Assessing influenza vaccination success to inform COVID-19 vaccination campaign.

Given recent downward trends in daily rates of COVID-19 vaccinations, it is important to reassess strategies to reach those most vulnerable. The success and efficacy of vaccination campaigns for other respiratory illnesses, such as influenza, may help inform messaging around COVID-19 vaccinations. This cross-sectional study examines the individual-level factors associated with, and the spatial distribution of, predictors of COVID-19 severity, and uptake of influenza and hepatitis B (as a negative control) vaccines across NYC. Data were obtained from the 2018 Community Health Survey (CHS), including self-reported influenza and hepatitis B vaccine uptake, diabetes, asthma, hypertension, body mass index (BMI), age, race/ethnicity, educational attainment, borough, and United Hospital Fund (UHF) neighborhood of residence. A CDC-defined COVID-19 severity risk score was created with variables available in the CHS, including diabetes, asthma, hypertension, BMI ≥ 30 kg/m2 , and age ≥65 years old. After adjustment, there was a significant positive association between COVID-19 severity risk score and influenza vaccine uptake (1: ORadj = 1.49, 95% CI 1.28-1.73; 2: ORadj = 1.99; 95% CI: 1.65-2.41; 3+: ORadj = 2.89; 95% CI: 2.32-3.60, compared to 0). Hepatitis B vaccine uptake was significantly inversely associated with COVID-19 severity risk score (1: ORadj = 0.67; 95% CI: 0.57-0.79; 2: ORadj = 0.54; 95% CI: 0.44-0.66; 3+: ORadj = 0.45; 95% CI: 0.36-0.56, compared to 0). The influenza vaccination campaign template is effective at reaching those most at risk for serious COVID-19 and, if implemented, may help reach the most vulnerable that have not yet been vaccinated against COVID-19.

Ecologic study of influenza vaccination uptake and COVID-19 death rate in New York City.

BACKGROUND: The aim of this ecological study was to assess the area-level relationship between cumulative death rate for COVID-19 and historic influenza vaccination uptake in the New York City population. METHODS: Predictors of COVID-19 death included self-reported influenza vaccination in 2017, as well as four CDC-defined risk factors of severe COVID-19 infection available at the ecological level, which were diabetes, asthma, BMI 30-100 (2 kg/m2) and hypertension, in addition to race and age (65 + years). RESULTS: After adjusting for potential confounders, for every one-unit increase in influenza vaccination uptake for each zip code area, the rate of COVID-19 deaths decreased by 5.17 per 100,000 residents (p < 0.0001). CONCLUSIONS: Zip codes with a higher prevalence of influenza vaccination had lower rates of COVID-19 mortality, inciting the need to further explore the relationship between influenza vaccination uptake and COVID-19 mortality at the individual level.

Bereavement Among Adult Siblings: An Examination of Health Services Utilization and Mental Health Outcomes.

We aimed to examine the association of young and middle-aged sibling bereavement with use of health services and risk of developing mental health disorders over 24 months before and after sibling's death. All persons aged 18-56 years who died of illness/natural causes between 2009 and 2016 were identified in the Danish Register of Causes of Death. The study sample included 31,842 bereaved siblings and 31,842 age- and sex-matched controls. Overall, the largest effect was observed for increased use of psychological services: For women, the peak was observed 4-6 months after the death (odds ratio (OR) = 3.31, 95% confidence interval (CI): 2.85, 3.85) and for men in the first 3 months after the death (OR = 2.63, 95% CI: 2.06, 3.36). The peak of being diagnosed in a hospital setting with any mental disorder for women was observed in the period 13-15 months after sibling death (OR = 1.52, 95% CI: 1.11, 2.07) and for men in the first 3 months after the death (OR = 1.75, 95% CI: 1.32, 2.32). Young and middle-aged adults who experienced the death of a sibling are more likely to use health services and are at risk of poorer mental health outcomes. During the bereavement process, young and middle-aged siblings are especially in need of mental health support, such as professional psychological counseling.

Deferred Action for Childhood Arrivals (DACA) medical students - an examination of their journey and experiences as medical students in limbo.

