Factors affecting pathways to care for children and adolescents with complex vascular malformations: Parental perspectives

BACKGROUND: Complex vascular malformations (VMs) are rare disorders that can cause pain, coagulopathy, disfigurement, asymmetric growth, and disability. Patients with complex VMs experience misdiagnosis, delayed diagnosis, delayed or inappropriate treatments, and worsened health. Given the potential consequences of delaying expert care, we must identify the factors that impede or facilitate this access to care. RESULTS: We performed semi-structured interviews with 24 parents (21 mothers; 3 fathers; median age = 42.5 years) of children with complex VMs and overgrowth disorders living in the US, recruited through two patient advocacy groups - CLOVES Syndrome Community, and Klippel-Trenaunay Support Group. We performed thematic analysis to assess parental perspectives on barriers and facilitators to accessing expert care. We identified 11 factors, representing 6 overarching themes, affecting families\u27 ability to access and maintain effective care for their child: individual characteristics (clinician behaviors and characteristics, parent behaviors and characteristics), health care system (availability of specialist multidisciplinary teams, care coordination and logistics, insurance and financial issues, treatments and services), clinical characteristics (accuracy and timing of diagnosis, features of clinical presentation), social support networks, scientific progress, and luck and privilege. Additionally, access to information about VMs and VM care was a crosscutting theme affecting each of these factors. These factors influenced both the initial access to care and the ongoing maintenance of care for children with VMs. CONCLUSION: Parents of children with VMs report multiple factors that facilitate or impede their ability to provide their child with optimal care. These factors represent possible targets for future interventions to improve care delivery for families affected by VMs

Communication interventions in adult and pediatric oncology: A scoping review and analysis of behavioral targets

BackgroundImproving communication requires that clinicians and patients change their behaviors. Interventions might be more successful if they incorporate principles from behavioral change theories. We aimed to determine which behavioral domains are targeted by communication interventions in oncology.MethodsSystematic search of literature indexed in Ovid Medline, Embase, Scopus, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Clinicaltrials.gov (2000-October 2018) for intervention studies targeting communication behaviors of clinicians and/or patients in oncology. Two authors extracted the following information: population, number of participants, country, number of sites, intervention target, type and context, study design. All included studies were coded based on which behavioral domains were targeted, as defined by Theoretical Domains Framework.FindingsEighty-eight studies met inclusion criteria. Interventions varied widely in which behavioral domains were engaged. Knowledge and skills were engaged most frequently (85%, 75/88 and 73%, 64/88, respectively). Fewer than 5% of studies engaged social influences (3%, 3/88) or environmental context/resources (5%, 4/88). No studies engaged reinforcement. Overall, 7/12 behavioral domains were engaged by fewer than 30% of included studies. We identified methodological concerns in many studies. These 88 studies reported 188 different outcome measures, of which 156 measures were reported by individual studies.ConclusionsMost communication interventions target few behavioral domains. Increased engagement of behavioral domains in future studies could support communication needs in feasible, specific, and sustainable ways. This study is limited by only including interventions that directly facilitated communication interactions, which excluded stand-alone educational interventions and decision-aids. Also, we applied stringent coding criteria to allow for reproducible, consistent coding, potentially leading to underrepresentation of behavioral domains

Prescribing unproven cancer drugs: Physician perspectives on expanded access and right to try

BACKGROUND: For gravely ill patients who have no treatment options and who are ineligible for clinical trials, the US Food and Drug Administration (FDA) established the Expanded Access Program (EAP). Motivated by efforts to weaken FDA regulation and sold as providing greater access to experimental drugs, the federal Right to Try Act (RTT) was passed in 2017. It reduces FDA oversight by not requiring physicians to report safety data and foregoes approval of protocols by local institutional review boards. METHODS: This study explored the views of 17 neuro-oncologists from 15 different academic medical centers with varying experience with EAP and RTT using convenience sampling. We conducted semi-structured interviews and qualitative analysis to identify emerging themes. RESULTS: Most oncologists were confused between the two pathways, had little familiarity with RTT, and had little knowledge about experimental medicine available through either pathway. Oncologists reported a preference of enrolling patients in clinical trials over off-trial preapproval pathways with scant data. As a result, oncologists revealed concerns over properly evaluating risks for their patients. CONCLUSION: Our findings suggest that neuro-oncologists need better resources and clearer mechanisms at their institutions to help navigate EAP and RTT in order to counsel patients interested in experimental medicine

