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Book ; Online ; E-Book: Pragmatic randomized clinical trials

Girman, Cynthia J. / Ritchey, Mary E. / Suarez, Elizabeth A.

using primary data collection and electronic health records

2021

Author's details	edited by Cynthia J. Girman, Mary E. Ritchey ; assistant editor Elizabeth A. Suarez
Keywords	Electronic books
Language	English
Size	1 Online-Ressource (xxii, 476 Seiten), Illustrationen, Diagramme
Publisher	Elsevier Academic Press
Publishing place	London
Publishing country	Great Britain
Document type	Book ; Online ; E-Book
Remark	Zugriff für angemeldete ZB MED-Nutzerinnen und -Nutzer
HBZ-ID	HT020902644
ISBN	978-0-12-817664-1 ; 9780128176634 ; 0-12-817664-4 ; 0128176636
Database	ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

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Article ; Online: Can Weight of Evidence, Quantitative Bias, and Bounding Methods Evaluate Robustness of Real-world Evidence for Regulator and Health Technology Assessment Decisions on Medical Interventions?

Rosen, Emma M / Ritchey, Mary E / Girman, Cynthia J

Clinical therapeutics

2023 Volume 45, Issue 12, Page(s) 1266–1276

Abstract: Purpose: High-quality evidence is crucial for health care intervention decision-making. These decisions frequently use nonrandomized data, which can be more vulnerable to biases than randomized trials. Accordingly, methods to quantify biases and weigh ... ...

Abstract	Purpose: High-quality evidence is crucial for health care intervention decision-making. These decisions frequently use nonrandomized data, which can be more vulnerable to biases than randomized trials. Accordingly, methods to quantify biases and weigh available evidence could elucidate the robustness of findings, giving regulators more confidence in making approval and reimbursement decisions. Methods: We conducted an integrative literature review to identify methods for determining probability of causation, evaluating weight of evidence, and conducting quantitative bias analysis as related to health care interventions. Eligible studies were published from 2012 to 2021, applicable to pharmacoepidemiology, and presented a method that met our objective. Findings: Twenty-two eligible studies were classified into 4 categories: (1) quantitative bias analysis; (2) weight of evidence methods; (3) Bayesian networks; and (4) miscellaneous. All of the methods have strengths, limitations, and situations in which they are more well suited than others. Some methods seem to lend themselves more to applications of health care evidence on medical interventions than others. Implications: To provide robust evidence for and improve confidence in regulatory or reimbursement decisions, we recommend applying multiple methods to triangulate associations of medical interventions, accounting for biases in different ways. This approach could lead to well-defined robustness assessments of study findings and appropriate science-driven decisions by regulators and payers for public health.
MeSH term(s)	Humans ; Technology Assessment, Biomedical ; Bayes Theorem ; Bias ; Delivery of Health Care
Language	English
Publishing date	2023-10-03
Publishing country	United States
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't
ZDB-ID	603113-4
ISSN	1879-114X ; 0149-2918
ISSN (online)	1879-114X
ISSN	0149-2918
DOI	10.1016/j.clinthera.2023.09.010
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Zs.A 1435: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Characterizing Imbalance in the Tails of the Propensity Score Distribution.

DiPrete, Bethany L / Girman, Cynthia J / Mavros, Panagiotis / Breskin, Alexander / Brookhart, M Alan

American journal of epidemiology

2024 Volume 193, Issue 2, Page(s) 389–403

Abstract: Understanding characteristics of patients with propensity scores in the tails of the propensity score (PS) distribution has relevance for inverse-probability-of-treatment-weighted and PS-based estimation in observational studies. Here we outline a method ...

