Jon C. Tilburt

Barriers to Recruiting Underrepresented Populations to Cancer Clinical Trials : A Systematic Review

Racial and ethnic minorities, older adults, rural residents, and individuals of low socioeconomic status are underrepresented among participants in cancer‐related trials. The authors conducted a systematic review to determine the barriers to participation of underrepresented populations in cancer‐related trials. Their search included English‐language publications that reported original data on the recruitment of underrepresented groups to cancer treatment or prevention trials between 1966 and December 2005 in multiple electronic databases. They also hand‐searched titles in 34 journals from January 2003 to December 2005 and they examined reference lists for eligible articles. Titles and abstracts were reviewed to identify relevant studies. Data on barriers to participation were synthesized both qualitatively and based on statistically significant associations with trial enrollment. Of 5257 studies that were cited, 65 studies were eligible for inclusion in the current analysis, including 46 studies on recruitment into cancer therapeutic trials, 15 studies on recruitment into prevention trials, and 4 studies on recruitment into both prevention and treatment trials. Numerous factors were reported as barriers to participation in cancer‐related trials. However, only 20 of the studies reported statistically significant associations between hypothesized barriers and enrollment. The available evidence had limitations in quality regarding representativeness, justification of study methods, the reliability and validity of data‐collection methods, potential for bias, and data analysis. The results indicated that underrepresented populations face numerous barriers to participation in cancer‐related trials. The current systematic review highlighting the literature on recruitment of underrepresented populations to cancer trials and may be used as the evidence base toward developing an agenda for etiologic and intervention research to reduce the disparities in participation in cancer‐related trials. Cancer 2008.

Prescribing “Placebo Treatments”: Results of National Survey of US Internists and Rheumatologists

Objective To describe the attitudes and behaviours regarding placebo treatments, defined as a treatment whose benefits derive from positive patient expectations and not from the physiological mechanism of the treatment itself. Design Cross sectional mailed survey. Setting Physicians’ clinical practices. Participants 1200 practising internists and rheumatologists in the United States. Main outcome measures Investigators measured physicians’ self reported behaviours and attitudes concerning the use of placebo treatments, including measures of whether they would use or had recommended a “placebo treatment,” their ethical judgments about the practice, what they recommended as placebo treatments, and how they typically communicate with patients about the practice. Results 679 physicians (57%) responded to the survey. About half of the surveyed internists and rheumatologists reported prescribing placebo treatments on a regular basis (46-58%, depending on how the question was phrased). Most physicians (399, 62%) believed the practice to be ethically permissible. Few reported using saline (18, 3%) or sugar pills (12, 2%) as placebo treatments, while large proportions reported using over the counter analgesics (267, 41%) and vitamins (243, 38%) as placebo treatments within the past year. A small but notable proportion of physicians reported using antibiotics (86, 13%) and sedatives (86, 13%) as placebo treatments during the same period. Furthermore, physicians who use placebo treatments most commonly describe them to patients as a potentially beneficial medicine or treatment not typically used for their condition (241, 68%); only rarely do they explicitly describe them as placebos (18, 5%). Conclusions Prescribing placebo treatments seems to be common and is viewed as ethically permissible among the surveyed US internists and rheumatologists. Vitamins and over the counter analgesics are the most commonly used treatments. Physicians might not be fully transparent with their patients about the use of placebos and might have mixed motivations for recommending such treatments.

Improving understanding in the research informed consent process: A systematic review of 54 interventions tested in randomized control trials

BackgroundObtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified.PurposeTo systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods.MethodsThe search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique.ResultsMeta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation existed between included studies: control processes, the presence of a human proctor, real vs. simulated protocol, and assessment formats.ConclusionsEnhanced consent forms and extended discussions were most effective in improving participant understanding. Interventions of all categories had no negative impact on participant satisfaction or study accrual. Identification of best practices for studies of informed consent interventions would aid future systematic comparisons.

Provider roles in the recruitment of underrepresented populations to cancer clinical trials

Providers play a vital role in the successful recruitment of underrepresented patients to cancer clinical trials because they often introduce the opportunity of clinical trials. The purpose of the current systematic review was to describe provider‐related factors influencing recruitment of underrepresented populations to cancer clinical trials.

The efficacy of resiliency training programs: a systematic review and meta-analysis of randomized trials.

