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Patients undergoing cancer treatment during the COVID-19 pandemic have experienced stress and uncertainty with respect to disruptions in cancer care and COVID-19 related risks. We examined whether clinicians' responsiveness to patients' uncertainty and difficult emotions were associated with better health and well-being.Patients were recruited from cancer support communities and a market research firm. Respondents assessed clinicians communication that addressed uncertainty and difficult emotions. Health status measures included mental and physical health, coping during the pandemic, and psychological distress.317 respondents participated in the study. Patients' perceptions of their clinicians responsiveness to patient uncertainty and negative emotions were associated with better mental health, physical health, coping, and less psychological distress (all p-values0.001). Respondents with greater self-efficacy and social support also reported better health.Even when controlling for patients' personal and health-related characteristics, clinicians' communication addressing patients' uncertainty and difficult emotions predicted better health, better coping, and less psychological distress. Access to social support and self-efficacy also were associated with better health status.Clinicians' communication focused on helping with uncertainty and difficult emotions is important to cancer patients, especially during the pandemic. Clinicians should also direct patients to resources for social support and patient empowerment.

Meeting recruitment targets for clinical trials and health research studies is a notable challenge. Unsuccessful efforts to recruit participants from traditionally underserved populations can limit who benefits from scientific discovery, thus perpetuating inequities in health outcomes and access to care. In this study, we evaluated direct mail and email outreach campaigns designed to recruit women who gave birth in North Carolina for a statewide research study offering expanded newborn screening for a panel of rare health conditions. Of the 54,887 women who gave birth in North Carolina from September 28, 2018, through March 19, 2019, and were eligible to be included on the study’s contact lists, we had access to a mailing address for 97.9% and an email address for 6.3%. Rural women were less likely to have sufficient contact information available, but this amounted to less than a one percentage point difference by urbanicity. Native American women were less likely to have an email address on record; however, we did not find a similar disparity when recruitment using direct‐mail letters and postcards was concerned. Although we sent letters and emails in roughly equal proportion by urbanicity and race/ethnicity, we found significant differences in enrollment across demographic subgroups. Controlling for race/ethnicity and urbanicity, we found that direct‐mail letters and emails were effective recruitment methods. The enrollment rate among women who were sent a recruitment letter was 4.1%, and this rate increased to 5.0% among women who were also sent an email invitation. Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? Under‐representation by traditionally underserved populations in clinical trials and health research is a challenge that may in part reflect inequitable opportunities to participate. WHAT QUESTION DID THIS STUDY ADDRESS? Are direct‐mail and email outreach strategies effective for reaching and recruiting women from traditionally underserved and rural populations to participate in large‐scale, population‐based research? WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE? Despite sending recruitment letters and email invitations in roughly equal proportion by urbanicity and race/ethnicity, women living in rural areas were less likely to enroll (2.8%) than women from urban areas (4.2%). Additionally, enrollment rates decreased as the probability that women were members of a racial or ethnic minority group increased. HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE? Results from this study might encourage researchers to take a holistic and participant‐centered view of barriers to study enrollment that may disproportionately affect underserved communities, including differences in willingness to participate, trust, and access to resources needed for uptake.

This study aimed to understand parental decisions, perspectives, values, and beliefs on next generation sequencing in the newborn period (NGS-NBS) to inform the development of a decision aid to support parental decision making in the North Carolina Newborn Exome Sequencing for Universal Screening study. We conducted dyadic interviews with 66 current or expectant parents (33 couples) to understand overall decisions about NGS-NBS and reasons for and against learning NGS-NBS results differing by age of onset and medical actionability. Audio recordings were transcribed, coded, and analyzed using qualitative framework analyses. Favorable views of NGS-NBS included benefits of early intervention, preparedness, child autonomy, and altruism. Unfavorable views were the potential negative effects from early intervention, psychosocial harm, and religious beliefs. Parents universally reported quality of life as important. Interviews elucidated what is important in deciding to have NGS-NBS. Understanding parental perspectives, values, and beliefs and integrating evidence-based findings into a parent-centric decision aid provides value and support in making decisions related to NGS-NBS, where there is no clear course of action.

