scholarly journals COVID-19 vaccination effectiveness rates by week and sources of bias

Author(s):  
Anna Ostropolets ◽  
George Hripcsak

Importance Randomized clinical trials and observational studies have demonstrated high overall effectiveness for the three US-authorized COVID-19 vaccines against symptomatic COVID-19 infection. Nevertheless, the challenges associated with the use of observational data can undermine the results of the studies. Objective To assess the feasibility of using observational data for vaccine effectiveness studies by examining granular weekly effectiveness. Design, Settings and Participants In this retrospective cohort study, we used Columbia University Medical Center data linked to State and City Immunization Registries to assess the weekly effectiveness of mRNA COVID-19 vaccines. We conducted manual chart review of cases in week one in both groups along with a set of sensitivity analyses for Pfizer- BioNTech, Moderna and Janssen vaccines. Main Outcomes and Measures We used propensity score matching with up to 54,987 covariates and fitted Cox proportional hazards models to estimate hazard ratios and constructed Kaplan-Meier plots for two main outcomes (COVID-19 infection and COVID-19-associated hospitalization). Results The study included 179,666 patients. We observed increasing effectiveness after the first dose of mRNA vaccines with week 6 effectiveness approximating 84% (95% CI 72-91%) for COVID-19 infection and 86% (95% CI 69-95) for COVID-19-associated hospitalization. When analyzing unexpectedly high effectiveness in week one, chart review revealed that vaccinated patients are less likely to seek care after vaccination and are more likely to be diagnosed with COVID-19 during the encounters for other conditions. Sensitivity analyses showed potential outcome misclassification for COVID-19 ICD10-CM diagnosis and the influence of excluding patients with prior COVID-19 infection and anchoring in the unexposed group. Overall vaccine effectiveness analysis in fully vaccinated patients matched the results of the randomized trials. Conclusions and Relevance Observational data can be used to ascertain vaccine effectiveness if potential biases are accounted for. The data need to be scrutinized to ensure that compared groups exhibit similar health seeking behavior and are equally likely to be captured in the data. Given the difference in temporal trends of vaccine exposure and baseline characteristics, indirect comparison of vaccines may produce biased results.

2021 ◽  
Author(s):  
Kristina Crothers ◽  
Rian DeFaccio ◽  
Janet Tate ◽  
Patrick R Alba ◽  
Matthew Goetz ◽  
...  

Objectives: To determine whether early oral or parenteral corticosteroids compared to no corticosteroids are associated with decreased mortality in patients hospitalized with coronavirus disease 2019 (COVID-19) who are not on intensive respiratory support (IRS) within 48 hours of admission. Design: Observational cohort study Setting: Nationwide cohort of patients receiving care in the Department of Veterans Affairs, a large integrated US national healthcare system Participants: 9,058 patients admitted to a Veterans Affairs Medical Center between June 7, 2020-December 5, 2020 within 14-days after SARS-CoV-2 positive test; exclusion criteria include less than a 48 hour stay, receipt of prior systemic corticosteroids, and no indication of acute medical care for COVID-19. Main outcome measure: 90-day all-cause mortality Results: Of 9,058 total patients (95% men, median age 71 years, 27% black), 6,825 (75%) were not on IRS within 48 hours. Among the 3,025 patients on no oxygen, 598 (20%) received corticosteroids and 283 (9%) died; of 3,800 patients on low-flow nasal cannula oxygen (NC), 2,808 (74%) received corticosteroids and 514 (13%) died. In stratified, inverse probability weighted Cox proportional hazards models comparing those who did and did not receive corticosteroids, patients on no oxygen experienced an 89% increased risk for 90-day mortality (hazard ratio [HR] 1.89, 95% confidence interval [CI] 1.33 to 2.68); there was weak evidence of increased mortality among patients on NC (HR 1.21, 95% CI 0.94 to 1.57). Results were robust in subgroup analyses including restricting corticosteroids to dexamethasone, and in sensitivity analyses employing different modeling approaches. Conclusions: In patients hospitalized with COVID-19, we found no evidence of a mortality benefit associated with early initiation of corticosteroids among those on no oxygen or NC in the first 48 hours, though there was evidence of potential harm. These real-world findings support that clinicians should consider withholding corticosteroids in these populations and further clinical trials may be warranted.


