A systematic review of the scientific evidence for the ...

C 2005 International Psychogeriatric Association International Psychogeriatrics (2005), 17:1, 31–40 doi:10.1017/S1041610205001018 Printed in the United Kingdom

REVIEW

A systematic review of the scientific evidence for the efficacy of a palliative care approach in advanced dementia ..............................................................................................................................................................................................................................................................................

E. L. Sampson,1 C. W. Ritchie,1 R. Lai,2 P. W. Raven1,3 and M. R. Blanchard1,3 Royal Free and University College Medical School, London, U.K., 1 Metabolic and Clinical Trials Unit, Department of Psychiatry and Behavioural Sciences and 2 University Library, Royal Free Campus. 3 Camden and Islington Mental Health and Social Care Trust, London, U.K.

ABSTRACT

Background: Patients with dementia often receive poor end-of-life care, with inadequate pain control and without access to the palliative care services that patients with cancer are offered. This has been identified as an area of need in recent U.K. Government reports and by the Alzheimer’s Society (U.K.). Our objective was to perform a systematic review of the scientific literature regarding the efficacy of a palliative care model in patients with dementia. Methods: A systematic review was carried out to identify controlled trials that investigated the efficacy of palliative care in patients with dementia. Data sources included were Medline, EMBASE, PsycINFO, CINAHL, British Nursing Index, AMED, Cochrane Database of Systematic Reviews, Web of Science, Cochrane Central Register of Controlled Trials, International Standard Randomised Controlled Trial register, the NHS Economic Evaluation Database and the System for Information on Grey Literature in Europe. Other data was sourced from hand searches of papers identified on electronic databases and review articles. Results: The search identified 30 review articles, but only four papers were eligible for full appraisal and only two of these met the full criteria for inclusion. These papers gave equivocal evidence of the efficacy for a palliative model of care in dementia. Conclusion: Despite the increased interest in palliative care for patients with dementia there is currently little evidence on which to base such an approach. Correspondence should be addressed to: E. L.Sampson, Metabolic and Clinical Trials Unit, Department of Psychiatry and Behavioural Sciences Royal Free Campus, Royal Free and University College Medical School, Rowland Hill Street, London, NW3 2PF, U.K. Phone: +44 (0)20 7794 0500 ext. 3951. FAX+44 (0)20 7830 2808. [email protected] Received 27 Jan 2004; revision requested; 16 Feb 2004; revised version received 20 Feb 2004; accepted 23 Feb 2004.

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E. L. Sampson et al. This may in part be due to the ethical difficulties surrounding such research, prognostic uncertainty in clinicians and the lack of clear outcome measures for patients who are unable to express their needs or wishes. Further systematic research is urgently needed to educate an important and developing area of clinical practice. Key words: Alzheimer’s disease, dementia, palliative care, end-of-life care, terminal care, systematic review

Introduction Standard 2 of the United Kingdom National Service Framework for Older People supports the use of better quality end-of-life care for the elderly, noting that: “many older people and their carers have (also) found that palliative care services have not been available to them” (Department of Health, 2001). To date, palliative care services have concentrated on those with cancer and less than 2% of patients under the care of hospices in the UK have a neurological illness (Addington-Hall, 1998). Research into the end-stage care of other terminal diseases such as congestive cardiac failure (Tanvetyanon and Leighton, 2003) and the National Hospice Council Report Reaching out: Specialist Palliative Care for Adults with Non-Malignant Diseases (Addington-Hall, 1998) concluded that palliative care services should be available on the basis of patient and family need, not diagnosis. Consequently, voluntary organizations such as the Alzheimer’s society have recognized research into end-of-life issues as a priority. There is increasing evidence that patients with dementia do not have access to adequate end-of-life care. The avoidance of iatrogenic suffering is fundamental to the provision of good quality medical treatment, yet studies suggest that patients with dementia are often subject to painful and unnecessary investigations during the terminal phase of their illness (Morrison and Siu, 2000b). The Regional Study of Care of the Dying found that significantly more dementia patients experienced pain in the last six months of life than those with cancer (75% vs. 60%) (McCarthy et al., 1997). Achieving adequate pain control in this population is rare; in a study of patients with fractured neck of femur, cognitively impaired patients were prescribed a third as much analgesia as cognitively intact controls (Morrison and Siu, 2000a). It has been argued that medical care based on cure and maximal prolongation of life is inappropriate for patients with advanced dementia and that a palliative care model should be adopted (Volicer et al., 1986). Specific approaches adopted from palliative care, such as the use of fevermanagement policies in patients with dementia (the avoidance of the empirical use of antibiotics) and interventions for agitation, constipation and pain may improve quality of care, decrease the number of unnecessary investigations and could lead to cost savings (Hurley et al., 1996; Lloyd-Williams and Payne, 2002).

