Downloaded from http://spcare.bmj.com/ on February 1, 2015 - Published by group.bmj.com
Review
Can palliative care reduce futile treatment? A systematic review Iain Harris, Scott A Murray
Primary Palliative Care Research Group, University of Edinburgh, Edinburgh, UK Correspondence to Iain Harris, Primary Palliative Care Research Group, University of Edinburgh, Medical School, Teviot Place, Edinburgh, EH8 9AG, UK; [email protected] Received 2 August 2012 Revised 16 November 2012 Accepted 29 November 2012 Published Online First 28 January 2013
To cite: Harris I, Murray SA. BMJ Supportive & Palliative Care 2013;3:389–398.
ABSTRACT Background Palliative care interventions have the potential to lower health service costs by reducing the intensity of treatments intended to have curative effect while concentrating on quality of life and, in due course, quality of death. A patient receiving treatment inspired by curative intent during the end stage of their life is potentially exposed to medical futility. Aim To conduct a systematic review of the evidence for palliative interventions reducing health service costs without impacting on quality of care. Method An electronic search of MEDLINE, EMBASE, AMED and CINAHL databases, augmented by hand-searching techniques, was performed. Only research where palliative care was the intervention or observation, and cost, together with either quality of life or patient satisfaction with care were outcome measures, was included in results. Results Of 1964 sources identified, only 12 measured both cost and an appropriate quality outcome. Evidence supported existing research that palliative care interventions generally reduce health service costs. Evidence of concurrent improvement in quality-of-life outcomes was limited; little available evidence derives from randomised trial designs. Small sample sizes and disparate outcome measures hamper statistical assessments. Conclusions Evidence that palliative interventions cut costs, without reducing quality of life, by minimising futile medical acts is limited. Further research, including both observational studies and controlled trials, should be conducted to collect empirical data in this field. Future research should examine palliative interventions earlier in chronic progressive illness, and incorporate standardised outcome measures to allow meta-analysis.
INTRODUCTION A futile treatment is one that is very unlikely to produce an effective therapeutic outcome.1 This might arise where a treatment has low odds of success
Harris I, et al. BMJ Supportive & Palliative Care 2013;3:389–398. doi:10.1136/bmjspcare-2012-000343
concurrent with high odds of burdensome side effects. It might also arise with multiple comorbidities where curing one ailment cannot materially improve a patient’s overall health. Multiple comorbidities are increasingly common towards the end of life;2 around 90% of deaths are ‘expected’ and occur after a period of life-limiting chronic illness.3 Typical trajectories, illustrated in figure 1, demonstrate how patients’ capacity to benefit from curative therapy generally reduces as their chronic illness progresses.4 By contrast, intensity of diagnostic testing and attempted therapy generally accelerate through the last years of life, and are at their greatest preceding death.5–12 These two trends are incongruous, with patients potentially exposed to burdensome side effects during a time when their capacity to benefit decreases. Palliative interventions might be effective in reducing the incidence of futile treatment.13 In recent years, palliative care has offered solutions generally during the terminal stage of illness, after curative attempts have ceased. An emerging concept, illustrated in figure 2, integrates palliative care from first diagnosis of potentially life-limiting chronic disease, initially, alongside attempted curative therapy.14 In theory, palliative intervention improves the management of patients’ physical and psychological distress, and helps recognise that death is normally the culmination of a chronic process rather than a self-contained acute event;15 hence, intensity of attempted therapeutic treatment should reduce in proportion with patients’ reducing capacity to realise benefit. Research comparing palliative with usual end-of-life care shows potential to reduce intensity of treatments toward end of life; a palliative approach generally reduces financial cost,16 17 a measure closely correlated to treatment intensity.6
389
Downloaded from http://spcare.bmj.com/ on February 1, 2015 - Published by group.bmj.com
Review METHOD Search strategy
A search strategy was designed to identify research examining the relationship between a palliative approach to end-of-life care, financial cost to the health system and patient quality of life. MEDLINE (1966 to June 2011), EMBASE (1974 to June 2011), and AMED (1885 to June 2011) were interrogated using Ovid Interface; CINAHL (1937 to June 2011) was interrogated using EBSCO Host Interface. The Journal of Palliative Medicine and Archives of Internal Medicine were hand-searched ( January 2010 to June 2011), as these titles returned the highest frequency of potentially relevant material during the first stage of literature search; documents from government, think-tank and charity sources, including The National Audit Office, King’s Fund, Joseph Rowntree Foundation and WHO were also examined, and citation tracking was employed on any articles selected for inclusion to optimise capture of latest work. Description of the full MEDLINE search is shown in table 1. No equivalent to ‘Medical Futility’ was included in EMBASE or AMED searches as no subject heading indexes this concept within either. The closest concept in EMBASE is ‘Treatment Outcome’; this heading, however, catalogues over 500 000 articles, and such volume was deemed impractical given time available for this project. These exceptions aside, the search strategy outlined for MEDLINE was replicated for all additional database searches, updating terminology for each search to ensure equivalent subject headings were captured. Study selection
Figure 1 Trajectories of decline at the end of life.4 Time is presented in arbitrary units on these diagrams, but the scale has been adjusted to demonstrate approximate relationships between the four trajectories.