Ethical, regulatory, and practical barriers to COVID-19 research: A stakeholder-informed inventory of concerns

INTRODUCTION: SARS-CoV-2 (COVID-19) has caused death and economic injury around the globe. The urgent need for COVID-19 research created new ethical, regulatory, and practical challenges. The next public health emergency could be worse than COVID-19. We must learn about these challenges from the experiences of researchers and Research Ethics Committee professionals responsible for these COVID-19 studies to prepare for the next emergency. MATERIALS AND METHODS: We conducted an online survey to identify the ethical, oversight, and regulatory challenges of conducting COVID-19 research during the early pandemic, and proposed solutions for overcoming these barriers. Using criterion-based, convenience sampling, we invited researchers who proposed or conducted COVID-19 research to complete an anonymous, online survey about their experiences. We administered a separate but related survey to Institutional Review Board (IRB) professionals who reviewed COVID-19 research studies. The surveys included open-ended and demographic items. We performed inductive content analysis on responses to open-ended survey questions. RESULTS: IRB professionals (n = 143) and researchers (n = 211) described 19 types of barriers to COVID-19 research, related to 5 overarching categories: policy and regulatory, biases and misperceptions, institutional and inter-institutional conflicts, risks of harm, and pressure of the pandemic. Researchers and IRB professionals described 8 categories of adaptations and solutions to these challenges: enacting technological solutions; developing protocol-based solutions; disposition and team management; establishing and communicating appropriate standards; national guidance and leadership; maintaining high standards; prioritizing studies before IRB review; and identifying and incorporating experts. DISCUSSION AND CONCLUSIONS: This inventory of challenges represents ongoing barriers to studying the current pandemic, and they represent a risk to research during future public health emergencies. Delays in studies of a pandemic during a pandemic threatens the health and safety of the public. We urge the development of a national working group to address these issues before the next public health emergency arises

Navigating care for rare diseases: Caregiver and patient advice for families and clinicians managing care for vascular malformations

OBJECTIVE: Families affected by rare diseases face many challenges finding adequate care and often report poor communication with clinicians. In the current study, we explore patient and caregiver advice for families and clinicians in the context of complex vascular malformations (VMs), a condition that is frequently misunderstood and misdiagnosed. METHODS: We performed semi-structured interviews with 21 adult patients with complex VMs and 24 caregivers of children with VMs. We analyzed the transcripts using thematic analysis. RESULTS: Participants advised patients and caregivers to advocate for care, address mental and emotional well-being, seek social support, and promote self-management and self-care. Participants advised clinicians to show care and concern, show commitment, empower and validate, communicate information clearly, address mental/emotional well-being, acknowledge the broad impact of disease and treatment, acknowledge your limitations, work as a team, and commit to learning. CONCLUSION: Participants\u27 advice revealed challenges related to family-centered communication and patient and caregiver quality of life and demonstrated the importance of self-advocacy and social support. PRACTICE IMPLICATIONS: The result of this study can help newly-diagnosed families overcome challenges related to care and communication. Clinicians can also use the results to support families by offering them our accompanying handout to validate families\u27 experiences and relay this advice

Identifying contributors to disparities in patient access of online medical records: Examining the role of clinician encouragement

