Promoting colonoscopy screening among low-income Latinos at average risk of colorectal cancer: A randomized clinical trial.

BACKGROUND: Screening colonoscopy (SC) for colorectal cancer (CRC) is underused by Latino individuals. The current randomized clinical trial examined the impact of 3 interventions: 1) patient navigation; 2) patient navigation plus standard Centers for Disease Control and Prevention print materials; and 3) patient navigation plus culturally targeted print materials for Latinos referred for SC. Demographic, personal and health history, and psychometric factors associated with SC also were examined. METHODS: A total of 344 urban Latino individuals aged 50 to 85 years with no personal and/or immediate family history of CRC diagnosed before age 60 years, no personal history of a gastrointestinal disorder, no colonoscopy within the past 5 years, with insurance coverage, and with a referral for SC were consented. Participants were randomized to patient navigation (20%), patient navigation plus standard Centers for Disease Control and Prevention print materials (40%), and patient navigation plus culturally targeted print materials (40%). The completion of SC was assessed at 12 months. RESULTS: The interventions had an overall SC rate of 82%. Counterintuitively, patients with an average income of <$10,000 were found to have higher SC rates (87%) than those with a greater income (75%). CONCLUSIONS: The addition of standard or culturally targeted print materials did not appear to increase SC rates above those for patient navigation. Indeed, after controlling for other variables, culturally targeted print materials were found to be associated with lower SC rates among Puerto Rican individuals.

Evaluating the Patient-Reported Outcomes Measurement Information System scales in acute intermittent porphyria.

PURPOSE: Acute intermittent porphyria (AIP) is a rare inborn error of heme biosynthesis characterized by life-threatening acute attacks. Few studies have assessed quality of life (QoL) in AIP and those that have had small sample sizes and used tools that may not have captured important domains. METHODS: Baseline data from the Porphyrias Consortium's Longitudinal Study were obtained for 259 patients, including detailed disease and medical history data, and the following Patient-Reported Outcomes Measurement Information System (PROMIS) scales: anxiety, depression, pain interference, fatigue, sleep disturbance, physical function, and satisfaction with social roles. Relationships between PROMIS scores and clinical and biochemical AIP features were explored. RESULTS: PROMIS scores were significantly worse than the general population across all domains, except depression. Each domain discriminated well between asymptomatic and symptomatic patients with symptomatic patients having worse scores. Many important clinical variables like symptom frequency were significantly associated with domain scores in univariate analyses, showing responsiveness of the scales, specifically pain interference and fatigue. However, most regression models only explained ~20% of the variability observed in domain scores. CONCLUSION: Pain interference and fatigue were the most responsive scales in measuring QoL in this AIP cohort. Future studies should assess whether these scales capture longitudinal disease progression and treatment response.

Prevalence of Intracranial Injury in Adult Patients With Blunt Head Trauma With and Without Anticoagulant or Antiplatelet Use.

STUDY OBJECTIVE: We determine the prevalence of significant intracranial injury among adults with blunt head trauma who are receiving preinjury anticoagulant or antiplatelet medications. METHODS: This was a multicenter, prospective, observational study conducted from December 2007 to December 2015. Patients were enrolled in 3 emergency departments (EDs) in the United States. Adults with blunt head trauma who underwent neuroimaging in the ED were included. Use of preinjury aspirin, clopidogrel, and warfarin was recorded. Data on direct oral anticoagulants were not specifically recorded. The primary outcome was prevalence of significant intracranial injury on neuroimaging. The secondary outcome was receipt of neurosurgical intervention. RESULTS: Among 9,070 patients enrolled in this study, the median age was 53.8 years (interquartile range 34.7 to 74.3 years) and 60.7% were men. A total of 1,323 patients (14.6%) were receiving antiplatelet medications or warfarin, including 635 receiving aspirin alone, 109 clopidogrel alone, and 406 warfarin alone. Compared with that of patients without any coagulopathy, the relative risk of significant intracranial injury was 1.29 (95% confidence interval [CI] 0.88 to 1.87) for patients receiving aspirin alone, 0.75 (95% CI 0.24 to 2.30) for those receiving clopidogrel alone, and 1.88 (95% CI 1.28 to 2.75) for those receiving warfarin alone. The relative risk of significant intracranial injury was 2.88 (95% CI 1.53 to 5.42) for patients receiving aspirin and clopidogrel in combination. CONCLUSION: Patients receiving preinjury warfarin or a combination of aspirin and clopidogrel were at increased risk for significant intracranial injury, but not those receiving aspirin alone. Clinicians should have a low threshold for neuroimaging when evaluating patients receiving warfarin or a combination of aspirin and clopidogrel.

