van het Reve 2014.
Methods |
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Participants |
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Interventions |
Type of experimental intervention: computerised CT group; treatment duration of 12 weeks; intervention provided in group format, under supervision
Type of control intervention: other; treatment duration of 12 weeks; intervention provided in group format, under supervision
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Outcomes |
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Notes | Due to strength‐balance training, which was given to both groups, we included the study in the inactive control comparison | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk |
Judgement: adequate random sequence generation Quote(s): "to ensure allocation concealment, participants in each home were enrolled by the health care staff, and randomized by the person assessing the outcome measures using simple (unrestricted) randomisation.. based on a table of random numbers" |
Allocation concealment (selection bias) | Unclear risk |
Judgement: unclear allocation concealment Quote(s): "the assessor generated an unpredictable allocation sequence, which was concealed until assignment occurred. Each participant in every home received a two digit number (01, 02, 03, …) resulting in a rank order of the participants. With the help of the random numbers table the assessor decided a priori to pick a number from the table with a pencil and go through the table either from bottom‐right to upper‐left in a diagonal way, horizontally from left‐to‐right or right‐to‐left, etc" |
Blinding of participants (performance bias) | Unclear risk |
Judgement: patient blinding was not reported, but it is unlikely Quote(s): "blinding of the investigator was not possible because the investigator conducted part of the assessments" |
Blinding of personnel (performance bias) | High risk |
Judgement: investigators were not blinded Quote(s): "blinding of the investigator was not possible because the investigator conducted part of the assessments" |
Blinding of outcome assessment (detection bias) All outcomes | High risk |
Judgement: outcome assessment was not blinded Quote(s): "blinding of the investigator was not possible because the investigator conducted part of the assessments" |
Incomplete outcome data (attrition bias) All outcomes | High risk |
Judgement: 69 out of 84 (82%) randomised were analysed in the experimental group, and 76 out of 98 (78%) randomised were analysed in the control group, although statistical analyses were reported to be done according to the intent‐to‐treat principle. In addition, 4 participants were re‐assigned by investigators to the control group despite being initially randomised to the intervention group Quote(s): "a total of 156 participants completed the intervention (137 subjects living in the homes‐for‐the‐aged and 19 subjects living in the vicinity) resulting in 14.3% attrition"; "Four participants that were not able to conduct the cognitive training due to vision problems were manually allocated to the SB group after randomization. Thus, we reported 98 participants in SB and 84 participants in SBC after this adaptation" |
Selective reporting (reporting bias) | Low risk | Judgement: all outcomes indicated in the methods section are reported in the results section |
Other bias | Low risk |
Judgement: no other sources of bias detected Quote(s): none |
AC: active control.
AE: adverse event.
APOE: apolipoprotein E.
AR: aerobics and resistance.
BDT‐DT: The Baddeley Dual Task
CCI: computerised cognitive intervention.
COWAT: Controlled Oral Word Association Test.
CT: computed tomography.
CWIT: Color‐Word Interference Test.
DT: dual task.
FCSRT: Free and Cued Selective Reminding Test.
GDS‐Sf: short‐form Geriatric Depression Scale.
HVLT: Hopkins Verbal Learning Test.
ITT: intention‐to‐treat.
MMRM: mixed model for repeated measures.
MMSE: Mini Mental State Examination.
MoCA: Montreal Cognitive Assessment.
RBMT: Rivermead Behavioural Memory Test.
RCT: randomised controlled trial.
RT: Reaction time.
SAE: serious adverse event.
SD: standard deviation.
ST: stretching and toning.
SVP: speed of visual information processing.
TMT: Trail Making Test.
WMS‐III: Wechsler Memory Scale, Third Edition.