Oncologist-Reported Barriers and Facilitators to Offering Cancer Clinical Trials to Their Patients.

NCCN guidelines indicate that cancer clinical trials (CCTs) are the best management for patients with cancer. However, only 5% of patients enroll in them. We examined oncologists' perceived barriers and facilitators to discussing CCTs. This qualitative study was part of the ASCO-ACCC Initiative to Increase Racial and Ethnic Diversity in Clinical Trials. Barriers and facilitators at the system, trial, provider, and patient levels were examined. To achieve triangulation, patient encounters were reviewed using chart-stimulated recall (CSR) methods, thereby obtaining a valid assessment of physician performance. Ten oncology providers participated in this study. Nine were oncologists, and one was a clinical research coordinator; five were female; four were White; three were Asian; and three were Black. Barriers to offering CCTs were a lack of trial availability; ineligibility; a lack of knowledge; assumptions about patient interest, benefits, or harms; patient's disease factors; and negative attitudes. Facilitators of offering CCTs were a physical space to discuss trials; greater trial availability; a systematic approach to offering trials; patient factors; patients seeking trials; a lack of comorbidities; patients being younger in age; patients being aware of, asking about, or hearing of trials from their surgeon; and higher levels of altruism. Many of the cited barriers are addressable with the cited facilitators. A larger study is needed to generalize and validate these findings.

Increasing Racial and Ethnic Equity, Diversity, and Inclusion in Cancer Treatment Trials: Evaluation of an ASCO-Association of Community Cancer Centers Site Self-Assessment.

Clinical trial participants do not reflect the racial and ethnic diversity of people with cancer. ASCO and the Association of Community Cancer Centers collaborated on a quality improvement study to enhance racial and ethnic equity, diversity, and inclusion (EDI) in cancer clinical trials. The groups conducted a pilot study to examine the feasibility, utility, and face validity of a two-part clinical trial site self-assessment to enable diverse types of research sites in the United States to (1) review internal data to assess racial and ethnic disparities in screening and enrollment and (2) review their policies, programs, procedures to identify opportunities and strategies to improve EDI. Overall, 81% of 62 participating sites were satisfied with the assessment; 82% identified opportunities for improvement; and 63% identified specific strategies and 74% thought the assessment had potential to help their site increase EDI. The assessment increased awareness about performance (82%) and helped identify specific strategies (63%) to increase EDI in trials. Although most sites (65%) were able to provide some data on the number of patients that consented, only two sites were able to provide all requested trial screening, offering, and enrollment data by race and ethnicity. Documenting and evaluating such data are critical steps toward improving EDI and are key to identifying and addressing disparities more broadly. ASCO and Association of Community Cancer Centers will partner with sites to better understand their processes and the feasibility of collecting screening, offering, and enrollment data in systematic and automated ways.

An Assessment of the Feasibility and Utility of an ACCC-ASCO Implicit Bias Training Program to Enhance Racial and Ethnic Diversity in Cancer Clinical Trials.

PURPOSE: Cancer trial participants do not reflect the racial and ethnic diversity in the population of people with cancer in the United States. As a result of multiple system-, patient-, and provider-level factors, including implicit bias, cancer clinical trials are not consistently offered to all potentially eligible patients. MATERIALS AND METHODS: ASCO and ACCC evaluated the utility (pre- and post-test knowledge changes) and feasibility (completion rates, curriculum satisfaction metrics, survey questions, and interviews) of a customized online training program combined with facilitated peer-to-peer discussion designed to help research teams identify their own implicit biases and develop strategies to mitigate them. Discussion focused on (1) specific elements of the training modules; (2) how to apply lessons learned; and (3) key considerations for developing a facilitation guide to support peer-to-peer discussions in cancer clinical research settings. We evaluated discussion via a qualitative assessment. RESULTS: Participant completion rate was high: 49 of 50 participating cancer programs completed training; 126 of 129 participating individuals completed the training (98% response rate); and 119 completed the training and evaluations (92% response rate). Training increased the mean percentage change in knowledge scores by 19%-45% across key concepts (eg, causes of health disparities) and increased the mean percentage change in knowledge scores by 10%-31% about strategies/actions to address implicit bias and diversity concerns in cancer clinical trials. Knowledge increases were sustained at 6 weeks. Qualitative evaluation validated the utility and feasibility of facilitated peer-to-peer discussion. CONCLUSION: The pilot implementation of the training program demonstrated excellent utility and feasibility. Our evaluation affirms that an online training designed to raise awareness about implicit bias and develop strategies to mitigate biases among cancer research teams is feasible and can be readily implemented in cancer research settings.

Designing and Evaluating a Gender-Affirming Educational Initiative for Optimal HIV Care: An Intrinsic Case Study.

