computationally expensive, did not capture possible interactions and high-order nonlinearities, and omitted potential confounders.MethodsWe proposed two new methods and reconducted the analysis using the same cohort of Medicare beneficiaries in Massachusetts during 2000–2012, which consisted of 1.5 million individuals with 3.8 billion person-days of follow-up. The first method, weighted least squares (WLS), leveraged large volume of data by aggregating person-days, which gave equivalent results to the linear probability model (LPM) method in the previous analysis but significantly reduced computational burden. The second method, m-out-of-n random forests (moonRF), implemented scaling random forests that captured all possible interactions and nonlinearities in the GPS model. To minimize confounding bias, we additionally controlled relative humidity and health care utilizations that were not included previously. Further, we performed low-level analysis by restricting to person-days with exposure levels below increasingly stringent thresholds.ResultsWe found consistent results between LPM/WLS and moonRF: all exposures were positively associated with mortality rate, even at low levels. For long-term PM2.5 and O3, the effect estimates became larger at lower levels. Long-term exposure to PM2.5 posed the highest risk: 1 μg/m3 increase in long-term PM2.5 was associated with 1053 (95% confidence interval [CI]: 984, 1122; based on LPM/WLS methods) or 1058 (95% CI: 988, 1127; based on moonRF method) early deaths each year among the Medicare population in Massachusetts.ConclusionsThis study provides more rigorous causal evidence between PM2.5, O3, and NO2 exposures and mortality, even at low levels. The largest effect estimate for long-term PM2.5 suggests that reducing PM2.5 could gain the most substantial benefits. The consistency between LPM/WLS and moonRF suggests that there were not many interactions and high-order nonlinearities. In the big data context, the proposed methods will be useful for future scientific work in estimating causality on an additive scale.

Time spent with HIV-RNA ≤ 200 copies/ml in a cohort of people with HIV during the U=U era.

Zero risk of linked HIV transmission in serodiscordant couples when the HIV-infected partner had viral load less than 200 copies/ml ('U status') was found in observational studies. We aimed at estimating the proportion of time in which 'U status' was maintained and identifying factors associated with the risk of losing it. Observational cohort study. We included participants in the ICONA cohort who had reached an established 'U status' (viral load ≤200 copies/ml for >6 months) as of December 2010. The outcome was the number of person-days of follow-up (PDFU) above a viral load greater than 200 copies/ml, relative to the total number of PDFU observed. A logistic regression model was used to identify factors independently associated with the risk of losing 'U status'. Eight thousand, two hundred and forty-one persons living with HIV were included in the analysis who contributed 2 670 888 PDFU. Of these, 1648 (20%) were women, 768 (9%) were people who inject drugs (PWID), and 2066 (25%) were foreign-born. The median of viral load measurements was 9 (IQR: 4-15). Overall, only 3.1% of PDFU were observed when viral load was above 200 copies/ml. The proportion of PDFU with viral load more than 200 copies/ml was higher than average in women (5.3%), unemployed (5.4%), PWID (4.7%), and in people with more than three previous virologic failures (6.3%). These variables were significant predictors of losing 'U status' in the multivariable logistic regression. Our results reinforce the validity of the U=U message in real-world setting. However, we identified subsets of our study population at higher risk of losing the 'U status' for whom additional efforts are needed.

An original risk scheme to predict in-hospital major bleeding in acute pulmonary embolism: The Syncope, Troponin, Anemia, Anti-platelet therapy, Renal dysfunction (STAR) bleeding score

