Djabelkhir 2017

Methods	Design: 2‐arm RCT with parallel‐group design Recruitment period: December 2014 to July 2015 No. of centres involved: 1 hospital in France Unit of randomisation: individuals No. randomised: 20 (10 participants each arm) Number of arms considered in this review: 2 Maximum trial duration: 3 months (12 weeks) Funding by non‐profit organisation: none described Funding by commercial organisation: computerised cognitive exercises web platform (KODRO) was provided by the company Publication status: full‐text report
Participants	Patient flow: 53 participants were screened and 20 were randomised: 10 participants received computerised cognitive stimulation (Intervention) (CCS) and 10 received computerised cognitive engagement (control) (CCE) Number of females: intervention (CCS): 7 of 10 (70%); control (CCE): 6 of 10 (60%) Average age (SD): intervention (CCS): 75.2 (6.4); control (CCE): 78.2 (7.0) Education (college degree or higher, n (%)): intervention (CCS): 4 (44.4%); control (CCE): 6 (60%) Baseline cognitive function in MMSE (mean, SD): intervention (CCS): 27.7 (1.9); control (CCE): 27.4 (2.0) Selection criteria: inclusion criteria: community‐dwelling older adults (≥ 60 years) meeting MCI criteria according to Petersen; mini Mental Status Examination (MMSE) score > 24; reported a subjective memory complaint, preferably corroborated by an informant; performed at/below 1.5 standard deviations (SDs) from the mean for age and education on more than 1 neuropsychological test, with preserved or minimal impairment in functional abilities; absence of dementia. Exclusion criteria: psychiatric and neurological disorders (e.g. bipolar disorder, schizophrenia, stroke, Parkinson’s disease, epilepsy); history of alcohol or other substance abuse; sensory and/or motor deficits affecting the use of a tablet PC Ethnicity: not reported APOE: not reported
Interventions	Type of experimental intervention: computerised cognitive training (CCS), group; treatment duration of 3 months (12 weeks); intervention provided in small group format under trained neuropsychologist supervision Details of experimental intervention: intervention group attended 1 group session per week (5 to 7 participants) for 3 months (12 sessions in total). The CCS programme was designed to stimulate several cognitive domains with computerised cognitive exercises and social interactions among participants. Each session was conducted as follows: presentation of the day’s programme, recall of the last session and discussion (15 minutes). Cognitive exercises on tablet with a short break between exercises (60 minutes). Feedback and group discussion about the session (15 minutes). Computerised cognitive exercises were selected from the institution version of KODRO (Altera‐Group, Paris, France), a web‐based platform that provided several applications (e.g. appointment and event reminding, cognitive games, communication, entertainment, videos and a library) tailored to older adults Type of concomitant treatment provided: not stated Session duration: 90 minutes in experimental group Number of treatment sessions: 12 in experimental group Treatment frequency: 1 session per week Maximum treatment duration in months: 3 months (12 sessions) in experimental group Type of control intervention: inactive; control group (CCE) attended 1 group session per week (5 to 7 participants) for 3 months (12 sessions in total). Each session lasted 90 minutes and was conducted by a trained neuropsychologist blinded to assessment Details of control intervention: CCE programme was designed to train participants to use a tablet PC and to stimulate social interactions among participants. CCE participants were involved in a casual atmosphere, while the content was preprogrammed. A specific topic was defined for each session, and participants were invited to explore different applications related to this. For example, for the theme “compensating for memory problems”, participants discovered the calendar and learned to schedule an appointment on it. During sessions, participants were invited to suggest a theme, and the neuropsychologist showed applications associated with the theme Type of concomitant treatment provided: not stated Session duration: 90 minutes in control group. Number of treatment sessions: 12 in control group Treatment frequency: 1/week in control group Maximum treatment duration in months: 3 months (12 sessions) in control group
Outcomes	Cognitive functioning outcome considered Global cognitive function with MMSE on a scale from 0 to 30 with higher values indicating benefit Episodic memory measured with 16‐FR/CR test on a scale from not reported to not reported with higher values indicating benefit Executive function measured in seconds with TMT‐B at 12 weeks on a scale from not reported to not reported with lower values indicating benefit Speed of processing measured with TMT‐A at 12 weeks, on a scale from not reported to not reported with lower values indicating benefit Working memory with the Backward Digit Span from the Wechsler Adult Intelligent Scale (WAIS) 4th edition, on a scale from not reported to not reported with higher values indicating benefit Verbal fluency measured in number of words with letter P in 2 minutes Physical functioning outcome considered: none reported Quality of life outcome considered: quality of life was assessed using the quality of life scale for older French people (Echelle de Qualité de Vie adpatée aux Personnes Agées) Safety outcome considered: none reported Depression outcome considered: depression symptoms measured with Goldberg Anxiety and Depression Scales, on a scale from not reported to not reported with lower values indicating benefit Other outcome data on cognitive functioning not considered in our meta‐analyses Episodic memory measured with Visuospatial memory test from the cognitive efficiency profile, on a scale from not reported to not reported with higher values indicating benefit Executive function measured with TMT‐B error on a scale from not reported to not reported with lower values indicating benefit Verbal fluency measured with Category Fluency, on a scale from not reported to not reported with higher values indicating benefit
Notes	KODRO provided access to the software; study authors reported no conflict of interest in the study
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Judgement: adequate method of random sequence generation Quote(s): "patients were assigned to either a computerized CS (CCS) group or a computerized cognitive engagement (CCE) group with a simple computerized randomization procedure
Allocation concealment (selection bias)	Unclear risk	Judgement: no description provided
Blinding of participants (performance bias)	Unclear risk	Judgement: study described as single‐blinded; however, it is not clear if and how participants were blinded Quote(s): "we designed a randomized single‐blind study conforming to Consolidated Standards of Reporting Trials criteria for pilot and feasibility studies"
Blinding of physicians / personnel	High risk	Judgement: therapists could not be blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Judgement: blinded outcome assessment Quote(s): "these were carried out by an experienced neuropsychologist blinded to the intervention"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Judgement: no participants were lost to follow‐up Quote(s): "none of the participants discontinued the intervention. Only one participant in the CCS group did not perform the M3 assessment for medical reasons (surgery), resulting in 19 subjects for the final analyses"
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 are apparent