Slides available at Bob Arnold, University of Pittsburgh School of Medicine James Tulsky, Duke...

Slides available at www.aahpm.org

Bob Arnold, University of Pittsburgh School of Medicine

James Tulsky, Duke University School of Medicine

Sonni Mun, Mount Sinai School of Medicine

Update in Hospice and Palliative Care


Acknowledgments

Daniel Fischberg

Karl Lorenz

Nathan Cherney

Rosanne Leipzig

Staff of AAHPM


2004: A Banner Year

• NIH State the Science– (http://consensus.nih.gov/ta/024/

endoflifeintro.html)

• National Consensus Project– (http://www.nationalconsensusproject.org)


2004: A Banner Year

• Review of Pediatric Palliative Care in NEJM– Himelstein B. P., Hilden J.M., Boldt A., Weissman

D., 350: 1752-1762, April 22, 204

• Review of Palliative Care in NEJM– Morrison, R.S., Meier, D., 350:2582-2590, June

17, 2004


Objectives

• Summarize seven important peer-reviewed articles from the last year

• Critically analyze their methodologies and understand their conclusions

• Determine if the findings are relevant to the care of your patients


Key Issues to Be Considered

• Is the question important?

• What are the results?

• Are the results valid?

• Can I apply the results to my patients


Methods

• Key Word search of evidence-based reviews– Nathan Cherney database

(www.cherneydatabase.org)– State of Science database

http://www.cherneydatabase.org/


Methods

• Hand search of leading journals

• Selection criteria– Quality of science– Represent breadth of domains– Appeal to breadth of interest– Potential for impact


Relief of Suffering

One breakthrough of the last year stands out above all others….


Case 1: Jerrold R

• Recently diagnosed stage IV lung cancer

• Presents to internist with chest wall pain

• Has not taken any analgesics as “not sure what to take?”


Is it appropriate to start with a strong opiate?

• WHO therapeutic ladder for the treatment of cancer pain

• Data supporting WHO guidelines are weak

Mild

Moderate

SevereStrong Opioid

Weak Opioid

Non-Opioid

Pain


Starting With Strong Opioids

• Study Design: Randomized controlled trial• Source of funding: Unknown• Participants: 100 patients• Inclusion Criteria:

– Cancer– Not eligible for disease oriented treatment– Home palliative care– >6/10 on VAS for last week



• Exclusion Criteria:– Impaired sensory or cognitive function– Predominately neuropathic pain– Previous opiates

• Intervention:– Grp A: WHO pain ladder– Grp B: Start with strong opioids– Both groups can get adjuvants



• Measurement– Daily

• Pain diary-intensity, general condition, side effects

– Once a week• Pain relief• Satisfaction with pain relief Y/N• Quality of life• Side effects

• Analysis: chi-square and t-tests



Group A Group B(n = 48) (n = 44)

Age 61.3 + 20.3 63.9 + 20.0

Sex %Male 62.5 56.8Female 37.5 43.2

Karnofsky 58.92 + 5.56 58.01 + 8.04

VAS 4.03 + 1.36 4.13 + 1.36



QOL change Pain Score change Nausea

A -16.55 -1.92 315

B -16.05 -2.61 437

P ns p=0.041 p=0.0001

* There was no significant difference in vomiting, constipation, GI bleeding, or mental confusion


Key Issues

• Is the question important?– Common clinical problem

• What are the results?– All patients had significant pain

reduction– Quicker pain relief with starting with

non-opiates


Key Issues

• Are the results valid?– Small study– Unclear about analgesic use– No controlling for co-morbidities– Poor measures


Key Issues

• Can I apply the results to my patients?

– Non-neuropathic, cancer pain– Young


Bottom Line

• In selected cancer patients presenting with severe pain, starting with strong opioids will lead to better pain relief.


Case 2: Jerrold R (continued)

• Stage IV lung cancer • Presents to internist six months later

with persistent left arm pain (4/10)• Has received radiation to the arm• Is currently on long acting morphine,

monthly bisphosphonates, steroids, and a NSAID

• What can you do?


Background

• What is the role of co-analgesics in pain relief?– NSAID– Steroids– Acetaminophen

• Does adding acetaminophen to opiates improve pain relief in cancer patients?


