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Anaesthesia Mar 2019Delirium is common in intensive care patients. Dexmedetomidine is increasingly used for sedation in this setting, but its effect on delirium remains unclear. The primary... (Meta-Analysis)
Meta-Analysis
Delirium is common in intensive care patients. Dexmedetomidine is increasingly used for sedation in this setting, but its effect on delirium remains unclear. The primary aim of this review was to examine whether dexmedetomidine reduces the incidence of delirium and agitation in intensive care patients. We sought randomised clinical trials in MEDLINE, EMBASE, PubMed and CENTRAL from their inception until June 2018. Observational studies, case reports, case series and non-systematic reviews were excluded. Twenty-five trials including 3240 patients were eligible for inclusion in the data synthesis. In the patients who received dexmedetomidine (eight trials, 1425 patients), delirium was reduced, odds ratio (95%CI) 0.36 (0.26-0.51), p < 0.001 and high quality of evidence. The use of dexmedetomidine was associated with a reduced incidence of agitation, OR (95%CI) 0.34 (0.20-0.59), p < 0.001, moderate quality of evidence. Patients who were randomly assigned to dexmedetomidine had a significantly higher incidence of bradycardia, OR (95%CI) 2.18 (1.46-3.24), p < 0.001, moderate quality of evidence; and hypotension, OR (95%CI) 1.89 (1.48-2.41), p < 0.001, high quality of evidence. We found no evidence of an effect on mortality, OR (95%CI) 0.86 (0.66-1.10), p = 0.23, moderate quality of evidence. The trial sequential analyses for the incidence of delirium, bradycardia and hypotension was conclusive but not for the incidence of agitation and mortality. In summary, this meta-analysis suggests that dexmedetomidine reduces the incidence of delirium and agitation in intensive care patients. The general quality of evidence ranged from moderate to high.
Topics: Delirium; Dexmedetomidine; Humans; Intensive Care Units; Psychomotor Agitation
PubMed: 30367689
DOI: 10.1111/anae.14472 -
The Cochrane Database of Systematic... Oct 2018Agitation has been reported in up to 90% of people with dementia. Agitation in people with dementia worsens carer burden, increases the risk of injury, and adds to the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Agitation has been reported in up to 90% of people with dementia. Agitation in people with dementia worsens carer burden, increases the risk of injury, and adds to the need for institutionalisation. Valproate preparations have been used in an attempt to control agitation in dementia, but their safety and efficacy have been questioned.
OBJECTIVES
To determine the efficacy and adverse effects of valproate preparations used to treat agitation in people with dementia, including the impact on carers.
SEARCH METHODS
We searched ALOIS - the Cochrane Dementia and Cognitive Improvement Group's Specialized Register on 7 December 2017 using the terms: valproic OR valproate OR divalproex. ALOIS contains records from all major health care databases (the Cochrane Library, MEDLINE, Embase, PsycINFO, CINAHL, LILACS) as well as from many trials databases and grey literature sources.
SELECTION CRITERIA
Randomised, placebo-controlled trials that assessed valproate preparations for agitation in people with dementia.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened the retrieved studies against the inclusion criteria and extracted data and assessed methodological quality of the included studies. If necessary, we contacted trial authors to ask for additional data, including relevant subscales, or for other missing information. We pooled data in meta-analyses where possible. This is an update of a Cochrane Review last published in 2009. We found no new studies for inclusion.
