Transgender women's perspectives on mental health care related to vaginoplasty for gender affirmation.

PURPOSE: This study aimed to describe patient experiences and attitudes about the role of the mental health professional as it relates to pursuing gender affirmation surgery. METHODS: This was a mixed-models study with semi-structured interviews. Participants who presented for gender affirming vaginoplasty and had completed pre-surgical requirements but had not yet had the procedure were invited to participate in the study. Semi-structured phone interviews were conducted from November 2019 and December 2020 until saturation of themes was achieved at a sample size of 14. Interviews were then transcribed verbatim and coded by theme. Qualitative analysis was performed using a grounded theory approach. RESULTS: Almost half of the patients did not identify any barriers to obtaining mental health care, but a majority brought up concerns for less advantaged peers, with less access to resources. Some patients also felt that there was benefit to be obtained from the mental health care required before going through with surgery, while others felt the requirements were discriminatory. Finally, a large proportion of our participants reported concerns with the role of mental health care and the requirements set forth by the World Professional Association for Transgender Health (WPATH), and patients gave suggestions for future improvements including decreasing barriers to care while rethinking how guidelines impact patients. CONCLUSION: There are many competing goals to balance when it comes to the guidelines for gender affirmation surgery, and patients had differing and complex relationships with mental health care and the pre-surgical process.

Virtual prenatal visits associated with high measures of patient experience and satisfaction among average-risk patients: a prospective cohort study.

BACKGROUND: Virtual visits have the potential to decrease barriers to prenatal care stemming from transportation, work, and childcare concerns. However, data regarding patient experience and satisfaction with virtual visits remain limited in obstetrics. To address this gap, we explore average-risk pregnant women's experiences with virtual visits and compare satisfaction with virtual vs. in-person visits as a secondary aim. METHODS: In this IRB-approved, prospective cohort study, we surveyed pregnant women after their first virtual visit between October 7, 2019 and March 20, 2020. Using heterogeneous purposive sampling, we identified a subset of respondents with diverse experiences and opinions for interviews. For comparison, Consumer Assessment of Healthcare Providers and Systems (CAHPS) satisfaction data were collected after in-person visits during the study timeframe from a control cohort with the same prenatal providers. Logistic regression controlling for age, previous pregnancies, and prior live births compared satisfaction data between virtual and in-person visits. Other quantitative survey data were analyzed through descriptive statistics. Free text survey responses and interview data were analyzed using content analysis. RESULTS: Ninety five percent (n = 165/174) of surveys and 90% (n = 18/20) of interviews were completed. Most participants were Caucasian, married, and of middle to high income. 69% (114/165) agreed that their virtual appointment was as good as in-person; only 13% (21/165) disagreed. Almost all (148/165, 90%) would make another virtual appointment. Qualitative data highlighted ease of access, comparable provider-patient communication, confidence in care quality, and positive remote monitoring experiences. Recognizing these advantages but also inherent limitations, interviews emphasized interspersing telemedicine with in-person prenatal encounters. CAHPS responses after in-person visits were available for 60 patients. Logistic regression revealed no significant difference in three measures of satisfaction (p = 0.16, 0.09, 0.13) between virtual and in-person visits. CONCLUSIONS: In an average-risk population, virtual prenatal visits provide a patient-centered alternative to traditional in-person encounters with high measures of patient experience and no significant difference in satisfaction. Obstetric providers should explore telemedicine to improve access - and, during the ongoing pandemic, to minimize exposures - using patients' experiences for guidance. More research is needed regarding virtual visits' medical quality, integration into prenatal schedules, and provision of equitable care for diverse populations.

Patient Perceptions of FDA Approval: Gaps in Education or Variation in Values?

