Experimental/Intervention Research Design

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Institution

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Research MethodsName: ______________________________________________________________

PART I: Please refer to the IARC Intervention Trials article (posted to Moodle) in answering the following questions.

Define Intervention Trials. (50 word max; 4 points)

It is a trials done prevent or control new diseases and deal with subjects who are disease-free. Intervention trials involve evaluation of whether an agent or procedure reduces the risk of developing disease among those free from that condition at enrolment.

Briefly list 3 strengths of trials. (50 word max; 6 points)

The trials can be selectively carried on individuals without interfering with the community. It can also be carried anywhere that is suitable for intervention and this can reduce cost of hiring of rooms hence cost effective and reliable as the researcher can administer it even at home.

Briefly list 3 weaknesses of trials. (50 word max; 6 points)

The study has ethical constraints as many people can shy away from participating in it. The trials require a greater number of subjects to be followed up for a longer periods hence time consuming. As the study involve healthy people, it is logistically difficult to carry out.

List major challenges in conducting clinical trials. (50 word max; 4 points)

It is relative difficult to assign many interventions to individual levels as the trials majorly suits the community as a whole and at the same time people in the group of intervention can be easily get contaminated by the sick . The trial can easily reveal the true effect of the intervention hence compromising the result.

PART II: Now that you are familiar with trial methodology…a burgeoning expert indeed. Please read the article by Brian et al. entitled “Effect of a behaviour-change intervention on hand-washing with soap in India (Super-Amma): A cluster-randomized trial. Answer the following questions in reference to this article. Please note that when asked to “comment” you should not just restate the facts, but provide your opinion as to whether it was good, adequate, poor AND why.

Comment on sample: Size. How participants were selected. Any inclusion or exclusion criteria? (60 word max; 5 points)

The sample size was manageable as it was reasonable for analysis. The random method of selection was best suited for this experiment as it reduces bias and facilitates participation of members. The method of clustering of the villages was the best way to enhance equal participation of both the sexes in the community and finally by giving 1:1 ratio is comprehensive and inclusive for every eligible member to participate in the intervention.

Consider Outcomes: What were they? How were they assessed/measured? (75 word max; 5 points)

The primary outcome was to check the proportion of key events while the secondary outcome was to ascertain hand washers who use soap double blind to measure the outcome. Hand washing with soap was low at the begging of the experiment, however, there was a considerable increase in percentage after the second and third visit. Interestingly, the hand washing with soap was relatively higher in intervention group than in the control group at all the stages of visits.

Comment on your perception as to quality/strengths of the intervention. Weaknesses? (75 word max; 5 points)

The quality of the intervention was reasonable as there was equal representation in the sample. The use of random and stratified sampling reduces biasness in the experiment. By use of double blind method and female observers in the process reduces fear of intimidation. Timing of the experiment and door-door approach was also commendable as it reached the targeted group. The researcher also conducted a successful follow up after every six weeks.

Consider limitations as presented in IARC article. Which of these limitations do you see operative in this study? (75 word max; 5 points)

Since the study was like clinical intervention, it was difficult to assign to individual member of the community and that could take longer time to administer hence time consuming and costly. There could be an easier way of people within the intervention becoming contaminated when they are put within the strata thereby risking the healthy individuals.

Consider biases that are operative in intervention trials. Which of them are operative in this study? (75 word max; 5 points)

Invention trials are under the direct control of the investigator and the result can be easily influenced by those in charge. The trial uses double masking that can be dangerous to both the correspondents and the observers as they are not told of the dangers they are exposed to. Finally by use of only young female as observers, the trials tend to be discriminative to gender and age of individuals in the community.

Conclusions: Do the data presented by the author support their conclusions/recommendations? Please explain. (75 word max; 5 points)

Yes the data presented support the author’s findings and conclusion. The data was representative and the use of simple random and stratified method of data collection was accurate. The data had a fair representation in the sample as it took more than fifty percent of the community and used a ratio of 1:1 to be inclusive. The inclusive data gives a representative result that shows that there is a substantial increase in those using soap to wash their hands.

References

Biran, A. et al., (2014). Effect of a behaviour-change intervention on hand washing with soap in India (SuperAmma): A cluster-randomized trial. HYPERLINK “http://www.thelancet.com/lancetgh Vol 2. ” www.thelancet.com/lancetgh Vol 2.

Ejemot R, Ehiri J, Meremikwu M, Critchley J. Hand washing for preventing diarrhoea. Cochrane Database Syst Rev 2008; 1: CD004265.