scholarly journals Comparative Efficacy over time of the mRNA-1273 (Moderna) vaccine and the BNT162b2 (Pfizer-BioNTech) vaccine

2021 ◽  
Author(s):  
Kenneth Cohen ◽  
PhD Nazmul Islam ◽  
MS Megan S. Jarvis ◽  
Natalie E. Sheils
Keyword(s):  
Statistical Significance ◽  
Administrative Claims ◽  
Separate Analysis ◽  
Research Database ◽  
Comparative Efficacy ◽  
Post Vaccination ◽  
Icu Admission ◽  
Incidence Of Hospitalization ◽  
Study Setting

Abstract Importance Real-world analysis of the incidence of SARS-CoV-2 infection post vaccination is important in determining the comparative efficacy of the available vaccines. Objective To study the incidence of SARS-CoV-2 infection in individuals fully vaccinated with either the BNT162b2 or the mRNA-1273 at 30-, 60-, and 90-days post vaccination Design Retrospective cohort study Setting Deidentified administrative claims for Medicare Advantage and commercially insured individuals in a research database. Participants Over 3.5 million fully-vaccinated individuals including 6,434 individuals with SARS-CoV-2 infection with a follow up period between 14 and 151 days after their second dose. Exposure Vaccination by either mRNA-1273 or BNT162b2. Main Outcome and Measures The rate of Covid-19 infection occurring at 30, 60, and 90 days at least 14 days after the second dose of either the mRNA-1273 vaccine or the BNT162b2 vaccine. Sub analyses included the incidence of hospitalization, ICU admission, and death/hospice transfer. Separate analysis was conducted for individuals ≥ age 65 and those without a prior diagnosis of Covid-19 and both yielded results similar to the general population. Results The mRNA-1273 vaccine provided slightly superior protection against SARS-CoV-2 infection compared to the BNT162b2 vaccine. In the full population, there were no significant differences in the risk of hospitalization, ICU admission, or death/hospice transfer. Conclusion Immunization with mRNA-1273, compared to BNT162b2, provided slightly more protection against SARS-CoV-2 infection that reached statistical significance at 90 days with a number needed to vaccinate of ≥292.There were no differences in vaccine efficacy for protection against hospitalization, ICU admission, or death/hospice transfer.

scholarly journals Association between intracytoplasmic sperm injection and neurodevelopmental outcomes among offspring

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0257268
Author(s):  
Cheng-Wei Wang ◽  
Tzu-Hao Chang ◽  
Nai-Chen Chuang ◽  
Heng-Kien Au ◽  
Chi-Huang Chen ◽  
...  
Keyword(s):  
Intracytoplasmic Sperm Injection ◽  
Neurodevelopmental Disorders ◽  
Multivariate Analyses ◽  
Multiple Birth ◽  
Research Database ◽  
Icu Admission ◽  
Male Sex ◽  
Single Birth

Purpose To compare the risk of neurodevelopmental disorders in children conceived via intracytoplasmic sperm injection (ICSI) and those conceived naturally. Materials and methods A population-based cohort study using data retrieved from the Taipei Medical University Research Database (TMURD) from January, 2004 to August, 2016. The data included maternal pregnancy history, perinatal history and developmental follow up of their babies up to 5 years of age. The study included 23885 children, of whom 23148 were naturally conceived and 737 were conceived via ICSI. Neurodevelopmental disorders defined by 21 ICD-9-CM codes. Results Of the 23885 children enrolled for analysis, 2778 children were included for further subgrouping analysis after propensity matching to reduce bias from maternal factors. The single-birth group included 1752 naturally conceived (NC) children and 438 ICSI children. The multiple-birth group included 294 NC and 294 ICSI children. The risk of neurodevelopmental disorders was not increased for ICSI children in both groups (single birth: adjusted hazard ratio aHR = 0.70, 95% CI = 0.39–1.27, p = 0.243; multiple-birth group aHR = 0.77, 95% CI = 0.43–1.35, p = 0.853). In the single-birth group, multivariate analyses showed that male sex (aHR = 1.81, 95% CI = 1.29–2.54, p < 0.001), and intensive care unit (ICU) admission (aHR = 3.10, 95% CI = 1.64–5.86, p < 0.001) were risk factors for neurodevelopmental disorders. In the multiple-birth group, multivariate analyses demonstrated that ICU admission (aHR = 3.58, 95% CI = 1.82–7.04, p < 0.001), was risk factor for neurodevelopmental disorders. Conclusion Our study indicated that the use of ICSI does not associated with higher risk of neurodevelopmental disorders in the offspring. But male sex, and ICU admission do have increased risk of neurodevelopmental disorders. However, long term follow up of this cohort on health outcomes in adolescence and adulthood will strengthen the conclusions that ICSI is safe regarding offspring long term outcome.