BACKGROUND: Although the value of DACA medical students has been hypothesized, no data are available on their contribution to US healthcare. While the exact number of DACA recipients in medical school is unknown, DACA medical students are projected to represent an increasing proportion of physicians in the future. The current literature on DACA students has not analyzed the experiences of these students. METHODS: A mixed-methods study on the career intentions and experiences of DACA medical students was performed utilizing survey data and in-depth interviews. The academic performance of a convenience sample of DACA medical students was compared to that of matriculated medical students from corresponding medical schools, national averages, and first-year residents according to specialty. RESULTS: Thirty-three DACA medical students completed the survey and five participated in a qualitative interview. The average undergraduate GPA (SD) of the DACA medical student sample was 3.7 (0.3), the same as the national GPA of 2017-2018 matriculated medical students. The most common intended residency programs were Internal Medicine (27.2%), Emergency Medicine (15.2%), and Family Medicine (9.1%). In interviews, DACA students discussed their motivation for pursuing medicine, barriers and facilitators that they faced in attending medical school, their experiences as medical students, and their future plans. CONCLUSIONS: The intent of this sample to pursue medical specialties in which there is a growing need further exemplifies the unique value of these students. It is vital to protect the status of DACA recipients and realize the contributions that DACA physicians provide to US healthcare.

Update on human exposure to glyphosate, with a complete review of exposure in children.

BACKGROUND: Glyphosate, a commonly used pesticide, has been the topic of much debate. The effects of exposure to glyphosate remains a contentious topic. This paper provides an update to the existing literature regarding levels of glyphosate exposure in occupationally exposed individuals and focuses or reviewing all the available published literature regarding glyphosate exposure levels in children. METHODS: A literature review was conducted and any articles reporting quantifiable exposure levels in humans published since January 2019 (the last published review on glyphosate exposure) were reviewed and data extracted and standardized. RESULTS: A total of five new studies reporting exposure levels in humans were found including 578 subjects. Two of these studies focused on occupationally exposed individuals while three of them focused on glyphosate exposure levels in children. Given the sparse nature of the new data, previously identified studies on exposure to glyphosate in children were included in our analysis of children's exposure. The lowest average level of glyphosate exposure reported was 0.28 µg/L and the highest average exposure levels reported was 4.04 µg/L. CONCLUSION: The literature on glyphosate exposure levels, especially in children, remains limited. Without more data collected in a standardized way, parsing out the potential relationship between glyphosate exposure and disease will not be possible.

New antidepressant utilization pre- and post-bereavement: a population-based study of partners and adult children.

PURPOSE: Bereavement is associated with increased morbidity and mortality, but few studies have examined the specific timing of depression onset. This study examines the risk of developing new-onset depression in adult children and partners by month, 1 year before and after death. METHODS: Using population-based registers in Denmark, we assembled a cohort of 236,000 individuals who died a natural death (2010-2016). Partners and adult children of the deceased were identified and demographic and prescription data were collected. GEE logistic regression was used to model whether the bereaved received a new antidepressant prescription around the death of their loved one across 24 time intervals (12 months before and after death). RESULTS: Male and female partners had an increase in receipt of new antidepressant prescriptions in the 11 months after the death of their partner, with a peak increase 2 or 3 months after death. Partners also increased new antidepressant prescription use 2 months before death. Characteristics of the decedents including cause of death were not associated with new antidepressant prescription in the surviving partner. Adult children did not have increased odds of being prescribed new antidepressants at any time. CONCLUSION: Both male and female partners have increase in new antidepressant utilization before and after the death of their partner. Our work points to the importance of supporting partners not only after the death of their partner, but also in the period before death when families may be actively engaged in caregiving for the seriously ill.

Biomarkers for malignant pleural mesothelioma: a meta-analysis.

Malignant pleural mesothelioma (MPM) is a rare but aggressive cancer, and early detection is associated with better survival. Mesothelin, fibulin-3 and osteopontin have been suggested as screening biomarkers. The study conducted a meta-analysis of the mean differences of mesothelin, osteopontin and fibulin-3 in blood and pleural samples. PubMed searches were conducted for studies that measured levels of mesothelin, osteopontin and fibulin-3 in participants with MPM compared with malignancy, benign lung disease or healthy participants. Thirty-two studies with mesothelin levels, 12 studies with osteopontin levels and 9 studies with fibulin-3 levels were included in the meta-analysis. Statistically significant mean differences were seen between MPM patients and all other comparison groups for mesothelin blood and pleural levels. Statistically significant differences in blood osteopontin levels were seen between participants with benign lung disease and healthy participants compared with participants with MPM, but not when comparing participants with cancer with MPM participants. There were not enough studies that reported osteopontin levels in pleural fluid to complete a meta-analysis. Statistically significant differences were seen in both blood and pleural levels of fibulin-3 in MPM patients compared with all other groups. On the basis of these results, mesothelin and fibulin-3 levels appear to be significantly lower in all control groups compared with those with MPM, making them good candidates for screening biomarkers. Osteopontin may be a useful biomarker for screening healthy individuals or those with benign lung disease but would not be useful for screening patients with malignancies.

