GLOSSARY
OF TERMS
     
     
P
Paired
design
A
study in which participants or groups of participants are matched
(e.g. based on prognostic factors) and one member of each pair
is allocated to the experimental (intervention) group
and the other to the control group.
Parallel
group trial
(synonym: independent group design)
A trial that compares two groups of people, one of which
receives the intervention of interest and one of which
is a control group. Some parallel trials have more than two
comparison groups and some compare different interventions without
including a non-intervention control group.
Peer
review
A
refereeing process used to check the quality and importance
of reports of research. An article submitted for publication
in a peer reviewed journal is reviewed by other experts
in the area. It aims to provide a wider check on the quality
and interpretation of a report and to improve its quality. See
also External
peer reviewer.
Performance
bias
Systematic
differences in care provided apart from the intervention being
evaluated. For example, if patients know they are in the control
group they may be more likely to use other forms of care, patients
who know they are in the experimental (intervention) group may
experience placebo effects, and care providers may treat patients
differently according to what group they are in. Blinding
of study participants (both the recipients and providers
of care) is used to protect against performance bias.
Phase
I studies
The
first stage in testing a new drug in humans. Usually performed
on healthy volunteers without a comparison group.
Phase
II studies
Second
stage in testing a new drug in humans. Often performed on healthy
volunteers. These are sometimes randomized
controlled trials.
Phase
III studies
Studies
that are a full-scale evaluation of treatment. After a drug
has been shown to be reasonably effective, it is essential to
compare it to the current standard treatments for the same condition.
Phase III studies are often randomized
controlled trials.
Phase
IV studies
Studies
that are concerned with post-marketing surveillance. They are
often promotional exercises aimed at bringing a new drug
to the attention of a large number of clinicians, and may be
of limited scientific value.
Placebo
An
inactive substance or procedure administered to a patient, usually
to compare its effects with those of a real drug or other intervention,
but sometimes for the psychological benefit to the patient
through a belief that s/he is receiving treatment. Placebos
are used in clinical trials to blind people to their treatment
allocation. Placebos should be indistinguishable from
the active intervention to ensure adequate blinding.
Placebo
effect
A
favorable response to an intervention, regardless of whether
it is the real thing or a placebo, attributable to the
expectation of an effect, i.e. the power of suggestion. The
effects of many healthcare interventions are attributable to
a combination of both placebo and "active" (non-placebo)
effects.
Point
estimate
The
results (e.g. mean, weighted difference, odds
ratio,
relative
risk
or risk
difference)
obtained in a sample (a study or a meta-analysis)
which are used as the best estimate of what is true for
the relevant population from which the sample is taken.
A confidence
interval
is a measure of the uncertainty (due to the play of chance)
associated with that estimate.
Positive
study
A
term used to refer to a study with results indicating a beneficial
effect of the intervention being studied. The term can
generate confusion because it can refer to both statistical
significance and the direction of effect, studies often have
multiple outcomes, the criteria for classifying studies as negative
or positive are not always clear and, in the case of studies
of risk or undesirable effects, "positive" studies
are ones that show a harmful effect. See also Negative
Study
Precision
- A
measure of the likelihood of random
errors
in the results of a study, meta-analysis
or measurement. Confidence
intervals
around the estimate of effect from each study are a measure
of precision, and the weight given to the results of each
study in a meta-analysis
(typically the inverse of the variance of the estimate of
effect) is a measure of precision (i.e. the degree to which
a study influences the overall estimate of effect in
a meta-analysis
is determined by the precision of its estimate of effect).
- The
proportion of relevant citations located using a specific
search strategy, i.e. the number of relevant studies
(meeting the inclusion criteria for a trials
register
or a review) divided by the total number of citations
retrieved.
Prevalence
The
number of existing cases of a particular disease or condition
in a given population at a designated time.
Prevalence
study
See
cross-sectional
study.
Primary
study
(synonyms: included study, original study)
"Original research" in which data is first collected;
a study included in a systematic
review.
The term primary research is sometimes used to distinguish it
from "secondary research" (reanalysis of previously
collected data), meta-analysis,
and other ways of combining studies (such as economic
analysis
and decision
analysis).
Probability
distribution
The
function that gives the probabilities that a variable equals
each of a sequence of possible values. Examples include
the binomial, chi square, normal and Poisson distributions.
Prospective
study
In
evaluations of the effects of healthcare interventions, a study
in which people are divided into groups that are exposed or
not exposed to the intervention(s) of interest before the outcomes
have occurred. Randomized
controlled trials
are always prospective
studies
and case
control studies
never are. Concurrent cohort studies are prospective studies,
whereas historical cohort studies are not (see cohort
study),
although in Epidemiology a prospective study is sometimes used
as a synonym for cohort study. See also Retrospective
Study.
Protocol
The
plan or set of steps to be followed in a study.
Publication
bias
A
bias in the published literature where the publication of research
depends on the nature and direction of the study results.
Studies in which an intervention is not found to be effective
are sometimes not published. Because of this, systematic reviews
that fail to include unpublished studies may overestimate
the true effect of an intervention.
P-value
The
probability (ranging from zero to one) that the observed results
in a study, or results more extreme, could have occurred
by chance. In a meta-analysis the P-value for the overall
effect assesses the overall statistical significance of the
difference between the treatment and control groups, whilst
the P-value for the heterogeneity statistic assesses the statistical
significance of differences between the effects observed in
each study.
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