OBJECTIVE: To assess perceptions and opinions about the Food and Drug Administration (FDA) approval process for disease-modifying therapies (DMT) in people living with multiple sclerosis (MS). METHODS: People living with MS were invited to complete a web-based survey of their perceptions of the FDA role and process for approval of MS medications. The survey asked about the role of the FDA, factors involved in the approval process, which voices should represent those with MS in deliberations about drug approval, and the level of comfort with uncertain safety of newly approved therapies. RESULTS: Three thousand thirty-three respondents met inclusion criteria for data analysis. Most respondents seemed to understand the role of the FDA, although only half understood a fundamental FDA role: balancing the risks and benefits when considering drug approval. Significant differences were observed in many areas between those who have and have not tried DMTs. Comfort with uncertainty was associated with several factors relating to side effects and benefits believed important for the FDA to consider. Most respondents reported that people who participated in the medication's clinical trial were particularly able to represent people living with MS. CONCLUSION: Perceptions regarding the FDA and views of who should represent people living with MS varied between those who have and have not tried DMT. There is variability in personal values that should be recognized and taken into account when considering regulatory responsibilities. Interventions are needed to address educational gaps regarding the mission and trustworthiness of the FDA as an oversight body.

Categorizing and Rating Patient Complaints: An Innovative Approach to Improve Patient Experience.

The Ombudsman Office at a large academic medical center created a standardized approach to manage and measure unsolicited patient complaints, including methods to identify longitudinal improvements, accounting for volume variances, as well as incident severity to prioritize response needs. Data on patient complaints and grievances are collected and categorized by type of issue, unit location, severity, and individual employee involved. In addition to granular data, results are collated into meaningful monthly leadership reports to identify opportunities for improvement. An overall benchmark for improvement is also applied based on the number of complaints and grievances received for every 1000 patient encounters. Results are utilized in conjunction with satisfaction survey results to drive patient experience strategies. By applying benchmarks to patient grievances, targets can be created based on historical performance. The utilization of grievance and complaint benchmarking helps prioritize resources to improve patient experiences.

Patient Experience in Virtual Visits Hinges on Technology and the Patient-Clinician Relationship: A Large Survey Study With Open-ended Questions.

BACKGROUND: Patient satisfaction with in-person medical visits includes patient-clinician engagement. However, communication, empathy, and other relationship-centered care measures in virtual visits have not been adequately investigated. OBJECTIVE: This study aims to comprehensively consider patient experience, including relationship-centered care measures, to assess patient satisfaction during virtual visits. METHODS: We conducted a large survey study with open-ended questions to comprehensively assess patients' experiences with virtual visits in a diverse patient population. Adults with a virtual visit between June 21, 2017, and July 12, 2017, were invited to complete a survey of 21 Likert-scale items and textboxes for comments following their visit. Factor analysis of the survey items revealed three factors: experience with technology, patient-clinician engagement, and overall satisfaction. Multivariable logistic regression was used to test the associations among the three factors and patient demographics, clinician type, and prior relationship with the clinician. Using qualitative framework analysis, we identified recurrent themes in survey comments, quantitatively coded comments, and computed descriptive statistics of the coded comments. RESULTS: A total of 65.7% (426/648) of the patients completed the survey; 64.1% (273/426) of the respondents were women, and the average age was 46 (range 18-86) years. The sample was geographically diverse: 70.2% (299/426) from Ohio, 6.8% (29/426) from Florida, 4.2% (18/426) from Pennsylvania, and 18.7% (80/426) from other states. With regard to insurance coverage, 57.5% (245/426) were undetermined, 23.7% (101/426) had the hospital's employee health insurance, and 18.7% (80/426) had other private insurance. Types of virtual visits and clinicians varied. Overall, 58.4% (249/426) of patients had an on-demand visit, whereas 41.5% (177/426) had a scheduled visit. A total of 41.8% (178/426) of patients had a virtual visit with a family physician, 20.9% (89/426) with an advanced practice provider, and the rest had a visit with a specialist. Most patients (393/423, 92.9%) agreed that their virtual visit clinician was interested in them as a person, and their virtual visit made it easy to get the care they needed (383/421, 90.9%). A total of 81.9% (344/420) of respondents agreed or strongly agreed that their virtual visit was as good as an in-person visit by a clinician. Having a prior relationship with their virtual visit clinician was associated with less comfort and ease with virtual technology among patients (odds ratio 0.58, 95% CI 0.35-0.98). In terms of technology, patients found the interface easy to use (392/423, 92.7%) and felt comfortable using it (401/423, 94.8%). Technical difficulties were associated with lower odds of overall satisfaction (odds ratio 0.46, 95% CI 0.28-0.76). CONCLUSIONS: Patient-clinician engagement in virtual visits was comparable with in-person visits. This study supports the value and acceptance of virtual visits. Evaluations of virtual visits should include assessments of technology and patient-clinician engagement, as both are likely to influence patient satisfaction.