Abstract	Understanding characteristics of patients with propensity scores in the tails of the propensity score (PS) distribution has relevance for inverse-probability-of-treatment-weighted and PS-based estimation in observational studies. Here we outline a method for identifying variables most responsible for extreme propensity scores. The approach is illustrated in 3 scenarios: 1) a plasmode simulation of adult patients in the National Ambulatory Medical Care Survey (2011-2015) and 2) timing of dexamethasone initiation and 3) timing of remdesivir initiation in patients hospitalized for coronavirus disease 2019 from February 2020 through January 2021. PS models were fitted using relevant baseline covariates, and tails of the PS distribution were defined using asymmetric first and 99th percentiles. After fitting of the PS model in each original data set, values of each key covariate were permuted and model-agnostic variable importance measures were examined. Visualization and variable importance techniques were helpful in identifying variables most responsible for extreme propensity scores and may help identify individual characteristics that might make patients inappropriate for inclusion in a study (e.g., off-label use). Subsetting or restricting the study sample based on variables identified using this approach may help investigators avoid the need for trimming or overlap weights in studies.
MeSH term(s)	Humans ; Propensity Score ; Computer Simulation
Language	English
Publishing date	2024-02-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	2937-3
ISSN	1476-6256 ; 0002-9262
ISSN (online)	1476-6256
ISSN	0002-9262
DOI	10.1093/aje/kwad200
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Article ; Online: Risk of acute pancreatitis among new users of empagliflozin compared to sulfonylureas in patients with type 2 diabetes: A post-authorization safety study.

Fazeli Farsani, Soulmaz / Iglay, Kristy / Zhang, Ling / Niyonkuru, Christian / Nessralla, Laurieann / Girman, Cynthia J

Pharmacoepidemiology and drug safety

2024 Volume 33, Issue 5, Page(s) e5800

Abstract: Purpose: This study was undertaken to evaluate the potential risk of acute pancreatitis with empagliflozin in patients with type 2 diabetes (T2D) newly initiating empagliflozin.: Methods: Data from two large US claims databases were analyzed in an ... ...

Abstract	Purpose: This study was undertaken to evaluate the potential risk of acute pancreatitis with empagliflozin in patients with type 2 diabetes (T2D) newly initiating empagliflozin. Methods: Data from two large US claims databases were analyzed in an observational study of patients with T2D receiving metformin who were newly prescribed empagliflozin versus sulfonylurea (SU). Because dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists have been associated with the risk of acute pancreatitis in some studies, patients on these agents were excluded. Using pooled analyses of data from the two databases (2014-2021), patients initiating empagliflozin were matched 1:1 within database to patients initiating SU using propensity scores (PS) that incorporated relevant demographic and clinical characteristics. Prespecified sensitivity analyses were performed for design parameters. Results: The analyses identified 72 661 new users of empagliflozin and 422 018 new users of SUs, with both patient groups on concurrent metformin therapy. Baseline characteristics within treatment groups appeared to be similar across the 72 621 matched pairs. After mean follow-up of ~6 months, incidence rates of acute pancreatitis in the pooled matched cohort were 10.30 (95% confidence interval [CI] 9.29-11.39) events per 1000 patient-years (PY) for empagliflozin and 11.65 (95% CI 10.59-12.77) events per 1000 PY for SUs. On a background of metformin, patients newly initiating empagliflozin did not have an increased risk of acute pancreatitis compared with those initiating an SU (pooled PS matched hazard ratio 0.88 [0.76-1.02]) across 75621.42 PY of follow-up. Conclusions: The results of this voluntary post-approval safety study provide additional evidence that the use of empagliflozin for the treatment of T2D is not associated with an increased risk of acute pancreatitis.
MeSH term(s)	Humans ; Benzhydryl Compounds/adverse effects ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/epidemiology ; Pancreatitis/chemically induced ; Pancreatitis/epidemiology ; Glucosides/adverse effects ; Glucosides/therapeutic use ; Glucosides/administration & dosage ; Sulfonylurea Compounds/adverse effects ; Sulfonylurea Compounds/therapeutic use ; Male ; Female ; Middle Aged ; Aged ; Metformin/adverse effects ; Metformin/administration & dosage ; Metformin/therapeutic use ; Hypoglycemic Agents/adverse effects ; Hypoglycemic Agents/administration & dosage ; Databases, Factual ; Incidence ; Product Surveillance, Postmarketing/statistics & numerical data ; Sodium-Glucose Transporter 2 Inhibitors/adverse effects ; Sodium-Glucose Transporter 2 Inhibitors/therapeutic use ; Adult ; United States/epidemiology ; Propensity Score
Chemical Substances	empagliflozin (HDC1R2M35U) ; Benzhydryl Compounds ; Glucosides ; Sulfonylurea Compounds ; Metformin (9100L32L2N) ; Hypoglycemic Agents ; Sodium-Glucose Transporter 2 Inhibitors
Language	English
Publishing date	2024-05-08
Publishing country	England
Document type	Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't ; Comparative Study
ZDB-ID	1099748-9
ISSN	1099-1557 ; 1053-8569
ISSN (online)	1099-1557
ISSN	1053-8569
DOI	10.1002/pds.5800
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Article ; Online: Real-world data: Assessing electronic health records and medical claims data to support regulatory decision-making for drug and biological products.

