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Are the findings valid? (i.e., as close to the truth as I. Are the study findings valid?
A. Were the subjects randomly assigned to the experimental
possible)
and control groups?Yes No Unknown
Are the findings important? (i.e., What is the impact
of the intervention [i.e., the size of the effect or the B. Were the follow-up assessments conducted long enough
extent to which the intervention or treatment to fully study the effects of the intervention?
worked]?) Yes No Unknown
Are the findings clinically relevant or applicable to
the patients for whom I am caring? C. Did at least 80% of the subjects complete the study?
Yes No Unknown
Critical Appraisal Questions for RCTs G. Were the subjects and providers kept blind to study
There are three major questions in the critical appraisal group?
process (see Table 1). The first critical appraisal question in Yes No Unknown
reviewing a RCT is whether the findings of the study are valid
(i.e., as close to the truth as possible?). In order to answer H. Were the instruments used to measure the outcomes
valid and reliable?
this first major question, a series of sub-questions should be
Yes No Unknown
asked (see Table 2). The first question is Was random
assignment to the experimental and control groups conduct- I. Were the subjects in each of the groups similar on demo-
ed and was random assignment concealed from the individ- graphic and baseline clinical variables?
uals who were first enrolling subjects into the study? Yes No Unknown
Concealment of study group to the individuals enrolling sub-
jects is important so that they are not biased when approach- 2. What are the results of the study and are they
ing potential subjects to participate in a study. For example, important?
if a researcher knows that individuals are going to be enrolled A. How large is the intervention or treatment effect
in the experimental group, his or her level of enthusiasm (NNT, NNH, effect size, level of significance)?
might be greater when approaching subjects targeted to be __________________
in the experimental intervention group than when approach- B. How precise is the intervention or treatment (Confidence
ing subjects who are designated to receive the control inter- interval)?
vention. Thus, this may result in a higher level of participa-
tion in the experimental intervention group. In addition, the 3. Will the results help me in caring for my patients?
experimental group subjects may enter the treatment proto- A. Are the results applicable to my patients?
col with a different set of expectations and enthusiasm, which Yes No Unknown
could impact the studys outcome variables.
The second question concerning validity of a study is B. Were all clinically important outcomes measured?
Yes No Unknown
Were the follow-up assessments conducted long enough to
study the effects of the intervention and did all subjects
C. What are the risks and benefits of the treatment?
complete the study? It is important for studies to include ______________________
follow-up assessments over time in order to assess the sus-
tainability of an intervention or treatment so that both the D. Is the treatment feasible in my clinical setting?
short- and long-term outcomes of an intervention can be Yes No Unknown
determined. In some instances, follow-up periods are too
short to determine the effects of the intervention, which will E. What are my patients/familys values and expectations for
affect the study results. Additionally, retention rate is critical the outcome that is trying to be prevented and the treat-
in a study. If a large percentage of subjects withdraw or are ment itself?
dropped from a study, the results could turn out differently
than if all of the subjects would have remained in the study,
since individuals with a certain characteristic may be more mation were then permitted to switch to the control group,
likely to discontinue their participation. they might contaminate the results of the pure control group
The third question under the topic of validity of a study and, therefore, the outcomes in the study could be altered.
has to do with analysis of the data, that is, Were patients The next question under validity is Was the control
analyzed in the group to which they were originally group appropriate? Unfortunately, many intervention trials
assigned? do not control for the time that is spent with subjects in the
This also is called intention to treat analysis. For exam- experimental group by providing some type of comparison
ple, if patients who were given partial experimental infor- intervention that does not contain the experimental treat-