- Email: [email protected]
Training caregivers of disabled patients after stroke
Comment
Training caregivers of disabled patients after stroke
www.thelancet.com Vol 382 December 21/28, 2013
673 (73%) of the 928 caregivers, was similar between caregivers allocated the LSCTC intervention and those allocated usual care (adjusted mean scores: 45·5 for the intervention group vs 45·0 for the control group; difference 0·5 points, 95% CI –1·7 to 2·7).10 Patients’ functional outcome, as measured by the self-reported Nottingham activities of daily living score in 690 (74%) of the 928 patients, was similar between patients allocated the LSCTC intervention and those allocated usual care (adjusted mean scores 27·4 vs 27·6; difference –0·2 points, –3·0 to 2·5).10 The mean cost of the LSCTC intervention was only £82 per patient, but the total patient costs and quality-adjusted life-years (QALYs) for patients and caregivers at any assessment were similar between the intervention and control groups, and the probability that the intervention was cost-effective, at accepted thresholds of £20 000 to £30 000 per QALY gained, was low.10 How do we interpret the discordant positive results of the small, single-centre randomised trial including individuals9 and the negative results of a larger, multicentre, randomised trial including clusters of stroke units?10 Similar examples of initial positive, and subsequent negative, results of randomised trials of other medical interventions populate the medical literature.11,12 The usual explanation is a false positive initial study due to random error associated with small numbers of patients. The initial single-centre randomised trial might have been a true positive, and the TRACS result a false
Published Online September 18, 2013 http://dx.doi.org/10.1016/ S0140-6736(13)61688-8 See Articles page 2069
Hattie Young/Science Photo Library
At least a third of stroke survivors remain disabled, making stroke the third leading cause of disabilityadjusted life-years (DALYs) worldwide.1,2 Most (about 75%) disabled survivors of stroke need assistance to undertake personal, domestic, and community-based activities of daily living.3 Assistance is often provided informally by family and friends who might be illinformed or ill-prepared physically and emotionally.3 Informal caregiving imposes a persistent burden on 25–50% of caregivers, dependent on the mental health, mood, and requirements of the caregiver as well as on the age, mental health, and function of the patient.4–7 Caregiver burden can compromise caregivers’ health and patients’ rehabilitation and recovery.4–7 Non-pharmacological interventions to reduce the burden on informal caregivers and facilitate patients’ recovery after stroke have been assessed in eight randomised trials including 1007 participants.8 Of these interventions, the most promising one is the London Stroke Caregivers Training Course (LSCTC).8,9 In a randomised trial within a single stroke unit,9 the caregivers received the LSCTC while the caree was still an inpatient. The LSCTC facilitated earlier hospital discharge of the patient and reduced caregivers’ stress, strain, and depression.8,9 However, whether the LSCTC was efficient in other stroke units was unknown. In The Lancet, Anne Forster and colleagues10 report the results of the training caregivers after stroke (TRACS) trial of the LSCTC in several stroke units throughout the UK. In this cluster randomised trial,10 36 stroke units were randomly assigned to either the LSCTC group (n=18, containing 450 dyads of patients and caregivers) or usual care (n=18, containing 478 dyads). The LSCTC was incorporated into routine practice by the multidisciplinary team of every assigned stroke unit, and carers were given (1) individualised information about stroke and instructions about communication, nutrition, positioning, gait facilitation, continence, secondary prevention, medicine compliance, and anticipation and prevention of strokerelated complications (eg, pressure areas); (2) advice on local services; and (3) hands-on training in assisting with personal activities of daily living, lifting and handling techniques, and facilitation of mobility and transfers. At 6 months after randomisation, the caregivers’ burden, assessed by the caregiver burden scale in
2043
Comment