Purpose: Gender-affirming care that integrates transgender and gender nonconforming (TGNC)-related and/or transition-related health care needs is an effective mechanism to increase the number of TGNC patients being screened for HIV and linked to HIV services. Methods: Evaluation of a gender-affirming education initiative to help clinicians in one clinic provides better care for TGNC patients. Results: Processes and factors that support the effective implementation of a gender-affirming clinical environment include (1) establishing credibility within the local TGNC community; (2) the critical role played by a patient navigator; and (3) awareness of the lived experience of being TGNC. Participating in the education initiative boosted team motivation, improved knowledge and competence, and provided opportunities for training nonclinical staff. Conclusion: This practice assessment interview offers a unique window into the impact of an education initiative on the effective implementation of a gender-affirming clinical environment.

Qualitative Outcomes in CME/CPD: Exploring Non-Linear Contexts and Lived Experiences in Patient-Directed Interventions.

Qualitative analysis is often used to gather insights about learning, behavioural and practice change. Given the rich detail that qualitative data delivers, we are puzzled at the relative absence of qualitative approaches to outcomes assessment in the field of CME/CPD, especially as patient-directed education becomes increasingly tethered or adjunctive to CME/CPD programmes as a way to directly engage patients in disease self-management and improve health outcomes. Education outcomes for both clinicians and patients are contextualised by norms, motivations, and values that shape how learners interact with education activities and materials. These properties are linked to and shape the mechanisms that drive education outcomes but are rarely the focus of assessments that are often rooted in quantitative, positivist frameworks. In order to illustrate the role that qualitative methodologies can play in outcomes assessment, we describe insights from three education programmes designed to improve the health of patients with specific conditions and outline a range of qualitative methodologies appropriate for outcomes evaluation.

Taking OAB seriously: A qualitative evaluation of primary care education on overactive bladder syndrome management.

BACKGROUND: Overactive bladder (OAB) syndrome has a diverse etiology that disrupts quality of life domains in affected patients. OAB is significantly under-recognised and undertreated, especially in the primary care setting. In order to educate primary care providers about OAB recognition, evaluation and management, we created a virtual live-streamed and enduring education program. METHODS: We evaluated the impact of education on provider knowledge and self-efficacy via qualitative interviews with a sample of education participants. We analysed participant responses via constant comparative method, an iterative approach that allows for exploration of a priori issues and identification of emergent themes. RESULTS: We identified four key themes: (a) taking OAB seriously; (b) variations in therapy; (c) patient motivation; and (d) education value. Participants were proactive about screening for and managing OAB and recognised urgency as a key symptom; some participants used diagnostic tests that are not are not considered necessary in the workup of uncomplicated OAB patients. Participants varied in their descriptions of initial approaches to treatment and most participants described a longer-than-recommended follow-up window to monitor patients. Some participants characterised patients as looking for a "quick fix" in ways that could lead to provider inaction in relation to behavioural/lifestyle interventions. Overall, participants felt that the education validated their current practice and provided new knowledge about evaluation, initiating behavioural treatment, and combination therapy. CONCLUSIONS: Participant responses were congruent with education messages, which likely reflect their "readiness to learn". The rationale for diagnostic tests and evidence on the effectiveness of behavioural regimens represent ongoing areas of unmet educational need.

Living With the Burden of Pseudobulbar Affect: A Qualitative Analysis of the Effects of Education on Patient Experience.

Pseudobulbar affect (PBA) is associated with several neurological diseases and is underrecognized in clinical practice; however, PBA symptoms are often attributed to psychiatric or mood disorders rather than to neurological etiology. Until recently, there were no US Food and Drug Administration therapies approved for treating this condition, and there are currently few resources to support patients in the recognition and self-management of PBA symptoms. We evaluated the impact of a virtual education symposium on patient knowledge and self-efficacy via qualitative interviews. This evaluation of education impact provides unique insight into the experience of managing PBA symptoms; suggests that there is extensive need for educational resources to support patients with PBA and enable them to engage effectively with their providers; and affirms that online learning is an effective mechanism for delivering education to patients that enables them to more effectively self-manage symptoms in the context of chronic neurological conditions such as PBA.

Best practices in care for menopausal patients: 16 years after the Women's Health Initiative.

The Women's Health Initiative (WHI) was a large, randomized clinical trial funded by the National Institutes of Health to determine whether menopause hormone therapy (MHT) prevented heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women. Two WHI trials were stopped early, and the findings had a profound effect on the clinical practice guidelines related to postmenopausal health. This article provides an overview of the WHI MHT clinical trials and findings, discusses the early stoppage of the trials and subsequent implications, and details the current nomenclature and treatment options for women transitioning through menopause in light of the WHI. This study is based on a comprehensive literature review and an education activity developed by the American Association of Nurse Practitioners. To best serve patients and individualize therapy, clinicians must provide the best estimate of potential risks or benefits to the individual patient. It is important to balance evidence of symptom relief with long-term risks and benefits that fit the patient's characteristics of family and personal health history. Armed with evidence to support various hormonal and non-hormonal options, well-informed clinicians can counsel women about MHT and potentially avoid negative impact on quality of life.

