Report on palliative sedation medication usage: a survey of palliative care experts in Eight European countries.

BACKGROUND: The practice of palliative sedation continues to raise ethical questions among people, which in turn leads to its varied acceptance and practice across regions. As part of the Palliative Sedation European Union (EU) project, the aim of the present study was to determine the perceptions of palliative care experts regarding the practice of palliative sedation in eight European countries (The Netherlands, Belgium, Germany, UK, Italy, Spain, Hungary, and Romania). METHODS: A specifically designed survey, including questions on the most frequently used medications for palliative sedation, their availability per countries and settings, and the barriers and facilitators to the appropriate practice of palliative sedation was sent to expert clinicians involved and knowledgeable in palliative care in the indicated countries. A purposive sampling strategy was used to select at least 18 participating clinicians per consortium country. Descriptive statistical analysis was conducted on the survey data. RESULTS: Of the 208 expert clinicians invited to participate, 124 participants completed the survey. Midazolam was perceived to be the most frequently used benzodiazepine in all eight countries. 86% and 89% of expert clinicians in Germany and Italy, respectively, perceived midazolam was used "almost always", while in Hungary and Romania only about 50% or less of the respondents perceived this. Levomepromazine was the neuroleptic most frequently perceived to be used for palliative sedation in the Netherlands, Spain, Germany, and the United Kingdom. Between 38- 86% of all eight countries´ expert clinicians believed that opioid medications were "almost always" used during palliative sedation. The perceived use of IV hydration and artificial nutrition "almost always" was generally low, while the country where both IV hydration and artificial nutrition were considered to be "very often" given by a third of the expert clinicians, was in Hungary, with 36% and 27%, respectively. CONCLUSIONS: Our study provides insight about the differences in the perceived practice of medication during palliative sedation between eight European countries. In countries where palliative care services have been established longer perceptions regarding medication use during palliative sedation were more in line with the recommended European guidelines than in Central and Eastern European countries like Romania and Hungary.

Monitoring the clinical practice of palliative sedation (PALSED) in patients with advanced cancer: an international, multicentre, non-experimental prospective observational study protocol.

BACKGROUND: Palliative sedation involves the intentional lowering of consciousness at the end of life. It can be initiated to relieve a patient's burden caused by refractory symptoms at the end of life. The impact of palliative sedation needs to be clinically monitored to adjust the proper dose and regimen of sedative medication to ensure that patients are at ease and comfortable at the end of their lives. Although there is consensus among health care professionals and within guidelines that efficacy of palliative sedation needs to be closely monitored, there is no agreement about how, when, and by whom, this monitoring should be performed. The aim of this study is to evaluate the effects of palliative sedation by measuring the discomfort levels and sedation/agitation levels of the patients at regular timepoints. In addition, the clinical trajectories of those patients receiving palliative sedation will be monitored and recorded. METHODS: The study is an international prospective non-experimental observational multicentre study. Patients are recruited from in-patient palliative care settings in Belgium, Germany, Italy, Spain and the Netherlands. Adult patients with advanced cancer are monitored by using proxy observations of discomfort (DS-DAT) and depth of sedation/agitation levels (RASS-PAL) during palliative sedation. After the palliative sedation period, the care for the specific participant case is evaluated by one of the attending health care professionals and one relative via a questionnaire. DISCUSSION: This study will be the first international prospective multicenter study evaluating the clinical practice of palliative sedation including observations of discomfort levels and levels of sedation. It will provide valuable information about the practice of palliative sedation in European countries in terminally ill cancer patients. Results from this study will facilitate the formulation of recommendations for clinical practice on how to improve monitoring and comfort in patients receiving palliative sedation. TRIAL REGISTRATION: This study is registered at Clinicaltrials.gov since January 22, 2021, registration number: NCT04719702.

Review of European Guidelines on Palliative Sedation: A Foundation for the Updating of the European Association for Palliative Care Framework.

