Get started on a new research project by bouncing ideas off of colleagues, mentors, and reviewing the literature to see what has already been completed. Identify gaps in the literature that could be filled by the proposed study.
Prior to your initial meeting with an SDBC collaborator, prepare a few relevant articles or examples of existing measures/surveys from your literature review and ideas on some of the following study design aspects:
- Develop your research question(s) and corresponding hypotheses – See Study Design Resources below
- Study design – Experimental or observational? Prospective or retrospective? Survey or focus group?
- Inclusion/exclusion criteria
- Sample size availability
- Potential outcome and predictor variables
- Major outcome variable(s): For example, a primary outcome could be mortality, secondary could be complications and/or adverse events.
- Major predictor/grouping variable(s): For example, Cases vs. Controls, Treatment A vs. Treatment B.
- Potential confounders: Variables associated with both predictor and outcome variable of interest. For example, age and time since procedure.
- Potential effect modifiers: Variables that exhibit different associations with the outcome within different strata of a predictor variable (i.e., variables that exhibit significant interactions with your predictor variable). For example, hip fractures are more common in young males (via trauma) than young females, but elderly females have a higher risk of hip fracture (due to osteoporosis) than elderly males. Thus the relationship between sex and hip fracture is modified by age (Methods in Observational Epidemiology, Kelsey, et al second edition).
Study Design Resources
Why Do You Need a Biostatistician?
- Why do you need a biostatistician? Zapf A, Rauch G, Kieser M. BMC Med Res Methodol. 2020 Feb 5;20(1):23. doi: 10.1186/s12874-020-0916-4.
Developing Your Research Question
- Evolve: Resources for Nursing Research, 8th Edition, Chapter 2 "Research Questions, Hypotheses and Clinical Questions" By Geri LoBiondo-Wood and Judith Haber
- Developing Hypothesis & Research Questions By Shalini Prasad, Ajith Rao, Eeshoo Rehani
Observational Studies Guidelines
- Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration. PLoS Med. 2007;4(10):e297.
- Standards for Reporting of Diagnostic Accuracy (STARD)
- REporting recommendations for tumour MARKer prognostic studies (REMARK)
- Reporting of Genetic Association Studies (STREGA)
- Reporting Meta Analyses (MOOSE)
Experimental Study Guidelines
- Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA. 1996 Aug 28;276(8):637-9
- Reporting of Noninferiority and Equivalence Randomized Trials: An Extension of the CONSORT Statement. JAMA. 2006 Mar 8;295(10):1152-60.
- Reporting of Noninferiority and Equivalence Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA. 2012 Dec 26;308(24):2594-604.
- Improving the quality of reports of meta-analyses of randomized controlled trials: the QUOROM statement. QUOROM Group. Br J Surg. 2000 Nov;87(11):1448-54.
Study Design/Statistics Training - Lancet & BMJ
Study Quality Assessment Tools
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Acknowledging the SDBC
Please use the following text to acknowledge the CTSI Study Design and Biostatistics Center:
"This investigation was supported by Translational Research: Implementation, Analysis and Design (TRIAD), with funding in part from the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UM1TR004409. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health."
"This investigation was supported by the Study Design and Biostatistics Center (SDBC), with funding in part from the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UM1TR004409. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health."