Objective The purpose of this study was to understand the ethical, legal, and social issues described by parents of children with known or suspected genetic conditions that cause intellectual and developmental disabilities regarding research use of their child’s electronic health record (EHR). Materials and Methods We conducted 4 focus groups with parents of children with a known (n = 12) or suspected (n = 11) genetic condition, as well as 2 comparison groups with parents who had a child with no known genetic condition (n = 15). Focus group transcripts were coded and analyzed using directed content analysis. Results After weighing the risks and benefits, parents of children with known or suspected genetic conditions were willing to share their child’s EHR for research studies under certain conditions. Preferences were for studies conducted by universities or nonprofits that might benefit their child or others with the same condition. Parents also valued return of research results. Discussion Trust, transparency, altruism, and concerns about privacy emerged as factors that affect parents’ willingness to allow research use of their child’s EHR. Conclusion Researchers should consider how to build trust with parents by increasing transparency of the research process and explaining specifically how they will ensure the confidentiality of EHR data.

The COVID-19 pandemic created significant disruptions in cancer care, much of which was transitioned to telehealth. Because telehealth alters the way clinicians and patients interact with one another, this investigation examined patients' perceptions of their communication with clinicians during the pandemic.Patients were recruited from the Cancer Support Community, Fight Colorectal Cancer, and a market research firm to participate in an online survey. In addition to demographic and health-related information, respondents completed measures of patient-centered communication and evaluated how their communication in telehealth sessions compared with in-person visits.From October to December 2020, 227 respondents (65.6% female, 64.6% Non-Hispanic White, 33.5% had 6 or more telehealth sessions, 55% were 50 or older) reported having some of their cancer care provided via telehealth. Respondents who were of racial/ethnic minorities, male, had more telehealth sessions, or had poorer mental health reported less patient-centered communication with clinicians. Most patients thought communication in telehealth sessions was "about the same" as in-person visits with respect to good communication (59%). However, patients thinking communication in telehealth sessions was "better" than in-person visits were more likely to be Hispanic (49%), Non-Hispanic Black (41%), under 50 years of age (32%), male (40%), and had more telehealth sessions (34%).Respondents reporting less patient-centered communication during the pandemic-e.g., persons of racial/ethnic minorities and males-were also more likely to evaluate communication in telehealth sessions as better than in-person visits. Further research is needed to understand reasons underlying this finding. Cancer care clinicians should take into account patient preferences regarding telehealth care, which may be particularly important for racial and ethnic minority patients.

BACKGROUND Advances in diagnostics testing and treatment of genetic conditions have led to increased demand for genetic services in the United States. At the same time, there is a shortage of genetic services professionals. Thus, understanding the models of service delivery currently in use can help increase access and improve outcomes for individuals identified with genetic conditions. OBJECTIVE This review aims to provide an overview of barriers and facilitators to genetic service delivery models to inform future service delivery. METHODS We conducted a scoping literature review of the evidence to more fully understand barriers and facilitators around the provision of genetic services. RESULTS There were a number of challenges identified, including the limited number of genetics specialists, wait time for appointments, delivery of services by nongenetics providers, reimbursement, and licensure. The ways to address these challenges include the use of health information technology such as telehealth, group genetic counseling, provider-to-provider education, partnership models, and training; expanding genetic provider types; and embedding genetic counselors in clinical settings. CONCLUSIONS The literature review highlighted the need to expand access to genetic services. Ways to expand services include telehealth, technical assistance, and changing staffing models. In addition, using technology to improve knowledge among related professionals can help expand access.

Background Data from electronic health records (EHRs) are increasingly used in the field of genetic research to further precision medicine initiatives. However, many of these efforts exclude individuals with intellectual disabilities, which often stem from genetic conditions. To include this important subpopulation in EHR research, important ethical, legal, and social issues should be considered. Objective The goal of this study was to review prior research to better understand what ethical, legal, and social issues may need further investigation when considering the research use of EHRs for individuals with genetic conditions that may result in intellectual disability. This information will be valuable in developing methods and best practices for involving this group in research given they are considered a vulnerable population that may need special research protections. Methods We conducted a scoping review to examine issues related to the use of EHRs for research purposes and those more broadly associated with genetic research. The initial search yielded a total of 460 unique citations. We used an evaluative coding process to determine relevancy for inclusion. Results This approach resulted in 59 articles in the following areas: informed consent, privacy and security, return of results, and vulnerable populations. The review included several models of garnering informed consent in EHR or genetic research, including tiered or categorical, blanket or general, open, and opt-out models. Second, studies reported on patients’ concerns regarding the privacy and security of EHR or genetic data, such as who has access, type of data use in research, identifiability, and risks associated with privacy breach. The literature on return of research results using biospecimens examined the dissension in the field, particularly when sharing individualized genetic results. Finally, work involving vulnerable populations highlighted special considerations when conducting EHR or genetic research. Conclusions The results frame important questions for researchers to consider when designing EHR studies, which include individuals with intellectual disabilities, including appropriate safeguards and protections.

