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Expert Working groups
Background
In
palliative care, there are still a variety of research topics
and many controversial issues without any guidelines or a
defined common approach. The Research Steering Committee (RSC)
has organised expert working groups on such topics.
The
experts were invited to examine clinical and evidential data
with the aim of creating clinical guidelines. The RSC is aware
that, especially in palliative care, there are many medical
issues that do not have a sufficiently mature evidence base
to derive such guidelines. In the absence of a best approach,
clinicians need to be aware of the range of available options,
their potential risks and benefits, and the clinical and pragmatic
considerations needed to choose between them.
If
an expert working group concludes that the current level of
evidence does not lend itself to the development of clinical
guidelines, then they will collate the data in the form of
a pragmatic report rather than clinical guidelines. The results
of all expert working groups should be an official publication.
EAPC
expert groups usually hold closed meetings but may start their
work during international or national conferences. Expert
group members may give presentations to an open audience and
then continue their work by corresponding with other members
and the RSC involved in the same project
ALL
EXPERT GROUPS MUST GUARANTEE THAT THE RESULTS OF THEIR WORK
AND PUBLICATIONS ARE UNDERTAKEN INDEPENDENTLY OF ANY COMMERCIAL
INTEREST OR INFLUENCE.
Prognostic
factors in advanced cancer patients
Download
pdf file of poster
BACKGROUND
The use of well identified prognostic factors (PFs) could allow
for most appropriate intervention to the patient, avoiding the
risks of over and under-treatment, as regards both therapeutic
aspects and planning of care (ie, timing of palliative care
program referral) (1). Moreover, knowledge of PFs can allow
to advise the family and to accompany it in the difficult task
of accepting the course of the disease.
On the other hand, it must be remembered that prognostic information
has only a probabilistic value and great caution has to be used
in every single case (2). Moreover, patients must be protected
by the temptation of health managers of using prognostic capacity
not in avoiding futile therapies, but in denying appropriate
therapies (“the cheapest patient, is the dead patient”).
OPEN
QUESTIONS
Some
open questions about prognostication deserved to be focused
and discussed by an EAPC expert group, to examine them closely
and get a consensus to be spread and published.
First, it remains to be evaluated the real prognostic power
of Clinical Prediction of Survival: some Authors report a
low correlation with Actual Survival with an excess of optimistic
previsions (3,4), while others have shown a low percentage
of errors and a good balance between overoptimistic and over-pessimistic
errors (5).
Second, there is not consensus about which clinical, laboratory,
and socio-demographic PFs can be considered “evidence
based”, and which have less convincing proofs of prognostic
capacity (6). In particular, the role of Prognostic Scores
has to be clarified, since in recent times we have assisted
to an uncontrolled proliferation of scores built with methodologically
doubtful procedures.
In fact, the third point to be faced is that many shortcomings
have been described in the studies reviewing the methodology
issues of published papers on PFs. In particular, lack of
a well-identified “inception cohort” and of a
Palliative Care Unit case-mix classification have been claimed
(3).
Forth, difficulties in expressing and communicating prognosis
seem to prevent from utilizing it in an appropriate way. What
to do with patients that do not want to know, and how to help
them to take part in clinical decision-making are just two
of the emerging problems in this field (7,8).
WORKSHOP
For
the mentioned reasons, the Steering Committee of the Research
Network of the EAPC a working group on PFs in advanced cancer
patients, convened in a workshop in Courmayeur, Italy on February
2004, with the aim of identifying which topics have a sufficient
level of evidence and which deserve more quantitative or qualitative
research.In particular, the role of Prognostic Scores was
to be clarified. Ethic implications and appropriate use of
PFs hold a special interest.
The workshop results should also suggest researchers a minimum
standard of methodologic requirements, to reduce the number
of studies not easily interpreteable or difficult to compare,
in particular as far as population of interest is concerned.
Working group
Participants
Chairman: Marco Maltoni, Forlì, Italy
Co-Chair: Augusto Caraceni, Milano, Italy
Members: Bert Broeckaert,
Leuven, Belgium; Nicholas Christakis, Chicago, USA;
Maria Nabal, Valencia, Spain;
Antonio Viganò, Edmonton, Canada; Paul
Glare, Sidney, Australia; Cinzia Brunelli, Milano,
Italy; Stephen Eychmuller, StGallen, Switzerland;
External
Reviewers: Franco
De Conno, Milano, Italy; Geoffrey
Hanks, Bristol, UK;
Stein Kaasa, Trondheim, Norway;
METHODS
The working group followed the SIGN (Scottish Intercollegiate
Guideline Network) method for developing clinical practice
guidelines and the Centre for Evidence Based Medicine , Oxford
Grading system following this scheme:
1. Identification of key points
The core recommendations closely reflects the main key points
emerging from the group discussion
2.
