Clinical ethics consultations: a scoping review of reported outcomes

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.

Introduction

Clinical ethics consultations (CEC) can be complex interventions involving multiple methods, stakeholders, and ethical principles or values, often in conflict. Despite longstanding calls for rigorous evaluation in the field of clinical ethics [1], progress continues to be limited. The Medical Research Council (MRC) proposed guidelines for evaluating the effectiveness of complex interventions [2]. Relevant stages to consider include the selection of appropriate study designs, identification of important outcomes, understanding processes, and the assessment of intervention fidelity. The evaluation of CEC may benefit from application of the MRC framework to advance the transparency and methodological rigour of this field [3]. A necessary first step is to understand the types of outcomes measured in primary studies of CEC in healthcare settings.

Background

CEC is broadly understood as “a service provided by an individual consultant, team, or committee to address the ethical issues involved in a specific clinical case. Its central purpose is to improve the process and outcomes of patient care by helping to identify, analyze, and resolve ethical problems” [4]. This definition encompasses a variety of clinical ethics cases, from the relatively straightforward (e.g., clarifying the role of the substitute decision maker) to more complex (e.g., mediating entrenched values-disagreement) and service models, including moral case deliberation, whereby the clinical ethicist is a well-trained facilitator with ethics knowledge. Other models suggest that the ethicist should have ethics expertise and decision-making authority or a consultative role. CEC frequently occur in acute care hospitals [5], with some programs focused on providing services in specific contexts such as intensive care units [6], pediatric areas, or end-of-life circumstances [7]. Since 2000, the rate of CEC has increased by 94% across U.S. hospitals with the median number of consults doubling in some areas. However, during this timeframe, published accounts of evaluations of CEC have decreased from 28 to 19.1% [5]. This decline is despite the fact that over the past 30 years, several journals have published special issues related to discussions about the need for evaluation and evidence of CEC quality [8, 9]. An editorial in 2017 laments the poor state of empirical studies evaluating CEC, despite national governments and health care organizations emphasizing its importance, and repeated calls from within the field for rigorous evaluation research [10,11,12].

The extant literature focuses on identifying the scope and expertise of ethics consultants, including ethics training [13] and credentialing [14]. Furthermore, despite some limitations, descriptive information about CEC services, including consult volumes [15], roles of consult requestors, and types of ethical issues prompting consultation is available in the U.S. and in Europe [16]. However, questions about the nature and scope of the role or roles of ethics professionals persist (e.g., are they moral authorities [17]? Are they advocates [18]?) and empirical or methodological issues continue to be debated (How do we measure morality? What is a ‘good’ consultation outcome [11]?). Studies assessing the quality of CEC are numerous [19,20,21]; however, some acknowledge the difficulty of measuring quality when there remains a lack of clarity and consensus about the goals of CEC and the best outcome domains to measure [22, 23]. Other studies discuss limitations posed by a lack of standardization in regard to the structure of CEC, the processes and methods employed, and the unique complexities of individual cases that inform the ethics consultant’s activities [24]. For example, a lack of standardized organizational policies that define CEC, training and education of consultants, consensus as to whether the consultant engages in a pure facilitation approach, authoritarian approach or a combination of approaches, and whether the goal of CEC is mediation, facilitation or the generation of a recommendation [25,26,27,28]. Feder and Firn argue that the CEC should “take a personalized and values-based approach to facilitating decision-making that acknowledges context and a plurality of possible ‘right’ answers” [29]. Contextual features may include the setting, inter-professional dynamics and behavior, interventionist characteristics, institutional culture, and nuances in patient cases (e.g., characteristics, diagnoses, values). Others have argued that the context-sensitive and value-laden nature of CEC is particularly challenging for developing effectiveness studies. Values-plurality and normativity of outcomes are presented as barriers to standardization and effectiveness studies; however, it is not necessarily the case that no outcome or measure can reliably be applied. An outcome may be more or less defensible because it aligns with the patient’s enduring values, or because it minimizes or averts harms that patients and clinicians agree are undesirable (e.g., pain, reduced life expectancy).

Some medical specialties have articulated positions that appear to presume which outcomes would be relevant or desired to CEC; for example, the American Thoracic Association and other critical care societies have recommended CEC as a way to prevent inappropriate treatment [30]. Although it is useful to know what outcomes would be regarded as desirable by critical care providers, it must be acknowledged that CEC serve a variety of stakeholders,¹ including patients and families, and their values may not be congruent with those of their clinicians. Furthermore, non-beneficial treatment and cost-effectiveness have been problematized from within the field and have been viewed as unreliable outcome measures, unable to capture the nuances and complexities of the consultation and the significance of patient values [11, 31]. There is a need to identify relevant outcomes that are meaningful for all stakeholders and to develop validated measurement tools to inform future study. A well-developed tool is the EURO-MCD questionnaire, which has been validated by Dutch professionals trained in MCD facilitation, and identifies 26 moral case deliberation-related outcomes [32,33,34]. Further understanding of the development of this tool and associated outcomes for evaluating CEC effectiveness internationally has the potential to support and advance this important work.