Objective This study assessed patient-centered communication (PCC) among newly diagnosed colorectal cancer patients. PCC, a key part of patient-centered care, contributes directly and indirectly to health-related quality of life, satisfaction with care, and other outcomes. Methods We conducted a survey of patients in North Carolina, using a theoretically-based and validated measure that provides an overall PCC score and subscale scores for six PCC functions. Results A total of 501 patients participated. The highest scores were for the PCC functions of Fostering Healing Relationships, Exchanging Information, and Making Decisions. The lowest scores were for the functions of Managing Uncertainty and Enabling Self-Management, yet these were functions respondents rated as most important. Respondents who thought about more than one health professional (versus oncologist) reported better communication. PCC also varied by treatment type, mental and physical health status, age, race, and education. Conclusion Most patients reported good communication overall, however patients in poor physical health and mental health reported worse communication. The quality of communication varied across the PCC functions. Practice implications Health professionals need to use a PCC approach that builds trust, respects the patient, provides salient information that patients can understand, provides emotional support, and facilitates the patient’s engagement in care.

Duchenne/Becker muscular dystrophy (DBMD) and spinal muscular atrophy (SMA) are rare neuromuscular disorders that present challenges to therapeutic and clinical trial decision making. We developed an interactive, evidence-based online tool designed to encourage thoughtful deliberation of the pros and cons of trial participation and to inform meaningful discussions with healthcare providers. Prior research demonstrates the importance of tool availability at the time each family is considering trial participation, which may be prior to the informed consent process. The tool is intended to be easily modified to other pediatric disease communities. Tool development was informed by prior qualitative research, literature reviews, and stakeholder input. Specific items were derived based on an online exploratory questionnaire of parents whose children participated in a trial for DBMD or SMA to understand motivations for participation. Parent participants in the exploratory survey reported strong impact of altruistic and individual benefit motivations and placed much greater emphasis on anticipated trial benefits than on harms when making participation decisions. We used this data to develop the evidence-based deliberation tool using a community-engaged approach. We initially targeted the tool for DBMD while using SMA survey data to evaluate ease of transition to that population. We conducted two iterative sets of activities to inform development and refinement of the tool: (1) community engagement of key stakeholders and (2) user experience testing. These activities suggest that the tool may increase deliberation and the weighing of benefits and harms. Ongoing evaluation will determine the acceptability and efficacy of this online intervention.

BACKGROUND Data from electronic health records (EHRs) are increasingly used in the field of genetic research to further precision medicine initiatives. However, many of these efforts exclude individuals with intellectual disabilities, which often stem from genetic conditions. To include this important subpopulation in EHR research, important ethical, legal, and social issues should be considered. OBJECTIVE The goal of this study was to review prior research to better understand what ethical, legal, and social issues may need further investigation when considering the research use of EHRs for individuals with genetic conditions that may result in intellectual disability. This information will be valuable in developing methods and best practices for involving this group in research given they are considered a vulnerable population that may need special research protections. METHODS We conducted a scoping review to examine issues related to the use of EHRs for research purposes and those more broadly associated with genetic research. The initial search yielded a total of 460 unique citations. We used an evaluative coding process to determine relevancy for inclusion. RESULTS This approach resulted in 59 articles in the following areas: informed consent, privacy and security, return of results, and vulnerable populations. The review included several models of garnering informed consent in EHR or genetic research, including tiered or categorical, blanket or general, open, and opt-out models. Second, studies reported on patients’ concerns regarding the privacy and security of EHR or genetic data, such as who has access, type of data use in research, identifiability, and risks associated with privacy breach. The literature on return of research results using biospecimens examined the dissension in the field, particularly when sharing individualized genetic results. Finally, work involving vulnerable populations highlighted special considerations when conducting EHR or genetic research. CONCLUSIONS The results frame important questions for researchers to consider when designing EHR studies, which include individuals with intellectual disabilities, including appropriate safeguards and protections.

