Literature DB >> 29389330

Research Techniques Made Simple: Pharmacoepidemiology Research Methods in Dermatology.

Megan H Noe1, Joel M Gelfand2.   

Abstract

Clinical trials have several important limitations for evaluating the safety of new medications, leading to many adverse events not being identified until the postmarketing period. Descriptive studies, including case reports, case series, cross-sectional, and ecologic studies, help identify potential safety signals and generate hypotheses. Further research using analytic study methods, including case-control studies and cohort studies, are necessary to determine if an association truly exists and to better understand the potential for causation. Pharmacoepidemiology research examines the use and effects of drugs when used in large populations of patients, using a variety of study designs and biostatistical techniques to reduce the confounding and systematic error associated with observational research. Understanding the strengths and limitations of pharmacoepidemiology research techniques is necessary to interpret the validity of drug safety studies, guiding both individual patient decisions and broader public health decisions.
Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

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Year:  2018        PMID: 29389330      PMCID: PMC5798480          DOI: 10.1016/j.jid.2017.10.026

Source DB:  PubMed          Journal:  J Invest Dermatol        ISSN: 0022-202X            Impact factor:   8.551


  10 in total

Review 1.  CIOMS and ICH initiatives in pharmacovigilance and risk management: overview and implications.

Authors:  Panos Tsintis; Edith La Mache
Journal:  Drug Saf       Date:  2004       Impact factor: 5.606

2.  Sensitivity analysis and external adjustment for unmeasured confounders in epidemiologic database studies of therapeutics.

Authors:  Sebastian Schneeweiss
Journal:  Pharmacoepidemiol Drug Saf       Date:  2006-05       Impact factor: 2.890

3.  Alleged isotretinoin-associated inflammatory bowel disease: disproportionate reporting by attorneys to the Food and Drug Administration Adverse Event Reporting System.

Authors:  Derrick J Stobaugh; Parakkal Deepak; Eli D Ehrenpreis
Journal:  J Am Acad Dermatol       Date:  2013-05-14       Impact factor: 11.527

4.  Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals.

Authors:  Cassie Frank; David U Himmelstein; Steffie Woolhandler; David H Bor; Sidney M Wolfe; Orlaith Heymann; Leah Zallman; Karen E Lasser
Journal:  Health Aff (Millwood)       Date:  2014-08       Impact factor: 6.301

5.  Mini-Sentinel and regulatory science--big data rendered fit and functional.

Authors:  Bruce M Psaty; Alasdair M Breckenridge
Journal:  N Engl J Med       Date:  2014-06-05       Impact factor: 91.245

6.  Isotretinoin use and the risk of inflammatory bowel disease: a population-based cohort study.

Authors:  Raed O Alhusayen; David N Juurlink; Muhammad M Mamdani; Richard L Morrow; Neil H Shear; Colin R Dormuth
Journal:  J Invest Dermatol       Date:  2012-10-25       Impact factor: 8.551

7.  Cutaneous squamous-cell carcinoma in patients treated with PUVA.

Authors:  R S Stern; N Laird; J Melski; J A Parrish; T B Fitzpatrick; H L Bleich
Journal:  N Engl J Med       Date:  1984-05-03       Impact factor: 91.245

8.  Trends in Prescription Drug Use Among Adults in the United States From 1999-2012.

Authors:  Elizabeth D Kantor; Colin D Rehm; Jennifer S Haas; Andrew T Chan; Edward L Giovannucci
Journal:  JAMA       Date:  2015-11-03       Impact factor: 56.272

Review 9.  Adverse drug reactions: current issues and strategies for prevention and management.

Authors:  Teck K Khong; Donald R J Singer
Journal:  Expert Opin Pharmacother       Date:  2002-09       Impact factor: 3.889

Review 10.  Does exposure to isotretinoin increase the risk for the development of inflammatory bowel disease? A meta-analysis.

Authors:  Stephanie Y Lee; Mohammad M Jamal; Emily T Nguyen; Matthew L Bechtold; Douglas L Nguyen
Journal:  Eur J Gastroenterol Hepatol       Date:  2016-02       Impact factor: 2.566

  10 in total
  2 in total

1.  Commentary: Does biologic treatment of psoriasis lower the risk of cardiovascular events and mortality?: A critical question that we are only just beginning to answer.

Authors:  Joel M Gelfand
Journal:  J Am Acad Dermatol       Date:  2018-04-03       Impact factor: 11.527

2.  Approaches to Optimize Medication Data Analysis in Clinical Cohort Studies.

Authors:  Matthew S Duprey; John W Devlin; Becky A Briesacher; Thomas G Travison; John L Griffith; Sharon K Inouye
Journal:  J Am Geriatr Soc       Date:  2020-10-01       Impact factor: 5.562

  2 in total

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