Adding Acetaminophen

• Study Design: RCT, placebo, crossover

• Source of Funding: Au Cancer Council Janssen

• Participants: 34 patients


Adding acetaminophen

• Exclusion Criteria:– Recent XRT– New chemotherapy– Neuropathic pain– Severe liver disease

.



.



• Primary outcome measure: – Pain as measured by 0-10 verbal scale and a 10-

cm VAS– Daily rating and at end of study preference

• Secondary measures– Breakthrough opiates– Well-being– Side effects



• Sample size• Analysis: ANOVA

– If not normal distribution then logit transformation


Adding acetaminophen-Visual scale-pain


Adding acetaminophen-Verbal scale - pain


Adding acetaminophen-visual scale-well being


Key Issues

• Is the question important?– Common clinical problem

• What are the results?– Consistent decrease in pain and increase in

QOL if add acetaminophen– 30% had >1 point change on 0-10 scale for

both pain and well-being


Key Issues

• Are the results valid?– Small study– Problematic intervention– Short duration– Poor measures


Key Issues

• Can I apply the results to my patients?

– Consistent with other studies– Cheap and easy– Can stop if does not help


Clinical Bottom Line

“Acetaminophen improved pain and well-being without major side-effects in people with cancer and persistent pain despite a strong opioid regimen.”

It can be tried in patients with persistent pain

Slides available at www.aahpm.org“His final wish was that all his

medical bills be paid promptly.”


Case 3: Mary R

• 74 year old with severe COPD

• Has dyspnea at rest

• Current medications– Albuterol/Atrovent– Oxygen– Steroids


• Frustrated because dyspnea has made her life “miserable

• Is there anything else besides her current regimen that will help alleviate her dyspnea?

Mary R’s Case: continued


Opioids for Dyspnea: Background

• Dyspnea is a common symptom

• Dyspnea is subjective

• Can impair functional status

• Particularly difficult for caregivers to observe


Opioids for Dyspnea: Background

• Concern over adverse reactions

• Conflicting consensus guidelines

• Not enough good studies – Small sample numbers– Difficult to blind


• 8 day RCT crossover

• 20 mg of sustained release morphine versus placebo

• Primary outcome variable: dyspnea on day #4

Opioids for Dyspnea: Methods


Participants were recruited from outpatient clinics for respiratory, cardiac, general, and palliative medicine

Opioids for Dyspnea: Methods continued

Inclusion criteria

•Adults with dyspnea at rest despite “optimal treatment of reversible factors”

•Opioid naive

Exclusion criteria•Recent use of opioids

•Confusion

•Obtundation

•Adverse reactions to opioids

•History of substance misuse


Opioids for Dyspnea: Demographics


• 104 screened - 87 eligible

• 48 consented - 39 refused or too sick

• 10 withdrew - 5 in each group

Opioids for Dyspnea: Results


• Morphine better than placebo– Evening: Improvement of 9.5 mm (SD 19,

and P=0.006%)– Morning: Improvement of 6.6 mm (SD 15,

and P=0.011)

Opioids for Dyspnea: Results


Opioids for Dyspnea: Results continued

• No change in respiratory rates

• No difference in vomiting, confusion, sedation, or anorexia

• No sequence or period effects

• Sensitivity analysis showed benefit


Opioids for Dyspnea: Is this Question Important

• Yes, prevalence high and high level of suffering associated with this symptom. Suffocation difficult to tolerate for even short periods of time.


Opioids for Dyspnea:Are the results valid?

• Crossover design

• No washout period

• No blinding for constipation

• Blinding


Opioids for Dyspnea: Other supporting literature

• Meta analysis confirms that opioids are effective for dyspnea (Jennings et al, Thorax 2002; 57: 939-44).

• Cochran database systematic review again confirms that opioids are effective for treatment of dyspnea


Opioids for Dyspnea: Key issues

• Can I apply these results to my patient– Study included patients with dyspnea due

to many diseases– Included older patients– Dyspnea at rest


• Morphine is effective

• Small doses effective so concern over side effects may be exaggerated

Opioids for Dyspnea: Bottom line


Case 4: Mary R. continued

• The patient did well after you started her on a low dose of sustained release morphine

• After about four months she is admitted with a COPD exacerbation

• While admitted she is found pulseless and the cardiac monitor indicates asystole and she is resuscitated for 15 minutes.