Association Between Public Trust and Provider Specialty Among Physicians With Financial Conflicts of Interest.

OBJECTIVES: To characterize public perception of physicians' conflicts of interest (COIs) across medical and surgical specialties. PATIENTS AND METHODS: A cross-sectional 6-arm randomized survey of a nonprobability sample from Amazon's Mechanical Turk occurred on December 11 to 16, 2018. Survey respondents were randomly assigned to vignettes that varied the physician specialty with COI. The primary outcome was mean difference in Mayer Trust, and the secondary outcome included the proportion who desire to discontinue care. RESULTS: There were 1729 of 1920 respondents who completed the experiment (90.1% completion rate). Respondents were male (52.5%; n=907), white (71.4%; n=1234), and between the ages of 25 and 44 years (70.9%; n=1227). Mean ± SD Mayer Trust across the 6 specialties was 3.7±.60, with the only between-specialty differences observed for psychiatry compared with the other specialties (F=5.4; P<.001). The median dollar amount that would affect respondents' trust in a physician was $5000 (interquartile range, $100-$100,000). A total of 75.1% (n=1298) of respondents desired COI information, with 41.6% (n=720) discontinuing care. Age older than 34 years (adjusted odds ratio [aOR], 0.7; 95%, CI, 0.49-0.99; P=.047), nonwhite race (aOR, 1.3; 95% CI, 1.02-1.6; P=.03), educational attainment of 4 or more years of college (aOR, 1.31; 95% CI, 1.05-1.6; P=.016), and physician specialty as a psychiatrist (aOR, 1.5; 95% CI, 1.03-2.2; P=.034) were predictors for discontinuing care. CONCLUSION: Public COI disclosure is a common method for managing financial conflicts. Although survey respondents were more likely to discontinue care with a physician with COI, they will act on this knowledge of COI differently depending on the specialty of the physician. The finding that psychiatry is an outlier may be a chance finding that warrants further confirmation. Continued efforts to ensure best practices for disclosure are required.

Use of Visual Decision Aids in Physician-Patient Communication: A Pilot Investigation.

INTRODUCTION: A risk calculator paired with a personalized decision aid (RC&DA) may foster shared decision-making in primary care. We assessed the feasibility of using an RC&DA with patients in a primary care outpatient clinic and patients' experiences regarding communication and decision-making. METHODS: This pilot study was conducted with 15 patients of 3 primary care physicians at a clinic within a tertiary medical center. An atherosclerotic cardiovascular disease (ASCVD) risk calculator was used to generate a personalized RC&DA that displayed absolute 10-year risk information as an icon array graphic. Patient perceptions of utility of the RC&DA, preferences for decision-making, and uncertainty with risk reduction decisions were measured with a semi-structured interview. RESULTS: Patients reported that the RC&DA was easy to understand and knowledge gained was useful to modify their ASCVD risk. Patients used the RC&DA to make decisions and reported low uncertainty with those decisions. CONCLUSIONS: Our findings demonstrate the feasibility of, and positive patient experiences related to using, an RC&DA to facilitate shared decision-making between physicians and patients in an outpatient primary care setting.

Implementing team-based primary care models: a mixed-methods comparative case study in a large, integrated health care system.

