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Pregnant women have been called therapeutic orphans because data supporting common interventions, medications, health teaching, and models of care are meager. The generation of quality evidence benefits from proactive approaches that ensure ethical standards are met to protect participants. The purpose of this article is to differentiate among health care, quality improvement, and research and to discuss ethical involvement of women who are pregnant and potentially childbearing in these initiatives. Health care is provided to protect and improve individual health. Quality improvement aims to enhance delivery of care for all those receiving care in particular settings. Research, whether retrospective or prospective, is designed to contribute to generalizable knowledge. This review includes vignettes to distinguish between research, quality improvement, and case study dissemination and to highlight the value of publication of information with applicability beyond a single site. As a community, perinatal care providers will be able to contribute more evidence to guide care if they err on the side of seeking institutional review board approval for activities that examine the care and outcomes of pregnant women and the fetus. Traditional research activities, including clinical trials, remain crucial. However, to fill gaps in knowledge, we must expedite our ability to report informative cases, examine clinical data, share lessons learned during quality improvement campaigns, and publish and disseminate these findings. Accelerating improvements in care demands expansion of the evidence base.
© 2017 by the American College of Nurse-Midwives.
BACKGROUND AND OBJECTIVES - Prognostic uncertainty is one barrier that impedes providers in engaging patients with CKD in shared decision making and advance care planning. The surprise question has been shown to identify patients at increased risk of dying.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS - In our prospective observational study, 488 patients ≥60 years of age with CKD stage 4 or 5 were enrolled. Binary surprise question (, "Would you be surprised if this patient died in the next 12 months?") responses were recorded, and dialysis planning preferences, presence of advance care planning documentation, and care preceding death were abstracted.
RESULTS - The median patient age was 71 (65-77) years old. Providers responded no and yes to the surprise question for 171 (35%) and 317 (65%) patients, respectively. Median follow-up was 1.9 (1.5-2.1) years, during which 18% of patients died (33% of surprise question no, 10% of surprise question yes; <0.001). In patients with a known RRT preference (58%), 13% of surprise question no participants had a preference for conservative management (versus 2% of yes counterparts; <0.001). A medical order (, physician order for life-sustaining treatment) was documented in 13% of surprise question no patients versus 5% of yes patients (=0.004). Among surprise question no decedents, 41% died at home or hospice, 38% used hospice services, and 54% were hospitalized in the month before death. In surprise question yes decedents, 39% died at home or hospice (=0.90 versus no), 26% used hospice services (=0.50 versus no), and 67% were hospitalized in the month before death (=0.40 versus surprise question no).
CONCLUSIONS - Nephrologists' prognostic perceptions were associated with modest changes in care, highlighting a critical gap in conservative management discussions, advance care planning, and end of life care among older adults with CKD stages 4 and 5 and high-risk clinical characteristics.
PODCAST - This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2017_09_18_CJASNPodcast_17_11.mp3.
Copyright © 2017 by the American Society of Nephrology.
BACKGROUND - To realize potential public health benefits from genetic and genomic innovations, understanding how best to implement the innovations into clinical care is important. The objective of this study was to synthesize data on challenges identified by six diverse projects that are part of a National Human Genome Research Institute (NHGRI)-funded network focused on implementing genomics into practice and strategies to overcome these challenges.
METHODS - We used a multiple-case study approach with each project considered as a case and qualitative methods to elicit and describe themes related to implementation challenges and strategies. We describe challenges and strategies in an implementation framework and typology to enable consistent definitions and cross-case comparisons. Strategies were linked to challenges based on expert review and shared themes.
RESULTS - Three challenges were identified by all six projects, and strategies to address these challenges varied across the projects. One common challenge was to increase the relative priority of integrating genomics within the health system electronic health record (EHR). Four projects used data warehousing techniques to accomplish the integration. The second common challenge was to strengthen clinicians' knowledge and beliefs about genomic medicine. To overcome this challenge, all projects developed educational materials and conducted meetings and outreach focused on genomic education for clinicians. The third challenge was engaging patients in the genomic medicine projects. Strategies to overcome this challenge included use of mass media to spread the word, actively involving patients in implementation (e.g., a patient advisory board), and preparing patients to be active participants in their healthcare decisions.
CONCLUSIONS - This is the first collaborative evaluation focusing on the description of genomic medicine innovations implemented in multiple real-world clinical settings. Findings suggest that strategies to facilitate integration of genomic data within existing EHRs and educate stakeholders about the value of genomic services are considered important for effective implementation. Future work could build on these findings to evaluate which strategies are optimal under what conditions. This information will be useful for guiding translation of discoveries to clinical care, which, in turn, can provide data to inform continual improvement of genomic innovations and their applications.
