Randomised control trial
Fiona E Shaw, John Bond, David A Richardson, Pamela Dawson, I Nicholas Steen, Ian G McKeith, Rose Anne KennyMultifactorial intervention after a fall in older people with cognitive impairment and dementia presenting to the accident and emergency department: randomised controlled trial
BMJ
2003 Jan 11; Vol 326(7380): 73-75
- Submitted by:Stefan Tino Kulnik - Physiotherapist
- Institution:Imperial College Healthcare NHS Trust
- Date submitted:15th November 2009
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Yes. To determine the effectiveness of multifactorial assessment and intervention after a fall compared with conventional care in older people with cognitive impairment and dementia presenting to the accident and emergency department. Authors put their objectives in context with the known increased risk of falls in older individuals with cognitive impairment and dementia, and with the UK National Service Framework for Older People giving priority to the prevention of further falls in older people who attend the accident and emergency department.
2
Design
2.1
Is the study design suitable for the objectives
Yes. Prospective single centre randomised controlled trial.
2.2
Who / what was studied?
Subjects included were: older people (age 65 or older) with cognitive impairment and dementia (defined as mini-mental state examination score less than 24) presenting to two accident and emergency departments in Newcastle upon Tyne after a fall (defined as event reported by the person who fell or a witness, resulting in the person inadvertently coming to rest on the ground or at another lower level with or without loss of consciousness or injury).
Subjects excluded were: individuals unable to walk; if a medical diagnosis was the likely cause for the fall (e.g. CVA); individuals unfit for investigation within 4 months; individuals unable to communicate for reasons other than dementia; individuals living outside a 15 mile radius of site of recruitment; individuals without 'major informant' (someone in contact with the individual at least twice a week); improved mini-mental state examination score to 24 or more two weeks after presentation (to exclude acute confusion).
The intervention investigated was: Multifactorial intervention for identified risk factors for falls. All subjects underwent multifactorial clinical assessment (medical, physiotherapy, occupational therapy and cardiovascular). Subjects in the intervention group received interventions for all identified risk factors (see protocol Table 1). Subjects in the control group received conventional care from all health professionals who were or became involved in their management during the one year follow up.
Subjects excluded were: individuals unable to walk; if a medical diagnosis was the likely cause for the fall (e.g. CVA); individuals unfit for investigation within 4 months; individuals unable to communicate for reasons other than dementia; individuals living outside a 15 mile radius of site of recruitment; individuals without 'major informant' (someone in contact with the individual at least twice a week); improved mini-mental state examination score to 24 or more two weeks after presentation (to exclude acute confusion).
The intervention investigated was: Multifactorial intervention for identified risk factors for falls. All subjects underwent multifactorial clinical assessment (medical, physiotherapy, occupational therapy and cardiovascular). Subjects in the intervention group received interventions for all identified risk factors (see protocol Table 1). Subjects in the control group received conventional care from all health professionals who were or became involved in their management during the one year follow up.
2.3
Was this the right sample to answer the objectives?
Yes. Representative for clinical reality. (NB: under-recruitment of subjects living in the community. 80% of subjects resided in residential or nursing homes.)
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
Sample size estimate was based on falls prevention data in cognitively normal older people. A 30% reduction in proportion of patients who fall over one year was judged as clinically significant and similar to that of cognitively normal older people. At the 5% level 90 subjects in each group would give an 80% power of detecting a reduction of 30% in the proportion of subjects who had at least one fall.
2.5
Were all subjects accounted for?
Yes. Refer to flowchart Recruitment and attrition rates
2.6
Were all appropriate outcomes considered?
Yes.
Primary outcome: number of participants who fell at least once in the year after intervention.
Secondary outcomes (all collected for the period of one year following recruitment): number of falls; time to first fall; injury rates; fall related attendances at accident and emergency department; fall related hospital admissions; mortality.
Primary outcome: number of participants who fell at least once in the year after intervention.
Secondary outcomes (all collected for the period of one year following recruitment): number of falls; time to first fall; injury rates; fall related attendances at accident and emergency department; fall related hospital admissions; mortality.
2.7
Has ethical approval been obtained if appropriate?
Yes. Approved by Newcastle and North Tyneside Health Authority ethics committee.
2.8
Were the patients randomised between treatments?
Yes.
