Palliative sedation - revised recommendations.

Palliative sedation is defined as the monitored use of medications intended to induce a state of decreased or absent awareness (unconsciousness) to relieve the burden of otherwise intractable suffering in a manner ethically acceptable to the patient, their family, and healthcare providers. In Switzerland, the prevalence of continuous deep sedation until death increased from 4.7% in 2001 to 17.5% of all deceased in 2013, depending on the research method used and on regional variations. Yet, these numbers may be overestimated due to a lack of understanding of the term "continuous deep sedation" by for example respondents of the questionnaire-based study. Inadequately trained and inexperienced healthcare professionals may incorrectly or inappropriately perform palliative sedation due to uncertainties regarding its definitions and practice. Therefore, the expert members of the Bigorio group and the authors of this manuscript believe that national recommendations should be published and made available to healthcare professionals to provide practical, terminological, and ethical guidance. The Bigorio group is the working group of the Swiss Palliative Care Society whose task is to publish clinical recommendations at a national level in Switzerland. These recommendations aim to provide guidance on the most critical questions and issues related to palliative sedation. The Swiss Society of Palliative Care (palliative.ch) mandated a writing board comprising four clinical experts (three physicians and one ethicist) and two national academic experts to revise the 2005 Bigorio guidelines. A first draft was created based on a narrative literature review, which was internally reviewed by five academic institutions (Lausanne, Geneva, Bern, Zürich, and Basel) and the heads of all working groups of the Swiss Society of Palliative Care before finalising the guidelines. The following themes are discussed regarding palliative sedation: (a) definitions and clinical aspects, (b) the decision-making process, (c) communication with patients and families, (d) patient monitoring, (e) pharmacological approaches, and (f) ethical and controversial issues. Palliative sedation must be practised with clinical and ethical accuracy and competence to avoid harm and ethically questionable use. Specialist palliative care teams should be consulted before initiating palliative sedation to avoid overlooking other potential treatment options for the patient's symptoms and suffering.

IDentification of patients in need of general and specialised PALLiative care (ID-PALL©): item generation, content and face validity of a new interprofessional screening instrument.

BACKGROUND: Early identification of patients requiring palliative care is a major public health concern. A growing number of instruments exist to help professionals to identify these patients, however, thus far, none have been thoroughly assessed for criterion validity. In addition, no currently available instruments differentiate between patients in need of general vs. specialised palliative care, and most are primarily intended for use by physicians. This study aims to develop and rigorously validate a new interprofessional instrument allowing identification of patients in need of general vs specialised palliative care. METHODS: The instrument development involved four steps: i) literature review to determine the concept to measure; ii) generation of a set of items; iii) review of the initial set of items by experts to establish the content validity; iv) administration of the items to a sample of the target population to establish face validity. We conducted a Delphi process with experts in palliative care to accomplish step 3 and sent a questionnaire to nurses and physicians non-specialised in palliative care to complete step 4. The study was conducted in the French and Italian-speaking regions of Switzerland. An interdisciplinary committee of clinical experts supervised all steps. RESULTS: The literature review confirmed the necessity of distinguishing between general and specialised palliative care needs and of adapting clinical recommendations to these different needs. Thirty-six nurses and physicians participated in the Delphi process and 28 were involved in the face validity assessment. The Delphi process resulted in two lists: a 7-item list to identify patients in need of general PC and an 8-item list to identify specialised PC needs. The content and face validity were deemed to be acceptable by both the expert and target populations. CONCLUSION: This instrument makes a significant contribution to the identification of patients with palliative care needs as it has been designed to differentiate between general and specialised palliative care needs. Moreover, diagnostic data is not fundamental to the use of the instrument, thus facilitating its use by healthcare professionals other than physicians, in particular nurses. Internal and criterion validity assessments are ongoing and essential before wider dissemination of the instrument.

Validation of the French Version of the Edmonton Symptom Assessment System.

