Reassessing the measurement and presence of therapeutic misconception in a phase 1 setting.

BACKGROUND: Therapeutic misconception (TM) refers to research subjects' failure to distinguish the goals of clinical research from standard personal care. TM has traditionally been determined by questioning the patient about the research study's purpose. Recent research, however, has questioned whether TM is as prevalent as reported due to discrepancies between patient/researcher interpretations of TM questions. The authors have created an interview tool receptive to these advancements to more accurately determine the prevalence of TM. METHODS: Patients were questioned about the trial's purpose as follows: 1) "Is the trial mostly intending to help research and gain knowledge?," 2) "Is it mostly intending to help you as a person?," or 3) "Don't know." Participants were then asked what they thought this question was asking: A) "What my own intentions are for participating," B) "What the official purpose of the research study is," or C) "Not sure." A patient exhibited TM by answering that the official trial purpose was to help him or her. RESULTS: Patients (n = 98) had a mean age of 60 years, were mostly White (64%), had a combined family annual income ≥$60,000 (61%), and 49% had a college degree. Twelve of 98 patients (12%) definitely exhibited TM. This was much lower than the author's original finding of 68% in a similar cohort. Twenty-four of 98 patients (24.5%) were unclear about what one or both questions were asking and could not be categorized. CONCLUSIONS: Previously, a patient was thought to have TM if they answered that the purpose of the trial was to benefit to him or her. An additional query about how patients interpreted that question revealed only 12% definitely had TM. LAY SUMMARY: Therapeutic misconception (TM) refers to research subjects' failure to distinguish the goals of clinical research from standard personal care. TM signals a basic misunderstanding of the purpose of clinical research, threatening valid informed consent to participate in clinical trials. TM has traditionally been determined by questioning patients about their research study's purpose. Recent research, however, has questioned whether TM is as prevalent due to discrepancies between patient/researcher interpretations of TM questions. By developing an interview-tool receptive to these advancements, we report a lower TM estimate in the phase 1 setting (12%) than we found previously in a similar cohort (68%).

Prostate Cancer: Community Education and Disparities in Diagnosis and Treatment.

Prostate cancer remains the leading diagnosed cancer and the second leading cause of death among American men. Despite improvements in screening modalities, diagnostics, and treatment, disparities exist among Black men in this country. The primary objective of this systematic review is to describe the reported disparities in screening, diagnostics, and treatments as well as efforts to alleviate these disparities through community and educational outreach efforts. Critical review took place of retrospective, prospective, and socially descriptive data of English language publications in the PubMed database. Despite more advanced presentation, lower rates of screening and diagnostic procedures, and low rates of trial inclusion, subanalyses have shown that various modalities of therapy are quite effective in Black populations. Moreover, patients treated on prospective clinical trials and within equal-access care environments have shown similar outcomes regardless of race. Additional prospective studies and enhanced participation in screening, diagnostic and genetic testing, clinical trials, and community-based educational endeavors are important to ensure equitable progress in prostate cancer for all patients. IMPLICATIONS FOR PRACTICE: Notable progress has been made with therapeutic advances for prostate cancer, but racial disparities continue to exist. Differing rates in screening and utility in diagnostic procedures play a role in these disparities. Black patients often present with more advanced disease, higher prostate-specific antigen, and other adverse factors, but outcomes can be attenuated in trials or in equal-access care environments. Recent data have shown that multiple modalities of therapy are quite effective in Black populations. Novel and bold hypotheses to increase inclusion in clinical trial, enhance decentralized trial efforts, and enact successful models of patient navigation and community partnership are vital to ensure continued progress in prostate cancer disparities.