Bleeding-prediction score may help guiding management of patients with acute pulmonary embolism (PE). We aimed to develop the first risk stratification scheme to predict in-hospital major bleeding in PE. We recorded in-hospital characteristics of 2754 PE patients included in a prospective observational multicenter cohort study contributing 18,028 person-days of follow-up. Bleeding events were independently adjudicated using medical record review. We used the best subsets logistic regression to select candidates included in the in-hospital major bleeding score. The final model was internally validated by bootstrapping (500 replicates) and compared to the PE-derived long-term bleeding RIETE and VTE-BLEED scores. We observed 82 first in-hospital major bleeding [3.0% (95% CI, 2.4–3.7]. Five independent variables were included in the final model and weighted by regression coefficients: anemia (hemoglobin < 12 g/dL) (2.5 points), syncope (2 points), concomitant medication usage predisposing to bleeding (1.5 points), renal dysfunction (eGFRCKD-EPI < 60 ml.min-1) (1 point), and positive troponin (1 point) (i.e., STAR bleeding score). Major bleeding rates ranged from 0.4% (0 point) to 15.6% (≥ 6 points). Collapsed into a 3-category risk score, major bleeding rates were 0.87% in the low risk group (0–1.5 points), 3.9% in intermediate risk (2–3 points), and 8.1% in high risk (> 3 points). The C-index for the continuous risk score was 0.78 and remained good (i.e., 0.75) in the bootstrapped internal validation. The global fit of the STAR bleeding score was significantly higher than those of the RIETE and VTE-BLED scores allowing net reclassification improvement of major bleeding predicted probabilities (37% and 41%, respectively). A simple 5-variable risk score was effective in quantifying the risk of PE-related in-hospital major bleeding in a large community-based cohort of patients. External validations are warranted.

Accuracy of available scoring systems for prediction of in-hospital major bleeding in acute pulmonary embolism patients

Bleeding prediction scores may help guide acute management of patients with pulmonary embolism (PE). However existing scoring systems have not been validated for in-hospital assessment. We compared 6 available bleeding scores for the prediction of major bleeding in the in-hospital phase in a real-life cohort. We recorded in-hospital characteristics of 2754 PE patients included in a prospective observational multicenter cohort study contributing 18,028 person-days of follow-up. The VTE-BLEED, RIETE, ORBIT, HEMORR 2 HAGES, ATRIA, and HAS-BLED scores were assessed at baseline. ISTH-defined bleeding events were independently adjudicated. The accuracy of the overall, original 3-level and newly defined optimal 2-level outcome of the scores were evaluated and compared. We observed 82 first in-hospital major bleeding events [3.0% (95% CI, 2.4–3.7)]. Overall, the predictive power of bleeding scores was poor, with a Harrel's C index ranging from 0.57 to 0.69. The Riete score had the numerically highest model fit and discrimination capacity but without reaching statistical significance versus the ORBIT, HEMORR 2 HAGES, and ATRIA scores. The VTE-BLEED and HAS-BLED scores had significantly lower C indices, integrated discrimination improvement, and net reclassification improvement compared to the others. The rate of observed in-hospital major bleeding in score-defined low-risk patients was high, at between 15% to 34%. Current available scoring systems are not sufficiently accurate for the prediction of in-hospital major bleeding in patients with acute PE. There is a need to develop risk scores specific to acute PE to optimally target bleeding-prevention strategies.

Causal effects of air pollution on mortality in Massachusetts

Background: Epidemiologic studies of air pollution and mortality have primarily investigated long- and short-term exposures separately, have used multiplicative models, and have been associational studies.Methods: We analyzed 1.5 million Medicare beneficiaries living in Massachusetts with 3.9 billion person-days of follow-up during 2000-2012. We implemented a generalized propensity score adjustment approach, which accounted for joint confounding by the concurrent exposures, individual- and area-level covariates, meteorological covariates, seasonal variations, and long-term time trend, to evaluate causal effects of long- (one-year moving average) and short-term (two-day moving average) exposures to PM2.5, O3, and NO2 on all-cause mortality. By modeling the binary outcome of death with linear probability model, we estimated the potential number of deaths that would occur per unit increase in each air pollutant exposure.Results: We found that long- and short-term PM2.5, O3, and NO2 were all associated with an increased risk of mortality. Specifically, per 10 million person-days, each 1 µg·m-3 increase in long- and short-term PM2.5 were associated with 35.4 (95% confidence interval [CI], 33.4-37.6) and 3.04 (95% CI, 2.17-3.94) excess deaths, respectively; each 1 ppb increase in long- and short-term O3 were associated with 2.35 (95% CI, 1.08-3.61) and 2.41 (95% CI, 1.81-2.91) excess deaths, respectively; and each 1 ppb increase in long- and short-term NO2 were associated with 3.24 (95% CI, 2.75-3.77) and 5.60 (95% CI, 5.24-5.98) excess deaths, respectively. Importantly, risk differences associated with long-term effects of PM2.5 and O3 increased substantially when the exposure levels went below the increasingly stringent thresholds, including those well below the current National Ambient Air Quality Standards (NAAQS).Conclusions: The findings suggest that air pollution exposures were causally associated with mortality, even at levels below NAAQS. The estimates on additive probability scale provide clearer insights into the relative magnitude of air pollution effects.

