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.

What are healthcare providers' understandings and experiences of compassion? The healthcare compassion model: a grounded theory study of healthcare providers in Canada.

BACKGROUND: Healthcare providers are considered the primary conduit of compassion in healthcare. Although most healthcare providers desire to provide compassion, and patients and families expect to receive it, an evidence-based understanding of the construct and its associated dimensions from the perspective of healthcare providers is needed. OBJECTIVES: The aim of this study was to investigate healthcare providers' perspectives and experiences of compassion in order to generate an empirically derived, clinically informed model. DESIGN: Data were collected via focus groups with frontline healthcare providers and interviews with peer-nominated exemplary compassionate healthcare providers. Data were independently and collectively analysed by the research team in accordance with Straussian grounded theory. SETTING AND PARTICIPANTS: 57 healthcare providers were recruited from urban and rural palliative care services spanning hospice, home care, hospital-based consult teams, and a dedicated inpatient unit within Alberta, Canada. RESULTS: Five categories and 13 associated themes were identified, illustrated in the Healthcare Provider Compassion Model depicting the dimensions of compassion and their relationship to one another. Compassion was conceptualised as-a virtuous and intentional response to know a person, to discern their needs and ameliorate their suffering through relational understanding and action. CONCLUSIONS: An empirical foundation of healthcare providers' perspectives on providing compassionate care was generated. While the dimensions of the Healthcare Provider Compassion Model were congruent with the previously developed Patient Model, further insight into compassion is now evident. The Healthcare Provider Compassion Model provides a model to guide clinical practice and research focused on developing interventions, measures and resources to improve it.

Healthcare providers' perspectives on perceived barriers and facilitators of compassion: Results from a grounded theory study.

AIMS AND OBJECTIVES: To explore healthcare provider perspectives and experiences of perceived barriers and facilitators of compassion. BACKGROUND: Compassion is considered a component of quality health care that healthcare providers are increasingly expected to provide. While there have been some studies exploring facets of healthcare providers' perspectives on the barriers and facilitators to providing compassion, a comprehensive understanding based on direct reports from healthcare providers is lacking. DESIGN: Data were collected via focus groups and semi-structured interviews. Data was analyzed in accordance with Straussian grounded theory. METHODS: Semistructured focus groups with frontline healthcare providers and individual interviews with peer-nominated exemplary compassionate care providers were audio-recorded, professionally transcribed and analysed. Fifty-seven participants were recruited from three healthcare settings within both rural and urban settings in Alberta, Canada, using convenience, snowball and theoretical sampling. RESULTS: Qualitative analysis of the data generated two categories and associated themes and subthemes delineating perceived barriers and facilitators to compassion. The first category, challenges to compassion, reflects participants' discomfort associating the notion of barriers to compassion and contained several themes participants conceptualised as challenges: personal challenges, relational challenges, systemic challenges and maladaptive responses. The second category, facilitators of compassion, included the themes of personal facilitators, relational facilitators, systemic facilitators and adaptive responses of intentional action. CONCLUSION: Although participants described certain factors such as system and time constraints along with interaction styles of patients and families that can challenge healthcare provider compassion, these challenges were not considered insurmountable. While acknowledging these as challenges, participants identified healthcare providers themselves, including their responses towards the identified challenges of compassion, as significant factors in this process-a novel finding from this study. This study provides insight into healthcare providers' perspectives on the notion of barriers and facilitators in the provision of compassion. RELEVANCE TO CLINICAL PRACTICE: This study provides a blueprint for optimising compassion on a personal, relational and system level.

Tetrodotoxin for Moderate to Severe Cancer-Related Pain: A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Trial.