Importance Poor mental health places a burden on individuals and populations. Resilient persons are able to adapt to life’s challenges and maintain high quality of life and function. Finding effective strategies to bolster resilience in individuals and populations is of interest to many stakeholders. Objectives To synthesize the evidence for resiliency training programs in improving mental health and capacity in 1) diverse adult populations and 2) persons with chronic diseases. Data Sources Electronic databases, clinical trial registries, and bibliographies. We also contacted study authors and field experts. Study Selection Randomized trials assessing the efficacy of any program intended to enhance resilience in adults and published after 1990. No restrictions were made based on outcome measured or comparator used. Data Extraction and Synthesis Reviewers worked independently and in duplicate to extract study characteristics and data. These were confirmed with authors. We conducted a random effects meta-analysis on available data and tested for interaction in planned subgroups. Main Outcomes The standardized mean difference (SMD) effect of resiliency training programs on 1) resilience/hardiness, 2) quality of life/well-being, 3) self-efficacy/activation, 4) depression, 5) stress, and 6) anxiety. Results We found 25 small trials at moderate to high risk of bias. Interventions varied in format and theoretical approach. Random effects meta-analysis showed a moderate effect of generalized stress-directed programs on enhancing resilience [pooled SMD 0.37 (95% CI 0.18, 0.57) p = .0002; I2 = 41%] within 3 months of follow up. Improvement in other outcomes was favorable to the interventions and reached statistical significance after removing two studies at high risk of bias. Trauma-induced stress-directed programs significantly improved stress [−0.53 (−1.04, −0.03) p = .03; I2 = 73%] and depression [−0.51 (−0.92, −0.10) p = .04; I2 = 61%]. Conclusions We found evidence warranting low confidence that resiliency training programs have a small to moderate effect at improving resilience and other mental health outcomes. Further study is needed to better define the resilience construct and to design interventions specific to it. Registration Number PROSPERO #CRD42014007185

Vaccinating Health Care Workers Against Influenza: The Ethical and Legal Rationale for a Mandate

Despite improvements in clinician education, symptom awareness, and respiratory precautions, influenza vaccination rates for health care workers have remained unacceptably low for more than three decades, adversely affecting patient safety. When public health is jeopardized, and a safe, low-cost, and effective method to achieve patient safety exists, health care organizations and public health authorities have a responsibility to take action and change the status quo. Mandatory influenza vaccination for health care workers is supported not only by scientific data but also by ethical principles and legal precedent. The recent influenza pandemic provides an opportunity for policymakers to reconsider the benefits of mandating influenza vaccination for health care workers, including building public trust, enhancing patient safety, and strengthening the health care workforce.

Effectiveness of strategies to recruit underrepresented populations into cancer clinical trials

Background Certain populations, including racial and ethnic minorities and older persons, have had a history of low participation in cancer-related trials, yet there has been little information reported on recruitment strategies tailored to improve their enrollment. Methods We conducted a systematic literature review to examine the methods used to study recruitment of underrepresented populations into cancer prevention and treatment trials and examined the studies that compared the efficacy and/or effectiveness of different recruitment strategies. We performed an electronic search through multiple databases including PubMed and a hand search of 34 journals. Potential studies were pulled and underwent title, abstract, and article review by at least two investigators. Results Fourteen articles examined recruitment of underrepresented populations into cancer trials and, of these, five compared efficacy or effectiveness of different strategies for recruitment of underrepresented populations into randomized or concurrent controlled trials. These five studies used various strategies but only three reported that specific recruitment strategies, such as media campaigns and churchbased project sessions, resulted in improvement in accrual to cancer trials. Conclusion There is limited evidence for efficacious or effective strategies to recruit underrepresented populations in cancer-related trials. The available evidence cannot be generalized to these heterogeneous groups. Further study is needed on efficacious strategies for recruitment of underrepresented populations into cancerrelated trials.

Value judgments in the analysis and synthesis of evidence

OBJECTIVE To describe the principal role of value judgments in the analysis and synthesis of evidence as they are involved in systematic reviews, meta-analyses, and health technology assessments. METHOD Using the tools of conceptual analysis, we characterize three main types of value judgments and propose an outline of how to enhance the appropriate role of value judgments in the process of analyzing and synthesizing evidence. RESULTS The production, analysis, and synthesis of evidence involve value judgments characterized as preferences of persons or groups that cannot be validated by appeal to facts alone. Because preferences across individuals can vary, value judgments can be a source of bias in science and unwarranted variation in the application of scientific evidence. However, it is not possible or desirable to eliminate all value judgments in the process from production to synthesis of evidence. CONCLUSION With respect to the value judgments that shape the analysis and synthesis of evidence, review authors should disclose and justify choices related to the three key value judgments outlined in this paper. Authors should also highlight how their value judgments differ from the stated or implicit value judgments of previously published reviews on the same topic.

Why the Ethics of Parsimonious Medicine Is Not the Ethics of Rationing

The ethics of rationing health care resources has been debated for decades. Opponents of rationing are concerned that societal interests will supplant respect for individual patient choice and professional judgment. Advocates argue that injustices in the current system necessitate that physicians use resources prudently on behalf of society, even in their daily work with individual patients. The debate is important, potentially divisive, and unavoidable.

Getting physicians to respond: the impact of incentive type and timing on physician survey response rates.

OBJECTIVE To study the effects of payment timing, form of payment, and requiring a social security number (SSN) on survey response rates. DATA SOURCE Third-wave mailing of a U.S. physician survey. STUDY DESIGN Nonrespondents were randomized to receive immediate U.S.