Strategies to Improve Prevention and Management in Diabetic Retinopathy: Qualitative Insights from a Mixed-Methods Study.

Nonproliferative and proliferative diabetic retinopathy (DR) are common, progressive complications of diabetes with a rising incidence. Over time, patients with nonproliferative DR may progress to more advanced stages of DR, with an increased risk of vision-threatening conditions such as diabetic macular edema (DME). DME is the most frequent cause of vision loss in patients with diabetes and eventually can lead to blindness. Early-stage DR is asymptomatic; therefore, a coordinated management strategy is crucial to prevent or limit the progression of DR. Such a strategy includes regular screening for DR risk factors, glycemic control, and prompt diagnosis of DR. Preventive care should include a comprehensive dilated eye exam, ancillary tests, and patient education involving a multidisciplinary team composed of ophthalmologists, retina specialists, and primary diabetes care providers, including primary care providers and endocrinologists/diabetologists. However, although guideline recommendations for regular screening and patient education are well disseminated, many people with diabetes are not receiving ophthalmological care that could prevent visual impairment and blindness. We designed a mixed-methods study to explore the impact of patient-focused education on patient knowledge and self-efficacy in relation to DR prevention and management and to assess how online education can help to change patient knowledge, competence, and practice. Analysis of in-depth, qualitative data involving people with diabetes with or without DR collected 5-16 weeks after education participation shows that online patient education is an effective tool in building patient knowledge and awareness about DR and in motivating action in DR self-care.

Perspectives on the Use of eHealth in the Management of Patients With Schizophrenia.

Mobile devices, digital technologies, and web-based applications-known collectively as eHealth (electronic health)-could improve health care delivery for costly, chronic diseases such as schizophrenia. Pharmacologic and psychosocial therapies represent the primary treatment for individuals with schizophrenia; however, extensive resources are required to support adherence, facilitate continuity of care, and prevent relapse and its sequelae. This paper addresses the use of eHealth in the management of schizophrenia based on a roundtable discussion with a panel of experts, which included psychiatrists, a medical technology innovator, a mental health advocate, a family caregiver, a health policy maker, and a third-party payor. The expert panel discussed the uses, benefits, and limitations of emerging eHealth with the capability to integrate care and extend service accessibility, monitor patient status in real time, enhance medication adherence, and empower patients to take a more active role in managing their disease. In summary, to support this technological future, eHealth requires significant research regarding implementation, patient barriers, policy, and funding.

Identifying psychiatrists' practice patterns when managing depression in patients with bipolar I disorder: a descriptive study to inform education needs.

OBJECTIVE: The purpose of this study was to describe practice patterns of US psychiatrists with regard to the diagnosis and management of depression in adults with bipolar I disorder and to identify relevant gaps in clinical knowledge and competence. METHODS: Two focus groups were conducted using nominal group technique via a web interface and teleconference to elicit barriers that psychiatrists face in managing depression in patients with bipolar I disorder. These results framed a case-based survey that was administered to 200 US-based psychiatrists to explore and quantitatively assess their knowledge and practice patterns with respect to the diagnosis and management of depression in patients with bipolar I disorder. We completed all statistical analyses with PASW Statistics 18 and used descriptive statistics to summarize survey responses. RESULTS: To identify previously undiagnosed mania, 67% of clinician respondents said that they asked depressed patients if they had previously experienced all Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision mania-defining symptoms. To treat a patient with symptoms of depression and no other risk factors for bipolar I disorder, 85% of the respondents said that they would use an antidepressant; 55% of respondents were not concerned that their choice of treatment would lead to a manic episode; 5% thought that there was no greater risk of treatment-emergent mood disorder when treating depression in patients with bipolar I disorder compared with major depressive disorder. If the patient had depression and risk factors for bipolar I disorder, 54% of the respondents said that they would still prescribe an antidepressant as monotherapy. CONCLUSION: The clinician responses were not adherent to evidence-based practice based on clinical trial results or current guideline recommendations. There is an unmet need for education to enable psychiatrists to differentiate between unipolar and bipolar depression, to identify the risk of treatment-emergent mood disorders with the use of antidepressants, and to effectively manage patients at risk for bipolar I disorder.

'Between the demands of truth and government': health practitioners, trust and immunisation work.

Applied and theoretical work on health governance and governmentality has often not engaged with the perspectives of practitioners and, in particular, with their understandings about trust. In this paper, we address these absences through looking at a critical technology of governmentality--child immunisation. We do this, first, by examining theoretical links between risk, trust and knowledge in relation to the governance of health. We then draw on findings from our secondary analysis of qualitative data based on interviews with key actors in primary care in Scotland charged with the delivery of a particular immunisation--the MMR vaccine. While many practitioners, like parents, have typically perceived immunisation--along with other public health initiatives-as obligatory and as part of 'good citizenship', we argue that in relation to MMR and in the context of clinical governance, practitioners are having to engage in complex negotiations about knowledge and trust--negotiations that are at the heart of governing health at a distance.