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

Kalra 2004 (Continued)
Outcomes Outcome measures: Frenchay Activities Index; Hospital Anxiety and Depression Scale;
CBS; EuroQol
Timing of assessment: 3 months, 12 months
Notes
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Low risk “We used computer generated random
numbers to prepare the allocation schedule
in advance.”
Allocation concealment (selection bias) Low risk “After baseline assessment the responsible
assessor telephoned the randomisation
office with patients’ identification details
only. A clerical worker entered these details
on a computer database in strict referral
order and was given a patient allocation,
which was relayed to the assessor.”
Blinding (performance bias and detection
bias)
All outcomes
Incomplete outcome data (attrition bias)
All outcomes
Non-pharmacological interventions for caregivers of stroke survivors (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Low risk “An observer who did not participate in
allocation or management of patients assessed
outcome at three and 12 months after
stroke onset.”
Unclear risk Description: 17/151 (11%) outcome data
missing for participants in the experimental
group and 15/149 (10%) outcome data
missing from participants in the comparator
group at the end of scheduled followup
Reason for missing data reported: “... communication
problems, perceived lack of relevance,
lack of time, fatigue, or disinclination
in patients and caregivers ...”, although
unclear if information refers to active intervention
or usual care group
Missing data balanced between groups: unclear
Statistical methods used to deal with missing
data: none - only completed assessments
were included at each time point.
However, sensitivity analyses were performed
to examine the effects of missing
values for caregiver burden and health-related
quality of life outcomes
26