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Larson 2005 (Continued) Notes Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Low risk “The investigator placed the envelopes on the table in front of the participant, who chose one envelope from the packet, thus the number of envelopes diminished with each new participant.” Allocation concealment (selection bias) Unclear risk “The randomisation was performed in blocks of 20, 10 in each arm. Sealed envelopes. With a note intervention group/control group. Were prepared before the meeting with the participant in each block.” “The investigator placed the envelopes on the table in front of the participant, who chose one envelope from the packet, thus the number of envelopes diminished with each new participant.” Blinding (performance bias and detection bias) All outcomes Incomplete outcome data (attrition bias) All outcomes Low risk “Outcomes were assessed by self-rated questionnaires.” Low risk 4/50 (8%) drop-outs in the intervention group after randomisation and 5/50 (10%) drop-outs in comparator group Reason for missing data reported: not reported Missing data balanced between groups: yes Statistical methods used to deal with missing data: none reported Judgement: reasons for missing data unlikely to be related to true outcome Selective reporting (reporting bias) Low risk All study’s pre-specified outcomes have been reported Mant 2000 Methods RCT Participants Source: any patient admitted with acute stroke (first or recurrent) to hospitals in Oxford between August 1995 and February 1998, identified from a hospital-based stroke register Definition of caregiver: the person (other than a health care professional) perceived by the patient or family as normally being most responsible for day-to-day decision-making and provision of care Caregivers’ inclusion criteria: none stated Caregivers’ exclusion criteria: none stated Stroke survivors’ inclusion criteria: aged ≥ 18; resident in Oxfordshire; had a close family caregiver Stroke survivors’ exclusion criteria: admitted to hospital from a nursing home; participating in another trial; identified for inclusion > 6 weeks after stroke or hospital discharge; main medical problem not stroke Non-pharmacological interventions for caregivers of stroke survivors (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 28
Mant 2000 (Continued) Number of stroke patients and caregivers randomised as a dyad: 520 Number of caregivers in intervention group: 258 Number of caregivers in comparator group: 262 Number of caregivers assessed at final follow-up: 267 Number of caregivers in intervention group: 130 Number of caregivers in comparator group: 137 Number of stroke survivors assessed at final follow-up: 323 Number of stroke patients in intervention group:156 Number of stroke patients in comparator group:167 Mean age of caregivers: 64.4 years % male caregivers: 32.6% Interventions Title: family support Characteristics: dependent on the problems, needs and requests of families Intervention provided by: family support organiser Intervention delivered: not stated Dose/frequency/timing of intervention: at the discretion of the family support organiser Intervention length: variable Title: normal care Characteristics: normal care Intervention provided by: not applicable Intervention delivered: not applicable Dose/frequency/timing of intervention: not applicable Outcomes Frenchay Activities Index; General Health Questionnaire 28; Caregiver strain index; Dartmouth co-op charts; knowledge about stroke and use of services Timing of assessment: 6 months Notes Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Low risk “Randomisation was ... prepared from computer generated random numbers.” Allocation concealment (selection bias) Low risk “Randomisation was done by staff not involved in the care of patients, by use of sequentially numbered (opaque sealed) envelopes in blocks of 10.” 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 “Follow-up visits were done 6 months after stroke, at families’ homes by a researcher who was unaware of the intervention group status.” Unclear risk 128/258 (50%) outcome data missing for participants in the experimental group and 125/262 (48%) outcome data missing from participants in the comparator group at the end of scheduled follow-up for the primary outcome (caregiver stress or strain 29
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