Mary R. continued

• She is “successfully” resuscitated and she regains her pulse and is sent to the intensive care unit

• You see her the next day and she is unresponsive and does not require any sedation on the ventilator

• The husband who is at the bedside asks you about her prognosis.

• What do you tell you the husband?


Prognosis after cardiac arrest: Background

• 500, 000 in hospital arrests• Public misunderstanding of hypoxic injury

after cardiac arrest (ER, Chicago Hope, Schiavo, fireman in Buffalo)

• Need information about expected level of recovery so appropriate decisions.

• The emotional, ethical, and financial aspects


Cardiac arrest: Methods

• Study design: systematic review

• Source of funding: Griffen Rotman

• Outcome measures: precision and accuracy of physical findings to determine prognosis



• Search strategy: Extensive MEDLINE, EMBASE, bibliography and abstracts from meetings search.

• Search terms: coma, cardiac arrest, prognosis, physical examination, sensitivity, specificity, and observer variation



• Inclusion criteria for accuracy– Accuracy of physical exam – Outcome data for individual clinical

variables measured at discrete time intervals

• Exclusion criteria accuracy studies– Traumatic coma



• Inclusion criteria for precision studies– Assessment of inter-observer agreement– Non-traumatic coma AND traumatic coma

• Exclusion criteria for precision studies– Not clear



• Studies had outcome data for severe disability, vegetative state, and death

• Quality of study assessed by two “blinded” researchers– Level 1: Prospective with >100 subjects– Level 2: <100 subjects– Level 3: Retrospective chart reviews– Level 4: Non-consecutive patients


Table 2



• Raw data used for positive and negative LR

• CPC 1 and 2 = good outcomes

• CPC 3, 4, and 5 = poor outcomes

• Summary LR if > 3 studies examined a clinical variable at same time after arrest


Cardiac Arrest: Results

• 5 articles of precision and 14 articles (11 studies) of accuracy – 11 accuracy studies

• 5 level 1• 3 level 2• 1 level 3• 2 level 4

– Heterogeneity in precision studies allowed only qualitative data



• 5 studies of precision– Kappa: 0.36 -0.79– Variables

• GCS motor• GCS eye• GCS verbal• Pupil response• Oculo-cephalic response• Spontaneous Eye Movements• Brainstem reflexes



• 1,914 survivors in accuracy studies

• Pre test probability of poor outcome = Percentage of the 1,914 that had bad outcome (self fulfilling prophesy)

• Random effects estimate of poor outcome was 77%



Time Highest Pooled LR Clinical FindingOnset 1.7 no withdrawal to

pain

24 hr 12.9 no corneal reflex

72 hr 9.2 no motor

response


Cardiac Arrest: Are the results Valid

• Dichotomizing outcomes as good and poor

• Poor prognoses tend to be self fulfilling

• Diverse backgrounds in terms of demographics and co-morbidities


Cardiac Arrest: Key Issues

• Can I apply these results to my patients– High pooled LR from studies evaluating

accuracy– Non-traumatic coma


Is this Question Important?

• Yes– Families need accurate information to

make decisions especially when it revolves around discontinuation of therapies.


Clinical Bottom Line

• Immediately after arrest no clinical signs are helpful

• No clinical findings were found to have LR that predicted a good outcome

• Simple physical exam findings can strongly predict poor outcome in survivors of cardiac arrest


• Mary R dies

• Four weeks after Mary R’s death the husband is in your office

• Because you did such a great job in caring for her, her husband decides that you should be his primary care provider

Case 5: Mary R. continued


• The husband is clearly distraught and appears to have lost weight

• He says that this is the first time he has bothered to get dressed and leave his home since his wife’s death

• He wants to know if anything other than time will help him with the grieving process

Sonni M’s husband’s case


• Physicians may not be aware of the associated morbidity.

• Uncertainty on how to help grieving patients

• How much of the process is “normal” ?

