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84


Development and Pilot Evaluation of a Decision Aid for Small Kidney Masses

Thomas, Shailin A; Siriruchatanon, Mutita; Albert, Stephanie L; Bjurlin, Marc; Hoffmann, Jason C; Langford, Aisha; Braithwaite, R Scott; Makarov, Danil V; Fagerlin, Angela; Kang, Stella K
OBJECTIVE:To develop and pilot test a patient decision aid (DA) describing small kidney masses and risks and benefits of treatment for the masses. METHODS:An expert committee iteratively designed a small kidney mass DA, incorporating evidence-based risk communication and informational needs for treatment options and shared decision making. After literature review and drafting content with the feedback of urologists, radiologists, and an internist, a rapid qualitative assessment was conducted using two patient focus groups to inform user-centered design. In a pilot study, 30 patients were randomized at the initial urologic consultation to receive the DA or existing institutional patient educational material (PEM). Preconsultation questionnaires captured patient knowledge and shared decision-making preferences. After review of the DA and subsequent clinician consultation, patients completed questionnaires on discussion content and satisfaction. Proportions between arms were compared using Fisher exact tests, and decision measures were compared using Mann-Whitney tests. RESULTS:Patient informational needs included risk of tumor growth during active surveillance and ablation, significance of comorbidities, and posttreatment recovery. For the DA, 84% of patients viewed all content, and mean viewing time was 20 min. Significant improvements in knowledge about small mass risks and treatments were observed (mean total scores: 52.6% DA versus 22.3% PEM, P < .001). DA use also increased the proportion of patients discussing ablation (66.7% DA versus 18.2% PEM, P = .02). Decision satisfaction measures were similar in both arms. DISCUSSION/CONCLUSIONS:Patients receiving a small kidney mass DA are likely to gain knowledge and preparedness to discuss all treatment options over standard educational materials.
PMID: 35714722
ISSN: 1558-349x
CID: 5282832

A novel simulation-based approach to training for recruitment of older adults to clinical trials

Fisher, Harriet; Zabar, Sondra; Chodosh, Joshua; Langford, Aisha; Trinh-Shevrin, Chau; Sherman, Scott; Altshuler, Lisa
BACKGROUND:The need to engage adults, age 65 and older, in clinical trials of conditions typical in older populations, (e.g. hypertension, diabetes mellitus, Alzheimer's disease and related dementia) is exponentially increasing. Older adults have been markedly underrepresented in clinical trials, often exacerbated by exclusionary study criteria as well as functional dependencies that preclude participation. Such dependencies may further exacerbate communication challenges. Consequently, the evidence of what works in subject recruitment is less generalizable to older populations, even more so for those from racial and ethnic minority and low-income communities. METHODS:To support capacity of research staff, we developed a virtual, three station simulation (Group Objective Structured Clinical Experience-GOSCE) to teach research staff communication skills. This 2-h course included a discussion of challenges in recruiting older adults; skills practice with Standardized Participants (SPs) and faculty observer who provided immediate feedback; and debrief to highlight best practices. Each learner had opportunities for active learning and observational learning. Learners completed a retrospective pre-post survey about the experience. SP completed an 11-item communication checklist evaluating the learner on a series of established behaviorally anchored communication skills (29). RESULTS:In the research staff survey, 92% reported the overall activity taught them something new; 98% reported it provided valuable feedback; 100% said they would like to participate again. In the SP evaluation there was significant variation: the percent well-done of items by case ranged from 25-85%. CONCLUSIONS:Results from this pilot suggest that GOSCEs are a (1) acceptable; (2) low cost; and (3) differentiating mechanism for training and assessing research staff in communication skills and structural competency necessary for participant research recruitment.
PMCID:9238219
PMID: 35764920
ISSN: 1471-2288
CID: 5278202

Chasing the storm: Recruiting non-hospitalized patients for a multi-site randomized controlled trial in the United States during the COVID-19 pandemic