scholarly journals The effect of delaying initiation with umeclidinium/vilanterol in patients with COPD: an observational administrative claims database analysis using marginal structural models

2018 ◽  
Vol 13 ◽  
Author(s):  
Beth Hahn ◽  
Ami R. Buikema ◽  
Lee Brekke ◽  
Amy Anderson ◽  
Eleena Koep ◽  
...  
Keyword(s):  
Structural Models ◽  
Medical Costs ◽  
Marginal Structural Models ◽  
Severe Exacerbation ◽  
Administrative Claims ◽  
Research Database ◽  
Adjusted Cost ◽  
Exacerbation Risk ◽  
The Impact

Background: Chronic obstructive pulmonary disease (COPD) is associated with high clinical and economic burden. Optimal pharmacological therapy for COPD aims to reduce symptoms and the frequency and severity of exacerbations. Umeclidinium/vilanterol (UMEC/VI) is an approved combination therapy for once-daily maintenance treatment of patients with COPD. This study evaluated the impact of delaying UMEC/VI initiation on medical costs and exacerbation risk. Methods: A retrospective analysis of patients with COPD who initiated UMEC/VI between 4/28/2014 and 7/31/2016 was conducted using the Optum Research Database. The index date was the first COPD visit after UMEC/VI available on US formulary (Commercial 4/28/2014; Medicare Advantage 1/1/2015). Patients were followed for 12 months post-index, and categorized into 12 cohorts corresponding to month (30-day period) of UMEC/VI initiation (i.e. Months 1–12) post-index. The outcomes studied during the follow up period included COPD-related and all-cause medical costs, and risk of COPD exacerbations. Marginal structural models (MSM) were used to control for time-varying confounding due to changes in treatment and severity during follow up. Results: 2,200 patients initiating UMEC/VI were included in the study sample. Patients’ average age was 69.3 years, 49.9% were female and 69.7% were Medicare insured. Following MSM analysis, 12-month adjusted COPD-related medical costs increased by 2.9% (95% confidence interval [CI]: 0.1–5.9%; p = 0.044) for each monthly delay in UMEC/VI initiation, with a 37.4% higher adjusted cost for patients initiating UMEC/VI in Month 12 versus Month 1 ($13,087 vs. $9524). The 12-month adjusted all-cause medical costs increased by 2.8% (95% CI: 0.6–5.2%; p = 0.013) for each monthly delay, with a 36.1% higher adjusted cost for patients initiating UMEC/VI at Month 12 versus Month 1 ($22,766 vs. $16,727). The monthly risk of severe exacerbation was significantly higher in patients who had not yet initiated UMEC/VI than those who had (hazard ratio: 1.74; 95% CI: 1.35–2.23; p < 0.001). Conclusions: Prompt use of UMEC/VI following a physician visit for COPD appears to result in economic and clinical benefits, with reductions in medical costs and exacerbation risk. Additional research is warranted to assess the benefits of initiating UMEC/VI as a first-line therapy compared with escalation to UMEC/VI from monotherapies.

scholarly journals Comparison of Near Total thyroidectomy with Sub total thyroidectomy for Multindular goipe in terms of recurrence rate.