2.9
How was randomisation carried out?
Block randomisation using computer generated numbers. Randomisation was stratified by mini-mental state examination score at recruitment (20-23: mild cognitive impairment; 12-19: moderate cognitive impairment; 4-11: severe cognitive impairment; 0-3: very severe cognitive impairment). Group allocation was performed by a researcher independent of the recruitment process and blind to baseline data.
2.10
Are the outcomes clinically relevant?
Yes.
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
Yes.
What was measured: outcome measures see 2.6. of this appraisal; also mini-mental state examination and multifactorial clinical assessment (see Table 1) at entry to study; cooperation with components of assessment, compliance with interventions.
How it was measured: falls data was provided by weekly diary postcard completed and sent in by the informant. If no postcard received for two consecutive weeks, the informant was contacted by telephone. Data on injuries collected from accident and emergency department records. Data on attendance at accident and emergency department and hospital admissions collected monthly from computerised records. Components of multifactorial assessment seem standardised as much as practicability allows, references are provided. Cooperation with assessment was judged clinically. Compliance with intervention was assessed after three months by questioning of the informant, inspection of drugs, review of physiotherapy documentation and observation of environment and patient.
What were the outcomes: see 2.6. of this appraisal.
What was measured: outcome measures see 2.6. of this appraisal; also mini-mental state examination and multifactorial clinical assessment (see Table 1) at entry to study; cooperation with components of assessment, compliance with interventions.
How it was measured: falls data was provided by weekly diary postcard completed and sent in by the informant. If no postcard received for two consecutive weeks, the informant was contacted by telephone. Data on injuries collected from accident and emergency department records. Data on attendance at accident and emergency department and hospital admissions collected monthly from computerised records. Components of multifactorial assessment seem standardised as much as practicability allows, references are provided. Cooperation with assessment was judged clinically. Compliance with intervention was assessed after three months by questioning of the informant, inspection of drugs, review of physiotherapy documentation and observation of environment and patient.
What were the outcomes: see 2.6. of this appraisal.
3.2
Are the measurements valid?
Primary and secondary outcome measures: yes.
Mini-mental state examination: yes.
Measurements that are part of the protocol for multifactorial assessment and intervention (Table 1): the background to this protocol is briefly discussed in the authors' discussion and references are provided. References are provided for individual standardised assessment tools used for multifactorial assessment. The validity of these is not commented on by the authors. The validity and effectiveness of the protocol as a whole is not commented on.
Cooperation with assessment, compliance with intervention: not commented on.
Mini-mental state examination: yes.
Measurements that are part of the protocol for multifactorial assessment and intervention (Table 1): the background to this protocol is briefly discussed in the authors' discussion and references are provided. References are provided for individual standardised assessment tools used for multifactorial assessment. The validity of these is not commented on by the authors. The validity and effectiveness of the protocol as a whole is not commented on.
Cooperation with assessment, compliance with intervention: not commented on.
3.3
Are the measurements reliable?
As 3.2. of this appraisal.
3.4
Are the measurements reproducible?
Primary and secondary outcome measures: yes.
Mini-mental state examination: yes.
Measurements that are part of the protocol for multifactorial assessment and intervention (Table 1): yes for standardised assessment tools with references provided. No for parts of the assessment that are not referenced or described, such as medical history and examination and visual acuity assessment.
Cooperation with assessment, compliance with intervention: briefly described, but insufficient to reproduce.
Mini-mental state examination: yes.
Measurements that are part of the protocol for multifactorial assessment and intervention (Table 1): yes for standardised assessment tools with references provided. No for parts of the assessment that are not referenced or described, such as medical history and examination and visual acuity assessment.
Cooperation with assessment, compliance with intervention: briefly described, but insufficient to reproduce.
3.5
Were the patients and the investigators blinded?
No comment on whether subjects and informants were blinded.
Data on primary outcome was collected (from postcards) by blinded researcher off site.
Data on secondary outcomes, compliance with intervention, treatment received by control group, and objective effects of intervention was collected by members of the research teams, who were not blind to randomisation.
No comment on whether assessors at 3-months re-assessment were blinded. No comment on whether professionals delivering the interventions for falls risks were blinded.
Data on primary outcome was collected (from postcards) by blinded researcher off site.