Hu, Kelly; Tardif, Jean-Claude; Huber, Melanie; Daly, Maria; Langford, Aisha T; Kirby, Ruth; Rosenberg, Yves; Hochman, Judith; Joshi, Avni; Bassevitch, Zohar; Pillinger, Michael H; Shah, Binita
Randomized controlled trials (RCTs) remain the gold standard to evaluate clinical interventions, producing the highest level of evidence while minimizing potential bias. Inadequate recruitment is a commonly encountered problem that undermines the completion and generalizability of RCTs-and is even more challenging when enrolling amidst a pandemic. Here, we reflect on our experiences with virtual recruitment of non-hospitalized patients in the United States for ColCorona, an international, multicenter, randomized, placebo-controlled coronavirus disease 2019 (COVID-19) drug trial. Recruitment challenges during a pandemic include constraints created by shelter-in-place policies and targeting enrollment according to national and local fluctuations in infection rate. Presenting a study to potential participants who are sick with COVID-19 and may be frightened, overwhelmed, or mistrusting of clinical research remains a challenge. Strategies previously reported to improve recruitment include transparency, patient and site education, financial incentives, and person-to-person outreach. Active measures taken during ColCorona to optimize United States recruitment involved rapid expansion of sites, adjustment of recruitment scripts, assessing telephone calls versus text messages for initial contact with participants, institutional review board-approved financial compensation, creating an infrastructure to systematically identify potentially eligible patients, partnering with testing sites, appealing to both self-interest and altruism, and large-scale media efforts with varying degrees of success.
PMID: 34953032
ISSN: 1752-8062
CID: 5100052

A Qualitative Study Eliciting Patient Preferences For Cabg Vs Pci [Meeting Abstract]

Dickson, V V; Langford, A; Katz, S
Eliciting patient preferences and goals of care are foundational to the shared decision-making process and are also important to consider in clinical trial design. This qualitative study was part of formative work of a planning study to determine optimal design for a future randomized clinical trial comparing revascularization with coronary artery bypass grafting vs. percutaneous coronary intervention in patients with ischemic cardiomyopathy.
Objective(s): To elicit patient preferences for CABG vs. PCI among ischemic heart disease patients for use in refining study design and methods.
Method(s): We conducted individual interviews and focus groups with 20 subjects (>age 18) with ischemic cardiomyopathy to elicit patient attitudes and descriptions of patient preferences for treatment option. A semi-structured interview guide that included open-ended questions "What is the most important thing you consider when" provided structure but allowed participants to communicate attitudes and patient preferences. All interviews and focus groups were audiotaped and transcribed verbatim; and analyzed using Atlas ti v 8.0 to identify attributes and levels of attributes that influence decision making.
Result(s): Among this sample of patients with ischemic cardiomyopathy (85% male; 80% non-hispanic White); patients described that they are most likely to take the advice of their trusted provider "he's the expert and he knows my caseI do what he says". Five attributes of patient preferences emerged: invasiveness, quality of life, sustainability, complications and recovery period. In each category, subjects described 3 levels of attributes they deemed as influential (e.g., critical, major or minor complication). They also described preferences as a trade off or balancing of attributes. For example trading a longer recovery period for sustainability "If I'm in the hospital longer, I'll manageI prefer one and done!" Or balancing procedure invasiveness with impact to quality of life "I don't want to crack my chest but if it means I will play tennis again".
Conclusion(s): Preferences for CABG vs. PCI among ischemic heart disease patients provide important data for determination of study feasibility, entry criteria and recruitment strategies to support planning of a future clinical trial.
Copyright
EMBASE:2017884879
ISSN: 1532-8414
CID: 5252542

Representation in Online Prostate Cancer Content Lacks Racial and Ethnic Diversity: Implications for Black and Latinx Men

Loeb, Stacy; Borno, Hala T; Gomez, Scarlett; Ravenell, Joseph; Myrie, Akya; Sanchez Nolasco, Tatiana; Byrne, Nataliya; Cole, Renee; Black, Kristian; Stair, Sabrina; Macaluso, Joseph N; Walter, Dawn; Siu, Katherine; Samuels, Charlotte; Kazemi, Ashkan; Crocker, Rob; Sherman, Robert; Wilson, Godfrey; Griffith, Derek M; Langford, Aisha T
PURPOSE/OBJECTIVE:Black men have the highest incidence and mortality from prostate cancer (PCa) and lower quality of life compared to other U.S. racial groups. Additionally, more Latinx men are diagnosed with advanced disease and fewer receive guideline-concordant care. As many men seek medical information online, high-quality information targeting diverse populations may mitigate disparities. We examined racial/ethnic representation and information quality in online PCa content. MATERIALS AND METHODS/METHODS:We retrieved 150 websites and 150 videos about "prostate cancer" using the most widely used search engine (Google) and social network (YouTube). We assessed quality of health information, reading level, perceived race/ethnicity of people featured in the content and discussion of racial/ethnic disparities. RESULTS:Among 81 websites and 127 videos featuring people, 37% and 24% had perceived Black representation, and racial/ethnic disparities were discussed in 27% and 17%, respectively. Among 1,526 people featured, 9% and 1% were perceived as Black and Latinx, respectively. No content with Black or Latinx representation was high quality, understandable, actionable and at the recommended reading level. CONCLUSIONS:Black and Latinx adults are underrepresented in online PCa content. Online media have significant potential for public education and combating health disparities. However, most PCa content lacks diversity and is not readily understandable.
PMID: 35114821
ISSN: 1527-3792
CID: 5153832