CONTEXT: The Edmonton Symptom Assessment System (ESAS) is a brief, widely adopted, multidimensional questionnaire to evaluate patient-reported symptoms. OBJECTIVES: The objective of this study was to define a standard French version of the ESAS (F-ESAS) to determine the psychometric properties in French-speaking patients. METHODS: In a first pilot study, health professionals (n = 20) and patients (n = 33) defined the most adapted terms in French (F-ESAS). In a prospective multicentric study, palliative care patients completed the three forms of F-ESAS (F-ESAS-VI, F-ESAS-VE, and F-ESAS-NU, where VI is visual, VE, verbal, and NU, numerical), the Hospital Anxiety and Depression Scale. All patients had a test-retest evaluation during the same half-day. Standardized distraction material was used between each scale. RESULTS: One hundred twenty-four patients were included (mean age [±SD]: 68.3 ± 12; 70 women; 54 men). Test-retest reliability was high for all three F-ESAS, and the correlation between these scales was nearly perfect (Spearman rs = 0.66-0.91; P < 0.05). F-ESAS-VI, F-ESAS-VE, and F-ESAS-NU performed similarly and were equally reliable, although there was a trend toward lower reliability for F-ESAS-VI. Correlation between F-ESAS depression and anxiety and HADS depression and anxiety, respectively, were positive (Spearman rs = 0.38-0.41 for depression; Spearman rs = 0.48-0.57 for anxiety, P < 0.05). Among patients, 59 (48%), 45 (36%), and 20 (16%) preferred to assess their symptoms with F-ESAS-VE, F-ESAS-NU, and F-ESAS-VI, respectively. CONCLUSION: The F-ESAS is a valid and reliable tool for measuring multidimensional symptoms in French-speaking patients with an advanced cancer. All forms of F-ESAS performed well with a trend for better psychometric performance for F-ESAS-NU, but patients preferred the F-ESAS-VE.

Attitudes Regarding Palliative Sedation and Death Hastening Among Swiss Physicians: A Contextually Sensitive Approach.

In Switzerland, where assisted suicide but not euthanasia is permitted, the authors sought to understand how physicians integrate palliative sedation in their practice and how they reflect on existential suffering and death hastening. They interviewed 31 physicians from different care settings. Five major attitudes emerged. Among specialized palliative care physicians, convinced, cautious and doubtful attitudes were evident. Within unspecialized settings, palliative sedation was more likely to be considered as death hastening: clinicians either avoid it with an inexperienced attitude or practice it with an ambiguous attitude, raising the issue of unskilled and abusive uses of sedatives at the end of life.

The use of palliative sedation: A comparison of attitudes of French-speaking physicians from Quebec and Switzerland.

OBJECTIVE: Previous literature has suggested that laws and regulations may impact the use of palliative sedation. Our present study compares the attitudes of French-speaking physicians practicing in the Quebec and Swiss environments, where different laws are in place regarding physician-assisted suicide. METHOD: Data were drawn from two prior studies, one by Blondeau and colleagues and another by Beauverd and coworkers, employing the same two-by-two experimental design with length of prognosis and type of suffering as independent variables. Both the effect of these variables and the effect of their interaction on Swiss and Quebec physicians' attitudes toward sedation were compared. The written comments of respondents were submitted to a qualitative content analysis and summarized in a comparative perspective. RESULTS: The analysis of variance showed that only the type of suffering had an effect on physicians' attitudes toward sedation. The results of the Wilcoxon test indicated that the attitudes of physicians from Quebec and Switzerland tended to be different for two vignettes: long-term prognosis with existential suffering (p = 0.0577) and short-term prognosis with physical suffering (p = 0.0914). In both cases, the Swiss physicians were less prone to palliative sedation. SIGNIFICANCE OF RESULTS: The attitudes of physicians from Quebec and Switzerland toward palliative sedation, particularly regarding prognosis and type of suffering, seem similar. However, the results suggest that physicians from Quebec could be slightly more open to palliative sedation, even though most were not in favor of this practice as an answer to end-of-life existential suffering.

Recombinant human insulin-like growth factor I (rhIGF-I) for the treatment of amyotrophic lateral sclerosis/motor neuron disease.

