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On the other hand, in cluster randomization there is a high risk of contamination between the study arms because the study intervention cannot be blinded.
Because the study intervention is focused on supervised contact between children in long-term care and their parents, the selection criteria developed was as follows: children aged up to 14 years in long-term care (on long-term care orders) having supervised contact with one or more parent which is managed by one of the participating agencies.
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Because the study interventions represent fixed-, one-time costs while the benefits of the interventions may last beyond the one year follow-up period in the KASTPain study, we will conduct sensitivity analyses that extrapolate differences in utilities measured at the end of follow-up over 3, 5, and 10 years, assuming that the interventions do not differentially impact survival.
The treating psychiatrist judges that it is difficult to continue the study intervention because of the emergence of adverse events or another appropriate reason that outweighs the benefit of receiving the study intervention.
not clear Because of the non-homogeneity of the studies' interventions, no pooling of data was possible.
From the individual-level interventions, we excluded 18 because outcomes were measured on the same day as the delivery of the intervention, 7 because they were not randomised controlled trials and 5 because the studies compared interventions with other interventions, rather than no intervention or usual care.
With approval of the appropriate authority, informed consent was not sought because the study-related intervention was noninvasive and bore no risk of interference with the clinical management of the patients.
Some Systems factors defined by the Andersen model are not included in this analysis because they are addressed by the parent study intervention (e.g. transportation, childcare), or because we did not have the data to assess them (homelessness length, language barriers).
The need for informed consent was waived because the study required no intervention and no breach of privacy or anonymity.
All protocols were approved by the local scientific ethics committee and the Danish Data Protection Agency (1995 1200/95 517); because the study required no intervention in addition to routine care, informed consent from patients was not required.
There was no evidence of heterogeneity (I=0%)." 142 "Because the study designs, participants, interventions, and reported outcome measures varied markedly, we focused on describing the studies, their results, their applicability, and their limitations and on qualitative synthesis rather than meta-analysis".
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