• No consensus or guidelines on the many different techniques

Bereavement: Background


Bereavement Interventions: Methods

• Study Design: systematic review

• Source of Funding: CHOP and Agency for Health Care Research and Quality

• Intervention: Any study evaluating “bereavement care interventions”


Bereavement Interventions: Methods continued

• Search Strategy– Traditional as well as complementary and

alternative literature– Databases from many disciplines– Primary search terms: bereaved,

bereavement, and grief



• Inclusion Criteria: Treatment of bereaved individuals AND evaluation of the method used as the intervention– Initial search = 737 citations

• After title reviews: 243 citations• After abstract review: 87 articles• 87 articles were reviewed: 74 included in this

paper



• Review organized on the basis of the social framework used to implement the intervention



• Structured therapeutic relationship model– Pharmacotherapy– Support groups or counseling– Psychotherapy

• Cognitive-behavioral therapy• Psychodynamic therapy• Psychoanalysis• Behavioral therapy• Interpersonal therapy

• Systems-oriented interventions


Bereavement Interventions: Results

• Pharmacotherapy – Effective for insomnia and depression– Mixed effect on bereavement intensity



• Support Groups– 39 studies

• 23 had controls and 15 had randomization• 29 were professionally led support groups• Great variation in number of sessions, targeted

population, and format



• Support groups continued.– Spontaneous improvement noted in

several studies– No summary conclusion possible– No harm



• Pharmacotherapy relieves depression and insomnia but not grief

• No conclusions regarding one type of intervention versus another


Bereavement Interventions: Are the results valid?

• Outcomes and measures to evaluate outcome heterogenous

• Internal and external validity poor

• Great variety in the treatments used (Apples versus promegranates)


Clinical Bottom line

• Highly prevalent and distressing

• There is lack of evidence to make recommendations

• More rigorous studies are needed


Bereavement: Key issues

• Can I apply these results to my patients– Unable to recommend one treatment

versus another– Pharmacotherapy can help with depression

and sleep disorders


“It’s a medical miracle you made it through that last medical miracle.”


Case 6

• Charlotte P is an 83 y/o retired lawyer with class IV CHF, moderate dementia and rapid functional decline.

• She was admitted with worsening dyspnea, narrowly avoiding intubation

• After one week, despite thorough testing and treatment trials, she feels no better.


Charlotte P. (Cont)

• The patient and her family recognize that she is at the end of her life.

• They want her to go home, yet she receives benefit from some treatments provided in the hospital.

• Everyone wonders what setting would be best for her.


Background

• Place of death has changed dramatically over the past century– All people used to die at home– Then shifted to most deaths in hospital– Now shifting back (dramatically in some states)

• 50% die in hospital, 2001 (range: 33-65%)

• Many people use place of death as a proxy for quality of death, but is it?


Background (cont.)

• One national study suggested that place of death less important than quality of death - having needs met

• Very little data on relationship between site of death and quality.

Slides available at www.aahpm.orgSlides available at www.aahpm.org


Family Perspectives:Methods

• Study Design: mortality follow-back survey• Source of Funding: RWJ Foundation• Participants:

– 1578 family members or close friends of decedents who died in 2000

• Inclusion Criteria– Identified through probability sampling of state death certificates

• Exclusion Criteria– States that would not allow sampling– Decedents under age 18– Death from trauma


Family Perspectives:Methods

• Measures– Telephone interview

• Quality of care in last place of life• Unmet needs for pain, dyspnea, emotional support• Shared decision-making• Treated with respect

• Analysis– Descriptive 2, logistic regression


Family Perspectives:Results

• Site of death– Hospital or nursing home 69%

• Nursing Services (of those at home)– No nursing services 36% (37% of these

functionally impaired)– Home nursing 12%– Home hospice 52%

• Cancer more likely hospice• Heart disease more likely no formal services


QuickTime™ and aTIFF (Uncompressed) decompressor

are needed to see this picture.


Family Perspectives:Results• Not any or enough help with:

– Pain 24%– Dyspnea 22%– Emotional support 50%

• Recipients of home hospice care had lower rates of unmet needs compared with others

• Home with home health services did worse on several parameters c/w other settings


Family Perspectives:Results

• Nursing homes did worse on pain, being treated with respect (OR 1.6 and 2.6)

• Overall satisfaction highest in hospice (71% vs. 50% rated “excellent”


Key Issues: Is the Question Important?

• Remarkably little large scale data describing end of life experience

• Little rigorous data supporting/refuting value of hospice

• Significant implications for clinical decision-making and design of health care services


Key Issues: What are the Results? Are they valid?

