Rofecoxib Case
Introduction
1. Is the reason for conducting the study discussed?
Yes. Three years of treatment with rofecoxib would reduce the risk of recurrent adenomatous polyps among patients with a history of colorectal adenomas.
2. Are the study objectives clearly defined?
Yes. Limited long-term data was available for analyzing the increased risk of thrombotic events associated with the use of COX-2 inhibitors so this was designed to be a long-term study (3 years of treatment plus follow-up).
3. Is the null hypothesis clear?
No. I don’t believe there was a null hypothesis. The study was designed to test a research hypothesis.
Methodology
For each of the following questions, access how this might influence the results or affect the validity of the study
Selection bias
Have adequate measures …show more content…
In general, what are the study’s strengths and weaknesses?
The study’s strength is that it acknowledges an increase in cardiovascular events and displays it well in graphs and tables. However, the study’s blatant sponsorship and investigator bias reflects a conflict of interest. Merck withdrew rofecoxib from the market shortly after this study was published and had to have known about its effects long before then.
Does the study have internal validity?
Yes, the study has internal validity because it can be concluded that there is a cause and effect between rofecoxib use and an increase in cardiovascular risk.
Does the study have external validity? Is it relevant to your problem/situation/practice?
The study does not have external validity because of the past medical history of the patients involved. They had a history of colorectal adenoma and the study didn’t specify the severity of disease. The study is relevant to pharmacy practice because rofecoxib was subsequently pulled from the market. As pharmacists, if the risks of a drug far outweighs its benefits then it doesn’t make sense to dispense
1. Is the reason for conducting the study discussed?
Yes. Three years of treatment with rofecoxib would reduce the risk of recurrent adenomatous polyps among patients with a history of colorectal adenomas.
2. Are the study objectives clearly defined?
Yes. Limited long-term data was available for analyzing the increased risk of thrombotic events associated with the use of COX-2 inhibitors so this was designed to be a long-term study (3 years of treatment plus follow-up).
3. Is the null hypothesis clear?
No. I don’t believe there was a null hypothesis. The study was designed to test a research hypothesis.
Methodology
For each of the following questions, access how this might influence the results or affect the validity of the study
Selection bias
Have adequate measures …show more content…
In general, what are the study’s strengths and weaknesses?
The study’s strength is that it acknowledges an increase in cardiovascular events and displays it well in graphs and tables. However, the study’s blatant sponsorship and investigator bias reflects a conflict of interest. Merck withdrew rofecoxib from the market shortly after this study was published and had to have known about its effects long before then.
Does the study have internal validity?
Yes, the study has internal validity because it can be concluded that there is a cause and effect between rofecoxib use and an increase in cardiovascular risk.
Does the study have external validity? Is it relevant to your problem/situation/practice?
The study does not have external validity because of the past medical history of the patients involved. They had a history of colorectal adenoma and the study didn’t specify the severity of disease. The study is relevant to pharmacy practice because rofecoxib was subsequently pulled from the market. As pharmacists, if the risks of a drug far outweighs its benefits then it doesn’t make sense to dispense