Table 4 Methodological advances of current trial relative to past sensor-technology intervention trials among patients with communication difficulties
Limitations in literaturea | Current study features |
|---|---|
Few controlled trials | Randomized controlled design |
Small sample sized/insufficient power/case studies | A sample of 38 patients allowing us to detect an 0.80 effect size |
Absence of studies using comparator interventions | Controlling for effect of study participation by including a group with delayed intervention |
Exclusion of most vulnerable patients | Inclusion of profoundly disabled patients |
Lack of standardized measures and biomarkers | HR, HRV and biochemical biomarkers in blood |
No adherence data | Routine signing of protocol by secondary participants to measure adherence |
Considerable heterogeneity of participants regarding type and level of communication need | Patients with ID ranging from severe to profound and ranging from ambulant to wheelchair user, loss of eyesight and hearing |