Systematic review of systematic reviews of non-pharmacological interventions to treat behavioural

29 Pages·2017·2.27 MB·English

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Systematic review of systematic reviews
of non-pharmacological interventions
to treat behavioural disturbances
in older patients with dementia.
The SENATOR-OnTop series
Iosief Abraha,1 Joseph M Rimland,1 Fabiana Mirella Trotta,1
Giuseppina Dell’Aquila,1 Alfonso Cruz-Jentoft,2 Mirko Petrovic,3
Adalsteinn Gudmundsson,4 Roy Soiza,5 Denis O’Mahony,6 Antonio Guaita,7
Antonio Cherubini1
Tocite:AbrahaI, ABSTRACT
Strengths and limitations of this study
RimlandJM,TrottaFM,etal. Objective:Toprovideanoverviewofnon-
Systematicreviewof
pharmacologicalinterventionsforbehaviouraland ▪ Non-pharmacological interventions have gained
systematicreviewsofnon-
pharmacologicalinterventions psychologicalsymptomsindementia(BPSD). increasingattentioninrecentyearsasanalterna-
totreatbehavioural Design:Systematicoverviewofreviews. tive first-line approach to treat behavioural and
disturbancesinolder Data sources:PubMed,EMBASE,CochraneDatabase psychologicalsymptomsindementia(BPSD).
patientswithdementia. ofSystematicReviews,CINAHLandPsycINFO(2009– ▪ Thestrengthofthis review is its extensive, com-
TheSENATOR-OnTopseries. March2015). prehensive systematic search of studies that
BMJOpen2017;7:e012759. Eligibility criteria:Systematicreviews(SRs)that investigated non-pharmacological interventions
doi:10.1136/bmjopen-2016-
includedatleastonecomparativestudyevaluatingany for BPSD. It provides a compendium of the
012759
non-pharmacologicalintervention,totreatBPSD. types of non-pharmacological interventions,
Data extraction:Eligiblestudieswereselectedand includingthecomponentofeachsingleinterven-
▸ Prepublicationhistoryand dataextractedindependentlyby2reviewers. tion, the dosage (when available) and the dur-
additionalmaterialis TheAMSTARchecklistwasusedtoassessthe ationofthetreatment.
available.Toviewpleasevisit qualityoftheSRs. ▪ Primarystudies were generally of limited sample
thejournal(http://dx.doi.org/
Data analysis:Extracteddataweresynthesisedusing size; there was substantial variation in the
10.1136/bmjopen-2016-
012759). anarrativeapproach. characteristics of the intervention and the
Results:38SRsand142primarystudieswere authorsofprimarystudiesreporteddifferentcon-
ceptual frameworks, and sometimes broad, and
identified,comprisingthefollowingcategoriesofnon-
quitegenericdescriptions,oftheinterventions.
Received23May2016 pharmacologicalinterventions:(1)sensorystimulation
Revised5September2016 interventions(12SRs,27primarystudies)that
Accepted4October2016 encompassed:acupressure,aromatherapy,massage/
implementationwerefoundtobeeffectivefor
touchtherapy,lighttherapyandsensorygarden;(2)
symptomaticandsevereagitation.
cognitive/emotion-orientedinterventions(33SRs;70
Conclusions:Alargenumberofnon-pharmacological
primarystudies)thatincludedcognitivestimulation,
interventionsforBPSDwereidentified.Themajorityof
music/dancetherapy,dancetherapy,snoezelen,
thestudieshadgreatvariationinhowthesametypeof
transcutaneouselectricalnervestimulation,
interventionwasdefinedandapplied,thefollow-up
reminiscencetherapy,validationtherapy,simulated
duration,thetypeofoutcomemeasured,usuallywith
presencetherapy;(3)behaviourmanagement
modestsamplesize.Overall,musictherapyand
techniques(6SRs;32primarystudies)and(4)other
behaviouralmanagementtechniqueswereeffectivefor
therapies(5SRs,12primarystudies)comprising
reducingBPSD.
exercisetherapy,animal-assistedtherapy,specialcare
unitanddiningroomenvironment-basedinterventions.
Musictherapywaseffectiveinreducingagitation
Fornumberedaffiliationssee (SMD,−0.49;95%CI−0.82to−0.17;p=0.003),and
endofarticle. anxiety(SMD,−0.64;95%CI−1.05to−0.24; INTRODUCTION
p=0.002).Home-basedbehaviouralmanagement Dementia is a neuropsychiatric syndrome
Correspondenceto techniques,caregiver-basedinterventionsorstaff characterised by cognitive decline and pro-
DrIosiefAbraha; trainingincommunicationskills,person-centredcare gressive deterioration of daily function, often
[email protected] ordementiacaremappingwithsupervisionduring associatedwith behaviouraldisturbances.
