Medical Information

Reviewing Clinical Papers

A. Review the main aims of the study.

Note any information that highlights the significance of the trial eg first long term study; first time the two drugs were compared

B. Patients:

• Determine the total number of patients in the trial.
• Determine the number of patient groups in the trial.
• Give details of the patient’s disease state and the criteria used for diagnosis.
• Determine whether the patients are inpatients (from a hospital trial), or outpatients (GP study).
• Determine if there is any specific age or sex data eg postmenopausal women.
• Are there any other relevant patient details that may affect the results of the trial eg concurrent disease.
• Examine the inclusion and exclusion criteria to determine what patients have been enrolled in the trial.

C. Trial design

Determine if the trial is:

• Multicentre
• Randomised
• Double blind, parallel or open
• Cross-over, parallel or sequential
• Or whether the study is retrospective or an epidemiological study.
• Note the formulation given (eg tablets, injection, suppository)
• Determine the duration of each treatment.
• Determine whether a baseline was established with a run-in period.
• Determine how the treatments were randomised. Determine if there was a washout period between treatments.
• Determine if other drugs given during the trial eg rescue medications - analgesia in rheumatoid arthritis.
• Determine if non-drug treatment was allowed.
• Determine if compliance was checked (tablet counts, blood levels).

D. Dosage:

• Give the dose and frequency of the treatment given (eg 200 mg, twice daily).
• State when the drugs were given in relation to meals.
• Note the route of administration eg po (orally) , im (intramuscularly), iv (intravenously)

E. Results:

• Identify the significant findings by considering the indication and the likely clinical relevance of the results.
• Comment on statistically significant changes.
• Consider if there were any advantages of the treatment over baseline or placebo. Were there any advantages of one drug over the other.
• Determine if any patients withdrew or were excluded from the trial and for what reasons.
• Do the authors make a claim of efficacy, cost-benefit or safety advantage of one drug over another.
• Note: the Discussion section of the paper often highlights the important findings. Statistically significant findings are not necessarily clinically important, and non-significant differences should not be ignored because they may be clinically important.

F. Side effects:

• Note the side effects for each study drug.
• Note the number of patients withdrawing because of side effects
• Who recorded the information - observer or patient.

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