Abstract 280: Defining Statin Intolerance Among High Cardiovascular Risk Patients: Do US Administrative Databases Lend Themselves to Identification Of Statin Intolerance?

2015 ◽  
Vol 8 (suppl_2) ◽  
Author(s):  
Joanne M Foody ◽  
Lois E Lamerato ◽  
Mehul R Dalal ◽  
Jennifer Sung ◽  
Irfan Khan ◽  
...  
Keyword(s):  
Adverse Events ◽  
Administrative Databases ◽  
Administrative Database ◽  
Statin Intolerance ◽  
Mixed Dyslipidemia ◽  
Henry Ford ◽  
Risk Patients ◽  
Artery Disease ◽  
Measures Of Concordance ◽  
Sensitivity Specificity

Introduction: The clinical and economic impact of statin intolerance (SI) in high CV risk patients is unknown due, in part, to a lack of consensus in its definition. We sought to define and validate an SI algorithm for use in an administrative database (AD) among high-CV risk patients Methods: Adults with ≥1 qualifying change (See Table 1) in statin therapy and ≥1 prior diagnosis of hyperlipidemia, hypercholesterolemia, or mixed dyslipidemia were identified from the AD of the Health Alliance Plan at Henry Ford Health System (HFHS). A sample of 1000 patients was drawn from the pool of eligible adults and stratified by high CV risk based on presence of comorbid conditions including diabetes, coronary heart disease, and peripheral artery disease. Statin utilization and adverse events data were abstracted both from the AD and the HFHS electronic medical record (EMR). SI was defined using both a primary definition inclusive of all possible statin related adverse events and a secondary definition that included only musculoskeletal events. SI was categorized as absolute (AI) or titration (TI) intolerance. The performance of the AD algorithm was assessed using measures of concordance (Cohen’s kappa [κ]) and accuracy (sensitivity, specificity, positive predictive value [PPV]) with the EMR as reference. Results: A total of 353 patients (48% female, 44% Caucasian, mean (SD) age 63 (12) years) were identified as high CV risk with 33% having a history of CHD, 77% diabetes and 2% PAD. Forty-two percent of patients were on simvastatin, 35% atorvastatin, 11% lovastatin, 7% rosuvastatin and 6% pravastatin/fluvastatin. Table 1 characterizes the validation sample. SI was identified in 19.3% and 20.7%, AI in 3.1% and 2.8%, and TI in 16.7% and 18.7% of patients in the EMR and AD, respectively. The algorithm identifying any SI had robust concordance (κ=0.73), good sensitivity (80.9%) and PPV (75.3%). The TI algorithm performed better (κ=0.78, sensitivity=86.4%, PPV=77.3%) than the AI algorithm (κ=0.56, sensitivity=54.5%, PPV=60.0%). Specificity was high (>94%) across all 3 algorithms. Conclusion: This study successfully defined SI among high-CV risk patients using an evidence-based validated algorithm. To our knowledge, this is the first such algorithm for use in AD to be made available to decision-makers.

scholarly journals Identifying High-Cost, High-Risk Patients Using Administrative Databases in Tuscany, Italy

2017 ◽  
Vol 2017 ◽  
pp. 1-12 ◽  
Author(s):  
Irene Bellini ◽  
Valentina Barletta ◽  
Francesco Profili ◽  
Alessandro Bussotti ◽  
Irene Severi ◽  
...  
Keyword(s):  
General Population ◽  
Positive Predictive Value ◽  
Predictive Value ◽  
Incidence Rates ◽  
Adverse Outcomes ◽  
Administrative Databases ◽  
Administrative Database ◽  
Complex Patients ◽  
Risk Patients ◽  
Health Registry