Chen and Chen argue that using quantitative methods to evaluate CEC will be challenging so long as there is a lack of standardization of CEC methods or a comparator group to demonstrate an intervention’s effect [24]. However, standardization can be achieved if there is a clear definition of the scope of the intervention and agreement about the recommended approach (e.g., focus on family meetings with values-disagreement, use of a facilitation approach). Comparisons can be made to usual care; that is, care provided without consultation support. It should be noted that there are similar challenges faced in evaluating other complex health interventions, e.g. mental health strategies [35]; therefore, it should not be assumed that these challenges are insurmountable nor should it deter scientific advancement. Identifying relevant outcomes to demonstrate CEC effectiveness and developing and validating measurement tools is required. This can be done in parallel with efforts to define the nature and scope of the ethics consultant’s role with a view toward providing a foundation for robust future research, evidence-based interventions, enhanced practice standards, and quality assurance. Ultimately, these efforts can provide a sound basis for demonstrating the value of CEC.

Previous research has explored issues related to outcomes in healthcare ethics consults. For example, using a Cochrane review, researchers evaluated the effectiveness of clinical ethics supports, including CEC, in controlled studies limited to adult patients in intensive care units [36]. Other systematic reviews have assessed clinical ethics support services in the end-of-life context, intensive care units [37], or have focused on the activities of ethics committees [38]. Another topic examined through systematic review was CEC quality assessment tools [39]. There remains a need to provide an overview of the available research on the evaluation of CEC that span the range of healthcare contexts and settings in order to inform the development of a set of core outcomes for future research.

To address this gap in the literature, we undertook a scoping review to identify and map the outcomes reported in evaluations of CEC. A secondary objective of this review was to provide a comprehensive overview of CEC structures, processes, and roles to enhance understanding and to inform standardization. A scoping review is the appropriate review methodology given the paucity of existing evidence and the need to clarify key concepts, the types of evidence available, and to map the relevant outcomes across clinical care settings [40, 41]. The research question guiding this scoping review question was the following: what types of outcomes of CEC have been reported?

Methods

We sought to identify primary studies of CEC involving patients, substitute decision-makers and/or family members, clinicians, healthcare staff and leaders. We searched the following electronic databases from inception to May 2021 to identify research articles examining CEC in healthcare settings: Ovid MEDLINE ALL: Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE® Daily and Ovid MEDLINE®, OVID Embase, OVID AMED (Allied and Complementary Medicine), EBSCO CINAHL, Cochrane Central, ProQuest Philosopher’s Index, ProQuest Sociological Abstracts, Ovid Social Work Abstracts, and Ovid PsycINFO. The search strategy was developed by an academic health science librarian (EN) in collaboration with the project leads. The search strategy was translated using each database platform’s command language, controlled vocabulary, and appropriate search fields. MeSH terms, EMTREE terms, AMED thesauri terms, CINAHL headings, Thesaurus of Sociological Indexing terms, APA thesauri terms, and text words were used for the core search concept of ethics consultations and evaluation. To capture the concept of evaluation, we used a combination of search terms designed to retrieve primary studies that met our methodological criteria, including randomized and non-randomized controlled trials; retrospective and prospective observational cohort studies; and qualitative studies. When appropriate, we incorporated validated search filters; for example, the Cochrane RCT filter for Medline [42]. Finally, we applied a human filter to the Medline and Embase strategies [42]. No date, language, or jurisdiction limits were imposed. The original search was run in January 2019 and run again in May 2021 (Fig. 1).

Fig. 1

MEDLINE ALL search strategy

We attempted to identify additional studies by searching the reference list of relevant studies included for full-text review, and by hand searching relevant journals identified from the database searches. In addition, we attempted to identify ongoing and/or unpublished studies by searching dissertation databases, relevant websites of professional organizations, and clinical trials registries [43]. The trial registry search did not yield any results.

Articles retrieved from the searches were exported and saved in EndNote X9 reference management software [44]. We used Covidence web-based literature review software and an in-house database for screening and data abstraction.

Screening

The search was executed and duplicates removed according to the auto- and hand-searching methods outlined by Qi et al. [45] The research team members (JB, AH, AB, RS, KR, DB, MS) independently screened titles of studies retrieved using the search strategy and those from additional sources to identify studies that met the inclusion criteria (see Table 1). If the eligibility of a study could not be determined by the study title, the reviewers screened the abstract for relevance. The full text of studies deemed potentially eligible were retrieved and independently assessed for relevance according to inclusion criteria. Any disagreement between reviewers over the eligibility of particular studies was resolved through consultation with a third reviewer. The reviewers requested missing data from the study authors when there was insufficient information to conduct the review. Studies with insufficient information regarding intervention content (e.g., unable to determine whether the intervention was an ethics consult) were excluded from the review.

