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50 Cards in this Set
- Front
- Back
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PRIMARY LITERATURE
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Original publications with original data
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DATA DREDGING
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Negative results prompt researchers to reconfigure data to find some sort of positive result
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ABSTRACT
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- Overview of the study or synopsis of major principles
- Highlights results |
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INTRODUCTION
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- Justifies/states the study rationale and purpose
- Review relevant work of others - Background information |
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METHODS
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- Trial design
- Description of subject selection - Comparative therapy description - Outcome measures - Statistical test selection |
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RESULTS
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- Primary and secondary endpoint results
- Graphics that summarize findings - Analysis of differences between groups |
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DISCUSSION
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- Investigators' evaluation and interpretation of study results
- Establish significance of work - Compare work with others' - Discuss strengths and limitations - Anticipate future research |
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REFERENCES/BIBLIOGRAPHY
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- Evidence that others' work was considered
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List the 4 STUDY PERSPECTIVES
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- Prospective
- Retrospective - Parallel - Crossover |
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PROSPECTIVE
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- Followed forward in time
- More control over confounding variables and biases - Randomization |
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RETROSPECTIVE
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- Reviewed back in time
- Ethical considerations - Less costly, less time |
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PARALLEL
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Subject receives either the study or control medication throughout the study. Two or more groups are receiving treatment at the same time; each group gets 1 treatment only, number of groups may vary
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CROSSOVER
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Each subject serves as his own control. The subject receives both the study and control treatments.
- Wash out period is ideal - Inner-patient variability - Not population-based data |
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DESCRIPTIVE
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- Quantitative research that describes naturally occurring events
- Document and communicate experience - Cannot draw conclusions |
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EXPLANATORY
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- Examine etiology, efficacy, or cause using a comparison strategy
a. Experimental b. Observational i. Case-Control ii. Cohort |
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Explanatory:EXPERIMENTAL
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- Evaluate efficacy of therapeutic or educational interventions
- Investigator controls allocation - Ex: randomized control, clinical trials, educational interventions |
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Explanatory: OBSERVATIONAL
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- Investigator observes nature
- No control over allocation - Ex: Case-control, cohort, cross-sectional, epidemiologic studies |
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Explanatory: Observational: CASE-CONTROL
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- Think DISEASE
- Retrospective - Patients with the disease (cases) and without the disease (controls) are compared to determine the exposure to the risk factor in question |
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Explanatory: Observational: COHORT
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- Think EXPOSURE
- Prospective or retrospective - Design may involve the evaluation of risk factors for disease development in a specified population i. Follow-Up ii. Prospective Follow-Up iii. Retrospective Follow-Up iv. Cross-Sectional |
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Explanatory: Observational: Cohort: FOLLOW-UP STUDY DESIGN
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- Study population and exposure to risk factor occurs in the present
- Disease or outcome evaluation occurs in the future |
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Explanatory: Observational: Cohort: PROSPECTIVE FOLLOW-UP STUDY DESIGN
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- Exposure to risk factor occurred in the past
- Study population determined in the present - Disease/outcome determination occurs in the future |
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Explanatory: Observational: Cohort: RETROSPECTIVE FOLLOW-UP STUDY DESIGN
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- Exposure to risk factor and development of disease/outcome occurred in the past
- Study population is determined in the present |
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Explanatory: Observational: Cohort: CROSS-SECTIONAL
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- Prevalence study
- "Slice in time" - Identifies existence of health problems - Study population, disease/outcome determination, and risk factor exposure occur in the present |
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Explanatory: Experimental: SUPERIORITY
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- Trial with the primary objective of showing that the response to the investigational product is superior to a comparator
- Superiority is shown as long as the line doesn't cross the 0-line |
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Explanatory: Experimental: EQUIVALENCE
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- Trial with the primary objective of showing that the response to 2 or more treatments differs by an amount that is clinically unimportant
- Usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence margin of clinically acceptable differences - Equivalence is shown as long as the line doesn't cross Negative-Delta or Positive-Delta |