OBJECTIVE: This study evaluated subcutaneous injections of tetrodotoxin (TTX) for the treatment of moderate to severe, inadequately controlled cancer-related pain. METHODS: Eligible patients were randomized to receive TTX (30 µg) or placebo subcutaneously twice daily for four consecutive days. Efficacy was assessed using pain and composite endpoints (including pain and quality of life measures), and safety was evaluated using standard measures. RESULTS: 165 patients were enrolled at 19 sites in Canada, Australia, and New Zealand, with 149 patients in the primary analysis "intent-to-treat" population. The primary analysis supports a clinical benefit of TTX over placebo based on the pain endpoint alone with a clinically significant estimated effect size of 16.2% (p = 0.0460). The p value was nominally statistically significant after prespecified (Bonferroni Holm) adjustment for the two primary endpoints but not at the prespecified two-sided 5% level. The mean duration of analgesic response was 56.7 days (TTX) and 9.9 days (placebo). Most common adverse events were nausea, dizziness, and oral numbness or tingling and were generally mild to moderate and transient. CONCLUSIONS: Although underpowered, this study demonstrates a clinically important analgesic signal. TTX may provide clinically meaningful analgesia for patients who have persistent moderate to severe cancer pain despite best analgesic care. This clinical study is registered with ClinicalTrials.gov (NCT00725114).

Sympathy, empathy, and compassion: A grounded theory study of palliative care patients' understandings, experiences, and preferences.

BACKGROUND: Compassion is considered an essential element in quality patient care. One of the conceptual challenges in healthcare literature is that compassion is often confused with sympathy and empathy. Studies comparing and contrasting patients' perspectives of sympathy, empathy, and compassion are largely absent. AIM: The aim of this study was to investigate advanced cancer patients' understandings, experiences, and preferences of "sympathy," "empathy," and "compassion" in order to develop conceptual clarity for future research and to inform clinical practice. DESIGN: Data were collected via semi-structured interviews and then independently analyzed by the research team using the three stages and principles of Straussian grounded theory. SETTING/PARTICIPANTS: Data were collected from 53 advanced cancer inpatients in a large urban hospital. RESULTS: Constructs of sympathy, empathy, and compassion contain distinct themes and sub-themes. Sympathy was described as an unwanted, pity-based response to a distressing situation, characterized by a lack of understanding and self-preservation of the observer. Empathy was experienced as an affective response that acknowledges and attempts to understand individual's suffering through emotional resonance. Compassion enhanced the key facets of empathy while adding distinct features of being motivated by love, the altruistic role of the responder, action, and small, supererogatory acts of kindness. Patients reported that unlike sympathy, empathy and compassion were beneficial, with compassion being the most preferred and impactful. CONCLUSION: Although sympathy, empathy, and compassion are used interchangeably and frequently conflated in healthcare literature, patients distinguish and experience them uniquely. Understanding patients' perspectives is important and can guide practice, policy reform, and future research.

Compassion training in healthcare: what are patients' perspectives on training healthcare providers?

BACKGROUND: The purpose of this qualitative study was to investigate advanced cancer patients' perspectives on the importance, feasibility, teaching methods, and issues associated with training healthcare providers in compassionate care. METHODS: This study utilized grounded theory, a qualitative research method, to develop an empirical understanding of compassion education rooted in direct patient reports. Audio-recorded semi-structured interviews were conducted to obtain an in-depth understanding of compassion training from the perspectives of hospitalized advanced cancer patients (n = 53). Data were analyzed in accordance with grounded theory to determine the key elements of the underlying theory. RESULTS: Three overarching categories and associated themes emerged from the data: compassion aptitude, cultivating compassion, and training methods. Participants spoke of compassion as an innate quality embedded in the character of learners prior to their healthcare training, which could be nurtured through experiential learning and reflective practices. Patients felt that the innate qualities that learners possessed at baseline were further fashioned by personal and practice experiences, and vocational motivators. Participants also provided recommendations for compassion training, including developing an interpersonal relationship with patients, seeing the patient as a person, and developing a human connection. Teaching methods that patients suggested in compassion training included patient-centered communication, self-reflection exercises, and compassionate role modeling. CONCLUSIONS: This study provides insight on compassion training for both current and future healthcare providers, from the perspectives of the end recipients of healthcare provider training - patients. Developing a theoretical base for patient centred, evidence-informed, compassion training is a crucial initial step toward the further development of this core healthcare competency.

Compassion: a scoping review of the healthcare literature.