Table 1 Study inclusion criteria

In total, our searches returned 56,479 articles. After removing duplicates and studies that did not meet the inclusion criteria, 48 articles comprised this scoping study (See Fig. 2).

Fig. 2

Study flow diagram

Data extraction

Data extracted from the included studies used a piloted standardized form. Extracted information included: study design; study setting; population and participants; discipline of requestor; intervention components (e.g., setting, purpose of consult, individual consultant vs. team), and outcome assessments. The first author (JB) and two other team members (ET, MS) extracted data independently and resolved discrepancies through discussion. A risk of bias assessment was not conducted as this is not applicable for scoping reviews [46].

Data synthesis

Information was collated, summarized and reported in accordance with PRISMA-ScR reporting standards [46].

An initial set of outcomes were identified across five conceptual domains a priori based on our clinical ethics experiences and preliminary literature searches. These domains included: psychological factors, process factors, healthcare utilization, clinical documentation, and quality outcomes. The domains were then refined or revised through an interpretative process of identifying and synthesizing the outcomes identified in the scoping review literature. For example, the domain “psychological factors”, which included predominantly moral distress, was revised early in the review process to “personal factors” to capture the broad array of individual-related outcomes that studies were reporting on. Additionally, healthcare utilization was re-interpreted as the more encompassing “resource outcomes” domain to include cost considerations. The final set of outcomes that studies reported on included: personal factors, process factors, clinical factors, quality, and resource factors.

Mapping the literature occurred through an iterative process of reviewing each study and interrogating which of the domains, if any, appropriately described outcomes depicted. If a study included multiple outcomes without reference to primary, secondary, etc., each outcome presented was categorized and interrogated separately in order of appearance in the study. Categorization occurred in accordance with the primary description or emphasis, and study context. For example, a quality improvement study that discussed the perceived usefulness of the CEC in clarifying ethical issues could be categorized as representing a quality (usefulness) or a process factor (clarifying ethical issues). Since the study was a quality improvement design and attention to usefulness was the primary focus, we categorized this outcome as quality-related. In addition, some studies reported outcomes within a particular domain, but were re-categorized according to our pre-specified criteria in an effort to systematize outcome domains in the field. For example, White (1997) reported increased knowledge as related to satisfaction [47]. This was re-categorized for the purposes of our review as a personal factor since increased knowledge relates more broadly to a change in stakeholder perspective or experience. When conflicts in categorization arose, the domain classification was discussed and interrogated until a consensus was reached on its assignment. Judicious notes and a decision bank of challenging outcome domain assignments were kept in the study database for the review team to access for help in categorizing domain assignments.

Results

Study characteristics

Forty-eight studies were included in the review, with a majority of studies conducted in the United States (n = 27). Other countries represented were Norway (n = 4), the Netherlands (n = 5), Sweden (n = 4), Germany (n = 2), as well as n = 1 each from Canada, Taiwan, Japan, Chile, and Australia. One study was conducted across Norway, Sweden, and the Netherlands. More than half of the studies were conducted within a hospital setting (n = 27). Three studies identified the setting as a pediatric hospital. Ten studies took place in adult intensive care units, and one study took place in a neonatal intensive care unit. Additional study sites included aged care, community health and care, psychiatric outpatient clinics, mental health care institutions, in-home care settings, mobile health clinics, and transgender care. Two studies occurred across multiple settings, and one did not identify a clinical setting (Table 2).

Table 2 Study characteristics

The predominant study design was quality improvement² (n = 13), followed by mixed method (n = 10), qualitative (n = 9), randomized controlled trial (n = 4), and retrospective/prospective or a combination (n = 10). Standalone methods included economic analysis and observational study. Twenty-eight studies identified a time period; among these the average length of study was 26.75 months. The majority of studies (n = 33) were published in 2016 or earlier; 15 studies were published within the past 5 years, with a greater proportion being conducted in European countries. The primary study population was healthcare professionals (n = 29). Few studies focused on patients (n = 7), even fewer on family members or substitute decision-makers (n = 1), and 11 studies combined two or more of these groups (i.e., patients, family members and/or health care professionals) (Table 2).

Delivery context

The CEC intervention was most often identified as a clinical/ethics/ethics committee consultation or service (n = 34). Six studies used the term moral case deliberation. Other descriptions referenced ethics consultation system, ethics case reflection sessions, ethics rounds, clinical ethics support, structured multidisciplinary medical-ethical decision making, ethics intervention, and clinical ethicist involvement. Differences in terminology reflected nuances in understanding and delivery of CEC, including format, timing of the intervention (e.g., proactive or reactive), and processes (see Table 3). Despite the different descriptors, studies nevertheless fell under the general category of clinical ethics consultation or moral case deliberation given the similarity in structure, delivery, and purpose.