Complementary biobank of rodent tissue samples to study the effect of World Trade Center exposure on cancer development.

World Trade Center (WTC) responders were exposed to mixture of dust, smoke, chemicals and carcinogens. New York University (NYU) and Mount Sinai have recreated WTC exposure in rodents to observe the resulting systemic and local biological responses. These experiments aid in the interpretation of epidemiological observations and are useful for understanding the carcinogenesis process in the exposed human WTC cohort. Here we describe the implementation of a tissue bank system for the rodents experimentally exposed to WTC dust. NYU samples were experimentally exposed to WTC dust via intratracheal inhalation that mimicked conditions in the immediate aftermath of the disaster. Tissue from Mount Sinai was derived from genetically modified mice exposed to WTC dust via nasal instillation. All processed tissues include annotations of the experimental design, WTC dust concentration/dose, exposure route and duration, genetic background of the rodent, and method of tissue isolation/storage. A biobank of tissue from rodents exposed to WTC dust has been compiled representing an important resource for the scientific community. The biobank remains available as a scientific resource for future research through established mechanisms for samples request and utilization. Studies using the WTC tissue bank would benefit from confirming their findings in corresponding tissues from organs of animals experimentally exposed to WTC dust. Studies on rodent tissues will advance the understanding of the biology of the tumors developed by WTC responders and ultimately impact the modalities of treatment, and the probability of success and survival of WTC cancer patients.

The evidence of human exposure to glyphosate: a review.

BACKGROUND: Despite the growing and widespread use of glyphosate, a broad-spectrum herbicide and desiccant, very few studies have evaluated the extent and amount of human exposure. OBJECTIVE: We review documented levels of human exposure among workers in occupational settings and the general population. METHODS: We conducted a review of scientific publications on glyphosate levels in humans; 19 studies were identified, of which five investigated occupational exposure to glyphosate, 11 documented the exposure in general populations, and three reported on both. RESULTS: Eight studies reported urinary levels in 423 occupationally and para-occupationally exposed subjects; 14 studies reported glyphosate levels in various biofluids on 3298 subjects from the general population. Average urinary levels in occupationally exposed subjects varied from 0.26 to 73.5 µg/L; environmental exposure urinary levels ranged from 0.16 to 7.6 µg/L. Only two studies measured temporal trends in exposure, both of which show increasing proportions of individuals with detectable levels of glyphosate in their urine over time. CONCLUSIONS: The current review highlights the paucity of data on glyphosate levels among individuals exposed occupationally, para-occupationally, or environmentally to the herbicide. As such, it is challenging to fully understand the extent of exposure overall and in vulnerable populations such as children. We recommend further work to evaluate exposure across populations and geographic regions, apportion the exposure sources (e.g., occupational, household use, food residues), and understand temporal trends.

The development of a Biobank of cancer tissue samples from World Trade Center responders.

BACKGROUND: World Trade Center (WTC) responders were exposed to mixture of dust, smoke, chemicals and carcinogens. Studies of cancer incidence in this population have reported elevated risks of cancer compared to the general population. There is a need to supplement current epidemiologic cancer follow-up with a cancer tissue bank in order to better elucidate a possible connection between each cancer and past WTC exposure. This work describes the implementation of a tissue bank system for the WTC newly diagnosed cancers, focused on advancing the understanding of the biology of these tumors. This will ultimately impact the modalities of treatment, and the probability of success and survival of these patients. METHODS: WTC Responders who participated (as employees or volunteers) in the rescue, recovery and cleanup efforts at the WTC sites have been enrolled at Mount Sinai in the World Trade Center Health Program. Responders with cancer identified and validated through linkages with New York, New Jersey, Pennsylvania, and Connecticut cancer registries were eligible to participate in this biobank. Potential participants were contacted through letters, phone calls, and emails to explain the research study, consent process, and to obtain the location where their cancer procedure was performed. Pathology departments were contacted to identify and request tissue samples. RESULTS: All the 866 solid cancer cases confirmed by the Data Center at Mount Sinai have been contacted and consent was requested for retrieval and storage of the tissue samples from their cancer. Hospitals and doctors' offices were then contacted to locate and identify the correct tissue block for each patient. The majority of these cases consist of archival paraffin blocks from surgical patients treated from 2002 to 2015. At the time of manuscript writing, this resulted in 280 cancer samples stored in the biobank. CONCLUSIONS: A biobank of cancer tissue from WTC responders has been compiled with 280 specimens in storage to date. This tissue bank represents an important resource for the scientific community allowing for high impact studies on environmental exposures and cancer etiology, cancer outcome, and gene-environment interaction in the unique population of WTC responders.

