Trebbastoni 2018.
Methods | A single‐blind RCT comparing effects on cognition of a group CT programme vs a no intervention control condition for persons with mild to moderate AD | |
Participants | 140 community‐dwelling participants (78 women) between 50 and 85 years of age with a diagnosis of Alzheimer‐type dementia, according to NINCDS‐ADRDA, were recruited in Rome, Italy | |
Interventions | Participants in the intervention condition (n = 54) participated in group CT sessions that involved paper‐and‐pencil tasks, as well as verbal‐learning exercises. Participants were trained twice a week over 24 weeks Participants assigned to the control condition (n = 86) received usual care at the hospital | |
Outcomes | Oucomes included performance on several cognitive domains, including memory, attention, language, visuospatial functions, frontal functions, and praxis Participants were assessed at baseline, post intervention, and 6 months later | |
Country | Italy | |
Registration status | No information provided; presumed to be unregistered | |
Conflict of Interests | No | |
Notes | Six participants from the experimental group (n = 54) were included only in the first part of the study (from T0 to T1), but not from T1 to T2. They were excluded because they had attended less than 80% of the sessions. Between T1 and T2, 3 participants were excluded from this group (1 loss to follow‐up; 1 decision to withdraw; 1 death). Therefore, 54 participants in the experimental group were assessed at T1, but only 45 were assessed at T2 (6 months' follow‐up) Study authors provided the original paper along with clarification on a discrepancy between the same score in 2 different tables |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The ratio of intended numbers of participants in each of the comparison groups depended on the resources available at our site. Hence, we used a random numbering with an unequal allocation ratio of 1:2 (1 treated:2 untreated). Ten days prior to the commencement of the training, we computer‐generated a randomisation list that assigned the patients belonging to the TG to nine treatment sub‐groups" |
Allocation concealment (selection bias) | Unclear risk | Study authors stated that they used a computerised randomisation system. It is likely that allocation concealment was done, but this is not specified |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Study authors did not mention blinding of participants; the study included a passive control condition, so blinding was not possible |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Independent expert evaluators, who were blinded to the treated or untreated status of the patients, recorded the outcome measures at T0, T1 and T2" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Researchers stated, "We analysed the data of all the participants who concluded the study and were tested at T2" Nine participants in the experimental condition and one in the control condition dropped out during the study; their data were not reported, which is likely to introduce attrition bias |
Selective reporting (reporting bias) | Low risk | All tests mentioned in the "Methods" section were reported in the "Results" section |
Other bias | Low risk | Study appears to be free of other sources of bias |