Table 1.
Deviations from protocol.
Original criteria | Change | Justification |
---|---|---|
Eligible participants must be adults aged 18 years and above | Participants were required to be adults aged 16 years and over, of either gender (studies where >80% of the sample was within this age range were also eligible) | The minimum age accepted for inclusion was reduced from 18 to 16 years old in order to be consistent with international definitions of the start of adulthood. The inclusion criteria was also broadened to state that 80% or more of the participants had to be in this age range. This catered for studies in which the inclusion criteria did not include an age range and/or when the sample age was only provided as mean and standard deviation with no range provided |
Traumatic brain injury of any severity will be accepted for the review—as diagnosed using any recognized criteria | “Recognized criteria” (i.e., GCS, PTA, LoC, coma) were not required for inclusion | Inclusion criteria broadened due to paucity of studies. Review authors agreed that if the study authors deemed the patient to have had a TBI and/or were assessing them in a hospital/rehabilitation outpatient setting and/or the cause of the injury was clearly TBI (e.g., gunshot wound), this was sufficient |
RCTs to be excluded | RCTs were eligible for inclusion in this review | The original intention was to separate this review into two reviews; focusing on RCTs and non-RCTs. However, due to the paucity of studies, it was decided to combine the study designs in a single review |
Risk of bias will be assessed using the Newcastle-Ottawa Scale | Risk of bias was assessed using the Cochrane tools (RCTs) and the Joanna Briggs Institute tools (non-RCT) | The review team felt these tools provided a clearer assessment of methodological quality |
GCS, Glasgow Coma Scale; LoC, loss of consciousness; PTA, post-traumatic amnesia; RCT, randomized controlled trial; TBI, traumatic brain injury.