A systematic review of palliative care in dementia

Given the above observations, our objective was to perform a systematic review of the scientific literature regarding the efficacy of a palliative care model in patients with dementia.

Method Both electronic and hand-searching strategies were used to identify suitable papers. The electronic databases searched up until 1 October 2003 were, Medline (1966+), EMBASE (Excerpta Medica Database 1980+), PsycINFO (1876+), CINAHL (Cumulative Index to Nursing and Allied Health 1982+), British Nursing Index (1985+), AMED (Allied and complementary Medicine 1985+), Cochrane Database of Systematic Reviews (3rd Quarter, 2003), Web of Science (1981+), Cochrane Central Register of Controlled Trials (3rd Quarter, 2003), ISRCTN (International Standard Randomised Controlled Trial register 3rd Quarter, 2003), NHS Economic Evaluation Database (3rd Quarter, 2003) and the System for Information on Grey Literature in Europe (SIGLE 1980+).

Compilation of the search strategy There were two main themes incorporated into this search strategy, first, dementia and second, palliative care. Both these themes encompass a broad range of subject areas. An initial search strategy was developed for the MEDLINE database by translating these two themes into thesaurus terms or Medical Subject Headings (MeSH headings). Broader conceptual headings were also checked by reading the associated “scope notes” and a list of relevant text words generated from these. The search included the subject headings “Palliative Care”, “Terminal Care”, “Attitude to Death”, “Death” and all subheadings. In addition the text terms “end-of-life care” or “comfort care” or “symptom control” or “end-stage disease” or “palliat$ adj (treatment OR care)” were searched. A broad range of subject headings for dementia were searched to capture studies of patients with other neurodegenerative diseases that may cause dementia. The MeSH headings “Alzheimer Disease”, “Dementia” and “Neurodegenerative Diseases”, plus the text words “dement$”, “alz$” and “senile$ adj (dement$ OR degen$)” were used. The studies generated from the two broad search themes of palliative care and dementia were combined using “AND”. The first filter incorporated in the search strategy was designed to capture randomized controlled trials, meta-analyses, clinical trials guidelines and practice guidelines. The aim was to identify any study where a palliative care approach had been evaluated in the care of patients with dementia. Studies were limited to human subjects aged 18 plus, with all languages included.

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The MEDLINE strategy was revised after assessment of the initial output. The thesaurus term “Death” was removed, as it leads to the retrieval of a large number of papers of low relevance. The final search strategy was translated and applied to the other databases listed above. The Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled trials, ISRCTN Register and NHS economic evaluation database were searched using the text words “dementia” and “care”. Hand-searching was undertaken of the most frequently cited journals which were: The Journal of the American Geriatrics Society, Palliative Medicine, Alzheimer’s Disease and Associated Disorders, and The International Journal of Geriatric Psychiatry. References in retrieved papers and major reviews of the subject were also included if relevant. All the titles generated by this method were assessed by ELS. Papers were excluded at the initial stage if it was clear that they did not relate to dementia and palliative, terminal or end-of-life care. The abstracts of remaining studies were appraised according to whether they involved a study of clinical guidelines or management using a palliative model of care in patients with dementia. Palliative care was defined using the World Health Organisation definition: “The active total care of patients whose disease is not responsive to curative treatment. Control of pain, of other symptoms, and of psychological, social and spiritual problems is paramount. The goal of palliative care is achievement of the best quality of life for patients and their families.” (World Health Organization, 1990). Selected papers did not have to use this precise definition, but were required to use a definition of palliative care based on these general principles. For those remaining, original manuscripts were assessed independently by CWR, who was blind to the assessment made by ELS. To be included, studies had to be a clinical trial of the adoption of a palliative care model (or a trial of the adoption of guidelines promoting the use of palliative care) in patients with a diagnosis of dementia. All papers that satisfied these criteria were tabulated and the complete paper reviewed. We used broad criteria at this stage, as we were aware that there was little work in this field and we wished to include as many papers as possible for final review. Only papers that involved controlled trials of palliative care in dementia were included in the final systematic review.

