CFCWP Spironolactone Use in Patients With Heart Failure

CFCWP Spironolactone Use in Patients With Heart Failure essay assignment

CFCWP Spironolactone Use in Patients With Heart Failure essay assignment

  1. Study Overview
  2. Title
  3. Authors (AMA format)
  4. Citation (AMA format)
  5. Funding
  6. Background
  7. What is this drug/condition? Explain the pathophysiology of the condition and the mechanism of the drugs involved.

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  1. Relevance (Why do we care about this trial? How will this help anyone?)
  2. One (1) relevant trial – Name and discuss two relevant clinical trials that validate the purpose of the study and/or expand on current clinical practice. Briefly discuss the primary outcome, treatment groups, study design/methods, conclusion, and your interpretation of why this information is important to your journal club presentation
  1. What gap is this study covering?

iii. Why is this study important/relevant? (This would improve care by…)

  1. Recommendations of current practice guidelines
  2. Objective/Purpose – What is the purpose of this study and what are the

authors trying to prove?

III. Methods

  1. Trial design (please know exactly how to describe your design)
  2. Location – centers, countries, populations
  3. IRB Approval
  4. Inclusion Criteria – the people that were included in the study
  5. Exclusion Criteria – the things that KICKED OUT the people that were

included. This is NOT just the opposite of the study.

  1. If the inclusion criteria for a pregnancy study is pregnant women, the

exclusion is NOT men. The exclusion would be something that would “kick

out” an included pregnant woman…such as a pregnant woman with

hypertension.

  1. Subjects – who was originally target for the study
  2. Primary endpoint(s)
  3. Secondary endpoint(s)
  4. Follow up – After initial treatment, what periods of time did we check in?
  5. Duration
  6. Populations (baseline characteristics)
  7. Arms (what treatment/control groups are present)
  8. Statistical test (what test did they use and was it correct?)
  9. Results
  10. Primary endpoint(s) – Include percentages, CI, P value etc.
  11. Secondary endpoint(s) – Include percentages, CI, P value etc.
  12. Adverse events – include percent, frequency, etc.
  13. Conclusion
  14. Author’s conclusion – what did the author conclude or think about the study
  15. Study goal met – was the original objective met? (go back to

purpose/objective)

  1. Strengths/Weaknesses (“Detailed” Critiques) – this is one of the most important sections.

Some critiques (such as population size, funding by company and number of participants)

are “surface” critiques and don’t require much study. More “detailed” critiques include

issues that you found based on additional analyzation and research. You must include at

least 3 “detailed” critiques and a few examples are found below. However, please be

prepared to answer questions regarding the study as it relates to strengths/weaknesses.

  1. Was the study design the most appropriate?
  2. Did the population/region match the condition? (i.e. 3% black population in Type

II DM trial)

  1. Did the trial meet their goal?
  2. Was the data misleading?
  3. What should have been improved in the methods? (i.e. Was this a lipid based trial

testing a PSCK9 inhibitor in patients that were NOT on high dose statins? Why not let

them max out a statin 1st?)

  1. Did they use the right statistical analysis?
  2. Did the study contradict current practice or further clinical practice
  3. It the conclusion of the trial statistically and clinically significant? (i.e. the new

blood pressure med that proves superiority over ACEI but only lowers BP by

4mmHg)

  1. Can the drug be afforded? (sure Hepatitis C meds are curing, but the cost is

$84,000 for the full regimen. Is it practical?)

  1. Efficacy compared to new drugs. (When Edoxoban came out for

Anticoagulation, what benefit did it have over Xarelto, Apixaban, or

Dabigatran?)

  1. Funding – is the source of the funding questionable?

VII. Further study

  1. How could this study be furthered or improved in any way? (i.e. now that this new

drug has come to market, in the future it would be good to have a head to head trial

with this drug and the standard of care/guideline based therapy.)

VIII. References (in AMA format on the last slide and in text references on each slide)

Formatting

Journal Club (PowerPoint)

  • References on each slide – When applicable, references should be listed at the

bottom of every slide (in AMA format). For example, if you refer to a specific trial,

you should include the citation based on AMA format.