2021 ◽  
Vol 28 (06) ◽  
pp. 861-865
Author(s):  
Sajid Rashid
Keyword(s):  
Total Thyroidectomy ◽  
Recurrence Rate ◽  
Multinodular Goiter ◽  
Statistical Significance ◽  
Completion Thyroidectomy ◽  
Set Inclusion ◽  
Chisquare Test ◽  
Rate Study ◽  
Study Setting

Objective: To compare the outcome of NTT and STT for multinodular goiter in terms of Recurrence rate. Study Design: Experimental study. Setting: Department of Surgery DHQ Teaching Hospital Rawalpindi. Period: July 2016 to December 2017. Material & Methods: All patients were admitted through OPD according to the already set inclusion and exclusion criteria. Two groups were made first group was NTT group and second group was STT group. Patients were divided into two groups by lottery method (Probability sampling). Follow up period for recurrence was 1 year. Analysis of data was done by SPSS version -20. Chisquare test was used to see the statistical significance. Value of P was set at 0.05. Results: A total of 63 (n=63) patients were included in the study. Over all there were 71.40% females and 28.60% males. Average age of the female patients was 36.3 years and in males average age was 40.60 years. In NTT group there were 32 patients (n=32) and in STT group there were 31 patients (n=31). There was no recurrence in NTT group whereas recurrence was noted in 5 out of 31 patients (16.10%) in STT group which was found statistically significant (p = 7.61). Overall incidental carcinoma was noted in 6 out of 63 patients (9.52%). So completion thyroidectomy had to be carried in 4 patients of incidental carcinoma from STT group whereas 2 patients of incidental carcinoma from NTT group did not require any further treatment. Conclusion: Results of this study prove the superiority of NTT over STT regarding recurrence rate and safety of treatment for multinodular goiter. NTT eliminates recurrence rate of MNG which is very high in STT. NTT also obviates the need for completion thyroidectomy in case of incidental carcinoma.

The Carpentier-Edwards Classic and Physio Mitral Annuloplasty Rings: A Randomized Trial

2006 ◽  
Vol 8 (5) ◽  
pp. 389 ◽  
Author(s):  
Ghada M. M. Shahin ◽  
Geert J. M. G. van der Heijden ◽  
Michiel L. Bots ◽  
Maarten-Jan Cramer ◽  
Wybren Jaarsma ◽  
...  
Keyword(s):  
Left Ventricular Function ◽  
Ventricular Function ◽  
Absolute Risk ◽  
Statistical Significance ◽  
Nyha Class ◽  
Left Ventricular ◽  
Mitral Annuloplasty ◽  
Risk Of Death ◽  
Late Failure

<P>Objective: To evaluate clinical and echocardiographic outcomes for the semi-flexible Carpentier-Edwards Physio and the rigid Classic mitral annuloplasty ring. </P><P>Methods: Ninety-six patients were randomized for either a Classic (n = 53) or a Physio (n = 43) ring from October 1995 through July 1997. Mean follow-up was 5.1 years (range .1-6.6). We included standard patient characteristics at baseline and during follow-up. Analyses were adjusted for age and gender, and for factors that differed across groups at baseline. In 2002, echocardiography was performed in 74% of the survivors. </P><P>Results: We found a 16% difference in mortality: 14% in the Physio group (n = 6) and 30% in the Classic group (n = 16) (adjusted P = .41). Life table analysis shows that the absolute risk of death after 30 months is lower in the Physio group. Intra-operative repair failure occurred in 3 patients (6%) of the Classic group, and in 4 (9%) of the Physio group, resulting in mitral valve replacement. Late failure occurred in 1 patient (2%) in the Classic group, and in 4 (9%) in the Physio group. At follow-up, left ventricular function did not differ across groups (ejection fraction 45% and 48% (adjusted P = .65)). The combined NYHA class III-IV had improved for the Classic group in 42% and for the Physio group in 34%. </P><P>Conclusion: Although the 16% difference in mortality did not reach statistical significance, it is considered clinically important. No differences in morbidity, valve function, and left ventricular function were found. Further research to explain the difference in mortality is required.</P>

scholarly journals Height in Adolescence as a Risk Factor for Glioma Subtypes: a Nationwide Retrospective Cohort Study of 2.2 Million Subjects