MAIN RESULTS
The review included five studies with 430 participants. Studies varied in the preparations of valproate, mean doses (480 mg/day to 1000 mg/day), duration of treatment (three weeks to six weeks), and outcome measures used. The studies were generally well conducted although some methodological information was missing and one study was at high risk of attrition bias.The quality of evidence related to our primary efficacy outcome of agitation varied from moderate to very low. We found moderate-quality evidence from two studies that measured behaviour with the total Brief Psychiatric Rating Scale (BPRS) score (range 0 to 108) and with the BPRS agitation factor (range 0 to 18). They found that there was probably little or no effect of valproate treatment over six weeks (total BPRS: mean difference (MD) 0.23, 95% confidence interval (CI) -2.14 to 2.59; 202 participants, 2 studies; BPRS agitation factor: MD -0.67, 95% CI -1.49 to 0.15; 202 participants, 2 studies). Very low-quality evidence from three studies which measured agitation with the Cohen-Mansfield Agitation Index (CMAI) were consistent with a lack of effect of valproate treatment on agitation. There was variable quality evidence on other behaviour outcomes reported in single studies of no difference between groups or a benefit for the placebo group.Three studies, which measured cognitive function using the Mini-Mental State Examination (MMSE), found little or no effect of valproate over six weeks, but we were uncertain about this result because the quality of the evidence was very low. Two studies that assessed functional ability using the Physical Self-Maintenance Scale (PSMS) (range 6 to 30) found that there was probably slightly worse function in the valproate-treated group, which was of uncertain clinical importance (MD 1.19, 95% CI 0.40 to 1.98; 203 participants, 2 studies; moderate-quality evidence).Analysis of adverse effects and serious adverse events (SAE) indicated a higher incidence in valproate-treated participants. A meta-analysis of three studies showed that there may have been a higher rate of adverse effects among valproate-treated participants than among controls (odds ratio (OR) 2.02, 95% CI 1.30 to 3.14; 381 participants, 3 studies, low-quality evidence). Pooled analysis of the number of SAE for the two studies that reported such data indicated that participants treated with valproate preparations were more likely to experience SAEs (OR 4.77, 95% CI 1.00 to 22.74; 228 participants, 2 studies), but the very low quality of the data made it difficult to draw any firm conclusions regarding SAEs. Individual adverse events that were more frequent in the valproate-treated group included sedation, gastrointestinal symptoms (nausea, vomiting, and diarrhoea), and urinary tract infections.
AUTHORS' CONCLUSIONS
This updated review corroborates earlier findings that valproate preparations are probably ineffective in treating agitation in people with dementia, but are associated with a higher rate of adverse effects, and possibly of SAEs. On the basis of this evidence, valproate therapy cannot be recommended for management of agitation in dementia. Further research may not be justified, particularly in light of the increased risk of adverse effects in this often frail group of people. Research would be better focused on effective non-pharmacological interventions for this patient group, or, for those situations where medication may be needed, further investigation of how to use other medications as effectively and safely as possible.
Topics: Aged; Aggression; Antimanic Agents; Cognition; Dementia; Humans; Psychomotor Agitation; Randomized Controlled Trials as Topic; Treatment Outcome; Valproic Acid
PubMed: 30293233
DOI: 10.1002/14651858.CD003945.pub4 -
Revista Gaucha de Enfermagem Aug 2018To describe the multiprofessional care for the management of critical patients in delirium in the ICU from the evidences found in the literature.
OBJECTIVE
To describe the multiprofessional care for the management of critical patients in delirium in the ICU from the evidences found in the literature.
METHODS
This integrative review was carried out in the period from February 1 to June 30, 2016 through searches on PubMed, Scopus, Web of Science, and CINAHL, with the following descriptors: delirium, critical care e intensive care units, which brought up 17 original papers.
RESULTS
A bundle and a guideline, two systematic reviews, evidence 1a and four clinical trials, evidence 1b and 2b, cohort and observational studies were found. The multiprofessional care was presented to better understand the diagnosis of delirium, sedation pause, early mobilization, pain, agitation and delirium guidelines, psychomotor agitation, cognitive orientation, sleep promotion, environment and family participation.
CONCLUSION
The care for delirium is wide and not specific, which determines its multifactorial aspect.
Topics: Antipsychotic Agents; Caregivers; Combined Modality Therapy; Critical Care; Delirium; Humans; Hypnotics and Sedatives; Intensive Care Units; Music Therapy; Orientation; Patient Care Bundles; Patient Care Team; Practice Guidelines as Topic; Psychomotor Agitation; Sensory Aids; Sleep
PubMed: 30088606
DOI: 10.1590/1983-1447.2018.2017-0157 -
The Cochrane Database of Systematic... Jul 2018Dementia is a clinical syndrome with a number of different causes which is characterised by deterioration in cognitive, behavioural, social and emotional functions.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Dementia is a clinical syndrome with a number of different causes which is characterised by deterioration in cognitive, behavioural, social and emotional functions. Pharmacological interventions are available but have limited effect to treat many of the syndrome's features. Less research has been directed towards non-pharmacological treatments. In this review, we examined the evidence for effects of music-based interventions.
OBJECTIVES
To assess the effects of music-based therapeutic interventions for people with dementia on emotional well-being including quality of life, mood disturbance or negative affect, behavioural problems, social behaviour and cognition at the end of therapy and four or more weeks after the end of treatment.
SEARCH METHODS
We searched ALOIS, the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group (CDCIG) on 19 June 2017 using the terms: music therapy, music, singing, sing, auditory stimulation. Additional searches were carried out on 19 June 2017 in the major healthcare databases MEDLINE, Embase, PsycINFO, CINAHL and LILACS; and in trial registers and grey literature sources.