Computerized cognitive training in prostate cancer patients on androgen deprivation therapy: a pilot study.

PURPOSE: Prostate cancer patients who have undergone androgen deprivation therapy (ADT) may experience cognitive impairment, yet there is an unmet need for nonpharmacological interventions to address cognitive impairment in this population. This study examines the feasibility, acceptability, and preliminary efficacy of a home-based computerized cognitive training (CCT) program to treat cancer-related cognitive impairment. METHODS: Sixty men who had received ≥ 3 months of ADT were screened for at least mild cognitive or neurobehavioral impairment and randomized to 8 weeks of CCT or usual care. Follow-up assessments occurred immediately post-intervention or equivalent (T2) and 8 weeks later (T3). The acceptability of CCT was also assessed. RESULTS: Feasibility:A priori feasibility thresholds were partially met (i.e., randomization rate > 50%, retention rate > 70% excluding CCT drop-outs, but < 70% for intent-to-treat). Acceptability: Participants were mostly satisfied with CCT and found it somewhat enjoyable, though barriers to uptake existed. Preliminary efficacy: Linear mixed models indicated significant time by group effects favorable to CCT in reaction time (p = .01), but unfavorable to CCT in verbal and visual memory (ps < .05). Memory was temporarily suppressed in the CCT group at T2, but normalized by T3. There was no effect of CCT on self-reported cognitive functioning, neurobehavioral functioning, nor quality of life. CONCLUSIONS: This study provides tentative support for the feasibility and acceptability of CCT to treat mild cognitive impairment in ADT patients. CCT had a beneficial effect on reaction time, but temporarily suppressed memory. CCT's benefits may be limited to a narrow area of functioning. Larger-scale studies are needed.

Optimism and barriers to colonoscopy in low-income Latinos at average risk for colorectal cancer.

OBJECTIVES: Colorectal cancer (CRC) screening continues to be underused, particularly by Latinos. CRC and colonoscopy fear, worry, and fatalism have been identified as screening barriers in Latinos. The study purpose was to examine the relationship of optimism, fatalism, worry, and fear in the context of Latinos referred for CRC screening. METHODS: Our sample included 251 Latinos between the ages of 50 and 83 years who had no personal or immediate family history of CRC, no personal history of gastrointestinal disorder, no colonoscopy in the past 5 years, and received a referral for a colonoscopy. Face-to-face interviews were performed, and data were analyzed using regression models. RESULTS: Greater optimism (ß = -1.72, p < 0.000), lower fatalism (ß = 0.29, p < 0.01), and absence of family history of cancer (ß = 1, p < 0.01) were associated with decreased worry about the colonoscopy. Being female (ß = 0.85, p < 0.05) and born in the USA (ß = 1.1, p < 0.01) were associated with greater worry about colonoscopy and the possibility of having CRC. Family history of cancer (ß = 2.6, p < 0.01), female gender (ß = 2.9, p < 0.000), not following the doctor's advice (ß = 2.7, p < 0.01), and putting off medical problems (ß = 1.9, p < 0.05) were associated with greater fear. In the multiple regression model, lower optimism (ß = -0.09, p < 0.05), higher fatalism (ß = 0.28, p < 0.01), and female gender (ß = 0.9, p < 0.05) were associated with greater worry. CONCLUSIONS: Interventions that address fatalism and promote optimistic beliefs may reduce worry among Latinos referred for colonoscopy. Interventions that alleviate colonoscopy fear because of family history of cancer particularly among Latino women may help improve distress about CRC screening.

New York City Taxi Drivers' Knowledge and Perceptions of the Affordable Care Act.

