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. 2021 Oct 12;2021(10):CD013379. doi: 10.1002/14651858.CD013379.pub2

Koszalinski 2020.

Study characteristics
Methods Quasi‐randomised controlled trial
Participants 36 participants
Inclusion criteria: hospitalisation on any of the participating units for any length of time; RASS score between −1 and +1 (awake, aware, and not agitated); able to use Speak For Myself‐Voice for 48 hours; able to manipulate a computer tablet; ability to read and write English.
Exclusion criteria: hospitalised on units other than those participating in the study; RASS score less than −1 or exceeding +1; unwilling to use Speak For Myself‐Voice for 48 hours; unable to manipulate the computer tablet; unable to read and write English.
Interventions Intervention
Participants provided the Speak for Myself‐Voice communication tablet app provided on an i‐Pad. This included an advanced care planning menu, pain indication, basic needs requests, a free‐text section app was used on i‐Pads. Participants were provided the Speak for Myself‐Voice app for 48 hours or until they no longer needed communication assistance.
Control
Alphabet and picture communication board as usual care.
Outcomes
  • Depression.

  • Anxiety.

Notes Secondary analyses paper reported each of the HADS items in detail (Koszalinki 2020).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Assignment to groups was not entirely random, the randomisation schedule was described as beginning with first participant assigned to the intervention group, second to control, third to intervention, etc.).
Allocation concealment (selection bias) High risk Allocation was known to the research team but concealed from the clinical team and participants.
Blinding of participants and personnel (performance bias)
All outcomes High risk Unable to blind due to nature of intervention.
Blinding of outcome assessment (detection bias)
All outcomes High risk Blinding of outcome assessors not performed (information provided by corresponding author).
Incomplete outcome data (attrition bias)
All outcomes Low risk No indication of incomplete data.
Selective reporting (reporting bias) Low risk No evidence of selective reporting.
Other bias Low risk No evidence of other bias.
Partially funded by the University of Tennessee, Center for Health Sciences Research – not considered a source of bias.
Author conflict of interest: none stated.