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DELTA
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Clinically relevant difference
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Explanatory: Experimental: NON-INFERIORITY
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- Trial with the primary objective of showing that the response to the investigational product is not clinically inferior to a comparative agent
- Pre-specified maximum allowable difference between the new and the standard treatment - Non-inferiority is shown as long as the line does not cross the Negative-Delta/Equivalence Margin/Non-Inferiority Margin line |
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N-OF-1 STUDY DESIGN
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Controlled study conducted in a single subject where periods of exposure to a treatment are compared to periods of exposure to placebo
- Useful for rare diseases with new treatments |
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STABILITY STUDY DESIGN
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- Study designed to determine the stability of drugs in various populations
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BIOEQUIVALENCE STUDY DESIGN
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- Study that evaluates whether products are similar in rate and extent of absorption
- More specific type of equivalence study |
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SURVEY RESEARCH
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- Research where the responses to questions asked of subjects are analyzed to determine the incidence, distribution, and relationships of sociological and psychological variables
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PROGRAMMATIC RESEARCH
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- Research focused on the impact and economic value to programs and services provided
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QUALITY OF LIFE STUDY DESIGN
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- Evaluation of a patient's living situation based on the patient's environment, family life, financial situation, education, and health
- Used mostly for diseases that are not curable, but are treatable |
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POST-MARKETING SURVEILLANCE STUDY
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- Study designed to examine drug use and frequency of side effects following FDA approval
- Phase IV study |
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PHARMACOECONOMIC STUDY
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- Study of economic impact of drug therapies or services
- Ex: benefit of formulary development |
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META-ANALYSIS
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- Process of systematically evaluating and combining the results of clinical trials that have been completed
- Systematically aggregates and quantifies results from multiple clinical trials |
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Meta-analysis: DATA POOLING TYPE 1
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- Combining raw data to increase study power
- Restart analysis from beginning - Strongest type of meta-analysis |
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Meta-analysis: DATA POOLING TYPE 2
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- Combining conclusions (ex odds ratios) of single trials to create an overall average odds ratio
- Most frequent type of meta-analysis |
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Meta-analysis: DATA POOLING TYPE 3
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- Summarizing individual results (ex. stating that 7 out of 10 trials support that drug A is more effective compared with placebo)
- Weakest form of meta-analysis - Looks like a systemic review |
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Meta-analysis: FUNNEL PLOT
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- Includes all studies included in the meta-analysis
- Open circles are unpublished studies - Measure precision against treatment effect - Absence of publication bias is suggested by a symmetrical inverted funnel |
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Meta-analysis: BLOBBOGRAM/ FOREST PLOT
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- Summary of results of meta-analysis
- Each line represents a clinical trial - line is confidence interval - Diamond is the result of the meta-analysis - Middle is the estimate of effect - Width is the confidence interval |
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INTENTION-TO-TREAT
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- Data are analyzed based on what the patients were intended to receive (disregards drug mix-ups and noncompliance issues)
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POPULATION
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Every individual in the universe with the specific characteristic(s) or disease state under study
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SAMPLE
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Group of individuals chosen as representatives from the population under study
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INCLUSION CRITERIA
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Characteristics that must be possessed by the patient in order to enroll in the study
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EXCLUSION CRITERIA
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Characteristics that prevent patient participation in the study
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RANDOMIZATION
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- Each subject has an equal and independent chance of being in any of the treatment arms
1. Simple 2. Block/Cluster 3. Non-randomization 4. Stratification |
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Randomization: SIMPLE
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Coin-tossing to divide people into treatment arms
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Randomization: BLOCK/CLUSTER
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- In the case of block size 4, there are 6 possible combinations of group assignments: AABB, ABAB, BAAB, BABA, BBAA, ABBA
- One is selected at random and the 4 participants are assigned accordingly |
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Randomization: NON-RANDOMIZATION
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Treatment arms are NOT assigned randomly; the participants or researchers may choose which group the participant will belong to
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