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| Δοκιμή N-of-1× | Τυχαιοποιημένη Ελεγχόμενη Δοκιμή (ΤΕΔ)× | |
|---|---|---|
| Πεδίο≠ | Κλινική Έρευνα | Πειραματικός Σχεδιασμός |
| Οικογένεια≠ | Process / pipeline | Hypothesis test |
| Έτος προέλευσης≠ | 1990s-2010s | 1948 |
| Δημιουργός≠ | Kravitz, Duan, Vohra, and single-patient methodology pioneers | James Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948) |
| Τύπος≠ | Research Design | Interventional comparative study |
| Θεμελιώδης πηγή≠ | Gabler, N. B., Duan, N., Vohra, S., & Kravitz, R. L. (2011). N-of-1 trials in the medical literature: a systematic review. Medical Care, 49(8), 761–768. DOI ↗ | Schulz, K.F., Altman, D.G., Moher, D., for the CONSORT Group (2010). CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. BMJ, 340, c332. DOI ↗ |
| Εναλλακτικές ονομασίες | single-patient RCT, n=1 trial, individual RCT, crossover n-of-1 | RCT, randomised controlled trial, clinical trial, Randomize Kontrollü Çalışma (RCT) Tasarımı |
| Συναφείς≠ | 3 | 7 |
| Σύνοψη≠ | An N-of-1 trial is a single-patient randomized controlled trial in which a patient alternates between treatment A and treatment B (or active drug and placebo) in repeated, randomized cross-over periods. Developed systematically in the 1990s–2010s by Kravitz, Duan, and Vohra, N-of-1 trials enable personalized medicine by determining which treatment works best for that specific individual, avoiding the assumption that population-average effects apply to all patients. They are ideal for chronic conditions with variable outcomes and heterogeneous treatment response. | A randomized controlled trial (RCT) is the gold standard experimental design in clinical and health research, in which participants are randomly allocated to a treatment group or a control group so that the effect of an intervention can be measured with the highest possible degree of internal validity. The modern parallel-group RCT was formalized by Austin Bradford Hill and the Medical Research Council in their landmark streptomycin trial of 1948, and its reporting is governed today by the CONSORT 2010 guidelines (Schulz et al., 2010). |
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