2021 ◽  
Vol 8 ◽  
Author(s):  
Jing Ma ◽  
Xiaowei Shi ◽  
Jiong Yu ◽  
Feifei Lv ◽  
Jian Wu ◽  
...  

Objectives: Evidence has shown that angiotensin-converting enzyme 2 (ACE2), which can be upregulated after angiotensin-converting enzyme inhibitor (ACEi) and angiotensin receptor blocker (ARB) treatment, may play a dual role in the pathogenesis and progression of coronavirus disease 2019 (COVID-19). We aimed to assess the association between the use of ACEi/ARB and the outcome of COVID-19 patients with preexisting hypertension in non-endemic areas.Methods: From January 17, 2020, to February 19, 2020, 286 patients with hypertension were enrolled in this retrospective study out of 1,437 COVID-19 patients from 47 centers in Zhejiang and Jiangsu Province. The composite endpoints consisted of mechanical ventilation, intensive care unit (ICU) admission, or death. Cox proportional hazards analysis was performed to assess the association between ACEi/ARB and clinical outcomes of COVID-19 patients with hypertension.Results: In the main analysis, 103 patients receiving ACEi/ARB were compared with 173 patients receiving other regimens. Overall, 44 patients (15.94%) had an endpoint event. The risk probability of crude endpoints in the ACEi/ARB group (12.62%) was lower than that in the non-ACEi/ARB group (17.92%). After adjusting for confounding factors by inverse probability weighting, the results showed that the use of ACEi/ARB reduced the occurrence of end events by 47% [hazard ratio (HR) = 0.53; 95% CI, 0.34–0.83]. Similar results were obtained in multiple sensitivity analyses.Conclusions: In this retrospective study, among COVID-19 patients with hypertension, the use of ACEi/ARB is not associated with an increased risk of disease severity compared with patients without ACEi/ARB. The trends of beneficial effects of ACEi/ARB need to be further evaluated in randomized clinical trials.


2021 ◽  
pp. 174749302110192
Author(s):  
Mahmoud H Mohammaden ◽  
Diogo C. Haussen ◽  
Leonardo Pisani ◽  
Alhamza Al-Bayati ◽  
Aaron Anderson ◽  
...  

Background Three randomized clinical trials have reported similar safety and efficacy for contact aspiration (CA) and Stent-retriever (SR) thrombectomy. Aim We aimed to determine whether the Combined Technique (SR+CA) was superior to SR alone as first-line thrombectomy strategy in a patient cohort where balloon-guide catheter was universally used. Methods A prospectively maintained mechanical thrombectomy database from January 2018-December 2019 was reviewed. Patients were included if they had anterior circulation proximal occlusion ischemic stroke (intracranial ICA or MCA-M1/M2 segments) and underwent SR alone thrombectomy or SR+CA as first-line therapy. The primary outcome was the first-pass effect (FPE) (mTICI2c-3). Secondary outcomes included modified FPE (mTICI2b-3), successful reperfusion (mTICI2b-3) prior to and after any rescue strategy, and 90-day functional independence (mRS ≤2). Safety outcomes included rate of parenchymal hematoma (PH) type-2 and 90-day mortality. Sensitivity analyses were performed after dividing the overall cohort according to first-line modality into two matched groups. Results A total of 420 patients were included in the analysis (mean age 64.4 years; median baseline NIHSS 16[11-21]). As compared to first-line SR alone, first-line SR+CA resulted in similar rates of FPE (53% vs. 51%,aOR 1.122, 95%CI[0.745-1.691],p=0.58), mFPE (63% vs. 60.4%,aOR1.250, 95%CI[0.782-2.00],p=0.35), final successful reperfusion (97.6% vs. 98%,p=0.75) and higher chances of successful reperfusion prior to any rescue strategy (81.8% vs. 72.5%,aOR 2.033, 95%CI[1.209-3.419],p=0.007). Functional outcome and safety measures were comparable between both groups. Likewise, the matched analysis (148 patient-pairs) demonstrated comparable results for all clinical and angiographic outcomes except for significantly higher rates of successful reperfusion prior to any rescue strategies with the first-line SR+CA treatment (81.8% vs. 73.6%,aOR 1.881, 95%CI[1.039-3.405],p=0.037). Conclusions Our findings reinforce the findings of ASTER-2 trial in that the first-line thrombectomy with a Combined Technique did not result in increased rates of first-pass reperfusion or better clinical outcomes. However, addition of contact aspiration after initial SR failure might be beneficial in achieving earlier reperfusion.