Fukushima Triple Disaster and the Road to Recovery: a Qualitative Exploration of Resilience in Internally Displaced Residents.

Six years after the March 2011 Triple Disaster, over 35,000 Japanese individuals remain in temporary housing. Evacuated residents, many of who are elderly, face mental health challenges. This study evaluates the well being of individuals living in temporary housing within Fukushima. Reactions to relocation were explored using Photovoice, a community-based participatory research method, in which a set of research questions are examined qualitatively through photographs and interviews. Seven participants (average age = 69.7) were provided cameras to answer a set of self-generated questions, a process that was repeated three times. An initial analysis found resilience among participants, which was explored using a theoretical framework of resiliency. Residents discussed how relocation has disrupted their lives and coping strategies they employ to ameliorate stressors. They were often optimistic and future-oriented, stating that they wanted to "live strong" after the disaster. These resilient mindsets were personified in action: all engaged in hobbies, critical for their emotional well being. Participants also emphasized the importance of community and familial support. The evidence of resilience in participants is encouraging, suggesting that these vulnerable elderly internally displaced residents are recovering from the disruption of relocation. These themes should be explored in larger temporary housing communities. Considering the number of relocated individuals today, understanding how to foster resilience could be used to inform the development of future temporary housing shelters.

Study Protocol for the Healing Opioid Misuse and Pain Through Engagement Trial: Integrated Treatment for Individuals With Co-occurring Chronic Pain and Opioid Use Disorder.

Chronic pain and opioid use disorder (OUD) are public health crises and their co-occurrence has led to further complications and public health impacts. Provision of treatments for comorbid chronic pain and OUD is paramount to address these public health crises. Medications for OUD (MOUD) are gold standard treatments for OUD that have also demonstrated benefit in pain management. However, clinics that provide MOUD for chronic pain or OUD often lack behavioral treatments to address the challenges experienced by individuals with both conditions. Developing and implementing a behavioral treatment that complements MOUD may better equip clinics to provide comprehensive care to the growing proportion of clients who present with comorbid chronic pain and OUD. In the Healing Opioid misuse and Pain through Engagement (HOPE) Trial, we are using an effectiveness-implementation hybrid design to examine the benefits of an integrated behavioral treatment and to determine the feasibility of implementing the integrated treatment into clinics that provide MOUD. The treatment integrated 2 evidence-based treatments-Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention-to target the emotional, behavioral, and physiological sequelae of OUD and chronic pain. Implementation feasibility will include assessing changes in implementation readiness and identifying facilitators and barriers to implementing the integrated treatment among all personnel employed in clinics that provide MOUD. This commentary offers an overview of the study and design and details adaptations we made to our study protocol, based largely on clinic personnel time constraints and variable clinic procedures during the COVID-19 pandemic.

Sexual Assaults, Bad Hookups, and Bad Dates: Comparisons of the Contextual Features Among College Women's Hypothetical and Real-Life Sexual and Dating Experiences.

Two hundred forty-seven (N = 247) undergraduate women at a medium-sized, Southwestern university provided written descriptions of a hypothetical sexual assault (SA). Women with a prior history of SA also described their actual SA experiences; women without a SA history provided a written description of a prior bad date or hookup. The contextual features of SA scripts were compared to those of actual SA experiences. Several characteristics of a stereotypical or "blitz rape" (e.g., physical force by a stranger) were more likely to be included in SA scripts relative to women's actual SA experiences. Victimized women were also more likely to include verbal coercion, a hangout/hookup context, and previous consensual kissing in their SA experiences, in comparison to their SA scripts. The contextual features of SA experiences were also compared to the contextual features of bad dates or bad hookups. SA experiences, relative to bad dates, were more likely to include alcohol use, physical and verbal coercion by the perpetrator, and passive resistance. SA experiences, relative to bad hookups, were more likely to include physical and verbal coercion by the perpetrator, and knowing the man for less than 1 week. Victimized participants SA experiences were also found to be less likely to include previous consensual kissing and consensual intercourse in comparison to bad hookup experiences of nonvictimized women. Overall, there was considerable overlap between the contextual features present across all experiences. The lack of differentiation among these events may explain why women experience difficulty acknowledging whether they have experienced SA.

Early-Stage Lung Cancer Patients' Perceptions of Presurgical Discussions.

