Randomised Controlled Trial- Case Study Assignment Help

Assessment 3 – Infographic

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 100 marks) presented in the document); and

2) the infographic (worth 10% - marking rubric available on Moodle in the Assessment 3 section)

Task 1: Randomised controlled trial- case study (65 marks)

Please read the following case study and address the tasks outlined in last sections of the 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 Latrobe 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 the proportion of patients who progressed 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.

Follow-up and study findings

Among 362 patients included, 32 patients (20 patients from the ‘Ivermectin plus standard of care’ group and 12 from the ‘standard of care only’ group) did not complete the study or withdrew consent.

Out of patients who completed the study, 38 in the intervention group and 59 patients in the control group progressed to severe disease during the study period and subsequently were transferred to the intensive care unit. A total of 46 adverse events occurred in 37 patients. Among the study participants who developed adverse events, 26 were in the ivermectin group and 11 in the control group.

Perform appropriate statistical analyses to answer the research question “Does adding ivermectin to the standard of care reduce the risk of severe disease and adverse events in patients with COVID-19?” adopting intention-to-treat approach.

(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) (5 marks)  

(b) Provide calculations for and interpret the relative risk of progressing to severe disease in the intervention group compared with those from the control group – (calculation 5 marks, interpretation 5 marks)

(c) Provide calculations for and interpret the relative risk of developing adverse events in the intervention group compared with those from the control group - (calculation 5 marks, interpretation 5 marks)

(d) Calculate and interpret the number needed to treat/harm, whichever appropriate, for the primary outcome of the study - (calculation 15 marks, interpretation 5 marks)

(e) Calculate and interpret the number needed to treat/harm, whichever appropriate, for the secondary outcome of the study - (calculation 15 marks, interpretation 5 marks)

Task 2: Interpreting survival curve (35 marks)

Please read and address the task presented below the figure. 

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 plane (lay) language.  

 Hint:

• Description of survival estimate “surgery alone” group (10 marks)
• Description of survival estimate “CRT +Surgery” group (10 marks)
• Comparison of survival estimates and concluding statement (15 marks)

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.

Frequently asked questions:

How to physically create an infographic without paying for additional access to resources? Piktochart is free and has lots of symbols and graphics; it is just that a free version attaches a Piktochart advertisement to your infographic, and it is ok if it stays in your infographic. For colleagues who have never created an infographic before, we suggest using PowerPoint. It has shapes and SmartArt, Charts that you may find helpful in creating your infographic. Also, many pictures and icons can be taken from the Internet (copy-pasted), and you can acknowledge them in the case-study Word document if you do not want to clutter your infographic. Referencing sources is not mandatory for this assessment, as these infographics will never be published; but it is always good to think of good practice of referencing/acknowledging sources.  

What are we putting in the infographic, our own data or those based on the previous research? This infographic should be a visual representation of the case study results. Imagine you have written the manuscript/paper and also written the abstract (required when publishing journal articles). You can think of your infographic as a visual representation of the abstract. From the case study itself and by addressing the case study tasks, you will get plenty of material for your infographic. For example, study design/population (case study; and based on the CONSORT diagram you created), multiple calculations/interpretation of study results. You can also add a summary of study results with potential implications for clinical practice.

Imagine you created your infographic and shared it with relevant stakeholders. Just by quickly looking at it, will they understand what your study is about, what the key messages are and why are those important? Please note the infographic is not a poster, so it should not be overloaded/cluttered with text.

Does the infographic need to be ‘clinical’ or more informal, colourful and a bit of fun? Infographic is different from a research poster and the intention is to get your messages across to people/audience who may not necessarily be researchers/have research background. While the language may be more on an informal side, it is also important that the language related to results interpretation is correct. Please don’t forget that once you send your infographic via social media, it will most likely be most interesting to people who are in the same/similar field and who do understand research terminology well (this just means that even if lay terminology is used, it still needs to be a correct representation/interpretation of results). Colours – personal preference J

When creating your infographic, you may find useful the document ‘The 7 G.R.A.P.H.I.C. principles of public health infographic design’ by Drs Stones and Gent.