Newborn screening (NBS) occupies a unique space at the intersection of translational science and public health. As the only truly population-based public health program in the United States, NBS offers the promise of making the successes of translational medicine available to every infant with a rare disorder that is difficult to diagnose clinically, but for which strong evidence indicates that presymptomatic treatment will substantially improve outcomes. Realistic NBS policy requires data, but rare disorders face a special challenge: Screening cannot be done without supportive data, but adequate data cannot be collected in the absence of large-scale screening. The magnitude and scale of research to provide this expanse of data require working with public health programs, but most do not have the resources or mandate to conduct research. To address this gap, we have established Early Check, a research program in partnership with a state NBS program. Early Check provides the infrastructure needed to identify conditions for which there have been significant advances in treatment potential, but require a large-scale, population-based study to test benefits and risks, demonstrate feasibility, and inform NBS policy. Our goal is to prove the benefits of a program that can, when compared with current models, accelerate understanding of diseases and treatments, reduce the time needed to consider inclusion of appropriate conditions in the standard NBS panel, and accelerate future research on new NBS conditions, including clinical trials for investigational interventions. Clinicaltrials.gov registration # NCT03655223 . Registered on August 31, 2018.

Background Advances in diagnostics testing and treatment of genetic conditions have led to increased demand for genetic services in the United States. At the same time, there is a shortage of genetic services professionals. Thus, understanding the models of service delivery currently in use can help increase access and improve outcomes for individuals identified with genetic conditions. Objective This review aims to provide an overview of barriers and facilitators to genetic service delivery models to inform future service delivery. Methods We conducted a scoping literature review of the evidence to more fully understand barriers and facilitators around the provision of genetic services. Results There were a number of challenges identified, including the limited number of genetics specialists, wait time for appointments, delivery of services by nongenetics providers, reimbursement, and licensure. The ways to address these challenges include the use of health information technology such as telehealth, group genetic counseling, provider-to-provider education, partnership models, and training; expanding genetic provider types; and embedding genetic counselors in clinical settings. Conclusions The literature review highlighted the need to expand access to genetic services. Ways to expand services include telehealth, technical assistance, and changing staffing models. In addition, using technology to improve knowledge among related professionals can help expand access.

Individuals increasingly access peer-generated health information (PGHI) through social media, especially online health communities (OHCs). Previous research has documented PGHI topics, credibility assessment strategies, and PGHI's connection with well-being. However, there is limited evidence on where, when, and why individuals seek PGHI and how they use PGHI in health decisions. We conducted in-person and online focus groups with verified OHC members (N = 89)-representing 50 different medical conditions and 77 OHCs-to explore these topics. Two researchers independently coded transcripts with NVivo 9.2 and thematically analyzed responses. Most individuals accidentally discovered PGHI during Web searches rather than intentionally seeking it. Individuals valued PGHI primarily as an alternative information source about treatment options, self-care activities, and health care provider questions rather than a source of emotional support, and they acknowledged PGHI's limitation as anecdotal evidence. Individuals used PGHI as a springboard for additional research and patient-provider discussions, ultimately making treatment decisions alongside providers. These findings suggest that individuals use PGHI in much the same way they use traditional online health information and that PGHI facilitates, rather than obstructs, shared decision making with health care providers.

Patient-centered communication (PCC) is an essential component of patient-centered care and contributes to patient satisfaction, health-related quality of life, and other important patient outcomes. The aim of this study was to develop and test survey questions to assess patients’ experiences with PCC in cancer care. We used a conceptual model developed by the National Cancer Institute as our framework. The survey questions align with the six core functions of PCC defined in the model: Exchanging Information, Managing Uncertainty, Enabling Patient Self-Management, Fostering Healing Relationships, Making Decisions, and Responding to Emotions. The study focused on colorectal cancer patients. We conducted two rounds of cognitive interviewing to evaluate patients’ ability to understand and provide valid answers to the PCC questions. Interviews were conducted in Maryland and North Carolina in 2014. We involved a patient advocacy group, Fight Colorectal Cancer, and a multidisciplinary panel of stakeholders throughout the measurement development process to ensure that the survey questions capture aspects of PCC that are important to patients and meet the needs of potential end users, including researchers, healthcare organizations, and health professionals. Patient and other stakeholder input informed revisions of draft survey questions, including changes to survey instructions, frame of reference for questions, response scales, and language. This study demonstrated the feasibility and value of engaging patients and other stakeholders in a measurement development study. The Patient-Centered Outcomes Research Institute (PCORI) conceptual model of patient-centered outcomes research provides a useful guide for patient engagement in research. Research funders should call for meaningful roles for patients and other stakeholders in health research, including in the development of patient-centered outcomes.

