Integrating mindfulness and the expressive arts for meaning making in cancer care: A grounded theory of the processes, facilitators, and challenges.

PURPOSE: There is a growing interest in mindfulness-based expressive arts interventions in oncology, to help patients process their experiences, learn how to live with cancer, and ameliorate psychological distress. Our research purpose was to explore how patients with cancer experience a mindfulness-based expressive arts group intervention, and to articulate individual and contextual factors influencing their experiences. METHODS: We conducted a constructivist grounded theory study and recruited 32 participants who experienced a 10-week mindfulness-based expressive arts group intervention at a tertiary cancer center in mid-Western Canada. We gathered socio-demographic data and descriptions of their experiences through semi-structured interviews. Participants brought art they had created to facilitate art elicitation. Socio-demographic data were analyzed with descriptive statistics and all other data with grounded theory methods. RESULTS: Our findings revealed how entering the group and meaning making processes through mindfulness enabled participants to let go of their ruminations and calm their minds so they could fully engage in arts activities. Participants found inspiration for their artistic expressions in mindfulness meditation which allowed them to express themselves in new ways. Although this work was challenging, combining mindfulness and the arts created a unique healing space in which individual work was nested within group processes. There were notable personal factors and perspectives that influenced participants' experiences, as well as factors related to the group design and facilitator. CONCLUSIONS: Our findings provide insight into how and when this intervention was meaningful for patients, and have important implications to guide ongoing intervention development, implementation, and evaluation.

Developing a question prompt list for family caregivers concerning the progression and palliative care needs of nursing home residents living with dementia.

Objective: Communication around a palliative approach to dementia care often is problematic or occurs infrequently in nursing homes (NH). Question prompt lists (QPLs), are evidence-based lists designed to improve communication by facilitating discussions within a specific population. This study aimed to develop a QPL concerning the progression and palliative care needs of residents living with dementia. Methods: A mixed-methods design in 2 phases. In phase 1, potential questions for inclusion in the QPL were identified using interviews with NH care providers, palliative care clinicians and family caregivers. An international group of experts reviewed the QPL. In phase 2, NH care providers and family caregivers reviewed the QPL assessing the clarity, sensitivity, importance, and relevance of each item. Results: From 127 initial questions, 30 questions were included in the first draft of the QPL. After review by experts, including family caregivers, the QPL was finalized with 38 questions covering eight content areas. Conclusion: Our study has developed a QPL for persons living with dementia in NHs and their caregivers to initiate conversations to clarify questions they may have regarding the progression of dementia, end of life care, and the NH environment. Further work is needed to evaluate its effectiveness and determine optimal use in clinical practice. Innovation: This unique QPL is anticipated to facilitate discussions around dementia care, including self-care for family caregivers.

Effect of core versus enhanced implementation strategies on adherence to a clinical pathway for managing anxiety and depression in cancer patients in routine care: a cluster randomised controlled trial.

BACKGROUND: Optimal strategies to facilitate implementation of evidence-based clinical pathways are unclear. We evaluated two implementation strategies (Core versus Enhanced) to facilitate implementation of a clinical pathway for the management of anxiety and depression in cancer patients (the ADAPT CP). METHODS: Twelve cancer services in NSW Australia were cluster randomised, stratified by service size, to the Core versus Enhanced implementation strategy. Each strategy was in place for 12 months, facilitating uptake of the ADAPT CP (the intervention being implemented). The Core strategy included a lead team with champions, staff training and awareness campaigns prior to implementation, plus access to feedback reports and telephone or online support during implementation. The Enhanced strategy included all Core supports plus monthly lead team meetings, and proactive, ongoing advice on managing barriers, staff training and awareness campaigns throughout implementation. All patients at participating sites were offered the ADAPT CP as part of routine care, and if agreeable, completed screening measures. They were allocated a severity step for anxiety/depression from one (minimal) to five (severe) and recommended management appropriate to their severity step. Multi-level mixed-effect regression analyses examined the effect of Core versus Enhanced implementation strategy on adherence to the ADAPT CP (binary primary outcome: adherent ≥ 70% of key ADAPT CP components achieved versus non-adherent < 70%), with continuous adherence as a secondary outcome. Interaction between study arm and anxiety/depression severity step was also explored. RESULTS: Of 1280 registered patients, 696 (54%) completed at least one screening. As patients were encouraged to re-screen, there were in total 1323 screening events (883 in Core and 440 in Enhanced services). The main effect of implementation strategy on adherence was non-significant in both binary and continuous analyses. Anxiety/depression step was significant, with adherence being higher for step 1 than for other steps (p = 0.001, OR = 0.05, 95% CI 0.02-0.10). The interaction between study arm and anxiety/depression step was significant (p = 0.02) in the continuous adherence analysis only: adherence was significantly higher (by 7.6% points (95% CI 0.08-15.1%) for step 3 in the Enhanced arm (p = .048) and trending to significance for step 4. DISCUSSION: These results support ongoing implementation effort for the first year of implementation to ensure successful uptake of new clinical pathways in over-burdened clinical services. TRIAL REGISTRATION: ANZCTR Registration: ACTRN12617000411347 (Trial registered 22/03/2017; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372486&isReview=true ).