Girman, Cynthia J / Ritchey, Mary E / Lo Re, Vincent

Pharmacoepidemiology and drug safety

2022 Volume 31, Issue 7, Page(s) 717–720

MeSH term(s)	Biological Products/adverse effects ; Databases, Factual ; Decision Making ; Electronic Health Records ; Humans
Chemical Substances	Biological Products
Language	English
Publishing date	2022-05-03
Publishing country	England
Document type	Journal Article
ZDB-ID	1099748-9
ISSN	1099-1557 ; 1053-8569
ISSN (online)	1099-1557
ISSN	1053-8569
DOI	10.1002/pds.5444
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Article ; Online: Evaluating the Feasibility of Electronic Health Records and Claims Data Sources for Specific Research Purposes.

Ritchey, Mary E / Girman, Cynthia J

Therapeutic innovation & regulatory science

2020 Volume 54, Issue 6, Page(s) 1296–1302

Abstract: Data collected in real-world clinical settings are increasingly being used to evaluate therapeutic options. While in its infancy for research assessing effectiveness, especially comparative effectiveness in the regulatory environment, electronic health ... ...

Abstract	Data collected in real-world clinical settings are increasingly being used to evaluate therapeutic options. While in its infancy for research assessing effectiveness, especially comparative effectiveness in the regulatory environment, electronic health records (EHR) and administrative insurance claims data are used extensively by both manufacturers and regulators to evaluate post-marketing safety of products in the real world. The feasibility of using these data for analysis in a research study depends on the specific research question and the availability, quality and relevance of the collected data to address the scientific question. It is unlikely that any specific database could be 'qualified' for use across all research questions, even within a specific therapeutic area, due to dependence of feasibility on the elements of the specific research question. This paper describes considerations for determining whether EHR or claims data can be used for specific research purposes. A new structured approach for assessing the feasibility of these data in research is proposed. The framework builds on and considers whether each element of the PICOTS framework for well-structured research questions is adequately captured to allow for viable reliance on EHR and claims data for that specific scientific question. Practical examples and discussion of the limitations of RWD for research are given along with approaches for interpretation of analyses using RWD.
MeSH term(s)	Data Collection ; Electronic Health Records ; Feasibility Studies ; Information Storage and Retrieval
Language	English
Publishing date	2020-05-07
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2708397-4
ISSN	2168-4804 ; 2168-4790
ISSN (online)	2168-4804
ISSN	2168-4790
DOI	10.1007/s43441-020-00139-x
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Article ; Online: Clarifying the causal contrast: An empirical example applying the prevalent new user study design.

