Ridgeway, Jennifer L.

End of life is difficult for all patients but sexual and gender minorities (SGM) are prone to isolation and loneliness, especially if their SGM status is unknown or unaccepted. In oncology clinics, where goals of care discussions about end of life are integral and frequent, querying patients about their SGM status and sexual health is of particular importance. The American Society of Clinical Oncology recently released a position statement that called for greater focus on SGM populations with the goal of reducing and eventually eliminating disparities in cancer care within this group. An important first step in addressing such disparities is learning how best to train cancer health-care providers to ask patients about their SGM status and about sexual health in general. This article summarizes the mandate for understanding cancer issues in SGM populations and the dearth of cancer-related data within this group. This article also describes an ongoing 3-part study intended to build a mini curriculum with the goal of helping cancer health-care providers to ask patients with cancer about SGM status and to ask all patients with cancer about sexual health issues. The results of this ongoing study could potentially improve end-of-life care for subgroups of patients.

Objective There exists a paucity of work in the development and testing of theoretical models specific to childhood health disparities even though they have been linked to the prevalence of adult health disparities including high rates of chronic disease. We conducted a systematic review and thematic analysis of existing models of health disparities specific to children to inform development of a unified conceptual framework. Methods We systematically reviewed articles reporting theoretical or explanatory models of disparities on a range of outcomes related to child health. We searched Ovid Medline In-Process & Other Non-Indexed Citations, Ovid MEDLINE, Ovid Embase, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus (database inception to 9 July 2015). A metanarrative approach guided the analysis process. Results A total of 48 studies presenting 48 models were included. This systematic review found multiple models but no consensus on one approach. However, we did discover a fair amount of overlap, such that the 48 models reviewed converged into the unified conceptual framework. The majority of models included factors in three domains: individual characteristics and behaviours (88%), healthcare providers and systems (63%), and environment/community (56%), . Only 38% of models included factors in the health and public policies domain. Conclusions A disease-agnostic unified conceptual framework may inform integration of existing knowledge of child health disparities and guide future research. This multilevel framework can focus attention among clinical, basic and social science research on the relationships between policy, social factors, health systems and the physical environment that impact children's health outcomes.

Background: Underrepresentation of African American women as research participants contributes to health disparities. Contemporary studies have focused on clinical trial (CT) participation; epidemiologic and genetic studies utilizing medical records and/or biological samples have received less attention. In partnership with The Links, Incorporated (The Links), a national service organization of professional African American women, this study sought to examine attitudes regarding chart review (CR) studies, genetic studies/biobanking (GEN), and CTs; develop; and evaluate an online education-to-action program. Methods: In phase 1, focus groups were convened with members of The Links to inform the content and format of the program. Phases 2 and 3 involved designing and evaluating the program, respectively. Results: Thirty-four women across three focus groups shared attitudes and perceptions regarding research and provided guidance for program development. Subsequently, 244 women completed the program (77% response rate), including pre- and post-assessments. Participants indicating that they “definitely” or “probably” (responses combined) intend to participate in research increased from 36.5% to 69.3% (pre/post-program). Agreement with the statement “research in the U.S. is ethical” increased (52.9% to 74.4%) as did factual knowledge regarding each of the study types. There was a decrease in reporting “little or no understanding” of study types (Pre/Post: GEN: 66%/24.9%, CR: 62.9%/18.4%, CTs: 40.7%/15.5%). Pre-program, few were “very positive” about the study types (14.3% GEN, 15.0% CR, 28.6% CTs); post-program ratings increased and equalized (42.8% GEN, 43.0% CR, 42.5% CTs). Conclusions: An online education-to-action program targeting professional African American women improved knowledge, perceptions of ethics, and intent to participate in biomedical research.