Correlates of knowledge of clinical trials among U.S. adults: Findings from the 2020 Health Information National Trends Survey

Langford, Aisha T; Orellana, Kerli T; Buderer, Nancy
BACKGROUND:Knowledge about clinical trials affects efficient and equitable clinical trial recruitment and retention. This study explored correlates of clinical trial knowledge in a nationally representative sample of US adults. METHODS:Cross-sectional data from the 2020 Health Information National Trends Survey (HINTS 5, Cycle 4) were evaluated. There were 3,865 responses in the full dataset; 2,648 remained after eliminating respondents without complete data for all covariates of interest. Participants were asked, "How would you describe your level of knowledge about clinical trials?" The response options "know a little bit" and "know a lot" were combined and compared to the response option "don't know anything." Covariates of interest included patient-provider communication, history of medical conditions, eHealth use, knowledge of clinicaltrials.gov, prior invitation to join a clinical trial, and socio-demographic factors. RESULTS:Participants with a history of cancer were 1.6 times more likely [CI 1.2, 2.2] to have knowledge of clinical trials. Participants who used electronic means to look for health information were 1.7 times more likely [CI 1.2, 2.4] to have knowledge of clinical trials. Participants who had heard of the website clinicaltrials.gov had 5.1 times greater odds of knowing about clinical trials [CI 2.6, 10.3] and 4.5 greater odds if they had been invited to participate in a clinical trial [CI 2.0, 9.8]. College graduates had higher odds than others. CONCLUSION/CONCLUSIONS:Several factors affect clinical trial knowledge in US adults. Findings from this study may inform interventions to raise awareness about clinical trials and thereby, potentially improve enrollment.
PMID: 35026434
ISSN: 1559-2030
CID: 5119002

ENHANCING EQUITABLE PARTICIPATION IN CLINICAL TRIALS: COMMUNITY AND SYSTEM-LEVEL CONSIDERATIONS [Meeting Abstract]

Langford, Aisha
ISI:000788118600192
ISSN: 0883-6612
CID: 5243812

Shared Decision-Making in Cardiac Electrophysiology Procedures and Arrhythmia Management

Chung, Mina K; Fagerlin, Angela; Wang, Paul J; Ajayi, Tinuola B; Allen, Larry A; Baykaner, Tina; Benjamin, Emelia J; Branda, Megan; Cavanaugh, Kerri L; Chen, Lin Y; Crossley, George H; Delaney, Rebecca K; Eckhardt, Lee L; Grady, Kathleen L; Hargraves, Ian G; True Hills, Mellanie; Kalscheur, Matthew M; Kramer, Daniel B; Kunneman, Marleen; Lampert, Rachel; Langford, Aisha T; Lewis, Krystina B; Lu, Ying; Mandrola, John M; Martinez, Kathryn; Matlock, Daniel D; McCarthy, Sarah R; Montori, Victor M; Noseworthy, Peter A; Orland, Kate M; Ozanne, Elissa; Passman, Rod; Pundi, Krishna; Roden, Dan M; Saarel, Elizabeth V; Schmidt, Monika M; Sears, Samuel F; Stacey, Dawn; Stafford, Randall S; Steinberg, Benjamin A; Youn Wass, Sojin; Wright, Jennifer M
Shared decision-making (SDM) has been advocated to improve patient care, patient decision acceptance, patient-provider communication, patient motivation, adherence, and patient reported outcomes. Documentation of SDM is endorsed in several society guidelines and is a condition of reimbursement for selected cardiovascular and cardiac arrhythmia procedures. However, many clinicians argue that SDM already occurs with clinical encounter discussions or the process of obtaining informed consent and note the additional imposed workload of using and documenting decision aids without validated tools or evidence that they improve clinical outcomes. In reality, SDM is a process and can be done without decision tools, although the process may be variable. Also, SDM advocates counter that the low-risk process of SDM need not be held to the high bar of demonstrating clinical benefit and that increasing the quality of decision-making should be sufficient. Our review leverages a multidisciplinary group of experts in cardiology, cardiac electrophysiology, epidemiology, and SDM, as well as a patient advocate. Our goal is to examine and assess SDM methodology, tools, and available evidence on outcomes in patients with heart rhythm disorders to help determine the value of SDM, assess its possible impact on electrophysiological procedures and cardiac arrhythmia management, better inform regulatory requirements, and identify gaps in knowledge and future needs.
PMID: 34865518
ISSN: 1941-3084
CID: 5080022