Objective To determine whether visual aids help people recall quantitative efficacy information in direct-to-consumer (DTC) prescription drug advertisements, and if so, which types of visual aids are most helpful. Methods Individuals diagnosed with high cholesterol ( n = 2504) were randomized to view a fictional DTC print or television advertisement with no visual aid or one of four visual aids (pie chart, bar chart, table, or pictograph) depicting drug efficacy. We measured drug efficacy and risk recall, drug perceptions and attitudes, and behavioral intentions. Results For print advertisements, a bar chart or table, compared with no visual aid, elicited more accurate drug efficacy recall. The bar chart was better at this than the pictograph and the table was better than the pie chart. For television advertisements, any visual aid, compared with no visual aid, elicited more accurate drug efficacy recall. The bar chart was better at this than the pictograph or the table. Conclusion Visual aids depicting quantitative efficacy information in DTC print and television advertisements increased drug efficacy recall, which may help people make informed decisions about prescription drugs. Practice implications Adding visual aids to DTC advertising may increase the public’s knowledge of how well prescription drugs work.

Spinal Muscular Atrophy (SMA) is one of the most common genetic causes of infant death. There is presently no cure, but the therapeutic pipeline is promising. Given the prevalence of SMA coupled with the potential for new treatment options, universal carrier screening, and newborn screening, we conducted a literature review of the awareness, knowledge, and attitudes held by the public and non-geneticist clinicians about various aspects of SMA. We then identify recommendations for targeting additional research, training, and educational efforts to increase awareness. In the limited available literature, we found that the public is generally unfamiliar with SMA but has favorable views of carrier and newborn screening. Clinicians also had limited understanding of SMA. Further research into knowledge and attitudes of healthcare providers and the general public will help develop a better understanding of education gaps and inform outreach efforts. These educational efforts are needed to complement the momentum as treatments are being developed and tested. Furthermore, professional societies are proposing routine carrier screening and SMA may achieve newborn screening status, which will change the SMA landscape for genetics professionals and families. Thus, it is important to explore knowledge and attitudes about SMA to allow us to prepare for when SMA attains higher public and clinician recognition.

Background Health researchers are increasingly using electronic health records (EHRs) to study the health care needs of people with neurodevelopmental disorders (NDDs). However, little is known about the preferences of people with NDDs for sharing EHRs for research. Objective To explore preferences for sharing EHRs for research among young adults ages 18–40 who make their own legal decisions and who have autism spectrum disorder (ASD), fragile X syndrome (FXS), or no NDDs. Methods We conducted a qualitative study with seven focus groups: 2 ASD groups, 3 FXS groups, and 2 no-NDD groups. We asked participants about factors that could affect their willingness to share their EHRs for research: type of organization, type of information, study purpose, duration, contact frequency, return of results, benefits, and risks. We analyzed the qualitative data using directed content analysis. Results Participants with NDDs valued personally relevant and directly beneficial EHR research. Participants with NDDs expressed willingness to share sensitive data if the study was personally relevant. Most participants wanted to receive results, but only participants with FXS indicated it would affect their willingness to participate. Participants were concerned about privacy risks, discrimination, researcher misconduct, and financial conflicts of interest. Conclusion This study provides initial evidence suggesting that young adults with NDDs prefer EHR research that is personally relevant, benefits themselves and their communities, and is conducted in the context of trusting, reciprocal participant-researcher relationships. The findings point to the need for researchers to improve the informed consent process and to better engage individuals with NDDs in research.