negative, if any of the following three circumstances prevailed. First, if the outcomes of the 26% of patients and 27% of caregivers who failed to complete follow-up in TRACS were substantially different to the outcomes of those who completed follow-up. Second, if suboptimum compliance with the intervention (average 44%) and completion of training records (72%) in TRACS minimised or negated a real effect—intervention compliance did not correlate with caregiver or patient outcome, however. Finally, if the LSCTC has been incorporated into usual care, thus minimising the difference between treatment groups. This final situation is unlikely since no evidence of widespread use of the LSCTC in routine care has been noted and the burden of caregiving for disabled stroke survivors remains substantial.4,5,7 I believe the TRACS results are a true negative. The internal validity of the results are supported by the balanced covariates between treatment groups, use of appropriate outcome measures, and consistency of the primary results with the secondary physical and psychological outcomes of patients and caregivers at 6 and 12 months. External validity is supported by consistent results among 36 stroke units throughout four regions of the UK. The initial single-centre trial might have been a true positive and the subsequent TRACS results a true negative because the LSCTC may be efficacious only when given under ideal circumstances by the multidisciplinary team who developed it, or by teams with similar expertise, enthusiasm, and intensity. When given under usual circumstances, in different geographical and healthcare settings and cascaded down by staff attending the training days to other ward workers, as in TRACS, its effectiveness might have been diluted or even negated. The implication of TRACS’ results10 for clinicians is that inpatient delivery of the LSCTC is not more effective or cost-effective than usual care in reducing the burden of caregiving or improving the functional outcome of disabled stroke survivors. The implications for researchers are that multicentre, cluster randomised trials of stroke rehabilitation strategies are feasible, but also challenging in adherence, compliance, and follow-up. Future trials should assess the potential complementary benefits of supplementing initial intensive hospital-based
2044
training of carers with integrated home-based and community-based carer training and support over the long term. Meanwhile, we await the results of a recently completed cluster randomised trial of a system of care for 800 community-based patients who have had a stroke and their carers, in 32 stroke services across the UK, which was delivered by health professionals undertaking a community-based liaison or coordinating role, and which aimed to meet the longer-term needs for stroke survivors and their carers living at home.13 Graeme J Hankey Department of Neurology, Sir Charles Gairdner Hospital, and School of Medicine and Pharmacology, The University of Western Australia, Nedlands, Perth, WA 6009, Australia [email protected] I declare that I have no conflicts of interest. 1
2
3
4 5
6
7 8
9 10
11 12
13
Luengo-Fernandez R, Paul NL, Gray AM, et al, on behalf of the Oxford Vascular Study. Population-based study of disability and institutionalization after transient ischemic attack and stroke: 10-year results of the Oxford Vascular Study. Stroke 2013; published online Aug 6. DOI:10.1161/STROKEAHA.113.001584. Murray CJL, Vos T, Lozano R, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2197–223. Dewey HM, Thrift AG, Mihalopoulos C, et al. Informal care for stroke survivors: results from the North East Melbourne Stroke Incidence Study (NEMESIS). Stroke 2002; 33: 1028–33. Rigby H, Gubitz G, Phillips S. A systematic review of caregiver burden following stroke. Int J Stroke 2009; 4: 285–92. Carod-Artal FJ, Ferreira Coral L, Trizotto DS, Menezes Moreira C. Burden and perceived health status among caregivers of stroke patients. Cerebrovasc Dis 2009; 28: 472–80. McCullagh E, Brigstocke G, Donaldson N, Kalra L. Determinants of caregiving burden and quality of life in caregivers of stroke patients. Stroke 2005; 36: 2181–86. Rigby H, Gubitz G, Eskes G, et al. Caring for stroke survivors: baseline and 1-year determinants of caregiver burden. Int J Stroke 2009; 4: 152–58. Legg LA, Quinn TJ, Mahmood F, et al. Non-pharmacological interventions for caregivers of stroke survivors. Cochrane Database Syst Rev 2011, 10: CD008179. Kalra L, Evans A, Perez I, et al. Training carers of stroke patients: randomised controlled trial. BMJ 2004; 328: 1099. Forster A, Dickerson J, Young J, et al, on behalf of the TRACS Trial Collaboration. A structured training programme for caregivers of inpatients after stroke (TRACS): a cluster randomised controlled trial and cost-effectiveness analysis. Lancet 2013; published online Sept 18. http://dx.doi.org/10.1016/S0140-6736(13)61603-7. Zhang J, Yang J, Zhang C, Jiang X, Zhou H, Liu M. Calcium antagonists for acute ischemic stroke. Cochrane Database Syst Rev 2012; 5: CD001928. Dávalos A, Alvarez-Sabín J, Castillo J, et al, International Citicoline Trial on acUte Stroke (ICTUS) trial investigators. Citicoline in the treatment of acute ischaemic stroke: an international, randomised, multicentre, placebo-controlled study (ICTUS trial). Lancet 2012; 380: 349–57. Forster A, Young J, Nixon J, et al. Protocol of a cluster randomized trial evaluation of a patient and carer-centered system of longer-term stroke care (LoTS care). Int J Stroke 2013; published online Feb 19. DOI:10.1111/ ijs.12038.
