1. Did the study address a clearly focused issue?
Yes. The study focused on the effectiveness of Vancomycin and Metronidazole by using a sample population of 47, 471 patients. This is a good number to conduct a drug trial test because it widens the scope of the research and is not affected by inconsistencies and errors caused by selection bias. The research can also be termed as focused as the patients used were suffering from Clostridium difficile infection, and the drug in the trial has been historically considered the first-line therapy for the same.
2. Was the cohort recruited in an acceptable way?
Yes. The recruitment of patients to be used for the cohort were the best choice; ones infected with Clostridium difficile toxins. However, the cohort could have been advanced by including healthy individuals who have a history of Clostridium difficile infection and interviewing them to find out about their diagnosis, treatment, and prognosis.
3. Was the exposure accurately measured to minimize bias?
Yes. The exposure had a relevant degree of accuracy. The measurements were objective and not subjective. This means that the figures and results indicated were based on facts as opposed to insinuation and trends. From the total of 47,471 patients used for the study, there were proportionately divided into two groups: ones treated with Vancomycin and those treated with Metronidazole to avoid errors in results. To further enhance the accuracy of exposure, sub cohorts were conducted using patients with mild to moderate disease to validate and back up the findings of the primary study.
4. Was the outcome accurately measured to minimize bias?
Yes. The measurements and subsequent outcomes were not manipulated in any way such as the use of prior research and trends. From the introduction of the research and statistics, the study showed that there was no significant difference in cure rates between the two drugs. Prior clinical trials seconded these findings and statistics. The research concluded the same meaning that there was minimal bias if any on the measures and outcomes.
5. (A) Have the authors identified all important confounding factors?
No. Although the authors used a retrospective study design that incorporated most of the significant factors, they missed out on some.
List the ones you think might be substantial, that the author missed.
Underlying diseases that the patients could have had.
If the patients were under any other form of medication
(B) Have they taken into account of the confounding factors in the design and analysis?
No. The research does not give any allowance for those confounding factors stated above. What is worse is that they assume that their study patients to have no underlying diseases and not to be under any other medication. This could be a relevant assumption had it been with a small study population, but for 47,471 patients, it is not advisable.
6. (A) Was the follow-up of the subjects complete enough?
Yes. The follow up on the subjects was good as the study accounts for all the patients it started with. This is a good sign as some of the researches tend to drop some of their subjects along the way.
(B) Was the follow-up of the subjects long enough?
No. 30 days is not enough to evaluate the prognosis of a disease like Clostridium difficile infection. The follow-up does not take into consideration of cases of latency.
Section B What are the Results?
7. What are the results of this study?
The study came to a conclusion that there is no difference in the effectiveness of the two drugs. Whenever each drug was taken, there were similar recurrence rates. However, the drugs did reduce a recurrence rate in the short term; 30 days. The research also vouched for Vancomycin as the preferred drug for the treatment of CDI.
8. How precise are the results?
The results are entirely accurate. First, because the findings of the research do not differ much with original researches and this is a positive sign. Secondly, the ranges of the cohort results are not wide to bring any suspicious doubt in the authenticity, validity, and reliability of the results. For instance, the recurrence rate for the full cohort was 95% with a deviation of roughly 0.87 to 1.10. This small variation is evidence of precision.
9. Do you believe the results?
Yes, I do. The results are valid because they account for every patient that the research began with. The methods used to collect the results and assess the patients are also very scientific and specific. The retrospective design employed by this research is also very detailed and covers most of the areas of interest paying attention to detail.
Section C Will The Results Help Locally?
10. Can the results be applied to the local population?
Yes. The results are very much applicable to the local population. Based on the fact that the subject population was derived from the local population, it means that all other factors constant, they are likely to follow the same prognosis and disease progression. Clostridium difficile infection is a bacterial infection, and most bacterial infections follow a similar disease progression trajectory. Genetic factors hardly play a role in bacterial infections meaning that the same condition is likely to exhibit similar characteristics in different patients.
11. Do the results of this study fit with other evidence?
Yes, they do. The evidence from prior studies concerning the same indicates that both Vancomycin and Metronidazole are affiliated with the recurrence of Clostridium difficile infection. At the beginning of the research, the author stated statistics that in the year 2011, about 450,000 people were infected with CDI and 83,000 had a recurrence of the disease. The research confirms this by concluding that neither Vancomycin nor Metronidazole can prevent a recurrence of CDI.
12. What are the implications of this study for practice?
The implications of this study is that health care providers should explore other options to prevent the recurrence of CDI among its patients. The fact that Vancomycin and Metronidazole cannot effectively prevent a recurrence should automatically rule them out of the treatment options.
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