SELECTION CRITERIA
We included randomised controlled trials of music-based therapeutic interventions (at least five sessions) for people with dementia that measured any of our outcomes of interest. Control groups either received usual care or other activities with or without music.
DATA COLLECTION AND ANALYSIS
Two review authors worked independently to screen the retrieved studies against the inclusion criteria and then to extract data and assess methodological quality of the included studies. If necessary, we contacted trial authors to ask for additional data, including relevant subscales, or for other missing information. We pooled data using random-effects models.
MAIN RESULTS
We included 22 studies with 1097 randomised participants. Twenty-one studies with 890 participants contributed data to meta-analyses. Participants in the studies had dementia of varying degrees of severity, and all were resident in institutions. Seven studies delivered an individual music intervention; the other studies delivered the intervention to groups of participants. Most interventions involved both active and receptive musical elements. The methodological quality of the studies varied. All were at high risk of performance bias and some were at high risk of detection or other bias.At the end of treatment, we found low-quality evidence that the interventions may improve emotional well-being and quality of life (standardised mean difference (SMD) 0.32, 95% confidence interval (CI) 0.02 to 0.62; 9 studies, 348 participants) and reduce anxiety (SMD -0.43, 95% CI -0.72 to -0.14; 13 studies, 478 participants). We found low-quality evidence that music-based therapeutic interventions may have little or no effect on cognition (SMD 0.15, 95% CI -0.06 to 0.36; 7 studies, 350 participants). There was moderate-quality evidence that the interventions reduce depressive symptoms (SMD -0.27, 95% CI -0.45 to -0.09; 11 studies, 503 participants) and overall behaviour problems (SMD -0.23, 95% CI -0.46 to -0.01; 10 studies, 442 participants), but do not decrease agitation or aggression (SMD -0.07, 95% CI -0.24 to 0.10; 14 studies, 626 participants). The quality of the evidence on social behaviour was very low, so effects were very uncertain.The evidence for long-term outcomes measured four or more weeks after the end of treatment was of very low quality for anxiety and social behaviour, and for the other outcomes, it was of low quality for little or no effect (with small SMDs, between 0.03 and 0.34).
AUTHORS' CONCLUSIONS
Providing people with dementia who are in institutional care with at least five sessions of a music-based therapeutic intervention probably reduces depressive symptoms and improves overall behavioural problems at the end of treatment. It may also improve emotional well-being and quality of life and reduce anxiety, but may have little or no effect on agitation or aggression or on cognition. We are uncertain about effects on social behaviour and about long-term effects. Future studies should examine the duration of effects in relation to the overall duration of treatment and the number of sessions.
Topics: Aged; Aggression; Dementia; Depression; Humans; Mental Disorders; Music Therapy; Psychomotor Agitation; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 30033623
DOI: 10.1002/14651858.CD003477.pub4 -
The Cochrane Database of Systematic... Jun 2018Fluphenazine is one of the first drugs to be classed as an 'antipsychotic' and has been widely available for five decades. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Fluphenazine is one of the first drugs to be classed as an 'antipsychotic' and has been widely available for five decades.
OBJECTIVES
To compare the effects of oral fluphenazine with placebo for the treatment of schizophrenia. To evaluate any available economic studies and value outcome data.
SEARCH METHODS
We searched the Cochrane Schizophrenia Group's Trials Register (23 July 2013, 23 December 2014, 9 November 2016 and 28 December 2017 ) which is based on regular searches of CINAHL, BIOSIS, AMED, EMBASE, PubMed, MEDLINE, PsycINFO, and registries of clinical trials. There is no language, date, document type, or publication status limitations for inclusion of records in the register.
SELECTION CRITERIA
We sought all randomised controlled trials comparing oral fluphenazine with placebo relevant to people with schizophrenia. Primary outcomes of interest were global state and adverse effects.
DATA COLLECTION AND ANALYSIS
For the effects of interventions, a review team inspected citations and abstracts independently, ordered papers and re-inspected and quality assessed trials. We extracted data independently. Dichotomous data were analysed using fixed-effect risk ratio (RR) and the 95% confidence interval (CI). Continuous data were excluded if more than 50% of people were lost to follow-up, but, where possible, mean differences (MD) were calculated. Economic studies were searched and reliably selected by an economic review team to provide an economic summary of available data. Where no relevant economic studies were eligible for inclusion, the economic review team valued the already-included effectiveness outcome data to provide a rudimentary economic summary.
