[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Community-dwelling adultswere recruited from July 2008 to May 2010 in Baltimore, Maryland. Eligibleparticipants were age≥70, English-speaking, community-residing in north-west Baltimore (28 postal codes), had a reliable study partner, met Diagnosticand Statistical Manual, Fourth Edition, Text Revision criteria for dementia orCognitive Disorder Not Otherwise Specified (American Psychiatric Associa-tion 2000), and had one or more unmet care needs on the Johns HopkinsDementia Care Needs Assessment (JHDCNA; Black et al. 2008).
Excluded criteria: Individualsin crisis, with signs of abuse, neglect, or danger to self or others, were excluded.
Pretreatment: Higher number of routine medications in the intervention group
Intervention Characteristics
Intervention
Control
No outcomes of relevance were reported
Study design: Cluster randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
IIncluded criteria: Eligible nursing homes had at least 60% of residents with dementia
Excluded criteria: Nursing homes were excluded if they were receiving special support from their local authority or if they failed to meet the 5 Care Quality Commission care home quality standards.
Intervention Characteristics
Intervention
Control
BPSD (NPI), SD
Antipsychotic medication administration, %
Agitation (CMAI), SD
Depressive symptoms (Cornell), SEM (mean difference!)
Quality of life (DEM-QoL), CI
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: The service managers of each facility were asked to identify all DCWs that providedmorning personal care (i.e., period of time between 07am and 12am when DCWs areinvolved on activities related to bathing, grooming, dressing and toileting) to people withdementia in a regular basis; and were employed for at least 2 months
Excluded criteria: Temporary DCWs and trainees were excluded as it was not possible to ensure their participation until the end of the study.
Intervention Characteristics
Intervention
Control
Caregivers burden (PSS), SD
Data obtained from:
Kim, Sun Kyung; Park, Myonghwa
Effectiveness of person-centered care on people with dementia: a systematic review and meta-analysis.
Clinical Interventions In Aging 2017;12(Journal Article):381-397
Data obtained from:
Kim, Sun Kyung; Park, Myonghwa
Effectiveness of person-centered care on people with dementia: a systematic review and meta-analysis.
Clinical Interventions In Aging 2017;12(Journal Article):381-397
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Included criteria: Staff members needed to have strong English to complete questionnaires
Intervention Characteristics
Intervention
Control
Antipsychotic medication administration, SD
Agitation (CMAI), SD
Quality of life (Qol-AD), SD
Data obtained from:
Kim, Sun Kyung; Park, Myonghwa
Effectiveness of person-centered care on people with dementia: a systematic review and meta-analysis.
Clinical Interventions In Aging 2017;12(Journal Article):381-397
Data obtained from:
Kim, Sun Kyung; Park, Myonghwa
Effectiveness of person-centered care on people with dementia: a systematic review and meta-analysis.
Clinical Interventions In Aging 2017;12(Journal Article):381-397
Study design: Cluster randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Eligible participants will be identified from among thepatients of the participating GP practices. The inclusioncriteria are that the person must be at least 70 years ofage, living at home, have screened positive for dementia(score 8 or lower) on the DemTect Scale [29,30](reference: Thyrian et al. 2012)
Excluded criteria: The exclusion criteriaare insufficient German-language competence andother medical conditions that do not allow testing (forexample, hearing impairment, visual impairment).(reference: Thyrian et al. 2012)
Intervention Characteristics
Intervention
Control
Caregivers burden (BIZA), SD
Quality of life, SD
Data obtained from:
Kim, Sun Kyung; Park, Myonghwa
Effectiveness of person-centered care on people with dementia: a systematic review and meta-analysis.
Clinical Interventions In Aging 2017;12(Journal Article):381-397
Wrong study design
Wrong intervention
Wrong intervention
Wrong comparator
Wrong intervention
Wrong comparator
Wrong outcomes
Wrong intervention
Wrong study design
Wrong intervention
Wrong patient population
Wrong study design
Wrong intervention
Wrong intervention
Wrong patient population
Wrong intervention
Wrong study design
Wrong intervention
Wrong patient population
Wrong intervention
Not in English
Wrong study design
Wrong outcomes
Wrong intervention
Wrong intervention
Wrong intervention
Wrong intervention
abstract only
Wrong intervention
Wrong intervention
Wrong comparator
abstract only
Wrong intervention
abstract only
abstract only
abstract only
Wrong study design
Wrong intervention
abstract only
Wrong intervention
Wrong intervention
Wrong intervention
Wrong intervention
abstract only
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Judgement Comment: From Samus et al., 2014: Participants were randomized by the PI within 48 hours of the BL visit to intervention oraugmented usual care group (1:2 allocation), using a custom Excel program which generateda random number from a uniform distribution.
Quote: "and preparation. Randomisation and blinding <b>Nursing homes were allocated to receive either the WHELD intervention or TAU using secure web access to the remote randomisation centre at the North Wales Organisation for Rando- mised Trials in Health Clinical Trial Unit (NWORTH CTU) at Bangor University.</b> Randomi- sation was performed by"
Judgement Comment: Randomization was performed using a random number generator
Refernce: Kim et al. 2017
Refernce: Kim et al. 2017
Judgement Comment: Mentioned as a randomised controlled trial. Nothing written on how it was done
Refernce: Kim et al. 2017
Refernce: Kim et al. 2017
Judgement Comment: Patient allocated to study group by study center.