BACKGROUND: Recent concerns about suboptimal patient care and a lack of compassion have prompted policymakers to question the preparedness of clinicians for the challenging environment in which they practice. Compassionate care is expected by patients and is a professional obligation of clinicians; however, little is known about the state of research on clinical compassion. The purpose of this scoping review was to map the literature on compassion in clinical healthcare. METHODS: Searches of eight electronic databases and the grey literature were conducted to identify empirical studies published over the last 25 years. Eligible studies explored perceptions or interventions of compassionate care in clinical populations, healthcare professionals, and healthcare students. Following the title and abstract review, two reviewers independently screened full-texts articles, and extracted study data. A narrative approach to synthesizing and mapping the literature was used. RESULTS AND DISCUSSION: Of 36,637 records, 648 studies were retrieved and 44 studies were included in the review. Less than one third of studies included patients. Six themes emerged from studies that explored perceptions of compassionate care: nature of compassion, development of compassion, interpersonal factors related to compassion, action and practical compassion, barriers and enablers of compassion, and outcomes of compassion. Intervention studies included two compassionate care trials with patients and eight educational programs that aimed to improve compassionate care in clinicians and students. CONCLUSIONS: This review identifies the limited empirical understanding of compassion in healthcare, highlighting the lack of patient and family voices in compassion research. A deeper understanding of the key behaviors and attitudes that lead to improved patient-reported outcomes through compassionate care is necessary.

Compassion in Health Care: An Empirical Model.

CONTEXT: Compassion is frequently referenced as a hallmark of quality care by patients, health care providers, health care administrators, and policy makers. Despite its putative centrality, including its institution in recent health care reform, an empirical understanding based on the perspectives of patients, the recipients of compassion, is lacking-making compassion one of the most referenced yet poorly understood elements of quality care. OBJECTIVES: The objective of this study was to investigate palliative cancer patients' understanding and experiences of compassion to provide a critical perspective on the nature and importance of compassion. METHODS: This grounded theory study used semi-structured interviews to investigate how patients understand and experience compassion in clinical care. Using convenience and theoretical sampling, 53 advanced cancer inpatients were recruited over a seven-month period from a specialized palliative care unit and hospital-wide palliative care service within a Canadian urban setting. Data were analyzed by four members of the research team through the three stages of Straussian grounded theory. RESULTS: Qualitative analysis yielded seven categories, each containing distinct themes and subthemes. Together, they constitute components of the compassion model-the first empirically based clinical model of compassion. The model defines compassion as a virtuous response that seeks to address the suffering and needs of a person through relational understanding and action. CONCLUSION: The components of the compassion model provide insight into how patients understand and experience compassion, providing the necessary empirical foundation to develop future research, measures, training, and clinical care based on this vital feature of quality care.

Assessment of study quality for systematic reviews: a comparison of the Cochrane Collaboration Risk of Bias Tool and the Effective Public Health Practice Project Quality Assessment Tool: methodological research.

BACKGROUND: The Cochrane Collaboration is strongly encouraging the use of a newly developed tool, the Cochrane Collaboration Risk of Bias Tool (CCRBT), for all review groups. However, the psychometric properties of this tool to date have yet to be described. Thus, the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity, in comparison with the Effective Public Health Practice Project Quality Assessment Tool (EPHPP). METHODS: Both tools were used to assess the methodological quality of 20 randomized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions to improve the management of cancer pain. Each study assessment was completed independently by two reviewers using each tool. We analysed the inter-rater reliability of each tool's individual domains, as well as final grade assigned to each study. RESULTS: The EPHPP had fair inter-rater agreement for individual domains and excellent agreement for the final grade. In contrast, the CCRBT had slight inter-rater agreement for individual domains and fair inter-rater agreement for final grade. Of interest, no agreement between the two tools was evident in their final grade assigned to each study. Although both tools were developed to assess 'quality of the evidence', they appear to measure different constructs. CONCLUSIONS: Both tools performed quite differently when evaluating the risk of bias or methodological quality of studies in knowledge translation interventions for cancer pain. The newly introduced CCRBT assigned these studies a higher risk of bias. Its psychometric properties need to be more thoroughly validated, in a range of research fields, to understand fully how to interpret results from its application.

Is there a role for clinical practice guidelines in multidisciplinary tumor board meetings? A descriptive study of knowledge transfer between research and practice.