Objective. (1) Assessing the performance of the algorithm in terms of sensitivity and positive predictive value, considering General Practitioners’ (GPs) judgement as benchmark, and (2) describing adverse events (hospitalisation, death, and health services’ consumption) of complex patients compared to the general population. Data Sources. (i) Tuscany administrative database containing health data (2013-5); (ii) lists of complex patients indicated by GPs; and (iii) annual health registry of Tuscany. Study Design. The present study is a validation study. It compares a list of complex patients extracted through an administrative algorithm (criteria of high health consumption) to a gold standard list of patients indicated by GPs. GPs’ decision was subjective but fairly well reasoned. The study compares also adverse outcomes (Emergency Room visits, hospitalisation, and death) between identified complex patients and general population. Principal Findings. Considering GPs’ judgement, the algorithm showed a sensitivity of 72.8% and a positive predictive value of 64.4%. The complex cases presented here have higher incidence rates/100,000 (death 46.8; ER visits 223.2, hospitalisations 110.87, laboratory tests 1284.01, and specialist examinations 870.37) compared to the general population. Conclusions. The final validated algorithm showed acceptable sensitivity and positive predictive value.

scholarly journals P057 THE ACCURACY OF INCISIONAL HERNIA CODES IN ADMINISTRATIVE DATA: A VALIDATION STUDY

2021 ◽  
Vol 108 (Supplement_8) ◽  
Author(s):  
Arturo Rios-Diaz ◽  
Jesse Y. Hsu ◽  
Robyn Broach ◽  
Bradford Bormann ◽  
John Fischer
Keyword(s):  
Abdominal Surgery ◽  
Incisional Hernia ◽  
Predictive Value ◽  
Large Scale ◽  
False Negative ◽  
International Classification Of Diseases ◽  
Administrative Databases ◽  
Administrative Database ◽  
Icd 10 ◽  
Sensitivity Specificity

Abstract Aim Administrative databases contain valuable information for studying incisional hernia (IH) following intra-abdominal procedures at a large scale. We assessed the validity of billing codes for the identification of IH in patients following abdominal surgery. Material and Methods Using International Classification of Diseases, Ninth and Tenth Revision, Clinical Modification (ICD-9-CM and ICD-10-CM), a random sample of 1,000 patients who underwent abdominal operations between 2006-2020 within a large health system-wide administrative database and ≥1 year of follow-up were screened for eligibility. Validation of IH codes was performed using the electronic medical record as reference. Validity metrics of interest included sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy. Patient factors associated with false positive (FP) and false negative (FN) were also explored within univariate and multivariate analyses. Results 759 patients were included. The sensitivity of IH codes was 94.7% (CI 91.4 – 97.0), specificity was 94.9% (CI 92.6 – 96.7), PPV was 84.4% (CI 78.5 – 88.9), NPV was 98.4 (CI 97.4 – 99.0), accuracy was 94.9% (CI 93.0 – 96.3). Within adjusted analyses, patients admitted to a non-surgical service (relative to patients admitted to surgical services; OR 4.46 [95% CI 1.06-18.66]; p = 0.04) were associated with FP; whereas every one-year increase in age was associated with a 5.0% (95% CI 1.0%-10.0%) increase in FN (p = 0.03). Conclusions We have validated the use of ICD-9-CM and ICD-10-CM codes for accurately identifying IH following abdominal surgery. This method yields >94% for key validity measures.

Abstract P71: The Accuracy of Coded Obesity in an Administrative Database

2011 ◽  
Vol 4 (suppl_2) ◽  
Author(s):  
Billie-Jean Martin ◽  
Guanmin Chen ◽  
Diane Galbraith ◽  
Merril L Knudtson ◽  
William A Ghali ◽  
...  
Keyword(s):  
Administrative Data ◽  
Predictive Value ◽  
Class I ◽  
Administrative Databases ◽  
Administrative Database ◽  
Diagnostic Code ◽  
Discharge Abstract Database ◽  
Diagnosis Codes ◽  
Low Sensitivity ◽  
Sensitivity Specificity