Refernce: Kim et al. 2017
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Judgement Comment: Insufficient information on allocation concealment
Quote: "Randomi- sation was performed by dynamic allocation [38] to protect against subversion while ensuring that the trial maintained a good balance to the allocation ratio of 1:1 both within each stratifi- cation variable and across the trial. Nursing homes were stratified by region and size."
Quote: "blind to treat- ment allocation. <b>Every attempt was made to minimise accidental un-blinding by minimising contact between therapists and the researchers collecting outcome data and with clear instruc- tions to researchers and nursing home staff to not discuss treatment allocation.</b> Sample size The target minimum"
Judgement Comment: Randomizarion occured at facility level because of possible contamination. Unknown if there was sufficient concealment.
Refernce: Kim et al. 2017
Refernce: Kim et al. 2017
Judgement Comment: Insufficient information on allocation concealment
Refernce: Kim et al. 2017
Refernce: Kim et al. 2017
Judgement Comment: Insufficient information on allocation concealment
Refernce: Kim et al. 2017
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Quote: "Single-blind RCT evaluating"
Judgement Comment: From samus et al. 2014: Due to project budget limitations, the 18-month unmet need data (JHDCNA)was collected by a non-blinded RN.
Judgement Comment: Insufficient information on blinding of participants and personnel
Judgement Comment: Insufficient information on blinding of participants and personnel
Refernce: Kim et al. 2017
Refernce: Kim et al. 2017
Judgement Comment: Insufficient information on blinding of participants and personnel
Refernce: Kim et al. 2017
Refernce: Kim et al. 2017
Judgement Comment: Blinding was not possible
Refernce: Kim et al. 2017
Detection bias due to knowledge of the allocated interventions by outcome assessors
Judgement Comment: Unclear who was blinded. From Samu: This was an 18-month prospective, single-blind, parallel group randomized pilot trial design comparing the MIND care coordination intervention to augmented usual care in a cohort of 303 elders age 70+ with cognitive disorders (265 with dementia, 38 with mild cognitive impairment) living at home in Baltimore, MD
Quote: "blind to treat- ment allocation. <b>Every attempt was made to minimise accidental un-blinding by minimising contact between therapists and the researchers collecting outcome data and with clear instruc- tions to researchers and nursing home staff to not discuss treatment allocation.</b> Sample size The target minimum"
Quote: "Clinicians and research assistants completing follow-up assessments were blind to treat- ment allocation."
Judgement Comment: Insufficient information on blinding of outcome assessors
Refernce: Kim et al. 2017
Refernce: Kim et al. 2017
Judgement Comment: Insufficcient information on blinding of outcome assessors
Refernce: Kim et al. 2017
Refernce: Kim et al. 2017
Judgement Comment: Blinding was not possible
Refernce: Kim et al. 2017
Attrition bias due to amount, nature or handling of incomplete outcome data
Quote: "An intention-to-treat approach was used in analyses, with participants included as randomized."
Judgement Comment: No apparent sources of bias
Quote: "plan for the current study. <b>The imputation model was less predictive in validation analyses than it had been in the factorial study. The completer analysis was therefore used as the primary outcome in place of the imputation analysis. Therefore, the primary analysis included all participants with data available at the 9-month assessment point, and the imputation model was used as a sensitivity analysis. The analysis model was finalised prior to the locking of the study database for the current trial.</b> The same approach was used"
Judgement Comment: Dropouts are accounted for and equally distributed across groups
Judgement Comment: The study appears to have no incomplete outcome data
Refernce: Kim et al. 2017
Refernce: Kim et al. 2017
Judgement Comment: No apparent sources of bias
Refernce: Kim et al. 2017
Refernce: Kim et al. 2017
Judgement Comment: Intention to treat analysis with multiple imputation replacing missing data
Refernce: Kim et al. 2017
Reporting bias due to selective outcome reporting
Judgement Comment: From Samus et al. 2014: clinicaltrials.gov; NCT01283750 No apparent sources of bias
Quote: "ISRCTN Registry ISRCTN62237498"
Judgement Comment: The study appears to be free of selective outcome reporting bias
Judgement Comment: There is no reference to study protocol, but the study appears to be free of selective outcome reporting
Refernce: Kim et al. 2017
Refernce: Kim et al. 2017
Judgement Comment: No apparent sources of bias
Refernce: Kim et al. 2017
Refernce: Kim et al. 2017
Judgement Comment: trial protocol available clinicaltrials.gov identifier: NCT01401582.The study appears to be free of selective outcome reporting. Matches study protocol.
Refernce: Kim et al. 2017
Bias due to problems not covered elsewhere in the table
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: The study appears to be free of other sources of bias
Refernce: Kim et al. 2017
Refernce: Kim et al. 2017
Judgement Comment: The study appears to be free of other sources of bias
Refernce: Kim et al. 2017
Refernce: Kim et al. 2017
Judgement Comment: The study appears to be free of other sources of bias
Refernce: Kim et al. 2017