Systematic literature search
| Limits: human studies and English language |
| #1 STRATEGY FOR SEARCHING PAPERS ON ADVANCED CANCER PATIENTS: |
| (Neoplasms (MesH term all subheadings)
OR cancer (tw) OR tumor
(tw) OR tumour(tw)
OR oncolog*(tw)) AND (terminal care(MesH
term all subheadings) OR terminally ill (MesH term all subheadings)OR palliative care(MesH term all subheadings
OR hospices (MesH term all subheadings) |
| #2 STRATEGY FOR SEARCHING PAPERS ON PROGNOSIS (FROM ALTMAN 2001 |
| incidence (MesH
term) OR mortality (MesH term
all subheadings) OR follow-up studies (MesH
term) OR mortality (subheading) OR prognos* (tw) OR predict (tw) OR course (tw) |
| #3 ONE OF THE FOLLOWING STRATEGIES
FOR SEARCHING PAPERS ON SPECIFIC TOPIC: |
| BIOLOGICAL FACTORS |
| SYMPTOMS AND CLINICAL AND PSYCHOSOCIAL VARIABLES |
| CLINICAL PREDICTION |
| PROGNOSTIC SCORES |
| #1 AND #2 AND #3 . |
3.
Assigning the level of evidence
Studies selected after the systematic literature search were
evaluated for quality and type in order tobe classified according
to the following grid (Table see pdf file)
4.
Formulating the recommendations and assigning strength
The
grading system proposed below is based on the SIGN grading
system, modified to adapt for prognostic factors studies
| 1a+ |
Impact
studies |
| 1b+ |
High
quality meta analyses, systematic reviews or confirmatory
studies with a very low risk of bias |
| 1b - |
Meta analyses, systematic reviews or
confirmatory studies with a high risk of bias |
| 2+ |
Exploratory
studies with a very low risk of bias |
| 2 - |
Exploratory
studies with a very high risk of bias |
| 3+ |
Investigative
studies with a very low risk of bias |
| 3- |
Investigative
studies with a very high risk of bias |
4 |
Non-analytic
studies, e.g. case reports, case series |
| 5 |
Expert
opinion |
PRELIMINARY
CORE RECOMMENDATIONS
- An
accurate prognostication of life expectancy in patients
is useful from a clinical and organizational point of view.
-
Clinicians should continue to use prediction of survival
based on their clinical judgement ONLY WHILE considering
that a number of factors* limit its accuracy
a.
CPS are more than twice as likely to be overoptimistic
than overpessimistic
b. CPS is subject to an horizon effect
c. Lack of Experience in oncology and palliative care
reduces accuracy therefore a second opinion by a more
experienced professional can be useful
d. Clinicians should consider using CPS in combination
with other prognostic factor to improve the accuracy of
their predictions
-
Clinicians
can use a number of clinical signs and symptoms showed
associated with life expectancy in this patients population
such as:
a. Anorexia, weight loss, troubled swallowing or dysphagia
b. Dyspnea
c. Delirium
-
Clinicians can use some laboratory variables associated
with life expectancy in this patients population, which
give additional prognostic information independently from
clinical prediction of survival, performance status and
some clinical signs and symptoms.
a. Low Vitamin B12
b. HighC reactive eprotein
c. High Bilirubin
d. Leucocytosis
e. Lymphocytopenia
f. Low pseudocholinesterase
-
Clinicians can use prognostic scores to improve their
ability to prognosticate life expectancy in the terminally
ill with cancer
-
Clinicians can assume that prognostication of life expectancy
in advanced cancer is feasible at least in probabilistic
terms, excessive negativism in this area of prognostication
is not warranted on the basis of the available evidences
REFERENCES
- Christakis
NA: Death Foretold: Prophecy and Prognosis and Medical Care.
Chicago, University of Chicago Press, 1999
- Selawry
OS: The individual and the median. In: Stoll BA, (ed). Mind
and Cancer Prognosis, Chichester: Wiley, 39-43, 1979
-
Viganò A, Dorgan M, Buckinham J, et al: Survival
prediction in terminal cancer patients: a systematic review
of the medical literature. Palliat Med 14 (5): 363-374,
2000
-
Christakis NA, Lamont EB: Extent and determinants of error
in doctors’ prognoses in terminally ill patients:
prospective cohort study. Br Med J 320 (7233): 469-472,
2000
-
Maltoni M, Nanni O, Derni S, et al: Clinical prediction
of survival is more accurate than the Karnofsky Performance
Status in estimating life span of terminally-ill cancer
patients. Eur J Cancer 30A (6): 764-766, 1994
-
Maltoni M, Amadori D: Prognosis in advanced cancer. Hematol
Oncol Clin N Am 16: 715-729, 2002
-
SUPPORT Principal Investigators: A controlled trial to improve
care for seriously ill hospitalized patients. The Study
to Understand Prognoses and Preferences for Outcomes and
Risks of Treatment. JAMA 274 (20): 1591-1598, 1995
-
The AM, Hak T, Koeter G, et al: Collusion in doctor-patient
communication about imminent death: an ethnographic study.
