Medical Writing Statistics Study design made easy
mew-vol-25-no-3jpg

Volume 25, Issue 3 - Statistics

Study design made easy

Abstract

Analysis of statistical data is an important part of any medical writer’s skill set, especially those professionals working in publication and regulatory areas. Under - standing the various study designs is key to a thorough understanding of study methodology. Nevertheless, many medical writers come from a non-clinical background and have a knowledge gap when it comes to study design options. This article describes the main types of study design. Case report, cross sectional, case control, cohort, quasi experimental, randomised controlled trials, and systematic reviews and meta analyses studies are explained and their uses, advantages, and limitations discussed.

Download the full article

References

  1. Adami HO, Hunter D, Trichopoulos D, editors. Textbook of Cancer Epidemiology. 2nd ed. Oxford: Oxford University Press; 2009.
  2. dos Santos Silva I. Cancer Epidemiology: Principles and Methods. 1st ed. Lyon: IARC Press; 1999.
  3. Levin KA. Study design IV. Cohort studies. Evid Based Dent. 2003;7(2):51–2.
  4. Haynes B. Of studies, syntheses, synopses, summaries, and systems: the “5S” evolution of information services for evidence-based healthcare decisions. Evid Based Nurs. 2007;10(1):6–7.
  5. Levin KA. Study design III: Crosssectional studies. Evid Based Dent. 2006;7(1):24–5.
  6. Levin KA. Study design V. Casecontrol studies. Evid Based Dent. 2006;7(3):83–4.
  7. Schulz KF, Grimes DA. Case-control studies: research in reverse. Lancet. 2002;359(9304):431–4.
  8. Mortensen PB. Ambidirectional studies – an extension of longitudinal studies in psychiatry. Psychiatr Dev. 1988;6(2):173–81.
  9. Harris AD, Bradham DD, Baumgarten M, Zuckerman IH, Fink JC, Perencevich EN. The use and interpretation of quasi-experimental studies in infectious diseases. Clin Infect Dis. 2004;38(11):1586–91.
  10. Levin KA. Study design VII. Randomised controlled trials. Evid Based Dent. 2007;8(1):22–3.
  11. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.
  12. Wechsler ME, Kelley JM, Boyd IO, Dutile S, Marigowda G, Kirsch I, et al. Active albuterol or placebo, sham acupuncture, or no intervention in asthma. N Engl J Med. 2011;365(2):119–26.
  13. Friedman LM, Furberg CD, DeMets DL. Fundamentals of clinical trials. New York: Springer; 2010.
  14. Higgins J, Churchill R, Cumpston M, Chandler J, editors. Cochrane Handbook for Systematic Reviews of Interventions. Ver. 5.0.2. New Jersey: Wiley-Blackwell; 2008.
  15. Group TWHIS. Design of the Women’s Health Initiative clinical trial and observational study. Control Clin Trials. 1998;19(1):61–109.
  16. Grodstein F, Manson JE, Colditz GA, Willett WC, Speizer FE, Stampfer MJ. A prospective, observational study of postmenopausal hormone therapy and primary prevention of cardiovascular disease. Ann Intern Med. 2000;133(12):933–41.
  17. Grodstein F, Stampfer MJ, Manson JE, Colditz GA, Willett WC, Rosner B, et al. Postmenopausal estrogen and progestin use and the risk of cardiovascular disease. N Engl J Med. 1996;335(7):453–61.
  18. Hernán MA, Alonso A, Logan R, Grodstein F, Michels KB, Willett WC, et al. Observational studies analyzed like randomized experiments: an application to postmenopausal hormone therapy and coronary heart disease. Epidemiology. 2008; 19(6):766–79.

Search

Articles

Statistics for medical writers
President's Message
EMWA News
History of biostatistics
The illusion of certainty and the certainty of illusion
Never P alone: The value of estimates and confidence intervals
A medical writer's guide to meta-analysis
Study design made easy
Statistical analyses and methods in the published literature: The SAMPL guidelines
How to interpret and report the results from multivariable analyses
Biostatistics and medical writing: Synergy in preparing clinical trials documents
Best friends forever: A pattern of collaboration between medical writers and biostatisticians within the Russian CRO
Where have all the UK entry level pharmaceutical regulatory medical writing jobs gone?
News from the EMA
Journal Watch
In the Bookstores
The Webscout
Good Writing Practice
Medical Communications
Getting Your Foot in the Door
Lingua Franca and Beyond
Gained in Translation
Teaching Medical Writing
Profile: An interview with Professor Peter Jüni on methodology and statistics in scientific manuscripts
Out On Our Own

Member Login

Links

The Write Stuff Archive Contact Instructions for Authors Feature Article Template (Word) Journal Policies

Editoral Board

Editor-in-Chief:

Co-Editor:

Managing Editor

  • Victoria White (Tampa, Florida, USA)
show all +

Associate Editors:

Section Editors:

Ad-hoc Editors:

  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

Editor Emeritus: