Epidemiology Project

Criteria:

· Randomized Clinical trial, phase 3, Sample size > 300, Published in the last 3 years
· Search it on PubMed
· Disease condition of your choice
· Intervention can be drug, device, or health care provider delivered patient education intervention
· Should be efficacy/effectiveness type of trial, and NOT cost-economics type of study
· See template – (*)- if no info is available on these 2 items, say N/A
· Be concise. Use bullet points. Stay focused on the main points and issues with the paper.
· Use more /fewer bullet point in the template as needed
· Do not exceed 2 pages of text/in the template above. If graph or diagram- you can add it on 3rd page, but no text on the 3rd page.
· Give enough details in the template so that I can understand the main things about the paper. I am more interested in how you interpret the results. Show your thinking. Even if it is not perfect, thinking is always better than no-thinking. I will not grade on perfection. I will grade on effort put to understand and think stuff through.
· You need to put the PubMed ID number so I can easily find the paper. If I do not have the PubMed ID number, I will not be able to invest time to find it and I will not be able to grade your assignment.

FIRST name

LAST name

PUBMED ID

Article Citation ( title, authors, journal, publication date)

Clinicaltrials.gov registration number*

Funding source *

Why the study was done/ Why was it important to be done?

Study question (s) ( primary, secondary)

· Z
· Z
· Z

Design ( be specific, what type of RCT)

·

P

· Z
· Z
· Z

I

· Z
· Z
· Z
· Z

C

· Z
· Z
· Z
· Z

O

· Z
· Z
· Z
· Z

Statistical methods (main methods done and why/what is each method good for?

· Z
· Z
· Z
· Z
· Z

Efficacy Results: for primary, secondary endpoints, actual absolute incidence, RD, RR (HR), NNT,95% CI

· Z
· Z
· Z
· Z

Additional info if needed- May include main graph, PP analysis, sensitivity analysis, subgrp.analysis, etc.

Safety results (if paper has any, if not- comment what w’d you want to see in terms of safety

· Z

·

Discuss biases- any issues with the methods, biases, selection bias, information bias, type of analysis, anything missing from reporting, anything dubious. Discuss. Go beyond what the authors say are their paper’s ‘limitations’ . Include both INTERNAL and EXTERNAL validity issues

· Z
· Z
· Z
· Z
· Z
· Z
· Z
· Z

Your verdict: on a scale from 0-100, where 0 is no confidence at all and 100 as much confidence as possible, how confident are you that the study is good quality/ you can trust the results

· Z

You may add a visual you did yourself- to diagram the study – so that it’s easy to understand what the design was

1