Objective: A growing number of cancer antineoplastic agents can cause life-threatening acute infusion reactions. Because previous studies have not studied these reactions from the perspective of patients, this study was undertaken with that objective in mind. Methods: Patients who had an acute infusion reaction were interviewed based on the Leventhal model. Once saturation of content was achieved, interviews were transcribed and analyzed with qualitative methodology. Results: Twenty-one patients were enrolled. Most were women (n = 15); the median age was 58 years, and paclitaxel was the most common inciting agent. Three themes emerged. First, these reactions are frightening; patients made remarks such as “I was just thinking oh my God, I am dying.” Second, prior education about these reactions seemed to mitigate this fear, “Basically everything the nurses told me potentially could happen, like happened. So, I was prepared.” Third, when health-care providers were prompt and attentive during the reaction, patients described less fear with future chemotherapy, “So no, I’m really not fearful about going in tomorrow because I know they’ll be there and they’ll be watching me.” Conclusion: These reactions evoke fear which can be mitigated with education prior to and with prompt responsiveness during the acute infusion reaction.

AbstractObjectiveThis study employs the concept of relational autonomy to understand how relational encounters with family members (FMs) and care providers may shape decisions around ovarian cancer patients’ clinical trial (CT) participation. The study also offers unique insights into howFMs view patients’ decision making.MethodsIn‐depth interviews were conducted with 33 patients with ovarian cancer who had been offered aCTand 39FMs. Data were inductively analysed using a thematic approach and deductively informed by constructs derived from the theory of relational autonomy (RA).ResultsPatients’ relationships, experiences and social status were significant resources that shaped their decisions. Patients did not give equal weight to all relationships and created boundaries around whom to include in decision making. Doctors’ recommendations and perceived enthusiasm were described as influential inCTdecisions. Both patients with ovarian cancer and theirFMs maintained that patients have the “final say,” indicating an individualistic autonomy. However, maintaining the “final say” in the decision‐making process is constitutive of patients’ relationships, emphasizing a relational approach to autonomy.FMs support patients’ autonomy and they do so particularly when they believe the patient is capable of making the right choices.ConclusionsAlthough ethical principles underlying informed consent forCTparticipation emphasize individual autonomy, greater attention to relational autonomy is warranted for a more comprehensive understanding ofCTdecision making.

ObjectiveTo explore the perspectives and experiences of patients with rheumatoid arthritis (RA) whose assessments of their disease differ from those of their rheumatology care provider.MethodsA total of 20 adult RA patients with patient‐provider discordance at their most recent rheumatology appointment (within 4 weeks) were recruited. Discordance was defined by an absolute difference of 25 or more between patient and provider global assessments on a visual analog scale (VAS) of disease activity. For descriptive purposes, participants completed the Health Assessment Questionnaire II, pain VAS, and Patient Health Questionnaire 9 depression scale. Interviews were conducted in person and individually with each patient with a semistructured interview guide. Topics ranged widely, including participants’ perspectives and experiences with living with RA, clinical disease assessments, patient‐provider communication, and psychosocial or other needs. Data from the interviews were analyzed using interpretive phenomenological analysis.ResultsSix major themes emerged from the patient interviews describing patient‐provider discordance and disease assessment: being misunderstood by others, limitations of provider assessments, discrepancy with provider findings, inadequate active listening on the part of health care providers, unmet psychosocial needs, and lack of patient empowerment.ConclusionPatients described discordance in terms of symptom assessment and understanding how RA affects everyday life. Typical clinical assessments did not capture their experience. The resulting conceptual framework should inform future interventional studies seeking to enhance concordance of patient‐physician communication and to optimize satisfaction with care and health‐related quality‐of‐life outcomes for patients with RA.