Table 3 CEC intervention delivery context

Twenty-nine interventions were described as involving an ethicist(s) or ethics consultant(s), six involved an ethics committee, and 13 involved a facilitator or healthcare professional with no formal ethicist title. Of the studies that described credentials or qualifications, the majority of CEC deliverers were described as having some training, education, or certification in ethics, ethics consultation, and/or moral case deliberation (n = 9). Other experience or training included postgraduate degrees (n = 5), with some specifying doctorate (n = 3) or master’s degree (n = 1), fellowship (n = 4), clinical experience (n = 5), training in medicine (n = 3), ethics teaching experience (n = 2), non-ethics specific skills training (n = 3), and “familiarity”, “knowledge,” or “expertise” with ethics (n = 4). Some studies only identified professional background (e.g., lawyer, philosopher). Twenty-five studies (52%) did not discuss or were not clear with respect to the training, credentials, or experience of the ethics consultant(s)/facilitator(s).

Twenty-six studies reported that the intervention began upon request. Physicians were most frequently identified as requesting the consult (n = 15), followed by relatives and family members (n = 10), nurses (n = 8), patients (n = 8), and others (n = 6). Twenty-two studies did not identify the requestor, or a requestor was not applicable given the study design or CEC delivery. Some studies described the purpose of the interventionist as delivering a recommendation, whereas others described the primary role as facilitating a discussion without offering a particular solution. For example, while Molewijk et al. described the role of the ethicist as, “that of a facilitator who does not give substantial advice and does not morally justify or legitimize a specific decision” [76], Wocial et al. described one of the goals as making specific recommendations [89]. Additionally, some studies described the process as involving stakeholder engagement, whereas a few studies described a more solitary process of deliberation. For example, Orr and Moon referred to the intervention as involving a consultant who discusses the case with the requestor and individually with members of the care team, patient, family, and others involved in the conflict [77]. Smith et al. identified the process as involving a written memorandum containing an ethical analysis and opinions about the case with no external deliberation [84]. For a full description of the interventions, see Table 3.

Outcome domain reporting

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 (see Table 4).

Table 4 Outcome domain reporting

Quality

Quality was the most frequently reported outcome domain (n = 31). This domain captured the quality of the CEC, consultant, and/or overall stakeholder experience as it related to perceived usefulness, satisfaction, timeliness, accessibility, and overall benefit. Quality-related outcomes were primarily measured by survey (n = 22), followed by qualitative interviews or focus groups (n = 7) and mixed methods (n = 6).

Usefulness was the most frequent construct measured and reported (n = 16). This construct referred to the perceived usefulness of the CEC in informing practice, the perceived overall benefit of the CEC, the extent to which the CEC was beneficial in assisting patient care, the importance for physician education and medical treatment, whether a CEC would be used in the future, effectiveness in providing emotional support, mediating disputes, and clarifying ethical issues, and improving communication (see Table 5). Other prominent quality subthemes included satisfaction (n = 11), overall experience (n = 6), effectiveness (n = 2), and ability to improve practice (n = 1).

Table 5 Quality reporting

Among the 16 studies evaluating usefulness, eight reported CEC to be useful. These eight studies understood usefulness as resolving issues or conflict (n = 5), identifying, analyzing, and clarifying issues and/or values (n = 5), and in providing education (n = 3). Some studies concluded that the intervention improved interpersonal and professional qualities such as mutual understanding and cooperation, personal ethical reflection and insight, and ability and confidence to act in practice. Respondents in a few studies would seek CEC again (n = 2) or would recommend the service to others (n = 4). Insights and cross-comparisons between participant groups who experienced higher or lower levels of usefulness are difficult to ascertain given insufficient statistical power or incomplete reporting on the perspectives of certain stakeholder groups, such as patients and families (Table 5).

Respondents in almost all studies reported a positive or beneficial encounter with CEC either in terms of overall experience, quality, usefulness, value, helpfulness, or satisfaction (n = 28), with healthcare professionals being the most frequently examined group (n = 26).³ Seven studies reported a moderate to high level of satisfaction with the CEC experience. These were described in various ways: an inclination to use the service again or recommend the service to others, the degree of consensus between stakeholders, the ability to meet perceived goals, general satisfaction with the service or intervention, the positive or negative nature of the experience, practical usefulness, and the impression of the intervention. White, Dunn, and Homer reported specifically on low levels of satisfaction, with shared decision making, documentation adequacy, and increased knowledge of ethical issues receiving the lowest satisfaction scores [47]. Only one study found respondents’ overall experience with CEC was negative [49], although other studies suggested areas for improvements [83]. Negative experiences were attributed to factors such as a lack of structure in the consult, a lack of timeliness, or an absence of integration into clinical practice [49, 83].

Process factors

Process factors comprised the second most reported outcome domain (n = 23). Process factors referred to any set of activities that occurred between the CEC provider and other stakeholders, such as identifying, clarifying, resolving ethical issues, reaching consensus, and facilitating understanding of different viewpoints (Table 6). Process factors were identified by qualitative interviews or focus groups (n = 13), survey (n = 10), mixed methods (n = 3) and record review (n = 1).