This study was conducted to assess New York City taxi drivers' knowledge and perceptions of the Affordable Care Act (ACA). A cross-sectional street-intercept study design was used to assess drivers' knowledge about the ACA. A 146-item questionnaire was administered from September 12 to December 6, 2013 to 175 yellow taxi and for-hire vehicle drivers. 91 % of drivers were foreign-born; 50 % were uninsured. Mean knowledge about the ACA was quite low; 78 % of the sample either knew nothing or only a little bit about the ACA. 77 % wanted more information about the ACA. Greater English proficiency, more years driving a taxi, and knowledge of having or not having a pre-existing health condition (vs. not knowing) were related to higher ACA knowledge levels. Knowledge of a pre-existing condition (whether they had one or not) compared to those who lacked such knowledge was also an important predictor of the perception of whether the ACA would have a positive impact. To facilitate enrollment, efforts should focus on occupationally-focused initiatives that educate drivers at their places of work and leisure, to raise the overall knowledge levels and enrollment of the community.

Support needs of Chinese immigrant cancer patients.

PURPOSE: To enable better psychosocial, informational, and practical support of Chinese patients with cancer, this study was conducted to identify the specific support needs of Chinese immigrant cancer patients. METHODS: The Cancer Portal Project at Memorial Sloan-Kettering Cancer Center's Center for Immigrant Health and Cancer Disparities is a patient navigation program that assists underserved and minority cancer patients in obtaining social and economic assistance at ten New York City cancer clinics. This need assessment was conducted as part of the Portal Project. Sixty-four questions were added to the existing Portal Intake Form about the needs and preferences for Chinese-language support and survivorship services. Descriptive analysis was performed, as well as an exploratory principal component's factor analysis to determine if there were any patterns in the services and programs in which patients were interested. RESULTS: Ninety-six patients were approached for participation; 59 agreed to participate. Eighty-eight percent of participants were born in China. Ninety-seven percent preferred to speak Mandarin, Cantonese, or Fujianese in the healthcare setting. When asked about general interest in support programs, 53 % of the participants were "very interested," 27 % were "maybe interested," and 17 % were "not interested." Programs in which more participants were "very interested" included those that would provide information about obtaining financial assistance (79 %) and social assistance (74 %), information on treatment options (67 %), help in coping with the burden of illness on the family (65 %), and information about general healthcare (63 %). The factor analysis resulted in the identification of five factors: social/financial/treatment and care issues, nutrition and exercise/networking/general health care, coping with fear and stress, herbs and dietary supplements, and acupuncture and acupressure. CONCLUSION: In this study, 80 % of the participants expressed interest in programs tailored for Chinese cancer patients. The most frequently preferred topics for potential services were information-based. Findings provide a foundation for future research and the development of culturally and linguistically targeted support programs and interventions for this unique population.

Associations among pain, pain attitudes, and pain behaviors in patients with metastatic breast cancer.

Metastatic breast cancer (MBC) patients often experience pain which can trigger pain behaviors, such as distorted ambulation. Psychological variables, such as individuals' attitudes toward pain, play a role in pain intervention. In this study, we used the cognitive-behavioral model of pain to examine the influence of patients' attitudes toward pain (as measured by the survey of pain attitudes or SOPA) on their pain behaviors (as measured by the pain behaviors checklist). Two hundred-one MBC patients completed surveys at treatment initiation and again 3 and 6 months later. Linear Mixed Model with repeated measures analyses showed that SOPA-solicitude, SOPA-emotions, SOPA-cure, SOPA-disability, and SOPA-medication pain attitudes were consistently significantly associated with pain behaviors at each assessment time point. Additionally, the belief that a medical cure for pain exists buffered the positive association between pain severity and pain behaviors. Our findings support and extend the cognitive-behavioral model of pain and suggest that it may be useful to target pain attitudes in pain management interventions for MBC patients.

Implementation of culturally targeted patient navigation system for screening colonoscopy in a direct referral system.

