Promoting nursing research and innovation by staff nurses.

Promoting nursing research participation is challenging. Since the creation of an internal fund for research and innovation, 11 projects have received funding with a doubling of staff participation. The success of this novel funding opportunity highlights the need for this type of support and demonstrates success in promoting nursing research.

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.

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.

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.

Does increased patient awareness improve accrual into cancer-related clinical trials?

BACKGROUND: Oncology literature cites that only 2% to 4% of patients participate in research. Up to 85% of patients are unaware that clinical trials research is being conducted at their treatment facility or that they might be eligible to participate. OBJECTIVES: It was hypothesized that patients' satisfaction with information regarding clinical trials would improve after targeted educational interventions, and accruals to clinical trials would increase in the year following those interventions. METHODS: All new patients referred to the cancer center over a 4-month period were mailed a baseline survey to assess their knowledge of clinical research. Subsequently, educational interventions were provided, including an orientation session highlighting clinical trials, a pamphlet, and a reference to a clinical trials Web site. A postintervention survey was sent to the responders of the initial survey 3 months after the initial mailing. RESULTS: Patient satisfaction with information significantly increased after the interventions. There was no increase in subsequent enrollment in clinical trials. Patients who indicated an inclination to participate in clinical trials tended to have greater satisfaction with the information they received. CONCLUSIONS: A set of educational interventions designed for cancer patients significantly improved their satisfaction with information on clinical research, but did not improve clinical trial enrollment of these participants as of 1 year after the study. IMPLICATIONS FOR PRACTICE: The development of educational interventions may be justified, but such interventions may require prolonged implementation to establish benefit. Information relating to research may be most effectively delivered by patients' primary cancer care providers.

Can the global uptake of palliative care innovations be improved? Insights from a bibliometric analysis of the Edmonton Symptom Assessment System.

Clinical research is undertaken to improve care for palliative patients, but little is known about how to support the broad uptake of resultant innovations. The objectives of this paper are to: (1) explore the uptake of the Edmonton Symptom Assessment System throughout the global palliative care community through the lens of a bibliometric review - a research method that maps out the journey of new knowledge uptake by evaluating where key articles are cited in published literature; (2) construct hypotheses on attributes of the global community of palliative care learners; and (3) make inferences on approaches that could improve knowledge transfer. While preliminary, results of the study suggest several specific approaches that could support widespread uptake of innovations in palliative care: targeting publication in high impact, international journals; explicitly focusing on how the innovation is applied to best practice; encouraging additional research to expand on early studies; consciously targeting key professional groups and organizations to promote discussion in the grey literature; and early translation and promotion within multiple languages.

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.

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.

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.

Assessment and management of breakthrough pain in cancer patients: current approaches and emerging research.

Cancer pain is highly prevalent and often severe. Fortunately, most cancer pain can be readily managed, with up to 90% of patients responding well to standard interventions. However, breakthrough cancer pain-brief flares of severe pain superimposed on baseline pain-is common, difficult to manage, and often negatively impacts patients' quality of life. Breakthrough cancer pain is traditionally managed with oral, immediate-release opioids. However, because of its sudden onset and severity, oral opioids often fall short of providing adequate control. Research into novel approaches to pain management has identified several innovative strategies for this difficult cancer pain problem. We describe current approaches to assess, define, characterize, and treat breakthrough cancer pain, and summarize recent clinical research on novel agents, novel routes of drug delivery, and other advances in its management.

The Alberta Breakthrough Pain Assessment Tool for cancer patients: a validation study using a delphi process and patient think-aloud interviews.

Breakthrough pain is a prevalent cancer pain syndrome, and research is needed to identify more effective interventions to manage it. A validated tool to assess breakthrough pain in a standard and reliable manner is urgently needed to support the conduct of clinical trials in breakthrough pain. To address this need, we developed a breakthrough pain assessment tool for research purposes. The current study was undertaken to gather validity evidence for this breakthrough pain assessment tool, using a Delphi process involving an expert panel review, followed by a think-aloud process involving patients with cancer-related breakthrough pain. Two expert panels were formed: a national panel (within Canada; n=16) and an international panel (including experts from North America, UK, Europe, the Middle East, Australia, and New Zealand; n=22). Each panel participated in one anonymous survey round. Response rates were 56% (national panel) and 73% (international panel). The Delphi process revealed substantial consensus on the content of the tool, which increased between rounds of review. The overall level of agreement with the tool, averaged over the four evaluated aspects of all items, was 80% among national panelists and 88% among international panelists. Nine patients completed the think-aloud study. They were able to understand and complete the tool and provided specific direction on its improvement. The validity evidence gathered in this study suggests the Alberta Breakthrough Pain Assessment Tool is conceptually grounded and is understandable by patients and clinicians. Further validation of this tool as an assessment measure within clinical trials research is warranted.