MAIN RESULTS
From over 1200 electronic records of 415 studies identified by our initial search and this updated search, we excluded 48 potentially relevant studies and included seven trials published between 1964 and 1999 that randomised 439 (mostly adult participants). No new included trials were identified for this review update. Compared with placebo, global state outcomes of 'not improved or worsened' were not significantly different in the medium term in one small study (n = 50, 1 RCT, RR 1.12 CI 0.79 to 1.58, very low quality of evidence). The risk of relapse in the long term was greater in two small studies in people receiving placebo (n = 86, 2 RCTs, RR 0.39 CI 0.05 to 3.31, very low quality of evidence), however with high degree of heterogeneity in the results. Only one person allocated fluphenazine was reported in the same small study to have died on long-term follow-up (n = 50, 1 RCT, RR 2.38 CI 0.10 to 55.72, low quality of evidence). Short-term extrapyramidal adverse effects were significantly more frequent with fluphenazine compared to placebo in two other studies for the outcomes of akathisia (n = 227, 2 RCTs, RR 3.43 CI 1.23 to 9.56, moderate quality of evidence) and rigidity (n = 227, 2 RCTs, RR 3.54 CI 1.76 to 7.14, moderate quality of evidence). For economic outcomes, we valued outcomes for relapse and presented them in additional tables.
AUTHORS' CONCLUSIONS
The findings in this review confirm much that clinicians and recipients of care already know, but they provide quantification to support clinical impression. Fluphenazine's global position as an effective treatment for psychoses is not threatened by the outcome of this review. However, fluphenazine is an imperfect treatment and if accessible, other inexpensive drugs less associated with adverse effects may be an equally effective choice for people with schizophrenia.
Topics: Administration, Oral; Akathisia, Drug-Induced; Antipsychotic Agents; Fluphenazine; Humans; Placebos; Randomized Controlled Trials as Topic; Recurrence; Schizophrenia
PubMed: 29893410
DOI: 10.1002/14651858.CD006352.pub3 -
British Journal of Clinical Pharmacology Jul 2018To determine the most efficacious and acceptable treatments of agitation in dementia. (Meta-Analysis)
Meta-Analysis
AIMS
To determine the most efficacious and acceptable treatments of agitation in dementia.
METHODS
MEDLINE, EMBASE, PsycINFO, CENTRAL and clinicaltrials.gov were searched up to 7 February 2017. Two independent reviewers selected randomized controlled trials (RCTs) of treatments to alleviate agitation in people with all-types dementia. Data were extracted using standardized forms and study quality was assessed using the revised Cochrane Risk of Bias Tool for RCTs. Data were pooled using meta-analysis. The primary outcome, efficacy, was 8-week response rates defined as a 50% reduction in baseline agitation score. The secondary outcome was treatment acceptability defined as treatment continuation for 8 weeks.
RESULTS
Thirty-six RCTs comprising 5585 participants (30.9% male; mean ± standard deviation age, 81.8 ± 4.9 years) were included. Dextromethorphan/quinidine [odds ratio (OR) 3.04; 95% confidence interval (CI), 1.63-5.66], risperidone (OR 1.96; 95% CI, 1.49-2.59) and selective serotonin reuptake inhibitors as a class (OR 1.61; 95% CI, 1.02-2.53) were found to be significantly more efficacious than placebo. Haloperidol appeared less efficacious than nearly all comparators. Most treatments had noninferior treatment continuation compared to placebo, except oxcarbazepine, which was inferior. Findings were supported by subgroup and sensitivity analyses.
CONCLUSIONS
Risperidone, serotonin reuptake inhibitors as a class and dextromethorphan/quinidine demonstrated evidence of efficacy for agitation in dementia, although findings for dextromethorphan/quinidine were based on a single RCT. Our findings do not support prescribing haloperidol due to lack of efficacy, or oxcarbazepine due to lack of acceptability. The decision to prescribe should be based on comprehensive consideration of the benefits and risks, including those not evaluated in this meta-analysis.
Topics: Antipsychotic Agents; Dementia; Dextromethorphan; Drug Combinations; Humans; Network Meta-Analysis; Psychometrics; Psychomotor Agitation; Quinidine; Randomized Controlled Trials as Topic; Risperidone; Selective Serotonin Reuptake Inhibitors; Severity of Illness Index; Treatment Outcome
PubMed: 29637593
DOI: 10.1111/bcp.13604 -
The Cochrane Database of Systematic... Apr 2018Aggressive, agitated or violent behaviour due to psychosis constitutes an emergency psychiatric treatment where fast-acting interventions are required. Risperidone is a... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Aggressive, agitated or violent behaviour due to psychosis constitutes an emergency psychiatric treatment where fast-acting interventions are required. Risperidone is a widely accessible antipsychotic that can be used to manage psychosis-induced aggression or agitation.