The aim of this study was to characterize practice patterns and decision-making processes of healthcare providers attending weekly neuro-oncology tumor board meetings, and to assess their familiarity with clinical practice guidelines (CPGs) in neuro-oncology. Members of the Neuro-Oncology Tumor Team at two tertiary cancer centers completed a web-based questionnaire assessing characteristics of weekly tumor board meetings and perceptions of CPGs. Twenty-three (66%) tumor team members responded. Diagnostic imaging results and interpretation, medical, surgical, and/or radiation treatment planning, and pathology results and interpretation were the most commonly identified aspects of patient care discussed at tumor board meetings, and almost all respondents indicated that these meetings were "very beneficial" to their own practice. When deciding on a treatment plan, respondents rely most on the clinical expertise of colleagues, medical literature, personal experience, active clinical trial protocols, and published CPGs. Opinions of the local CPGs varied considerably, and while 56% of respondents supported regular discussion of them during meetings, only 32% indicated that they were routinely reviewed. Updating the literature more frequently, implementing a formal grading system for the evidence, and incorporating clinical care pathways were the most frequently cited methods to improve the CPGs. Tumor board meetings are beneficial to the treatment planning process for neuro-oncology patients.

Furthering the prostate cancer screening debate (prostate cancer specific mortality and associated risks).

Screening for prostate cancer remains a contentious issue. As with other cancer screening programs, a key feature of the debate is verification of cancer-specific mortality reductions. Unfortunately the present evidence, two systematic reviews and six randomized controlled trials, have reported conflicting results. Furthermore, half of the studies are poor quality and the evidence is clouded by key weaknesses, including poor adherence to screening in the intervention arm or high rates of screening in the control arm. In high quality studies of prostate cancer screening (particularly prostate-specific antigen), in which actual compliance was anticipated in the study design, there is good evidence that prostate cancer mortality is reduced. The numbers needed to screen are at least as good as those of mammography for breast cancer and fecal occult blood testing for colorectal cancer. However, the risks associated with prostate cancer screening are considerable and must be weighed against the advantage of reduced cancer-specific mortality. Adverse events include 70% rate of false positives, important risks associated with prostate biopsy, and the serious consequences of prostate cancer treatment. The best evidence demonstrates prostate cancer screening will reduce prostate cancer mortality. It is time for the debate to move beyond this issue, and begin a well-informed discussion on the remaining complex issues associated with prostate cancer screening and appropriate management.

Design and implementation of an online course on research methods in palliative care: lessons learned.

BACKGROUND: Research capacity in palliative and end-of-life care is less than some other fields of medicine where there is a longer track record of biomedical research. Palliative medicine clinicians often receive little or no formal research training during their postgraduate education; hence, education efforts may prove pivotal to increasing palliative care research capacity. To that end, our group established a national online training program on palliative care research methodologies, called Foundations of Palliative Care Research. This report describes the development and implementation of the course, and its evaluation. To inform decisions on the overall course objectives, length, design, and implementation, formal needs assessments were conducted through surveys of Canadian palliative medicine residency program directors and of Canadian palliative medicine residents. METHODS: A 12-week, online, module-based course was designed. The first iteration of the course was offered to English-speaking palliative medicine residents from across Canada between October 2008 and March 2009. The course utilized Web-based communication methods, and was delivered using a combination of asynchronous and synchronous learning strategies and activities. RESULTS: Ten palliative care residents from different parts of the country registered and all completed the course with passing marks. Participants evaluated the course through a post course survey. The formal evaluation of the course, along with successes, challenges, and lessons applicable to future ventures, are discussed.

Formal feasibility studies in palliative care: why they are important and how to conduct them.

The concept of clinical trial feasibility is of great interest to the community of palliative care researchers, clinicians, and granting agencies. Significant allocation of resources is required in the form of funding, time, intellect, and motivation to carry out clinical research, and understandably, clinical investigators, institutions, and granting agencies are disappointed when funded trials are unsuccessfully conducted. We argue that for many trials conducted in palliative care, the feasibility of conducting the proposed trial should be formally explored before implementation. There is substantial information available within the literature on the topic of study feasibility but no singular guide on how one can pragmatically apply this advice in the palliative care setting. We suggest that a Formal Feasibility Study for palliative care trials should be commonly conducted before development of a larger pivotal trial, to prospectively identify barriers to research, develop strategies to address these barriers, and predict whether the larger study is feasible. If a Formal Feasibility Study is not required, elements of feasibility can be specifically tested before launching clinical trials. The purpose of this article is to offer a draft framework for the design and conduct of a Formal Feasibility Study that, if implemented, could concretely support successful completion of high-quality research in a timely fashion. Additionally, we hope to foster dialogue within the palliative care research community regarding the relevance of establishing feasibility before initiation of definitive trials in the palliative care population.