Results The electronic and hand search yielded 885 titles, of which 49 met the criteria for further assessment of the abstracts. At this stage, 30 review articles were excluded. Despite the broad criteria employed, of the remaining 19 papers (see Appendix 1), only 4 fulfilled the criteria for review of the complete paper (see Table 1). There was complete concordance between the two investigators that

Table 1. Studies included in the final review PALLIATIVE CARE STUDY

DIAGNOSTIC

RANDOM-

INTERVENTION

NUMBER

CONTROL

AUTHOR

TITLE

TYPE

CRITERIA

DEFINED

OF SUBJECT

GROUP

IZED

RESULTS

Ahronheim et al., 2000

Palliative care in advanced dementia: A randomized controlled trial and descriptive analysis

Randomized controlled trial

Not stated

yes

48 intervention 51 control

yes

yes

Volicer et al., 1994

Impact of special care unit for patients with advanced Alzheimer’s disease on patients’ discomfort and costs

Prospective cohort study

DSM III-R

yes

114 intervention yes 50 “traditional long-term care”

no

Description of a care programme

DSM III-R

Yes

43

no

no

The palliative care intervention had no influence on length of hospital stay or reduction in painful interventions Patients in the dementia special care unit had higher mortality, lower observed discomfort, fewer transfers to the acute medical setting and lower cost of care There was no significant increase in mortality

yes

27

no

no

.....................................................................................................................................................................................................................................................................................................................................................................................................................................................

Hospice approach to the treatment of patients with advanced dementia of the Alzheimer type Lloyd-Williams Can multidisciplinary and Payne, 2002 guidelines improve the palliation of symptoms in the terminal phase of dementia?

Description of Not stated the adoption of guidelines

There was a significant decrease in the prescription of antibiotics and an increase in prescription of analgesia


Volicer et at., 1986

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only two papers satisfied the full inclusion criteria above for systematic review (Ahronheim et al., 2000; Volicer et al., 1994). The study by Volicer et al. (1994) was a two-year prospective cohort study comparing two treatment settings, traditional long-term care (TLTC n = 50) and a Dementia Special Care Unit (DSCU n = 114). No hypothesis was stated, but the study aimed to compare comfort, mortality rate and the use of medical resources between patients with Alzheimer’s disease on DSCU and TLTC units. Subjects were not randomized to groups; results were analyzed according to the care setting in which the patient had previously been placed. Because of this, study personnel, those involved in patient care and patients were not blind to the intervention and it is unlikely that both groups, aside from the experimental intervention, were treated in the same way. The TLTC population was older (four years), had shorter illness duration and less severe disease on Mini-mental State Examination (MMSE, Folstein et al.,1975) (all of these differences were significant at the 0.05 level). DSCU care involved a palliative care approach, “maintenance of patients’ comfort rather than maximal survival”. Specific details of the palliative care intervention were not given. Principal outcome measures were patient discomfort as measured on the Discomfort Scale for Patients with Advanced Dementias of the Alzheimer Type (DS-DAT), medical resource utilization and mortality rates. TLTC patients received significantly more analgesia, antibiotics, intravenous therapy, hypnotics and anxiolytics ( p < 0.05 on all measures). Despite the difference in prescription of analgesia, patients in the DSCU group experienced significantly less discomfort. However, they had a higher mortality rate than the TLTC patients (Cox proportional hazard regression revealed a hazard ratio of 2.2). Costs of medication, radiology and laboratory procedures were significantly less in the DSCU group and there were fewer patients transferred to acute medical settings ( p < 0.05). The study by Ahronheim et al. (2000) was of higher methodological quality. This was a randomized control trial within an acute general hospital setting. There were 51 patients in the control group and 48 patients in the intervention group. There were no differences in disease severity or demographic features between the study groups and all of the patients were accounted for at the end of the trial. The authors did not use specific diagnostic criteria for dementia and the type of dementia was not given. The investigator who gathered outcomes was blind to patient randomization. The palliative care intervention was described in detail and outcome measures were mortality, site of discharge, length of hospital stay, number of readmissions, use of non-palliative procedures, do-notresuscitate orders and the use of antibiotics. The study failed to demonstrate any influence of a palliative care approach on the care of dementia patients in the acute hospital setting. Intervention patients were significantly more likely to


