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.

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.

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.

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).

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.

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.

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.