Effectiveness of knowledge translation interventions to improve cancer pain management.

CONTEXT: Cancer pain is prevalent, yet patients do not receive best care despite widely available evidence. Although national cancer control policies call for education, effectiveness of such programs is unclear and best practices are not well defined. OBJECTIVES: To examine existing evidence on whether knowledge translation (KT) interventions targeting health care providers, patients, and caregivers improve cancer pain outcomes. METHODS: A systematic review and meta-analysis were undertaken to evaluate primary studies that examined effects of KT interventions on providers and patients. RESULTS: Twenty-six studies met the inclusion criteria. Five studies reported interventions targeting health care providers, four focused on patients or their families, one study examined patients and their significant others, and 16 studies examined patients only. Seven quantitative comparisons measured the statistical effects of interventions. A significant difference favoring the treatment group in least pain intensity (95% confidence interval [CI]: 0.44, 1.42) and in usual pain/average pain (95% CI: 0.13, 0.74) was observed. No other statistical differences were observed. However, most studies were assessed as having high risk of bias and failed to report sufficient information about the intervention dose, quality of educational material, fidelity, and other key factors required to evaluate effectiveness of intervention design. CONCLUSION: Trials that used a higher dose of KT intervention (characterized by extensive follow-up, comprehensive educational program, and higher resource allocation) were significantly more likely to have positive results than trials that did not use this approach. Further attention to methodological issues to improve educational interventions and research to clarify factors that lead to better pain control are urgently needed.

A patient-completed and optically read data acquisition system for clinical trials.

Data collection and management within multicentre clinical trials can be challenging. We describe an adaptation of Teleform® technology to enable data recording by patients and their families on teleforms faxed and optically read directly into an electronic database, eliminating the need for case report forms. Preliminary results from a modest study sample size support the use of optically read forms for data collection by patients and their families, requiring only a pen, paper, and fax machine at participating sites.

Neuropathic pain features in patients with bone metastases referred for palliative radiotherapy.

PURPOSE: To estimate the prevalence of pain with neuropathic features among patients with metastatic bone pain and to assess differences between patients with and without neuropathic features by pain severity, functional interference, and quality-of-life (QOL) measures. PATIENTS AND METHODS: A prospective cross-sectional survey of consecutive patients with symptomatic bone metastases was conducted between December 2006 and March 2008 at a comprehensive cancer center. Patients completed the Brief Pain Inventory (BPI), the Self-Reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS), and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30). Statistical associations between pain with neuropathic features and other measures were explored. RESULTS: Ninety-eight patients were enrolled. Seventeen percent of patients (95% CI, 10% to 24%) had positive S-LANSS scores suggesting pain with neuropathic features. Mean worst pain and mean interference scores were 7.2 (standard deviation [SD], 2.0) and 5.8 (SD, 2.5), respectively. EORTC QLQ-C30 global QOL, function, and symptom scores were 42 (SD, 24), 52 (SD, 20), and 46 (SD, 17), respectively. Patients with neuropathic features had a higher BPI worst pain score than patients without neuropathic features (8.3 v 7.0, respectively; P = .016). Corticosteroid use, oral morphine equivalent dosing, and site of bone pain were not associated with neuropathic features. CONCLUSION: Some patients with bone metastases manifest bone pain with distinguishable neuropathic features, and these patients reported greater pain intensity. Additional work is required to validate the S-LANSS against clinical criteria for neuropathic pain in this context and to explore the unmet pain management needs in this population.

A formal feasibility study of sublingual methadone for breakthrough cancer pain.