BACKGROUND: Recombinant human insulin-like growth factor I (rhIGF-I) is a possible disease modifying therapy for amyotrophic lateral sclerosis (ALS, which is also known as motor neuron disease (MND)). OBJECTIVES: To examine the efficacy of rhIGF-I in affecting disease progression, impact on measures of functional health status, prolonging survival and delaying the use of surrogates (tracheostomy and mechanical ventilation) to sustain survival in ALS. Occurrence of adverse events was also reviewed. SEARCH METHODS: We searched the Cochrane Neuromuscular Disease Group Specialized Register (21 November 2011), CENTRAL (2011, Issue 4), MEDLINE (January 1966 to November 2011) and EMBASE (January 1980 to November 2011) and sought information from the authors of randomised clinical trials and manufacturers of rhIGF-I. SELECTION CRITERIA: We considered all randomised controlled clinical trials involving rhIGF-I treatment of adults with definite or probable ALS according to the El Escorial Criteria. The primary outcome measure was change in Appel Amyotrophic Lateral Sclerosis Rating Scale (AALSRS) total score after nine months of treatment and secondary outcome measures were change in AALSRS at 1, 2, 3, 4, 5, 6, 7, 8, 9 months, change in quality of life (Sickness Impact Profile scale), survival and adverse events. DATA COLLECTION AND ANALYSIS: Each author independently graded the risk of bias in the included studies. The lead author extracted data and the other authors checked them. We generated some missing data by making ruler measurements of data in published graphs. We collected data about adverse events from the included trials. MAIN RESULTS: We identified three randomised controlled trials (RCTs) of rhIGF-I, involving 779 participants, for inclusion in the analysis. In a European trial (183 participants) the mean difference (MD) in change in AALSRS total score after nine months was -3.30 (95% confidence interval (CI) -8.68 to 2.08). In a North American trial (266 participants), the MD after nine months was -6.00 (95% CI -10.99 to -1.01). The combined analysis from both RCTs showed a MD after nine months of -4.75 (95% CI -8.41 to -1.09), a significant difference in favour of the treated group. The secondary outcome measures showed non-significant trends favouring rhIGF-I. There was an increased risk of injection site reactions with rhIGF-I (risk ratio 1.26, 95% CI 1.04 to 1.54). . A second North American trial (330 participants) used a novel primary end point involving manual muscle strength testing. No differences were demonstrated between the treated and placebo groups in this study. All three trials were at high risk of bias. AUTHORS' CONCLUSIONS: Meta-analysis revealed a significant difference in favour of rhIGF-I treatment; however, the quality of the evidence from the two included trials was low. A third study showed no difference between treatment and placebo. There is no evidence for increase in survival with IGF1. All three included trials were at high risk of bias.

Description of a Tertiary Swiss University Hospital palliative population based on the International Classification of Disease (ICD): a retrospective pilot study.

BACKGROUND: The factors for assessing the utilization rate of a palliative care service are various and complex. Several authors have described different methods to address this problem. McNamara and colleagues have proposed criteria to determine "minimal," "mid-range," and "maximal" palliative population estimates. In order to evaluate the utilization of our intrahospital palliative care consult team (PCT), it appeared necessary to better describe and define the population who dies in our institution, a Swiss university hospital. The goal of this pilot study was to determine what percentage of patients who died in our hospital over a 4-month period in 2007 was seen by the palliative care consult team (PCT), using "minimal" and "maximal" population estimates. METHODS: The hospital database was searched for all adult patients who died during that period and the "maximal" and "minimal" populations determined. The PCT's database was searched to identify those patients who had been seen by the PCT. The charts of a random sample of patients who did not initially meet the "minimal" criteria were hand searched. RESULTS: A total of 294 adult deaths were reported: 263 (89%) met the "maximal" criteria and 83 (28%) met the "minimal" criteria initially. The random search of 56 charts of the 180 patients who did not meet the "minimal" criteria revealed that 21 (38%) should have been included in the "minimal" population. The PCT saw 67/263 (25.5%) of the "maximal" palliative patient population and 56/151 (37.1%) of the "minimal" palliative population. CONCLUSION: This study highlights the usefulness of the method proposed by McNamara and colleagues to determine palliative populations. However, it also illustrates an important limitation of the "minimal" estimate and reliance on the accuracy of the cause of death as noted on the death certificate. A strategy to address this limitation is suggested. The "maximal" estimate suggests that the PCT is being underutilized.

[Evidence-based medicine and palliative medicine]. / Evidence-based medicine et médecine palliative.

Efficacy of treatments used in patients at the end-of-life must be evaluated according to ethical issues and specificities of the palliative population, i.e.: major vulnerability, difficulties to obtain informed consent, fragility of balance between research and clinical role, problems to evaluate risks and benefits of palliative care research. Improvements in the use of opioids have come from clinical research. Treatment of delirium has improved thanks to clinical trials conducted in cancer and AIDS patients. Emerging themes in palliative medicine now come with alleviating moral distress and utility of psychotherapeutic approach as well as the place of spirituality measured through quality-of-life evaluation.

[Clinical and practical aspects of palliative sedation]. / Sédation palliative: aspects cliniques pratiques.

Patients at the end-of-life may present with refractory symptoms which cannot be adequately relieved despite the use of all traditional means. When refractory symptoms lead to intolerable suffering, palliative sedation is a last recourse temporary or definitive treatment. While discussing ethical issues, clinical practice dimensions of palliative sedation are explored in this article.