Critical analysis of the “Dexmedetomidine or Propofol for Sedation in Mechanically Ventilated Adults with Sepsis” study.

Critical analysis of the “Dexmedetomidine or Propofol for Sedation in Mechanically Ventilated Adults with Sepsis” study.
This assignment is worth 60 points—6 points per question.

Case:
Your clinical facility currently uses primarily propofol for sedation of critically ill patients. A study published in The New England Journal of Medicine in February 2021 compared the use of dexmedetomidine vs propofol for light sedation in mechanically ventilated patients with sepsis as dexmedetomidine has some anti-inflammatory effects. You have been selected as the person to see what the evidence supports and to make a recommendation.

Here is the PICO/Clinical Question based on this scenario:
P/population/problem: ventilated adults with sepsis
I/Intervention: light sedation with dexmedetomidine
C/comparison: propofol
O/outcome: improved patient outcomes, such as days alive without delirium or ventilator free days
PICO/Clinical Question: In mechanically ventilated adults with sepsis, does light sedation with dexmedetomidine or propofol lead to better outcomes such as days alive without delirium/coma or ventilator free days?

Use the MAARIE framework questions below to evaluate the study and generate an answer for your facility.

Method- The purpose and population for the investigation
1. Study population What specific population is being investigated and what are the inclusion and exclusion criteria for the subjects of the investigation? Your answer should NOT include information about the randomization process.
Assignment- Selection of participants for the study and control groups

2. Masking/blinding
Are the participants and/or the investigators aware of the participants’ assignment to a particular study or control group? If the groups aren’t blinded look for some statement about an independent reviewer or group of reviewers who will evaluate the data collected by the study. It is not simply enough to answer this is a double-blind study (for example)—provide evidence (more than just “the authors say”) to support your answer.
Assessment- Measurement of outcomes or endpoints in the study and control groups

3. Accurate and precise
How will the outcomes selected be accurately and precisely measured? Remember that the focus of this question in the MAARIE framework is to identify the process that will be used to accurately and precisely measure the selected outcomes. A correct answer will include specific descriptions about HOW the primary and secondary outcomes will be measured. In other words, the focus of your answer should not be listing the outcomes.
Results – Comparison of outcomes in the study and control groups
This statement is from page 5 of this study: “Similarly, we found no significant differences between the dexmedetomidine and propofol groups in the number of deaths at 90 days (81 patients [38%] vs. 82 patients [39%]; hazard ratio, 1.06; 95% CI, 0.74 to 1.52).

4. Explain what a hazard ratio (HR) of 1.06 means specific to this study’s results.
To answer this question do more than just “generically” explain what a HR of 1.06 means — explain it in the context of this study.

5. What is the correct interpretation of the CI of 0.74-1.52 in the statement above? When answering this question:
a) Demonstrate that you understand what a 95% CI means,
b) evaluate whether the CI range include the value of no effect/no difference and let me know you understand if zero or one is the value of no effect,
c) Explain what a CI of 0.74-1.52 means – what does this specifically mean in the context of this study?
d) The authors did not report a p-value for the CI range of 0.74-1.52. If the p-value was reported, would it be greater than (>) 0.05 or less than (<) 0.05? Explain. e) State whether the result is clinically significant. Explain NOTE: When answering questions four and five it would be wise to review the feedback from the Week Three assignment. 6. Some of the results in this study were adjusted. List three of the factors that the results in this study were adjusted for and explain “adjustment” to me. The Week Three assignment document explains adjustment. Hint: search the study supplement for a statement “adjusted for the following…” Extrapolation – Meaning for those not included in the investigation 7. To similar individuals, groups or populations: The authors should not discuss extending the conclusions to individuals, groups, or populations that are different than those who participated in the investigation. Do they? Provide at least one example and tell me why you think that example demonstrates extrapolating to similar or different individuals, groups or populations. 8. Subgroups: Are the outcomes observed in subgroups within the investigation different from outcomes observed in the overall investigation? Look for pre-specified groups or groups that emerged when the numbers were crunched. Watching this week’s video lecture will help you answer this question. Hint: sometimes the best place to look for answers to this question are in the discussion section of a study or in the study supplement. 9. Cost: To the best of your ability, determine whether the study results justify the cost of the intervention. Remember, this question is NOT ASKING ABOUT THE COST OF PERFORMING THE STUDY rather, is there an additional cost or cost savings if we implement what this study shows is best? Use your understanding and knowledge, ask at your facility, or conduct a Google search to estimate cost. Most of the newer studies (but not all) that are published will include this information in the discussion section of their study. 10. Reread the scenario at the beginning of this document and then answer the PICO question? NOTE: This question is NOT asking you to create a PICO question; rather you are asked to ANSWER the PICO question that is posted with the introductory scenario on page one of this document.