scholarly journals Recombinant Human Follicle-Stimulating Hormone Alfa Dose Adjustment in US Clinical Practice: An Observational, Retrospective Analysis of a Real-World Electronic Medical Records Database

2021 ◽  
Vol 12 ◽  
Author(s):  
Mary C. Mahony ◽  
Brooke Hayward ◽  
Gilbert L. Mottla ◽  
Kevin S. Richter ◽  
Stephanie Beall ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Retrospective Analysis ◽  
Real World ◽  
Ovarian Reserve ◽  
Medical Records ◽  
Dose Adjustment ◽  
Follicle Stimulating Hormone ◽  
Dose Increase ◽  
The Usa ◽  
Constant Dose

PurposeTo determine the pattern of dose adjustment of recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa) during ovarian stimulation (OS) for assisted reproductive technology (ART) in a real-world setting.MethodsThis was an observational, retrospective analysis of data from an electronic de-identified medical records database including 39 clinics in the USA. Women undergoing OS for ART (initiated 2009–2016) with r-hFSH-alfa (Gonal-f® or Gonal-f RFF Redi-ject®) were included. Assessed outcomes were patients’ baseline characteristics and dosing characteristics/cycle.ResultsOf 33,962 ART cycles, 13,823 (40.7%) underwent dose adjustments: 23.4% with ≥1 dose increase, 25.4% with ≥1 dose decrease, and 8.1% with ≥1 increase and ≥1 decrease. Patients who received dose adjustments were younger (mean [SD] age 34.8 [4.58] years versus 35.9 [4.60] years, p<0.0001) and had lower BMI (25.1 [5.45] kg/m2 versus 25.5 [5.45] kg/m2, p<0.0001) than those who received a constant dose. The proportion of patients with non-normal ovarian reserve was 38.4% for those receiving dose adjustment versus 51.9% for those with a constant dose. The mean (SD) number of dose changes/cycle was 1.61 (0.92) for cycles with any dose adjustment, 1.72 (1.03) for cycles with ≥1 dose increase, 2.77 (1.00) for cycles with ≥1 dose increase and ≥1 decrease (n=2,755), and 1.88 (1.03) for cycles with ≥1 dose decrease.ConclusionsDose adjustment during OS is common in clinical practice in the USA and occurred more often in younger versus older patients, those with a high versus non-normal ovarian reserve or those with ovulation disorders/polycystic ovary syndrome versus other primary diagnoses of infertility.

scholarly journals Glioblastoma treatment patterns, survival, and healthcare resource use in real-world clinical practice in the USA

2015 ◽  
Vol 4 ◽  
pp. 1-12 ◽  
Author(s):  
Allicia Girvan ◽  
Gebra Carter ◽  
Li Lin ◽  
Anna Kaltenboeck ◽  
Jasmina Ivanova ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Resource Use ◽  
Real World ◽  
Healthcare Resource ◽  
Treatment Patterns ◽  
Healthcare Resource Use ◽  
The Usa

Invited Commentary: Theoretical Considerations and Real-World Challenges for Research on Proxy Exposures and Ovarian Reserve

2020 ◽  
Vol 190 (1) ◽  
pp. 125-128
Author(s):  
Brian W Whitcomb
Keyword(s):  
Real World ◽  
Ovarian Reserve ◽  
Environmental Influence ◽  
Follicle Stimulating Hormone ◽  
Real Data ◽  
Epidemiologic Studies ◽  
Careful Consideration ◽  
Covariate Adjustment ◽  
Theoretical Considerations ◽  
Stimulating Hormone

Abstract In this issue of the Journal, Upson et al. (Am J Epidemiol. 2021;190(1):116–124) assess urinary cadmium level as a potential environmental influence on ovarian reserve, as measured using serum follicle-stimulating hormone, in data from 1,681 US women (1988–1994). They compare 3 methods for modeling urinary proxy exposures—standardization, covariate adjustment, and covariate-adjusted standardization. Observing positive associations with all 3 approaches but higher-magnitude estimates using covariate adjustment as compared with standardization and covariate-adjusted standardization—proposed to be the result of collider-stratification bias—the authors conclude that cadmium may affect ovarian aging, and they recommend careful consideration of modeling approach. Comparisons of methodology in practice using real data are not straightforward, and additional complication arises from using a proxy outcome—serum follicle-stimulating hormone level to represent diminished ovarian reserve. In this commentary, I describe the theoretical basis for approaches for modeling urinary proxy exposures; consider potential explanations for why the approaches may yield different results in practice and describe why measurement error may play a larger role than collider-stratification bias; discuss challenges related to studies of ovarian reserve; and emphasize the importance of addressing both theoretical concerns and real-world challenges in methodological research and epidemiologic studies of ovarian reserve.

scholarly journals Development of a Risk Score for QT Prolongation in the Intensive Care Unit Using Time-Series Electrocardiogram Data and Electronic Medical Records

2021 ◽  
Vol 27 (3) ◽  
pp. 182-188
Author(s):  
Tae Young Kim ◽  
Byung Jin Choi ◽  
Yeryung Koo ◽  
Sukhoon Lee ◽  
Dukyong Yoon
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Clinical Practice ◽  
Electronic Medical Records ◽  
Real World ◽  
Medical Records ◽  
Qt Prolongation ◽  
Icu Patients ◽  
Scoring Model ◽  
Risk Scoring

Objectives: Drug-induced QT prolongation can lead to life-threatening arrhythmia. In the intensive care unit (ICU), various drugs are administered concurrently, which can increase the risk of QT prolongation. However, no well-validated method to evaluate the risk of QT prolongation in real-world clinical practice has been established. We developed a risk scoring model to continuously evaluate the quantitative risk of QT prolongation in real-world clinical practice in the ICU.Methods: Continuous electrocardiogram (ECG) signals measured by patient monitoring devices and Electronic Medical Records data were collected for ICU patients. QT and RR intervals were measured from raw ECG data, and a corrected QT interval (QTc) was calculated by Bazett’s formula. A case-crossover study design was adopted. A case was defined as an occurrence of QT prolongation ≥12 hours after any previous QT prolongation. The patients served as their own controls. Conditional logistic regression was conducted to analyze prescription, surgical history, and laboratory test data. Based on the regression analysis, a QTc prolongation risk scoring model was established.Results: In total, 811 ICU patients who experienced QT prolongation were included in this study. Prescription information for 13 drugs was included in the risk scoring model. In the validation dataset, the high-risk group showed a higher rate of QT prolongation than the low-and low moderate-risk groups.Conclusions: Our proposed model may facilitate risk stratification for QT prolongation during ICU care as well as the selection of appropriate drugs to prevent QT prolongation.

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