AbrahaI,etal.BMJOpen2017;7:e012759.doi:10.1136/bmjopen-2016-012759 1
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The prevalence of dementia in older participants is METHODS
reported to be ∼6% worldwide1 and, with global popula- This work is part of the Optimal Evidence-Based
tion ageing, it is expected to rise, although some recent Non-drug Therapies in Older People (ONTOP) project,
studies have suggested declining trends in dementia a work package of a European Union funded FP7
frequency.2 Dementia presents a considerable burden to research named SENATOR (Software ENgine for the
familiesandcaregiversandisbecomingamajorchallenge Assessment & Optimization of drug and non-drug
forall healthcaresystems,aswellasforsocietyat large.34 Therapy in Older peRsons). The ONTOP aim is to
Alzheimer’s disease (AD) is the most common form of undertake a literature search of systematic reviews (SRs)
dementiainolderpeople,accountingfor60%ofcases. and provide clinical recommendations concerning
Approximately five out of every six patients with evidence-based non-pharmacological treatments of
dementia, including those living at home, will develop several prevalent medical conditions affecting older
behavioural and psychological symptoms during the people, including delirium,32 33 pressure ulcers,33–35
course of the disease.5–8 Behavioural and psychological falls,36 37 stroke and heart failure. A protocol that
symptoms in dementia (BPSD) are defined as signs and describesthesearchstrategy,screeningand inclusion cri-
symptoms ofdisturbed behaviour,mood, thought or per- teria, has been previously published.38 Briefly, to obtain
ception.9 These disturbances, namely agitation, depres- the evidence regarding the non-pharmacological inter-
sion, elation, delusions and hallucinations, are strongly ventions,wefirstidentifiedpublishedSRsusingasystem-
correlated with each other.10 11 Twenty per cent of those atic search across several databases. After processing
initially without symptoms will manifest them within eligible SRs, we identified and obtained primary studies
2years of dementia diagnosis,12 whereas 50–80% of from these SRs to generate the compendium of non-
those with clinically important symptoms remain agi- pharmacological interventions. In a subsequent work
tated for several months.13 In addition, at least 50% of will present the assessment of the body of evidence and
patients with dementia present with significant BPSD on provide recommendations according to the GRADE
a monthly basis.14 Agitation, together with depression, approach.38
hinder activities and relationships, cause feelings of
helplessness and distress in families and formal care- Searchstrategyand inclusion criteriafor systematic
givers15 and are strong predictors for poor quality of reviews
life,16 as well as nursing home admission.17 The search sources included the Cochrane Database of
Currently, options for treating BPSD include pharma- Systematic Reviews, PubMed, PsycINFO and CINAHL
cological and non-pharmacological therapies.18 19 (see online supplementary appendix 1). Two criteria
Psychotropic medications are often used to reduce the were considered for further evaluation of an abstract:
frequency and severity of BPSD, but in the majority of (1) a paper defined as a review or a meta-analysis; (2)
patients, they provide only modest symptom control.20–22 the use of any non-pharmacological intervention to treat
A recent trial reported that the addition of citalopram behavioural disturbances in patients with dementia. The
to psychosocial support significantly reduced agitation publication years ranged from 2009 to March 2015.
and caregiver distress.23 However, their adverse effects Subsequently, full-texts of relevant abstracts were
are common and problematic, in particular the obtained and screened to identify SRs of interest based
increased risk of falls and fractures,24 stroke and even on (1) the use of at least one medical literature data-
mortality.25 In addition, there is some evidence that the base; (2) the inclusion of at least one primary study and
use of benzodiazepines to treat agitation in patients with (3) the use of at least one non-pharmacological inter-
dementia may increase cognitive decline24 and may vention to treat behavioural disturbances in people aged
expose patients to an immediate risk of injurious falls.26 60+years.
Finally, memantine and cholinesterase inhibitors are We assessed the methodological quality of each SR
considered to be of very limited value to improve agita- using the AMSTAR (A Measurement Tool to Assess
tion inparticipants with AD.27 28 Reviews) instrument that contains 11 items.39 Final
In general, non-pharmacological interventions are grading of the methodological quality of each SR was
considered a preferable alternative to psychotropic based on the overall score and reported as either ‘high’
pharmacotherapy for treating BPSD.29 However, there is (score≥8), ‘medium’ (score 4–7) or ‘low’ (score≤3).
conflicting evidence concerning the efficacy and practi- Two reviewers independently assessed the quality of the
cality of non-pharmacological interventions to improve SRs, and disagreements wereresolved by consensus.