Background: Virtual focus groups—such as online chat and video groups—are increasingly promoted as qualitative research tools. Theoretically, virtual groups offer several advantages, including lower cost, faster recruitment, greater geographic diversity, enrollment of hard-to-reach populations, and reduced participant burden. However, no study has compared virtual and in-person focus groups on these metrics. Objective: To rigorously compare virtual and in-person focus groups on cost, recruitment, and participant logistics. We examined 3 focus group modes and instituted experimental controls to ensure a fair comparison. Methods: We conducted 6 1-hour focus groups in August 2014 using in-person (n=2), live chat (n=2), and video (n=2) modes with individuals who had type 2 diabetes (n=48 enrolled, n=39 completed). In planning groups, we solicited bids from 6 virtual platform vendors and 4 recruitment firms. We then selected 1 platform or facility per mode and a single recruitment firm across all modes. To minimize bias, the recruitment firm employed different recruiters by mode who were blinded to recruitment efforts for other modes. We tracked enrollment during a 2-week period. A single moderator conducted all groups using the same guide, which addressed the use of technology to communicate with health care providers. We conducted the groups at the same times of day on Monday to Wednesday during a single week. At the end of each group, participants completed a short survey. Results: Virtual focus groups offered minimal cost savings compared with in-person groups (US $2000 per chat group vs US $2576 per in-person group vs US $2,750 per video group). Although virtual groups did not incur travel costs, they often had higher management fees and miscellaneous expenses (eg, participant webcams). Recruitment timing did not differ by mode, but show rates were higher for in-person groups (94% [15/16] in-person vs 81% [13/16] video vs 69% [11/16] chat). Virtual group participants were more geographically diverse (but with significant clustering around major metropolitan areas) and more likely to be non-white, less educated, and less healthy. Internet usage was higher among virtual group participants, yet virtual groups still reached light Internet users. In terms of burden, chat groups were easiest to join and required the least preparation (chat = 13 minutes, video = 40 minutes, in-person = 78 minutes). Virtual group participants joined using laptop or desktop computers, and most virtual participants (82% [9/11] chat vs 62% [8/13] video) reported having no other people in their immediate vicinity. Conclusions: Virtual focus groups offer potential advantages for participant diversity and reaching less healthy populations. However, virtual groups do not appear to cost less or recruit participants faster than in-person groups. Further research on virtual group data quality and group dynamics is needed to fully understand their advantages and limitations. [J Med Internet Res 2017;19(3):e80]

Objective To evaluate the psychometric properties of questions that assess patient perceptions of patient-provider communication and design measures of patient-centered communication (PCC). Methods Participants (adults with colon or rectal cancer living in North Carolina) completed a survey at 2 to 3 months post-diagnosis. The survey included 87 questions in six PCC Functions: Exchanging Information, Fostering Health Relationships, Making Decisions, Responding to Emotions, Enabling Patient Self-Management, and Managing Uncertainty. For each Function we conducted factor analyses, item response theory modeling, and tests for differential item functioning, and assessed reliability and construct validity. Results Participants included 501 respondents; 46% had a high school education or less. Reliability within each Function ranged from 0.90 to 0.96. The PCC-Ca-36 (36-question survey; reliability=0.94) and PCC-Ca-6 (6-question survey; reliability=0.92) measures differentiated between individuals with poor and good health (i.e., known-groups validity) and were highly correlated with the HINTS communication scale (i.e., convergent validity). Conclusion This study provides theory-grounded PCC measures found to be reliable and valid in colorectal cancer patients in North Carolina. Future work should evaluate measure validity over time and in other cancer populations. Practice implications The PCC-Ca-36 and PCC-Ca-6 measures may be used for surveillance, intervention research, and quality improvement initiatives.

To enhance the health and well-being of patients managing type 2 diabetes, the five grantees comprising the Alliance to Reduce Disparities in Diabetes implemented evidence-based approaches to patient self-management education as part of their programs. This article describes strategies implemented by the grantees that may help explain program success, defined as improvement in clinical values and patient-reported outcomes. A process evaluation of grantee programs included interviews and document review at the beginning, midpoint, and end of the Alliance initiative. A total of 97 interviews were conducted over time with 65 program representatives. The Alliance programs served 2,328 people from diverse racial and ethnic backgrounds and provided 36,826 diabetes self-management sessions across the intervention sites. Framework analysis of the interviews identified four key themes that emerged across time and program sites that may help account for program success: empowerment, increasing access and support, addressing local needs and barriers, and care coordination. The overall evaluation findings may help other diabetes self-management programs seeking to translate and implement evidence-based approaches to reduce disparities and enhance patient well-being.

