Jennifer A H Bell1,2,3,4,5, Marina Salis6,7,8, Eryn Tong9, Erica Nekolaichuk10, Claudia Barned11,12,6,13, Andria Bianchi11,12,6,14, Daniel Z Buchman6,15, Kevin Rodrigues11,12,6, Ruby R Shanker11,12,6, Ann M Heesters11,12,6. 1. Department of Clinical and Organizational Ethics, University Health Network, Toronto, ON, Canada. jennifer.bell2@uhn.ca. 2. Department of Supportive Care Research, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada. jennifer.bell2@uhn.ca. 3. The Institute for Education Research, University Health Network, Toronto, ON, Canada. jennifer.bell2@uhn.ca. 4. Dalla Lana School of Public Health and Joint Centre for Bioethics, University of Toronto, Toronto, ON, Canada. jennifer.bell2@uhn.ca. 5. Department of Psychiatry, University of Toronto, Toronto, ON, Canada. jennifer.bell2@uhn.ca. 6. Dalla Lana School of Public Health and Joint Centre for Bioethics, University of Toronto, Toronto, ON, Canada. 7. Department of Philosophy, University of Toronto, Toronto, ON, Canada. 8. William Osler Health System, Brampton, ON, Canada. 9. Department of Supportive Care Research, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada. 10. Gerstein Science Information Centre, University of Toronto Libraries, University of Toronto, Toronto, ON, Canada. 11. Department of Clinical and Organizational Ethics, University Health Network, Toronto, ON, Canada. 12. The Institute for Education Research, University Health Network, Toronto, ON, Canada. 13. Pragmatic Health Ethics Research Unit, Institut de Recherches Cliniques de Montreal, Montreal, QC, Canada. 14. KITE Research Institute, Toronto Rehabilitation, Toronto, ON, Canada. 15. Centre for Addiction and Mental Health, Toronto, ON, Canada.
Abstract
BACKGROUND: Clinical ethics consultations (CEC) can be complex interventions, involving multiple methods, stakeholders, and competing ethical values. Despite longstanding calls for rigorous evaluation in the field, progress has been limited. The Medical Research Council (MRC) proposed guidelines for evaluating the effectiveness of complex interventions. The evaluation of CEC may benefit from application of the MRC framework to advance the transparency and methodological rigor of this field. A first step is to understand the outcomes measured in evaluations of CEC in healthcare settings. OBJECTIVE: The primary objective of this review was to identify and map the outcomes reported in primary studies of CEC. The secondary objective was to provide a comprehensive overview of CEC structures, processes, and roles to enhance understanding and to inform standardization. METHODS: We searched electronic databases to identify primary studies of CEC involving patients, substitute decision-makers and/or family members, clinicians, healthcare staff and leaders. Outcomes were mapped across five conceptual domains as identified a priori based on our clinical ethics experience and preliminary literature searches and revised based on our emerging interpretation of the data. These domains included personal factors, process factors, clinical factors, quality, and resource factors. RESULTS: Forty-eight studies were included in the review. Studies were highly heterogeneous and varied considerably regarding format and process of ethical intervention, credentials of interventionist, population of study, outcomes reported, and measures employed. In addition, few studies used validated measurement tools. The top three outcome domains that studies reported on were quality (n = 31), process factors (n = 23), and clinical factors (n = 19). The majority of studies examined multiple outcome domains. All five outcome domains were multidimensional and included a variety of subthemes. CONCLUSIONS: This scoping review represents the initial phase of mapping the outcomes reported in primary studies of CEC and identifying gaps in the evidence. The confirmed lack of standardization represents a hindrance to the provision of high quality intervention and CEC scientific progress. Insights gained can inform the development of a core outcome set to standardize outcome measures in CEC evaluation research and enable scientifically rigorous efficacy trials of CEC.
BACKGROUND: Clinical ethics consultations (CEC) can be complex interventions, involving multiple methods, stakeholders, and competing ethical values. Despite longstanding calls for rigorous evaluation in the field, progress has been limited. The Medical Research Council (MRC) proposed guidelines for evaluating the effectiveness of complex interventions. The evaluation of CEC may benefit from application of the MRC framework to advance the transparency and methodological rigor of this field. A first step is to understand the outcomes measured in evaluations of CEC in healthcare settings. OBJECTIVE: The primary objective of this review was to identify and map the outcomes reported in primary studies of CEC. The secondary objective was to provide a comprehensive overview of CEC structures, processes, and roles to enhance understanding and to inform standardization. METHODS: We searched electronic databases to identify primary studies of CEC involving patients, substitute decision-makers and/or family members, clinicians, healthcare staff and leaders. Outcomes were mapped across five conceptual domains as identified a priori based on our clinical ethics experience and preliminary literature searches and revised based on our emerging interpretation of the data. These domains included personal factors, process factors, clinical factors, quality, and resource factors. RESULTS: Forty-eight studies were included in the review. Studies were highly heterogeneous and varied considerably regarding format and process of ethical intervention, credentials of interventionist, population of study, outcomes reported, and measures employed. In addition, few studies used validated measurement tools. The top three outcome domains that studies reported on were quality (n = 31), process factors (n = 23), and clinical factors (n = 19). The majority of studies examined multiple outcome domains. All five outcome domains were multidimensional and included a variety of subthemes. CONCLUSIONS: This scoping review represents the initial phase of mapping the outcomes reported in primary studies of CEC and identifying gaps in the evidence. The confirmed lack of standardization represents a hindrance to the provision of high quality intervention and CEC scientific progress. Insights gained can inform the development of a core outcome set to standardize outcome measures in CEC evaluation research and enable scientifically rigorous efficacy trials of CEC.
Authors: Nadine Mulfinger; Anja Sander; Felicitas Stuber; Regina Brinster; Florian Junne; Ronald Limprecht; Marc N Jarczok; Tanja Seifried-Dübon; Monika A Rieger; Stephan Zipfel; Martin Peters; Maja Stiawa; Imad Maatouk; Madeleine Helaß; Christoph Nikendei; Eva Rothermund; Nicole Hander; Ute Ziegenhain; Manuela Gulde; Melanie Genrich; Britta Worringer; Janna Küllenberg; Karl Blum; Stefan Süß; Elena Gesang; Sascha Ruhle; Andreas Müller; Jochen Schweitzer-Rothers; Peter Angerer; Harald Gündel Journal: BMC Public Health Date: 2019-12-17 Impact factor: 3.295