Transcript Why Don`t Generalists in Private Practice Do Pap Smears?

Update in Hospice and
Palliative Care
Bob Arnold,
University of Pittsburgh School of Medicine
James Tulsky,
Duke University School of Medicine
Sonni Mun,
Mount Sinai School of Medicine
Slides available at www.aahpm.org
Acknowledgments
Daniel Fischberg
Karl Lorenz
Nathan Cherney
Rosanne Leipzig
Staff of AAHPM
Slides available at www.aahpm.org
2004: A Banner Year
• NIH State the Science
– (http://consensus.nih.gov/ta/024/endoflifeintro.h
tml)
• National Consensus Project
– (http://www.nationalconsensusproject.org)
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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
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Objectives
• Summarize seven important peerreviewed 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
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
Methods
• Key Word search of evidence-based
reviews
– Nathan Cherney database
(www.cherneydatabase.org)
– State of Science database
Slides available at www.aahpm.org
Methods
• Hand search of leading journals
• Selection criteria
– Quality of science
– Represent breadth of domains
– Appeal to breadth of interest
– Potential for impact
Slides available at www.aahpm.org
Relief of Suffering
One breakthrough of the last year stands
out above all others….
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Slides available at www.aahpm.org
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?”
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Is it appropriate to start with a
strong opiate?
• WHO therapeutic ladder for the treatment of
cancer pain
• Data supporting WHO guidelines are weak
Pain
Strong Opioid
Weak Opioid
Non-Opioid
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Slides available at www.aahpm.org
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
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Starting With Strong Opioids
• 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
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Starting With Strong Opioids
• 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
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Starting With Strong Opioids
Group A
(n = 48)
Group B
(n = 44)
Age
61.3 + 20.3
63.9 + 20.0
Sex %
Male
Female
62.5
37.5
56.8
43.2
Karnofsky
58.92 + 5.56
58.01 + 8.04
VAS
4.03 + 1.36
4.13 + 1.36
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Starting With Strong Opioids
QOL change
A
B
P
Pain Score change
Nausea
-16.55
-1.92
315
-16.05
-2.61
437
ns
p=0.041
p=0.0001
* There was no significant difference in vomiting,
constipation, GI bleeding, or mental confusion
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Starting With Strong Opioids
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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
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Key Issues
•
Are the results valid?
–
–
–
–
Small study
Unclear about analgesic use
No controlling for co-morbidities
Poor measures
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Key Issues
•
Can I apply the results to my
patients?
– Non-neuropathic, cancer pain
– Young
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Bottom Line
• In selected cancer patients presenting
with severe pain, starting with strong
opioids will lead to better pain relief.
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Slides available at www.aahpm.org
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?
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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?
Slides available at www.aahpm.org
Slides available at www.aahpm.org
Adding Acetaminophen
• Study Design: RCT, placebo, crossover
• Source of Funding: Au Cancer Council
Janssen
• Participants: 34 patients
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Adding acetaminophen
• Exclusion Criteria:
–
–
–
–
Recent XRT
New chemotherapy
Neuropathic pain
Severe liver disease
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.
Adding acetaminophen
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.
Adding acetaminophen
• Primary outcome measure:
– Pain as measured by 0-10 verbal scale and a 10cm VAS
– Daily rating and at end of study preference
• Secondary measures
– Breakthrough opiates
– Well-being
– Side effects
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Adding acetaminophen
• Sample size
• Analysis: ANOVA
– If not normal distribution then logit
transformation
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Slides available at www.aahpm.org
Adding acetaminophen-Visual
scale-pain
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Adding acetaminophen-Verbal
scale - pain
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Adding acetaminophen-visual
scale-well being
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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
Slides available at www.aahpm.org
Key Issues
•
Are the results valid?
–
–
–
–
Small study
Problematic intervention
Short duration
Poor measures
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Key Issues
•
Can I apply the results to my
patients?
– Consistent with other studies
– Cheap and easy
– Can stop if does not help
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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
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“His final wish was that all his
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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
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Mary R’s Case: continued
• Frustrated because dyspnea has made
her life “miserable
• Is there anything else besides her
current regimen that will help alleviate
her dyspnea?
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Opioids for Dyspnea: Background
•
•
•
•
Dyspnea is a common symptom
Dyspnea is subjective
Can impair functional status
Particularly difficult for caregivers to
observe
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Opioids for Dyspnea:
Background
• Concern over adverse reactions
• Conflicting consensus guidelines
• Not enough good studies
– Small sample numbers
– Difficult to blind
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Slides available at www.aahpm.org
Opioids for Dyspnea: Methods
• 8 day RCT crossover
• 20 mg of sustained release morphine
versus placebo
• Primary outcome variable: dyspnea on
day #4
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Opioids for Dyspnea: Methods
continued
Participants were recruited from outpatient
clinics for respiratory, cardiac, general, and
palliative medicine
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
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Opioids for Dyspnea:
Demographics
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Opioids for Dyspnea: Results
• 104 screened - 87 eligible
• 48 consented - 39 refused or too sick
• 10 withdrew - 5 in each group
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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)
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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
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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.