2021 ◽  
Author(s):  
Roi Tschernichovsky ◽  
Lior H Katz ◽  
Estela Derazne ◽  
Matan Ben-Zion Berliner ◽  
Maya Simchoni ◽  
...  
Keyword(s):  
Risk Factor ◽  
Statistical Significance ◽  
Positive Association ◽  
High Grade Glioma ◽  
Low Grade ◽  
Cox Proportional Hazard ◽  
Cox Proportional Hazard Models ◽  
Glioma Risk ◽  
Incident Cases

Abstract Background Gliomas manifest in a variety of histological phenotypes with varying aggressiveness. The etiology of glioma remains largely unknown. Taller stature in adulthood has been linked with glioma risk. The aim of this study was to discern whether this association can be detected in adolescence. Methods The cohort included 2,223,168 adolescents between the ages of 16-19. Anthropometric measurements were collected at baseline. Incident cases of glioma were extracted from the Israel National Cancer Registry over a follow-up period spanning 47,635,745 person-years. Cox proportional hazard models were used to estimate the hazard ratio for glioma and glioma subtypes according to height, body mass index (BMI) and sex. Results 1,195 patients were diagnosed with glioma during the study period. Mean(SD) age at diagnosis was 38.1 (11.7) years. Taller adolescent height (per 10cm increase) was positively associated with the risk for glioma of any type (HR 1.15; p=0.002). The association was retained in subgroup analyses for low-grade glioma (HR 1.17; p=0.031), high-grade glioma (HR 1.15; p=0.025), oligodendroglioma (HR 1.31; p=0.015), astrocytoma (HR 1.12; p=0.049), and a category of presumed IDH-mutated glioma (HR 1.17; p=0.013). There was a trend towards a positive association between height and glioblastoma, however this had borderline statistical significance (HR: 1.15; p=0.07). After stratification of the cohort by sex, height remained a risk factor for men, but not for women. Conclusions The previously - established association between taller stature in adulthood and glioma risk can be traced back to adolescence. The magnitude of association differs by glioma subtype.

scholarly journals Chronic kidney disease progression among patients with type 2 diabetes identified in US administrative claims: a population cohort study

2020 ◽  
Author(s):  
Csaba P Kovesdy ◽  
Danielle Isaman ◽  
Natalia Petruski-Ivleva ◽  
Linda Fried ◽  
Michael Blankenburg ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Chronic Kidney Disease ◽  
Cohort Study ◽  
Kidney Disease ◽  
Disease Progression ◽  
Administrative Claims ◽  
Short Period ◽  
Ckd Stage

Abstract Background Chronic kidney disease (CKD), one of the most common complications of type 2 diabetes (T2D), is associated with poor health outcomes and high healthcare expenditures. As the CKD population increases, a better understanding of the prevalence and progression of CKD is critical. However, few contemporary studies have explored the progression of CKD relative to its onset in T2D patients using established markers derived from real-world care settings. Methods This retrospective, population-based cohort study assessed CKD progression among adults with T2D and with newly recognized CKD identified from US administrative claims data between 1 January 2008 and 30 September 2018. Included were patients with T2D and laboratory evidence of CKD as indicated by the established estimated glomerular filtration rate (eGFR) and urine albumin:creatinine ratio (UACR) criteria. Disease progression was described as transitions across the eGFR- and UACR-based stages. Results A total of 65 731 and 23 035 patients with T2D contributed to the analysis of eGFR- and UACR-based CKD stage progression, respectively. CKD worsening was observed in approximately 10–17% of patients over a median follow-up of 2 years. Approximately one-third of patients experienced an increase in eGFR values or a decrease in UACR values during follow-up. Conclusions A relatively high proportion of patients were observed with disease progression over a short period of time, highlighting the need for better identification of patients at risk of rapidly progressive CKD. Future studies are needed to determine the clinical characteristics of these patients to inform earlier diagnostic and therapeutic interventions aimed at slowing disease progression.