OBJECTIVES
To examine whether oral risperidone alone is an effective treatment for psychosis-induced aggression or agitation.
SEARCH METHODS
We searched the Cochrane Schizophrenia Group's Study-Based Register of Trials (up to April 2017); this register is compiled by systematic searches of major resources (including AMED, BIOSIS CINAHL, Embase, MEDLINE, PsycINFO, PubMed, and registries of clinical trials) and their monthly updates, handsearches, grey literature, and conference proceedings. There are no language, date, document type, or publication status limitations for inclusion of records into the register.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing rapid use of risperidone and other drugs, combinations of drugs or placebo for people exhibiting aggression or agitation (or both) thought to be due to psychosis.
DATA COLLECTION AND ANALYSIS
We independently inspected all citations from searches, identified relevant abstracts, and independently extracted data from all included studies. For binary data we calculated risk ratio (RR) and for continuous data we calculated mean difference (MD), all with 95% confidence intervals (CI) and used a fixed-effect model. We assessed risk of bias for the included studies and used the GRADE approach to produce a 'Summary of findings' tables.
MAIN RESULTS
The review now contains data from nine trials (total n = 582) reporting on five comparisons. Due to risk of bias, small size of trials, indirectness of outcome measures and a paucity of investigated and reported 'pragmatic' outcomes, evidence was graded as very-low quality. None of the included studies provided useable data on our primary outcome 'tranquillisation or asleep' by 30 minutes, repeated need for tranquillisation or any economic outcomes. Data were available for our other main outcomes of agitation or aggression, needing restraint, and incidence of adverse effects.Risperidone versus haloperidol (up to 24 hours follow-up)For the outcome, specific behaviour - agitation, no clear difference was found between risperidone and haloperidol in terms of efficacy, measured as at least 50% reduction in the Positive and Negative Syndrome Scale - Psychotic Agitation Sub-score (PANSS-PAS) (RR 1.04, 95% CI 0.86 to 1.26; participants = 124; studies = 1; very low-quality evidence) and no effect was observed for need to use restraints (RR 2.00, 95% CI 0.43 to 9.21; participants = 28; studies = 1; very low-quality evidence). Incidence of adverse effects was similar between treatment groups (RR 0.94, 95% CI 0.54 to 1.66; participants = 124; studies = 1; very low-quality evidence).Risperidone versus olanzapineOne small trial (n = 29) reported useable data for the comparison risperidone versus olanzapine. No effect was observed for agitation measured as PANSS-PAS endpoint score at two hours (MD 2.50, 95% CI -2.46 to 7.46; very low-quality evidence); need to use restraints at four days (RR 1.43, 95% CI 0.39 to 5.28; very-low quality evidence); specific movement disorders measured as Behavioural Activity Rating Scale (BARS) endpoint score at four days (MD 0.20, 95% CI -0.43 to 0.83; very low-quality evidence).Risperidone versus quetiapineOne trial reported (n = 40) useable data for the comparison risperidone versus quetiapine. Aggression was measured using the Modified Overt Aggression Scale (MOAS) endpoint score at two weeks. A clear difference, favouring quetiapine was observed (MD 1.80, 95% CI 0.20 to 3.40; very-low quality evidence). No evidence of a difference between treatment groups could be observed for incidence of akathisia after 24 hours (RR 1.67, 95% CI 0.46 to 6.06; very low-quality evidence). Two participants allocated to risperidone and one allocated to quetiapine experienced myocardial ischaemia during the trial.Risperidone versus risperidone + oxcarbazepineOne trial (n = 68) measured agitation using the Positive and Negative Syndrome Scale - Excited Component.(PANSS-EC) endpoint score and found a clear difference, favouring the combination treatment at one week (MD 2.70, 95% CI 0.42 to 4.98; very low-quality evidence), but no effect was observed for global state using Clinical Global Impression - Improvement (CGI-I) endpoint score at one week (MD -0.20, 95% CI -0.61 to 0.21; very-low quality evidence). Incidence of extrapyramidal symptoms after 24 hours was similar between treatment groups (RR 1.59, 95% CI 0.49 to 5.14; very-low quality evidence).Risperidone versus risperidone + valproic acidTwo trials compared risperidone with a combination of risperidone plus valproic acid. No clear differences between the treatment groups were observed for aggression (MOAS endpoint score at three days: MD 1.07, 95% CI -0.20 to 2.34; participants = 54; studies = 1; very low-quality evidence) or incidence of akathisia after 24 hours: RR 0.75, 95% CI 0.28 to 2.03; participants = 122; studies = 2; very low-quality evidence).
