Literature Evaluation and Review II

Question 1

Describe the two types of clinical trial validity.

Answer 1

i. Internal validity: The degree to which the study design and execution accurately measure what the trial intended to evaluate. High internal validity ensures that the observed outcomes are directly attributable to the interventions or variables being studied rather than to biases or confounding factors.

ii. External validity: This pertains to how well the study’s findings can be generalized to other populations or settings. If the study conditions or participants significantly differ from real-world clinical practice, the external validity may be limited, reducing the study’s applicability to broader patient care.
For example, if a clinical trial on patients with type 2 diabetes mellitus (DM) excluded individuals with concomitant hypertension, but most patients with type 2 DM in clinical practice also have hypertension, the findings would have limited external validity and applicability to the typical patient population.

Question 2

What is a confounding variable?

Answer 2

Confounding variables are factors associated with both the condition being studied and the potential outcomes, which can introduce bias and affect the validity of the study results.
A confounding variable is a factor that is related to both the independent variable (cause) and the dependent variable (effect) but is not accounted for in the study. It can create a false impression of an association between the variables being studied or hide a true relationship.

Question 3

What are randomised controlled trials?

Answer 3

A Randomized Controlled Trial (RCT) is a scientific study design used to test the effectiveness and safety of a treatment, intervention, or drug by comparing it against a control group. In this controlled trial, placement of participants in the different groups is random. It is considered the gold standard for clinical research because it minimizes bias and allows for causal conclusions.

Question 4

Name two types of control.

Answer 4

1. Placebo-control
2. Active control

Question 5

Regardless of the study design and objective, fundamental elements should be reported in all studies, including:

Answer 5

• Appropriate qualifications of the investigators conducting the research
• Valid investigational methods
• Proper research techniques, and
• Appropriate analysis and interpretation of the results.

Question 6

Highlight the format and content of a controlled clinical trial.

Answer 6

1. Abstract: brief overview of the research project
2. Introduction:
   i. Research background
   ii. Rationale for study
   iii. Objectives/hypothesis
3. Methods:
   i. Study design
   ii.Study setting
   iii. Study Population
   iv. Inclusion and exclusion criteria
   v. Intervention and control groups
   vi. Randomization
   vii.Blinding
   viii. Procedure
4. Results:
   i. Subject characteristics
   ii. Subject dropouts/adherence
   iii. Endpoints quantified
   iv. Statistical significance
   v. Safety assessments
5. Discussion:
   i. Interpretation of results
   ii. Clinical significance
   iii. Other study results compared
   iv. Limitations
   v. Conclusion/application to practice
6. Acknowledgements:
   i. Contributors
   ii. Funding source
   iii. Peer review dates
7. References:
   i. Citations for information included from other resources

Question 7

Mention 10 important considerations for evaluating a clinical trial

Answer 7

1. journal and peer review
2. publication types
3. authorship
4. title
5. abstract
6. introduction
7. methods….

study design, patient inclusion/ exclusion criteria, intervention and control groups, institutional board review (health research ethics committee review)/ participants consent, blinding, randomization, randomization techniques, endpoints, follow-up schedule, data collection, sample size, statistical analysis, power analysis, results, result interpretation, discussion, conclusion.

Question 8

What is CONSORT?

Answer 8

Consolidated Standards of Reporting Trials Statement

The CONSORT comprises a 25-item checklist, which focuses on reporting the trial design, analysis, and interpretation, and a flow diagram for documenting the patients at each stage of the trial.

Question 9

Outline the steps in the literature review process.

Answer 9

1. Define the research question
2. Determine inclusion/exclusion criteria
3. Choose databases and conduct the search
4. Review your results
5. Synthesize the information gathered
6. Analyze the information gathered
7. Write the literature review

[Refer to note for more in-depth understanding]

Question 10

Mention 3 citation management tools.

Answer 10

i. Zotero
ii. Mendeley
iii. EndNote