2020 ◽  
Vol 154 (Supplement_1) ◽  
pp. S152-S152
Author(s):  
S Fathima ◽  
A R Gardner ◽  
A J Sohn ◽  
R Benavides

Abstract Introduction/Objective In teaching hospitals, patients receive direct care from a succession of different physicians, each of whom may order diagnostic tests on the same patient resulting in multiple physicians unknowingly ordering the same test in the same time period, leading to overutilization. We examined the association of test-ordering by multiple physicians with duplication of two tests, Beta D-Glucan (BDG) and CMV Viral Load by PCR non blood, as aid for detection of fungal and cytomegaloviral infections, respectively Methods Retrospective medical records at Baylor University Medical Center, Dallas were examined in between 10/1/2019- 10/30/2019. A total 167 test orders were identified for CMV Viral Load non blood and BDG presence in blood. Each medical record was assessed for frequency of ordering along with the physicians who ordered them Results A total 167 tests were ordered in which, 120 times BDG was ordered and 52 times CMV was ordered. Singleton orders were noted in 85(50%) instances of BDG & 30(17%) for CMV.Multiple test orders were 44 (25%) for BDG and 8 (4%) for CMV respectively. Both CMV and BDG were ordered together 57 times. The time stamps of multiple test orders in individual patients was assessed for instances of orders that were less than 3 days apart and analysis showed out of the 44 multiple test orders, 34% (15) test orders were ordered less than 3 days apart and 66%(29) tests were ordered more than 3 days apart for BDG. Upon chart review, most of these quickly successive orders were by different physicians. The estimated costs of the duplicate orders are 4334.0$ & 1104.16$ for BDG and CMV respectively. Conclusion CMV and BDG are commonly ordered on many patients. Analysis shows that many times, physicians order testing when the same test has been ordered very recently by a separate physician. Note that for both tests, retesting in less than three days is not normally indicated, however this happens often, especially for BDG. This is most likely due to difficulty in determining within the EHR what tests are drawn and “pending’ but not yet finalized and reported. With usage of prompts/ alerts in EMR that warn of existing “pending’ orders by another caregiver, the frequency of duplicate test ordering for the same patient may be reduced, in turn reducing the costs of healthcare.


2021 ◽  
pp. 019459982110129
Author(s):  
Randall S. Ruffner ◽  
Jessica W. Scordino

Objectives During septoplasty, normal cartilage and bone are often sent for pathologic examination despite benign appearance. We explored pathology results following septoplasty from April 2016 to April 2018, examining clinical value and relevance, implications, and cost analysis. Study Design Retrospective chart review. Setting Single-institution academic medical center. Methods A retrospective chart review was compiled by using Current Procedural Terminology code 30520 for septoplasty for indication of nasal obstruction, deviated septum, and nasal deformity. Results A total of 236 consecutive cases were identified spanning a 2-year period. Septoplasty specimens were sent for pathology evaluation in 76 (31%). The decision to send a specimen for histopathology was largely physician dependent. No cases yielded unexpected or significant pathology that changed management. The average total charges for septoplasty were $10,200 at our institution, with 2.2% of procedural charges accounting for pathology preparation and review, averaging $225. Nationally, this results in an estimated charged cost of $58.5 million. The Centers for Medicare and Medicaid Services (CMS) reimbursement for septoplasty pathology charges was $46 in 2018, accounting for 1.3% of hospital-based reimbursements and 2.2% of ambulatory center reimbursements. With CMS as a national model for reimbursement, $11.8 million is spent yearly for septoplasty histopathology. Given that CMS reimbursement is significantly lower than private insurers, national total reimbursement is likely considerably higher. Conclusion Routine pathology review of routine septoplasty specimens is unnecessary, unremarkable, and wasteful. Correlation of the patient’s presentation and intraoperative findings should justify the need for pathology evaluation. This value-based approach can offer significant direct and indirect cost savings. Level of evidence 4.


