Page 44 - Demo

Chapter 242proven intervention based on anecdotal reports of efficacy and prejudices were reported to have affected recruitment of participants, compliance, and, subsequently, outcome scores.31 Also, a difference between ratings by caregivers and research personnel was perceived in some studies without assessing an interrater agreement. Finally, difficulty with statistical analysis was identified. As N-of-1 studies could have different purposes such as a proof of concept, providing an individual treatment decision, or estimating the treatment effect at a population level, the level of complexity and necessity of statistical analyses might be contingent on the reason for the study. Specifically, the degree of certainty desired was taken into consideration by the author(s) in 1 study where a visual analysis clearly showed that the active intervention was beneficial compared with placebo, but the statistical analyses did not reveal significant results in some cases.28Figure 3. Schematic Representation of the Risk of Bias in N-of-1 Trials (RoBiNT) Scale.(A) Items of internal validity. (B) Items on external validity and interpretation. The y-axis indicates the included N-of-1 studies ordered per first authors. Circles indicate scores on the 3-point rating scale where 2 points were awarded for meeting the recommended stringent criteria (green), 1 point to otherwise defined criteria (yellow), and 0 points for not meeting the stringent criteria of the design standards (red).Annelieke Muller sHL.indd 42 14-11-2023 09:07