Stress and Depression are Associated with Life's Simple 7 Among African Americans with Hypertension: Findings from the Jackson Heart Study

Langford, Aisha T; Butler, Mark; Booth Iii, John N; Jin, Peng; Bress, Adam P; Tanner, Rikki M; Kalinowski, Jolaade; Blanc, Judite; Seixas, Azizi; Shimbo, Daichi; Sims, Mario; Ogedegbe, Gbenga; Spruill, Tanya M
BACKGROUND:The American Heart Association created the Life's Simple 7 (LS7) metrics to promote cardiovascular health by achieving optimal levels of blood pressure, cholesterol, blood sugar, physical activity, diet, weight, and smoking status. The degree to which psychosocial factors such as stress and depression impact one's ability to achieve optimal cardiovascular health is unclear, particularly among hypertensive African Americans. METHODS:Cross-sectional analyses included 1,819 African Americans with hypertension participating in the Jackson Heart Study (2000-2004). Outcomes were LS7 composite and individual component scores (defined as poor, intermediate, ideal). High perceived chronic stress was defined as the top quartile of Weekly Stress Inventory scores. High depressive symptoms were defined as Center for Epidemiologic Studies Depression scale scores of ≥16. We compared four groups: high stress alone; high depressive symptoms alone; high stress and high depressive symptoms; low stress and low depressive symptoms (reference) using linear regression for total LS7 scores and logistic regression for LS7 components. RESULTS:Participants with both high stress and depressive symptoms had lower composite LS7 scores (B [95% confidence interval-CI]= -0.34 [-0.65 to -0.02]) than those with low stress and depressive symptoms in unadjusted and age/sex-adjusted models. They also had poorer health status for smoking (OR [95% CI]= 0.52 [0.35-0.78]) and physical activity [OR (95% CI)= 0.71 (0.52-0.95)] after full covariate adjustment. CONCLUSIONS:The combination of high stress and high depressive symptoms was associated with poorer LS7 metrics in hypertensive African Americans. Psychosocial interventions may increase the likelihood of engaging in behaviors that promote optimal cardiovascular health.
PMID: 34272853
ISSN: 1941-7225
CID: 4947672

Interaction between race and prostate cancer treatment benefit in the Veterans Health Administration

Rude, Temitope; Walter, Dawn; Ciprut, Shannon; Kelly, Matthew D; Wang, Chan; Fagerlin, Angela; Langford, Aisha T; Lepor, Herbert; Becker, Daniel J; Li, Huilin; Loeb, Stacy; Ravenell, Joseph; Leppert, John T; Makarov, Danil V
BACKGROUND:Studies have demonstrated that Black men may undergo definitive prostate cancer (CaP) treatment less often than men of other races, but it is unclear whether they are avoiding overtreatment of low-risk disease or experiencing a reduction in appropriate care. The authors' aim was to assess the role of race as it relates to treatment benefit in access to CaP treatment in a single-payer population. METHODS:The authors used the Veterans Health Administration (VHA) Corporate Data Warehouse to perform a retrospective cohort study of veterans diagnosed with low- or intermediate-risk CaP between 2011 and 2017. RESULTS:The authors identified 35,427 men with incident low- or intermediate-risk CaP. When they controlled for covariates, Black men had 1.05 times the odds of receiving treatment in comparison with non-Black men (P < .001), and high-treatment-benefit men had 1.4 times the odds of receiving treatment in comparison with those in the low-treatment-benefit group (P < .001). The interaction of race and treatment benefit was significant, with Black men in the high-treatment-benefit category less likely to receive treatment than non-Black men in the same treatment category (odds ratio, 0.89; P < .001). CONCLUSIONS:Although race does appear to influence the receipt of definitive treatment in the VHA, this relationship varies in the context of the patient's treatment benefit, with Black men receiving less definitive treatment in high-benefit situations. The influence of patient race at high treatment benefit levels invites further investigation into the driving forces behind this persistent disparity in this consequential group.
PMID: 34184271
ISSN: 1097-0142
CID: 4926392