www.thelancet.com Vol 382 December 21/28, 2013
Training caregivers of disabled patients after stroke
www.thelancet.com Vol 382 December 21/28, 2013
673 (73%) of the 928 caregivers, was similar between caregivers allocated the LSCTC intervention and those allocated usual care (adjusted mean scores: 45·5 for the intervention group vs 45·0 for the control group; difference 0·5 points, 95% CI –1·7 to 2·7).10 Patients’ functional outcome, as measured by the self-reported Nottingham activities of daily living score in 690 (74%) of the 928 patients, was similar between patients allocated the LSCTC intervention and those allocated usual care (adjusted mean scores 27·4 vs 27·6; difference –0·2 points, –3·0 to 2·5).10 The mean cost of the LSCTC intervention was only £82 per patient, but the total patient costs and quality-adjusted life-years (QALYs) for patients and caregivers at any assessment were similar between the intervention and control groups, and the probability that the intervention was cost-effective, at accepted thresholds of £20 000 to £30 000 per QALY gained, was low.10 How do we interpret the discordant positive results of the small, single-centre randomised trial including individuals9 and the negative results of a larger, multicentre, randomised trial including clusters of stroke units?10 Similar examples of initial positive, and subsequent negative, results of randomised trials of other medical interventions populate the medical literature.11,12 The usual explanation is a false positive initial study due to random error associated with small numbers of patients. The initial single-centre randomised trial might have been a true positive, and the TRACS result a false
Published Online September 18, 2013 http://dx.doi.org/10.1016/ S0140-6736(13)61688-8 See Articles page 2069
Hattie Young/Science Photo Library
At least a third of stroke survivors remain disabled, making stroke the third leading cause of disabilityadjusted life-years (DALYs) worldwide.1,2 Most (about 75%) disabled survivors of stroke need assistance to undertake personal, domestic, and community-based activities of daily living.3 Assistance is often provided informally by family and friends who might be illinformed or ill-prepared physically and emotionally.3 Informal caregiving imposes a persistent burden on 25–50% of caregivers, dependent on the mental health, mood, and requirements of the caregiver as well as on the age, mental health, and function of the patient.4–7 Caregiver burden can compromise caregivers’ health and patients’ rehabilitation and recovery.4–7 Non-pharmacological interventions to reduce the burden on informal caregivers and facilitate patients’ recovery after stroke have been assessed in eight randomised trials including 1007 participants.8 Of these interventions, the most promising one is the London Stroke Caregivers Training Course (LSCTC).8,9 In a randomised trial within a single stroke unit,9 the caregivers received the LSCTC while the caree was still an inpatient. The LSCTC facilitated earlier hospital discharge of the patient and reduced caregivers’ stress, strain, and depression.8,9 However, whether the LSCTC was efficient in other stroke units was unknown. In The Lancet, Anne Forster and colleagues10 report the results of the training caregivers after stroke (TRACS) trial of the LSCTC in several stroke units throughout the UK. In this cluster randomised trial,10 36 stroke units were randomly assigned to either the LSCTC group (n=18, containing 450 dyads of patients and caregivers) or usual care (n=18, containing 478 dyads). The LSCTC was incorporated into routine practice by the multidisciplinary team of every assigned stroke unit, and carers were given (1) individualised information about stroke and instructions about communication, nutrition, positioning, gait facilitation, continence, secondary prevention, medicine compliance, and anticipation and prevention of strokerelated complications (eg, pressure areas); (2) advice on local services; and (3) hands-on training in assisting with personal activities of daily living, lifting and handling techniques, and facilitation of mobility and transfers. At 6 months after randomisation, the caregivers’ burden, assessed by the caregiver burden scale in
2043
Comment