Causal Effects of Air Pollution on Mortality Rate in Massachusetts

Air pollution epidemiology studies have primarily investigated long- and short-term exposures separately, have used multiplicative models, and have been associational studies. Implementing a generalized propensity score adjustment approach with 3.8 billion person-days of follow-up, we simultaneously assessed causal associations of long-term (1-year moving average) and short-term (2-day moving average) exposure to particulate matter with an aerodynamic diameter less than or equal to 2.5 μm (PM2.5), ozone, and nitrogen dioxide with all-cause mortality on an additive scale among Medicare beneficiaries in Massachusetts (2000-2012). We found that long- and short-term PM2.5, ozone, and nitrogen dioxide exposures were all associated with increased mortality risk. Specifically, per 10 million person-days, each 1-μg/m3 increase in long- and short-term PM2.5 exposure was associated with 35.4 (95% confidence interval (CI): 33.4, 37.6) and 3.04 (95% CI: 2.17, 3.94) excess deaths, respectively; each 1-part per billion (ppb) increase in long- and short-term ozone exposure was associated with 2.35 (95% CI: 1.08, 3.61) and 2.41 (95% CI: 1.81, 2.91) excess deaths, respectively; and each 1-ppb increase in long- and short-term nitrogen dioxide exposure was associated with 3.24 (95% CI: 2.75, 3.77) and 5.60 (95% CI: 5.24, 5.98) excess deaths, respectively. Mortality associated with long-term PM2.5 and ozone exposure increased substantially at low levels. The findings suggested that air pollution was causally associated with mortality, even at levels below national standards.

1559. Hematopoietic Cell Transplantation with Post-transplant Cyclophosphamide: Impact of Donor Type on Pre-engraftment Blood-Stream Infections

BackgroundThe aim of the study was to estimate the cumulative incidence of pre-engraftment blood stream infections (PE-BSI), its predictive factors and the infection-related mortality (IRM) after hematopoietic cell transplantation (HCT) from any donor type, with post-transplant cyclophosphamide (PT-Cy).MethodsRetrospective cohort study on 235 adults who underwent peripheral blood HCT from every donor type with PT-Cy platform, from 2013 to 2017 at San Raffaele Scientific Institute. The Poisson regression was used to estimate the crude incidence rate (IR) of PE-BSI. The Fine-Gray competing risk model was applied to estimate the cumulative incidence function (CIF) of the first PE-BSI and its predictive factors and of IRM.ResultsPatients’ characteristics are reported in Table 1. During 5,316 person-days of follow-up (PDFU), 77 PE-BSI episodes occurred in 72 patients: IR = 1.45 per 100-PDFU [95% confidence interval (95% CI) 1.13–1.77]. The median time to PE-BSI was 13 days (IQR: 7–17) and the estimated CIF at 28 days was 32% (95% CI: 26–39%); no differences in CIF according to donor type [30% vs. 34% vs. 32% in match-related, match-unrelated and haploidentical donor, respectively; Gray’s test: P = 0.968]. Among the 87 isolated pathogens, 60% were Gram-positive bacteria (GPB), 39% Gram-negative bacteria (GNB) and 1% nontuberculous mycobacteria. CIFs of GNB and GPB PE-BSI by type of donor are shown in Figure 1. By multivariate analysis (Table 2), after adjustment for age, sex, year of HCT, donor type and disease phase at HCT, the CIF of any PE-BSI was higher in subjects with absolute neutrophils count ≤500 for ≥7 days before HCT [adjusted hazard ratio (AHR) = 2.90] and in multi-drug resistant (MDR) GNB rectal carriers before HCT [AHR = 2.68]. These covariates were confirmed as independent factors also for GNB PE-BSI. Overall, IRM at 30 days was 5% (95% CI: 2–8%) with no differences by donor type (Gray’s test: P = 0.106).ConclusionHCT with PT-Cy platform showed a 32% of cumulative incidence of PE-BSI at 28 days and donor type did not affect its occurrence, which was conversely increased by prolonged and severe neutropenia and MDR GNB rectal carriage before HCT. Haploidentical setting did not retain a higher IRM at 30 days than match-related and match-unrelated donors. Disclosures All authors: No reported disclosures.

