Question

Is the journal considered reputable? Is the journal appropriate to find an

article relating to this particular subject?
(A journal is considered reputable if it is peer reviewed.)
Do the researchers appear to have the appropriate qualifications for
undertaking the study? Was the research performed in an appropriate
medical facility? (Department of Pediatrics, Cystic Fibrosis Center,
Shaare Zedek Medical Center, Hebrew University, Jerusalem; Cystic
Fibrosis Center, Schneider Childrens Hospital, Petach Tiqva; Cystic
Fibrosis Center, Carmel Medical Center, Haifa; Cystic Fibrosis Center,
Sheba Medical Center, Tel Hashomer; Cystic Fibrosis Center, Hadassah
University Hospital, Jerusalem; and Department of Genetics, Life
Sciences Institute, Hebrew University, Jerusalem, Israel)
What was the source of financial support for the study?
Do the authors give sufficient background information for the study?
Did they demonstrate that the study was important and ethical?
Are the purpose and the objectives clearly stated and free from bias?
Was the study approved by an investigational review board?
Does the investigator state the null hypothesis? Is the alternative
hypothesis stated?
Is the sample size large enough? Is the sample representative of the
population?
Are the inclusion and exclusion criteria clearly stated, and are they
appropriate?
Was the study randomized correctly? Even if the study is adequately
randomized, are the groups (treatment and control) equivalent?
(Did they randomize the study? How did they do it? Random number
tables or names pulled from a hat are legitimate ways to do this. Did
they provide a table or chart comparing the demographic information
between groups? Does it look as though the groups are relatively equal,
or are they characteristically (demographically) similar? There are
other ways to randomize besides simple random samples. These can be
legitimate ways to allocate subjects. Research design textbooks will
elaborate on these other methods.
What is the study design? Is it appropriate? What is the study design?
Common study designs include :
the clinical trial (experimental design comparing therapies between
groups), cohort studies (long-term studies observing disease patterns

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related to risk factor exposures), case-control studies (comparison of

cases who have a condition with controls without the condition to
determine if a risk factor could have caused the differences), intentionto-treat (a type of clinical trial that often controls for subjects dropping
out of studies prematurely), meta-analysis (statistical combination of
previous studies data and determining if the conclusions would be
different). Does the type of design they chose make sense? Would a
different study design have been better to answer the proposed
hypothesis?
Was the study adequately controlled? Were the controls adequate and
appropriate?
Was the study adequately blinded?
Were appropriate doses and regimens used for the disease state under
study?
Was the length of the study adequate to observe outcomes?
If the study is a crossover study, was the washout period adequate?
Were operational definitions given?
Were appropriate statistical tests chosen to assess the data? Were the
levels of and error chosen before the data were gathered? Were
multiple statistical tests applied until a significant result was achieved?
Was patient compliance monitored?
If multiple observers were collecting data, did the authors describe how
variations in measurements were avoided?
Did the authors justify the instrumentation used in the study?
Were measurements or assessments of effects made at the appropriate
times and frequency?
Are the data presented in an appropriate, understandable format?
Are standard deviations or confidence intervals shown along with mean
values?
Are there any problems with type I () or type II () errors?
Are there any potential problems with internal validity or external
validity? Internal validity types include history, maturation,
instrumentation, selection, morbidity, and mortality.
Are adverse reactions reported in sufficient detail?
Are the conclusions supported by the data? Is some factor other than
the study treatment responsible for the outcomes?
Are the results both statistically and clinically significant?
Do the authors discuss study limitations in their conclusions?
Were appropriate references used? Are references timely and
reputable? Have any of the studies been disproven or updated? Do

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references cited represent a complete background?

Would this article change clinical practice or a recommendation that
you would give to a patient or health-care professional?