In 2009, the European Association for Palliative Care (EAPC) developed a framework on palliative sedation, acknowledging this practice as an important and ethically acceptable intervention of last resort for terminally ill patients experiencing refractory symptoms. Before and after that, other guidelines on palliative sedation have been developed in Europe with variations in terminology and concepts. As part of the Palliative Sedation project (Horizon 2020 Funding No. 825700), a revision of the EAPC framework is planned. The aim of this article is to analyze the most frequently used palliative sedation guidelines as reported by experts from eight European countries to inform the discussion of the new framework. The three most reported documents per country were identified through an online survey among 124 clinical experts in December 2019. Those meeting guideline criteria were selected. Their content was assessed against the EAPC framework on palliative sedation. The quality of their methodology was evaluated with the Appraisal Guideline Research and Evaluation (AGREE) II instrument. Nine guidelines were included. All recognize palliative sedation as a last-resort treatment for refractory symptoms, but the criterion of refractoriness remains a matter of debate. Most guidelines recognize psychological or existential distress as (part of) an indication and some make specific recommendations for such cases. All agree that the assessment should be multiprofessional, but they diverge on the expertise required by the attending physician/team. Regarding decisions on hydration and nutrition, it is proposed that these should be independent of those for palliative sedation, but there is no clear consensus on the decision-making process. Several weaknesses were highlighted, particularly in areas of rigor of development and applicability. The identified points of debate and methodological weaknesses should be considered in any update or revision of the guidelines analyzed to improve the quality of their content and the applicability of their recommendations.

Added value of anti-SARS-CoV-2 antibody testing in a Flemish nursing home during an acute COVID-19 outbreak in April 2020.

OBJECTIVES: To examine the added value of anti-SARS-CoV-2 antibody testing in a nursing home during an acute COVID-19 outbreak. RT-PCR is the gold standard, but can be false-negative. METHODS: 119 residents and 93 staff members were tested with RT-PCR test and/or a rapid IgM/IgG test. Of these participants, 176 had both tests, 24 only RT-PCR, and 12 only IgM/IgG in the period April 14 to 16 April 2020. RESULTS: 40 (34%) residents and 11 (13%) staff were PCR-positive. Using a rapid IgM/IgG test, 17 (17%) residents and 18 (20%) staff were positive for IgM and/or IgG (IgM/IgG). Thirty-two PCR-positive residents had an IgM/IgG test: 9 (28%), 11 (34%), and 13 (41%) were positive for IgM, IgG, and IgM/IgG. Ten PCR-positive staff had an IgM/IgG test: 3 (30%), 6 (60%), and 6 (60%) were positive for IgM, IgG, and IgM/IgG. Additional IgM/IgG tests were performed in 9 residents 11 to 14 days after the positive RT-PCR test. Of those, 7 (78%) tested positive for IgM/IgG. When retested 3 weeks later, the 2 remaining residents also tested positive. Of the 134 PCR-negative participants who had an IgM/IgG test, 15 were positive for IgM/IgG (8% of the 200 participants tested with RT-PCR). CONCLUSIONS: During an acute outbreak in a nursing home, 26% of residents and staff were PCR-positive. An additional 8% was diagnosed using IgM/IgG antibody testing. The use of RT-PCR alone as the sole diagnostic method for surveillance during an acute outbreak is insufficient to grab the full extent of the outbreak.

A search for relevant contextual factors in intervention studies: a stepwise approach with online information.

OBJECTIVE: The aim of the present study is to describe a stepwise approach to study which contextual factors might moderate the effect of healthcare interventions and to test feasibility of this approach within the D-SCOPE project. DESIGN: Exploratory case study. SETTING: In the D-SCOPE project, a complex intervention by means of home visits was set up to improve access to tailored care in three municipalities (Ghent, Knokke-Heist and Tienen). METHODS: One designed and tested an approach including five steps: (1) a theoretical/conceptual discussion of relevant contextual factor domains was held; (2) a search was done to find appropriate web-based public datasets which covered these topics with standardised information; (3) a list of all identified contextual factors was made (inventory); (4) to reduce the long list of contextual factors, a concise list of most relevant contextual factors was developed based on the opinion of two independent reviewers and (5) a nominal grouping technique (NGT) was applied. RESULTS: Three public web-based datasets were found resulting in an inventory of 157 contextual factors. After the selection by two independent reviewers, 41 contextual factors were left over and presented in a NGT which selected 10 contextual factors. The NGT included seven researchers, all familiar with the D-SCOPE intervention, with various educational backgrounds and expertise and lasted approximately 1 hour. CONCLUSION: The present study shows that a five-step approach is feasible to determine relevant contextual factors that might affect the results of an intervention study. Such information may be used to correct for in the statistical analyses and for interpretation of the outcomes of intervention studies.NCT03168204.

