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To help interpret the information provided throughout the web site, following are key terms and definitions. |
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Case review
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When a number of individuals are studied by themselves (i.e., a
case study), stronger conclusions can be drawn as to the efficacy
of a treatment than if one single individual is the basis for the
conclusion. Usually statistical analysis of data is missing, or
limited to very simple summary statistics. While this type of evidence
is important to identify a possible relationship between a treatment
and outcome, it does not constitute rigorous scientific evidence.
Once a possible relationship has been observed in a case series,
the next step would be to design a clinical trial involving randomization
and control conditions.
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Consensus statement
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Once evidence from many studies has been evaluated, it may be possible
to draw some general conclusions about the implications of the findings
for clinical practice. A panel of experts is convened to review
and discuss the findings, and issue a consensus statement regarding,
for example, the clinical effectiveness of a particular therapy
or drug, or the state of knowledge regarding the treatment of a
particular medical condition. For example, the National Institutes
of Health (NIH) have been conducting consensus development conferences
for a number of years, and has issued a number of consensus statements
on many different conditions and treatments. A recent example (1997)
is their consensus statement regarding the effectiveness of acupuncture
for certain conditions such as pain and nausea.
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Controlled clinical trial |
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In the medical world, when we observe two events occurring, there
is a tendency to assume that the two are connected, in a way that
one event may have "caused" the other. There are, however, many
other reasons that could explain these events, such as the caring
attention of the doctor, the belief in getting well and a positive
attitude toward healing, naturally getting better (even without
the treatment), or some other uncontrolled occurrence. To help eliminate
these other possibilities, procedures are introduced in a research
study that are designed to "control for" these other explanations.
Some common examples of controls are: Placebo interventions are
commonly used as control condition. Some of the patients in a study
are given an inert substance that has the appearance of the real
treatment. If the person with the real treatment and not the placebo
experiences improvement, the explanation that the patient got better
because of beliefs or positive attitudes is eliminated. If the placebo
is given by an interested and compassionate doctor, just as in the
"real" condition, we have also eliminated the idea that the patient
improved because of the "attention" that was paid to her/him.
Sometimes there is the possibility that a patient will react differently
to a drug if he/she knows what it is, and knows that it is supposed
to help. The person administering the therapy may have similar beliefs
and act differently in very subtle ways that affect how the patient
responds. Therefore whenever possible, the study is set up so that
none of these people know whether they are getting a placebo or
the real treatment. "Double-blinded" means that at least two of
the participants are unaware of who is getting the real treatment
and who is getting the placebo. Someone else keeps track of who
received what type of treatment and when the analyses of the outcomes
are done if the real therapy did better than the control, then all
of the possible biases mentioned here are eliminated as explanations
for the results.
Sometimes it is difficult to control everything as described above.
People vary in their response to a drug and many other additional
factors could be influencing the results. To eliminate these factors
as explanations for the results, participants of studies get assigned
randomly to the "real" and "control" conditions. This way all of
these unknown factors even out and therefore do not effect the results
of either condition.
For these reasons, the ideal study (the "gold standard") is a randomized,
double-blind, placebo-controlled clinical trial RCT. This cannot
always happen, however, because circumstances do not always allow
for this much rigor. Thus many other types of designs also exist,
many of which are very good, but none of which has the degree of
rigor that an RCT has.
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Guidelines and Recommendations
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Similar to a consensus statement, the government as well as medical
societies will periodically review and evaluate the evidence from
many studies on a particular health issue. Based on this review
they may formulate and publish clinical practice guidelines or recommendations
to clarify accepted and effective standards of practice for a particular
health concern.
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Literature review
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After many studies have been published, it is useful to review
these studies and draw conclusions based on the aggregated results.
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Meta-analysis
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This is a special type of literature review in which statistical
methods are used to combine the results of different studies and
synthesize summaries and conclusions. This type of study design
is commonly used to evaluate and compare the therapeutic effectiveness
of particular treatments.
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Multi-center study
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After a number of preliminary studies suggest that a particular
therapy might be effective and safe it is usually necessary to conduct
at least one very large randomized controlled trial (RCT), involving
several hundred participants in order to be as certain as possible
that the preliminary results will hold up. Because of the large
number of participants needed, and because of the need to be sure
that local or regional factors aren't playing a role in the results,
the study will be conducted at several locations around the country,
usually at different academically oriented medical centers.
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Outcome study
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When research examines the effects of a treatment on a number of
patients in a natural setting, without imposing experimental control
conditions, the process is referred to as an outcome study. Outcomes
can be of several types, including improvement in the symptoms of
the condition being treated, but can also include quality of life
measures, activities of daily living, mood, depression and feelings
of well-being.
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Systematic review
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In a systematic review previously reported studies are identified
systematically according to predetermined rules and then conclusions
are drawn from only those studies reviewed. Rules include the type
of study that will or will not be included (e.g., only clinical
trials, or only studies with control/comparison groups) and the
type of subjects involved (human or animal). Rules also cover where
and how to look for studies. Major databases such as MEDLINE, Embase,
PsychInfo, CINAHL, International Pharmaceutical Abstracts, etc.,
would be explicitly identified at the beginning of the search, and
explored fully.
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