BPSD, particularlyagitation.9 30
The purpose of the present overview is to assess the Data extractionandmanagement
evidence supporting these non-pharmacological inter- From each SR, the following data were collected: the
ventions with a view to providing a working compen- publication year, the databases searched, the study popu-
dium for the non-drug management ofBPSD. lation, the non-pharmacological interventions, the
The present overview updates the evidence on the number of primary studies included, the outcome mea-
same theme gathered by a previous systematic overview sures and the AMSTAR score. Pairs of reviewers inde-
published in2011.31 pendently screened titles, abstracts and full texts of
2 AbrahaI,etal.BMJOpen2017;7:e012759.doi:10.1136/bmjopen-2016-012759
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Open Access
articles. Disagreements were resolved by discussion or, potential biases (eg, balance in baseline characteristics).
wherenecessary,by consulting anotherauthor. The overall quality of evidence was assessed using the
GRADE (Grading of Recommendations, Assessment,
Outcome measures Development and Evaluation) methodology that takes
into account the risk of bias, consistencyof results across
We focused on reviews that considered BPSD, as a
the studies, precision of the results, directness and likeli-
primary outcome, measured by (1) multidomain scales
hood of publication bias.43 Results regarding the risk of
(eg, Neuropsychiatric Inventory (NPI), Brief Psychiatric
Rating Scale, BPRS), (2) scales specific to agitation (eg, bias assessment, and grading the qualityof evidence, will
Cohen-Mansfield Agitation Inventory, CMAI) and (3) be provided in acompanion paper.
scales specific to depression or anxiety (eg, Cornell
Scale for Depression in Dementia, CSDD).
RESULTS
Our search strategy identified 4392 abstracts of which
Inclusion criteriafor primarystudies and assessment
2549 were duplicates and were subsequently removed.
From the included SRs, we obtained any experimental After abstract screening, 67 records were identified for
comparative study, either randomised or non-randomised,
full-text assessment. Of these, 38 reviews were included
that investigated any non-pharmacological intervention to
in this overview. From these SRs, we obtained 142
treat BPSD in older patients. Observational studies or
primary studies from which we abstracted details of the
before–afterstudies,withhistoricalcontrols,wereexcluded.
non-pharmacological interventions. Figure 1 shows the
As outlined in our protocol, we extracted data from
study screening process. Table 1 depicts the basic
primary studies to perform meta-analyses and heterogen-
characteristics of the included SRs. The characteristics of
eity was addressed using the Cochrane Collaboration
relevant primary studies are reported in online
approach.38
supplementary appendix 2 as electronic tables (etable).
The AMSTAR evaluation are summarised in online
Riskof bias assessment and gradingthe quality supplementaryappendix 3.
of evidence The interventions in this overview were classified
Weused theCochraneCollaborationmethod toevaluate according to the following categories: (1) sensory stimu-
the risk of bias. The domains considered were random lationinterventionsthatencompassacupuncture,aroma-
sequence generation, allocation concealment,40 blinding therapy, massage therapy, light therapy, sensory garden
of participants, personnel, oroutcome assessor,40 incom- intervention, cognitive stimulation, music/singing and
plete outcome data,41 selective reporting42 and other dance therapy, snoezelen and transcutaneous electrical
Figure1 Studyscreening
process.
AbrahaI,etal.BMJOpen2017;7:e012759.doi:10.1136/bmjopen-2016-012759 3
4
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Library,Lilacs,trialregisters, (Alzheimer’sdisease, neuropsychiatricsymptomsand
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Open Access
nerve stimulation (TENS) therapy; (2) cognitive/ symptoms (n=63, MD 2.80, 95% CI −5.84 to 11.44). The
emotion-oriented interventions that include reminis- review authors remarked that the published studies used
cence therapy, validation therapy, simulated presence different scales to assess the behavioural symptoms and
therapy (SPT); (3) behavioural management technique were limited in sample size and methodological quality,
and (4) other interventions, such as exercise therapy, particularlybecauseofselectivereportingbias.
pet-therapyand special careunit. ThesecondreviewbySeitzetal29consistedofanynon-
pharmacological interventions, including aromatherapy,
Sensorystimulation interventions to treat outcomes relevant to patients with dementia.