The Institute of Medicine's list of 100 priority topics for comparative effectiveness research highlights the importance of translating and disseminating medical information to clinicians and consumers. In line with these priorities, the National Heart, Lung, and Blood Institute supported a study of the Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in children and adolescents prior to its release. The primary purpose of the study was to identify implementation of the Guidelines and communication barriers among clinicians who see children. The innovative, evidence-based guidelines encompass the development, progression, and management of 14 risk factors from birth through 21 years of age. A growing body of evidence supports the need for active multifaceted dissemination and implementation support strategies to address chronic health problems. This study qualitatively assessed clinician receptivity to guideline implementation and communication of pediatric cardio...

This article discusses the social marketing planning process and strategies used to design a preconception health campaign, Show Your Love, launched in February 2013. Developing a social marketing strategy for preconception health is a challenging endeavor, in part because preconception health represents a set of diverse behaviors and the audience for the campaign is quite large, encompassing all women of childbearing age whether they intend to become pregnant or not. The network of organizations implementing the campaign, the National Preconception Health Consumer Workgroup, required a broad audience segmentation strategy; therefore, two large audiences were selected. This commentary describes the two primary audiences selected for the campaign based on the Transtheoretical Model—intenders (those in contemplation, preparation, and action) and nonintenders (precontemplators)—and explores how levels of knowledge, motivations, the campaign product, and the campaign goals are distinct for each audience. Additionally, the authors describe potential extensions to the segmentation strategy that could offer finer grained approaches for social marketers who may be building on the Show Your Love campaign or designing other programs in this area.

Background Informed consent requires that individuals understand the nature of the study, risks and benefits of participation. Individuals with intellectual disabilities (ID) have cognitive and adaptive impairments that may affect their ability to provide informed consent. New treatments and clinical trials for fragile X syndrome, the most commonly known inherited cause of ID, necessitate the development of methods to improve the informed consent process. The goal of this study was to compare the efficacy of a digital decision support tool with that of standard practice for informed consent and to examine whether the tool can improve decisional capacity for higher functioning individuals. Methods Participants (N = 89; mean age = 21.2 years) were allocated to the experimental group (consenting information provided via the digital decision support tool), or the comparison group (information provided via standard practice). Participants were assessed on four aspects of decisional capacity (Understanding, Appreciating, Reasoning, and Expressing a choice). We used regression analyses to test the impact of the tool on each outcome, repeating the analyses on the higher functioning subsample. Results No differences existed in any domain of decisional capacity for the sample in full. However, participants in the higher IQ subsample who used the tool scored better on Understanding after adjustment (β = 0.25, p = 0.04), but not on Appreciating or Reasoning. No differences by experimental group existed in the decision to join the hypothetical trial for the full sample or higher functioning subsample. Conclusions A decision support tool shows promise for individuals with fragile X syndrome with higher cognitive abilities. Future studies should examine the level of cognitive ability needed for sufficient understanding, whether these findings can be translated to other clinical populations, and the impact of the tool in larger trials and on trial retention.

Women who are or may become pregnant need up-to-date information about Down syndrome (DS). Asking women about their knowledge, opinions, resources, and information needs on the topic of DS is an important precursor to develop effective strategies for education. We conducted 24 focus groups (N = 111) in two US cities with women who were recently pregnant (who had a child ≤ 3 years old without DS) and women who planned to have a child in the next year. Groups were further segmented by age and race-ethnicity. Questions explored women's knowledge, attitudes, and beliefs about DS; resources used to obtain information about health and DS; and information needs on the topic of DS. All participants reported having some knowledge of DS: facial features, chromosomal condition, and maternal age as a risk factor. Many participants had misconceptions, including the life expectancy for persons with DS, other maternal and paternal risk factors, and the idea that having a child with DS would disrupt their lives. Participants requested stories to help illustrate what life is like for families with DS. Many Hispanic and African American participants said they only saw or knew of Caucasian persons with DS and requested culturally diverse educational materials about DS. Participants said they would seek information on DS from the Internet and from their health care providers. Results suggest that women need tailored materials that contain clinical information about DS as well as information about living with a child with DS. Published 2012. This article is a U.S. Government work and is in the public domain in the USA.