Low-income minorities often face system-based and personal barriers to screening colonoscopy (SC). Culturally targeted patient navigation (CTPN) programs employing professional navigators (Pro-PNs) or community-based peer navigators (Peer-PNs) can help overcome barriers but are not widely implemented. In East Harlem, NY, USA, where approximately half the residents participate in SC, 315 African American patients referred for SC at a primary care clinic with a Direct Endoscopic Referral System were recruited between May 2008 and May 2010. After medical clearance, 240 were randomized to receive CTPN delivered by a Pro-PN (n = 106) or Peer-PN (n = 134). Successful navigation was measured by SC adherence rate, patient satisfaction and navigator trust. Study enrollment was 91.4% with no significant differences in SC adherence rates between Pro-PN (80.0%) and Peer-PN (71.3%) (P = 0.178). Participants in both groups reported high levels of satisfaction and trust. These findings suggest that CTPN Pro-PN and Peer-PN programs are effective in this urban primary care setting. We detail how we recruited and trained navigators, how CTPN was implemented and provide a preliminary answer to our questions of the study aims: can peer navigators be as effective as professionals and what is the potential impact of patient navigation on screening adherence?

"Doctor, what do i have?" Knowledge of cancer diagnosis among immigrant/migrant minorities.

This study explores patient knowledge of cancer diagnosis among underserved immigrant/migrant minorities. Patients were recruited at a hospital-based cancer clinic in New York City. Demographic and self-reported diagnosis and treatment information were collected; charts were reviewed to ascertain cancer diagnosis. Four hundred thirty-four patients were included. Eighty-seven percent preferred to speak a language other than English in the health care setting. Sixteen percent had incorrect knowledge of their cancer diagnosis. Multivariate analysis indicated that both preference for a non-English language and diagnosis of a "below the belt" cancer were jointly predictive of incorrect knowledge (LR = 17.01; p = 0.0002). "Below the belt" cancers included bladder, colorectal, gynecological, penile, prostate, and testicular cancers. Among this cohort of immigrant/migrant cancer patients, a considerable proportion was unaware of their correct cancer diagnoses. This may have a significant impact on subsequent cancer education, treatment, and care. Limited-English-proficiency patients may be at particular risk.

Self-efficacy beliefs mediate the relationship between subjective cognitive functioning and physical and mental well-being after hematopoietic stem cell transplant.

OBJECTIVE: Cognitive problems are commonly reported by hematopoietic stem cell transplant (HSCT) survivors and are associated with poorer physical and mental well-being. It was hypothesized that adverse effects of subjective cognitive impairment occur because cognitive difficulties reduce survivors' confidence that they can manage HSCT-related symptoms-that is, self-efficacy for symptom management. METHODS: Hematopoietic stem cell transplant survivors (n = 245), 9 months to 3 years post-HSCT, completed measures of subjective cognitive functioning, self-efficacy for symptom management, and clinically important outcomes: depressed mood, anxiety, and quality of life. Mediation analyses using bootstrapping were conducted to investigate whether effects of subjective cognitive impairment on these outcomes were mediated by self-efficacy for cognitive, emotional (SE-Emotional), social (SE-Social), and physical (SE-Physical) symptom management. RESULTS: Self-efficacy mediated relations between subjective cognitive impairment and depressed mood (total indirect effect = -0.0064 and 95% CI -0.0097 to -0.0036), anxiety (total indirect effect = -0.0045, CI -0.0072 to -0.0021), and quality of life (total indirect effect = 0.0952, CI 0.0901 to 0.2642). SE-Emotional was a unique mediator when the outcome was depressed mood and anxiety. SE-Social, SE-Physical, and SE-Emotional were specific mediators when outcome was quality of life. CONCLUSIONS: Findings support the conclusion that subjective cognitive impairment reduces HSCT survivors' confidence in their ability to manage common post-HSCT symptoms, with implications for physical and mental well-being. Interventions that help enhance survivors' self-efficacy, particularly self-efficacy for the management of emotional symptoms, are likely to benefit HSCT survivors who report subjective cognitive impairment.

Daily ultrafiltration results in improved blood pressure control and more efficient removal of small molecules during hemodialysis.