AUTHORS' CONCLUSIONS
Overall, results for the main outcomes show no real effect for risperidone. The only data available for use in this review are from nine under-sampled trials and the evidence available is of very low quality. This casts uncertainty on the role of risperidone in rapid tranquillisation for people with psychosis-induced aggression. High-quality pragmatic RCTs are feasible and are needed before clear recommendations can be drawn on the use of risperidone for psychosis-induced aggression or agitation.
Topics: Administration, Oral; Aggression; Antipsychotic Agents; Carbamazepine; Humans; Oxcarbazepine; Psychomotor Agitation; Psychotic Disorders; Quetiapine Fumarate; Randomized Controlled Trials as Topic; Risperidone; Tranquilizing Agents; Valproic Acid
PubMed: 29634083
DOI: 10.1002/14651858.CD009412.pub2 -
The Cochrane Database of Systematic... Feb 2018People with dementia who are being cared for in long-term care settings are often not engaged in meaningful activities. Offering them activities which are tailored to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
People with dementia who are being cared for in long-term care settings are often not engaged in meaningful activities. Offering them activities which are tailored to their individual interests and preferences might improve their quality of life and reduce challenging behaviour.
OBJECTIVES
∙ To assess the effects of personally tailored activities on psychosocial outcomes for people with dementia living in long-term care facilities.∙ To describe the components of the interventions.∙ To describe conditions which enhance the effectiveness of personally tailored activities in this setting.
SEARCH METHODS
We searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group's Specialized Register, on 16 June 2017 using the terms: personally tailored OR individualized OR individualised OR individual OR person-centred OR meaningful OR personhood OR involvement OR engagement OR engaging OR identity. We also performed additional searches in MEDLINE (Ovid SP), Embase (Ovid SP), PsycINFO (Ovid SP), CINAHL (EBSCOhost), Web of Science (ISI Web of Science), ClinicalTrials.gov, and the World Health Organization (WHO) ICTRP, to ensure that the search for the review was as up to date and as comprehensive as possible.
SELECTION CRITERIA
We included randomised controlled trials and controlled clinical trials offering personally tailored activities. All interventions included an assessment of the participants' present or past preferences for, or interests in, particular activities as a basis for an individual activity plan. Control groups received either usual care or an active control intervention.
DATA COLLECTION AND ANALYSIS
Two authors independently checked the articles for inclusion, extracted data and assessed the methodological quality of included studies. For all studies, we assessed the risk of selection bias, performance bias, attrition bias and detection bias. In case of missing information, we contacted the study authors.
MAIN RESULTS
We included eight studies with 957 participants. The mean age of participants in the studies ranged from 78 to 88 years and in seven studies the mean MMSE score was 12 or lower. Seven studies were randomised controlled trials (three individually randomised, parallel group studies, one individually randomised cross-over study and three cluster-randomised trials) and one study was a non-randomised clinical trial. Five studies included a control group receiving usual care, two studies an active control intervention (activities which were not personally tailored) and one study included both an active control and usual care. Personally tailored activities were mainly delivered directly to the participants; in one study the nursing staff were trained to deliver the activities. The selection of activities was based on different theoretical models but the activities did not vary substantially.We found low-quality evidence indicating that personally tailored activities may slightly improve challenging behaviour (standardised mean difference (SMD) -0.21, 95% confidence interval (CI) -0.49 to 0.08; I² = 50%; 6 studies; 439 participants). We also found low-quality evidence from one study that was not included in the meta-analysis, indicating that personally tailored activities may make little or no difference to general restlessness, aggression, uncooperative behaviour, very negative and negative verbal behaviour (180 participants). There was very little evidence related to our other primary outcome of quality of life, which was assessed in only one study. From this study, we found that quality of life rated by proxies was slightly worse in the group receiving personally tailored activities (moderate-quality evidence, mean difference (MD) -1.93, 95% CI -3.63 to -0.23; 139 participants). Self-rated quality of life was only available for a small number of participants, and there was little or no difference between personally tailored activities and usual care on this outcome (low-quality evidence, MD 0.26, 95% CI -3.04 to 3.56; 42 participants). We found low-quality evidence that personally tailored activities may make little or no difference to negative affect (SMD -0.02, 95% CI -0.19 to 0.14; I² = 0%; 6 studies; 589 participants). We found very low quality evidence and are therefore very uncertain whether personally tailored activities have any effect on positive affect (SMD 0.88, 95% CI 0.43 to 1.32; I² = 80%; 6 studies; 498 participants); or mood (SMD -0.02, 95% CI -0.27 to 0.23; I² = 0%; 3 studies; 247 participants). We were not able to undertake a meta-analysis for engagement and the sleep-related outcomes. We found very low quality evidence and are therefore very uncertain whether personally tailored activities improve engagement or sleep-related outcomes (176 and 139 participants, respectively). Two studies that investigated the duration of the effects of personally tailored activities indicated that the intervention effects persisted only during the delivery of the activities. Two studies reported information about adverse effects and no adverse effects were observed.
