Non-pharmacological interventions for caregivers ... - Update Software

Excluded studies
For details of excluded studies with reasons see the Characteristics
of excluded studies table.
Risk of bias in included studies
For each included trial we extracted information about the method
of randomisation and allocation concealment, blinding of outcome
assessment and whether all the randomised patients were
accounted for in the analysis.
Allocation
The inclusion criteria for this analysis required a study to be randomised.
Six studies reported an adequately generated allocation
sequence (Draper 2007; Kalra 2004; Larson 2005; Mant 2000;
Pierce 2004; Yoo 2007). Two studies (Kalra 2004; Mant 2000) reported
adequately concealed allocation. Two studies did not conceal
allocation (Draper 2007; Pierce 2004). Four studies were unclear
(Grant 2002; Hartke 2003; Larson 2005; Yoo 2007).
Blinding
It is not possible to blind key study personnel or participants in
studies which do not use a placebo comparator. However, nonblinding
of participants and study personnel is unlikely to introduce
bias if the outcome assessment is blinded (Higgins 2008).
Four studies report blinding of the outcome assessment/assessor
(Draper 2007; Grant 2002; Kalra 2004; Mant 2000).
Incomplete outcome data
Missing continuous outcome data due to attrition is an issue across
all studies. However, the extent and nature of attrition varies across
trials. For details of the amount and distribution of missing outcome
data, the reasons provided for missing outcome data, the
investigators’ handling of missing data, as well as the clinical context
and judgement on risk of bias, see the ’Risk of bias’ tables
(Characteristics of included studies). Missing outcome data are
likely to be associated with the outcome or perceived relevance of
the intervention to the study participants.
Selective reporting
The majority of included studies appeared to be free from the
suggestion of selective outcome reporting.
Other potential sources of bias
Two studies did not provide information on baseline characteristics
(Grant 2002; Kalra 2004), there was baseline imbalance in two
studies (Hartke 2003; Mant 2000) and insufficient information
in one study to permit judgement about baseline imbalance (Yoo
2007).
Effects of interventions
Overall, 1007 participants were included in this review. For details
of the comparisons made for trials with outcome data, see Data
and analyses. We considered meta-analysis of all studies across all
outcomes inappropriate because of the heterogeneous nature of
the interventions across the included studies.
Primary outcomes
Informal caregiver stress and strain
Teaching procedural knowledge
One study with 155 participants (Kalra 2004) assessed the effect of
’teaching procedural knowledge’ on informal caregiver stress and
strain, measured by the Caregiver Strain Index (Robinson 1983).
Individual participant total scores were provided by the author.
The analysis presented here is not available from the published
report. The mean difference (MD) between the intervention and
comparator group at the end of scheduled follow-up was -8.67
(95% confidence interval (CI) -11.30 to -6.04, P < 0.001) in
favour of the ’teaching procedural knowledge’ type intervention
group (Analysis 1.1).
Support and information
Two studies (Mant 2000; Yoo 2007) included support and information
type interventions (219 participants). One study (Mant
2000) used the Caregiver Strain Index (Robinson 1983) to measure
informal caregiver stress and strain; the other study (Yoo 2007)
used a measure specially developed for the study. Caregiver stress
and strain scores were available for 219 participants from the two
trials. The pooled result, combined as a standardised mean difference
(SMD), was -0.29 (95% CI -0.86 to 0.27, P = 0.11), with
substantial statistical heterogeneity (I 2 = 61%)
Psycho-educational
Non-pharmacological interventions for caregivers of stroke survivors (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Two studies (Draper 2007; Hartke 2003) included psycho-educational
type interventions (125 participants). One study (Hartke
2003) used the Burden Interview (Zarit 1983) and one (Draper
2007) used the Relatives’ Stress Scale (Greene 1982). The pooled
result combined as a SMD was 0.01 (95% CI -0.34 to 0.36, P
= 0.94) showing no significant benefit for the psycho-educational
intervention group, with no significant heterogeneity (P = 0.50, I
2 = 0%).
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