Program Leaders' and Educators' Perspectives on the Factors Impacting the Implementation and Sustainment of Compassion Training Programs: A Qualitative Study.

PHENOMENON: Training programs have been used to improve compassion in healthcare, but the factors necessary to make such programs successful and sustainable have not been identified. This thematic analysis aimed to bridge the gap between theory and practice by drawing on the experiences of international leaders and educators of compassion training programs to develop a clear understanding of what is relevant and effective and how compassion training is implemented and sustained. APPROACH: International leaders and educators of compassion training programs (N = 15) were identified through convenience sampling based on academic and gray literature searches. Semi-structured face-to-face interviews with these participants were conducted between June 2020 and November 2020 in order to identify facilitators, barriers, and environmental conditions influencing the implementation and maintenance of compassion training programs. The interviews were recorded, transcribed verbatim, and analyzed using thematic analysis. FINDINGS: Six categories affecting the operationalization of compassion training programs were identified 1) origins, foundational principles and purpose, 2) curricular content, 3) methods of teaching and learning, 4) trainer qualities, 5) challenges and facilitators, and 6) evaluation and impact. INSIGHTS: Compassion training should be rooted in the construct of interest and incorporate patients' needs and their experience of compassion, with patient-reported compassion scores integrated before and after training. Compassion training should be delivered by highly qualified educators who have an understanding of the challenges associated with integrating compassion into clinical practice, a dedicated contemplative practice, and a compassionate presence in the classroom. Prior to implementing compassion training, leadership support should be secured to create an ethos of compassion throughout the organization.

Including migrant oncology patients in research: A multisite pilot randomised controlled trial testing consultation audio-recordings and question prompt lists.

Background: Oncology patients who are migrants or refugees face worse outcomes due to language and communication barriers impacting care. Interventions such as consultation audio-recordings and question prompt lists may prove beneficial in mediating communication challenges. However, designing robust research inclusive of patients who do not speak English is challenging. This study therefore aimed to: a) pilot test and assess the appropriateness of the proposed research design and methods for engaging migrant populations, and b) determine whether a multi-site RCT efficacy assessment of the communication intervention utilising these methods is feasible. Methods: This study is a mixed-methods parallel-group, randomised controlled feasibility pilot trial. Feasibility outcomes comprised assessment of: i) screening and recruitment processes, ii) design and procedures, and iii) research time and costing. The communication intervention comprised audio-recordings of a key medical consultation with an interpreter, and question prompt lists and cancer information translated into Arabic, Greek, Traditional, and Simplified Chinese. Results: Assessment of feasibility parameters revealed that despite barriers, methods utilised in this study supported the inclusion of migrant oncology patients in research. A future multi-site RCT efficacy assessment of the INFORM communication intervention using these methods is feasible if recommendations to strengthen screening and recruitment are adopted. Importantly, hiring of bilingual research assistants, and engagement with community and consumer advocates is essential. Early involvement of clinical and interpreting staff as key stakeholders is likewise recommended. Conclusion: Results from this feasibility RCT help us better understand and overcome the challenges and misconceptions about including migrant patients in clinical research.

What is the Most Valid and Reliable Compassion Measure in Healthcare? An Updated Comprehensive and Critical Review.