The time required to get a device to market is critical to a successful design, development, and manufacturing process [1]. Achieving status of the first device to market is often a priority for manufacturers and developers. Upon market introduction, it is well known that device performance must meet at least minimum standards in order to provide consumer satisfaction and be a successful product to prevent competitive devices from taking over the market [1]. However, if a design only meets minimum expectations, it may struggle to maintain market control. This demonstrates the tradeoffs of speed-to-market and performance, for which optimization has not been clearly defined [2]. Product performance and usability can be designed in, evaluated and enhanced in order to avoid user errors and achieve optimal profitability. For medical devices, clinical trials are a key step in preparing to take a device to market. Clinical trials can allow for analyses of the effectiveness of the device in the patient care process. For wearable medical devices, patient usability is crucial to patient adherence and safety since the device will be operated by non-medically trained individuals [3,4]. Without adequate usability, adherence and continuity of care are greatly reduced which will reduce the overall effectiveness of the device [5,6]. Human factors principles can best be incorporated in the design process to improve the usability of medical devices and patient safety [5,6,7], specifically for those used in telemedicine [4] and cardiovascular treatment [3]. The objective of this project was to evaluate a telemedicine heart rate monitoring device for patient usability in order to improve the next device’s performance and lead to greater patient adherence for the current version via an improved user manual.

Remote monitoring has the potential to improve patient care and satisfaction while reducing the cost of care and burden on the healthcare system for Congestive Heart Failure (CHF) and Atrial Fibrillation (AF) patients. However, the device must be convenient and easy for the population to use correctly. In this study, human factors and qualitative researchers evaluated the use of a remote cardiac monitoring device during a clinical trial with 74 CHF and AF patients. Human factors usability concerns centered on device use and the information presented in the manual. The key themes identified during the qualitative analysis were related to patient education. These findings were incorporated into device design, user manual, or education material updates. This study illustrates how these methods can infuse patient experience into device design to inform continued quality improvement and usability refinement specifically in devices to aid CHF and AF patients without added burden.

Abstract Addressing underrepresentation of minorities and women as research participants has largely focused on clinical trials, while little is known about attitudes and knowledge regarding other types of biomedical research, e.g., epidemiologic and genetic studies. These types of studies are essential for advances in cancer research, including development of targeted therapies for women and minorities. As part of an academic/community partnership between Mayo Clinic and The Links, Incorporated, a national volunteer service organization of professional African American women, this study sought to: (1) examine attitudes regarding participation in research involving access to the medical record, genetic studies/biobanking, and clinical trials; and (2) develop and evaluate a novel, targeted online educational program addressing these 3 types of biomedical research. Initial qualitative inquiry via 3 focus groups (n=34) found that most women associated health-related research with clinical trials; few women were familiar with other study types. Women expressed more concerns about how information is collected, used, and shared by investigators than with personal mistreatment in research regardless of study type (genetic research (GEN), chart review (CR), clinical trial (CT)) or the kind of information (social, health, genetic) collected. The importance of investigator transparency regarding the significance of the disease in African Americans, research funding source, the investigator’s agenda, and commitment to the population being studied was emphasized. Qualitative results informed development of the educational program. A total of 244 Links members completed the program (77% response rate) and answered pre- and post-assessments of intentions, attitudes and knowledge. The percent of women indicating that they “definitely” or “probably” intend to participate in research increased from 9.4% to 19.5% and 27.1% to 49.8%, respectively, after program completion. Agreement with the statement “research in the U.S. is ethical” increased from 52.9% to 74.4%. Factual knowledge related to each of the 3 study types also increased. Prior to completing the program many women reported “little or no understanding” of the 3 types of studies (66% GEN, 62.9% CR, 40.7% CT) whereas after program completion, these numbers decreased to 24.9%, 18.4%, and 15.5%, respectively. While few women rated their opinion of the study types as “very positive” prior to beginning the program (14.3% GEN, 15.0% CR, 28.6% CT), upon completion these proportions increased and equalized (42.8% GEN, 43.0% CR, 42.5% CT). Two-month follow-up will evaluate longer-term impact including knowledge dissemination, visiting clinicaltrials.gov, and enrolling in ResearchMatch. An online education-to-action program targeting professional African American women improved knowledge, perceptions of research ethics, and intent to participate in biomedical research. Citation Format: Carmen Radecki Breitkopf, Karen P. Williams, Jennifer L. Ridgeway, Alice L. Strong Simmons, Monica W. Parker, Michele Y. Halyard, Sharonne N. Hayes. Linking education to action: A program to increase research participation among African American women [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 4233. doi:10.1158/1538-7445.AM2017-4233