Isoniazid Prophylactic Therapy for the Prevention of Tuberculosis in HIV-Infected Adults: A Systematic Review and Meta-Analysis of Randomized Trials is the article chosen for this project. The article was done by Ayele, Mourik, Debray & Bonten (2015).
What was the hypothesis of the study?
The article reviewed studies whose objectives were to determine the effects of IPT on the prevention of TB in adult HIV patients. It does not state the hypothesis of the studies. However, the following hypothesis can be deduced from the objectives of the study.
Hypothesis: IPT is effective in the prevention of TB in adult HIV patients.
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"Module 09 Written Assignment: Designing a Randomized Trial".
What kind of trial was it (Efficacy, Effectiveness?)?
According to Gartlehner, Hansen, Nissman, Lohr & Carey (2006), efficacy trials, also referred to as explanatory trials, are conducted to determine whether interventions produce the expected results under ideal circumstances. On the other hand, effectiveness trials, also referred to as pragmatic trials, are conducted to determine the degree beneficial effects of an intervention under ideal clinical settings. The studies reviewed in the article were effectiveness trials. Their aim was to investigate the extent to which Isoniazid Prophylactic Therapy would help in the prevention of TB among HIV patients.
How was outcome defined for the study (Preventative, Treatment, New dosing, Surgery)?
The outcome of the studies reviewed in the article was preventative. They revealed that Isoniazid Prophylactic Therapy was beneficial in the prevention of TB in HIV patients.
What were the groups in the trial (Treatment group, placebo group, control group, or another standard of care group)?
The studies reviewed in the article used placebos to group participants. They blindly and randomly allocated HIV patients into experimental groups for the clinical investigation of the importance of Isoniazid Prophylactic Therapy in the Prevention of TB in HIV patients.
What was the sample for the study?
The study used a sample of 7619 HIV patients from 10 countries.
Describe the inclusion or exclusion criteria for the selection of groups.
The following were the inclusion criteria for the studies reviewed in the selected article:
Participants were adults living with HIV, with or without ART
The occurrence of active TB disease among the participants.
Pregnancy was the exclusion criteria.
Was everyone involved in the study (participants and investigators) “blind” to treatment?
In randomized trials, blinding refers to the act of concealing the allocation of groups from one or more individuals. The participants of the studies selected for the review were blind to treatment. The studies were conducted in ten different countries, and the participants from each country were not made aware of the treatments given to participants from other countries. However, the investigators were not blind to the treatment.
Was any Type 1 or Type II error reported? Was power of study reported?
As stated in part (a), the article was a review of various studies conducted to determine the impact of IPT on the prevention of TB in adult HIV patients. No hypothesis was stated in the article. As such, type I and type II errors, which are used to test the hypothesis, were reported.
How were the results of RCT expressed? (Relative risk/Odds ratio, Hazard ration, NNT)?
The results of the study were expressed in terms of relative risk (RR). For instance, it found out that the relative risk of TB reduction among all participants was 0.65.
What was the conclusion of the study?
The study concluded that the use of Isoniazid Preventive Therapy (IPT) contributes towards the prevention of TB in persons infected with the HIV in general. The study found out that IPT is particularly helpful in the prevention of TB in Tuberculin Skin Test (TST) positive persons.