scholarly journals Risk of herpes zoster in psoriasis patients receiving systemic therapies: a nationwide population-based cohort study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Sze-Wen Ting ◽  
Sze-Ya Ting ◽  
Yu-Sheng Lin ◽  
Ming-Shyan Lin ◽  
George Kuo
Keyword(s):  
Cohort Study ◽  
Herpes Zoster ◽  
Population Based ◽  
Research Database ◽  
Newly Diagnosed ◽  
Increased Risk ◽  
Taiwan National Health Insurance ◽  
Reduced Risk ◽  
Systemic Therapies

AbstractThe incidence of herpes zoster in psoriasis patients is higher than in the general population. However, the association between herpes zoster risk and different systemic therapies, especially biologic agents, remains controversial. This study investigated the association between herpes zoster risk and several systemic antipsoriasis therapies. This prospective open cohort study was conducted using retrospectively collected data from the Taiwan National Health Insurance Research Database. We included 92,374 patients with newly diagnosed psoriasis between January 1, 2001, and December 31, 2013. The exposure of interest was the “on-treatment” effect of systemic antipsoriasis therapies documented by each person-quarter. The outcome was the occurrence of newly diagnosed herpes zoster. During a mean follow-up of 6.8 years, 4834 (5.2%) patients were diagnosed with herpes zoster after the index date. Among the systemic antipsoriasis therapies, etanercept (hazard ratio [HR] 4.78, 95% confidence interval [CI] 1.51–15.17), adalimumab (HR 5.52, 95% CI 1.72–17.71), and methotrexate plus azathioprine (HR 4.17, 95% CI 1.78–9.82) were significantly associated with an increased risk of herpes zoster. By contrast, phototherapy (HR 0.76, 95% CI 0.60–0.96) and acitretin (HR 0.39, 95% CI 0.24–0.64) were associated with a reduced risk of herpes zoster. Overall, this study identified an association of both etanercept and adalimumab with an increased risk of herpes zoster among psoriasis patients. Acitretin and phototherapy were associated with a reduced risk.

scholarly journals Role of Ambulatory Blood Pressure Monitoring in Predicting Adverse Maternofetal Events in Pregnancy

2021 ◽  
Author(s):  
Satish Kumar Rao Vavilala ◽  
Indrani Garre ◽  
Sumalatha Beeram
Keyword(s):  
Blood Pressure ◽  
Logistic Regression ◽  
Standard Deviation ◽  
Ambulatory Blood Pressure ◽  
Blood Pressure Monitoring ◽  
Statistical Significance ◽  
Binary Logistic Regression ◽  
Pressure Monitoring ◽  
In Pregnancy