Although studies suggest that patients with limited health literacy and/or low numeracy skills may stand to gain the most from shared decision making (SDM), the impact of these conditions on the effective implementation of SDM in the emergency department (ED) is not well understood. In this article from the proceedings of the 2016 Academic Emergency Medicine Consensus Conference on Shared Decision Making in the Emergency Department we discuss knowledge gaps identified and propose consensus-driven research priorities to help guide future work to improve SDM for this patient population in the ED.
© 2016 by the Society for Academic Emergency Medicine.
BACKGROUND AND OBJECTIVES - Despite the potential benefits of conservative management, providers rarely discuss it as a viable treatment option for patients with advanced CKD. This survey was to describe the knowledge, attitudes, and practices of nephrologists and primary care providers regarding conservative management for patients with advanced CKD in the United States.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS - We developed a questionnaire on the basis of a literature review to include items assessing knowledge, attitudes, and self-reported practices of conservative management for patients with advanced CKD. Potential participants were identified using the American Medical Association Physician Masterfile. We then conducted a web-based survey between April and May of 2015.
RESULTS - In total, 431 (67.6% nephrologists and 32.4% primary care providers) providers completed the survey for a crude response rate of 2.7%. The respondents were generally white, men, and in their 30s and 40s. Most primary care provider (83.5%) and nephrology (78.2%) respondents reported that they were likely to discuss conservative management with their older patients with advanced CKD. Self-reported number of patients managed conservatively was >11 patients for 30.6% of nephrologists and 49.2% of primary care providers. Nephrologists were more likely to endorse difficulty determining whether a patient with CKD would benefit from conservative management (52.8% versus 36.2% of primary care providers), whereas primary care providers were more likely to endorse limited information on effectiveness (49.6% versus 24.5% of nephrologists) and difficulty determining eligibility for conservative management (42.5% versus 14.3% of nephrologists). There were also significant differences in knowledge between the groups, with primary care providers reporting more uncertainty about relative survival rates with conservative management compared with different patient groups.
CONCLUSIONS - Both nephrologists and primary care providers reported being comfortable with discussing conservative management with their patients. However, both provider groups identified lack of United States data on outcomes of conservative management and characteristics of patients who would benefit from conservative management as barriers to recommending conservative management in practice.
Copyright © 2016 by the American Society of Nephrology.
Little research has examined the association of health literacy and numeracy with patients' preferred involvement in the problem-solving and decision-making process in the hospital. Using a sample of 1,249 patients hospitalized with cardiovascular disease from the Vanderbilt Inpatient Cohort Study (VICS), we assessed patients' preferred level of involvement using responses to two scenarios of differing symptom severity from the Problem-Solving Decision-Making Scale. Using multivariable modeling, we determined the relationship of health literacy, subjective numeracy, and other patient characteristics with preferences for involvement in decisions, and how this differed by scenario. The authors found that patients with higher levels of health literacy desired more participation in the problem-solving and decision-making process, as did patients with higher subjective numeracy skills, greater educational attainment, female gender, less perceived social support, or greater health care system distrust (p<.05 for each predictor in multivariable models). Patients also preferred to participate more in the decision-making process when the hypothetical symptom they were experiencing was less severe (i.e., they deferred more to their physician when the hypothetical symptom was more severe). These findings underscore the role that patient characteristics, especially health literacy and numeracy, play in decisional preferences among hospitalized patients.
BACKGROUND - Sickle cell disease (SCD) is the most common genetic disease among persons with African ancestry. This article provides a background to SCD and reviews many important aspects of travel preparation in this population.
METHODS - The medical literature was searched for studies on travel-associated preparedness and complications in individuals with SCD. Topics researched included malaria, bacterial infections, vaccinations, dehydration, altitude, air travel, and travel preparedness.
RESULTS - There is very little published literature that specifically addresses the risks faced by travelers with SCD. Rates of medical complications during travel appear to be high. There is a body of literature that describes complications of SCD in indigenous populations, particularly within Africa. The generalizability of these data to a traveler is uncertain. Combining these sources of data and the broader medical literature, we address major travel-related questions that may face a provider preparing an individual with SCD for safe travel.
CONCLUSIONS - Travelers with SCD face considerable medical risks when traveling to developing tropical countries, including malaria, bacterial infections, hypovolemia, and sickle cell-associated vaso-occlusive crises. For individuals with SCD, frank counseling about the risks, vigilant preventative measures, and contingency planning for illness while abroad are necessary aspects of the pre-travel visit.
© 2014 International Society of Travel Medicine.