Table 6 Process factors reporting

The most reported subtheme in the process factors domain was purpose and/or impact of the intervention (n = 14). Other subthemes included establishing consensus and integration (n = 3), helpfulness (n = 2), identification (n = 1), advancing care (n = 1), support (n = 1), and clarification (n = 1).

With respect to the dominant subdomain, the data demonstrate diverse understandings within and across stakeholder groups regarding the purpose and impact of ethics intervention. Many study respondents perceived ethics involvement to be most effective with respect to identifying or further elucidating core [ethical] tensions or barriers to resolution (n = 8), achieving resolution, consensus, or clarity on the problem, plan of action, or desired outcome (n = 7), and/or facilitating the sharing of viewpoints and better communication between stakeholders (n = 5). Five studies additionally reported ethics intervention as having an impact by improving individuals’ feelings of safety and support (n = 2), trust (n = 2), and confidence in decisions (n = 1). Two studies reported ethics intervention as increasing mutual understanding and respect within and between stakeholder groups, as well as providing valuable education (n = 4) or an objective opinion on the problem at hand (n = 3).

Some studies, however, were less sanguine about these descriptors. For example, Weidema et al. reported that ethics intervention revealed team conflicts, but maintained that it did not assist in solving them due to the ethical issues being too complex or ambiguous [86]. This finding is corroborated by Vrouenraets et al. who reported that enabling concrete steps to navigate ethically difficult situations was the least common outcome associated with ethics interventions [93]. In some studies, the positive impact of CEC was not consistent across stakeholder groups. Yen and Schneiderman, and Schneiderman et al., for example, found that the positive experience reported by physicians was not experienced by family members, with 75% strongly disagreeing that an ethics intervention was important for resolving ethical issues [81, 91]. Other studies reported dissatisfaction when expected outcomes were not met, such as the expectation of resolution or the formulation of a clear plan of action [56]. In studies that provided recommendations for process-related improvement, respondents prescribed better communication with the health care team [90]. Poor communication, complexity, and ambiguity were also reported as barriers to the resolution of ethical problems in other studies in the process domain category [86].

Clinical factors

Nineteen studies were coded under the clinical factors domain, which related to a change in the clinical care of the patient, including, but not limited to, adherence with a recommendation, agreement with a recommendation, a decision about care or treatment, concordance between patient wishes and treatment delivered, a change in treatment plan, a reduction of non-beneficial treatment, conflict resolution regarding patient care, and patient survival/mortality (Table 7). The majority of studies in this domain utilized record review as the method of data collection (n = 15). Other methods included survey (n = 6), qualitative interviews (n = 2) and mixed methods (n = 1).

Table 7 Clinical factors reporting

Studies that reported on clinical factors examined a narrower set of characteristics compared to other domains; patient management and provision of care was the most frequently reported construct (n = 11). Patient management and provision of care included the following indicators: the presence of, or recommendation to change, particular orders or decisions (e.g. do-not-resuscitate orders, withholding/withdrawal orders, life-sustaining treatment, limits of care, requests for services, and pain management), provision of palliative care and/or chaplaincy services, agreement with a decision, and a change in treatment plan, plan of care, or patient management. Other subthemes reported in this domain included non-beneficial care (n = 3), patient mortality (n = 3), clinical consensus (n = 2), suffering (n = 1), quality of care (n = 1), and coercion (n = 1).

Constructs, outcomes, and measures varied considerably between the studies examining patient management and provision of care, despite their similarities. For example, Dowdy, Robertson, and Bander measured the presence of particular constituents of care, understood by the term quality of communication index—communication and decision making that resulted in a treatment order between a control and ethics intervention group. These researchers noted a “higher communication score” and significant difference between intervention and control with respect to the presence of do-not-resuscitate (DNR) and life-sustaining treatment decisions [60]. Another study by Cohn et al. examining communication and decision-making, measured the level of agreement with the decision and the degree of change that occurred due to CEC. Healthcare provider respondents were significantly more likely than family members to report a high degree of agreement with the outcome of the ethics consultation, and both healthcare providers and patient/family perceived similar degrees of change to the plan of care following CEC [55]. Other studies measuring patient management considered whether consultations changed patient care, measuring the change rather than the presence (or not) of particular types of care. Outcomes demonstrated that the majority of respondents reported CEC as changing patient management in some regard, with most changes occurring due to the consultation prompting the withholding of life support therapies that would have otherwise been used [79]. Thus, despite parallels across the various constructs, differences exist with regards to the terminology (and their related understandings) and measurement of outcomes.