BACKGROUND: Successful implementation of new care models within a health system is likely dependent on contextual factors at the individual sites of care. OBJECTIVE: To identify practice setting components contributing to uptake of new team-based care models. DESIGN: Convergent mixed-methods design. PARTICIPANTS: Employees and patients of primary care practices implementing two team-based models in a large, integrated health system. MAIN MEASURES: Field observations of 9 practices and 75 interviews, provider and staff surveys to assess adaptive reserve and burnout, analysis of quality metrics, and patient panel comorbidity scores. The data were collected simultaneously, then merged, thematically analyzed, and interpreted by a multidisciplinary team. KEY RESULTS: Based on analysis of observations and interviews, the 9 practices were categorized into 3 groups-high, partial, and low uptake of new team-based models. Uptake was related to (1) practices' responsiveness to change and (2) flexible workflow as related to team roles. Strength of local leadership and stable staffing mediated practices' ability to achieve high performance in these two domains. Higher performance on several quality metrics was associated with high uptake practices compared to the lower uptake groups. Mean Adaptive Reserve Measure and Maslach Burnout Inventory scores did not differ significantly between higher and lower uptake practices. CONCLUSION: Uptake of new team-based care delivery models is related to practices' ability to respond to change and to adapt team roles in workflow, influenced by both local leadership and stable staffing. Better performance on quality metrics may identify high uptake practices. Our findings can inform expectations for operational and policy leaders seeking to implement change in primary care practices.

Genetic Counselors' Perspectives About Cell-Free DNA: Experiences, Challenges, and Expectations for Obstetricians.

The expansion of cell-free fetal DNA (cfDNA) screening for a larger and diverse set of genetic variants, in addition for use among the low-risk obstetric population, presents important clinical challenges for all healthcare providers involved in the delivery of prenatal care. It is unclear how to leverage the different members of the healthcare team to respond to these challenges. We conducted interviews with 25 prenatal genetic counselors to understand their experience with the continued expansion of cfDNA screening. Participants supported the use of cfDNA screening for the common autosomal aneuploidies, but noted some reservations for its use to identify fetal sex and microdeletions. Participants reported several barriers to ensuring that patients have the information and support to make informed decisions about using cfDNA to screen for these different conditions. This was seen as a dual-sided problem, and necessitated additional education interventions that addressed patients seeking cfDNA screening, and obstetricians who introduce the concepts of genetic risk and cfDNA to patients. In addition, participants noted that they have a professional responsibility to educate obstetricians about cfDNA so they can be prepared to be gatekeepers of counseling and education about this screening option for use among the general obstetric population.

Patient-Centered Obstetric Care in the Age of Cell-Free Fetal DNA Prenatal Screening.

PURPOSE: The clinical introduction of innovative prenatal genetic technologies challenges patients and providers to find new ways of fostering informed decision-making in a setting characterized by complexity and uncertainty. As prenatal genetic technology advances, important questions remain about how to structure patient-centered conversations that effectively prepare pregnant patients to make informed choices about the different genetic conditions for which this new form screening may be used. METHODS: Focus groups were conducted with 23 pregnant women to identify informational needs and decision-making preferences regarding emerging and anticipated applications of cell-free fetal DNA screening, the newest form of prenatal genetic screening. RESULTS: Participants were in favor of obtaining more genetic information about the fetus than provided by conventional screens but acknowledged the challenges inherent in navigating the unique complexities of the decision-making process. The provider-patient relationship was seen as an important resource to navigate the associated uncertainties at each stage of the screening process. Participants emphasized the need for initiatives to support a personalized, accurate, and unbiased discussion about prenatal genetic risk and assessment. CONCLUSION: Continued advances in prenatal genetic screening call for new approaches to structure patient-centered communication to facilitate increasingly complex decisions about fetal genetic risk and assessment.

Physician, Scribe, and Patient Perspectives on Clinical Scribes in Primary Care.