Our previous review of compassion measures in healthcare between 1985 and 2016 concluded that no available measure assessed compassion in healthcare in a comprehensive or methodologically rigorous fashion. The present study provided a comparative review of the design and psychometric properties of recently updated or newly published compassion measures. The search strategy of our previous review was replicated. PubMed, MEDLINE, CINAHL, and PsycINFO databases and grey literature were searched to identify studies that reported information on instruments that measure compassion or compassionate care in clinicians, physicians, nurses, healthcare students, and patients. Textual qualitative descriptions of included studies were prepared. Instruments were evaluated using the Evaluating Measures of Patient-Reported Outcomes (EMPRO) tool. Measures that underwent additional testing since our last review included the Compassion Competence Scale (CCS), the Compassionate Care Assessment Tool (CCAT)©, and the Schwartz Center Compassionate Care Scale (SCCCS)™. New compassion measures included the Sussex-Oxford Compassion for Others Scale (SOCS-O), a self-report measure of compassion for others; the Bolton Compassion Strengths Indicators (BSCI), a self-report measure of the characteristics (strengths) associated with a compassionate nurse; a five-item Tool to Measure Patient Assessment of Clinician Compassion (TMPACC); and the Sinclair Compassion Questionnaire (SCQ). The SCQ was the only measure that adhered to measure development guidelines, established initial construct validity by first defining the concept of interest, and included the patient perspective across all stages of development. The SCQ had the highest EMPRO overall score at 58.1, almost 9 points higher than any other compassion measure, and achieved perfect EMPRO subscale scores for internal consistency, reliability, validity, and respondent burden, which were up to 43 points higher than any other compassion measure. These findings establish the SCQ as the 'gold standard' compassion measure, providing an empirical basis for evaluations of compassion in routine care.

What works for whom in compassion training programs offered to practicing healthcare providers: a realist review.

BACKGROUND: Patients and families want their healthcare to be delivered by healthcare providers that are both competent and compassionate. While compassion training has begun to emerge in healthcare education, there may be factors that facilitate or inhibit the uptake and implementation of training into practice. This review identified the attributes that explain the successes and/or failures of compassion training programs offered to practicing healthcare providers. METHODS: Realist review methodology for knowledge synthesis was used to consider the contexts, mechanisms (resources and reasoning), and outcomes of compassion training for practicing healthcare providers to determine what works, for whom, and in what contexts. RESULTS: Two thousand nine hundred ninety-one articles underwent title and abstract screening, 53 articles underwent full text review, and data that contributed to the development of a program theory were extracted from 45 articles. Contexts included the clinical setting, healthcare provider characteristics, current state of the healthcare system, and personal factors relevant to individual healthcare providers. Mechanisms included workplace-based programs and participatory interventions that impacted teaching, learning, and the healthcare organization. Contexts were associated with certain mechanisms to effect change in learners' attitudes, knowledge, skills and behaviors and the clinical process. CONCLUSIONS: In conclusion this realist review determined that compassion training may engender compassionate healthcare practice if it becomes a key component of the infrastructure and vision of healthcare organizations, engages institutional participation, improves leadership at all levels, adopts a multimodal approach, and uses valid measures to assess outcomes.

Digital Storytelling as a Patient Engagement and Research Approach With First Nations Women: How the Medicine Wheel Guided Our Debwewin Journey.

When research is conducted from a Western paradigm alone, the findings and resultant policies often ignore Indigenous peoples' health practices and fail to align with their health care priorities. There is a need for decolonized approaches within qualitative health research to collaboratively identify intersecting reasons behind troubling health inequities and to integrate Indigenous knowledge into current health care services. We engaged with First Nations women to explore to what extent digital storytelling could be a feasible, acceptable, and meaningful research method to inform culturally safe health care services. This novel approach created a culturally safe and ethical space for authentic patient engagement. Our conversations were profound and provided deep insights into First Nations women's experiences with breast cancer and guidance for our future qualitative study. We found that the digital storytelling workshop facilitated a Debwewin journey, which is an ancient Anishinabe way of knowing that connects one's heart knowledge and mind knowledge.

Development and validation of a patient-reported measure of compassion in healthcare: the Sinclair Compassion Questionnaire (SCQ).