negative, if any of the following three circumstances prevailed. First, if the outcomes of the 26% of patients and 27% of caregivers who failed to complete follow-up in TRACS were substantially different to the outcomes of those who completed follow-up. Second, if suboptimum compliance with the intervention (average 44%) and completion of training records (72%) in TRACS minimised or negated a real effect—intervention compliance did not correlate with caregiver or patient outcome, however. Finally, if the LSCTC has been incorporated into usual care, thus minimising the difference between treatment groups. This final situation is unlikely since no evidence of widespread use of the LSCTC in routine care has been noted and the burden of caregiving for disabled stroke survivors remains substantial.4,5,7 I believe the TRACS results are a true negative. The internal validity of the results are supported by the balanced covariates between treatment groups, use of appropriate outcome measures, and consistency of the primary results with the secondary physical and psychological outcomes of patients and caregivers at 6 and 12 months. External validity is supported by consistent results among 36 stroke units throughout four regions of the UK. The initial single-centre trial might have been a true positive and the subsequent TRACS results a true negative because the LSCTC may be efficacious only when given under ideal circumstances by the multidisciplinary team who developed it, or by teams with similar expertise, enthusiasm, and intensity. When given under usual circumstances, in different geographical and healthcare settings and cascaded down by staff attending the training days to other ward workers, as in TRACS, its effectiveness might have been diluted or even negated. The implication of TRACS’ results10 for clinicians is that inpatient delivery of the LSCTC is not more effective or cost-effective than usual care in reducing the burden of caregiving or improving the functional outcome of disabled stroke survivors. The implications for researchers are that multicentre, cluster randomised trials of stroke rehabilitation strategies are feasible, but also challenging in adherence, compliance, and follow-up. Future trials should assess the potential complementary benefits of supplementing initial intensive hospital-based
2044
training of carers with integrated home-based and community-based carer training and support over the long term. Meanwhile, we await the results of a recently completed cluster randomised trial of a system of care for 800 community-based patients who have had a stroke and their carers, in 32 stroke services across the UK, which was delivered by health professionals undertaking a community-based liaison or coordinating role, and which aimed to meet the longer-term needs for stroke survivors and their carers living at home.13 Graeme J Hankey Department of Neurology, Sir Charles Gairdner Hospital, and School of Medicine and Pharmacology, The University of Western Australia, Nedlands, Perth, WA 6009, Australia [email protected] I declare that I have no conflicts of interest. 1
2
3
4 5
6
7 8
9 10
11 12
13
Luengo-Fernandez R, Paul NL, Gray AM, et al, on behalf of the Oxford Vascular Study. Population-based study of disability and institutionalization after transient ischemic attack and stroke: 10-year results of the Oxford Vascular Study. Stroke 2013; published online Aug 6. DOI:10.1161/STROKEAHA.113.001584. Murray CJL, Vos T, Lozano R, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2197–223. Dewey HM, Thrift AG, Mihalopoulos C, et al. Informal care for stroke survivors: results from the North East Melbourne Stroke Incidence Study (NEMESIS). Stroke 2002; 33: 1028–33. Rigby H, Gubitz G, Phillips S. A systematic review of caregiver burden following stroke. Int J Stroke 2009; 4: 285–92. Carod-Artal FJ, Ferreira Coral L, Trizotto DS, Menezes Moreira C. Burden and perceived health status among caregivers of stroke patients. Cerebrovasc Dis 2009; 28: 472–80. McCullagh E, Brigstocke G, Donaldson N, Kalra L. Determinants of caregiving burden and quality of life in caregivers of stroke patients. Stroke 2005; 36: 2181–86. Rigby H, Gubitz G, Eskes G, et al. Caring for stroke survivors: baseline and 1-year determinants of caregiver burden. Int J Stroke 2009; 4: 152–58. Legg LA, Quinn TJ, Mahmood F, et al. Non-pharmacological interventions for caregivers of stroke survivors. Cochrane Database Syst Rev 2011, 10: CD008179. Kalra L, Evans A, Perez I, et al. Training carers of stroke patients: randomised controlled trial. BMJ 2004; 328: 1099. Forster A, Dickerson J, Young J, et al, on behalf of the TRACS Trial Collaboration. A structured training programme for caregivers of inpatients after stroke (TRACS): a cluster randomised controlled trial and cost-effectiveness analysis. Lancet 2013; published online Sept 18. http://dx.doi.org/10.1016/S0140-6736(13)61603-7. Zhang J, Yang J, Zhang C, Jiang X, Zhou H, Liu M. Calcium antagonists for acute ischemic stroke. Cochrane Database Syst Rev 2012; 5: CD001928. Dávalos A, Alvarez-Sabín J, Castillo J, et al, International Citicoline Trial on acUte Stroke (ICTUS) trial investigators. Citicoline in the treatment of acute ischaemic stroke: an international, randomised, multicentre, placebo-controlled study (ICTUS trial). Lancet 2012; 380: 349–57. Forster A, Young J, Nixon J, et al. Protocol of a cluster randomized trial evaluation of a patient and carer-centered system of longer-term stroke care (LoTS care). Int J Stroke 2013; published online Feb 19. DOI:10.1111/ ijs.12038.
www.thelancet.com Vol 382 December 21/28, 2013