Endpoints and Outcomes

September 13 Lecture Slides – Jordan A. Kempker, MD, MSc

Endpoint Library – I compiled a library of references pertaining to Endpoints and Outcomes that you may or may not find interesting for further reading.

National Death Index – This branch of the National Center or Health Statistic’s National Vital Statistics System provides a fee-based service for investigators to help them determine the vital status of study participants.

Social Security Death Index – The Social Security Administration also provides vital status information for health service researchers.

Proposed steps in using a causal framework diagram for your study hypothesis to develop study outcomes/endpoints array.  (disclaimer: this is my own anecdotal method.  There may be better ways)

1.Draw causal diagram from intervention to most final outcome

2.Include as many intermediate causal steps, surrogate measures, intermediate outcomes as possible

3.Include any potential adverse outcomes, competing events…

4.Consider and annotate what’s fea$ible, measurable and reliable

5.Consider what outcomes are important to patients (consider consulting professional societies)

6.Select primary outcome

7.Secondary outcomes may be competing events, adverse events and/or intermediate steps in the causal pathway.