Clinical Study Terminology Handout

Types of Study Designs
Meta-Analysis
A way of combining data from many different research studies. A meta-analysis is a statistical
process that combines the findings from individual studies. Example: Anxiety outcomes after
physical activity interventions: meta-analysis findings. Conn V. Nurs Res. 2010 May-
Jun;59(3):224-31.
Systematic Review
A summary of the clinical literature. A systematic review is a critical assessment and evaluation
of all research studies that address a particular clinical issue. The researchers use an organized
method of locating, assembling, and evaluating a body of literature on a particular topic using a
set of specific criteria. A systematic review typically includes a description of the findings of the
collection of research studies. The systematic review may also include a quantitative pooling of
data, called a meta-analysis. Example: Complementary and alternative medicine use among
women with breast cancer: a systematic review. Wanchai A, Armer JM, Stewart BR. Clin J
Oncol Nurs. 2010 Aug;14(4):E45-55.
Randomized Controlled Trial

A controlled clinical trial that randomly (by chance) assigns participants to two or more groups.
There are various methods to randomize study participants to their groups. Example:
Meditation or exercise for preventing acute respiratory infection: a randomized controlled trial.
Barrett B, et al. Ann Fam Med. 2012 Jul-Aug;10(4):337-46.
Cohort Study (Prospective Observational Study)

A clinical research study in which people who presently have a certain condition or receive a
particular treatment are followed over time and compared with another group of people who are
not affected by the condition. Example: Smokeless tobacco cessation in South Asian
communities: a multi-centre prospective cohort study. Croucher R, et al. Addiction. 2012
Dec;107 Suppl 2:45-52.
Case-control Study
Case-control studies begin with the outcomes and do not follow people over time. Researchers
choose people with a particular result (the cases) and interview the groups or check their records
to ascertain what different experiences they had. They compare the odds of having an experience
with the outcome to the odds of having an experience without the outcome. Example: Non-use
of bicycle helmets and risk of fatal head injury: a proportional mortality, case-control study.
Persaud N, et al. CMAJ. 2012 Nov 20;184(17):E921-3.
Clinical study terminology handout

Dr. Md. Tanveer Ahsan
Cross-sectional study
The observation of a defined population at a single point in time or time interval. Exposure and
outcome are determined simultaneously. Example: Fasting might not be necessary before lipid
screening: a nationally representative cross-sectional study. Steiner MJ, et al. Pediatrics. 2011
Sep;128(3):463-70.
Case Reports and Series

A report on a series of patients with an outcome of interest. No control group is involved.
Example: Students mentoring students in a service-learning clinical supervision experience: an
educational case report. Lattanzi JB, et al. Phys Ther. 2011 Oct;91(10):1513-24.
Ideas, Editorials, Opinions

Put forth by experts in the field. Example: Health and health care for the 21st century: for all the
people. Koop CE. Am J Public Health. 2006 Dec;96(12):2090-2.
Animal Research Studies

Studies conducted using animal subjects. Example: Intranasal leptin reduces appetite and
induces weight loss in rats with diet-induced obesity (DIO). Schulz C, Paulus K, Jöhren O,
Lehnert H. Endocrinology. 2012 Jan;153(1):143-53.
Test-tube Lab Research

"Test tube" experiments conducted in a controlled laboratory setting.
Adapted from Study Designs. In NICHSR Introduction to Health Services Research: a Self-
Study Course. http://www.nlm.nih.gov/nichsr/ihcm/06studies/studies03.html and Glossary of
EBM Terms. http://www.cebm.utoronto.ca/glossary/index.htm#top