have an overall palliative care plan (p = 0.008) but in 9 of 11 cases, this was not adopted until after discharge from hospital.

Discussion The results from this systematic review confirm that there are few studies on the efficacy of a palliative care approach in dementia, with only two fulfilling our criteria, both of which were carried out in the U.S.A. In general, the four studies included did not use standardized diagnostic criteria for dementia, were not randomized and lacked control groups. There are a number of reasons why there is so little literature in this area. This type of research is methodologically problematic. It is difficult to obtain ethical approval for controlled trials of an intervention that alters end-of-life care in patients who are unable to give fully informed consent. It should be noted that both of the studies meeting the final inclusion criteria were carried out in the U.S.A., where the legal framework around palliative care is different. For example, the study by Ahronheim et al. (2000) was performed in New York where there is stringent law stating that in the absence of an advance directive, tube-feeding is mandatory. It is difficult therefore to extend the results of these studies to care settings in other countries, which do not share this approach. The negative result may also suggest that a palliative care approach in advanced dementia is not an effective intervention. The lack of treatment effect in the study by Ahronheim et al. (2000) was attributed to the absence of prognostic indicators in advanced dementia and perceived prognostic uncertainty amongst physicians. The authors also suggested that these findings may be due to the small sample size and the fact that patients were randomized over a week after admission, when a care plan had already been instituted by the medical team: it was difficult to influence a care plan that was already well established. The assessment of outcomes for end-of-life care in patients with dementia is methodologically difficult. Standard measures of quality and efficacy of care, such as survival time or resource utilization may not be appropriate in advanced dementia. In particular, there are few validated pain scales available for people with dementia, and proxy reports for pain and quality of life may not be accurate (Volicer et al., 1994). Patients in the advanced stages of dementia are unlikely to be able to use quality-of-life rating scales and again, proxy reports may not be reliable (Logsdon et al., 2002). The contrast between the very small number of adequately controlled studies and the number of reviews in this area is remarkable. This suggests that there is increasing interest and recognition of the need for adequate end-of-life care in

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dementia patients. There is, however, a very limited evidence-base with which to develop appropriate interventions or services. There was no evidence that the number of empirical studies in this field is increasing, despite the recent interest in promoting palliative care for patients with dementia (Department of Health, 2001). Funding bodies and service providers will require good quality evidence from randomized control trials to ensure first, that services of this type become available, and second that care is appropriate to the needs of this particularly vulnerable patient population.

Conflict of interest declaration 1. Sources of financial support for the research: none 2. Sponsors: none

Description of Author’s Roles ELS had the original research idea, designed the study, conducted the literature search, rated the papers and wrote the manuscript. RL assisted in the formulation of the search strategy and preparation of the manuscript. CWR independently rated the papers, provided methodological advice, assisted in the writing of the manuscript. PR and MB supervised the project and provided independent adjudication and advice.

