Best Evidence Topics

Review or meta-analysis

Gustavo Christofoletti, Merlyn Mercia Oliani, Sebastiao Gobbi, Florindo Stella
Effects of Motor Intervention In Elderly Patients With Dementia. An Analysis of Randomized Controlled Trials.
Topics in Geriatric Rehabilitation
2007, April 18, Vol.23, No.2, 149-154
  • Submitted by:Stefan Tino Kulnik - Physiotherapist
  • Institution:Imperial College Healthcare NHS Trust
  • Date submitted:5th December 2009
Before CA, i rated this paper: 5/10
1 Objectives and hypotheses
1.1 Are the objectives of the study clearly stated?
'To analyse randomised controlled trials published in the last decades involving motor intervention as a nonpharmacological approach in the treatment of dementia'. Authors do not explain what outcomes they are interested in. If the intention was to find any RCTs that investigated the intervention, including all possible outcomes, the rationale for this could have been pointed out more clearly in the introduction.
2 Design
2.1 Is the study design suitable for the objectives?
  Yes. An adequate number of RCTs has been published to warrant a review.
2.2 Were the search methods used to locate relevant studies comprehensive?
Authors searched the following databases: Medline, PubMed, Evidence Based Reviews, Lilacs, SciELO, PsychINFO, and Biological Abstracts.
The search terms are described. Hand-searching of reference lists or communication with researchers are not commented on.
The complete search strategy/search history is not provided. The date(s) of the search is not given.
The selection process is not described. No QUOROM flow-chart provided.
NB: Authors of this review from 2007 found 10 RCTs to include. An earlier systematic review by Heyn et al (2004, The Effects of Exercise Training on Elderly Persons With Cognitive Impairment and Dementia: A Meta-Analysis. Arch Phys Med Rehabil) identified 30 RCTs (!)
2.3 Was this the right sample to answer the objectives?
Included were:
- RCTs
- 'from the last decades' (not further specified)
- with 'physiotherapy, occupational therapy and physical education as motor intervention in the treatment of primary or secondary dementia'
- and meeting PEDro criteria for RCTs (described in the paper, reference provided).
2.4 Is the study large enough to achieve its objectives?
  Yes. Sizeable number of search results, 10 studies included in review.
2.5 Were all the studies accounted for?
  Yes. Number of excluded search results given, reason for exclusion explained.
2.6 Were all appropriate outcomes considered?
  Not applicable, as the search strategy (presumably) was to search for RCTs with a motor intervention for people with dementia, regardless of the investigated outcomes.
The 10 included studies did include a representative number of outcomes: cognitive performance, behaviour, mood, mobility, risk of falls, functioning (activities of daily living), and caregiver's distress.
2.7 Has ethical approval been obtained if appropriate?
  Not applicable for review.
For included studies: not commented on by authors. Studies were rated for their quality using the PEDro scale, which does not include the question of ethical approcal.
3 Measurement and observation
3.1 Is it clear what was measured, how it was measured and what the outcomes were?
  Included RCTs were assessed for their quality using the PEDro rating (reference provided). The authors do not clarify whether they adopted the PEDro rating system and rated the studies themselves. From Table 2 it can be assumed that PEDro ratings were taken from the official PEDro database, as 3 out of the 10 included studies are listed as 'not yet classified by PEDro' with no quality score given.
For the individual included studies, the authors do not describe the actual outcome measures used. They only describe the outcomes in terms of their general category, e.g. cognitive performance, mobility, behaviour, etc. To find out about the actual outcome measures used, the reader would have to read the individual RCT report.
3.2 Were explicit methods used to determine which studies to include in the review?
  Yes, see 2.3 of this appraisal for inclusion criteria.
3.3 Was the selection of primary studies re-producible and free from bias?
  Partly. Selection process not described. Inclusion criteria 'study investigating motor intervention in dementia' may possibly allow for some subjective interpretation, but overall the inclusion criteria are quite clear and should prevent bias.
3.4 Was the methodologic quality of the primary studies assessed?
  Yes, see 3.1. of this appraisal.
3.5 Are the measurements valid?
  With regards to PEDro rating: yes.
With regards to the individual outcome measures used in the individual included RCTs: unclear. Also, this point is not included in the PEDro rating.