The relation between age of retirement and frailty in later life? A cross-sectional study in Flemish older adults.

BACKGROUND: Policymakers in several European countries, concerned about the sustainability of their pension system, have raised the statutory retirement age. While several studies investigated the effect of retirement on health, the relationship between retirement and frailty is neglected. Notwithstanding, frailty is associated with adverse outcomes. OBJECTIVE: The aim of this study was to examine the relationship between age of retirement and frailty in later life. METHODS: Data of the Belgian Ageing Studies, a cross-sectional research project was used. The present study includes N=12659 participants (>60y) in 83 Flemish municipalities. To address reverse causality, only participants not retired because of health-related reasons were included. The Comprehensive Frailty Assessment Instrument, a multidimensional frailty scale with four domains (physical, psychological, social and environmental) was used to operationalize frailty. Univariate general linear regression analyses (GLM) were performed for scores on the total frailty scale and the four subdomains separately. The analysis was done for men and women separately, since both groups have different labor trajectories. RESULTS: The present study found a negative association between age of retirement and physical frailty for both men and women in later life, and total frailty for men, although the differences were small. No evidence was found for a relation between age of retirement and the other subdomains of frailty. CONCLUSIONS: The results suggest that age of retirement is not a clinically relevant predictor for frailty in later life. Differences within and between subpopulations (e.g., profession) can shed a new light on this relation.

Clinical Aspects of Palliative Sedation in Prospective Studies. A Systematic Review.

CONTEXT: Near the end of life when patients experience refractory symptoms, palliative sedation may be considered as a last treatment. Clinical guidelines have been developed, but they are mainly based on expert opinion or retrospective chart reviews. Therefore, evidence for the clinical aspects of palliative sedation is needed. OBJECTIVES: To explore clinical aspects of palliative sedation in recent prospective studies. METHODS: Systematic review was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and registered at PROSPERO. PubMed, CINAHL, Cochrane, MEDLINE, and EMBASE were searched (January 2014-December 2019), combining sedation, palliative care, and prospective. Article quality was assessed. RESULTS: Ten prospective articles were included, involving predominantly patients with cancer. Most frequently reported refractory symptoms were delirium (41%-83%), pain (25%-65%), and dyspnea (16%-59%). In some articles, psychological and existential distress were mentioned (16%-59%). Only a few articles specified the tools used to assess symptoms. Level of sedation assessment tools were the Richmond Agitation Sedation Scale, Ramsay Sedation Scale, Glasgow Coma Scale, and Bispectral Index monitoring. The palliative sedation practice shows an underlying need for proportionality in relation to symptom intensity. Midazolam was the main sedative used. Other reported medications were phenobarbital, promethazine, and anesthetic medication-propofol. The only study that reported level of patient's discomfort as a palliative sedation outcome showed a decrease in patient discomfort. CONCLUSION: Assessment of refractory symptoms should include physical evaluation with standardized tools applied and interviews for psychological and existential evaluation by expert clinicians working in teams. Future research needs to evaluate the effectiveness of palliative sedation for refractory symptom relief.

Validation of replacement questions for slowness and weakness to assess the Fried Phenotype: a cross-sectional study.

PURPOSE: When screening large populations, performance-based measures can be difficult to conduct because they are time consuming and costly, and require well-trained assessors. The aim of the present study is to validate a set of questions replacing the performance-based measures slowness and weakness as part of the Fried frailty phenotype (FRIED-P). METHODS: A cross-sectional study was conducted among community-dwelling older adults (≥ 60 years) in three Flemish municipalities. The Fried Phenotype (FRIED-P) was used to measure physical frailty. The two performance-based measures of the Fried Phenotype (slowness and weakness) were also measured by means of six substituting questions (FRIED-Q). These questions were validated through sensitivity, specificity, Cohen's kappa value, observed agreement, correlation analysis, and the area under the curve (AUC, ROC curve). RESULTS: 196 older adults participated. According to the FRIED-P, 19.5% of them were frail, 56.9% were pre-frail and 23.6% were non-frail. For slowness, the observed sensitivity was 47.0%, the specificity was 96.5% and the AUC was 0.717. For weakness, the sensitivity was 46.2%, the specificity was 83.7%, and the AUC was 0.649. The overall Spearman correlation between the FRIED-P and the FRIED-Q was r = 0.721 with an observed agreement of 76.6% (weighted linear kappa value = 0.663, quadratic kappa value = 0.738). CONCLUSIONS: The concordance between the FRIED-P and FRIED-Q was substantial, characterized by a very high specificity, but a moderate sensitivity. This alternative operationalization of the Fried Phenotype-i.e., including six replacement questions instead of two performance-based tests-can be considered to apply as screening tool to screen physical frailty in large populations.