Abstract Aims To correlate the relationship between the ambulatory blood pressure parameters and the occurrence of the antenatal and postnatal adverse maternofetal events in pregnancy. Methods Observational study designed for 50 pregnant patients who had an appointment to the obstetrics with abnormal blood pressure (BP) measurements and for whom ambulatory blood pressure monitoring (ABPM) was studied between January 2019 and June 2019. Data about age, personal history, obstetrics, family, body mass index (BMI), weight gain in pregnancy, values of blood pressure in the appointment, values recorded in ABPM, delivery and newborn, pregnancy and postpartum events, and follow-up of woman and child. Data were analyzed using descriptive and inferential statistics with Minitab 17.0 for Windows. Results Patients demographic data, clinical history, and laboratory results, including the ABPM parameters, were compiled. Antenatal complications occurred in 22 patients (44%), and postpartum complications were found in 41 patients (82%) whose ABPM values were deranged. Antenatal complications were studied using the binary logistic regression analysis for calculating the role each factor played in the development of hypertension. In the sample studied, mean age was 24.980 with a standard deviation of 4.876 (p = 0.003; minimum age of 19 years and maximum age of 38 years), mean weight of patient was 63.71 with a standard deviation of 63.71 (p = 0.001), mean gravida was 1.780 with a standard deviation of 0.910 (p = 0.034), mean gestation weeks at presentation was 33.000 weeks with a standard deviation of 4.086 (p = 0.041), mean birth weight was 2.226 with a standard deviation of 0.797 (p = 0.000), mean maximum diastole was 109.22 with a standard deviation of 16.53 (p = 0.002), mean day maximum systole was 187.2 with a standard deviation of 203.5 (p = 0.009), mean day minimum diastole was 63.50 with a standard deviation of 12.99 (p = 0.013), all of which had statistical significance. It is found that the nighttime diastolic blood pressure (DBP) and daytime maximum systolic blood pressure (SBP) were the best predictors of adverse events. Among antenatal complications (ANC), the most common complication is intrauterine growth restriction (IUGR), noted in (n = 19, 86.36%) preterm delivery (n = 17, 77.27%) among the 17 babies who were delivered preterm; 12 (70.5%) needed neonatal intensive care unit (NICU) care of which 4 (25%) babies died because of prematurity; intrauterine death (IUD) was noted in 7 (31.81%) patients and eclampsia was seen in 5 (22.72%). Nondippers proðle had a worse survival rate at follow-up until delivery compared with those with a dipper proðle. Postnatal complications were seen in 41 patients; among them, 13 patients (31.7%) had abnormal fundus examination, 15 patients (36.58%) required usage of antihypertensive beyond first postpartum, 9 patients (21.95%) required blood transfusion for severe bleeding in the form of postpartum hemorrhage. Binary logistic regression for systolic dippers versus nondippers shows statistical significance in age (p = 0.023), weight (p = 0.038), and para (p = 0.045) (Table 3). Binary logistic regression for diastolic dippers versus nondippers shows statistical significance in age (p = 0.039), weight (p = 0.020), birth weight (p = 0.010), maximum heart rate (p = 0.043), and ANC (p = 0.007) Adverse events occurred most commonly in nondippers. Systole nondippers is noted in (n = 41, 82%). Dippers is noted in (n = 9, 18%), Diastole nondippers is noted in (n = 39, 78%) Dippers is noted in (n = 11, 22%). Conclusion ABPM recorded blood pressure is very precise. ABPM is the advised method for both diagnostic and therapeutic monitoring of hypertensive pregnancy diseases, mainly in situations like whitecoat hypertension, masked hypertension, nocturnal hypertension, and nondipping profile. In patients with high-risk pregnancy, elderly primigravida, and precious pregnancy, who have a high-risk of developing pregnancy-induced hypertension (PIH) and related complications, early use of ABPM predicts adverse maternofetal events, which when intervened at an earlier date can prevent antenatal and postnatal complications.

scholarly journals AB0185 PROSPECTIVE PROFILE OF URINE METABOLOME IN RHEUMATOID ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1392.2-1392
Author(s):  
M. De Oliveira ◽  
P. V. Alabarse ◽  
M. Farinon ◽  
R. Cavalheiro Do Espírito Santo ◽  
R. Xavier
Keyword(s):  
Rheumatoid Arthritis ◽  
Skeletal Muscle ◽  
Disease Activity ◽  
Pearson Correlation ◽  
Statistical Significance ◽  
Resonance Spectroscopy ◽  
Metabolome Analysis ◽  
Orthogonal Projections ◽  
Urine Metabolome