3.6 Are the measurements reliable?
  As 3.5. of this appraisal.
3.7 Are the measurements reproducible?
  As 3.5. of this appraisal.
4 Presentation of results
4.1 Are the basic data adequately described?
All 10 included RCTs are summarized in Table 1. It would have been useful to include further information, e.g. the severity of cognitive impairment/dementia, the setting, the frequency and intensity of the intervention, and the actual outcome measures used.
NB: there appears to be an inconsistency between Table 1 ('level of confidence' column and legend) and the authors description of the results in the text. A single cross symbol supposedly points out better results after the motor intervention, e.g. for mobility in RCT by Pomeroy et al - in the text, however, the authors write that results related to mobility were not statistically significant.
Also, the alignment of 'dependent variables' column and 'level of confidence' column appears to be inappropriate in some places, as the two should line up to allow comparison of the outcome with the corresponding p-value.
4.2 Were the differences between studies adequately described?
PEDro scores given. Basic characteristics for studies summarized in Table 1.
See 4.1 of this appraisal for additional information that would have been useful.
4.3 Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
See 4.1 and 4.2 of this appraisal.
The main criticism would be that without including the actual outcome measures used for the individual RCTs in the analysis, it is difficult to appreciate the clinical/practical value of the improvement - in those studies that did show improvement.
4.4 Are the results internally consistent, i.e. do the numbers add up properly?
See 4.1 of this appraisal about inconsistencies in Table 1.
5 Analysis
5.1 Were the results of primary studies combined appropriately?
  No meta-analyses were performed.
5.2 Has a sensitivity analysis been performed?
  Not applicable.
5.3 Were all the important outcomes considered?
  Yes. See 2.6 of this appraisal.
5.4 Are the data suitable for analysis?
  Not applicable.
5.5 Are the methods appropriate to the data?
  Not applicable.
5.6 Are any statistics correctly performed and interpreted?
  Not applicable.
6 Discussion
6.1 Are the results discussed in relation to existing knowledge on the subject and study objectives?
In their introduction authors briefly describe the growing importance of dementia as a health condition in society, and the reported benefits of motor intervention on health and quality of life.
In their discussion authors describe limitations to the reviewed RCTs, including possible confounding factors (differences in: age, gender, type of dementia, presence of depression, frequency and intensity of treatment; and the validity and reliability of used questionnaires).
At the beginning of their discussion the authors write: 'This review indicated physiotherapy, occupational therapy, and physical education as important tools promoting patient benefits regarding psychosocial function, physical health and function, affective status, and caregiver's distress. Motor intervention was not shown to have a significant effect on mobility. Behaviour, cognitive performance, activities of daily living and risk of falls were not similar among the articles.'
(?: improvements in psychosocial function and in physical health and function on the one hand - and no significant effect on mobility and inconsistent findings for activities of daily living on the other hand? The contradictions and inconsistencies seem apparent).
In their concluding paragraph the authors write: 'This review concludes that motor intervention contributes to minimize physical and mental decline inherent to dementia.'
The overall conclusion the authors draw seems too general and too positive in comparison to the limitations identified.
6.2 Is the discussion biased?
  As 6.1 of this appraisal.
The tenor of the overall conclusion seems too positive in light of the contradictions and inconsistencies identified.
7 Interpretation
7.1 Are the author's conclusions justified by the data?
  See 6.1 and 6.1 of this appraisal.
7.2 What level of evidence has this paper presented?
  CEBM level of evidence: 1a- (minus-sign due to significant heterogeneity of included RCTs)
7.3 Does this paper help me to answer my problem?
It re-iterates findings from other systematic reviews, namely that published studies are very heterogeneous and provide variable and contradicting evidence.
After CA, i rated this paper: 3/10
8 Implementation
8.1 Can any necessary change be implemented in practice?
  No change in practice is indicated from this paper in my current field of work (physiotherapist on an acute hospital ward in acute elderly medicine). The team practices a multidisciplinary approach, including multidisciplinary assessment and intervention for prevention and rehabilitation following a fall according to current UK guidelines. For individuals with cognitive impairment and dementia the approach is individualised as required.
8.2 What aids to implementation exist?
  Not applicable.
8.3 What barriers to implementation exist?
  Not applicable.