[Summary text]
Outcomes målt ved 6mdr er afrapporteret i dette studie, selvom interventionen strakte sig til 12 mdr.
Data obtained from:
Moniz, Cook E.; Swift K.; James I.; Malouf R.; De, Vugt M.; Verhey F.
Functional analysis-based interventions for challenging behaviour in dementiaCochrane database of systematic reviews (Online) 2012;2(Journal Article):CD006929United Kingdom 2012
Data obtained from:
Moniz, Cook E.; Swift K.; James I.; Malouf R.; De, Vugt M.; Verhey F.
Functional analysis-based interventions for challenging behaviour in dementiaCochrane database of systematic reviews (Online) 2012;2(Journal Article):CD006929United Kingdom 2012
Outcomes
Antipsychotic usage: not clear if the numbers are proportions or percent. We have assumed they are proportions
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Included criteria: Resident 1) had been at the nursing home => 3 weeks 2) had been identified by nursing staff as agitatied at least several times a day 3) was aged =>60 years and 4) had a diagnosis of dementia
Excluded criteria: Resident 1) had life expectancy of 3months 2) had a diagnosis of bipolar disorder, schizophrenia or mental retardation 3) was expected to leave nursing home within 4 months 4) had MMSE = > 25 or 5) had participated in a previous TREA trial
Intervention Characteristics
Intervention
Control
Agitation (ABMI), SD
Data obtained from:
Moniz, Cook E.; Swift K.; James I.; Malouf R.; De, Vugt M.; Verhey F.
Functional analysis-based interventions for challenging behaviour in dementiaCochrane database of systematic reviews (Online) 2012;2(Journal Article):CD006929United Kingdom 2012
Data obtained from:
Moniz, Cook E.; Swift K.; James I.; Malouf R.; De, Vugt M.; Verhey F.
Functional analysis-based interventions for challenging behaviour in dementiaCochrane database of systematic reviews (Online) 2012;2(Journal Article):CD006929United Kingdom 2012
Data obtained from:
Moniz, Cook E.; Swift K.; James I.; Malouf R.; De, Vugt M.; Verhey F.
Functional analysis-based interventions for challenging behaviour in dementiaCochrane database of systematic reviews (Online) 2012;2(Journal Article):CD006929United Kingdom 2012
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: MMSE score indicating moderate to severe cognitive impairment. Advanced funcitonal impairment. No chronic psychiatric diagnosi. At least 4 weeks postadmission to skilled nursing care at this nursing home
Intervention Characteristics
Intervention
Control
BPSD (BEHAVE-AD), SD
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Included criteria: The inclusion crite-ria required a positive diagnosis of dementia, and thepresence of at least one challenging behavior, defined as‘any behavior associated with dementia which causes dis-tress or danger to the person with dementia and/or others’(Bird et al.,2009).
Intervention Characteristics
Intervention
Control
Agitation (CMAI), SD
Study design: Cluster randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: et thecriteria, that at least one psychogeriatric unit was willing toparticipate and no major organizational changes or buildingactivities were planned or performed during the study per-iod. In each nursing home, residents with moderate to sev-ere cognitive impairment (Reisberg Global DeteriorationScale (GDS) Stage 5, 6, or 7),15no psychiatric diagnosisother than dementia, and clinically significant symptoms ofchallenging behavior (Neuropsychiatric Inventory—NursingHome version (NPI-NH) score>4 or Cohen-Mansfield Agi-tation Inventory (CMAI) score>44)16,17were eligible for participation, providing that written proxy consent wasreceived
Intervention Characteristics
Intervention
Control
BPSD (NPI) CI
Antipsychotic usage, OR
Depression (Cornell), CI
Agitation (CMAI), CI
Data obtained from:
Moniz, Cook E.; Swift K.; James I.; Malouf R.; De, Vugt M.; Verhey F.
Functional analysis-based interventions for challenging behaviour in dementiaCochrane database of systematic reviews (Online) 2012;2(Journal Article):CD006929United Kingdom 2012
Data obtained from:
Moniz, Cook E.; Swift K.; James I.; Malouf R.; De, Vugt M.; Verhey F.