Shiatsuandacupressure The review reported data in a narrative way and cited
Only one SR was identified. Robinson 201144 only one study of aromatherapy,53 which was also
(AMSTAR=7) investigated the evidence available for included in the Cochrane review above.48 The review
shiatsu and acupressure in BPSD. Shiatsu is a form of received an AMSTAR scoreof 6.
complementary medicine primarily developed in Japan, The third study was a review by Fung et al,47 which
which employs gentle manipulations, stretches and pres- considered only aromatherapy as a non-pharmacological
sure with the fingers, elbows, knees and feet. intervention. The review was judged to have moderate
Acupressure is similar, but exerts pressure for longer on methodological quality (AMSTAR score=6). After per-
specific meridian points according to traditional forming a comprehensive search in several electronic
Chinese medicine or acupoints of the human body in databases, 11 studies were identified, with a total of 405
order to ‘balance energy fields’. patients in different settings, including long-term care
The authors identified 40 RCTs, 8 controlled clinical (LTC) homes, clinical centres and general and old age
trials, 5 crossover trials, 6 within-participants studies, psychiatry. In addition to the trials included in the above
1 observational study, 10 uncontrolled studies and 1 pro- cited Cochrane review, the review by Fung et al47
spective study. Onlyone randomised trial (n=133 partici- included one randomised trial55 which was excluded in
pants) using acupressure in dementia participants was the Cochrane review because the routeof administration
relevant for our assessment.45 The authors reported that was not reported and there was no mention of the type
agitation, aggression and physically non-aggressive of the aromatherapy, in addition to five controlled clin-
behaviour all declined significantly in demented ical trials.56–60 Moreover, the Fung et al review47 did not
participants. include the two trials49 51 61 that were evaluated in the
Cochrane review. The controlled clinical trials could not
Aromatherapy be included in a meta-analysis because of heterogeneity.
Aromatherapy is proposed as acomplementary interven- The review highlighted the methodological limitations
tion, to treat a wide-range of health problems, including of the studies and reported promising results of aroma-
lack of sleep and behavioural symptoms for people with therapy. Online supplementary etable 1 describes the
dementia.46 Aromatherapy is based on the use of plant type of interventions, the outcomes and the results of
products or aromatic plant oils to produce essential oils the primary studies included in the aromatherapy
and blends of aromatic compounds. Aromatherapy can reviews.
be delivered through massage or topical application,
inhalation and water immersion. Massage therapy
Our systematic search identified three SRs that consid- Massage and touch therapy have been proposed as non-
ered aromatherapy as an intervention to treat agitated pharmacological interventionstobe used in dementiato
behaviours and other outcomes in patients with demen- offset manifestations of cognitive decline and beha-
tia. The AMSTAR scores ranged from 6 to 8 across the vioural disturbances, including related psychological
reviews. The range of included primary studies varied problems, such as depression and anxiety, and to
from 4 to 13.29 47 48 improvequalityof life.62
The most recent SR was a Cochrane review,48 which Two reviews were identified. The first was a Cochrane
had the highest AMSTAR quality score (8). The review review63 that was included in the review by O’Neil et al.31
included only randomised trials and launched its last This review assessed the efficacy of massage and touch
search strategy in January 2013. Seven studies with 428 therapy for the treatment of BPSD. Its last search strat-
participants were identified. The types of interventions egy was launched in 2006. The aim of the overview was
included lavender-based (four studies49–52), Melissa- to evaluate the effects of a range of massage and touch
based (two studies53 54) and lemon balm oil (1 study) therapies on conditions associated with dementia, such
aromatherapy. However, only two of these had usable as anxiety, agitated behaviourand depression, to identify
dataforpooling.Thefirststudy(n=71)reportedafavour- any adverse effects and to provide recommendations for
able treatment effect on measures of agitation (MD future trials. The review considered only randomised
−11.1,95%CI−19.9to−2.2)andbehaviouralsymptoms trials. The primary outcome measures were changes in
(MD −15.8, 95% CI −24.4 to −7.2), whereas the second the frequency and severity of various types of agitated
trial (n=63) did not detect any difference in agitation behaviour, as observed by staff or investigators (short-
(MD 0.00, 95% CI −1.36 to 1.36) or behavioural term and long-term using any rating method), and the
AbrahaI,etal.BMJOpen2017;7:e012759.doi:10.1136/bmjopen-2016-012759 9
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Open Access
emotional well-being and the quality of life of the was unclear whether the outcome assessor was blinded.
patients (rated by staff, investigators and/or patients Massage therapy was significantly associated with
themselves using any method). improvement for four of the five outcomes examined,
Remington (2002)64 assessed the effect of music and including wandering (0.38 vs 0.16, p<0.001), verballyagi-
massage in 68 nursing home residents with dementia tated behavioural symptoms (0.59 vs 0.49, p=0.002),
(AD, multi-infarct dementia or senile dementia). The physically agitated behavioural symptoms (0.82 vs 0.40,
participants were randomly allocated into four groups: p<0.001) and resistance to care (0.10 vs 0.09, p=0.022).
calming music, hand massage, simultaneous calming Online supplementary etable 2 describes the type of
musicandhandmassageandnointervention.Theinter- interventions, the outcomes and the results of the
ventionlasted10minandwasgiventoeachpatientonce. primarystudies included in the massage therapy reviews.