Background: Challenges in the clinical and research consent process indicate the need to develop tailored, supportive interventions for all individuals, especially those with limited decisional capacity. We developed a tool to enhance shared decision making and the decisional capacity for individuals with fragile X syndrome engaged in the informed consent process for a clinical trial. Objective: We describe the design and development process of a tablet-based decision support tool. Methods: Our development process for the decision support tool employed a user-centered, feature-driven design approach. We began with an environmental scan to catalog relevant mobile apps, and we conducted interviews with people with a diagnosis of fragile X syndrome and clinicians at fragile X syndrome clinics. To develop content for the decision support tool, we extracted key concepts and elements from a real clinical trial consent form and rewrote it using plain-language principles. Results: We used iterative testing to continuously evaluate and revise the decision support tool content. The tool was finalized in 2016 and contained a series of vignettes, quiz questions, and a sorting activity. A randomized controlled trial was then conducted to compare the efficacy of the decision support tool with a standard verbal presentation of material that mimicked typical informed consent practice. Conclusions: The informed consent process is primed to leverage digital health resources that promote increased understanding and engagement of research participants in the consent and research process. The process and experiences we describe may provide a model for other digital health design and development initiatives seeking to create more interactive and accessible decision support resources. Trial Registration: ClinicalTrials.gov NCT02465931; https://www.clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/6zx2KY9YW)

Women who are or may become pregnant need up-to-date information about Down syndrome (DS). Asking women about their knowledge, opinions, resources, and information needs on the topic of DS is an important precursor to develop effective strategies for education. We conducted 24 focus groups (N = 111) in two US cities with women who were recently pregnant (who had a child ≤ 3 years old without DS) and women who planned to have a child in the next year. Groups were further segmented by age and race-ethnicity. Questions explored women's knowledge, attitudes, and beliefs about DS; resources used to obtain information about health and DS; and information needs on the topic of DS. All participants reported having some knowledge of DS: facial features, chromosomal condition, and maternal age as a risk factor. Many participants had misconceptions, including the life expectancy for persons with DS, other maternal and paternal risk factors, and the idea that having a child with DS would disrupt their lives. Participants requested stories to help illustrate what life is like for families with DS. Many Hispanic and African American participants said they only saw or knew of Caucasian persons with DS and requested culturally diverse educational materials about DS. Participants said they would seek information on DS from the Internet and from their health care providers. Results suggest that women need tailored materials that contain clinical information about DS as well as information about living with a child with DS. Published 2012. This article is a U.S. Government work and is in the public domain in the USA.

Objective Many Internet users seek health information through online health communities (OHCs) and other social media. Yet few studies assess how individuals use peer-generated health information, and many healthcare providers (HCPs) believe OHCs interfere with patient–provider relationships. This study explored how individuals use OHC content in clinical discussions and how HCPs react to it. Methods We conducted in-person and virtual focus groups with patients/caregivers who visited OHCs ( n = 89). A trained moderator asked about reasons for membership, sharing OHC content with providers, HCP reactions, and preferred roles for HCPs. Two researchers independently coded verbatim transcripts (NVivo 9.2) and conducted thematic response analysis. Results Participants described OHCs as supplementing information from HCPs, whom they perceived as too busy for detailed discussions. Almost all participants shared OHC content with HCPs, although only half cited OHCs as the source. Most HCPs reacted negatively to OHC content, making participants feel disempowered. Despite these reactions, participants continued to use OHCs, and most desired HCP feedback on the accuracy of OHC content. Conclusions Individuals do not use OHCs to circumvent HCPs but instead to gather more in-depth information. Practice implications HCPs should discuss OHC content with patients to help them avoid misinformation and make more informed decisions.

Objective We evaluated whether presenting prescription drug efficacy information in direct-to-consumer (DTC) advertising helps individuals accurately report a drug's benefits and, if so, which numerical format is most helpful. Methods We conducted a randomized, controlled study of individuals diagnosed with high cholesterol ( n =2807) who viewed fictitious prescription drug print or television ads containing either no drug efficacy information or efficacy information in one of five numerical formats. We measured drug efficacy recall, drug perceptions and attitudes, behavioral intentions, and drug risk recall. Results Individuals who viewed absolute frequency and/or percentage information more accurately reported drug efficacy than participants who viewed no efficacy information. Participants who viewed relative frequency information generally reported drug efficacy less accurately than participants who viewed other numerical formats. Conclusion Adding efficacy information to DTC ads—both in print and on television—may potentially increase an individual's knowledge of a drug's efficacy, which may improve patient-provider communication and promote more informed decisions. Practice implications Providing quantitative efficacy information in a combination of formats (e.g., absolute frequency and percent) may help patients remember information and make decisions about prescription drugs.