Table 1

Variables and Definitions Used in Systematic Review

Variable
Definition

Sample size
Number of subjects who participated in the research at the initiation of the study
Gender
Percent of sample male/female
Age
Average age of sample
Ethnicity
Percent of identified racial or ethnic categories
Response rate
Sample size divided by the total number of people approached for participation
Attrition rate
Number of subjects finishing study divided by sample size
Sampling Frame
How sample was identified–random, systematic, mixed, none, not indicated
Research Design
Prospective, cross-sectional or retrospective design
Statistics
Based on highest level used: descriptive, univariate, or multivariate
Funding Source
Who paid for research
Control Group
Whether or not a control group was used in design
Reliability
Any indication of the reliability of any measure used.
Random assignment
Use of random assignment to groups
Confounding variable
Any measurement or statistical applications that attempt to identify and control for variables that might influence outcomes independent of treatment.

Threats to validity

Threats to Statistical Conclusion Validity
Low statistical power
Rated as any groups < 10 or correlations with fewer than 30 pairs.
Violated assumption
Evidence of non-normal distributions with parametric statistics
Fishing/error rate
More than 10 statistical tests without a Bonferroni (or similar) correction.
Reliability of measures
Failure to test, note or reference information on measures
Reliability of treatment
Failure to test or note consistently of the application of treatments
Random irrelevancies
Absence of effort to make measurements reasonably consistent.
Random heterogeneity representative
Absence of effort to ensure that sample is reasonably
Threats to Internal validity
History
Repeated measures without temporal control
Maturation
Repeated measures without temporal control on developmentally sensitive outcomes.
Testing
Use of measures that are sensitive to the testing process.
Instrumentation
Use of poorly or uncalibrated measures.
Statistical regression
Study of cases selected from extremes without control group
Mortality
More than 30% of sample did not complete study
Interaction with selection
Evidence that selection into groups might interact with history, maturation, or testing.
Ambiguity of cause
An association that can be interpreted in either direction vis-à-vis cause and effect.
Diffusion of treatment
Contact between experimental and control subjects.
Compensatory work to Equalization
Evidence that groups are knowledgeable about design and might Equal things out.
Compensatory rivalry
Evidence that groups are knowledge about design and might compete with other group members.
Resentful demoralization
Evidence that one group feels disadvantaged through group assignment process.
Threats to Construct Validity
Inadequate explication
Evidence that choice of measurement operations does not represent the construct.
Mono-operation bias
Use of only one question for central outcome
Mono-method bias
Use of only one measurement approach (e.g self report) for central outcome
Hypothesis guessing
Evidence that subjects might attempt to guess what results should be (absence of appropriate blinding procedures).
Evaluation apprehension
Evidence that subjects might become anxious during assessments.
Experimenter bias
Absence of controls to keep invested parties from participating in the measurement procedures.
Confounding constructs
Range restriction in measurement
With level of constructs

Threats to External Validity
Interaction of different Treatment
Failure to assess additional treatment received during study.
Interaction of testing And treatment
Evidence that testing might be related to the treatment so that subjects complete tests differently after treatment.
Restricted generalizability
Evidence of a limited measurement approach that may not generalize.
Sample bias
Evidence of a poorly chosen sample that does not represent the population considered.
Interaction of selection And treatment
Evidence that group assignment is influenced by variables related to the likelihood of response to treatment
Interaction of setting And treatment
Evidence that treatment works only in some settings.
Interaction of history And treatment
Evidence that the time during which the study was done may have an impact on findings.

Jonas et al. BMC Complementary and Alternative Medicine 2001 1:12   doi:10.1186/1472-6882-1-12

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