Concordances and differences between a unidimensional and multidimensional assessment of frailty: a cross-sectional study.

BACKGROUND: Many instruments to identify frail older people have been developed. One of the consequences is that the prevalence rates of frailty vary widely dependent on the instrument selected. The aims of this study were 1) to examine the concordances and differences between a unidimensional and multidimensional assessment of frailty, 2) to assess to what extent the characteristics of a 'frail sample' differ depending on the selected frailty measurement because 'being frail' is used in many studies as an inclusion criterion. METHOD: A cross-sectional study was conducted among 196 community-dwelling older adults (≥60 years), which were selected from the census records. Unidimensional frailty was operationalized according to the Fried Phenotype (FP) and multidimensional frailty was measured with the Comprehensive Frailty Assessment Instrument (CFAI). The concordances and differences were examined by prevalence, correlations, observed agreement and Kappa values. Differences between sample characteristics (e.g., age, physical activity, life satisfaction) were investigated with ANOVA and Kruskall-Wallis test. RESULTS: The mean age was 72.74 (SD 8.04) and 48.98% was male. According to the FP 23.59% was not-frail, 56.92% pre-frail and 19.49% frail. According to the CFAI, 44.33% was no-to-low frail, 37.63% was mild frail and 18.04% was high frail. The correlation between FP and the CFAI was r = 0.46 and the observed agreement was 52.85%. The Kappa value was κ = 0.35 (quadratic κ = 0.45). In total, 11.92% of the participants were frail according to both measurements, 7.77% was solely frail according to the FP and 6.21% was solely frail according to the CFAI. The 'frail sample respondents' according to the FP had higher levels of life satisfaction and net income, but performed less physical activities in comparison to high frail people according to the CFAI. CONCLUSION: The present study shows that the FP and CFAI partly measure the same 'frailty-construct', although differences were found for instance in the prevalence of frailty and the composition of the 'frail participants'. Since 'being frail' is an inclusion criterion in many studies, researchers must be aware that the choice of the frailty measurement has an impact on both the estimates of frailty prevalence and the characteristics of the selected sample.

The Social Environment's Relationship With Frailty: Evidence From Existing Studies.

Increasingly, policymakers assume that informal networks will provide care for frail older people. While the literature has mainly discussed the role of the family, broader social networks are also considered to be important. However, these social networks can diminish in later life. This systematic review investigates whether the social environment increases the risk of frailty or helps to prevent it. Findings from 15 original studies were classified using five different factors, which denoted five dimensions of the social environment: (a) social networks, (b) social support, (c) social participation, (d) subjective neighborhood experience, and (e) socioeconomic neighborhood characteristics. The discussion highlights that the social environment and frailty are indeed related, and how the neighborhood dimensions and social participation had more consistent results than social support and social networks. Conclusively, recommendations are formulated to contemplate all dimensions of the social environment for further research examining frailty and community care.

Access to care of frail community-dwelling older adults in Belgium: a qualitative study.