Patient experience can also be improved by palliative care.18–20 However, these outcomes are generally studied separately21 and it is therefore possible that treatment intensity is reduced at the expense of complete patient care. Reducing the intensity of treatment and improving patient outcomes concurrently would imply palliative interventions successfully avoiding futile elements. This review assesses the extent to which existing evidence supports the ability of palliative interventions to routinely reduce treatment intensity, thereby reducing cost and simultaneously improving patient outcomes at the end of life. 390
Studies were deemed suitable for inclusion if they explored differences between palliative and usual approaches to end-of-life care, measuring financial cost and either patient satisfaction or quality-of-life outcomes. Studies were excluded if they investigated specific treatments, rather than a general palliative approach, or if they measured only one aspect of quality of life, for instance, pain. Narrative review articles were also excluded. PICOS criteria are set out in table 2 for clarity. Search criteria were set by both authors. The literature search and review of all sources identified were conducted by IH. A flowchart summarising the papers retained and excluded at each stage in the selection process is provided in figure 3. Assessment of sources’ quality
Sources retained for full reading were reviewed for quality against predetermined outcome criteria: ‘cost’ and either ‘patient quality of life’ or ‘satisfaction with care.’ Data were extracted per a form based on criteria set out in the Cochrane Handbook of Systematic
Harris I, et al. BMJ Supportive & Palliative Care 2013;3:389–398. doi:10.1136/bmjspcare-2012-000343
Downloaded from http://spcare.bmj.com/ on February 1, 2015 - Published by group.bmj.com
Review
Figure 2 Graphic representations of traditional and emerging concepts of palliative care.14 In the traditional concept, specialised care is provided after curative attempts have ceased. In the emerging concept, palliative care is integrated into end-of-life care from the onset of life-limiting disease, to ensure patients’ emotional and spiritual needs are considered alongside their physical needs.
Reviews. Date of publication, country of origin, type and setting of intervention, patients’ terminal illness, study design, recruitment process, sample size, statistical methodology and study duration were all noted. Values were extracted for financial cost per patient in intervention and control; amounts not reported in US $ were converted at the average exchange rate during their year of publication. Values were extracted for all reported quality-of-care outcomes together with a note of their scale or unit of measurement. Studies not accounting for cost at the level of individual patient were excluded. Quality outcomes are more complicated to describe, as a number of factors
Table 1 Step 1
Medline search strategy
Subject heading or search term
Cost benefit analysis, OR Costs and cost analysis, OR Healthcare costs 2 ‘End of Life’.tw, OR ‘Last Year of Life’.tw OR, ‘Overzealous Treatment’.tw, OR ‘Futil$’. tw 3 Medical futility 4 Life support care 5 Palliative care 6 Terminal care 7 Resuscitation orders 8 Hospice care 9 2 OR 3 OR 4 OR 5 OR 6 OR 7 OR 8 10 1 and 9 $ indicates a truncation; .tw indicates ‘text word’.