OBJECTIVES: Compassion is a key indicator of quality care that is reportedly eroding from patients' care experience. While the need to assess compassion is recognised, valid and reliable measures are lacking. This study developed and validated a clinically informed, psychometrically rigorous, patient-reported compassion measure. DESIGN: Data were collected from participants living with life-limiting illnesses over two study phases across four care settings (acute care, hospice, long term care (LTC) and homecare). In phase 1, data were analysed through exploratory factor analysis (EFA), with the final items analysed via confirmatory factor analysis (CFA) in phase 2. The Schwartz Center Compassionate Care Scale (SCCCS), the revised Edmonton Symptom Assessment Scale (ESAS-r) and Picker Patient Experience Questionnaire (PPEQ) were also administered in phase 2 to assess convergent and divergent validity. SETTING AND PARTICIPANTS: 633 participants were recruited over two study phases. In the EFA phase, a 54-item version of the measure was administered to 303 participants, with 330 participants being administered the final 15-item measure in the CFA phase. RESULTS: Both EFA and CFA confirmed compassion as a single factor construct with factor loadings for the 15-item measure ranging from 0.76 to 0.86, with excellent test-retest reliability (intraclass correlation coefficient range: 0.74-0.89) and excellent internal reliability (Cronbach's alpha of 0.96). The measure was positively correlated with the SCCCS (r=0.75, p<0.001) and PPEQ (r=0.60, p<0.001). Participants reporting higher experiences of compassion had significantly greater well-being and lower depression on the ESAS-r. Patients in acute care and hospice reported significantly greater experiences of compassion than LTC residents. CONCLUSIONS: There is strong initial psychometric evidence for the Sinclair Compassion Questionnaire (SCQ) as a valid and reliable patient-reported compassion measure. The SCQ provides healthcare providers, settings and administrators the means to routinely measure patients experiences of compassion, while providing researchers a robust measure to conduct high-quality research.

More than just a task: intimate care delivery in the nursing home.

Purpose: Intimate care procedures, such as bathing and toileting, are often regarded as simple, humble tasks. However, the provision of such care transforms a very private, personal activity into a social process. Understanding this complex process and the psychological impact it has on those providing and receiving care is critical in order to mitigate potential distress. The purpose of this study to examine the experience of delivering and receiving intimate personal care in the NH.Methods: A focused ethnographic approach with participant observation, semi-structured interviews, focus groups and drop-in sessions, document review, and field notes. Data were analysed using constant comparative analysis.Results: Quality care in this context is predicated on the care provider recognition of the emotional impact of care delivery on the care recipient. Our analysis identified that the overarching theme, of providing quality person-centred intimate care, requires creating and maintaining a relational space that promotes integrity.Conclusions: The provision of intimate personal care consists of a complex interplay at the level of resident/care provider interaction (micro level); health care organization (meso level); and policy (macro level). Each of these levels interacts with and influences the other two. The components identified in our model may provide the basis from which to further examine resident experiences of quality intimate personal care.

What Is the State of Compassion Education? A Systematic Review of Compassion Training in Health Care.

PURPOSE: To investigate the current state and quality of compassion education interventions offered to health care providers during training or practice, determine how the components of each education intervention map onto the domains of an empirically based clinical model of compassion, and identify the most common approaches to compassion education. METHOD: The MEDLINE, Embase, CINAHL Plus with Full Text, Sociological Abstracts, Web of Science, ERIC, and Education Research Complete databases were searched from inception to March 2020 in this systematic review. Studies that evaluated a compassion education intervention for health care providers or those in training to enhance compassion toward patients and/or families were included. A narrative synthesis of the included studies was performed. The components of each intervention were mapped onto the domains of compassion described in the Patient Compassion Model. RESULTS: One hundred eight peer-reviewed publications describing 103 interventions were included. Modalities ranged from establishing curricula and interventions in clinical settings to programs that used humanities-based reflective practices, clinical simulation, role modeling, and contemplative practices, with many education interventions adopting a multimodal approach. Most interventions mapped to the virtuous response domain of the Patient Compassion Model; very few mapped to the other domains of this model. CONCLUSIONS: Most interventions were limited as they focused on a single domain of compassion; did not adequately define compassion; were assessed exclusively by self-report; were devoid of a comparator/control group; and did not evaluate retention, sustainability, and translation to clinical practice over time. The authors suggest that compassion education interventions be grounded in an empirically based definition of compassion; use a competency-based approach; employ multimodal teaching methods that address the requisite attitudes, skills, behaviors, and knowledge within the multiple domains of compassion; evaluate learning over time; and incorporate patient, preceptor, and peer evaluations.

Impact of consultation recordings on patient-reported outcomes in patients with brain tumors: a parallel randomized controlled trial.