Objective: Obesity is becoming an increasingly prevalent problem. Gathering information on the adiposity of a population is difficult, so being able to take advantage of existing data, such as that in administrative databases, is appealing. The objective of our study was to assess the validity of obesity coding in administrative databases. Methods: This study was conducted using the Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease (APPROACH) database and the Discharge Abstract Database (DAD) for Calgary. BMI was calculated within APPROACH; BMI ≥30kg/m2 defined obesity. In the DAD obesity was defined by diagnosis codes 278 (ICD-9-CM) and E65-E68 (ICD-10). Databases were linked using provincial health numbers. The sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of a diagnosis of obesity in the DAD was determined using the obesity diagnosis in APPROACH as the referent. The accuracy of coding obesity was compared across demographic categories and diagnoses. Results: A total of 17,380 subjects included in the analysis. The study population was largely male (68.8%) and had a mean BMI of 26.96 kg/m2. The overall sensitivity of a diagnosis of obesity in the administrative data was 7.75%. However, it was highly specific at 98.98%, with a NPV of 80.84% and a PPV of 65.94%. When considered by year, there were minor variations in the sensitivity of obesity coding in the administrative data, but it remained poor at under 10% throughout. The prevalence of obesity and the PPV was higher amongst those subjects with conditions associated with obesity, including diabetes and hypertension. Of those coded obese in DAD, the majority (72.89%) were Class I obese; of those not coded obese, 84.31% were Class I obese. Conclusions: Obesity coding in the DAD is poor, as reflected in the low sensitivity of the diagnostic code. However, once obesity is coded in this database, it is coded highly accurately. At present, using administrative databases to define cohorts of obese subjects for surveillance is not a viable option.

Management of the Asymptomatic Diabetic Patient with Evidence of Ischaemia

2010 ◽  
Vol 6 (1) ◽  
pp. 62
Author(s):  
Dimitrios Bliagos ◽  
Ajay J Kirtane ◽  
Jeffrey W Moses ◽  
◽  
◽  
...  
Keyword(s):  
Coronary Artery ◽  
Medical Therapy ◽  
Artery Bypass ◽  
Coronary Intervention ◽  
Diabetic Patients ◽  
Ageing Population ◽  
Patients With Diabetes ◽  
Risk Patients ◽  
Asymptomatic Diabetic Patient ◽  
Artery Disease

In the US, a total of 23.6 million people have diabetes, representing 7.8% of the population, and the prevalence of diabetes is on the rise due to an increasingly sedentary lifestyle, increasing obesity and an ageing population. Coronary artery disease is the leading cause of death in patients with diabetes, despite a reduction in cardiovascular events over the last 50 years, due in part to better medical therapy. Asymptomatic diabetic patients with evidence of ischaemia on stress testing have higher cardiac mortality; increasing amounts of ischaemia are associated with higher mortality rates. Revascularisation of high-risk patients, or those with significant ischaemia, has the potential to improve outcomes in this patient population. The choice of which revascularisation strategy to choose – either percutaneous coronary intervention (PCI) or coronary artery bypass grafting – should be carefully individualised, and must always be implemented against the background of optimal medical therapy.

scholarly journals RNAi inhibition of angiopoietin-like protein 3 (ANGPTL3) with ARO-ANG3 mimics the lipid and lipoprotein profile of familial combined hypolipidemia

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
G.F Watts ◽  
C Schwabe ◽  
R Scott ◽  
P Gladding ◽  
D Sullivan ◽  
...  
Keyword(s):  
Adverse Events ◽  
Dose Response ◽  
Minimal Change ◽  
Funding Source ◽  
Private Company ◽  
Good Tolerability ◽  
Duration Of Action ◽  
Mixed Dyslipidemia ◽  
Genetic Deficiency