Number of references 104350
are amenable to measurement. Patient satisfaction is generally a product of treatment quality and, therefore, a valid outcome measure.22 Sources have been excluded where quality of life is not measured either using a patient satisfaction scale, or a multidimensional quality-of-life scale encompassing more than one discreet measure. All studies reporting appropriate data for both outcomes were included in the review, and any methodological limitations noted in Results to allow assessment of their strength. The final assessment of included sources appraised their heterogeneity and determined their potential for conducting a meta-analysis. Different timescales, disparate interventions and diverse research settings, in conjunction with different outcome measures utilised suggested that, for this study, narrative synthesis would be more appropriate than full meta-analysis. However, arithmetical average percentage cost saving, weighted by study size, was calculated by multiplying
11199
Table 2 PICOS summary 2031 6538 34380 18402 2726 3806 63975 1008
Population Intervention Comparison Outcome Study design
Harris I, et al. BMJ Supportive & Palliative Care 2013;3:389–398. doi:10.1136/bmjspcare-2012-000343
Patients thought to be in their final year, months or weeks of life. A consciously palliative approach to their terminal care. The routine package of care prevailing in the health service under scrutiny. Financial cost, and patient quality of life or satisfaction with care. Randomised or non-randomised controlled trial designs, prospective or retrospective cohort studies, and case control studies.
391
Downloaded from http://spcare.bmj.com/ on February 1, 2015 - Published by group.bmj.com
Review
Figure 3 Stages of evaluation, inclusion and exclusion for studies considered during this systematic review. EOL, end of life; QOL, quality of life.
the saving demonstrated in each study by its sample size, then dividing the sum of these by the sum of all sample sizes. RESULTS Characteristics of excluded studies
Literature searching identified 1964 potential sources including 321 duplicate records which were discarded. A further 1487 records were excluded following evaluation based on their titles and abstracts: 356 did not report appropriate quality of life or patient satisfaction measures, 183 did not report costs based on individual patient data and the remaining 948 were not original research comparing palliative and usual approaches with end-of-life care. An additional 25 potential sources were identified by hand searching. The 181 remaining sources were read in full. A further 168 were excluded: 93 did not report sufficient quality of life or patient satisfaction measures, 28 did not report sufficient cost data and the remaining 48 did not research relevant interventions. Characteristics of included studies
Characteristics of the remaining 12 studies are displayed in table 3. They comprise six randomised clinical trial studies, two prospective cohort studies and four retrospective case-controlled studies. Study sample size ranged from 28 to 1754, median value 247. Nine were conducted in the USA and one each from UK, The Netherlands and Canada. Two were published in the 1980s, three in the 1990s and the remaining seven in the 2000s. 392
Research settings spanned hospital-based services, including specialist palliative care and other medical disciplines, hospice services and primary care. Patients with cancer were most frequently represented within samples although patients with a diagnosis of organ failure were also included. The reported time between admission to study and death ranged from 76 to 242 days with weighted average value of 128 days. Quality of included studies
A specific quality scale was not employed; such tools are not supported by empirical evidence.23 Full analysis is presented covering common areas where methodological challenges can occur: recruitment of participants, measurement of outcomes and reporting of results. Selection bias in recruitment and randomisation
All included case-controlled studies24–27 recruited from patients already referred into the interventions they investigated. Consequently, there is a concern that their research samples may not accurately reflect the wider population of patients from which they are drawn. One26 confirmed all referred patients and potential case controls were contacted and listed separate refusal rates for each arm; however, a significantly higher refusal rate in the control arm of this study removed a significantly older and frailer group from the control. Impact from this was impossible to quantify, but it is clear that the control cannot be a complete reflection of the wider population, and this limitation may be equally present in the remaining
Harris I, et al. BMJ Supportive & Palliative Care 2013;3:389–398. doi:10.1136/bmjspcare-2012-000343
Downloaded from http://spcare.bmj.com/ on February 1, 2015 - Published by group.bmj.com
Review Table 3
Characteristics of studies included in review
Lead author
Year
Country
Description of sample
Podymow
2006
Canada
Smeenk
1998
Nether-lands
Terminally ill patients: primarily liver failure, AIDS and cancer Terminal cancer patients
Raferty
1996
UK
Brumley
2003
USA
Brumley
2007
USA
Ciemins
2007
USA
Terminally ill cancer patients. Prognosis
Review
Can palliative care reduce futile treatment? A systematic review Iain Harris, Scott A Murray
Primary Palliative Care Research Group, University of Edinburgh, Edinburgh, UK Correspondence to Iain Harris, Primary Palliative Care Research Group, University of Edinburgh, Medical School, Teviot Place, Edinburgh, EH8 9AG, UK; [email protected] Received 2 August 2012 Revised 16 November 2012 Accepted 29 November 2012 Published Online First 28 January 2013
To cite: Harris I, Murray SA. BMJ Supportive & Palliative Care 2013;3:389–398.
