Aspect | Issue | Description | |
---|---|---|---|
Informed consent | ~ | (3a)* | May be difficult to obtain from subjects at the start of the study [13], and both SWDs and parallel group CRTs need modified informed consent procedures [57] |
In cross-sectional SWDs the informed consent is in essence similar to that of a parallel group CRT. In cohort SWDs participants will have to understand that the moment of receiving the new intervention is being randomized | |||
Study participation | - | (3b)* | An SWD may have increased risk of drop-outs and drop-ins (contamination) [6, 13, 18, 21, 22, 54] |
†Inclusion rate | - | (3c)* | An SWD suffers relatively more from low inclusion rates because adding a cluster or extending the steps during the trial disrupts the symmetry of the design |
†Study duration | ~ | (3d) | The possible longer study duration of SWDs might require interim analyses to avoid long exposure of clusters of participants to suboptimal care when the new intervention would be clearly inferior/superior to usual care. The statistical analysis aspects of interim analyses in an SWD are, however, still unclear |
†Number of measurements | - | (3e) | If collecting data on health outcomes or costs is expensive, it may not be feasible to collect health economic evidence at each time point (step) in a cohort (longitudinal) SWD. This is particularly relevant if the number of steps (and hence number of measurements per participant), would be large. Even though a similar parallel group CRT would require more participants it might require fewer measurements in total [5, 34–36], and therefore could be more feasible |
- | (3f) | Repeated measurements within the SWD may lead to a higher burden on everyone involved in the study. In the cross-sectional setting, this will not be a problem for individual participants, but may still be for research personnel [13, 16, 18, 19, 22, 35] | |
Blinding | - | (3g) | Blinding of participants and care providers is often impossible within SWD, however this also holds for the parallel group CRT. Hence, blinding of assessors of the outcomes is advised [6, 11–13, 19] |
Improving intervention | ~ | (3h) | Within the SWD it is possible to improve the intervention during the study, though it is questionable whether it is desirable to do so [12, 18, 22, 56] |