Patient-Reported Distress in Myelodysplastic Syndromes and Its Association With Clinical Outcomes: A Retrospective Cohort Study.

Background: NCCN defines distress as a multifactorial, unpleasant emotional experience of a psychological nature that may interfere with patients' ability to cope with cancer symptoms and treatment. Patients with myelodysplastic syndromes (MDS) are at risk for distress due to the largely incurable nature of this hematopoietic malignancy and its symptom burden, yet associations with clinical outcomes are unknown. Methods: We retrospectively reviewed patient-reported distress data from adult ambulatory patients with MDS visiting a single, tertiary care medical center from July 2013 to September 2015. Demographic, diagnostic, treatment, and comorbidity information were abstracted from records along with NCCN Distress Thermometer (DT) and Problem List (PL) scores. Survival was analyzed using the Kaplan-Meier method and Cox proportional hazards regression. Results: We abstracted 376 DT scores (median, 1; range, 0-10) from 606 visits and 110 patients (median, 2 DT scores/patient; range, 1-16). NCCN Guidelines suggest that patients with DT scores ≥4 should be evaluated for referral to specialty services to address unmet needs. A total of 54 patients (49%) had at least 1 DT score ≥4 and 20 (18%) had 2 or more DT scores ≥4; 98 patients (89.1%) reported 1,379 problems during 23,613 person-days of follow-up (median, 4 problems/patient/visit; range, 1-23). The 5 most frequently reported problems were fatigue (181 times; 78 patients), pain (95 times; 46 patients), worry (80 times; 45 patients), sleep (78 times; 41 patients), and tingling hands/feet (68 times; 33 patients). After adjustment for risk stratification at diagnosis, a single point increase on the DT was associated with an increased risk of death (hazard ratio, 1.18; 95% CI, 1.01-1.36). Conclusions: Patients with MDS experience a high burden of distress, and patient-reported distress is associated with clinical outcomes. Distress should be further studied as a prognostic variable and a marker of unmet needs in MDS.

Presentation and survival in patients with hematologic malignancies in Jos, Nigeria: A retrospective cohort analysis.

Haematologic malignancies cause significant morbidity and mortality and are not uncommon in resource-limited-low income countries. However, the types, pattern of presentation and treatment outcomes vary across regions. We assessed the presentation and overall survival over an 11-year period in adult patients presenting with haematologic cancers in Jos, North Central Nigeria. This retrospective outcome study evaluated patients who presented with haematologic malignancies between 2005-2015 at the Jos University Teaching Hospital (JUTH), Jos. Variables of interest were abstracted through chart reviews. Descriptive statistics were used to evaluate baseline and follow-up parameters. Overall survival (OS) was assessed using Kaplan-Meier method. Sixty patients, contributing 25,994 person-days of follow-up were evaluated. The mean age was 43+17 years and 61.7% were males. Thirty-one patients (51.7%) presented with leukemia, 45.0% with lymphoma, and 3.3% with multiple myeloma. Forty-two (70.0%) presented with advanced disease, 5 (5.2%) were HIV positive and 4 (6.7%) had died at the end of follow-up. OS was 84.3% (95% CI: 58.1-94.7). Survival differed by disease group (p=0.01) and having fever at presentation (p=0.02). We found long-term OS to be impacted by disease type and status of fever at presentation. Disease-specific Strategies to improve early diagnosis and therapies are needed to ensure optimal outcomes in Nigerian patients.