Data on secondary outcomes, compliance with intervention, treatment received by control group, and objective effects of intervention was collected by members of the research teams, who were not blind to randomisation.
No comment on whether assessors at 3-months re-assessment were blinded. No comment on whether professionals delivering the interventions for falls risks were blinded.
4
Presentation of results
4.1
Are the basic data adequately described?
Yes. Baseline characteristics (Table 2), risk factors for falls (Table 3), outcomes (Tables 4, 5 and 6)
4.2
Were groups comparable at baseline?
Yes, refer to Tables 2 and 3. No significant differences in baseline characteristics and risk factors for falls.
Information on whether subjects were living in their own home, in residential care home or in nursing care home would be of interest.
Information on whether subjects were living in their own home, in residential care home or in nursing care home would be of interest.
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
Yes.
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
Yes.
4.5
Were side effects reported?
Not applicable in the context of the study. An increased number of falls and falls related injuries for the control group would be the main adverse effect in the context of the study, which is commented on as these are investigated outcomes.
5
Analysis
5.1
Are the data suitable for analysis?
Yes.
5.2
Are the methods appropriate to the data?
As far as my professional background allows, I believe that the statistical methods are appropriate. Also, published in renowned journal (BMJ).
Data analysed on an intention to treat basis.
Data analysed on an intention to treat basis.
5.3
Are any statistics correctly performed and interpreted?
As 5.2. of this appraisal.
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
Yes. The results are compared and put in context with the success of multifactorial risk assessment and intervention to prevent falls in older people with normal cognition. The authors' assumption was that a reduction of falls by 30%, similar to the success rates in older people with normal cognition, would be clinically significant in the studied group of older people with dementia and cognitive impairment. Falls prevention work with older people with normal cognition is referenced.
Authors state that this is the first randomised controlled trial of its kind.
Authors state that this is the first randomised controlled trial of its kind.
6.2
Is the discussion biased?
No. Objective discussion of limitations of the study and possible causes and implications of the negative outcome of the study.
7
Interpretation
7.1
Are the authors' conclusions justified by the data?
Yes.
Authors acknowledge that they did not show a significant reduction in proportion of subjects who fell or in number of falls by using a multifactorial assessment and intervention strategy after a fall in patients with cognitive impairment and dementia presenting to the accident and emergency department. This suggests multifactorial intervention is less effective in this population than in cognitively normal older people.
Authors suggest that limited resources may be used more effectively if targeted towards cognitively older people. Authors call for further work to identify best strategies for falls prevention in group of older people with cognitive impairment and dementia, who are at particularly high risk of falls.
Authors acknowledge that they did not show a significant reduction in proportion of subjects who fell or in number of falls by using a multifactorial assessment and intervention strategy after a fall in patients with cognitive impairment and dementia presenting to the accident and emergency department. This suggests multifactorial intervention is less effective in this population than in cognitively normal older people.
Authors suggest that limited resources may be used more effectively if targeted towards cognitively older people. Authors call for further work to identify best strategies for falls prevention in group of older people with cognitive impairment and dementia, who are at particularly high risk of falls.
7.2
What level of evidence has this paper presented? (using CEBM levels)
CEBM level of evidence: 1b
7.3
Does this paper help me answer my problem?
Yes.
8
Implementation
8.1
Can any necessary change be implemented in practice?
In my current working environment (physiotherapist on an acute hospital ward for acute elderly medicine) the team is practising a multidisciplinary approach to falls prevention and rehabilitation, including multidisciplinary assessment and intervention. This approach is currently applied to patients with normal cognition and patients with cognitive impairment and dementia. According to the individual patient's presentation and circumstances interventions are adapted as it is thought appropriate and required.
Knowing of this study will certainly guide me in my communication with the team, family and carers, especially with regards to expected success and outcomes. Knowing of this study will not significantly change the physiotherapy input I am providing, as I am applying a highly individualised approach for the person with dementia or cognitive impairment.
Knowing of this study will certainly guide me in my communication with the team, family and carers, especially with regards to expected success and outcomes. Knowing of this study will not significantly change the physiotherapy input I am providing, as I am applying a highly individualised approach for the person with dementia or cognitive impairment.
8.2
What aids to implementation exist?
Not applicable. See 8.1. of this appraisal.
8.3
What barriers to implementation exist?
Not applicable. See 8.1. of this appraisal.