Lecture bioinformatic databases - Thursday - Pragmatic and explanatory research
26 important questions on Lecture bioinformatic databases - Thursday - Pragmatic and explanatory research
How can research be categorised?
- Explanatory is also called pathophysiological
- Economic is an example of pragmatic research
- Phase 1 to phase IV
- Laboratory - patient - society
- Proof of principle - efficacy - effectiveness
What is the difference between explanatory and pragmatic research?
Pragmatic = does it help the patients
What do you have to do when there is overlap between your experimental groups? (=ceteris paribus)
--> when difference (delta) is small
--> when SD is large
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Why is overlap between experimental groups bad?
- more difficult to draw statistically significant conclusions
- can be solved by increasing sample size
What are the seven aspects of research design?
- Choice of comparative treatments
- Choice of patient groups
- Blinding
- Control group
- Analysis: PP, AT, ITT
- Outcome measures
- Timing of measurements
What would you compare your new treatment with to know if it helps the patient?
Compare new policy to usual care
No checks on execution and compliance
What type of patient group would you study if you want to know how your treatment works?
- Homogeneous population with largest effect
- strict inclusion criteria
- reduces variation, thus increasing statistical efficiency
What type of patient group would you study if you want to know whether the treatment helps?
- Everyday heterogeneous patients
Would you blind patients if you want to know how treatment works?
- ideally double blind
Would you blind patients if you want to know if treatment helps the patient?
- usually non-blinded
- in daily practice patients and doctor know treatment
- possibly measurements by blinded observer
What are disadvantages of randomization?
- Retrospective data cannot be randomized
- If long follow-up is required you need to wait
- but chance can be analyzed using standard statistics
How can randomization be bad for external validity?
- more aware of the research -> influence on compliance
- more aware of the alternative -> influence on reporting
- 'contamination' -> care provider may apply elements of the experimental treatment in the control group
What is minimization (type of randomization)?
--> example: assign men with 75% probability to group with the least men
What is cluster randomization?
- patients are clustered = all patients from one physician, practice, region etc.
--> good for external validity (prevents contamination)
--> can be bad for internal validity
- clusters may not be comparable (many clusters needed)
- Inclusion criteria can differ between clusters
- Randomization is performed before inclusion (not blinded)
WHat is the difference between PP (per-protocol) and as-treated (AT) analysis?
AT = groups defined according to treatment, irrespective of randomization (fewer exclusions)
--> both explanatory
Are PP and AT explanatory or pragmatic?
What is ITT analysis?
Evaluation according to randomization without any exclusion (includes all errors)
You want to evaluate the policy (and errors are made during policy)
-- pragmatic
Is ITT pragmatic or explanatory?
Is ITT bad/good for internal and external validity?
- Mixed effect on internal validity
- Groups remain comparable (++)
- PP and AT mess up randomization
- Loss of statistical efficiency (-)
- Discrepancy between randomization and primary treatment
How would you measure disease burden?
- patient burden (quality of life and mortality)
- societal burden (costs)
--> costs per QALY
How to measure quality of life?
- questionnaire
- expensive and slow!
- intermediary outcome measures (BP, cholesterol etc.) --> relationship with disease burden
Timing of measurements for explanatory and pragmatic non-economic research
Pragmatic non economic = measure at time of largest expected difference, disease burden (long term needed). Measurments bring distortion -> don't measure too much
How can utility (value for the quality of life) be measured?
- Time Trade-Off (TTO)
- Standard gamble (SG)
- Questionnaires (like EQ-5D)
What is the visual analog scale (VAS)?
What is the Standard Gamble method?
- A: remaining life years blind
- B: 50% immediate death or 50% life in perfect health
--> the percentages you can differ (P and 1-P) and somewhere there is a break-even point.
Differences between VAS, TTO and SG
TTO trades quality for life years
SG trades quality for mortality
Usually, VAS < TTO < SG
--> TTO considered more valid method
What is the prefered method in the Netherlands to measure quality of life?
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