References Addington-Hall, J. Reaching Out; Specialist Palliative Care for Adults with Non-Malignant Diseases. (1998). London National Council for Hospice and Specialist Palliative Care Services. Ahronheim, J. C., Morrison, R. S., Morris, J., Baskin, S. and Meier, D. E. (2000). Palliative care in advanced dementia: a randomized controlled trial and descriptive analysis. Journal of Palliative Medicine, 3, 265–73. Department of Health. National Service Framework for Older People. (2001). London: DOH. Folstein, M. F., Folstein, S. E. and McHugh, P. R. (1975). “Mini-mental State.” A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research, 12, 189–198. Hurley, A. C., Volicer, B. J. and Volicer, L. (1996). Effect of fever-management strategy on the progression of dementia of the Alzheimer type. Alzheimer Disease and Associated Disorders., 10, 5–10. Lloyd-Williams, M. and Payne, S. (2002). Can multidisciplinary guidelines improve the palliation of symptoms in the terminal phase of dementia? International Journal of Palliative Nursing, 8, 370–375. Logsdon, R. G., Gibbons, L. E., McCurry, S. M. and Teri, L. (2002). Assessing quality of life in older adults with cognitive impairment. Psychosomatic Medicine, 64, 510–519. McCarthy, M., Addington-Hall, J. and Altmann, D. (1997). The experience of dying with dementia: a retrospective study. International Journal of Geriatric Psychiatry, 12, 404–409. Morrison, R. S. and Siu, A. L. (2000a). A comparison of pain and its treatment in advanced dementia and cognitively intact patients with hip fracture. Journal of Pain and Symptom Management, 19, 240–248.

A systematic review of palliative care in dementia Morrison, R. S. and Siu, A. L. (2000b). Survival in end-stage dementia following acute illness. Journal of the American Medical Association, 284, 47–52. Tanvetyanon, T. and Leighton, J. C. (2003). Life-sustaining treatments in patients who died of chronic congestive heart failure compared with metastatic cancer. Critical Care Medicine, 31, 60–64. Volicer, L., Collard, A., Hurley, A., Bishop, C., Kern, D. and Karon, S. (1994). Impact of special care unit for patients with advanced Alzheimer’s disease on patients’ discomfort and costs. Journal of the American Geriatrics Society. 42, 597–603. Volicer, L., Rheaume, Y., Brown, J., Fabiszewski, K. and Brady, R. (1986). Hospice approach to the treatment of patients with advanced dementia of the Alzheimer type. Journal of the American Medical Association, 256, 2210–2213. Volicer, L., Hurley, A. C. and Blasi, Z. V. (2001). Scales for evaluation of end-of-life care in dementia. Alzheimer Disease and Associated Disorders, 15, 194–200. World Health Organization. Cancer Pain Relief and Palliative Care. Technical Report Series 804. (1990). Geneva: WHO.

Appendix 1 Included papers Ahronheim, J. C., Morrison, S. and Morris (2000). Palliative care in advanced dementia: a randomized controlled trial and descriptive analysis. Journal of Palliative Medicine, 3, 265–273. (U.S.A.) Lloyd-Williams, M. and Payne, S. (2002). Can multidisciplinary guidelines improve the palliation of symptoms in the terminal phase of dementia? International Journal of Palliative Nursing, 8, 370–375. (U.K.) Volicer, L., Collard, A., Hurley, A., Bishop, C., Kern, D. and Karon, S. (1994). Impact of special care unit for patients with advanced Alzheimer’s disease on patients’ discomfort and costs. Journal of the American Geriatrics Society, 42, 597–603. (U.S.A.) Volicer, L., Rheaume, Y., Brown, J., Fabiszewski, K. and Brady, R. (1986). Hospice approach to the treatment of patients with advanced dementia of the Alzheimer type. Journal of the American Medical Association, 256, 2210–2213. (U.S.A.)