Functional analysis-based interventions for challenging behaviour in dementiaCochrane database of systematic reviews (Online) 2012;2(Journal Article):CD006929United Kingdom 2012
Outcomes
Only total no. of patient was reported (n=31). For the analysis we assumed that there was 16 in the intervention og 15 in the control group
Data obtained from:
Moniz, Cook E.; Swift K.; James I.; Malouf R.; De, Vugt M.; Verhey F.
Functional analysis-based interventions for challenging behaviour in dementiaCochrane database of systematic reviews (Online) 2012;2(Journal Article):CD006929United Kingdom 2012
Wrong intervention
Wrong intervention
Abstract only
Wrong patient population
Wrong intervention
Wrong patient population
Wrong patient population
Wrong intervention
Wrong outcomes
Wrong intervention
Wrong study design
Not in English
Wrong patient population
Wrong patient population
Wrong study design
Wrong intervention
Wrong intervention
Wrong intervention
Wrong intervention
Wrong patient population
Wrong patient population
Wrong intervention
Wrong outcomes
Wrong patient population
Abstract only
Abstract only
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Judgement Comment: Participants were randomised either by units (for larger nursing homes with many eligible participants) or by nursing homes (when there were fewer eligible participants). Randomisation was performed using random numbers via a ration of 1.5:1
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Judgement Comment: Randomly assigned using coin toss
Quote: "the study agreed to participate. <b>Facilities were randomized to one of the four study/intervention conditions using a clus- ter randomized controlled design (i.e., the facility rather than the participants/residents or staff were the unit of ran- domization). Randomization occurred by facilities being allocated to one of the conditions as they were recruited into the study. The numbers 1, 2, 3, and 4 were placed in a box (in each of the two locations) in both year 1 and year 2. The number that was drawn out for the facility deter- mined which of the four conditions the facility was allo- cated to.</b> Aged-care residents were recruited through"
Quote: "An independent researcher (who was unaware of the identity of the units) performed the allocation using a computer-generated sequence program"
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Judgement Comment: The research assistents were blind to group allocation, until the treatment began
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Judgement Comment: Randomly assigned using coin toss
Quote: "were recruited into the study. <b>The numbers 1, 2, 3, and 4 were placed in a box (in each of the two locations) in both year 1 and year 2. The number that was drawn out for the facility deter- mined which of the four conditions the facility was allo- cated to.</b> Aged-care residents were recruited through"
Quote: "An independent researcher (who was unaware of the identity of the units) performed the allocation using a computer-generated sequence program (Random"
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Judgement Comment: participants were blinded, but not the personnel
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Judgement Comment: Research subjects described as blinded
Judgement Comment: Nothing mentioned
Quote: "The trial was single blinded (the researcher knew the condi- tion, but the research assistants performing the measure- ments were blinded)."
Judgement Comment: Participants were not blinded
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Detection bias due to knowledge of the allocated interventions by outcome assessors
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Judgement Comment: Blinding not possible
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Judgement Comment: Data collectors described as blinded
Judgement Comment: Nothing mentioned
Quote: "The trial was single blinded (the researcher knew the condi- tion, but the research assistants performing the measure- ments were blinded). 13 Residents"
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Attrition bias due to amount, nature or handling of incomplete outcome data
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Judgement Comment: 62 participants withdrew from the intervention group and 36 from the placebo group. However, as ITT analyses was performed, the risk of bias is considered low. No apparent sources of bias
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Judgement Comment:127 ramdomized and 114 completed
Judgement Comment: Number of withdrawers are not described
Judgement Comment: No apparent sources of bias
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Reporting bias due to selective outcome reporting
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Judgement Comment: Matches study protocol
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Judgement Comment: None detected
Judgement Comment: No apparent sources of bias
Quote: "This trial is registered at the Netherlands National Trial Register (NTR1967)."
Judgement Comment: According to the protocol, Quality of Life should have been measured using Qualidem. There is no reportings on Qualidem in thi study
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Bias due to problems not covered elsewhere in the table
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Judgement Comment: No apparent sources of bias
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
Judgement Comment: No other apparent sources of bias
Judgement Comment: No other apparent sources of bias
Judgement Comment: No apparent sources of bias
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012
reference: Moniz Cook et al. 2012