Page 34 - Demo

Chapter 232A B B A CRun-in WashoutPeriod PeriodPair / block BlockCycle CycleA: Active interventionB: PlaceboC: Alternate interventionN-of-1 designBaseline Follow-upFollow-up measurementFigure 1. Schematic Presentation of Terminology Used for N-of-1 Trials.Table 1. N-of-1 Methodological Terminology.Adherence The extent to which a patient’s behavior matches agreed recommendations from a health care provider taking into account the patient’s perspectives.Block A repeated unit of a set number of periods.Compliance The extent to which the patient’s behavior corresponds with the prescriber’s recommendations.Cycle Each repeated unit of a set number of periods within a sequence (e.g., ABA).Generalization The degree to which results observed in a study may extend to other patients or settings, providing an indication of the external validity. Generalization measure Dependent variables in addition to the target behavior used to evaluate transfer effects of the intervention to a broader domain of functioning including other behaviors or settings. Internal validity The degree to which the study’s outcomes could be attributed to the intervention being responsible for change in the dependent variable.N-of-1 study A prospectively planned randomized, controlled multiple crossover trial to determine the effectiveness of an intervention (A) in a single participant. Comparators (B) may include placebo, usual care, alternate treatment or no intervention.Pair A repeated unit containing only two periods.Period The duration of an intervention, comparator, washout, or run-in.Suggested inference Interpretation of the extent of generalization of the study’s outcomes to either the individual participants or patients in general with that specific disorder. Responsiveness to changeThe ability of an instrument to detect change over time in a construct being measured.Run-in Time preceding starting treatment at intended dose to avoid sudden introduction of a fixed therapeutic dose to determine participant compliance or to wash out effects of a previous drug.Washout Time without an intervention following a treatment period to ensure that effects of treatment have disappeared.Annelieke Muller sHL.indd 32 14-11-2023 09:07