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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: |
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(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)
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| #2 STRATEGY FOR SEARCHING PAPERS ON PROGNOSIS (FROM ALTMAN 2001 |
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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)
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| #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
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1a+
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Impact studies
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1b+
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High quality meta analyses, systematic reviews or confirmatory studies with a very low risk of bias
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1b -
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Meta analyses, systematic reviews or confirmatory studies with a high risk of bias
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2+
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Exploratory studies with a very low risk of bias
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2 -
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Exploratory studies with a very high risk of bias
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3+
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Investigative studies with a very low risk of bias
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3-
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Investigative studies with a very high risk of bias
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4
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Non-analytic studies, e.g. case reports, case series
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5
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Expert opinion
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PRELIMINARY CORE RECOMMENDATIONS
- An accurate prognostication of life expectancy in patients is useful from a clinical and organizational point of view.
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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
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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
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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
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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: 12 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 AbuSaad.
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 79 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 AddingtonHall, 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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