Healthcare Articles

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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By Dr Glenn Carter, Managing Director of Pharmaceutical Professionals, a Sydney professional services company.

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