Applying the Delphi process to palliative care tool development: lessons learned.

BACKGROUND: The Delphi technique is an effective method for collecting and synthesizing informed opinions on a highly focused task, from a diverse group of experts who have specialized knowledge in an area of interest. This method has been successfully applied to palliative care research but not commonly to palliative care tool development. The Delphi technique has recently been employed in the development of two palliative pain assessment tools: the Edmonton Classification System for Cancer Pain (ECS-CP) and the Alberta Breakthrough Pain Assessment Tool for Research (ABPAT-R). AIMS: The purpose of this paper is to: (a) report on our experience of using the Delphi technique for gathering validity evidence for the ECS-CP and ABPAT-R; (b) identify challenges in using this technique including sampling, study and survey design, consensus setting and response rates; and (c) suggest approaches that can add to its effectiveness in national and international collaborations in palliative care instrument development and research. CONCLUSIONS: Depending on the design, the Delphi technique can facilitate national or international cooperation both asynchronously (e.g., with mail-out or electronic surveys) and synchronously (e.g., with face-to-face meetings or videoconferencing). International input can assure palliative care tools are relevant in diverse clinical settings and practice cultures. The use of the Delphi technique in palliative care tool development may thereby facilitate international collaborations, rapid knowledge transfer, and effective uptake of novel tools across diverse palliative care settings.

Sublingual methadone for the management of cancer-related breakthrough pain: a pilot study.

BACKGROUND: Breakthrough pain is a highly prevalent and difficult to manage cancer pain problem. Current strategies are frequently ineffective, in part because of a mismatch between the sudden onset and brief duration of breakthrough pain and the slower onset and more prolonged duration of oral immediate-release opioids. Novel analgesic interventions are needed to provide a closer match between the temporal profile of the pain and the pharmacodynamics of the pain medication, and novel models of study of breakthrough pain are needed to evaluate them. METHODS: This is an open-label feasibility study of a model to evaluate sublingual methadone for cancer-related breakthrough pain. The model has three phases: screening, upward titration, and optimal dose evaluation. RESULTS: Seven patients with breakthrough pain because of cancer entered the upward titration phase of the trial, and 61 episodes of breakthrough pain were evaluated with sublingual methadone at escalating doses ranging from 2-18 mg. Toxicity was generally mild and similar to patients' prior breakthrough medication. Four patients entered the optimal dose evaluation phase, and 39 discrete episodes of breakthrough pain were available for evaluation. Significant relief of pain occurred with a median onset of 5 minutes, and no serious adverse events were encountered. CONCLUSIONS: This model of assessment of breakthrough pain, whereby each episode of pain is treated as a separate data set and multiple discrete episodes of breakthrough pain are assessed every 5 minutes in each patient, appears to be feasible within the cancer pain population. Preliminary results suggest a very rapid onset of relief of breakthrough pain with sublingual methadone when administered at the optimal dose, consistent with a highly favorable early pharmacodynamic profile of methadone administered via this route. Further study is warranted.

Characterization of the early pharmacodynamic profile of oral methadone for cancer-related breakthrough pain: a pilot study.

Methadone is effective for chronic cancer pain, but its early pharmacodynamic profile and effectiveness for breakthrough pain remain uncertain. This was an open-label, non-randomized, crossover study comparing the use of oral methadone for breakthrough pain with patients' usual opioid. Study variables included pain intensity (pretreatment and at 10-minute intervals post treatment), treatment-related side effects, and treatment satisfaction. In 37 discrete episodes of breakthrough pain, onset of analgesic effect of a titrated dose of oral methadone was rapid for all patients; 3 of 6 study patients experienced an onset of relief by 10 minutes post-ingestion. The adverse effect profile of oral methadone was not different from patients' usual 'rescue' opioid, and patients were moderately to completely satisfied with oral methadone as a breakthrough pain medication. These observations suggest that oral methadone can have a rapid onset of analgesic action and may have a legitimate role in the management of cancer-related breakthrough pain.