Professional Documents
Culture Documents
RCT Critical Appraisal
RCT Critical Appraisal
trials
Specific Types of Study
Advantages
• Allows rigorous evaluation of a single variable in a
previously defined population e.g. a new drug.
• Prospective i.e. collect the information after you decide
to do the study.
• Tries to disprove the null hypothesis
• Tries to eradicate bias because the two groups are
identical.
• Allows for meta-analysis later.
RCT’s are
• Unnecessary if:
• Clearly successful intervention
• Previous RCT’s or meta-analyses
• Impractical when:
• Unethical to randomise
• Large number needed
• Inappropriate when:
• Looking at prognosis
• Looking at validity of diagnostic tests
• Looking at quality of care
Background (1)
2. Also, identify
• Sponsor (federal, industry)
• Data management team
• Statistical analysis team
Reporting in Clinical Trials
“The Published Paper”
3. Introduction & Background
a. Biochemical theory
b. Animal work
c. Phase I/II clinical studies
d. Previous large clinical studies
e. Other pharmaceutical analogues
Reporting in Clinical Trials
Definition of question
• Allocation concealment
Method used to implement the random
allocation sequence
• Implementation
Who generated the allocation sequence, who
enrolled participants, and who assigned
participants to their groups
Allocation concealment
• A technique used to prevent selection bias by
concealing the allocation sequence from those
assigning participants to intervention groups,
until the moment of assignment.
Lancet 1992;340:1421-25
Obstetrics & Gynecology
Bacterial Vaginosis: Treatment with Topical
Intravaginal Clindamycin Phosphate
We tested topical intravaginal clindamycin phosphate at practitioners use systemic metronidazole and
ac
concentrations of 0.1, 1.0, and 2.0% in the treatment of common gastrointestinal side effects.
Alternative
62 women with symtomatic bacterial vaginosis in a pro- apy, particularly for pregnant women, is highly
pective, randomized, double-blind, placebo-controlled able. This study examined the safety and
efficacy
“. . . prospective, randomized,
double-blind, placebo-controlled
trial.”
“Design - Longitudinal,
prospective randomized . . .”
Br J Obstet Gynaecol 1991;98:980-7
A Controlled Trial of Povidone-Iodine as Prophylaxis
Against Ophthalmia Neonatorum
Abstract Background. Neonatal conjunctivitis Ophthalmic neonatorum) continues
to cause blindness, because the agents used prophylactically to prevent this condition
are not completely effective and are not widely available in many parts of the world.
Povidone--iodine ophthalmic solution is an effective antibacterial agent with broad
antibacterial and antiviral activity to which no bacteria are known to be resistant, and
it is
NEJM 1995;332:562-6
March 1991, Vol. 98, pp 260-264
Am J Obstet Gynecol;1991;165:679-81
On completion of the procedures, the
patients were randomly assigned to
prophylaxis or nonprophylaxis groups
according to hospital number. Both the
physician and the nurse technician were
blind as to which assignment the patient
received. Patients in group A received
nitrofurantoin 50 mg four times and
phenazopyridine hydrochloride 200 mg
three times for 1 day. Patients in group B
received phenazopyridine hydrochloride
only. The code was broken at the
completion of the study.
Randomization Process
Proper Approach 4 Major General
Medical Journals
Both 15%
Moher D, Jones A, Lepage L, for the CONSORT group. Use of the CONSORT
statement and quality of reports of randomized trials: a comparative before and
after evaluation? JAMA 2001;285:1992-1995.