Wide variation also existed in measures and outcomes with respect to non-beneficial treatment, with minimal consensus on what might be considered and measured as non-beneficial, as well as what can be concluded with respect to the impact of CEC on the provision of non-beneficial treatment. For example, Schneiderman, Gilmer, and Teetzel measured the number of ICU days and life-sustaining treatments in patients who died before discharge. They reported a reduction in ICU days, days receiving artificial nutrition and hydration, percentage on ventilation, and days receiving ventilation in patients receiving consultation compared with the control [81]. In later research, which focused on number of ICU days, hospital days, and life-sustaining treatment in patients who did not survive to discharge, Schneiderman et al. found no significant difference between intervention and control; however, a pattern in the reduction of hospital and ICU days with ethics intervention was observed. Additionally, this study justified outcomes as “non-beneficial” because they were perceived to “represent a failure to achieve a fundamental goal of medicine” [82]. Another study by Andereck et al. examined non-beneficial treatment among patients receiving ventilation and/or artificial nutrition. While the intervention and control groups varied by one median day, the authors did not make any causal claim with respect to ethics intervention and reduction in the provision of these treatments [48]. With respect to patient outcomes, no significant difference in mortality rate was observed between participants who received ethics intervention and those who did not [48, 65, 82].

Personal factors

Personal factors was the fourth most reported on domain (n = 8). Studies coded under this domain related to changes in personal state or stakeholder (patient/family/surrogate/health care professionals) perspective or experience; for example, moral distress, enhanced knowledge, and/or feeling supported (Table 8). Data collection methods included survey (n = 7) and qualitative interviews (n = 1).

Table 8 Personal factors reporting

Subthemes explored under the personal factors domain included perceived value and outcomes (n = 3), experience (n = 2), moral distress (n = 2), learning (n = 1), confidence (n = 1), and clarity (n = 1). With respect to perceived value and outcomes, understandings consisted of value for self and practice, impact on the individual, impact on values, changes to perspective during the session, changes to perspective in practice, and whether any outcomes were experienced at all during the session and/or in practice. Interestingly, other subthemes did not demonstrate as much variation.

Findings of the studies that examined the perceived value of CEC resulted in a variety of understandings of perceived values and outcomes with respect to ethics interventions. Respondents most frequently reported ethics interventions as valuable for enhancing their understanding and awareness of ethical issues (n = 4), developing confidence (n = 2), fostering open communication and expression of feelings (n = 2), improving mutual understanding and cooperation (n = 2), enabling and delivering solutions (n = 2), improving skills (n = 2), and achieving consensus (n = 2). Brännström et al. described the experience as encouraging stakeholders to meet in an ethical “free zone” in which the nature of the intervention created a safe and inclusive forum for stakeholders to express their viewpoints and to be heard in a space where they felt confident and trusted [54]. Wocial, Molnar, and Ott recommended effective communication with the health care team as an area for improvement [90].

Notably, most respondents in the two studies measuring moral distress reported a reduction in levels of distress following CEC intervention. Respondents in these studies consisted of health care providers, such as nurses and physicians. Moral distress levels were not measured among patients, families, or other stakeholder groups [66, 89]. Other studies reported perceived increases in clarity, confidence, and learning among providers [79].

Resource outcomes

A few studies reported on resource outcomes (n = 5). Data collection methods consisted primarily of medical record review. Studies coded under this domain evaluated outcomes in terms of service users’ consumption of health-related resources and cost or cost avoidance (Table 9).

Table 9 Resource factors reporting

All four studies that evaluated outcomes in terms of length of stay sought to examine whether length of stay was reduced following ethics intervention, both in terms of length of hospital stay (n = 4) and length of stay in the ICU, specifically (n = 3) pre- and post-intervention. While two studies denoted a shorter length of stay in the intervention arm compared to the control [64, 65], one study identified no statistically significant difference [48], and one study found length of stay in relation to discharge status significant [60].

Four studies reported on the subthemes cost or cost avoidance. These studies measured the financial impacts of CEC or used hospital records to compare cases involving ethics interventions to those that did not. Cost was described as total cost of stay, inpatient stay costs (total service cost + acute inpatient cost + ICU room and board), net cost of consultation, and charges for patients. Cost avoidance included variables such as cost for treatment, expenses avoided or added for patients receiving consultation, and total cost avoidance (variable costs + fixed costs) (Table 8).

Outcomes across studies reporting on cost and cost avoidance were not congruent with respect to actual and perceived impact of CEC. A study by Meltzer, Heilicser, and Siegler examining cost avoidance through retrospective record review drew a strong connection between ethics intervention and cost, reporting a $288,827.00 total cost avoidance over a six-month period, with savings obtained by decreasing length of stay, costs associated with resuscitation, number of surgical and diagnostic procedures, among other factors. This was compared to the expense of ethics support and resources, which was reported to be $12,000 for each patient who received consultation. Qualitative reporting in this study reflected similar outcomes: 69% of consultations resulted in cost avoidance, and an additional 10% resulted in potential cost savings. Researchers in this study asserted that cost savings would have been greater if ethical recommendations were followed [75]. Similarly, Gilmer et al. demonstrated comparable findings with an estimated annual savings of $157,380.00 related to ethics consultation practice [64]. On the other hand, while reporting a reduction in average charges compared to baseline groups, two studies did not report significant differences between intervention and control with ethics intervention [48, 60]. Dowdy, Robertson, and Bander specifically asserted that despite a reduction in costs, this difference was not statistically significant enough to demonstrate the efficacy or causal relationship between ethics consultation and cost reduction [60].

