Clarifying the causal contrast: An empirical example applying the prevalent new user study design.

Autor: Young JC; Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.; Real World Evidence & Patient Outcomes, CERobs Consulting, LLC, Wrightsville Beach, North Carolina, USA.; Unit of Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden., Webster-Clark M; Real World Evidence & Patient Outcomes, CERobs Consulting, LLC, Wrightsville Beach, North Carolina, USA.; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.; McGill University Department of Biostatistics, Epidemiology, and Occupational Health, Quebec, Canada., Shmuel S; Real World Evidence & Patient Outcomes, CERobs Consulting, LLC, Wrightsville Beach, North Carolina, USA.; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA., Garry EM; Scientific Research, Aetion, Inc., New York, New York, USA., Mavros P; KREDHERA, LLC, Hampton, New Jersey, USA.; Janssen Scientific Affairs, Janssen Pharmaceutical Companies of J&J, Titusville, New Jersey, USA., Stürmer T; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA., Girman CJ; Real World Evidence & Patient Outcomes, CERobs Consulting, LLC, Wrightsville Beach, North Carolina, USA.; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

Publikováno v: Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2024 Apr; Vol. 33 (4), pp. e5790.

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?

Autor: Rosen EM; Department of Epidemiology, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA; CERobs Consulting, LLC, Wrightsville Beach, North Carolina, USA., Ritchey ME; CERobs Consulting, LLC, Wrightsville Beach, North Carolina, USA; Med Tech Epi, LLC; Philadelphia, Pennsylvania, USA; Center for Pharmacoepidemiology & Treatment Science, Rutgers University, New Brunswick, New Jersey, USA., Girman CJ; Department of Epidemiology, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA; CERobs Consulting, LLC, Wrightsville Beach, North Carolina, USA. Electronic address: Cindy.girman@cerobs.com.

Publikováno v: Clinical therapeutics [Clin Ther] 2023 Dec; Vol. 45 (12), pp. 1266-1276. Date of Electronic Publication: 2023 Oct 03.

Assessment of Codispensing Patterns of Mirabegron and Prespecified CYP2D6 Substrates in Patients with Overactive Bladder.

Autor: Wang J; Sumitovant Biopharma, Inc, New York, NY, USA., Ritchey ME; CERobs Consulting, LLC, Chapel Hill, NC, USA., Reynolds K; CERobs Consulting, LLC, Chapel Hill, NC, USA.; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA., Carbonneau M; Sumitovant Biopharma, Inc, New York, NY, USA.; Roivant Sciences, New York, NY, USA., Carrera A; Urovant Sciences, 5281 California Ave, Suite 100, Irvine, CA, 92617, USA. adam.carrera@urovant.com., Goti N; Urovant Sciences, 5281 California Ave, Suite 100, Irvine, CA, 92617, USA., Horn JR; Department of Pharmacy, School of Pharmacy, University of Washington, Seattle, WA, USA., Girman CJ; CERobs Consulting, LLC, Chapel Hill, NC, USA.

Publikováno v: Drugs - real world outcomes [Drugs Real World Outcomes] 2023 Sep; Vol. 10 (3), pp. 439-446. Date of Electronic Publication: 2023 May 23.

CYP2D6 Substrate Dispensing Among Patients Dispensed Mirabegron: An Administrative Claims Analysis.

Autor: Ritchey ME; CERobs Consulting, LLC, Chapel Hill, NC, USA., Wang J; Sumitovant Biopharma, Inc, New York, NY, USA., Young JC; CERobs Consulting, LLC, Chapel Hill, NC, USA., Chandra R; Sumitovant Biopharma, Inc, New York, NY, USA., Carrera A; Urovant Sciences, 5281 California Ave, Suite 100, Irvine, CA, 92617, USA. adam.carrera@urovant.com., Goti N; Urovant Sciences, 5281 California Ave, Suite 100, Irvine, CA, 92617, USA., Horn JR; Department of Pharmacy, School of Pharmacy, University of Washington, Seattle, WA, USA., Girman CJ; CERobs Consulting, LLC, Chapel Hill, NC, USA.

Publikováno v: Drugs - real world outcomes [Drugs Real World Outcomes] 2023 Mar; Vol. 10 (1), pp. 119-129. Date of Electronic Publication: 2022 Dec 02.

Risk of bias in non-randomized observational studies assessing the relationship between proton-pump inhibitors and adverse kidney outcomes: a systematic review.

Autor: Rajan P; CERobs Consulting, LLC, 2612 N Lumina Beach, Wrightsville Beach, NC, USA., Iglay K; CERobs Consulting, LLC, Wrightsville Beach, NC, USA., Rhodes T; CERobs Consulting, LLC, Wrightsville Beach, NC, USA., Girman CJ; CERobs Consulting, LLC, Wrightsville Beach, NC, USA., Bennett D; Global Evidence and Outcomes, Takeda Pharmaceuticals USA, Inc., Cambridge, MA, USA., Kalantar-Zadeh K; Division of Nephrology, Hypertension & Kidney Transplantation, School of Medicine, University of California, Irvine, Irvine, CA, USA.

Publikováno v: Therapeutic advances in gastroenterology [Therap Adv Gastroenterol] 2022 Feb 10; Vol. 15, pp. 17562848221074183. Date of Electronic Publication: 2022 Feb 10 (Print Publication: 2022).