BACKGROUND: Although prior studies have shown that frequent hemodialysis (HD) can lead to improved control of dry weight in end-stage renal disease patients, there are no clinical studies examining whether this can improve blood pressure (BP) control and can also shorten the dialysis time needed to achieve satisfactory removal of small molecules. Several models of wearable dialysis systems are now under various stages of development. These devices present the possibility of hemodialyzing patients to their dry weights. We have built a prototype of a wearable ultrafiltration (UF) device that can provide daily UF. Apart from better fluid control, we hypothesize that separating HD from UF will result in better BP control, and adequate weekly small molecule removal could be achieved with a decreased duration of dialysis. We tested the hypothesis in current HD patients using conventional dialysis equipment. METHODS: Thirteen patients were selected from a large urban HD center. The experimental period consisted of 4 weeks of daily UF (4 days/week of UF alone and 2 days/week of HD with UF). The duration of the HD sessions was increased by 15-30 min to maintain weekly standard Kt/V >2.0. The patients were then returned to their conventional 3 days/week of HD with UF and studied for 4 weeks. Predialysis BPs, interdialytic weight gains, and Kt/V results of the experimental and return periods were compared with those of the 3-month control period. No changes were made in antihypertensive or other medication during the study. RESULTS: During the experimental period, mean arterial pressure decreased from 110 to 95 mm Hg (p < 0.001), systolic BP from 158 to 136 mm Hg (p < 0.001), while interdialytic weight gains were reduced from 3.25 to 1.21 liters (p < 0.0001). During the experimental period, weekly standard Kt/V of 2.16 was achieved in 8.24 h/week of HD, as compared to 11.14 h/week. CONCLUSIONS: Volume control with daily UF results in improved BP control and, by separating the UF function from HD, adequate weekly standard Kt/V >2 can be achieved with twice weekly HD.

Employment Quality and Mental and Self-Reported Health Inequities among Latinx Housecleaners: The Safe and Just Cleaners Study.

Precarious employment, such as housecleaning, is one important structural contributor to health inequities. We used an employment quality (EQ) framework to characterize the impact of employment conditions on mental and self-reported ill-health among Latinx housecleaners in the New York City metropolitan area. Using a community-based participatory research approach, we collected cross-sectional survey data from 402 housecleaners between August 2019 and February 2020 to characterize housecleaners' EQ and its association with depression, perceived stress, and self-reported health. We also measured work-related irritant eye, skin, and respiratory symptoms, which have been shown in previous research to be associated with housecleaners' exposure to chemical components of cleaning products. Our housecleaner cohort was largely female and immigrant and most had worked at least five years. Survey items capturing the EQ dimensions of unbalanced interpersonal relations, low material resources, and violations of workers' rights were associated with increased odds of depression, perceived stress, and self-reported ill-health. Work-related irritant eye, skin, and respiratory symptoms were also independently associated with mental and self-reported ill-health and some of the effects of EQ on health were potentially partially mediated through their association with work-related irritant symptoms. Findings can inform directions for community-based educational and policy initiatives to improve housecleaners' employment quality.

Examining the Efficacy of Bright Light Therapy on Cognitive Function in Hematopoietic Stem Cell Transplant Survivors.

Patients who have undergone hematopoietic stem cell transplant (HSCT) may experience cognitive impairment that can persist after treatment. Several studies have shown that bright light therapy may improve cognition, potentially due to its effects on the circadian system via brain regions that respond preferentially to light. In this double-blind randomized controlled trial, the efficacy of bright light therapy on cognition was examined in HSCT survivors. Forty-seven HSCT survivors at an urban hospital in the United States were screened for mild cognitive impairment, randomized to either bright white light (BWL) or comparison dim red light (DRL) conditions using a block randomization approach, and instructed to use their assigned light box every morning upon awakening for 30 min for 4 weeks. Assessments occurred at baseline, the end of the second week of the intervention, the end of the intervention, and at follow-up (8 weeks later). The primary outcome was objective cognitive function as measured by a global composite score on neuropsychological tests. Secondary outcomes included cognitive performance in individual domains, self-reported cognitive function, fatigue, sleep and sleep quality, and circadian rhythm robustness. Repeated-measures linear mixed models for both objective and self-reported cognitive function indicated significant main effects for time (ps < 0.05) suggesting significant improvements in both conditions over time. Time by light condition interaction effects were not significant. Models focused on secondary outcomes yielded no significant effects. Both BWL and DRL groups demonstrated significant improvements in objective cognitive and self-reported cognitive function over time, but there was no hypothesized effect of BWL over DRL nor associations with circadian rhythm robustness. Therapeutic effects of both light conditions, practice effects, and/or placebo effects may account for the findings.Trial registration: ClinicalTrials.gov Identifier: NCT02677987 (9 February 2016).