Study Design Terminology
Bias - Any deviation of results or inferences from the truth, or processes leading to such
deviation. Bias can result from several sources: one-sided or systematic variations in
measurement from the true value (systematic error); flaws in study design; deviation of
inferences, interpretations, or analyses based on flawed data or data collection; etc. There is no
sense of prejudice or subjectivity implied in the assessment of bias under these conditions.
Case Control Studies - Studies which start with the identification of persons with a disease of
interest and a control (comparison, referent) group without the disease. The relationship of an
attribute to the disease is examined by comparing diseased and non-diseased persons with regard
to the frequency or levels of the attribute in each group.
Causality - The relating of causes to the effects they produce. Causes are termed necessary when
they must always precede an effect and sufficient when they initiate or produce an effect. Any of
several factors may be associated with the potential disease causation or outcome, including
predisposing factors, enabling factors, precipitating factors, reinforcing factors, and risk factors.
Control Groups - Groups that serve as a standard for comparison in experimental studies. They
are similar in relevant characteristics to the experimental group but do not receive the
experimental intervention.
Controlled Clinical Trials - Clinical trials involving one or more test treatments, at least one
control treatment, specified outcome measures for evaluating the studied intervention, and a bias-
free method for assigning patients to the test treatment. The treatment may be drugs, devices, or
procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures
include placebos, active medicines, no-treatment, dosage forms and regimens, historical
comparisons, etc. When randomization using mathematical techniques, such as the use of a
random numbers table, is employed to assign patients to test or control treatments, the trials are
characterized as Randomized Controlled Trials.
Cost-Benefit Analysis - A method of comparing the cost of a program with its expected benefits
in dollars (or other currency). The benefit-to-cost ratio is a measure of total return expected per
unit of money spent. This analysis generally excludes consideration of factors that are not
measured ultimately in economic terms. Cost effectiveness compares alternative ways to achieve
a specific set of results.
Cross-Over Studies - Studies comparing two or more treatments or interventions in which the
subjects or patients, upon completion of the course of one treatment, are switched to another. In
the case of two treatments, A and B, half the subjects are randomly allocated to receive these in
the order A, B and half to receive them in the order B, A. A criticism of this design is that effects
of the first treatment may carry over into the period when the second is given.

Cross-Sectional Studies - Studies in which the presence or absence of disease or other health-
related variables are determined in each member of the study population or in a representative
sample at one particular time. This contrasts with LONGITUDINAL STUDIES which are
followed over a period of time.
Double-Blind Method - A method of studying a drug or procedure in which both the subjects
and investigators are kept unaware of who is actually getting which specific treatment.
Empirical Research - The study, based on direct observation, use of statistical records,
interviews, or experimental methods, of actual practices or the actual impact of practices or
policies.
Evaluation Studies - Works consisting of studies determining the effectiveness or utility of
processes, personnel, and equipment.
Genome-Wide Association Study - An analysis comparing the allele frequencies of all

available (or a whole genome representative set of) polymorphic markers in unrelated patients
with a specific symptom or disease condition, and those of healthy controls to identify markers
associated with a specific disease or condition.
Intention to Treat Analysis - Strategy for the analysis of Randomized Controlled Trial that
compares patients in the groups to which they were originally randomly assigned.
Logistic Models - Statistical models which describe the relationship between a qualitative
dependent variable (that is, one which can take only certain discrete values, such as the presence
or absence of a disease) and an independent variable. A common application is in epidemiology
for estimating an individual's risk (probability of a disease) as a function of a given risk factor.
Longitudinal Studies - Studies in which variables relating to an individual or group of

individuals are assessed over a period of time.
Lost to Follow-Up - Study subjects in cohort studies whose outcomes are unknown e.g., because
they could not or did not wish to attend follow-up visits.
Matched-Pair Analysis - A type of analysis in which subjects in a study group and a
comparison group are made comparable with respect to extraneous factors by individually
pairing study subjects with the comparison group subjects (e.g., age-matched controls).
Meta-Analysis - Works consisting of studies using a quantitative method of combining the

results of independent studies (usually drawn from the published literature) and synthesizing
summaries and conclusions which may be used to evaluate therapeutic effectiveness, plan new
studies, etc. It is often an overview of clinical trials. It is usually called a meta-analysis by the
author or sponsoring body and should be differentiated from reviews of literature.
Numbers Needed To Treat - Number of patients who need to be treated in order to prevent one
additional bad outcome. It is the inverse of Absolute Risk Reduction.

