Answer the following questions using the study from the NEJM provided. Describe

Answer the following questions using the study from the NEJM provided.

Describe the extended Glasgow outcome scale (GOSE)? [4]

The investigators used the GOSE tool as their key outcome measure in this study – list two limitations in their approach. [2]

List the key selection criteria for this trial. [6]


What is blinding in a study? [1]

What level of blinding was used in this study? [1]

What is a potential risk of the approach taken by the investigators? [1]

List three issues around the consenting process this study. [3]

List four potential ethical considerations in planning this study. [4]

Give two benefits and two limitations of having a multicentre study. [4] 13.

What is bias? [1]

Give a potential example of bias in the study design. [1]

What is the role of the steering committee? [1]


What is the internal validity? [2]

List 3 things that can improve internal validity in a study. [3]

List 3 things that can have a negative impact validity of the study. [3]

List five specific exclusion criteria listed in the protocol. [5]

Why was the study recruitment discontinued? [3]

Discuss what is meant by an open-label pragmatic study design. [6]

Discuss whether you would support using therapeutic hypothermia is this case. Give reasons for your decision. [10]

You have been asked to provide an opinion of whether the hospital you work at (in the case if you work in pre-hospital care choose one which is close to you) would have the capacity to participate in this study. Limit your answer to no more than 250 words and explain your answer with examples supporting your decision and what your resources would need to run this study. For this exercise make the assumption that your hospital does accept this category of patients. [10]