General Methodological Concepts of Research Flashcards by Madelaine Hess

Define Quantitative

Numbers used to represent data

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Define Qualitative

Words used to represent data

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What are the two branches of quantitative research?

Interventional, Observational

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Define Interventional

Forced allocation to study groups

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Define Observational

No forced allocation into study groups

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Which study design is considered to be experimental?

Interventional

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Which study design is considered to be natural?

Observational

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This study design is useful for unethical study designs using forced interventions.

Observational

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T/F: Most observational study designs are able to prove Causation

False; most observational studies are not able to prove Causation

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What are the study designs of interventional studies?

Phases; 0-4

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What are the study designs of observational studies?

Cross-Sectional
Case-Control
Cohort
Case Reports/Series; Ecological

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List interventional phases in order of increasing evidence

Phase 0 –> Phase 4

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List observational study designs in order of increasing evidence

Case Reports/Series
Ecological
Cross-Sectional
Case-Control
Cohort

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In the research evidence pyramid, name the top two studies

Systematic Reviews; Meta-Analyses

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In the research evidence pyramid, name the second-tier studies

Interventional (exploratory) trials; Pragmatic (explanatory) trials

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What increases moving up the research evidence pyramid?

Strength of evidence

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What study is truly capable of showing causation?

Interventional (exploratory) trials

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There are about 7 elements which study design is based on, list them

Perspective of research question (hypothesis)
Ability/desire of researcher to force group allocation (randomization)
Ethics of methodology
Efficiency and practicality
Costs
Validity of acquired information (internal validity)
Applicability of acquired information to non-study patients (external validity, generalization)

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What is the population in a human study?

All individuals making up a common group; from which a sample can be obtained if desired

What is the difference between “population” and “study population” in human studies?

A study population is a sample of the population, a sample to represent the whole population

What processes are used in drawing a sample from a population?

Random processes

Study population selection is based on…

Research hypothesis/questions
Population of interest
Inclusion & exclusion selection criteria (iInterventional studies) and case & control group OR exposed & non-exposed group selection criteria (observational studies) impact external validity

Define Null Hypothesis

A research perspective which states there will be no (true) difference between the groups being compared

What is the null hypothesis asking of the data?

“To change our minds”

T/F: Null hypothesis is the most conservative and commonly utilized

True

What are the three statistical-perspectives a researcher can take?

- Superiority - Noninferiority - Equivalency

What does superiority compare to? What is its null?

- The placebo, asking if we are better | - Ho: I am not superior

What does non inferiority compare to? What is its null?

- The "gold standard," asking if as effective but with another benefit (ie, less expensive, not taking Rx as often) - Ho: I am worse

What is equivalency looking for? What is its null? What must the data do?

- Equality - Ho: I am not equal - Data must change our minds

What are the two types of error in inaccurately-accepting or rejecting null hypothesis?

Type I and Type II

What is a Type I error?

False positive | think: male, you're pregnant

What is a Type II error?

False negative | think: pregnant female, you're not pregnant

What are the kinds of sampling schemes?

- Probability samples | - Non-probability sampling schemes

What are the kinds of probability sampling schemes?

- Simple Random - Systematic Random - Stratified Simple Random - Stratified Disproportionate Random - Multi-Stage Random - Cluster Multi-Stage Random

What is the probability sampling scheme?

Most common; every element in the population has a known (non-zero) probability of being included in sample

Define Simple Random Sampling

- Assign random numbers, then take randomly-selected numbers to get desired sample size OR - Assign random numbers, then sequentially-list numbers and take desired sample size from top (or bottom) of listed numbers

Define Systematic Random Sampling

Assign random numbers, randomly sort these random numbers, select highest (or lowest) number, systematically (by pre-determined sampling-interval) take every Nth number to get desired sample size

Define Stratified Simple Random Sampling

Stratify sampling frame by desired characteristics (ie gender), use Simple random sampling to select desired sample size

Define Stratified Disproportionate Random Sampling

- Disproportionately utilizes Stratified Simple Random Sampling when baseline population is not at the desired proportional percentages to the referent population - Stratified sample 'weighted' to return sample population back to baseline population **useful for over-sampling**

Define Multi-Stage Random Sampling

Uses Simple random sampling at multiple-stages towards patient selection "random on random on random on random"

Define Cluster Multi-Stage Random Sampling

Also "random on random" but ALL 'elements' clustered together (at any stage) are selected for inclusion ie, ALL clinics or ALL households in a community

What is the non-probability sampling scheme?

Quasi-systematic or convenience samples

What is the Quasi-Systematic or Convenience sample?

Decide on what fraction of population is to be sampled and how they will be sampled ex: all ppl last name beginning w/ M-Z, all ppl attending clinic e/ M/W/F for 6 mons, all ppl referred by selected-peers

What sort of bias is a concern in Quasi-Systematic or Convenience samples?

- Selection bias | - There is some known or unknown order to the sample generated by the selected scheme which may introduce bias

What are the two outcomes in human studies?

- Patient-oriented (vs. disease-oriented) | - Individual vs. combined

What is the most important and most useful outcome?

Patient-oriented