Intimacy-enhancing psychological intervention for men diagnosed with prostate cancer and their partners: a pilot study.

INTRODUCTION: Few couple-focused interventions have been developed to improve distress and relationship outcomes among men diagnosed with localized prostate cancer and their partners. AIMS: We examined the effects of a five-session Intimacy-Enhancing Therapy (IET) vs. Usual Care (UC) on the psychological and relationship functioning of men diagnosed with localized prostate cancer and their partners. Pre-intervention levels of psychological and relationship functioning were evaluated as moderators of intervention effects. METHODS: Seventy-one survivors and their partners completed a baseline survey and were subsequently randomly assigned to receive five sessions of IET or UC (no treatment). Eight weeks after the baseline assessment, a follow-up survey was administered to survivor and partner. MAIN OUTCOME MEASURES: Distress, well-being, relationship satisfaction, relationship intimacy, and communication were investigated as the main outcomes. RESULTS: IET effects were largely moderated by pre-intervention psychosocial and relationship factors. Those survivors who had higher levels of cancer concerns at pretreatment had significantly reduced concerns following IET. Similar moderating effects for pre-intervention levels were reported for the effects of IET on self-disclosure, perceived partner disclosure, and perceived partner responsiveness. Among partners beginning the intervention with higher cancer-specific distress, lower marital satisfaction, lower intimacy, and poorer communication, IET improved these outcomes. CONCLUSIONS: IET had a marginally significant main effect upon survivor well-being but was effective among couples with fewer personal and relationship resources. Subsequent research is needed to replicate these findings with a larger sample and a longer follow-up.

Screening adherence for colorectal cancer among immigrant Hispanic women.

PURPOSE: We sought to assess factors related to colorectal cancer (CRC) screening adherence among immigrant, Hispanic women in Harlem, New York City. METHOD: Adherence for colonoscopy and fecal occult blood test (FQBT) screening was measured among 255 women based on self-reported screening behaviors using American Cancer Society guidelines. RESULTS: Univariate results showed that age, language of the interview (English/Spanish), years in the United States, physician recommendation for either test, marital status (living alone/living with someone), and mammography adherence were associated with CRC screening adherence (p's < .05). In the multivariate analysis, having an age greater than 65 years, being interviewed in Spanish, having lived in the United States longer, having a regular doctor and a physician recommendation, and being currently adherent for mammography were associated with higher CRC screening adherence. CONCLUSION: Among this sample, there proved to be differences between having ever been screened and adherence with a greater proportion of women having ever completed either colonoscopy and/or FOBT compared to women who were adherent (72.9% vs 58.8%). Therefore, it is important to determine factors associated with adherence, not just screening utilization, in order to design strategies to increase adherence among immigrant Hispanic women.

Mental health mediators of subjective cognitive concerns among World Trade Center responders.

Decline in cognitive functioning among rescue and recovery workers who responded in the aftermath of the September 11, 2001, World Trade Center (WTC) attacks is of emerging interest. Responders are vulnerable to cognitive decline from exposure to airborne toxins present at the WTC site, as well as from WTC-related mental and physical health conditions. To better understand the relationship between occupational WTC exposure, mental health, physical health and subjective cognitive functioning, we examined the mediating role of health status in the association between exposure and subjective cognitive concerns in a multi-site, longitudinal investigation of the WTC General Responder cohort (n = 16,380 responders; n = 58,575 visits) for the period 2002-2015. Through latent class analyses, we identified a four-level marker of cognitive concerns based on information from a Self-Administered Mental Health Questionnaire. Using generalized linear mixed models with random intercepts, we observed that a higher intensity WTC exposure composite was associated with greater cognitive concerns, and that this association was operating almost entirely through mental health comorbidities, not physical health comorbidities. In fully adjusted models, the inclusion of probable depression, anxiety, PTSD and use of psychotropic medications attenuated the association between highest WTC exposure and greatest cognitive concerns. Physical health did not appear to be on the pathway between WTC exposure and cognitive concerns. Understanding the underlying sources of cognitive concerns may help identify vulnerable members of the General Responder cohort and potentially aid clinical decision-making, such as treatment choice and enhanced screening options. Earlier diagnosis and symptom treatment may help preserve functional independence.