Excluded Papers Excluded – not a trial or intervention study Ahronheim, J. C., Morrison, R. S., Baskin, S. A., Morris, J. and Meier, D. E. (1996). Treatment of the dying in the acute care hospital: advanced dementia and metastatic cancer. Archives of Internal Medicine, 156, 2094–2100. (U.S.A.) Evers, M. M. P. (2002). Palliative and aggressive end-of-life care for patients with dementia. Psychiatric Services, 53, 609–613. (U.S.A.)

Excluded – case study Filley, C. M., Chapman M. M. and Dubovsky S. L. (1996). Ethical concerns in the use of palliative drug treatment for Alzheimer’s Disease. Journal of Neuropsychiatry and Clinical Neurosciences, 8, 202–205. (U.S.A.) Salmon, R. B. (1984). Care of the elderly, demented, and dying patient. Journal of Family Practice, 18, 377–386. (U.S.A.)

Excluded – survey of attitudes Albinsson, L. S. (2002). A palliative approach to existential issues and death in end-stage dementia care, Journal of Palliative Care, 18, 168–174. (Canada)

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E. L. Sampson et al. Albinsson, L. S. (2003). Differences in supporting families of dementia patients and cancer patients: a palliative perspective. Palliative Medicine, 17, 359–367. (Sweden) Casarett, D., Takesaka, J., Karlawish, J., Hirschman, K. B. and Clark, C. M. (2002). How should clinicians discuss hospice for patients with dementia? Anticipating caregivers’ preconceptions and meeting their information needs. Alzheimer Disease and Associated Disorders, 16, 116–122. (U.S.A.) Chen, W. T., Wang, S. J., Lu S. R. and Fuh, J. L. (2002). Which level of care is preferred for end-stage dementia? Survey of Taiwanese caregivers, Journal of Geriatric Psychiatry and Neurology, 15, 16–19. (Taiwan) Forbes, S., Bern-Klug, M. and Gessert, C. (2000). End-of-life decision making for nursing home residents with dementia. Journal of Nursing Scholarship, 32, 251–258 (U.S.A.) Gessert, C. E., Forbes, S. and Bern-Klug, X. (2001). Planning end-of-life care for patients with dementia: roles of families and health professionals. Omega — Journal of Death and Dying, 42, 273–291. (U.S.A.) Fujikawa, T., Furuta, T. and Akita, S. (2000). Terminal care in patients with dementia: questionnaire to nursing staff about the medical treatment. [Japanese]. Seishin Igaku (Clinical Psychiatry), 42, 761–767. (Japan) Hanrahan, P. and Luchins, D. J. (1995). Access to hospice programs in end-stage dementia: A national survey of hospice programs. Journal of the American Geriatrics Society, 43, 56–59. (U.S.A.) Luchins, D. J. and Hanrahan, P. (1993). What is appropriate health care for end-stage dementia? Journal of the American Geriatrics Society, 41, 25–30. (U.S.A.) Moss, M. S., Braunschweig, H. and Rubinstein, R. L. (2002). Terminal care for nursing home residents with dementia. Alzheimer’s Care Quarterly, 3, 233–246. (U.S.A.) Owen, J. E., Goode, K. T. and Haley, W. E. (2001). End-of-life care and reactions to death in African-American and White family caregivers of relatives with Alzheimer’s disease. Journal of Death and Dying, 43, 349–361. (U.S.A.) Potkins, D., Bradley, S., Shrimanker, J., O’Brien, J., Swann, A. and Ballard, C. (2000). End-of-life treatment decisions in people with dementia: carers’ views and the factors which influence them. International Journal of Geriatric Psychiatry, 15, 1005–100.(U.K.)

Excluded – description of service provision Brechling, B. G. K. (1989). A specialized hospice for dementia patients and their families, American Journal of Hospice Care, 6, 27–30. (U.S.A) Shega, J. W. L. (2003). Palliative excellence in Alzheimer care efforts (PEACE): a program description. Journal of Palliative Medicine, 6, 315–320. U.S.A. Volicer, L. H. A. (2003). Characteristics of dementia end-of-life care across care settings. American Journal of Hospice and Palliative Care, 20, 191–200. U.S.A.