Initial investigations had suggested that a pre existing medication for treating fungal infections could also be used to prevent hospitalisation in young children infected with a new infectious viral disease To test whether the medication could prevent hospitalisation, a randomised controlled trial wasconducted to compare the performance of the fungal medication (Tablet A) against control (no tablet) A total sample of 199 newly infected young children were randomly allocated to receive a daily dose of either Tablet A or no tablet for a period of 30 days post infection To monitor adherence, the children received a regular blood test It was determined that 27 mothers of children randomised to the control group (no tablet) had obtained Tablet A through online stores In addition, it was found that 15 mothers of the children randomised to receive Tablet A had not given the tablet to their child due to concerns about safety after reading online discussion posts The results are provided below Allocation Tablet A (intervention) No tablet (control) (n 102) (n 97) Adherence Took Tablet A No tablet No tablet Took Tablet A hospitalised 4 3 7 1 non hospitalised 83 12 63 26 TOTALS 87 15 70 27 Please conduct an Intention to Treat analysis to determine the cumulative incidences and risk ratio of hospitalisation for those allocated to be treated with Tablet A and those allocated to the control group Please show your work and then explain the effect in percentage terms (4 marks) Using the data in the table above, please conduct an As Treated analysis to determine the cumulative incidences and risk ratio of hospitalisation for the treatment control Please show your work and then explain the effect in percentage terms (4 marks) Comparing the results (risk ratios) of the Intention to Treat and As Treated analyses, what conclusions can you draw about the effectiveness of Tablet A (2 marks) Which of the two risk ratio values would you focus on and why (2 marks) Explain how confounding could be an issue with the 'As Treated' analysis (1 mark) What does the 'generalisability' of the study findings refer to (1 mark) What aspect of the study methods can help us to evaluate the generalisability of the findings (2 marks)

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. Initial investigations had suggested that a pre-existing medication for treating fungal infections could also be used to prevent hospitalisation in young children infected with

.Initial investigations had suggested that a pre-existing medication for treating fungal infections could also be used to prevent hospitalisation in young children infected with a new infectious viral disease. To test whether the medication could prevent hospitalisation, a randomised controlled trial wasconducted to compare the performance of the fungal medication (Tablet A) against control (no tablet). A total sample of 199 newly infected young children were randomly allocated to receive a daily dose of either Tablet A or no tablet for a period of 30 days post infection. To monitor adherence, the children received a regular blood test. It was determined that 27 mothers of children randomised to the control group (no tablet) had obtained Tablet A through online stores. In addition, it was found that 15 mothers of the children randomised to receive Tablet A had not given the tablet to their child due to concerns about safety after reading online discussion posts. The results are provided below:

Allocation	Tablet A (intervention)	No tablet (control)
(n = 102)	(n = 97)
Adherence	Took Tablet A	No tablet	No tablet	Took Tablet A

hospitalised	4	3	7	1
non hospitalised	83	12	63	26
TOTALS	87	15	70	27

Please conduct an "Intention-to-Treat" analysis to determine the cumulative incidences and risk ratio of hospitalisation for those allocated to be treated with Tablet A and those allocated to the control group. Please show your work and then explain the effect in percentage terms. (4 marks)

Using the data in the table above, please conduct an "As Treated" analysis to determine the cumulative incidences and risk ratio of hospitalisation for the treatment/control. Please show your work and then explain the effect in percentage terms. (4 marks)

Comparing the results (risk ratios) of the "Intention-to-Treat" and "As Treated" analyses, what conclusions can you draw about the effectiveness of Tablet A? (2 marks). Which of the two risk ratio values would you focus on and why? (2 marks) Explain how confounding could be an issue with the 'As Treated' analysis. (1 mark)

What does the 'generalisability' of the study findings refer to? (1 mark) What aspect of the study methods can help us to evaluate the generalisability of the findings? (2 marks)