We conducted a feasibility study of sublingual methadone for breakthrough cancer pain, to determine whether a larger, randomized trial was warranted, and to identify a study design that would be likely to succeed. From approximately 1930 patients in the initial pool, nine patients were enrolled. Five patients completed the study, generating data on 83 discrete episodes of breakthrough cancer pain at optimal dose. Mean pain intensity dropped by 1.7 points (on a 10 point numerical scale) within 10 min of sublingual methadone administration, and by 3.2 points after 15 min. No serious or severe toxicity was encountered. Based on the results of this feasibility study, a larger randomized clinical trial of sublingual methadone for breakthrough cancer pain using this trial model would not be successful. Extensive information obtained from small numbers of carefully studied patients provides proof of concept that sublingual methadone is effective, safe, and well tolerated.

An integrated, population-based framework for knowledge management for cancer control.

Cancer control organizations commonly refer to the critical role of clinical practice guidelines to support the best possible cancer care. But how can a cancer care program ensure the systematic implementation of those guidelines? The goals of this article are to describe the process of developing a cancer control system driven by knowledge management, to highlight the key elements of this system and to foster discussion on the implementation of such frameworks. In order to promote best cancer practices within an expanded radiation service model for the province of Alberta, we developed an integrated conceptual framework for knowledge management. We identified six key elements of a knowledge management framework for the cancer program: evidence-based provincial guidelines, funding decisions, harmonized care pathways, targeted knowledge transfer projects, performance measurement and feedback to the system. We are establishing a process to characterize the explicit linkages and accountabilities between each of these elements as part of a broader cancer care quality agenda. We will implement the framework to support the start-up of the first of three new radiation treatment services in the province. The basic elements of a guidelines-supported cancer care system are not in doubt; how to unambiguously engage them within an integrated care system remains an area of intense interest.

Clinical trials focusing on cancer pain educational interventions: core components to include during planning and reporting.

CONTEXT: Robust recommendations on the reporting of methods and results of clinical trials such as therapeutic intervention trials are widely used, such as the Consolidated Standards of Reporting Trials (CONSORT) recommendation. There has not been agreement on analogous publication standards for educational intervention trials, making interpretation of educational intervention studies difficult. OBJECTIVES: The purpose of this report is to describe common deficiencies in reporting of educational intervention trials for cancer pain control, and to offer suggestions for authors to consider as they plan their studies, and report and publish research findings for educational interventions that use randomized controlled trials and other educational trial methodologies. METHODS: A systematic review of published knowledge translation intervention trials intended to improve cancer pain was undertaken, of which most were educational interventions. RESULTS: Many educational intervention clinical trials designed to improve management of cancer pain appeared methodologically weak, and their results were more difficult to interpret because of reporting deficiencies. In the course of the review, patterns of deficiencies in reporting of methods and trial results were documented. Deficiencies in reporting were compared with the CONSORT recommendations for reporting clinical trials, and parallel recommendations were drafted for educational intervention trials. Patterns of deficiency in reporting cancer pain educational intervention trials were synthesized into seven domains, generically applicable to a range of study designs. Draft recommendations intended to address these deficiencies were constructed to improve communication of educational research results. CONCLUSION: Development of a standardized reporting template for clinical trials in cancer pain educational interventions could advance knowledge transfer research and thereby increase effectiveness of national and international cancer control policy designed to support cancer pain control.

A proposed taxonomy of terms to guide the clinical trial recruitment process.

CONTEXT: The successful conduct of clinical trials in palliative care is challenged by low accrual rates, high attrition of study patients during trials, difficulties managing comorbidity, and other factors. But what has been learned about improving the feasibility of palliative care research studies? OBJECTIVE: To develop standard terms to describe patient accrual, and using these terms, describe an approach to allow investigators to predict trial feasibility. METHODS: We proposed a standard language and definitions for specific elements of feasibility within clinical trial design and conduct. We then developed an approach to apply data generated from the use of these terms to allow researchers to predict feasibility at the design stage of a clinical trial's development. RESULTS: We developed a taxonomy and then retrospectively applied the approach to four trials selected from our library of completed studies, to provide preliminary validity evidence. The approach includes a framework to help predict the number of patients needed to be assessed to achieve a study's accrual targets, as part of ongoing operational oversight to monitor the conduct and feasibility of a clinical trial. CONCLUSION: Challenges to successful completion of palliative care trials are prevalent and serious. A taxonomy to characterize the eligible patient pool, and an approach by which feasibility is systematically investigated, hold the promise to enhance the effectiveness of scarce resources applied to palliative and end-of-life research.