BACKGROUND: Extending medical assistants and nursing roles to include in-visit documentation is a recent innovation in the age of electronic health records. Despite the use of these clinical scribes, little is known regarding interactions among and perspectives of the involved parties: physicians, clinical scribes, and patients. OBJECTIVE: The purpose of this project is to describe perspectives of physicians, clinical scribes, and patients regarding clinical scribes in primary care. DESIGN: We used qualitative content analysis, using Interpretive Description of semi-structured audio-recorded in-person and telephone interviews. PARTICIPANTS: Participants included 18 physicians and 17 clinical scribes from six healthcare systems, and 36 patients from one healthcare system. KEY RESULTS: Despite physician concerns regarding terminology within notes, physicians, clinical scribes, and patients perceived more detailed notes because of real-time documentation by scribes. Most patients were comfortable with the scribe's presence and perceived increased attention from their physicians. Clinical scribes also performed more active roles during a patient visit, leading to formation of positive scribe-patient relationships. The resulting shift in workflow, however, led to stress. Our theoretical model for successful physician-scribe teams emphasizes the importance of interpersonal aspects such as communication, mutual respect, and adaptability, as well as system level support such as training and staffing. CONCLUSIONS: Both interpersonal fit between physician and scribe, and system level support including adequate training, transition time, and staffing support are necessary for successful use of clinical scribes. Future directions for research regarding clinical scribes include study of care continuity, scribe medical knowledge, and scribe burnout.

The use of noninvasive prenatal testing in obstetric care: educational resources, practice patterns, and barriers reported by a national sample of clinicians.

OBJECTIVE: The aim of this study was to identify how physicians develop their knowledge base and practice patterns regarding noninvasive prenatal testing (NIPT). METHODS: A survey was used to assess physicians' informational sources and practice patterns regarding NIPT. RESULTS: While most of the 258 participants acquire knowledge about NIPT from the medical literature or didactic educational programming, 74 (28.7%) cite commercial laboratories as an initial source and 124 (47.8%) as a way to keep current with changes in NIPT. About one-third (n = 94, 36.4%) seek information about ethical issues related to NIPT. Half of the OB/GYN respondents (n = 136, 52.7%) provide pretest counseling; fewer refer to a genetic counselor or maternal fetal medicine specialist (MFM) (n = 94, 34.6%, n = 29, 11.2%, respectively). Pretest counseling content and the comfort with which participants discuss topics pertinent to patients' utilization of NIPT varied between OB/GYNs and MFMs. CONCLUSIONS: Advances in cff DNA technology emphasize the need for effective strategies for physicians to develop competency and practice patterns regarding NIPT. Study findings speak to the need for effective educational resources for obstetric providers, not just early adopters of NIPT but also for primary OB/GYNs as they serve in the role of the first point of contact for women considering their prenatal testing options. © 2016 John Wiley & Sons, Ltd.

A Pilot Evaluation of Portfolios for Quality Attestation of Clinical Ethics Consultants.

Although clinical ethics consultation is a high-stakes endeavor with an increasing prominence in health care systems, progress in developing standards for quality is challenging. In this article, we describe the results of a pilot project utilizing portfolios as an evaluation tool. We found that this approach is feasible and resulted in a reasonably wide distribution of scores among the 23 submitted portfolios that we evaluated. We discuss limitations and implications of these results, and suggest that this is a significant step on the pathway to an eventual certification process for clinical ethics consultants.

A first look at women's perspectives on noninvasive prenatal testing to detect sex chromosome aneuploidies and microdeletion syndromes.

OBJECTIVE: The aim of this study is to explore women's opinions about the use of noninvasive prenatal testing (NIPT) to assess the risk of sex chromosome aneuploidies and microdeletion syndromes. METHODS: Focus groups were conducted with women who were currently pregnant or had recently delivered. Qualitative analysis using interpretive description was used to generate study findings. RESULTS: Thirty-one women (mean age 32.4 years) participated in the focus groups. Participants were unfamiliar with sex chromosome aneuploidies but expressed support for the use of NIPT to detect these conditions. Participants were uncertain about the utility and actionability of receiving information about microdeletion syndromes with variable or unknown phenotypic expression. Participants voiced their desire to be informed of all conditions assessed by NIPT prior to testing. They considered clinicians to be the key provider of such information, although stated that patients have a responsibility to be knowledgeable prior to testing in order to support informed decision making. CONCLUSIONS: The use of NIPT to identify sex chromosome aneuploidies and microdeletion syndromes will introduce new challenges for clinicians to ensure pregnant women have the information and resources to make informed choices about NIPT when used for these conditions.

It's More Than a Blood Test: Patients' Perspectives on Noninvasive Prenatal Testing.

