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

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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
Kalra 2004 (Continued) Judgement: insufficient reporting of reasons for missing data across interventions groups to permit judgement Selective reporting (reporting bias) Low risk All study’s pre-specified outcomes have been reported Larson 2005 Methods RCT Participants Source: the spouses of stroke survivors admitted to the stroke unit at Danderyd University Hospital, Stockholm, Sweden, between November 2000 and July 2002 Definition of caregiver: not stated Caregivers’ inclusion criteria: none stated Caregivers’ exclusion criteria: if it was not possible to obtain information from the spouse Stroke survivors’ inclusion criteria: none stated Stroke survivors’ exclusion criteria: the stroke survivor was not going to return home after discharge Number of caregivers randomised: 100 Number of caregivers in intervention group: 50 Number of caregivers in comparator group: 50 Number of caregivers assessed at final follow-up: 91 Number of caregivers in intervention group: 46 Number of caregivers in comparator group: 45 Mean age of caregivers: 67 % male caregivers: 20% Interventions Title: nurse-led support and education programme Characteristics: education programme, delivered to groups of 10 caregivers. Topics covered included the nature of stroke, treatment and recovery, psychological and social effects of stroke and prevention of further stroke. Participants were free to contact the stroke nurse specialist if and when required Intervention provided by: stroke nurse specialist Intervention delivered: hospital setting Dose/frequency/timing of intervention: 6 sessions over a period of 6 months Intervention length: 6 months Title: control Characteristics: routine information during stroke survivor’s stay in hospital and at discharge. A 1.5-hour open session provided by a stroke specialist physician was also available for control group to attend should they wish First comparator intervention provided by: stroke physician First comparator intervention delivered: in hospital Dose/frequency/timing of first comparator intervention: not applicable Outcomes QOL; Bradley’s well-being questionnaire; LISS questionnaire; EuroQol Timing of assessment: 6 months; 12 months Non-pharmacological interventions for caregivers of stroke survivors (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 27
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