2014 ◽  
Vol 143 (7) ◽  
pp. 1417-1426 ◽  
Author(s):  
M. HABER ◽  
Q. AN ◽  
I. M. FOPPA ◽  
D. K. SHAY ◽  
J. M. FERDINANDS ◽  
...  

SUMMARYAs influenza vaccination is now widely recommended, randomized clinical trials are no longer ethical in many populations. Therefore, observational studies on patients seeking medical care for acute respiratory illnesses (ARIs) are a popular option for estimating influenza vaccine effectiveness (VE). We developed a probability model for evaluating and comparing bias and precision of estimates of VE against symptomatic influenza from two commonly used case-control study designs: the test-negative design and the traditional case-control design. We show that when vaccination does not affect the probability of developing non-influenza ARI then VE estimates from test-negative design studies are unbiased even if vaccinees and non-vaccinees have different probabilities of seeking medical care against ARI, as long as the ratio of these probabilities is the same for illnesses resulting from influenza and non-influenza infections. Our numerical results suggest that in general, estimates from the test-negative design have smaller bias compared to estimates from the traditional case-control design as long as the probability of non-influenza ARI is similar among vaccinated and unvaccinated individuals. We did not find consistent differences between the standard errors of the estimates from the two study designs.


2021 ◽  
pp. 1-10
Author(s):  
Anne Sofie D. Laursen ◽  
Anne L. Thomsen ◽  
Anne Beck ◽  
Kim Overvad ◽  
Marianne U. Jakobsen

Abstract A daily intake of dairy products is recommended in many countries in order to maintain optimal health throughout life. However, evidence regarding the association between intake of individual dairy products and mortality is limited. We therfore, explored associations between intake of different dairy products and all-cause and cause-specific mortality using specified theoretical substitution analyses. We analysed data from 55 775 Danish men and women aged 50–64 years between 1993 and 1997. Information about dairy product intake at baseline was collected using a validated food frequency questionnaire. Information about vital status and causes of death was obtained through national registers. Measures of associations were calculated using Cox proportional hazards regression. During a median follow-up of 19·0 years, 11 586 participants died. For all-cause mortality, we observed that the intake of low-fat milk, whole-fat milk or low-fat yogurt products in place of cheese was associated with a higher rate of death (hazard ratios between 1·03 and 1·12 per serving/d substituted). The same pattern was present for CVD mortality. For cancer mortality, whole-fat milk and low-fat yogurt products in place of cheese were also associated with a higher rate of death for men while for women, whole-fat milk in place of buttermilk was associated with a higher cancer mortality rate. The results appeared robust in several sensitivity analyses. Our results suggest that intake of low-fat milk, whole-fat milk or low-fat yogurt products in place of cheese is associated with a higher rate of all-cause and cause-specific mortality.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Rahul Aggarwal ◽  
Nicholas Chiu ◽  
Rishi Wadhera ◽  
Changyu Shen ◽  
Robert W Yeh ◽  
...  

Introduction: Hypertension is a major risk factor for cardiovascular disease. The US government, through the Healthy People Initiative 2020, set targets to improve hypertension prevalence and treatment rates in US adults by a relative 10% from 2005 to 2020, and increase control rates by a relative 40%. We examined US progress towards this goal from 2005-2018. Methods: We analyzed data from 38,876 non-pregnant US adults from the NHANES 2005-2018 surveys to determine nationally representative estimates of hypertension prevalence, treatment rates, and control. Temporal trends in hypertension prevalence, treatment, and control were assessed using weighted linear regression after age adjustment to the 2000 US census (per the Healthy People Initiative approach). In the base case, we defined hypertension as blood pressure >140/90 or on an antihypertensive; we used the ACC/AHA definition of blood pressure >130/80 in sensitivity analyses. Results: In 2017-2018, 34.3% (±1.7) of US adults had hypertension, of these 69.7% (±1.5) were on treatment, and 43.7% (±1.6) were controlled. After age-adjustment, no statistically significant changes in hypertension prevalence, treatment rates, or control were observed from 2005-2018 (p for trend 0.91, ,0.98, 0.66, Figure 1). In sensitivity analyses, applying the ACC/AHA definition increased the estimated prevalence of hypertension during the period, but trends in prevalence remained unchanged. Conclusions: There has been no material progress in reducing the prevalence of hypertension or improving rates of treatment and control from 2005 to 2018. As planning is underway for Healthy People Initiative 2030, setting of hypertension targets must be accompanied with investments in cost-effective, scalable programs to improve blood pressure control nationwide, with a focus on high-risk populations.