Noninvasive prenatal testing (NIPT) offers pregnant women a new risk assessment tool for fetal aneuploidy that is superior to conventional screening tests. We conducted focus groups with women who were currently pregnant or had recently delivered in the past year to characterize their perspectives about NIPT and to explore factors they would consider during decision making about its use. Women identified accuracy, early timing, testing ease, and determination of fetal sex as advantages of NIPT over other screens, and the noninvasive method of NIPT as an advantage over diagnostic tests. False positive and false negative results, anxiety, cost and insurance coverage were seen as disadvantages of NIPT. Women who do not want fetal aneuploidy information most likely will not undergo NIPT, despite its advantages over other screening tests. However, given its advantages, the decision to have NIPT is straightforward for women who want genetic information about the fetus. Women emphasized the need to make autonomous, private, and informed choices about NIPT, as they would with any prenatal genetic testing option. These perspectives may guide clinicians to conduct effective and clinically relevant counseling with pregnant women who consider utilizing this new genetic technology.

An analysis of online messages about probiotics.

Internet websites are a resource for patients seeking information about probiotics. We examined a sample of 71 websites presenting probiotic information. We found that descriptions of benefits far outnumbered descriptions of risks and commercial websites presented significantly fewer risks than noncommercial websites. The bias towards the presentation of therapeutic benefits in online content suggests that patients are likely interested in using probiotics and may have unrealistic expectations for therapeutic benefit. Gastroenterologists may find it useful to initiate conversations about probiotics within the context of a comprehensive health management plan and should seek to establish realistic therapeutic expectations with their patients.

Experiences of patients with chronic gastrointestinal conditions: in their own words.

BACKGROUND: Irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) are chronic conditions affecting millions of individuals in the United States. The symptoms are well-documented and can be debilitating. How these chronic gastrointestinal (GI) conditions impact the daily lives of those afflicted is not well documented, especially from a patient's perspective. METHODS: Here we describe data from a series of 22 focus groups held at three different academic medical centers with individuals suffering from chronic GI conditions. All focus groups were audio recorded and transcribed. Two research team members independently analyzed transcripts from each focus group following an agreed upon coding scheme. RESULTS: One-hundred-thirty-six individuals participated in our study, all with a chronic GI related condition. They candidly discussed three broad themes that characterize their daily lives: identification of disease and personal identity, medications and therapeutics, and daily adaptations. These all tie to our participants trying to deal with symptoms on a daily basis. We find that a recurrent topic underlying these themes is the dichotomy of experiencing uncertainty and striving for control. CONCLUSIONS: Study participants' open dialogue and exchange of experiences living with a chronic GI condition provide insight into how these conditions shape day-to-day activities. Our findings provide fertile ground for discussions about how clinicians might best facilitate, acknowledge, and elicit patients' stories in routine care to better address their experience of illness.

Risk and uncertainty: shifting decision making for aneuploidy screening to the first trimester of pregnancy.

PURPOSE: The clinical introduction of first trimester aneuploidy screening uniquely challenges the informed consent process for both patients and providers. This study investigated key aspects of the decision-making process for this new form of prenatal genetic screening. METHODS: Qualitative data were collected by nine focus groups that comprised women of different reproductive histories (N = 46 participants). Discussions explored themes regarding patient decision making for first trimester aneuploidy screening. Sessions were audio recorded, transcribed, coded, and analyzed to identify themes. RESULTS: Multiple levels of uncertainty characterize the decision-making process for first trimester aneuploidy screening. Baseline levels of uncertainty existed for participants in the context of an early pregnancy and the debate about the benefit of fetal genetic testing in general. Additional sources of uncertainty during the decision-making process were generated from weighing the advantages and disadvantages of initiating screening in the first trimester as opposed to waiting until the second. Questions of the quality and quantity of information and the perceived benefit of earlier access to fetal information were leading themes. Barriers to access prenatal care in early pregnancy presented participants with additional concerns about the ability to make informed decisions about prenatal genetic testing. CONCLUSIONS: The option of the first trimester aneuploidy screening test in early pregnancy generates decision-making uncertainty that can interfere with the informed consent process. Mechanisms must be developed to facilitate informed decision making for this new form of prenatal genetic screening.