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Opioids for Dyspnea:Are the
results valid?
•
•
•
•
Crossover design
No washout period
No blinding for constipation
Blinding
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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
Slides available at www.aahpm.org
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
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Opioids for Dyspnea: Bottom line
• Morphine is effective
• Small doses effective so concern over
side effects may be exaggerated
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Slides available at www.aahpm.org
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.
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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?
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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
Slides available at www.aahpm.org
Slides available at www.aahpm.org
Cardiac arrest: Methods
• Study design: systematic review
• Source of funding: Griffen Rotman
• Outcome measures: precision and
accuracy of physical findings to
determine prognosis
Slides available at www.aahpm.org
Cardiac arrest: Methods
• Search strategy: Extensive MEDLINE,
EMBASE, bibliography and abstracts
from meetings search.
• Search terms: coma, cardiac arrest,
prognosis, physical examination,
sensitivity, specificity, and observer
variation
Slides available at www.aahpm.org
Cardiac arrest: Methods
• 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
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Cardiac arrest: Methods
• Inclusion criteria for precision studies
– Assessment of inter-observer agreement
– Non-traumatic coma AND traumatic coma
• Exclusion criteria for precision studies
– Not clear
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Cardiac arrest: Methods
• 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
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Table 2
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Cardiac arrest: Methods
• 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
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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
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Cardiac Arrest: Results
• 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
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Cardiac Arrest: Results
• 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%
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Cardiac Arrest: Results
Time
Onset
Highest Pooled LR
1.7
Clinical Finding
24 hr
12.9
no corneal reflex
72 hr
9.2
no withdrawal to
pain
no motor
response
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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
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Cardiac Arrest: Key Issues
• Can I apply these results to my patients
– High pooled LR from studies evaluating
accuracy
– Non-traumatic coma
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Is this Question Important?
• Yes
– Families need accurate information to
make decisions especially when it revolves
around discontinuation of therapies.
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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
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Slides available at www.aahpm.org
Case 5: Mary R. continued
• 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
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Sonni M’s husband’s case
• 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
Slides available at www.aahpm.org
Bereavement: Background
• 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
Slides available at www.aahpm.org
Slides available at www.aahpm.org
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”
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
Bereavement Interventions:
Methods continued
• 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
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Bereavement Interventions:
Methods continued
• Review organized on the basis of the
social framework used to implement the
intervention
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Bereavement Interventions:
Methods continued
• Structured therapeutic relationship model
– Pharmacotherapy
– Support groups or counseling
– Psychotherapy
•
•
•
•
•
Cognitive-behavioral therapy
Psychodynamic therapy
Psychoanalysis
Behavioral therapy
Interpersonal therapy
• Systems-oriented interventions
Slides available at www.aahpm.org
Bereavement Interventions: Results
• Pharmacotherapy
– Effective for insomnia and depression
– Mixed effect on bereavement intensity
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Bereavement Interventions:
Results
• 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
Slides available at www.aahpm.org
Bereavement Interventions:
Results
• Support groups continued.
– Spontaneous improvement noted in
several studies
– No summary conclusion possible
– No harm
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Bereavement Interventions: Results
• Pharmacotherapy relieves depression
and insomnia but not grief
• No conclusions regarding one type of
intervention versus another
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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)
Slides available at www.aahpm.org
Clinical Bottom line
• Highly prevalent and distressing
• There is lack of evidence to make
recommendations
• More rigorous studies are needed
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
“It’s a medical miracle you made it through
that
last
medical
miracle.”
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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.
Slides available at www.aahpm.org
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.
Slides available at www.aahpm.org
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?
Slides available at www.aahpm.org
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.org
Slides 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
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
QuickTime™ and a
TIFF (Uncompressed) decompressor
are needed to see this picture.
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
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”
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
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….
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
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
Slides available at www.aahpm.org
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?
Slides available at www.aahpm.org
Key Issues:
Can I Apply this to my Patients?
• Australian sample (85% Anglo-Saxon;
remainder likely Asian/Aboriginal)
• Western, English-speaking healthcare
system
Slides available at www.aahpm.org
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?
Slides available at www.aahpm.org
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:
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•
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Palliative care
Terminal Care
Attitude to death
Terminally ill
Life support care
Hospices
Slides available at www.aahpm.org
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
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Journals (J Pall Med, J Pain Sympt Man)
PC FACS, Cochrane Collaborative
Fast Facts
Textbooks (Oxford Textbook of Palliative Care)
Organizations (AAHPM)
Slides available at www.aahpm.org