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. 2019 Mar 13;2019(3):CD012279. doi: 10.1002/14651858.CD012279.pub2
Methods
  • Design: 2‐arm RCT with parallel‐group design

  • Recruitment period: not reported to not reported

  • No. of centre involved: 1

  • Unit of randomisation: individuals

  • No. randomised: 22

  • Number of arms considered in this review: 2

  • Maximum trial duration: 9 months

  • Funding by non‐profit organisation: unclear

  • Funding by commercial organisation: unclear

  • Publication status: full‐text report

Participants
  • Type of MCI: amnestic MCI multiple domains subtype (A‐MCImd) consistent with Petersen 2004 criteria

  • Patient flow: 11 randomised, 11 described at baseline in experimental group; 11 randomised, 11 described at baseline in control group

  • Number of females: 5 of 11 (45%) in experimental group 1; 6 of 11 (55%) in control group 1

  • Average age (SD): 75 (2.0) years in experimental group 1; 78 (1.4) years in control group 1

  • Average (SD) education: not reported. Experimental group 1: primary: 54%; secondary: 36%; more than secondary: 10%. Control group 1: primary: 37%; secondary: 45%; more than secondary: 18%

  • Baseline cognitive function: 3 selection criteria on cognition overall: 1) participants meet definition criteria for A‐MCImd (Petersen 2004); 2) all patients had memory complaint; and 3) have normal general cognitive functioning as determined by a Mini‐Mental State Examination (MMSE) score ≥ 24.

  • Selection criteria on cognition: experimental group 1: amnestic MCI multiple domains subtype (A‐MCImd, according to Petersen 2004). All participants had memory complaint, usually verified by an informant. MMSE, mean (SD): 27.36 (0.53). Control group 1: amnestic MCI multiple domains subtype (A‐MCImd, according to Petersen 2004). All participants had memory complaint, usually verified by an informant. MMSE, mean (SD): 27.18 (0.40)

  • Ethnicity: not reported

  • APOE: number of participants positive for APOE not reported

Interventions
  • Type of experimental intervention: computerised CT group; treatment duration 12 weeks; Intervention provided in group format, under supervision

  • Details of experimental intervention: training involved a memory task and an attention task. It was programmed in Java (Release 1.4) and conducted on a Microsoft Windows‐based computer. Stimuli were pictures belonging to various categories (e.g. animals, flowers, objects of everyday life) and common words pronounced by the computer. Each picture was 256 × 256 pixels in size. Responses to training tasks were given using a tactile screen, a standard keyboard (using only 2 keys), and a computer mouse. For attention training, we used response time tasks to yes/no choice; for memory training, we used recognition memory tasks with forced choice

  • Type of concomitant treatment provided: none reported

  • Session duration: 60 minutes in experimental group

  • Number of treatment sessions: 24 in experimental group

  • Treatment frequency: 2/week in experimental group

  • Maximum treatment duration in weeks: 12 in experimental group

  • Type of control intervention: other; treatment duration 12 weeks; Intervention provided as individual training, under supervision

  • Details of control intervention: cognitive activities consisting of exercises in which participants were asked to find names of countries and corresponding capitals, to organise a list of purchases in categories, to find similarities and differences, to choose a newspaper article and bar all the letters ‘‘A’’, to read a text and then answer questions, to tell a story or construct a sentence from a list of words in disorder, etc.

  • Session duration: 60 minutes in control group

  • Number of treatment sessions: 24 in control group

  • Treatment frequency: 2/week in control group

  • Maximum treatment duration in weeks: 12 in control group

Outcomes
  • Cognitive functioning outcome considered

    • Episodic memory measured with 16‐item free and cued reminding test (16‐FR/CR test) at 3 and 9 months, on a scale from 0 to 16 with higher values indicating benefit

    • Working memory measured with Digit span test, backward (type of digit span test used not stated) at 3 and 9 months, on a scale from 0 to not reported with higher values indicating benefit

  • Physical functioning outcome considered: none reported

  • Quality of life outcome considered: none reported

  • Safety outcome considered: none reported

  • Depression outcome considered: none reported

  • Available cognitive functioning outcomes not considered in this review

    • Episodic memory measured with MMSE‐recall of 3 words at 3 months, on a scale from 0 to not reported with higher values indicating benefit

    • Episodic memory measured with Doors recognition subtest (doors and people battery) set A/12 at 3 and 9 months, on a scale from 0 to not reported with higher values indicating benefit

    • Episodic memory measured with Doors recognition subtest (doors and people battery) set B/12 at 3 and 9 months, on a scale from 0 to not reported with higher values indicating benefit

    • Episodic memory measured with 12‐word‐list recall test from BEM‐144 memory battery (Signoret 1991) at 3 and 9 months, on a scale from 0 to 12 with higher values indicating benefit

    • Episodic memory measured with recall of the Rey–Osterrieth Complex Figure at 3 and 9 months, on a scale from 0 to 36 with higher values indicating benefit

    • Episodic memory measured with delayed matching‐to‐sample 48 test (DMS48 test)‐set 1 expressed as recognition score (%) at 3 and 9 months, on a scale from 0 to not reported with higher values indicating benefit

    • Working memory measured with Digit span test, forward, at 3 months, on a scale from 0 to not reported with higher values indicating benefit

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Judgement: no methods for randomising participants have been described
Quote(s): "the 22 patients were randomly assigned into two groups (11 patients per group): a group that performed training (Trained group) and a group that participated in stimulating cognitive activities (Control group)"
Allocation concealment (selection bias) Unclear risk Judgement: no description provided
Blinding of participants (performance bias) Unclear risk Judgement: blinding not reported and interventions are clearly different. Nevertheless, depending on the information participants received, blinding could have been successful. As trial authors did not measure this, we judged unclear risk of bias
Blinding of physicians / personnel High risk Judgement: therapists could not be blinded
Quote(s): "three trained neuropsychologists were involved in the study: one administered and scored the pre‐tests, post‐tests, and follow‐up tests (this person was kept blind to the group membership of patients), one supervised training, and one supervised cognitive activities"
Blinding of outcome assessment (detection bias) All outcomes Low risk Judgement: assessors were blinded to the treatment assigned, although the method of blinding is not described in detail
Quote(s): "three trained neuropsychologists were involved in the study: one administered and scored the pre‐tests, post‐tests, and follow‐up tests (this person was kept blind to the group membership of patients), one supervised training, and one supervised cognitive activities"
Incomplete outcome data (attrition bias) All outcomes Low risk Judgement: 11 out of 11 (100%) randomised were analysed in the experimental group, and 11 out of 11 (100%) randomised were analysed in the control group. It is not clearly reported if all randomised participants were evaluated for this test, so for statistical analyses, we used the number randomised as the number analysed
Selective reporting (reporting bias) Low risk Judgement: all outcomes described in the methods section are adequately addressed in the results section
Other bias Unclear risk Judgement: the selection process for participants is not described in sufficient detail; few baseline characteristics are described, not allowing a judgement whether between‐group baseline imbalances occurred in this small trial