Abstract Background Elevated LDL-C and triglyceride rich lipoproteins (TRLs) are independent risk factors for cardiovascular disease (CVD). Genetic deficiency of angiopoietin-like protein 3 (ANGPTL3) is associated with reduced circulating levels of LDL-C, triglycerides (TGs), VLDL-C, HDL-C and reduced CVD risk, with no described adverse phenotype. ARO-ANG3 is a RNA interference drug designed to silence expression of ANGPTL3. Single doses of ARO-ANG3 have been shown to reduce ANGPTL3, TGs, VLDL-C and LDL-C in healthy volunteers (HVs, AHA 2019). We report the effects of multiple doses of ARO-ANG3 in HVs with a focus on the duration of action. Methods ARO-ANG3 was administered subcutaneously to HVs on days 1 and 29 at doses of 100, 200 or 300 mg (n=4 per group). Measured parameters included ANGPTL3, LDL-C, TGs, VLDL-C and HDL-C. Follow up is ongoing. Results All HVs have received both doses and follow-up is currently through week 16 (12 weeks after second dose). Mean nadir for ANGPTL3 levels occurred 2 weeks after the second dose (−83–93%) with minimal change for 200 and 300 mg but 16% recovery for 100 mg at week 16. Mean TGs and VLDL-C reached nadir earlier (3 wks, −61–65%) without apparent dose response and minimal change for any dose at wk 16. LDL-C nadir occurred 4–6 wks after the second dose (−45–54%), again with minimal evidence for dose response or change through wk 16. HDL-C was reduced 14–37% at wk 16. ARO-ANG3 was well tolerated without serious or severe adverse events or dropouts related to drug. The most common adverse events have been headache and upper respiratory infections. Conclusions Genetic deficiency of ANGPTL3 is a cause of familial combined hypolipemia and is associated with a decreased risk of CVD. Using RNAi to selectively suppress ANGPTL3 production reproduces these genetic effects with a duration of at least 12 weeks following a second dose and with good tolerability over 16 wks. ANGPTL3 inhibition results in lowering of LDL-C and TRLs which may confer protection against CVD in patients with atherogenic mixed dyslipidemia. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Arrowhead Pharmaceuticals

Does ProCore fine needle biopsy really improve the clinical outcome of endoscopic ultrasound-guided sampling of pancreatic masses?

2021 ◽  
Author(s):  
Gabriele Delconte ◽  
Federica Cavalcoli ◽  
Andrea Magarotto ◽  
Giovanni Centonze ◽  
Cristina Bezzio ◽  
...  
Keyword(s):  
Adverse Events ◽  
Diagnostic Accuracy ◽  
Likelihood Ratio ◽  
Endoscopic Ultrasound ◽  
Needle Biopsy ◽  
Clinical Performance ◽  
Negative Likelihood Ratio ◽  
Fine Needle Biopsy ◽  
Fine Needle ◽  
Sensitivity Specificity

Introduction: Fine Needle Biopsy (FNB) has been suggested to provide better histological samples as compared to endoscopic ultrasound fine needle aspiration (EUS-FNA). However, studies comparing EUS-FNA and EUS-FNB for pancreatic lesions reported contrasting results. The aim of this study was to compare the clinical performance of EUS-FNA versus EUS-FNB with ProCore needle for the investigation of pancreatic lesions. Methods: We reviewed all patients undergoing EUS for the investigation of pancreatic lesions from August 2012 to September 2018. From August 2012 to January 2015 all procedures were performed with standard needles, whereas from February 2015 to September 2018 the use of ProCore needles had been introduced. Data on diagnostic accuracy, number of needle passes and/or adverse events were collected. Results: 324 patients were retrospectively evaluated: 190 (58.6%) underwent EUS-FNA and 134 (41.4%) EUS-FNB. Both EUS-FNA and EUS-FNB showed high diagnostic accuracy for malignancy [94% (CI 95%:89-97%) vs 94% (CI 95%:89-98%)]. Notable, there were no differences between EUS-FNA and EUS-FNB in terms of sensitivity, specificity, positive and negative likelihood ratio, histological core tissue retrieval, adverse events or number of needle passes. However, subgroup analysis noted a higher diagnostic accuracy for 25G EUS-FNB as compared to 25G EUS-FNA (85,7% vs 55,5%; *p=0.023). Conclusion: EUS-FNB with ProCore needle is safe and feasible in pancreatic lesions. ProCore needle did not provide any advantage in terms of diagnostic accuracy, sensitivity, specificity, positive and/or negative likelihood ratio, or acquisition of core specimen, therefore its routine application is not

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