Version 2021-2022

Before starting, general considerations to be taken into account

Schwab, Simon, et al. “Ten Simple Rules in Good Research Practice for Early Career Researchers.” OSF Preprints, 27 Nov. 2021. Web.s

Should we do this research, and if so, how do we do it?

Emanuel EJ, Wendler D and Grady C (2000) What makes clinical research ethical? JAMA: the journal of the American Medical Association 283(20): 2701–2711. 

Lecture Ethics in Biomedical Research Playlist

Is all medical research important?

Chalmers I, Bracken MB, Djulbegovic B, et al. (2014) How to increase value and reduce waste when research priorities are set. The Lancet 383(9912): 156–165.

Macleod MR, Michie S, Roberts I, et al. (2014) Biomedical research: increasing value, reducing waste. The Lancet 383(9912): 101–104.

What are the types of research designs for answering questions in medicine?

Grimes DA and Schulz KF (2002) 01 An overview of clinical research: the lay of the land. The Lancet 359(9300): 57–61.

What are the key concepts for understanding the design and interpretation of medical studies?

Levin KA (2005) Study design II. Issues of chance, bias, confounding and contamination. Evidence-based dentistry 6(4): 102–103.

Balevi B and Abt E (n.d.) Statistics Tutorial Part II: Statistical and Clinical Significance.paperpile.com/app/p/82a084ca-4245-0bf3-ad9e-11cff63e259b

What are observational designs and what are they for?

Grimes DA and Schulz KF (2002) 02 Descriptive studies: what they can and cannot do. The Lancet 359(9301): 145–149.

Grimes DA and Schulz KF (2002a) 03 Bias and causal associations in observational research. The Lancet 359(9302): 248–252.

Grimes DA and Schulz KF (2002b) 04 Cohort studies: marching towards outcomes. The Lancet 359(9303): 341–345.

Schulz KF and Grimes DA (2002) 05 Case-control studies: research in reverse. The Lancet 359(9304): 431–434.

Grimes DA and Schulz KF (04/2005) 06 Compared to what? Finding controls for case-control studies. The Lancet 365(9468): 1429–1433.

What are experimental designs and what are they for?

Hulley (2013) Hulley Chapters 1 & 2. In: Hulley S: Cummings S: Browner W: Grady D: Newman T (ed.) Designing Clinical Research, pp. v–vi.

Farrugia P, Petrisor BA, Farrokhyar F, et al. (2010) Research questions, hypotheses and objectives. Canadian journal of surgery. Journal canadien de chirurgie 53(4): 278.

Pihlstrom BL and Barnett ML (2010) Design, operation, and interpretation of clinical trials. Journal of Dental Research 89(8): 759–772.

Braga LHP, Farrokhyar F and Bhandari M (2012) Practical Tips for Surgical Research: Confounding: What is it and how do we deal with it? Canadian journal of surgery. Journal canadien de chirurgie 55(2): 132.

Karanicolas PJ, Farrokhyar F and Bhandari M (2010) Blinding: Who, what, when, why, how? Canadian journal of surgery. Journal canadien de chirurgie 53(5): 345.

Pilot Studies: What are clinical pilot studies for?

Why does this treatment work in some patients only? 

Redekop WK and Mladsi D (2013) The faces of personalized medicine: a framework for understanding its meaning and scope. Value in health: the journal of the International Society for Pharmacoeconomics and Outcomes Research 16(6 Suppl): S4–9.

Glasziou PP and Irwig LM (1995) An evidence based approach to individualising treatment. BMJ 311(7016): 1356–1359.

What care should I take when entering and managing data in a clinical investigation?

Broman, K.W., Woo, K.H., 2018. Data Organization in Spreadsheets. Am. Stat. 72, 2–10. 

Wilkinson et al., 2016. The FAIR Guiding Principles for scientific data management and stewardship. Sci Data 3, 160018.

How should I report the results of studies in general?

Brooke BS, Ghaferi AA and Kibbe MR (2021) Effective Use of Reporting Guidelines to Improve the Quality of Surgical Research. JAMA surgery. DOI: 10.1001/jamasurg.2021.0519.

Dodson TB (2007) A guide for preparing a patient-oriented research manuscript. Oral surgery, oral medicine, oral pathology, oral radiology, and endodontics 104(3): 307–315.

What are the minimum elements that a clinical study report should have?

Moher D, Hopewell S, Schulz KF, et al. (2010) CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 340: c869.