AUTHORS' CONCLUSIONS
Offering personally tailored activities to people with dementia in long-term care may slightly improve challenging behaviour. Evidence from one study suggested that it was probably associated with a slight reduction in the quality of life rated by proxies, but may have little or no effect on self-rated quality of life. We acknowledge concerns about the validity of proxy ratings of quality of life in severe dementia. Personally tailored activities may have little or no effect on negative affect and we are uncertain whether they improve positive affect or mood. There was no evidence that interventions were more likely to be effective if based on one specific theoretical model rather than another. Our findings leave us unable to make recommendations about specific activities or the frequency and duration of delivery. Further research should focus on methods for selecting appropriate and meaningful activities for people in different stages of dementia.
Topics: Affect; Aged; Aged, 80 and over; Dementia; Humans; Long-Term Care; Non-Randomized Controlled Trials as Topic; Psychomotor Agitation; Quality of Life; Randomized Controlled Trials as Topic; Social Participation
PubMed: 29438597
DOI: 10.1002/14651858.CD009812.pub2 -
Aripiprazole (intramuscular) for psychosis-induced aggression or agitation (rapid tranquillisation).The Cochrane Database of Systematic... Jan 2018People experiencing psychosis may become aggressive. Antipsychotics, such as aripiprazole in intramuscular form, can be used in such situations. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
People experiencing psychosis may become aggressive. Antipsychotics, such as aripiprazole in intramuscular form, can be used in such situations.
OBJECTIVES
To evaluate the effects of intramuscular aripiprazole in the treatment of psychosis-induced aggression or agitation (rapid tranquillisation).
SEARCH METHODS
On 11 December 2014 and 11 April 2017, we searched the Cochrane Schizophrenia Group's Study-based Register of Trials which is based on regular searches of CINAHL, BIOSIS, AMED, Embase, PubMed, MEDLINE, PsycINFO, and registries of clinical trials.
SELECTION CRITERIA
All randomised controlled trials (RCTs) that randomised people with psychosis-induced aggression or agitation to receive either intramuscular aripiprazole or another intramuscular intervention.
DATA COLLECTION AND ANALYSIS
We independently inspected citations and, where possible, abstracts, ordered papers and re-inspected and quality assessed these. We included studies that met our selection criteria. At least two review authors independently extracted data from the included studies. We chose a fixed-effect model. We analysed dichotomous data using risk ratio (RR) and the 95% confidence intervals (CI). We analysed continuous data using mean differences (MD) and their CIs. We assessed risk of bias for included studies and used GRADE to create 'Summary of findings' tables.