OBJECTIVE: We aimed to determine the impact of a primary treatment consultation recording on perception of being informed, satisfaction with cancer care, satisfaction with the oncologist, and psychological distress in patients with brain tumors. METHODS: This was a prospective, double-blind, parallel, randomized controlled trial conducted in 3 Canadian cities, in which patients who had their initial treatment consultation recorded were assigned to either receive their digital recording or not. It was hypothesized that patients who received their recording would realize statistically significant benefit on the outcomes of interest at 1 week, 3 months, and 6 months post-consultation in comparison to patients who did not receive their recording. Outcome measures included the following: Patient Satisfaction with Cancer Scale, Hospital Anxiety and Depression Scale, PrestMan Satisfaction with Doctor Scale, and Perception of Being Informed Scale. RESULTS: Of the 246 eligible patients, 133 participated (60.9% male; age M=52.4 years; 53.4% grade IV disease). Of these, 63 received their consultation recording and 70 did not. Intention-to-treat analysis showed that, compared to baseline, patients who received their consultation recording reported being more fully informed about their disease and treatment at 1 week post-consultation than patients who did not receive their recording (p = 0.007), but this finding was no longer significant at 3 and 6 months. There were no statistically significant differences observed between the two groups on the measures of satisfaction with cancer care, satisfaction with the doctor, and depression or anxiety at any assessment time point, though the study was under-powered. CONCLUSION: The study findings show that primary treatment consultation recordings may provide limited benefit beyond brain tumor patients' perception of being informed, despite being highly valued by these patients, and high listening rates among their significant others. The lack of statistical power should be considered when interpreting the findings. TRIAL REGISTRATION: ClinicalTrials.gov - NCT01866228.

The patient needs assessment in cancer care: identifying barriers and facilitators to implementation in the UK and Canada.

PURPOSE: Personalised information and support can be provided to cancer survivors using a structured approach. Needs assessment tools such as the Holistic Needs Assessment (HNA) in the UK and the Comprehensive Problem and Symptom Screening (COMPASS) questionnaire in Canada are recommended for use in practice; however, they are not widely embedded into practice. The study aimed to determine the extent to which nurses working in cancer care in the UK and Manitoba value NA and identify any barriers and facilitators they experience. METHOD: Oncology nurses involved in the care of cancer patients in the UK (n = 110) and Manitoba (n = 221) were emailed a link to an online survey by lead cancer nurses in the participating institutions. A snowball technique was used to increase participation across the UK resulting in 306 oncology nurses completing the survey in the UK and 116 in Canada. RESULTS: Participants expressed concerns that these assessments were becoming bureaucratic "tick-box exercises" which did not meet patients' needs. Barriers to completion were time, staff shortages, lack of confidence, privacy, and resources. Facilitators were privacy for confidential discussions, training, confidence in knowledge and skills, and referral to resources. CONCLUSION: Many busy oncology nurses completed this survey demonstrating the importance they attach to HNAs and COMPASS. The challenges faced with implementing these assessments into everyday practice require training, time, support services, and an appropriate environment. It is vital that the HNA and COMPASS are conducted at optimum times for patients to fully utilise time and resources.

Elevating the uses of storytelling approaches within Indigenous health research: a critical and participatory scoping review protocol involving Indigenous people and settlers.

BACKGROUND: There is a complicated and exploitative history of research with Indigenous peoples and accompanying calls to meaningfully and respectfully include Indigenous knowledge in healthcare. Storytelling approaches that privilege Indigenous voices can be a useful tool to break the hold that Western worldviews have within the research. Our collaborative team of Indigenous and non-Indigenous researchers, and Indigenous patients, Elders, healthcare providers, and administrators, will conduct a critical participatory, scoping review to identify and examine how storytelling has been used as a method in Indigenous health research. METHODS: Guided by two-eyed seeing, we will use Bassett and McGibbon's adaption of Arksey and O'Malley's scoping review methodology. Relevant articles will be identified through a systematic search of the gray literature, core Indigenous health journals, and online databases including Scopus, MEDLINE, Embase, CINAHL, AgeLine, Academic Search Complete, Bibliography of Native North Americans, Canadian Reference Centre, and PsycINFO. Qualitative and mixed-methods research articles will be included if the researchers involved Indigenous participants or their healthcare professionals living in Turtle Island (i.e., Canada and the USA), Australia, or Aotearoa (New Zealand); use storytelling as a research method; focus on healthcare phenomena; and are written in English. Two reviewers will independently screen titles/abstracts and full-text articles. We will extract data, identify the array of storytelling approaches, and critically examine how storytelling was valued and used. An intensive collaboration will be woven throughout all review stages as academic researchers co-create this work with Indigenous patients, Elders, healthcare professionals, and administrators. Participatory strategies will include four relational gatherings throughout the project. Based on our findings, we will co-create a framework to guide the respectful use of storytelling as a method in Indigenous health research involving Indigenous and non-Indigenous peoples. DISCUSSION: This work will enable us to elucidate the extent, range, and nature of storytelling within Indigenous health research, to critically reflect on how it has been and could be used, and to develop guidance for the respectful use of this method within research that involves Indigenous peoples and settlers. Our findings will enable the advancement of storytelling methods which meaningfully include Indigenous perspectives, practices, and priorities to benefit the health and wellbeing of Indigenous communities. SYSTEMATIC REVIEW PROTOCOL REGISTRATION: Open Science Framework ( https://osf.io/rvf7q ).