OBJECTIVE: The aim of this study was to understand the influence of clinician encouragement and sociodemographic factors on whether patients access online electronic medical records (EMR). MATERIALS AND METHODS: We analyzed 3279 responses from the Health Information National Trends Survey 5 cycle 4 survey, a cross-sectional, nationally representative survey administered by the National Cancer Institute. Frequencies and weighted proportions were calculated to compare clinical encouragement and access to their online EMR. Using multivariate logistic regression, we identified factors associated with online EMR use and clinician encouragement. RESULTS: In 2020, an estimated 42% of US adults accessed their online EMR and 51% were encouraged by clinicians to access their online EMR. In multivariate regression, respondents who accessed EMR were more likely to have received clinician encouragement (odds ratio [OR], 10.3; 95% confidence interval [CI], 7.7-14.0), college education or higher (OR, 1.9; 95% CI, 1.4-2.7), history of cancer (OR, 1.5; 95% CI, 1.0-2.3), and history of chronic disease (OR, 2.3; 95% CI, 1.7-3.2). Male and Hispanic respondents were less likely to have accessed EMR than female and non-Hispanic White respondents (OR, 0.6; 95% CI, 0.5-0.8, and OR, 0.5; 95% CI, 0.3-0.8, respectively). Respondents receiving encouragement from clinicians were more likely to be female (OR, 1.7; 95% CI, 1.3-2.3), have college education (OR, 1.5; 95% CI, 1.1-2.0), history of cancer (OR, 1.8; 95% CI, 1.3-2.5), and greater income levels (OR, 1.8-3.6). DISCUSSION: Clinician encouragement of patient EMR use is strongly associated with patients accessing EMR, and there are disparities in who receives clinician encouragement related to education, income, sex, and ethnicity. CONCLUSIONS: Clinicians have an important role to ensure that all patients benefit from online EMR use

Exploring perceptions of healthcare technologies enabled by artificial intelligence: An online, scenario-based survey

BACKGROUND: Healthcare is expected to increasingly integrate technologies enabled by artificial intelligence (AI) into patient care. Understanding perceptions of these tools is essential to successful development and adoption. This exploratory study gauged participants\u27 level of openness, concern, and perceived benefit associated with AI-driven healthcare technologies. We also explored socio-demographic, health-related, and psychosocial correlates of these perceptions. METHODS: We developed a measure depicting six AI-driven technologies that either diagnose, predict, or suggest treatment. We administered the measure via an online survey to adults (N = 936) in the United States using MTurk, a crowdsourcing platform. Participants indicated their level of openness to using the AI technology in the healthcare scenario. Items reflecting potential concerns and benefits associated with each technology accompanied the scenarios. Participants rated the extent that the statements of concerns and benefits influenced their perception of favorability toward the technology. Participants completed measures of socio-demographics, health variables, and psychosocial variables such as trust in the healthcare system and trust in technology. Exploratory and confirmatory factor analyses of the concern and benefit items identified two factors representing overall level of concern and perceived benefit. Descriptive analyses examined levels of openness, concern, and perceived benefit. Correlational analyses explored associations of socio-demographic, health, and psychosocial variables with openness, concern, and benefit scores while multivariable regression models examined these relationships concurrently. RESULTS: Participants were moderately open to AI-driven healthcare technologies (M = 3.1/5.0 ± 0.9), but there was variation depending on the type of application, and the statements of concerns and benefits swayed views. Trust in the healthcare system and trust in technology were the strongest, most consistent correlates of openness, concern, and perceived benefit. Most other socio-demographic, health-related, and psychosocial variables were less strongly, or not, associated, but multivariable models indicated some personality characteristics (e.g., conscientiousness and agreeableness) and socio-demographics (e.g., full-time employment, age, sex, and race) were modestly related to perceptions. CONCLUSIONS: Participants\u27 openness appears tenuous, suggesting early promotion strategies and experiences with novel AI technologies may strongly influence views, especially if implementation of AI technologies increases or undermines trust. The exploratory nature of these findings warrants additional research