Young, Jessica C / Webster-Clark, Michael / Shmuel, Shahar / Garry, Elizabeth M / Mavros, Panagiotis / Stürmer, Til / Girman, Cynthia J

Pharmacoepidemiology and drug safety

2024 Volume 33, Issue 4, Page(s) e5790

Abstract: Purpose: The prevalent new user design extends the active comparator new user design to include patients switching to a treatment of interest from a comparator. We examined the impact of adding "switchers" to incident new users on the estimated hazard ... ...

Abstract	Purpose: The prevalent new user design extends the active comparator new user design to include patients switching to a treatment of interest from a comparator. We examined the impact of adding "switchers" to incident new users on the estimated hazard ratio (HR) of hospitalized heart failure. Methods: Using MarketScan claims data (2000-2014), we estimated HRs of hospitalized heart failure between patients initiating GLP-1 receptor agonists (GLP-1 RA) and sulfonylureas (SU). We considered three estimands: (1) the effect of incident new use; (2) the effect of switching; and (3) the effect of incident new use or switching, combining the two population. We used time-conditional propensity scores (TCPS) and time-stratified standardized morbidity ratio (SMR) weighting to adjust for confounding. Results: We identified 76 179 GLP-1 RA new users, of which 12% were direct switchers (within 30 days) from SU. Among incident new users, GLP-1 RA was protective against heart failure (adjHR Conclusions: When analyses were conducted only among incident new users, GLP-1 RA had a protective effect. However, among switchers from SU to GLP-1 RA, the effect estimates substantially shifted toward the null. Combining patients with varying treatment histories can result in poor confounding control and camouflage important heterogeneity.
MeSH term(s)	Humans ; Diabetes Mellitus, Type 2/epidemiology ; Sulfonylurea Compounds/therapeutic use ; Risk Factors ; Heart Failure/drug therapy ; Heart Failure/epidemiology ; Heart Failure/chemically induced ; Glucagon-Like Peptide 1/agonists ; Glucagon-Like Peptide-1 Receptor ; Hypoglycemic Agents/therapeutic use
Chemical Substances	Sulfonylurea Compounds ; Glucagon-Like Peptide 1 (89750-14-1) ; Glucagon-Like Peptide-1 Receptor ; Hypoglycemic Agents
Language	English
Publishing date	2024-04-04
Publishing country	England
Document type	Journal Article
ZDB-ID	1099748-9
ISSN	1099-1557 ; 1053-8569
ISSN (online)	1099-1557
ISSN	1053-8569
DOI	10.1002/pds.5790
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Article ; Online: Randomization versus Real-World Evidence.

Winterstein, Almut G / Girman, Cynthia J / Pottegård, Anton

The New England journal of medicine

2020 Volume 383, Issue 4, Page(s) e21

MeSH term(s)	Random Allocation ; Research Design
Language	English
Publishing date	2020-07-23
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc2020020
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Article: Risk of bias in non-randomized observational studies assessing the relationship between proton-pump inhibitors and adverse kidney outcomes: a systematic review.

Rajan, Pradeep / Iglay, Kristy / Rhodes, Thomas / Girman, Cynthia J / Bennett, Dimitri / Kalantar-Zadeh, Kamyar

Therapeutic advances in gastroenterology

2022 Volume 15, Page(s) 17562848221074183

Abstract: Background: Proton-pump inhibitors (PPIs) are widely prescribed as acid-suppression therapy. Some observational studies suggest that long-term use of PPIs is potentially associated with certain adverse kidney outcomes. We conducted a systematic ... ...

