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Martje S
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Decks in this class (18)
1. Classes of intervention studies
(e.g. pre-experimental, quasi-experimental and true experimental designs; parallel group designs, cross-over designs, N-of-1 design, non-inferiority trials etc.)
18
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2. Rationale of and prerequisites for experimental intervention research
0
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3. Historical development of intervention trials
In 1747,
In 1854,
In 1918
4
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4. Core elements of the ‘classic’ intervention study design
(RCT = parallel, placebo-controlled, double-blind, randomized trial): choice of study subjects (in-and exclusion criteria, study size), choice of outcome measures and follow-up time (PICOT)
0
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5. Intervention strategies
informed consent procedure, randomization, prestratification, blinding, dealing with protocol deviations (drop-outs, non-compliance, missing values), registration of (serious) adverse events.
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6. Alternative intervention study designs
(e.g., cross-over design, factorial design, Latin square design, prerandomization design (Zelen design), sequential analysis approaches, N of 1 trial designs, single case methodology designs, group-randomized trial design).
2
cards
7. Random allocation
adaptive vs. fixed allocation randomization procedures (e.g., simple randomization, stratified randomization, block randomization, response randomization, replacement randomization, biased coin method, minimization, balancing, unequal randomization).
9
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8. Study population
(e.g., inclusion and exclusion criteria, eligibility considerations, source for selection, recruitment procedures, patient registration, ethical considerations).
0
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9. Design/choice of the intervention
(e.g., treatment schedule (route of administration, dosage, duration), intervention contrast (placebo, usual care), dealing with co-interventions).
0
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10. Outcome measurement
(e.g., primary vs. secondary outcome measures, timing of measurements, quality aspects (validity, reliability, sensitivity-to-change / responsiveness), intended vs. unintended effects).
0
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11. Pros and cons of a run-in period (qualification period).
What are the pros and cons of a r...
1
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12. Role of placebo intervention within the context of a randomized trial.
0
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13. Pragmatic vs. explanatory designs
0
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14. Mixed methods designs
What is a convergent parallel model,
What is explanatory sequential,
What is exploratory sequential
4
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15. Protocol violations
What are protocol violations,
What can cause protocol violations,
What are the effects of protocol ...
3
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16. Statistical analysis of intervention trial results
(e.g., intention-to-treat vs. per-protocol (valid cases) analysis, appropriate statistical techniques).
0
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17. Sample size and power calculation
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21. Ethical and legislative aspects of intervention trials
(e.g., METC-procedures, WMO, GCP, international harmonization, requirements).
0
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Interventional Research
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