What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care

Background/aims: Serious adverse event reporting guidelines have largely been developed for pharmaceutical trials. There is evidence that serious adverse events, such as psychological distress, can also occur in non-pharmaceutical trials. Managing serious adverse event reporting and monitoring in palliative care non-pharmaceutical trials can be particularly challenging. This is because patients living with advanced malignant or non-malignant disease have a high risk of hospitalisation and/or death as a result of progression of their disease rather than due to the trial intervention or procedures. This paper presents a number of recommendations for managing serious adverse event reporting that are drawn from two palliative care non-pharmacological trials. Methods: The recommendations were iteratively developed across a number of exemplar trials. This included examining national and international safety reporting guidance, reviewing serious adverse event reporting procedures from other pharmacological and non-pharmacological trials, a review of the literature and collaboration between the ACTION study team and Data Safety Monitoring Committee. These two groups included expertise in oncology, palliative care, statistics and medical ethics and this collaboration led to the development of serious adverse event reporting procedures. Results: The recommendations included; allowing adequate time at the study planning stage to develop serious adverse event reporting procedures, especially in multi-national studies or research naïve settings; reviewing the level of trial oversight required; defining what a serious adverse event is in your trial based on your study population; development and implementation of standard operating procedures and training; refining the reporting procedures during the trial if necessary and publishing serious adverse events in findings papers. Conclusions: There is a need for researchers to share their experiences of managing this challenging aspect of trial conduct. This will ensure that the processes for managing serious adverse event reporting are continually refined and improved so optimising patient safety. Trial registration: ACTION trial registration number: ISRCTN63110516 (date of registration 03/10/2014). Namaste trial registration number: ISRCTN14948133 (date of registration 04/10/2017)

What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care

Background/aims: Serious adverse event reporting guidelines have largely been developed for pharmaceutical trials. There is evidence that serious adverse events, such as psychological distress, can also occur in non-pharmaceutical trials. Managing serious adverse event reporting and monitoring in palliative care non-pharmaceutical trials can be particularly challenging. This is because patients living with advanced malignant or non-malignant disease have a high risk of hospitalisation and/or death as a result of progression of their disease rather than due to the trial intervention or procedures. This paper presents a number of recommendations for managing serious adverse event reporting that are drawn from two palliative care non-pharmacological trials. Methods: The recommendations were iteratively developed across a number of exemplar trials. This included examining national and international safety reporting guidance, reviewing serious adverse event reporting procedures from other pharmacological and non-pharmacological trials, a review of the literature and collaboration between the ACTION study team and Data Safety Monitoring Committee. These two groups included expertise in oncology, palliative care, statistics and medical ethics and this collaboration led to the development of serious adverse event reporting procedures. Results: The recommendations included; allowing adequate time at the study planning stage to develop serious adverse event reporting procedures, especially in multi-national studies or research naïve settings; reviewing the level of trial oversight required; defining what a serious adverse event is in your trial based on your study population; development and implementation of standard operating procedures and training; refining the reporting procedures during the trial if necessary and publishing serious adverse events in findings papers. Conclusions: There is a need for researchers to share their experiences of managing this challenging aspect of trial conduct. This will ensure that the processes for managing serious adverse event reporting are continually refined and improved so optimising patient safety. Trial registration: ACTION trial registration number: ISRCTN63110516 (date of registration 03/10/2014). Namaste trial registra

Care staff's self-efficacy regarding end-of-life communication in the long-term care setting:Results of the PACE cross-sectional study in six European countries

Background: An important part of palliative care is discussing preferences at end of life, however such conversations may not often occur. Care staff with greater self-efficacy towards end-of-life communication are probably more likely to have such discussions, however, there is a lack of research on self-efficacy towards end-of-life discussions among long-term care staff in Europe and related factors. Objectives: Firstly, to describe and compare the self-efficacy level of long-term care staff regarding end-of-life communication across six countries; secondly, to analyse characteristics of staff and facilities which are associated to self-efficacy towards end-of-life communication. Design: Cross-sectional survey. Settings: Long-term care facilities in Belgium, England, Finland, Italy, the Netherlands and Poland (n = 290). Participants: Nurses and care assistants (n = 1680) completed a self-efficacy scale and were included in the analyses. Methods: Care staff rated their self-efficacy (confidence in their own ability) on a scale of 0 (cannot do at all) to 7 -(certain can do) of the 8-item communication subscale of the Self-efficacy in End-of-Life Care survey. Staff characteristics included age, gender, professional role, education level, training in palliative care and years working in direct care. Facility characteristics included facility type and availability of palliative care guidelines, palliative care team and palliative care advice. Analyses were conducted using Generalized Estimating Equations, to account for clustering of data at facility level. Results: Thde proportion of staff with a mean self-efficacy score >5 was highest in the Netherlands (76.4%), ranged between 55.9% and 60.0% in Belgium, Poland, England and Finland and was lowest in Italy (29.6%). Higher levels of self-efficacy (>5) were associated with: staff over 50 years of age (OR 1.86 95% CI[1.30–2.65]); nurses (compared to care assistants) (1.75 [1.20–2.54]); completion of higher secondary or tertiary education (respectively 2.22 [1.53–3.21] and 3.11 [2.05–4.71]; formal palliative care training (1.71 [1.32–2.21]); working in direct care for over 10 years (1.53 [1.14–2.05]); working in a facility with care provided by onsite nurses and care assistants and offsite physicians (1.86 [1.30–2.65]); and working in a facility where guidelines for palliative care were available (1.39 [1.03–1.88]). Conclusion: Self-efficacy towards end-of-life communication was most often low in Italy and most often high in the Netherlands. In all countries, low self-efficacy was found relatively often for discussion of prognosis. Palliative care education and guidelines for palliative care could improve the self-efficacy of care staff

Physician involvement and recognition of the resident's last phase of life in long-term care facilities: Findings from an EU FP7 funded cross-sectional study in 6 European countries (PACE)

Research aims: Ensuring the delivery of prompt, comprehensive palliative care in long-term care facilities (LTCFs) requires a multidisciplinary approach, including involvement of the physician. This study aims to describe and compare among 6 European countries (1) to what extent physicians are involved in the care of residents living in LTCFs; (2) to what extent physicians recognize the resident's last phase of life and; (3) how (1) and (2) are associated. Study population: 1094 deceased residents of 239 LTCFs, about whom 505 physicians in Belgium (BE), Finland (FI), Poland (PL), Italy (IT), The Netherlands (NL) and England (EN) reported on the number of visits they paid to the resident, treatment goals, whether they recognized a resident's terminal illness and whether they expected death. Study design and methods: In each country, a cross-sectional study was conducted within representative samples of LTCFs. Participating LTCFs reported all deaths of residents in the previous 3 months, and structured questionnaires were sent to several proxies among which the treating physician. Method of statistical analysis: To control for clustering within LTCFs and countries, differences in involvement in care and recognition of the last phase of life were analyzed using multilevel analyses. Results and interpretation: Physician involvement varied widely between countries; in the last 3 months of life, residents from PL were visited most often (median: 15 times), compared to residents from FI (12), NL (10), BE (7), IT (6) and EN (5). In the last week of life, this ranged from 4 visits (NL) to 1 visit (EN). Among all countries, physicians from PL and IT least often recognized the resident's terminal phase in the last week of life (63.0% in PL up to 80.3% in NL), and least often initiated a palliative treatment (31.8% in IT up to 92.6% in NL). On overall level though, positive associations were found between the level of involvement and the recognition of the last phase of life and initiation of palliative care. LTCFs should therefore work together with and involve physicians as much as possible in caring for their residents