Abstract	Background: Proton-pump inhibitors (PPIs) are widely prescribed as acid-suppression therapy. Some observational studies suggest that long-term use of PPIs is potentially associated with certain adverse kidney outcomes. We conducted a systematic literature review to assess potential bias in non-randomized studies reporting on putative associations between PPIs and adverse kidney outcomes (acute kidney injury, acute interstitial nephritis, chronic interstitial nephritis, acute tubular necrosis, chronic kidney disease, and end-stage renal disease). Methods: We searched the medical literature within 10 years of 17 December 2020. Pre-specified criteria guided identification of relevant English language articles for assessment. Risk of bias on an outcome-specific basis was evaluated using the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tool by two independent reviewers. Results: Of 620 initially identified records, 26 studies met Conclusion: Using ROBINS-I, we found that non-randomized observational studies suggesting kidney harm by PPIs have moderate to serious risk of bias, making it challenging to establish causality. Additional high-quality, real-world evidence among generalizable populations are needed to better understand the relation between PPI treatment and acute and chronic kidney outcomes, accounting for the effects of varying durations of PPI treatment, self-treatment with over-the-counter PPIs, and potential critical confounders.
Language	English
Publishing date	2022-02-10
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2440710-0
ISSN	1756-2848 ; 1756-283X
ISSN (online)	1756-2848
ISSN	1756-283X
DOI	10.1177/17562848221074183
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Article ; Online: Treatment patterns and burden of myelosuppression for patients with small cell lung cancer: A SEER-medicare study.

Epstein, Robert S / Nelms, Jerrod / Moran, Donald / Girman, Cynthia / Huang, Huan / Chioda, Marc

Cancer treatment and research communications

2022 Volume 31, Page(s) 100555

Abstract: Purpose: To depict the treatment journey for patients with small cell lung cancer (SCLC) and evaluate health care resource utilization (HCRU) associated with myelosuppression, a complication induced by chemotherapy or chemotherapy plus radiation therapy. ...

Abstract	Purpose: To depict the treatment journey for patients with small cell lung cancer (SCLC) and evaluate health care resource utilization (HCRU) associated with myelosuppression, a complication induced by chemotherapy or chemotherapy plus radiation therapy. Patients and methods: This was a descriptive, retrospective study of patients with SCLC aged ≥65 years, identified from linked Surveillance, Epidemiology, and End Results (SEER)-Medicare data curated between January 2012 and December 2015. Treatment types (chemotherapy, radiation therapy, surgery) were classified as first, second, or third line, depending on the temporal sequence in which regimens were prescribed. For each year, the proportions of patients completing 4- or 6-cycle chemotherapy regimens, with hospital admissions associated with myelosuppression, or who used granulocyte colony-stimulating factors (G-CSFs), blood/platelet transfusions, or erythropoiesis-stimulating agents (ESAs), were calculated. Results: Chemotherapy was administered as initial treatment in 7,807/11,907 (65.6%) patients whose treatment journey was recorded. Approximately one-third (n = 3,985) subsequently received radiation therapy. In total, 5,791 (57.8%) patients completed the guideline-recommended 4-6 cycles of chemotherapy. Among all chemotherapy-treated patients, 10,370 (74.3%) experienced ≥1 inpatient admission associated with myelosuppression (anemia, 7,366 [52.8%]; neutropenia, 4,642 [33.3%]; thrombocytopenia, 2,375 [17.0%]; pancytopenia, 1,983 [14.2%]). Supportive care interventions included G-CSF (6,756 [48.4%] patients), ESAs (1,534 [11.0%]), and transfusions (3,674 [26.3%]). Conclusion: Chemotherapy remains a cornerstone of care for patients with SCLC. Slightly over half of patients completed the recommended number of cycles, underscoring the frailty of patients and aggressiveness of SCLC. HCRU associated with myelosuppression was prominent, suggesting a substantial burden on older patients with SCLC.
MeSH term(s)	Aged ; Granulocyte Colony-Stimulating Factor/adverse effects ; Humans ; Lung Neoplasms/drug therapy ; Medicare ; Neutropenia/chemically induced ; Neutropenia/drug therapy ; Retrospective Studies ; Small Cell Lung Carcinoma/drug therapy ; United States/epidemiology
Chemical Substances	Granulocyte Colony-Stimulating Factor (143011-72-7)
Language	English
Publishing date	2022-04-04
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2468-2942
ISSN (online)	2468-2942
DOI	10.1016/j.ctarc.2022.100555
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