Discussion

The current study is the first scoping review focused on outcome measures in CEC across healthcare settings. The 48 studies were highly heterogeneous and varied considerably with regard to format and processes of ethical intervention, the credentials of interventionist, the population of study, the outcomes reported, and the measures employed. In addition, few studies used validated measures. Regarding the quality domain, which was the most frequently reported domain, “usefulness” was the most common feature of quality and related to a variety of goals and processes of the CEC or was a standalone assessment of overall experience with CEC. Across the various studies that assessed usefulness within this domain, we did not identify consistency in characteristics of this subtheme, CEC approaches, population sampled, measures, or how potential biases about the outcome of the consultation (agreement/disagreement with the decision or recommendation) were managed in this context. Standardization of outcomes would be an important first step in helping to ensure reliable measurements and meaningful comparisons.

Previous systematic reviews have highlighted the methodological limitations of studies evaluating CEC effectiveness and the challenges associated with identifying relevant outcomes [7, 36]. To address these shortcomings, recent research has attempted to identify relevant outcomes using the Delphi method of consensus [95]. Although this study represents a strong starting point, it is not comprehensive and did not engage all relevant stakeholders. This is salient given the broad variety of persons that CEC serves, including patients. It is important to address patient-reported outcomes, as patient voices are increasingly recognized as central to research legitimacy and scientific advancement. Additionally, McClimans et al. focused more broadly on the role of support services in clinical ethics. However, without clear understanding of what these services encompass, and lack of standardized intervention, the field requires further research that addresses CEC specifically to more accurately evaluate and assess the effects of ethics interventions. As was the case with the McClimans et al. study, the current review notes the omission of patient perspectives in CEC evaluations. Most respondents in the studies reviewed were healthcare professionals, and very few surveyed the views of patients and families in assessing CECs.

The lack of consistent constructs, variation in how constructs are named and understood, different models of CEC intervention, and a lack of validated measurement tools detract from our ability to build an evidence base for CEC. Ultimately, without this evidence base, our ability to meaningfully support patient and professional decision-making remains in question as there is uncertainty regarding CEC effectiveness. Moreover, our ability to engage with what constitutes ‘good’ patient care may be compromised, especially within the context of an increasingly diverse patient population.

The findings of our review need to be interpreted within the broader socio-political context where more evidence is being shared regarding the colonial structures upon which our healthcare systems are built [96,97,98]. In particular, evidence pertaining to racist practices and policies, conscious and unconscious bias, and the outright discrimination and inequities in access to care experienced by racialized and marginalized groups [99, 100]. As a field, bioethics, and by extension those who practice CEC, are also impacted by conscious and unconscious bias and must grapple with how best to combat racism and other forms of oppression in the provision of our services and in health care more generally [101,102,103]. Historically, the field has responded to racism or issues related to racial oppression with a view towards ‘neutrality’ or the “idea that ideal [ethical] deliberation would ignore race and hence prevent bias” [104]. However, neutrality perpetuates racism by ignoring the systemic injustices experienced by racialized and marginalized groups that differentially affect their health. Neutrality is thus not only inappropriate for ensuring anti-discriminatory and anti-racist practices, but it is ultimately an affront to human dignity and the right to safe, accessible care. At present, we do not know whether CEC is doing a good job in addressing racism and promoting social justice, since this review reveals that CEC evaluation is not inclusive of diverse patient perspectives nor are we measuring outcomes such as anti-racism, patient safety and the provision of culturally appropriate care. Without a more inclusive understanding and evidence base for CEC, we risk grave human rights and safety implications for those who experience marginalization and oppression due to intersecting aspects of their identity, such as race, class, age, ability, and gender.

To resolve the lack of diverse perspectives and consensus in evaluating CEC, we offer two potential recommendations: enhanced international collaboration and the development of a core set of outcomes as identified in the MRC framework, both of which are to be guided by a commitment to the principles of equity, diversity and inclusion.

International collaboration

Almost all the studies included in this scoping review were conducted in the United States (n = 27) or European countries (n = 18). Other countries were Japan (n = 1), Taiwan (n = 1), and Chile (n = 1). It may be advantageous for ethicists to collaborate on research internationally even though study sites and roles may be unique to different jurisdictions. In order to be more attentive to and inclusive of the perspectives of diverse groups globally, understanding of how CEC might differ in varied cultural contexts and the nuances of CEC beyond European and Westernized approaches to CEC may provide valuable learnings of benefit to all. There is also opportunity to seek insights and potential collaboration from colleagues involved in evaluating research ethics review and oversight (e.g., the Consortium to Advance Ethics Effective Research Ethics Oversight (AERO)). Although there are important differences between research ethics and CEC, the challenges with measurement and identifying relevant outcomes within a value-laden context are similar.