2005 ◽  
Vol 23 (34) ◽  
pp. 8606-8612 ◽  
Author(s):  
Stefanos Bonovas ◽  
Kalitsa Filioussi ◽  
Nikolaos Tsavaris ◽  
Nikolaos M. Sitaras

Purpose A growing body of evidence suggests that statins may have chemopreventive potential against breast cancer. Laboratory studies demonstrate that statins induce apoptosis and reduce cell invasiveness in various cell lines, including breast carcinoma cells. However, the clinical relevance of these data remains unclear. The nonconclusive nature of the epidemiologic data prompted us to conduct a detailed meta-analysis of the studies published on the subject in peer-reviewed literature. Patients and Methods A comprehensive search for articles published up until 2005 was performed; reviews of each study were conducted; and data were abstracted. Before meta-analysis, the studies were evaluated for publication bias and heterogeneity. Pooled relative risk (RR) estimates and 95% CIs were calculated using the random and the fixed-effects models. Subgroup and sensitivity analyses were also performed. Results Seven large randomized trials and nine observational studies (five case-control and four cohort studies) contributed to the analysis. We found no evidence of publication bias or heterogeneity among the studies. Statin use did not significantly affect breast cancer risk (fixed effects model: RR = 1.03; 95% CI, 0.93 to 1.14; random effects model: RR = 1.02; 95% CI, 0.89 to 1.18). When the analyses were stratified into subgroups, there was no evidence that study design substantially influenced the estimate of effects. Furthermore, the sensitivity analysis confirmed the stability of our results. Conclusion Our meta-analysis findings do not support a protective effect of statins against breast cancer. However, this conclusion is limited by the relatively short follow-up times of the studies analyzed. Further studies are required to investigate the potential decrease in breast cancer risk among long-term statin users.


2020 ◽  
Author(s):  
Anne Eudes Jean Baptiste ◽  
John Wagai ◽  
Richard Ray Luce ◽  
Balcha Girma Masresha ◽  
Don Klinkenberg ◽  
...  

Abstract Background: From January to May 2019, large measles outbreaks affected Nigeria. Borno state was the most affected, recording 15,237 suspected cases with the state capital of Maiduguri having 1,125 cases investigated and line-listed by March 2019. In Borno state, 22 of the 27 Local Government Areas (LGAs or Districts), including 37 internally displaced persons (IDPs) camps were affected. In response to the situation, an outbreak response immunization (ORI) campaign was conducted in the 13 most affected LGAs. In addition to conventional vaccination teams, special teams were deployed in security compromised areas, areas with migrants, and for nomadic and IDPs. Here we describe the outbreak and the ORI campaign. We also assess the measles-containing vaccine (MCV) coverage and vaccine effectiveness (VE) in order to quantify the population-level impactMethods: We reviewed the ORI activities, and conducted an analysis of the surveillance and the outbreak investigation reports. We assessed VE of MCV by applying the screening-method. Sensitivity analyses were also conducted to assess the effect of final classification of cases on the VE of MCV. The MCV coverage was assessed by a post-campaign coverage survey (PCCS) after completion of the ORI through a quantitative survey in the 12 LGAs that were accessible. . Results: Of the total 15,237 reported measles cases, 2,002 cases were line-listed and investigated, and 737 were confirmed for measles by week 9 of 2019. Of the investigated cases 67.3% (n = 1,348) were between 9 and 59 months of age. Among the 737 confirmed cases, only 9% (n = 64) stated being vaccinated with at least 1 dose of MCV. The overall VE for MCV was 98.4 (95%CI: 97.8 – 98.8). No significant differences were observed in the VE estimates of lab-confirmed and epi-linked cases when compared to the original estimates. The aggregated weighted vaccination coverage was 85.7% (95% CI: 79.6 – 90.1).Conclusion: The experience in Borno demonstrates that adequate VE can be obtained in conflict-affected areas. In complex emergency affected by measles outbreaks, health authorities may consider integration with other health strategies and the engagement of security personnel as part of the ORI activities.


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