MAIN RESULTS
Searching found 63 records referring to 21 possible trials. We could only include three studies, all completed over the last decade, with 885 participants, of which 707 were included for quantitative analyses in this systematic review. Due to limited comparisons, small size of trials and a paucity of investigated and reported 'pragmatic' outcomes, evidence was mostly graded as low or very low quality. No trials reported useful data for one of our primary outcomes of tranquil or asleep by 30 minutes. Economic outcomes were also not reported in the trials.When compared with placebo, fewer people in the aripiprazole group needed additional injections compared to the placebo group (2 RCTs, n = 382, RR 0.69, 95% CI 0.56 to 0.85, very low-quality evidence). Clinically important improvement in agitation at two hours favoured the aripiprazole group (2 RCTs, n = 382, RR 1.50, 95% CI 1.17 to 1.92, very low-quality evidence). The numbers of non-responders after the first injection also favoured aripiprazole (1 RCT, n = 263, RR 0.49, 95% CI 0.34 to 0.71, low-quality evidence). Although no effect was found, more people in the aripiprazole compared to the placebo group experienced adverse effects (1 RCT, n = 117, RR 1.51, 95% CI 0.93 to 2.46, very low-quality evidence).Aripiprazole required more injections compared to haloperidol (2 RCTs, n = 477, RR 1.28, 95% CI 1.00 to 1.63, very low-quality evidence), with no significant difference in agitation (2 RCTs, n = 477, RR 0.94, 95% CI 0.80 to 1.11, very low-quality evidence), and similar non-responders after first injection (1 RCT, n = 360, RR 1.18, 95% CI 0.78 to 1.79, low-quality evidence). Aripiprazole and haloperidol did not differ when taking into account the overall number of people that experienced at least one adverse effect (1 RCT, n = 113, RR 0.91, 95% CI 0.61 to 1.35, very low-quality evidence).Compared to aripiprazole, olanzapine was better at reducing agitation (1 RCT, n = 80, RR 0.77, 95% CI 0.60 to 0.99, low-quality evidence) and had a more favourable effect on global state change scores (1 RCT, n = 80, MD 0.58, 95% CI 0.01 to 1.15, low-quality evidence), both at two hours. No differences were found in terms of experiencing at least one adverse effect during the 24 hours after treatment (1 RCT, n = 80, RR 0.75, 95% CI 0.45 to 1.24, very low-quality evidence). However, participants allocated to aripiprazole experienced less somnolence (1 RCT, n = 80, RR 0.25, 95% CI 0.08 to 0.82, low-quality evidence).
AUTHORS' CONCLUSIONS
The available evidence is of poor quality but there is some evidence aripiprazole is effective compared to placebo and haloperidol, but not when compared to olanzapine. However, considering that evidence comes from only three studies, caution is required in generalising these results to real-world practice. This review firmly highlights the need for more high-quality trials on intramuscular aripiprazole in the management of people with acute aggression or agitation.
Topics: Aggression; Antipsychotic Agents; Aripiprazole; Benzodiazepines; Haloperidol; Humans; Injections, Intramuscular; Olanzapine; Psychomotor Agitation; Randomized Controlled Trials as Topic; Tranquilizing Agents
PubMed: 29308601
DOI: 10.1002/14651858.CD008074.pub2 -
Academic Emergency Medicine : Official... May 2018We aimed to clarify the definition, epidemiology, and pathophysiology of excited delirium syndrome (ExDS) and to summarize evidence-based treatment recommendations.
OBJECTIVE
We aimed to clarify the definition, epidemiology, and pathophysiology of excited delirium syndrome (ExDS) and to summarize evidence-based treatment recommendations.
METHODS
We conducted a systematic literature search of MEDLINE, Ovid, Web of Knowledge, and Cochrane Library for articles published to March 18, 2017. We also searched the gray literature (Google Scholar) and official police or medical expert reports to complete specific epidemiologic data. Search results and full-text articles were independently assessed by two investigators and agreements between reviewers assessed with K statistics. We classified articles by study type, setting, and evidence level.
RESULTS
After reviewing the title and abstract of 3,604 references, we fully reviewed 284 potentially relevant references, from which 66 were selected for final review. Six contributed to the definition of ExDS, 24 to its epidemiology, 38 to its pathophysiology, and 27 to its management. The incidence of ExDS varies widely with medical or medicolegal context. Mortality is estimated to be as much as 8.3% to 16.5%. Patients are predominantly male. Male sex, young age, African-American race, and being overweight are independent risk factors. Pathophysiology hypotheses mostly implicate dopaminergic pathways. Most cases occur with psychostimulant use or among psychiatric patients or both. Proposed treatments are symptomatic, often with rapid sedation with benzodiazepines or antipsychotic agents. Ketamine is suggested as an alternative.
CONCLUSION
The overall quality of studies was poor. A universally recognized definition is lacking, remaining mostly syndromic and based on clinical subjective criteria. High mortality rate may be due to definition inconsistency and reporting bias. Our results suggest that ExDS is a real clinical entity that still kills people and that has probably specific mechanisms and risk factors. No comparative study has been performed to conclude whether one treatment approach is preferable to another in the case of ExDS.
Topics: Antipsychotic Agents; Delirium; Female; Humans; Ketamine; Male; Psychomotor Agitation; Retrospective Studies; Risk Factors; Substance-Related Disorders; Syndrome; Young Adult
PubMed: 28990246
DOI: 10.1111/acem.13330