Clearly, randomization is crucial to eliminate certain bias and have an accurate trial.
6. Explain how the intervention(s) in the treatment arm differed from how participants in the control arm were treated. In other words, what is the trial testing?
Participants in the treatment arm were given 12.5 milligram Zinc Sulfate, whereas the participants in the control arm were given a placebo. The trial is testing whether Zinc Sulfate is beneficial to children who have Malaria or not.
7. Was the trial single- or double-blinded or neither? Report evidence of assignment rejection or contamination. Indicate why this is an important issue.
The trial was double blinded, so neither participants nor health staff knew who was in the treatment and control group. There was no sign of contamination or assignment rejection states by the authors. Contamination occurs when the blinding in the trial is broken; however, there was no actions recorded by the authors on the double blinding process. Because it was double blinded, it was probably harder to understand which group people are in. Also, the subjects are kids who are six to thirty months old, so it is unlikely that their parents would try to break the contamination. The authors also mentioned that they believed there was no mixing up of drugs and placebo by the health workers because they were trained well. Also, another proof can be that the treatment group had a significant increase on Zinc in their blood while the control group did not have any significant change in the Zinc level. 8. Was a placebo used? How effective was the placebo in maintaining blinding? In other words, how good was the placebo (which means you have to know what a good placebo is)? A placebo was used for the control group. It is stated that the placebo looked exactly like the Zinc supplement in shape and taste. I believe it was good that placebo could not be differentiated by the patients or the medical staff because it was identical to the Zinc supplement. It is important that a person looking at the drug can not differentiate whether it is the real drug or the placebo because it would lead to a contamination of the study. 9. Evaluate loss to follow up. Indicate why this is an important issue. It is stated that loss to follow up was insignificantly low for the trial. …show more content…
When the sample size of seven hundred twenty was calculated by the researchers, they gave room for a 20% loss to follow up, so they already assumed that there would be people who do not keep up with the trial. In fact, there were total of twenty eight children who could not stay in the study for different reasons. Since the loss to follow up was about 4% of the sample size, and the authors expected as high as 20%, this small loss did not significantly affect the trial. It is an important issue because it may affect the outcome of the trial. For instance, if there would be many people leaving the trial, there could be a significant difference between the treatment and the control arm of the study. And, the results would be different because the trial would lose its randomization benefits. Therefore, it is important to record the loss to follow up, and make sure that the sample is large enough in case of a high loss to follow up. 10. Principal outcome: How was it measured? The principal outcome was to measure how many new cases of Malaria occur within the sample group. The researchers looked at malaria episodes and measured the mean temperature and parasite densities in the patients. The risk ratio of the incidence between the groups was 0.98. The 95% confidence interval of risk ratio was 0.86 to 1.11. And, 1.0 was within the confidence interval. It is important to check whether or not 1.0 is within the confidence interval because it simply tells the reader that the association between malaria incidence and zinc supplements were not statistically significant at 95% significance level. 11. Secondary outcomes, if any. How was it measured? The secondary outcomes were to analyze how long and dangerous the episodes of malaria and widespread the symptoms of diseases were. They have calculated the number of diarrhea, cough and fever prevalence during the
6. Explain how the intervention(s) in the treatment arm differed from how participants in the control arm were treated. In other words, what is the trial testing?
Participants in the treatment arm were given 12.5 milligram Zinc Sulfate, whereas the participants in the control arm were given a placebo. The trial is testing whether Zinc Sulfate is beneficial to children who have Malaria or not.
7. Was the trial single- or double-blinded or neither? Report evidence of assignment rejection or contamination. Indicate why this is an important issue.
The trial was double blinded, so neither participants nor health staff knew who was in the treatment and control group. There was no sign of contamination or assignment rejection states by the authors. Contamination occurs when the blinding in the trial is broken; however, there was no actions recorded by the authors on the double blinding process. Because it was double blinded, it was probably harder to understand which group people are in. Also, the subjects are kids who are six to thirty months old, so it is unlikely that their parents would try to break the contamination. The authors also mentioned that they believed there was no mixing up of drugs and placebo by the health workers because they were trained well. Also, another proof can be that the treatment group had a significant increase on Zinc in their blood while the control group did not have any significant change in the Zinc level. 8. Was a placebo used? How effective was the placebo in maintaining blinding? In other words, how good was the placebo (which means you have to know what a good placebo is)? A placebo was used for the control group. It is stated that the placebo looked exactly like the Zinc supplement in shape and taste. I believe it was good that placebo could not be differentiated by the patients or the medical staff because it was identical to the Zinc supplement. It is important that a person looking at the drug can not differentiate whether it is the real drug or the placebo because it would lead to a contamination of the study. 9. Evaluate loss to follow up. Indicate why this is an important issue. It is stated that loss to follow up was insignificantly low for the trial. …show more content…
When the sample size of seven hundred twenty was calculated by the researchers, they gave room for a 20% loss to follow up, so they already assumed that there would be people who do not keep up with the trial. In fact, there were total of twenty eight children who could not stay in the study for different reasons. Since the loss to follow up was about 4% of the sample size, and the authors expected as high as 20%, this small loss did not significantly affect the trial. It is an important issue because it may affect the outcome of the trial. For instance, if there would be many people leaving the trial, there could be a significant difference between the treatment and the control arm of the study. And, the results would be different because the trial would lose its randomization benefits. Therefore, it is important to record the loss to follow up, and make sure that the sample is large enough in case of a high loss to follow up. 10. Principal outcome: How was it measured? The principal outcome was to measure how many new cases of Malaria occur within the sample group. The researchers looked at malaria episodes and measured the mean temperature and parasite densities in the patients. The risk ratio of the incidence between the groups was 0.98. The 95% confidence interval of risk ratio was 0.86 to 1.11. And, 1.0 was within the confidence interval. It is important to check whether or not 1.0 is within the confidence interval because it simply tells the reader that the association between malaria incidence and zinc supplements were not statistically significant at 95% significance level. 11. Secondary outcomes, if any. How was it measured? The secondary outcomes were to analyze how long and dangerous the episodes of malaria and widespread the symptoms of diseases were. They have calculated the number of diarrhea, cough and fever prevalence during the