Background:Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by increased mortality and associated with metabolic disorders. Since the metabolomic profile is known to vary in response to different inflammatory conditions, metabolome analysis could substantially improve diagnosis and prognosis of RA.Objectives:To analyze the urine metabolome profile in RA patients and correlate it with disease activity changes over 12 monthsMethods:Seventy-nine RA patients, according to ACR/EULAR 2010 classification criteria, between 40 and 70 years old, were recruited and followed for 12 months. Metabolome analysis was performed by Nuclear Magnetic Resonance spectroscopy (NMR), resulting in the identification of 93 metabolites in urine collected at the baseline and after 12 months. Frequency analysis, Pearson Correlation and Multivariate data analysis with orthogonal projections to latent structures (OPLS) method were performed and a statistical significance was considered as p<0.05.Results:The study population was characterized by the majority of women (86.7%), mean age of 56 years old, around 80% with positive anti-CCP or Rheumatoid Factor. During the one year of follow-up, there was no substantial variation in the DAS28 measurement (baseline: 3.8, after 12 months: 4.0). There was no significant correlation between the metabolome pattern and DAS28 score (p>0.05) over time. However, multivariate analysis (OPLS-DA) demonstrated an adequate differentiation of the population with 0.92 of accuracy (Q2: 0.72 and R2: 0.89).There was a significant increase of L-cysteine, choline, L-Phenylalanin, creatine, L-histidine, oxalacetic acid and xanthine, and a decrease of L-threonine, taurine, butyric and gluconic acid (p<0.05) during the follow-up, metabolites that are involved in the skeletal muscle metabolism.Conclusion:The observed biomarkers indicate,as expected, that the RA metabolic profile is associated with inflammation injury and skeletal muscle amino acid metabolism. Correlations with disease activity changes was compromised by the stable disease status during the 12 months. More studies evaluating correlations with skeletal muscle function and mass are underway.Acknowledgments:Disclosure of interest: Marianne Oliveira: None declared, Rafaela Santo: None declared, Mirian Farinon: None declared, Ricardo Xavier Consultant of: Abbvie, Pfizer, Novartis, Janssen, Lilly, RocheDisclosure of Interests:Marianne de Oliveira: None declared, Paulo Vinicius Alabarse: None declared, Mirian Farinon: None declared, Rafaela Cavalheiro do Espírito Santo: None declared, Ricardo Xavier Consultant of: AbbVie, Pfizer, Novartis, Janssen, Eli Lilly, Roche

scholarly journals Characterization of bariatric surgery and outcomes using administrative claims data in the research network of a nationwide commercial health plan

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Qinli Ma ◽  
Michael Mack ◽  
Sonali Shambhu ◽  
Kathleen McTigue ◽  
Kevin Haynes
Keyword(s):  
Bariatric Surgery ◽  
Health Systems ◽  
Comparative Effectiveness ◽  
Claims Data ◽  
Research Network ◽  
Hospital Death ◽  
Administrative Claims ◽  
Administrative Claims Data ◽  
Abdominal Operations

Abstract Background The supplementation of electronic health records data with administrative claims data may be used to capture outcome events more comprehensively in longitudinal observational studies. This study investigated the utility of administrative claims data to identify outcomes across health systems using a comparative effectiveness study of different types of bariatric surgery as a model. Methods This observational cohort study identified patients who had bariatric surgery between 2007 and 2015 within the HealthCore Anthem Research Network (HCARN) database in the National Patient-Centered Clinical Research Network (PCORnet) common data model. Patients whose procedures were performed in a member facility affiliated with PCORnet Clinical Research Networks (CRNs) were selected. The outcomes included a 30-day composite adverse event (including venous thromboembolism, percutaneous/operative intervention, failure to discharge and death), and all-cause hospitalization, abdominal operation or intervention, and in-hospital death up to 5 years after the procedure. Outcomes were classified as occurring within or outside PCORnet CRN health systems using facility identifiers. Results We identified 4899 patients who had bariatric surgery in one of the PCORnet CRN health systems. For 30-day composite adverse event, the inclusion of HCARN multi-site claims data marginally increased the incidence rate based only on HCARN single-site claims data for PCORnet CRNs from 3.9 to 4.2%. During the 5-year follow-up period, 56.8% of all-cause hospitalizations, 31.2% abdominal operations or interventions, and 32.3% of in-hospital deaths occurred outside PCORnet CRNs. Incidence rates (events per 100 patient-years) were significantly lower when based on claims from a single PCORnet CRN only compared to using claims from all health systems in the HCARN: all-cause hospitalization, 11.0 (95% Confidence Internal [CI]: 10.4, 11.6) to 25.3 (95% CI: 24.4, 26.3); abdominal operations or interventions, 4.2 (95% CI: 3.9, 4.6) to 6.1 (95% CI: 5.7, 6.6); in-hospital death, 0.2 (95% CI: 0.11, 0.27) to 0.3 (95% CI: 0.19, 0.38). Conclusions Short-term inclusion of multi-site claims data only marginally increased the incidence rate computed from single-site claims data alone. Longer-term follow up captured a notable number of events outside of PCORnet CRNs. The findings suggest that supplementing claims data improves the outcome ascertainment in longitudinal observational comparative effectiveness studies.

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