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Hartke 2003 (Continued) Dose/frequency/timing of intervention: 8 x 1-hour sessions Intervention length: not applicable Co-interventions: not applicable Title: control condition Characteristics: a publication on stress management and a brief description of caregivers’ stress and stroke First comparator provided by: not applicable First comparator delivered: not applicable Dose/frequency/timing of first comparator: not applicable Outcomes Outcome measures: CES-D; UCLA Loneliness Scale; the Caregiver Competence Scale; BI; the Pressing Problem Index Timing of assessment: immediately after support group; and 6 months after enrolling in study Notes Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were then randomly assigned to a usual care or telephone support group condition and were followed-up for 6 months to test the enduring effects of the intervention.” Allocation concealment (selection bias) Unclear risk “Participants were then randomly assigned to a usual care or telephone support group condition and were followed-up for 6 months to test the enduring effects of the intervention.” Blinding (performance bias and detection bias) All outcomes Incomplete outcome data (attrition bias) All outcomes Unclear risk “All assessments were conducted by members of the research staff via individual telephone interviews.” High risk Description: 25/68 (37%) participants in treatment arm lost to follow-up and 11/56 (20%) participants in the comparator group lost to follow-up Reason for missing data reported: yes, but not in sufficient detail: “the most frequent reason for dropping out of control group was difficulty scheduling appointments, whereas the most frequent reasons for dropping out of the treatment group were death of spouse or perception of lack of need for intervention.” Missing data balanced between groups: no Statistical methods used to deal with missing data: none Judgement: difference in means among missing outcomes enough to induce clinically relevant bias in observed effect size Selective reporting (reporting bias) Low risk All study’s pre-specified outcomes have been reported Non-pharmacological interventions for caregivers of stroke survivors (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 24
Kalra 2004 Methods Procedures for enrolling a participant and allocating the treatment (allocation concealment procedures) Methods used to generate the sequence in which participants will be randomised (sequence generation) Procedures for preventing knowledge of the allocated intervention Who is/are masked/blinded? Participants Source: stroke patients admitted to a stroke rehabilitation unit, London, UK Definition of caregiver: the main person (other than health, social or voluntary care provider) helping with activities of daily living and advocating on behalf of the stroke survivors Caregivers’ inclusion criteria: no notable disability; Rankin score 0 to 2; willing to participate Caregivers’ exclusion criteria: none stated Stroke survivors’ inclusion criteria: independent in activities of daily living prior to stroke onset; medically and neurologically stable; expected to return home with residual disability Stroke survivors’ exclusion criteria: none stated Number of stroke patients and caregivers randomised as a dyad: 300 Number of caregivers in intervention group: 151 Number of caregivers in comparator group: 149 Number of stroke patients and caregivers assessed at final follow-up as a dyad: 268 Number of caregivers in intervention group: 134 Number of caregivers in comparator group: 134 Mean age of caregivers: unclear % male caregivers: unclear Interventions Title: caregiver training Characteristics: formal training of caregivers in the prevention and management of common problems after stroke including: instruction on management of pressure sores and prevention of bed sores; continence; positioning; nutrition; gait facilitation; and ’hands on’ training in: lifting and handling techniques; mobility and transfers; assistance with activities of daily living and communication. All tailored towards individual patients. A formal follow-up session was provided when the stroke survivor had returned home Intervention provided by: members of the multidisciplinary team as appropriate Intervention delivered: in stroke rehabilitation unit Dose/frequency/timing of intervention: 3 to 5 sessions depending on need. Each session lasted 30 to 45 minutes. Training commenced when patient was considered suitable for discharge Intervention length: not applicable Title: conventional hospital care Characteristics: conventional care was provided according to existing guidelines. Conventional care consisted of information on stroke; encouragement to attend nursing and allied health professional sessions to gain information on, for example, facilitating transfers; and advice on community services, benefits, support services organised and run by voluntary organisations First comparator provided by: multidisciplinary team First comparator delivered: in stroke rehabilitation unit Dose/frequency/timing of first comparator: not applicable First comparator length: not applicable Non-pharmacological interventions for caregivers of stroke survivors (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 25
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