Mutations in the PIK3CA gene are common in breast cancer and represent a clinically useful therapeutic target. Several larger, population-based studies have shown a positive prognostic significance associated with these mutations. This study aims to further identify characteristics of patients harboring PIK3CA mutations while evaluating the clinical impact of genomic testing for these mutations. Tumors from 312 patients at Vanderbilt-Ingram Cancer Center were analyzed for PIK3CA mutations using a multiplex screening assay (SNaPshot). Mutation rates, receptor status, histopathologic characteristics, and time to recurrence were assessed. The number of patients participating in clinical trials, specifically trials relating to the PIK3CA mutation, was examined. Statistically significant differences between wild-type and mutated tumors were determined using the Wilcoxon, Pearson, and Fischer exact tests. The PIK3CA mutation was found in 25 % of tumors tested. Patients with PIK3CA mutations were significantly more likely to express hormone receptors, be of lower combined histological grade, and have a reduced time to recurrence. Patients found to have a PIK3CA mutation were significantly more likely to enter a PIK3CA-specific clinical trial. In addition to confirming previously established positive prognostic characteristics of tumors harboring PIK3CA mutations, this study demonstrates the feasibility and utility of mutation profiling in a clinical setting. PIK3CA mutation testing impacted treatment and resulted in more patients entering mutation-specific clinical trials.
BACKGROUND - While randomized controlled trials represent the highest level of evidence we can generate in comparative effectiveness research, there are clinical scenarios where this type of study design is not feasible. The Comparative Effectiveness Analyses of Surgery and Radiation in localized prostate cancer (CEASAR) study is an observational study designed to compare the effectiveness and harms of different treatments for localized prostate cancer, a clinical scenario in which randomized controlled trials have been difficult to execute and, when completed, have been difficult to generalize to the population at large.
METHODS - CEASAR employs a population-based, prospective cohort study design, using tumor registries as cohort inception tools. The primary outcome is quality of life after treatment, measured by validated instruments. Risk adjustment is facilitated by capture of traditional and nontraditional confounders before treatment and by propensity score analysis.
RESULTS - We have accrued a diverse, representative cohort of 3691 men in the USA with clinically localized prostate cancer. Half of the men invited to participate enrolled, and 86% of patients who enrolled have completed the 6-month survey.
CONCLUSION - Challenging comparative effectiveness research questions can be addressed using well-designed observational studies. The CEASAR study provides an opportunity to determine what treatments work best, for which patients, and in whose hands.
BACKGROUND - The Internet can be leveraged to provide disease management support, including medication adherence promotion that, when tailored, can effectively improve adherence to medications. The growing adoption of patient portals represents an opportunity to support medication management and adherence more broadly, but virtually no data exist about the real and potential impact of existing portals on these outcomes.
OBJECTIVE - We sought to (1) understand who uses an existing patient portal and reasons for use and nonuse, (2) understand how portal users are using a portal to manage their medications, and (3) explore participants' ideas for improving portal functionality for medication management and adherence support.
METHODS - A total of 75 adults with type 2 diabetes participated in a mixed-methods study involving focus groups, a survey, and a medical chart review. We used quantitative data to identify differences between portal users and nonusers, and to test the relationship between the frequency of portal use and glycemic control among users. We used qualitative methods to understand how and why participants use a portal and their ideas for improving its medication management functionality.
RESULTS - Of the enrolled participants, 81% (61/75) attended a focus group and/or completed a survey; portal users were more likely than nonusers to participate in that capacity (Fisher exact test; P=.01). Users were also more likely than nonusers to be Caucasian/white (Fisher exact test; P<.001), have higher incomes (Fisher exact test; P=.005), and be privately insured (Fisher exact test; P<.001). Users also tended to have more education than nonusers (Mann-Whitney U; P=.05), although this relationship was not significant at P<.05. Among users, more frequent use of a portal was associated with better A1C (Spearman rho =-0.30; P=.02). Reasons for nonuse included not knowing about the portal (n=3), not having access to a computer (n=3), or having a family member serve as an online delegate (n=1). Users reported using the portal to request prescription refills/reauthorizations and to view their medication list, and they were enthusiastic about the idea of added refill reminder functionality. They were also interested in added functionality that could streamline the refill/reauthorization process, alert providers to fill/refill nonadherence, and provide information about medication side effects and interactions.
CONCLUSIONS - Although there are disparities in patient portal use, patients use portals to manage their medications, are enthusiastic about further leveraging portals to support medication management and adherence, and those who use a portal more frequently have better glycemic control. However, more features and functionality within a portal platform is needed to maximize medication management and adherence promotion.