Read the article Koutsky et al 2007 and briefly answer the following questions:

Article - Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions

Question 1:

1.1 State the research question the authors plan to answer. Hint use PICO.

1.2 Identify the type of study design used in this study. Randomized Case control study.

1.3 List at least two key characteristics of this study design?

1.4 What was the source population for this research trial?

1.5 Identify the inclusion criteria applied to the study population.

1.6 Identify the interventions given to the people in the treatment group and the control group.

1.7 Identify the primary outcome/s or dependent variable/s for this study.

The next 3 questions ask you to briefly list the characteristics, and provide some examples, if relevant, you would consider when appraising a research study, such as Koutsky et al 2007.

Question 1.8 focuses on how to determine if the study is relevant or generalisable (or externally valid) to your clinical practice, or, your research question. What characteristics of the study do you consider to determine if it is generalisable?               

A. List or describe factors related to generalisability.

B. Discuss generalisability specifically in relation to Koutsky et al 2007.

Question 1.9 focuses on how to determine the importance of the findings...for this question, focus on the internal validity of the study. What characteristics of this type of study design will you consider to determine if its findings are valid?

A. List or describe factors related to internal validity

B. Discuss internal validity specifically in relation to Koutsky et al 2007

Question 1.10 focuses on how to determine the clinical significance and statistical significance of the reported measures of effect. What characteristics of the findings of this type of study design will you consider to determine their magnitude and significance (clinical and statistical)?

A. List or describe factors related to significance

B. Discuss significance specifically in relation to Koutsky et al 2007

Question 2: Read Koutsky et al 2007 and the appendices, answer the questions with brief justifications:

2.1 Was the assignment of participants to groups randomised?

2.2 Was the allocation sequence concealed? How.

2.3 Were the groups similar at baseline or the start of the trial? Discuss.

2.4 Were participants blind to which study group they were in?

2.5 Were the assessors of the outcomes measured blind to the participants study group?

2.6 Were the outcomes measures used reliable?

2.7 Were all participants who entered the research study properly accounted for at the study conclusion, and how complete was the follow-up?

2.8 What is intention to treat analysis?

2.9 Was intention to treat analysis used?

2.10 Did the study have enough participants to minimise the play of chance?

Question 3: From the research study findings of Koutsky et al 2007, calculate the following using Cumulative Incidence for any HPV type (show your working):

3.1 Experimental Event Rate (EER) for the primary outcome

3.2 Control Event Rate (CER) for the primary outcome

3.3 Relative Risk (RR) of for the primary outcome in the intervention group compared with the control group

3.4 Is this a rate ratio or risk ratio?

3.5 Risk Difference

3.6 Number Needed to Treat

3.7 Describe the NNT in words.

Attachment:- Article.rar