The efficacyoftreatmenton ‘agitation level’was evalu-
ated with a modified version of the CMAI administered Light therapy
by trained research assistants who were blinded to treat- Rest-activity and sleep-wake cycles are controlled by the
ment allocation when possible. The method of randomi- endogenous circadian rhythm generated by the supra-
sation was unclear and to conceal allocation, sealed chiasmatic nucleus (SCN) of the hypothalamus.
envelopes, without further explanation, were used. Degenerative changes in the SCN appear to be a bio-
However, patients could have been excluded afteralloca- logical cause of circadian rhythm disturbances in people
tion(if theyhad aCMAI scoreof0at baseline) and con- with dementia. In addition to the internal regulatory
sequently the study was considered to have high risk of loss, older people (especially those with dementia)
selection bias. experience a reduction in sensory input, due to less
The trial found that agitated behaviour decreased, visual sensitivity to light and less exposure to bright
more so in the group receiving hand massage than in environmental light. Evidence suggests that circadian
the group receiving no treatment. This treatment effect rhythm disturbances may be reversed by stimulation of
was consistently found, compared to baseline, for mea- the SCN with light.67
surements taken during treatment, immediately after Four reviews considered the use of bright light
treatment and 1-hour after treatment, and it was practic- therapy to treat behavioural problems in patients with
ally identical among the three groups receiving treat- dementia.
ment (hand massage, calming music or both). The The first was a Cochrane review67 (AMSTAR=10) with
mean agitation score was in favour of massage therapy the aim of evaluating the effectiveness of light therapy
immediately after treatment (MD 7.83 (4.30 to 11.36)) to improve cognition, activities of daily living (ADLs),
and 1-hourafter treatment (MD 12.12 (6.58 to17.66)). sleep, challenging behaviour and psychiatric distur-
The second review by Moyle et al65 conducted a search bances associated with dementia. The search strategy
in 10 databases in October 2011. The authors identified was launched in January 2014. The included studies
13 studies that evaluated massage therapy for the treat- were randomised trials that compared any bright light
ment of behavioural disturbances in patients with therapy, including dim red light or dim, low-frequency
dementia, but only one study with a high methodo- blinking light <300 lux, to usual care. The primary
logical score, using the Validity Rating Tool, was identi- outcome measures included cognition (global or single
fied. The included study, performed by Holliday- domain, eg, memory), ADLs, sleep-wake disturbances,
Welsh,66 was a prospective before–after study in which challenging behaviour (eg, agitation), psychiatric distur-
52 participants (39 women and 13 men; mean age bances (eg, depression) and adverse effects. Secondary
90years) from two skilled nursing facilities in outcomes were rates of institutionalisation and overall
Northeastern Minnesota, USA, were enrolled. Patients cost of care. The authors identified 11 studies, but stated
were cognitively impaired and had a history of agitated that three of the studies could not be included in the
behaviour confirmed by the facility staff. The interven- analyses either because the data were insufficient or
tion consisted of a 10-min to 15-min massage of the could not be retrieved from the trial authors. Only four
upper extremities (including the head, shoulders and of the included studies considered challenging behav-
hands), undertaken by a physical therapy assistant, iour as an outcome, but the sample sizes were limited
during a 1-hour period identified by caregivers as the and the outcome measures were not the same acrossthe
time the participant was usually most agitated (indivi- studies.68–71 A meta-analysis of challenging behaviour,
dualised for each participant). The outcomes of interest however, was performed and no substantial heterogen-
were assessed with a scale that used the five behavioural eity was found, although the results were not statistically
symptoms from the minimum data set; (1) wandering; in favourofbright light therapy.
(2) verballyabusive behavioural symptoms; (3) physically The second review aimed to identify which non-
abusive behavioural symptoms; (4) socially inappropri- pharmacological interventions were most effective for
ate/disruptivebehaviourand (5)resistance tocare. BPSD in LTC.29 Only two studies68 69 were included in
Methodologically, the study was considered at high the review (which were already included in the Forbes
risk of selection and performance bias given the study review67), but were not assessed in detail. The review
design and the nature of the intervention. In addition, it received four points inthe AMSTAR rating system.
10 AbrahaI,etal.BMJOpen2017;7:e012759.doi:10.1136/bmjopen-2016-012759