ABSTRACT Background Palliative care interventions have the potential to lower health service costs by reducing the intensity of treatments intended to have curative effect while concentrating on quality of life and, in due course, quality of death. A patient receiving treatment inspired by curative intent during the end stage of their life is potentially exposed to medical futility. Aim To conduct a systematic review of the evidence for palliative interventions reducing health service costs without impacting on quality of care. Method An electronic search of MEDLINE, EMBASE, AMED and CINAHL databases, augmented by hand-searching techniques, was performed. Only research where palliative care was the intervention or observation, and cost, together with either quality of life or patient satisfaction with care were outcome measures, was included in results. Results Of 1964 sources identified, only 12 measured both cost and an appropriate quality outcome. Evidence supported existing research that palliative care interventions generally reduce health service costs. Evidence of concurrent improvement in quality-of-life outcomes was limited; little available evidence derives from randomised trial designs. Small sample sizes and disparate outcome measures hamper statistical assessments. Conclusions Evidence that palliative interventions cut costs, without reducing quality of life, by minimising futile medical acts is limited. Further research, including both observational studies and controlled trials, should be conducted to collect empirical data in this field. Future research should examine palliative interventions earlier in chronic progressive illness, and incorporate standardised outcome measures to allow meta-analysis.
INTRODUCTION A futile treatment is one that is very unlikely to produce an effective therapeutic outcome.1 This might arise where a treatment has low odds of success
Harris I, et al. BMJ Supportive & Palliative Care 2013;3:389–398. doi:10.1136/bmjspcare-2012-000343
concurrent with high odds of burdensome side effects. It might also arise with multiple comorbidities where curing one ailment cannot materially improve a patient’s overall health. Multiple comorbidities are increasingly common towards the end of life;2 around 90% of deaths are ‘expected’ and occur after a period of life-limiting chronic illness.3 Typical trajectories, illustrated in figure 1, demonstrate how patients’ capacity to benefit from curative therapy generally reduces as their chronic illness progresses.4 By contrast, intensity of diagnostic testing and attempted therapy generally accelerate through the last years of life, and are at their greatest preceding death.5–12 These two trends are incongruous, with patients potentially exposed to burdensome side effects during a time when their capacity to benefit decreases. Palliative interventions might be effective in reducing the incidence of futile treatment.13 In recent years, palliative care has offered solutions generally during the terminal stage of illness, after curative attempts have ceased. An emerging concept, illustrated in figure 2, integrates palliative care from first diagnosis of potentially life-limiting chronic disease, initially, alongside attempted curative therapy.14 In theory, palliative intervention improves the management of patients’ physical and psychological distress, and helps recognise that death is normally the culmination of a chronic process rather than a self-contained acute event;15 hence, intensity of attempted therapeutic treatment should reduce in proportion with patients’ reducing capacity to realise benefit. Research comparing palliative with usual end-of-life care shows potential to reduce intensity of treatments toward end of life; a palliative approach generally reduces financial cost,16 17 a measure closely correlated to treatment intensity.6
389
Downloaded from http://spcare.bmj.com/ on February 1, 2015 - Published by group.bmj.com
Review METHOD Search strategy
A search strategy was designed to identify research examining the relationship between a palliative approach to end-of-life care, financial cost to the health system and patient quality of life. MEDLINE (1966 to June 2011), EMBASE (1974 to June 2011), and AMED (1885 to June 2011) were interrogated using Ovid Interface; CINAHL (1937 to June 2011) was interrogated using EBSCO Host Interface. The Journal of Palliative Medicine and Archives of Internal Medicine were hand-searched ( January 2010 to June 2011), as these titles returned the highest frequency of potentially relevant material during the first stage of literature search; documents from government, think-tank and charity sources, including The National Audit Office, King’s Fund, Joseph Rowntree Foundation and WHO were also examined, and citation tracking was employed on any articles selected for inclusion to optimise capture of latest work. Description of the full MEDLINE search is shown in table 1. No equivalent to ‘Medical Futility’ was included in EMBASE or AMED searches as no subject heading indexes this concept within either. The closest concept in EMBASE is ‘Treatment Outcome’; this heading, however, catalogues over 500 000 articles, and such volume was deemed impractical given time available for this project. These exceptions aside, the search strategy outlined for MEDLINE was replicated for all additional database searches, updating terminology for each search to ensure equivalent subject headings were captured. Study selection
Figure 1 Trajectories of decline at the end of life.4 Time is presented in arbitrary units on these diagrams, but the scale has been adjusted to demonstrate approximate relationships between the four trajectories.