• Increasing #’s of patients die in nursing homes, but quality is lacking in this setting

• Home death not a proxy for quality, unless hospice involved

• Limitations:– Non-randomized, selection bias (by state etc)– Non-response bias (favored Caucasians)– Family members may not be accurate observers


Key Issues:Can I Apply this to my Patients?

• Probably as generalizable data as we will get on a national scale

• Makes one aware of limitations in EOL care in nursing homes, home health nursing


Bottom Line

• Many dying patients have unmet needs

• Targeted systems of care for dying patients are necessary for highest quality care

• Mortality follow-back is a useful methodology in EOL research


Case 7

• Mike M is a 55 y/o social scientist with peritoneal mesothelioma

• He first presented with progressive ascites

• After surgical debulking and infusion of heated chemotherapy, he achieved complete symptom relief


Mike M. (Cont)

• One year later he had evidence of recurrence by CT/PET, but felt well, working out daily and traveling extensively

• In speaking with him, his physicians struggle with how much information about his prognosis to share….


Background

• Although we know something about preferences for bad news, much less data on prognosis

• MD’s tend not to communicate about prognosis, or to do so vaguely– And, have an optimistic bias

• Worried about balancing truth and hope


Background (cont.)

• Patients overestimate prognosis• Conflicting data on preferences for

information:– Clear majority want detailed info on

disease– But…not sure if want prognostic info

• Not clear what pts with advanced disease want to hear about prognosis


Patient Preferences for Communication:Methods

• Study Design: cross-sectional survey• Source of Funding: NSW Cancer Council• Participants:

– 126 Australian advanced cancer pts (from 218)– 30 oncologists (from 106)

• Inclusion Criteria– All oncologists in New South Wales– Patients > age 18

• Metastatic cancer diagnosed 6 wks to 6 mos earlier• English speaking

• Exclusion Criteria– Psychiatric disease


Patient Preferences for Communication:Methods

• Measures– Written survey

• 2 gender-specific hypothetical scenarios

• Prognostic information desired

• Pref presentation of survival stats (e.g., words, #’s)

• When to discuss, and who initiates

• Demographics and depression/anxiety scores

• Analysis– Descriptive 2, ANOVA, logistic regression


Patient Preferences for Communication:Results

• 54% Male

• 25% breast ca, 18% colorectal, 15% prostate, 10% lung, 30% other

• 95-99% wanted common information related to side effects, symptoms, treatment

• Most wanted info on survival duration– 65% 1-year survival; 80% 5-year survival

• Words/numbers > pie charts/graphs


Preferences for Communication - Results• 59% want to discuss survival when first learn

metastatic

• 1/3 wanted to discuss dying/pall care when diagnosed; 1/3 later– 24% only when they ask for it

– Patients with children more likely to want to wait

• More depressed more likely to want to discuss survival

• Worse prognosis less desiring to discuss


Key Issues: Is the Question Important?

• Clinicians face this issue frequently - much debate among them about what to say

• Patient experience and satisfaction can be dependent upon how information is shared


Key Issues: What are the Results? Are they valid?

• Most patients want information about symptoms and treatment; desire for prognostic information highly variable

• High refusal rate among both oncologists and patients threatens validity

• Do hypothetical scenarios mimic real life?


Key Issues:Can I Apply this to my Patients?

• Australian sample (85% Anglo-Saxon; remainder likely Asian/Aboriginal)

• Western, English-speaking healthcare system


Bottom Line

• Patient preferences for prognostic information are highly variable

• Cannot predict preferences

• Must negotiate the sharing of information– Ask first!– How much, and when to tell?


Pearls for Finding High Quality Evidence in Palliative Care

• Traditional randomized controlled trials– Look at the data differently– Study the survival curves

• Searching Medline– Keywords:

• Palliative care• Terminal Care• Attitude to death• Terminally ill• Life support care• Hospices


Conclusions

• Palliative Care is a growing field with a growing evidence base

• Although challenges exist, when faced with a clinical problem, first go to the literature

• Data is available from a variety of sources– Journals (J Pall Med, J Pain Sympt Man)– PC FACS, Cochrane Collaborative– Fast Facts– Textbooks (Oxford Textbook of Palliative Care)– Organizations (AAHPM)

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