Carla Stiles

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.

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.

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.

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.

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.

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 trials 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 studys 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.

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.