Healthcare providers perspectives on compassion training: a grounded theory study.

BACKGROUND: There is little concrete guidance on how to train current and future healthcare providers (HCPs) in the core competency of compassion. This study was undertaken using Straussian grounded theory to address the question: "What are healthcare providers' perspectives on training current and future HCPs in compassion?" METHODS: Fifty-seven HCPs working in palliative care participated in this study, beginning with focus groups with frontline HCPs (n = 35), followed by one-on-one interviews with HCPs who were considered by their peers to be skilled in providing compassion (n = 15, three of whom also participated in the initial focus groups), and end of study focus groups with study participants (n = 5) and knowledge users (n = 10). RESULTS: Study participants largely agreed that compassionate behaviours can be taught, and these behaviours are distinct from the emotional response of compassion. They noted that while learners can develop greater compassion through training, their ability to do so varies depending on the innate qualities they possess prior to training. Participants identified three facets of an effective compassion training program: self-awareness, experiential learning and effective and affective communication skills. Participants also noted that healthcare faculties, facilities and organizations play an important role in creating compassionate practice settings and sustaining HCPs in their delivery of compassion. CONCLUSIONS: Providing compassion has become a core expectation of healthcare and a hallmark of quality palliative care. This study provides guidance on the importance, core components and teaching methods of compassion training from the perspectives of those who aim to provide it-Healthcare Providers-serving as a foundation for future evidence based educational interventions.

A Practical Guide for Item Generation in Measure Development: Insights From the Development of a Patient-Reported Experience Measure of Compassion.

BACKGROUND AND PURPOSE: Although various measure development guidelines exist, practical guidance on how to systematically generate items is nascent. This article provides practical guidance on item generation in measure development and the use of a Table of Specifications (TOS) in this process. METHODS: In addition to a review of the literature, the item generation process within an ongoing study to develop a valid and reliable patient-reported measure of compassion is provided. RESULTS: Consensus on an initial pool of 109 items and their response scale was achieved with the aid of a TOS. CONCLUSIONS: Dynamic, experiential, and relational care constructs such as compassion lie at the heart of nursing. Practical guidance on item generation is needed to allow nurses to identify, measure, and improve compassion in research and practice.

Initial Validation of a Patient-Reported Measure of Compassion: Determining the Content Validity and Clinical Sensibility among Patients Living with a Life-Limiting and Incurable Illness.

BACKGROUND: Although compassionate care is considered a cornerstone of quality palliative care, there is a paucity of valid and reliable measures to study, assess, and evaluate how patients experience compassion/compassionate care in their care. OBJECTIVE: The aim was to develop a patient-reported compassion measure for use in research and clinical practice with established content-related validity evidence for the items, question stems, and response scale. METHODS: Content validation for an initial 109 items was conducted through a two-round modified Delphi technique, followed by cognitive interviews with patients. A panel of international Subject Matter Experts (SMEs) and a Patient Advisory Group (PAG) assessed the items for their relevancy to their associated domain of compassion, yielding an Item-level Content Validity Index (I-CVI), which was used to determine content modifications. The SMEs and the PAG also provided narrative feedback on the clarity, flow, and wording of the instructions, questions, and response scale, with items being modified accordingly. Cognitive interviews were conducted with 16 patients to further assess the clarity, comprehensibility, and readability of each item within the revised item pool. RESULTS: The first round of the Delphi review produced an overall CVI of 72% among SMEs and 80% among the PAG for the 109 items. Delphi panelists then reviewed a revised measure containing 84 items, generating an overall CVI of 84% for SMEs and 86% for the PAG. Sixty-eight items underwent further testing via cognitive interviews with patients, resulting in an additional 14 items being removed. CONCLUSIONS: Having established this initial validity evidence, further testing to assess internal consistency, test-retest reliability, factor structure, and relationships to other variables is required to produce the first valid, reliable, and clinically informed patient-reported measure of compassion.

