MPH5040 - Introductory Epidemiology Infographic Assignment

Assignment Task

This assessment will consolidate your knowledge on measures of disease frequency, measures of association, randomised controlled trials and equip you with skills to graphically present your study results. The infographic assessment is worth 20% of your overall mark for this unit.

You are required to submit two documents:

1) A working document that will address below mentioned assessment Tasks 1 and 2 (worth 10%; mark distribution (out of marks) presented in the document); and

2) The infographic (worth - marking rubric available on Moodle in the Assessment 3 section)

Task

1. Randomised controlled trial- case study

Aim of the study

The aim of the study was to determine the efficacy of Ivermectin, an inexpensive antiparasitic drug, in preventing progression to severe disease among high-risk patients with COVID-19.

Design

Your team have conducted an interventional study at 10 Victorian public hospitals between November 15, 2021 and March 14, 2022. A total of 440 patients aged 50 years and older, with laboratory-confirmed COVID-19 and with mild to moderate disease were approached to participate. Among these, 362 were eligible to participate in the study based on the pre-set eligibility criteria. They signed the informed consent and were enrolled in the study. The participants were informed that, if they wish, regardless of the reason, they can withdraw from the study at any point. The study obtained the ethics approval from University Ethics review board.

Included patients were randomized (1:1) to receive either ‘Ivermectin plus standard of care’ (n = 182) or ‘standard of care’ alone (n = 180). Randomization sequence was concealed, as patients, intervention provider and the outcome assessors were blinded of the patient’s intervention status.

Intervention

Patients in the intervention group received oral Ivermectin, 0.4 mg/kg of body weight for 5 days since randomization plus standard of care for COVID-19. The standard of care comprised symptomatic therapy and monitoring for signs of early deterioration based on clinical findings, laboratory test results, and chest imaging. The control group received the standard of care only. Storage, dispensary, and administration of ivermectin were handled by trained study investigators, pharmacists, and nurses.

Outcome of the study

The primary outcome of the study was ‘progression to severe COVID-19’ (defined as the hypoxic stage requiring supplemental oxygen) and the secondary outcome of the study was the ‘development of adverse events’ (Anaphylactic, gastrointestinal, vascular, cardiac and neurological and psychological). Both primary and secondary outcome data were captured from the day of randomization until discharge from the study sites or day 28 of the study enrolment, whichever was earlier.

(a) Draw a flow diagram covering Enrolment, Allocation, Follow-up and Analysis (The details on the flow diagram are in the CONSORT 2010 Explanation and Elaboration Document and in the flow diagram template. Both can be found on the CONSORT website) 

(b) Provide calculations for and interpret the risk of progressing to severe disease in the intervention group compared with those from the control group 

(c) Provide calculations for and interpret the risk of developing adverse events in the intervention group compared with those from the control group - 

(d) Calculate and interpret the number needed to treat/harm, whichever appropriate, for the primary outcome of the study 

(e) Calculate and interpret the number needed to treat/harm, whichever appropriate, for the secondary outcome of the study 

2. Interpreting survival curve

The Kaplan-Meier curve compares overall 5-year survival (calculated in months) in patients with Oesophageal cancer who underwent Neoadjuvant chemotherapy (CRT) followed by surgery vs. those who underwent surgery only. Briefly describe the findings of the comparison based on the survival curve and generate the concluding message in plain (lay) language .

1. Description of survival estimate “surgery alone” group 

2. Description of survival estimate “CRT +Surgery” group

3. Comparison of survival estimates and concluding statement

Infographic

You have just presented your study results at the world Congress of Epidemiology, and you are now eager to share the results with other colleagues and the public via social media. For that you are creating an infographic to help the public better understand the results of your trial.

Infographic size: please use A4 size measures 210 x 297 mm (8.27 x 11.69 inch). If you are creating your infographic in Power Point, you can adjust the size by going File – page setup where you already have A4 measures provided under the ‘Slides sized for’ dropdown menu.

Please see examples of infographics in the Assessment tab on Moodle.

Please note that the infographic will include only the results of the case study (Task 1) and NOT results of the Task 2 of the assessment that refers to interpretation of survival curve.

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