Br Med J 321 (7273): 1376-1381, 2000
Fatigue in palliative care patients
Chair: Lukas Radbruch, Florian
Strasser.
Fatigue is frequently reported
by cancer patients, as well as by other patients receiving palliative
care. Fatigue after chemotherapy or radiotherapy may severely
impair the quality of life of palliative care patients, as well
as that of long-term survivors. However, fatigue is a multidimensional
construct and may not be used with the same meaning by physicians,
palliative care staff and patients.
The term ‘fatigue’ is not available in some European
languages, such as German, and can be used with different meanings
in others. Research has correlated a number of factors, such
as anaemia or cytokine levels, with the intensity of fatigue
assessed by the patient. However, it is not yet clear whether
subtypes of fatigue with different aetiologies can be distinguished,
or to what extent multiple aetiologies may add to the patient’s
subjective feeling of fatigue.
With increasing focus on fatigue, differing treatment options
have been proposed, including drugs, such as methylphenidate
or modafinil, physical and psychological therapies. However,
little data from clinical trials have been published and there
are no standards for treatment available. The time has now come
to gather evidence and expertise and to agree on a pragmatic
treatment approach for clinical practice. The RSC has decided
to organise an expert working group on fatigue. This group consisting
of invited experts and of participating RSC members, has met
for a workshop in Aachen, Germany, from 28 to 30 November 2003.
A manuscript is in preparation.
Sedation in palliative care
First meeting: 1–2 October 2000, St Raphael,
France
Chair:
Philippe Poulain, Silvain Pourchet.
Experts: Nessa Coyle, Carl Johan Fürst, Stein Kaasa,
Lars Johan Materstvedt, Nicole Silvestre, Vittorio Ventafridda,
Raymond Voltz, Joseph Porta I Sales.
Participating RSC members: Franco De Conno, Augusto Caraceni,
Jose Antionio Ferraz Goncalves, Geoffrey Hanks, Sebastiano
Mercadante, Lukas Radbruch, Carla Ripamonti, Huda Huyer Abu–Saad.
Subjects
debated:
- Needs
and limits of sedation in palliative care
- Sedation
– techniques and drugs
- Italian
experience with sedation in palliative care
- Norway:
'100 hundred death analysed'
- Psychological
impact of sedation in patients and their family
- Environmental
care of patients family under sedation
- Sedation
and euthanasia, two words, two concepts, only one result
- The
morality of terminal sedation and its relationship with
euthanasia. The philosopher point of view
- Sedation
and emergencies in palliative care
- Survey
about sedation, experience of Catalonia.
Philippe
Poulain presented the concept for the work of the group for
discussion to the participants of the 1st R&D Congress
in Berlin 7–9 December 2000. He reported about the input
of this discussion to the RSC in thair meeting on 10 December.
The very lively debate in the session on sedation in the Congress
showed important differences in the need for clarification
on this topic between the United States and Europe with different
problems to face. Europe may need to discuss more about concepts.
Philippe Poulain will circulate with the first draft of the
paper an abstract about the session on sedation in the Berlin
Conference to the RSC and the experts.
The
subject was again debated during the Palermo Congress and
the paper was reviewed and completed following the comments
collected. The second version has been agreed among the experts
and has been circulated to the and the RSC members. Once it
is agreed by the RSC, Philippe Poulain intends to submit it
for comments to the ethics task force.
Psychosocial
research July 1999, London
The
RSC recognises the need to develop research in psychosocial
issues in palliative care and will be giving thought to how
this should progress.
In preparation for a fuller discussion, an expert group met
in London in July 1999. The group included some of the most
active researchers in psychosocial issues and comprised Julia
Addington–Hall, Sheila Payne, Frances Sheldon, Barbara
Monroe, Marilyn Relf and David Oliviere (Chair). The group
identified possible areas for research which include:
- What
is psychosocial care and which professions are involved
- Minimum
standards for family assessment
- Social
deprivation and place of death
- Social
exclusion
- Single
person households
- The
bereavement care of children
- Complementary
therapies
- Volunteers
- The
needs of family carers
- Gender
and palliative care
- Cultural
aspects of pain
- Life
review.
Other
groups were identified for possible collaboration and funding.
We
are at an early stage of developing 'psychosocial palliative
care research' therefore:
- The
RSC should consider at their next meetings some priority
areas and identify some goals
- The
RSC should try to encourage an expert working group, with
European representation, at the next conference where members
can make proposals to the Scientific Committee
- All
colleagues working in the field should actively participate
and make comments and recommendations.
David
Oliviere & Frances Sheldon
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