The Elusive Search for Success: Defining and Measuring Implementation Outcomes in a Real-World Hospital Trial.

Objective and Study Setting: Research efforts to identify factors that influence successful implementation are growing. This paper describes methods of defining and measuring outcomes of implementation success, using a cluster randomized controlled trial with 12 cancer services in Australia comparing the effectiveness of implementation strategies to support adherence to the Australian Clinical Pathway for the Screening, Assessment and Management of Anxiety and Depression in Adult Cancer Patients (ADAPT CP). Study Design and Methods: Using the StaRI guidelines, a process evaluation was planned to explore participant experience of the ADAPT CP, resources and implementation strategies according to the Implementation Outcomes Framework. This study focused on identifying measurable outcome criteria, prior to data collection for the trial, which is currently in progress. Principal Findings: We translated each implementation outcome into clearly defined and measurable criteria, noting whether each addressed the ADAPT CP, resources or implementation strategies, or a combination of the three. A consensus process defined measures for the primary outcome (adherence) and secondary (implementation) outcomes; this process included literature review, discussion and clear measurement parameters. Based on our experience, we present an approach that could be used as a guide for other researchers and clinicians seeking to define success in their work. Conclusions: Defining and operationalizing success in real-world implementation yields a range of methodological challenges and complexities that may be overcome by iterative review and engagement with end users. A clear understanding of how outcomes are defined and measured, based on a strong theoretical framework, is crucial to meaningful measurement and outcomes. The conceptual approach described in this article could be generalized for use in other studies. Trial Registration: The ADAPT Program to support the management of anxiety and depression in adult cancer patients: a cluster randomized trial to evaluate different implementation strategies of the Clinical Pathway for Screening, Assessment and Management of Anxiety and Depression in Adult Cancer Patients was prospectively registered with the Australian New Zealand Clinical Trials Registry Registration Number: ACTRN12617000411347.

Comparison of implementation strategies to influence adherence to the clinical pathway for screening, assessment and management of anxiety and depression in adult cancer patients (ADAPT CP): study protocol of a cluster randomised controlled trial.

BACKGROUND: Health service change is difficult to achieve. One strategy to facilitate such change is the clinical pathway, a guide for clinicians containing a defined set of evidence-based interventions for a specific condition. However, optimal strategies for implementing clinical pathways are not well understood. Building on a strong evidence-base, the Psycho-Oncology Co-operative Research Group (PoCoG) in Australia developed an evidence and consensus-based clinical pathway for screening, assessing and managing cancer-related anxiety and depression (ADAPT CP) and web-based resources to support it - staff training, patient education, cognitive-behavioural therapy and a management system (ADAPT Portal). The ADAPT Portal manages patient screening and prompts staff to follow the recommendations of the ADAPT CP. This study compares the clinical and cost effectiveness of two implementation strategies (varying in resource intensiveness), designed to encourage adherence to the ADAPT CP over a 12-month period. METHODS: This cluster randomised controlled trial will recruit 12 cancer service sites, stratified by size (large versus small), and randomised at site level to a standard (Core) versus supported (Enhanced) implementation strategy. After a 3-month period of site engagement, staff training and site tailoring of the ADAPT CP and Portal, each site will "Go-live", implementing the ADAPT CP for 12 months. During the implementation phase, all eligible patients will be introduced to the ADAPT CP as routine care. Patient participants will be registered on the ADAPT Portal to complete screening for anxiety and depression. Staff will be responsible for responding to prompts to follow the ADAPT CP. The primary outcome will be adherence to the ADAPT CP. Secondary outcomes include staff attitudes to and experiences of following the ADAPT CP, using the ADAPT Portal and being exposed to ADAPT implementation strategies, collected using quantitative and qualitative methods. Data will be collected at T0 (baseline, after site engagement), T1 (6 months post Go-live) and T2 (12 months post Go-live). DISCUSSION: This will be the first cluster randomised trial to establish optimal levels of implementation effort and associated costs to achieve successful uptake of a clinical pathway within cancer care. TRIAL REGISTRATION: The study was registered prospectively with the ANZCTR on 22/3/2017. Trial ID ACTRN12617000411347.