Topic 8: The rise and fall of HRT : Topic 8: The rise and fall of HRT

Module: Epidemiology and Statistics

Topic 8

Topic 8: The rise and fall of HRT

Objectives

When you have completed the reading and participated in the taught components for this week, we hope you will be able to

Locate clinical trials in the hierarchy of evidence from quantitative research
Describe the practical and ethical issues involved in setting up a clinical trial
Interpret the clinical and statistical significance of the results of a clinical trial
Critically appraise a report of a clinical trial

Lecture

Randomised controlled trials are considered to provide some of the most persuasive evidence in favour of a healthcare innovation. Sometimes to the frustration of researchers, however, trials may fail to confirm the conclusions drawn from previous, observational studies, and may even reverse them. In illustrating this process, the lecture will also describe the unique elements that make up a randomised, controlled and blinded clinical trial, and the practical problems of designing and running trials.

Seminar

The seminar will offer students a practical introduction to trial design, and further experience interpreting the results from clinical trials. Tools and resources to help them critically appraise published reports of trials will also be used and discussed. See here for seminar instructions

Preparation for this week

Before the lecture

Read the two papers by Stampfer (1991) and Women’s Health Initiative investigators. (2002)

The set reading below provides you with reference material for the ideas covered in the lecture: you may want to look at this reading between the lecture and the seminar in order to consolidate these ideas.

Before the seminar

Read the papers by Hulley (1998) and Schulz (2010) and bring them with you to the seminar along with a copy of the CASP Checklist for appraising randomised controlled trials. We will not be providing paper copies in the seminar.

Set reading

BOOK CHAPTERS

Bland M (2000) An introduction to medical statistics (3^rd ed). OUP (Oxford) Chapters 2 (Check library availability)
Barker D, Cooper C, Rose G. Epidemiology in medical practice. (1998) Churchill Livingstone; 5th edition. Chapter 6 (Check library availability)

ACADEMIC PAPERS

Stampfer MJ et al. Postmenopausal estrogen therapy and cardiovascular disease: Ten year follow-up from the Nurses’ Health Study. New England J Med 1991;325:756-762 (Read it here)
Women’s Health Initiative investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women’s Health Initiative randomised controlled trial. JAMA 2002;288:321-333. (Read it here)
Hulley S et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. JAMA 1998;280:605-613 (read it here)
Schulz KF et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332 http://www.bmj.com/content/340/bmj.c332
(Read it here)
Critical Appraisal Skills Programme (CASP) Checklist for appraising randomised controlled trials http://www.casp-uk.net/wp-content/uploads/2011/11/CASP_RCT_Appraisal_Checklist_14oct10.pdf

Further reading