Set of core outcomes

The current scoping review highlights the need to create a set of core outcomes through a comprehensive stakeholder engagement process that considers the action-guiding values of equity and anti-oppressive practices. The creation of this outcome set could also consider the agreement and disagreement among various stakeholders on the importance of each outcome, and note any limitations that should be recognized when applying these outcomes in empirical study. For example, the context and values-plurality of CEC has been recognized as an important factor in identifying outcomes in ethics consultations. Problems arise with pragmatic outcomes such as non-beneficial treatment or cost and satisfaction, when these overwhelm or conflict with the ultimate goals of CEC such as addressing value-related conflicts [11]. Defining non-beneficial treatment solely by measuring a patient’s days in the ICU could, after all, be seen as discordant with a fundamental goal of CEC, which is to ensure respect for patients’ values. The meaning of “benefit,” by most accepted accounts, is contingent on the patient’s wishes and values, which are to be understood as culturally and historically located, as well as dependent upon the unique circumstances of the case [11]. A patient’s desire to continue with ventilator support until their grandchild is born, for example, might strike the clinical team as a poor use of healthcare resources, but it is not inconceivable that a good CEC outcome would include the recommendation to retain the patient’s full code status until that wish is fulfilled. There may be an additional layer of cultural meaning ascribed to beginning of life rituals or religious practices that is contributing to the patient’s wishes, in which case supporting the recommendation to maintain full code status would also respect the patient’s cultural or religious identity.

A core outcome set can identify the most relevant outcomes based on the intervention (e.g., ethics committee or moral case deliberation), stakeholder perspectives and empirical research, and the limitations of these outcomes. This allows for flexibility in applying outcomes to a particular empirical study on CEC effectiveness while preserving the theoretical underpinnings of the particular CEC, context specificity of CEC, and the value-laden nature of the study outcome. Standardization, then, can (in time) be constructed within a robust and comprehensive core outcome set with accepted definitions and validated measures. Contemporaneously, the actual application of outcomes to the study of CEC will depend on the context and intervention. This requires multi-variable measurement to assess a thorough combination of relevant outcomes. Description of the methods and outcomes and any methodological limitations will need to be described in the study, but this is similar to any scientific enterprise and complex intervention where value-neutrality cannot be assumed. The process outcomes identified allow for flexibility in terms of CEC and values—thus they might be the preferred outcomes. Also, the outcomes identified may not be complete; there may be additional outcomes that have not yet been identified but that would be regarded as important by relevant stakeholders. Thus, pursuant to The Core Outcome Measurement in Effectiveness Trials initiative (an international collaborative that has described methodology to pursue core outcome sets) future research should seek to engage stakeholders and to develop consensus engagement and consultation.

Limitations

This study was confined to peer-reviewed academic literature and did not retrieve grey literature that might have shed light on some of the issues discussed. Further, the study method did not analyze or categorize the set of articles in terms of publication year; results published in the last 5 years were treated in the same way as results published 20 years ago. Finally, although the search strategy was not limited to English language, one study that was potentially eligible for inclusion in the review based on its title was excluded at full-text screening because it was not written or translated into English.

Conclusion

There is a need for the international clinical ethics community to determine standardized outcome measures for CEC evaluation research. Despite the benefits of standardized outcomes in research, there is also a need to resist the gravitational bias of evidence-based medicine and the hegemony of the physical sciences in the quest for definitive cause and effect [105]. The MRC framework, while on the one hand offers a useful guide to position CEC as relevant to health care, should be recognized as reproducing the development of complex interventions within a positivist paradigm inherent to medical practice and clinical science generally. There is a need to broaden the framework to include alternate epistemologies, including traditional and Aboriginal ways of knowing, and an anti-oppressive lens. Conflicts in values between patients and professionals, or between patients and families and clinical teams and hospital administrators, are not easily resolved and may relate to systemic injustices and historical trauma. These issues do not lend themselves to methodologies and methods that privilege the dominant perspective, observable facts, and concrete causality. The values-based realm of clinical ethics is context-bound, difficult to measure, and requires highly skilled facilitation to be effective. As is the case with other fields that encompass complex human behaviors and values (e.g., educational science), generalizable knowledge of CEC outcomes constitute one part of the overall research life-cycle. If the goal is to improve understanding of ethics in healthcare practice, producing generalizable knowledge should not necessarily be viewed as “the pinnacle and primary goal of research activity” [105], although it can provide an important contribution. While we appreciate the challenges to precision in the development of measures for CEC, we should not rest content with less precision than our field will allow. As Aristotle’s famous aphorism from the Nichomachean Ethics concludes:

Our discussion will be adequate if it has as much clearness as the subject-matter admits of, for precision is not to be sought for alike in all discussions, any more than in all the products of the craft [106].