AIM: This paper aims to identify barriers that frail community-dwelling older adults experience regarding access to formal care and support services. BACKGROUND: Universal access to healthcare has been set by the World Health Organisation (WHO) as a main goal for the post-2015 development agenda. Nevertheless, regarding access to care, particular attention has to be paid to the so-called vulnerable groups, such as (frail) older adults. METHODS: Both inductive and deductive content analyses were performed on 22 individual interviews with frail, community-dwelling older adults who indicated they lacked care and support. The coding scheme was generated from the conceptual framework '6A's of access to care and support' (referring to work of Penchansky and Thomas, 1981; Wyszewianski, 2002; Saurman, 2016) and applied on the transcripts. FINDINGS: Results indicate that (despite all policy measures) access to a broad spectrum of care and support services remains a challenge for older people in Belgium. The respondents' barriers concern: 'affordability' referring to a lot of Belgian older adults having limited pensions, 'accessibility' going beyond geographical accessibility but also concerning waiting lists, 'availability' referring to the lack of having someone around, 'adequacy' addressing the insufficiency of motivated staff, the absence of trust in care providers influencing 'acceptability', and 'awareness' referring to limited health literacy. The discussion develops the argument that in order to make care and support more accessible for people in order to be able to age in place, governments should take measures to overcome these access limitations (eg, by automatic entitlements) and should take into account a broad description of access. Also, a seventh barrier (a seventh A) within the results, namely 'ageism', was discovered.

Relational aspects of mastery for frail, older adults: The role of informal caregivers in the care process.

Frail, older care recipients are often thought of as individuals with a decreased mastery of everyday life skills. Various authors have proposed to acknowledge a relational dimension of mastery, defined as the ability to maintain control over one's life with the help of others. This study explores how frail, older adults experience relational aspects of mastery and the role of their informal caregivers in maintaining these aspects of mastery over the care process. Qualitative interviews (N = 121) were conducted in 2016 with potentially frail, community-dwelling older adults participating in the Detection, Support and Care for Older people: Prevention and Empowerment (D-SCOPE) project. A secondary analysis of 65 interviews reveals that, according to frail, older adults, informal caregivers contribute in various ways to the preservation of their mastery. This differs across the four elements of care: caring about (attentiveness), taking care of (responsibility), care-giving (competence), and care-receiving (responsiveness). However, in some cases, older adults experienced a loss of mastery; for example, when informal caregivers did not understand their care needs and did not involve them in the decision, organisation, and provision of care. A relational dimension of mastery needs to be acknowledged in frail, older care recipients since stimulating mastery is a crucial element for realising community care objectives and person-centred and integrated care.

Interventions for frail community-dwelling older adults have no significant effect on adverse outcomes: a systematic review and meta-analysis.

BACKGROUND: According to some studies, interventions can prevent or delay frailty, but their effect in preventing adverse outcomes in frail community-dwelling older people is unclear. The aim is to investigate the effect of an intervention on adverse outcomes in frail older adults. METHODS: A systematic review and meta-analysis of Medline, Embase, the Cochrane Library, and Social Sciences Citation Index. Randomized controlled studies that aimed to treat frail community-dwelling older adults, were included. The outcomes were mortality, hospitalization, formal health costs, accidental falls, and institutionalization. Several sub-analyses were performed (duration of intervention, average age, dimension, recruitment). RESULTS: Twenty-five articles (16 original studies) were included. Six types of interventions were found. The pooled odds ratios (OR) for mortality when allocated in the experimental group were 0.99 [95% CI: 0.79, 1.25] for case management and 0.78 [95% CI: 0.41, 1.45] for provision information intervention. For institutionalization, the pooled OR with case management was 0.92 [95% CI: 0.63, 1.32], and the pooled OR for information provision intervention was 1.53 [95% CI: 0.64, 3.65]. The pooled OR for hospitalization when allocated in the experimental group was 1.13 [95% CI: 0.95, 1.35] for case management. Further sub-analyses did not yield any significant findings. CONCLUSION: This systematic review and meta-analysis does not provide sufficient scientific evidence that interventions by frail older adults can be protective against the included adverse outcomes. A sub-analysis for some variables yielded no significant effects, although some findings suggested a decrease in adverse outcomes. TRIAL REGISTRATION: Prospero registration CRD42016035429 .

Randomized controlled trial to evaluate a prevention program for frail community-dwelling older adults: a D-SCOPE protocol.