Surrogate consent for research involving adults with impaired decision making: survey of Institutional Review Board practices.

OBJECTIVES: Most critically ill adults have impaired decision-making capacity and are unable to consent to research. Yet, little is known about how Institutional Review Boards interpret the Common Rule's call for safeguards in research involving incapacitated adults. We aimed to examine Institutional Review Board practices on surrogate consent and other safeguards to protect incapacitated adults in research. DESIGN, SETTINGS, AND PARTICIPANTS: A cross-sectional survey of 104 Institutional Review Boards from a random sample of U.S. institutions engaged in adult human subject research (response rate, 68%) in 2007 and 2008. INTERVENTIONS: None. MEASUREMENTS: Institutional Review Board acceptance of surrogate consent, research risks, and other safeguards in research involving incapacitated adults. MAIN RESULTS: Institutional Review Boards reported that, in the previous year, they sometimes (49%), frequently (33%), or very frequently (2%) reviewed studies involving patients in the intensive care unit. Six Institutional Review Boards (6%) do not accept surrogate consent for research from any persons, and 22% of Institutional Review Boards accept only an authorized proxy, spouse, or parent as surrogates, excluding adult children and other family. Institutional Review Boards vary in their limits on research risks in studies involving incapacitated adults: 15% disallow any research regardless of risk in studies without direct benefit, whereas 39% allow only minimal risks. When there was potential benefit, fewer Institutional Review Boards limit the risk at minimal (11%; p < .001). Even in populations at high risk for impaired decision making, many Institutional Review Boards rarely or never required procedures to determine capacity (13%-21%). Institutional Review Boards also varied in their use of independent monitors, research proxies, and advanced research directives. CONCLUSIONS: Much variability exists in Institutional Review Board surrogate consent practices and limits on risks in studies involving incapacitated adults. This variability may have adverse consequences for needed research involving incapacitated adults. Clarification of current regulations is needed to provide guidance.

Validation of the group-based medical mistrust scale among urban black men.

BACKGROUND: Socioculturally relevant measures of medical mistrust are needed to better address health disparities, especially among Black men, a group with lower life expectancy and higher death rates compared to other race/gender groups. OBJECTIVES: The study aim was to investigate the psychometric properties of the Group-Based Medical Mistrust Scale (GBMMS) in a Black male sample. DESIGN: Data were collected as part of a randomized controlled trial testing educational strategies to support Black men's decisions about prostate cancer screening. PARTICIPANTS: Participants included 201 Black men ages 40-75 years recruited in New York City during 2006-2007. MAIN MEASURES: The primary measures included: race-based medical mistrust, health care participation, avoidance of health care, perceived access to health care, health care satisfaction, racial identity, residential racial segregation, attitudes towards prostate cancer screening, and past prostate cancer screening behavior. KEY RESULTS: An exploratory factor analysis suggested a three-factor structure. Confirmatory factor analysis supported the three-factor model. Internal consistency was high for the total GBMMS and the three sub-scales: Suspicion, Discrimination, and Lack of Support. Construct validity was supported by: significant positive correlations between GBMMS and avoidance of health care and racial identity as well as significant negative correlations with health care access, health care satisfaction, and attitudes about prostate cancer screening. ANOVA showed that the GBMMS was associated with greater residential racial segregation. Higher total GBMMS scores were associated with not visiting a physician in the last year and not having a regular physician. CONCLUSIONS: The present findings provide strong additional evidence that the GBMMS is a valid and reliable measure that may be used among urban Black men.