Patient experience can also be improved by palliative care.18–20 However, these outcomes are generally studied separately21 and it is therefore possible that treatment intensity is reduced at the expense of complete patient care. Reducing the intensity of treatment and improving patient outcomes concurrently would imply palliative interventions successfully avoiding futile elements. This review assesses the extent to which existing evidence supports the ability of palliative interventions to routinely reduce treatment intensity, thereby reducing cost and simultaneously improving patient outcomes at the end of life. 390
Studies were deemed suitable for inclusion if they explored differences between palliative and usual approaches to end-of-life care, measuring financial cost and either patient satisfaction or quality-of-life outcomes. Studies were excluded if they investigated specific treatments, rather than a general palliative approach, or if they measured only one aspect of quality of life, for instance, pain. Narrative review articles were also excluded. PICOS criteria are set out in table 2 for clarity. Search criteria were set by both authors. The literature search and review of all sources identified were conducted by IH. A flowchart summarising the papers retained and excluded at each stage in the selection process is provided in figure 3. Assessment of sources’ quality
Sources retained for full reading were reviewed for quality against predetermined outcome criteria: ‘cost’ and either ‘patient quality of life’ or ‘satisfaction with care.’ Data were extracted per a form based on criteria set out in the Cochrane Handbook of Systematic
Harris I, et al. BMJ Supportive & Palliative Care 2013;3:389–398. doi:10.1136/bmjspcare-2012-000343
Downloaded from http://spcare.bmj.com/ on February 1, 2015 - Published by group.bmj.com
Review
Figure 2 Graphic representations of traditional and emerging concepts of palliative care.14 In the traditional concept, specialised care is provided after curative attempts have ceased. In the emerging concept, palliative care is integrated into end-of-life care from the onset of life-limiting disease, to ensure patients’ emotional and spiritual needs are considered alongside their physical needs.
Reviews. Date of publication, country of origin, type and setting of intervention, patients’ terminal illness, study design, recruitment process, sample size, statistical methodology and study duration were all noted. Values were extracted for financial cost per patient in intervention and control; amounts not reported in US $ were converted at the average exchange rate during their year of publication. Values were extracted for all reported quality-of-care outcomes together with a note of their scale or unit of measurement. Studies not accounting for cost at the level of individual patient were excluded. Quality outcomes are more complicated to describe, as a number of factors
Table 1 Step 1
Medline search strategy
Subject heading or search term
Cost benefit analysis, OR Costs and cost analysis, OR Healthcare costs 2 ‘End of Life’.tw, OR ‘Last Year of Life’.tw OR, ‘Overzealous Treatment’.tw, OR ‘Futil$’. tw 3 Medical futility 4 Life support care 5 Palliative care 6 Terminal care 7 Resuscitation orders 8 Hospice care 9 2 OR 3 OR 4 OR 5 OR 6 OR 7 OR 8 10 1 and 9 $ indicates a truncation; .tw indicates ‘text word’.