Odds Ratio - The ratio of two odds. The exposure-odds ratio for case control data is the ratio of
the odds in favor of exposure among cases to the odds in favor of exposure among noncases. The
disease-odds ratio for a cohort or cross section is the ratio of the odds in favor of disease among
the exposed to the odds in favor of disease among the unexposed. The prevalence-odds ratio
refers to an odds ratio derived cross-sectionally from studies of prevalent cases.
Patient Selection - Criteria and standards used for the determination of the appropriateness of
the inclusion of patients with specific conditions in proposed treatment plans and the criteria
used for the inclusion of subjects in various clinical trials and other research protocols.
Predictive Value of Tests - In screening and diagnostic tests, the probability that a person with a
positive test is a true positive (i.e., has the disease), is referred to as the predictive value of a
positive test; whereas, the predictive value of a negative test is the probability that the person
with a negative test does not have the disease. Predictive value is related to the sensitivity and
specificity of the test.
Prospective Studies - Observation of a population for a sufficient number of persons over a

sufficient number of years to generate incidence or mortality rates subsequent to the selection of
the study group.
Qualitative Studies - Research that derives data from observation, interviews, or verbal
interactions and focuses on the meanings and interpretations of the participants.
Quantitative Studies - Quantitative research is research that uses numerical analysis.

Random Allocation - A process involving chance used in therapeutic trials or other research
endeavor for allocating experimental subjects, human or animal, between treatment and control
groups, or among treatment groups. It may also apply to experiments on inanimate objects.
Randomized Controlled Trial - Clinical trials that involve at least one test treatment and one
control treatment, concurrent enrollment and follow-up of the test- and control-treated groups,
and in which the treatments to be administered are selected by a random process, such as the use
of a random-numbers table.
Reproducibility of Results - The statistical reproducibility of measurements (often in a clinical

context), including the testing of instrumentation or techniques to obtain reproducible results.
The concept includes reproducibility of physiological measurements, which may be used to
develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of
occurrence of a condition; and reproducibility of experimental results.
Retrospective Studies - Studies used to test etiologic hypotheses in which inferences about an
exposure to putative causal factors are derived from data relating to characteristics of persons
under study or to events or experiences in their past. The essential feature is that some of the
persons under study have the disease or outcome of interest and their characteristics are
compared with those of unaffected persons.

Sample Size - The number of units (persons, animals, patients, specified circumstances, etc.) in a
population to be studied. The sample size should be big enough to have a high likelihood of
detecting a true difference between two groups.
Sensitivity and Specificity - Binary classification measures to assess test results. Sensitivity or
recall rate is the proportion of true positives. Specificity is the probability of correctly
determining the absence of a condition.
Single-Blind Method - A method in which either the observer(s) or the subject(s) is kept
ignorant of the group to which the subjects are assigned.
Time Factors - Elements of limited time intervals, contributing to particular results or situations.
Source: NLM MeSH Database


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Types of Study Designs

Randomized Controlled Trial

Cohort Study (Prospective Observational Study)

Clinical study terminology handout

Case Reports and Series

Ideas, Editorials, Opinions

Animal Research Studies

Test-tube Lab Research

Clinical study terminology handout

Clinical study terminology handout

Genome-Wide Association Study - An analysis comparing the allele frequencies of all

Longitudinal Studies - Studies in which variables relating to an individual or group of

Meta-Analysis - Works consisting of studies using a quantitative method of combining the

Clinical study terminology handout

Prospective Studies - Observation of a population for a sufficient number of persons over a

Quantitative Studies - Quantitative research is research that uses numerical analysis.

Reproducibility of Results - The statistical reproducibility of measurements (often in a clinical

Clinical study terminology handout

Source: NLM MeSH Database

Clinical study terminology handout

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