BACKGROUND: Frail community-dwelling older adults, whom might experience problems regarding physical, cognitive, psychological, social and environmental factors, are at risk for adverse outcomes such as disability, institutionalization and mortality. People in need of help do not always find their way to care and support services and are left undetected. The aim of the D-SCOPE project is to detect frail community-dwelling older adults who previously went unnoticed and to improve their access to care and support. Goal is to increase their frailty-balance, quality of life, meaning in life, life satisfaction, mastery, community inclusion and ageing well in place. METHODS/DESIGN: The study is a prospective, longitudinal randomized four-armed controlled trial with follow-up at 6 months. The study group aims to include 900 community-dwelling older adults aged 60 years and over from 3 municipalities in Flanders (Belgium). While selecting the study group, risk profiles for frailty will be taken into account. Participants will be randomly selected from the census records in each municipality. Data will be collected prospectively at baseline (T0) and at follow-up, 6 months after baseline (T1). At baseline, participants who are at least mild frail on one of the 5 domains of frailty (CFAI-plus) or feel frail based on the subjective assessment of frailty will be randomly assigned to (1) the study group or (2) the control group. A mixed method design with the inclusion of quantitative and qualitative data analyses will be used to evaluate the efficacy and experiences of the detection and prevention program on frailty. DISCUSSION: The study will contribute to an innovative vision concerning the organization of care and support, and a timely and accurate detection and support of community-dwelling older adults at risk for frailty. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov, on May 26, 2017, identifier: NCT03168204 .

Detecting frail, older adults and identifying their strengths: results of a mixed-methods study.

BACKGROUND: The debate on frailty in later life focuses primarily on deficits and their associations with adverse (health) outcomes. In addition to deficits, it may also be important to consider the abilities and resources of older adults. This study was designed to gain insights into the lived experiences of frailty among older adults to determine which strengths can balance the deficits that affect frailty. METHODS: Data from 121 potentially frail community-dwelling older adults in Flemish-speaking Region of Belgium and Brussels were collected using a mixed-methods approach. Quantitative data were collected using the Comprehensive Frailty Assessment Instrument (CFAI), Montreal Cognitive Assessment (MoCA), and numeric rating scales (NRS) for quality of life (QoL), care and support, meaning in life, and mastery. Bivariate analyses, paired samples t-tests and means were performed. Qualitative data on experiences of frailty, frailty balance, QoL, care and support, meaning in life, and mastery were collected using semi-structured interviews. Interviews were subjected to thematic content analysis. RESULTS: The "no to mild frailty" group had higher QoL, care and support, meaning in life, and mastery scores than the "severe frailty" group. Nevertheless, qualitative results indicate that, despite being classified as frail, many older adults experienced high levels of QoL, care and support, meaning in life, and mastery. Respondents mentioned multiple balancing factors for frailty, comprising individual-level circumstances (e.g., personality traits, coping strategies, resilience), environmental influences (e.g., caregivers, neighborhood, social participation), and macro-level features (e.g., health literacy, adequate financial compensation). Respondents also highlighted that life changes affected their frailty balance, including changes in health, finances, personal relationships, and living situation. CONCLUSION: The findings indicate that frailty among older individuals can be considered as a dynamic state and, regardless of frailty, balancing factors are important in maintaining a good QoL. The study investigated not only the deficits, but also the abilities, and resources of frail, older adults. Public policymakers and healthcare organizations are encouraged to include these abilities, supplementary or even complementary to the usual focus on deficits.

Identifying frailty risk profiles of home-dwelling older people: focus on sociodemographic and socioeconomic characteristics.

OBJECTIVES: This paper investigates risk profiles of frailty among older people, as these are essential for detecting those individuals at risk for adverse outcomes and to undertake specific preventive actions. Frailty is not only a physical problem, but also refers to emotional, social, and environmental hazards. METHODS: Using data generated from the Belgian Ageing Studies, a cross-sectional study (n = 28,049), we tested a multivariate regression model that included sociodemographic and socioeconomic indicators as well as four dimensions of frailty, for men and women separately. RESULTS: The findings indicated that for both men and women, increased age, having no partner, having moved house in the previous 10 years, having a lower educational level and having a lower household income are risk characteristics for frailty. Moreover, when looking at the different frailty domains, different risk profiles arose, and gender-specific risk characteristics were detected. DISCUSSION: This paper elaborates on practical implications, and formulates a number of future research recommendations to tackle frailty in an aging society. The conclusion demonstrates the necessity for a thorough knowledge of risk profiles of frailty, as this will save both time and money and permit preventive actions to be more individually tailored.