Number of references 104350
are amenable to measurement. Patient satisfaction is generally a product of treatment quality and, therefore, a valid outcome measure.22 Sources have been excluded where quality of life is not measured either using a patient satisfaction scale, or a multidimensional quality-of-life scale encompassing more than one discreet measure. All studies reporting appropriate data for both outcomes were included in the review, and any methodological limitations noted in Results to allow assessment of their strength. The final assessment of included sources appraised their heterogeneity and determined their potential for conducting a meta-analysis. Different timescales, disparate interventions and diverse research settings, in conjunction with different outcome measures utilised suggested that, for this study, narrative synthesis would be more appropriate than full meta-analysis. However, arithmetical average percentage cost saving, weighted by study size, was calculated by multiplying
11199
Table 2 PICOS summary 2031 6538 34380 18402 2726 3806 63975 1008
Population Intervention Comparison Outcome Study design
Harris I, et al. BMJ Supportive & Palliative Care 2013;3:389–398. doi:10.1136/bmjspcare-2012-000343
Patients thought to be in their final year, months or weeks of life. A consciously palliative approach to their terminal care. The routine package of care prevailing in the health service under scrutiny. Financial cost, and patient quality of life or satisfaction with care. Randomised or non-randomised controlled trial designs, prospective or retrospective cohort studies, and case control studies.
391
Downloaded from http://spcare.bmj.com/ on February 1, 2015 - Published by group.bmj.com
Review
Figure 3 Stages of evaluation, inclusion and exclusion for studies considered during this systematic review. EOL, end of life; QOL, quality of life.
the saving demonstrated in each study by its sample size, then dividing the sum of these by the sum of all sample sizes. RESULTS Characteristics of excluded studies
Literature searching identified 1964 potential sources including 321 duplicate records which were discarded. A further 1487 records were excluded following evaluation based on their titles and abstracts: 356 did not report appropriate quality of life or patient satisfaction measures, 183 did not report costs based on individual patient data and the remaining 948 were not original research comparing palliative and usual approaches with end-of-life care. An additional 25 potential sources were identified by hand searching. The 181 remaining sources were read in full. A further 168 were excluded: 93 did not report sufficient quality of life or patient satisfaction measures, 28 did not report sufficient cost data and the remaining 48 did not research relevant interventions. Characteristics of included studies
Characteristics of the remaining 12 studies are displayed in table 3. They comprise six randomised clinical trial studies, two prospective cohort studies and four retrospective case-controlled studies. Study sample size ranged from 28 to 1754, median value 247. Nine were conducted in the USA and one each from UK, The Netherlands and Canada. Two were published in the 1980s, three in the 1990s and the remaining seven in the 2000s. 392
Research settings spanned hospital-based services, including specialist palliative care and other medical disciplines, hospice services and primary care. Patients with cancer were most frequently represented within samples although patients with a diagnosis of organ failure were also included. The reported time between admission to study and death ranged from 76 to 242 days with weighted average value of 128 days. Quality of included studies
A specific quality scale was not employed; such tools are not supported by empirical evidence.23 Full analysis is presented covering common areas where methodological challenges can occur: recruitment of participants, measurement of outcomes and reporting of results. Selection bias in recruitment and randomisation
All included case-controlled studies24–27 recruited from patients already referred into the interventions they investigated. Consequently, there is a concern that their research samples may not accurately reflect the wider population of patients from which they are drawn. One26 confirmed all referred patients and potential case controls were contacted and listed separate refusal rates for each arm; however, a significantly higher refusal rate in the control arm of this study removed a significantly older and frailer group from the control. Impact from this was impossible to quantify, but it is clear that the control cannot be a complete reflection of the wider population, and this limitation may be equally present in the remaining
Harris I, et al. BMJ Supportive & Palliative Care 2013;3:389–398. doi:10.1136/bmjspcare-2012-000343
Downloaded from http://spcare.bmj.com/ on February 1, 2015 - Published by group.bmj.com
Review Table 3
Characteristics of studies included in review
Lead author
Year
Country
Description of sample
Podymow
2006
Canada
Smeenk
1998
Nether-lands
Terminally ill patients: primarily liver failure, AIDS and cancer Terminal cancer patients
Raferty
1996
UK
Brumley
2003
USA
Brumley
2007
USA
Ciemins
2007
USA
Terminally ill cancer patients. Prognosis