Background: Patients with early-stage non-small-cell lung cancer (NSCLC) have high survival rates, but patients often say they did not anticipate the effect of the surgery on their postsurgical quality of life (QoL). This study adds to the literature regarding patient and surgeon interactions and highlights the areas where the current approach is not providing good communication. Design: Since its start in 2016, the Initiative for Early Lung Cancer Research on Treatment (IELCART), a prospective cohort study, has enrolled 543 patients who underwent surgery for stage I NSCLC within the Mount Sinai Health System. Presurgical patient and surgeon surveys were available for 314 patients, postsurgical surveys for 420, and both pre- and postsurgical surveys for 285. Results: Of patients with presurgical surveys, 31.2% said that their surgeon recommended multiple types of treatment. Of patients with postsurgical surveys, 85.0% felt very well prepared and 11.4% moderately well prepared for their postsurgical recovery. The median Functional Assessment of Cancer Therapy-Lung Cancer score and social support score of the patients who felt very well prepared was significantly higher than those moderately or not well prepared (24.0 v. 22.0, P < 0.001) and (5.0 [interquartile range: 4.7-5.0] v. 5.0 [IQR: 4.2-5.0], p = 0.015). Conclusions: This study provides insight into the areas where surgeons are communicating well with their patients as well as the areas where patients still feel uninformed. Most surgeons feel that they prepare their patients well or very well for surgical recovery, whereas some patients still feel that their surgeons did not prepare them well for postsurgical recovery. Surgeons may want to spend additional time emphasizing postsurgical recovery and QoL with their patients or provide their patients with additional avenues to get their questions and concerns addressed. Highlights: Pretreatment discussions could help surgeons understand patient priorities and patients understand the anticipated outcomes for their surgeries.There is an association between feeling prepared for surgery and higher quality of life and social support scores after adjustment for confounders.Despite these pretreatment discussions, patients still feel that they are not well prepared about what to expect during their postsurgical recovery.

Assessing the Feasibility and Effectiveness of a Linkage Into Mental Health Care Program for Adults Affected by Hurricane Sandy.

OBJECTIVE: Research indicates that greater exposure to Hurricane Sandy is associated with increased mental health difficulties. This study examined whether Project Restoration, a program that linked adults into mental health care (L2C), was effective in reducing post-Sandy mental health difficulties as compared to a cohort of adults matched on mental health difficulties that were not linked into post-Sandy mental health care. METHODS: Project Restoration participants (n = 52) with elevated self-reported mental health difficulties had the option to enroll into L2C. Project LIGHT (n = 63) used similar methodologies but did not have a L2C component and served as the matched control group. RESULTS: Multivariable modeling showed significant decreases in all mental health difficulties except for depression in the Project Restoration group, whereas there were no significant decreases in LIGHT. The decrease in anxiety from baseline to follow-up was significantly greater for Project Restoration as compared to LIGHT. CONCLUSION: Findings confirm the powerful impact community outreach and treatment have on reducing mental health difficulties after a disaster.

Interferon gamma expression and mortality in unselected cohorts of urothelial bladder cancer patients.

BACKGROUND: The role of interferon gamma (IFN-γ) expression in long-term survival has not been studied in patients with urinary bladder cancer (UBC). IFN-γ expression was characterized among various UBC patient cohorts to assess if IFN-γ status is associated with overall survival (OS). METHODS: A tumor-based IFN-γ gene signature was evaluated among adult UBC patients newly diagnosed between 2004 and 2017 from two hospital systems in New York. Patient cohorts included metastatic (stage IV or progressing to stage IV [MBC]), muscle-invasive (stages T2a to T4a [MIBC]), and non-muscle-invasive (carcinoma in situ or stages 0a, 0is, and I [NMIBC]) disease. Descriptive analyses were conducted comparing IFN-γ signature in the highest tertile to those in the lowest two tertiles. RESULTS: 234 patients with bladder cancer were evaluated (56 MBC, 38 MIBC, and 140 NMIBC). Median OS was only reached in the MIBC cohort for those with an IFN-γ signature in the lowest two tertiles (15.03 months [95% CI, 8.50-50.60]). Those with an IFN-γ signature in the highest tertile had a decreased risk of mortality in all cohorts indicating better survival, but this was statistically significant in only the MIBC cohort (adjusted HR = 0.09 [95% CI, 0.01-0.73]). CONCLUSION: IFN-γ signature status was associated with a decreased mortality risk in all cohorts, particularly MIBC, indicating that it may be a prognostic marker of survival in patients with UBC.

Unequal social vulnerability to Hurricane Sandy flood exposure.

Disparities exist in post-disaster flooding exposure and vulnerable populations bear a disproportionate impact of this exposure. We describe the unequal burden of flooding in a cohort of New York residents following Hurricane Sandy and assess whether the likelihood of flooding was distributed equally according to socioeconomic demographics, and whether this likelihood differed when analyzing self-reported or FEMA flood exposure measures. Residents of New York City and Long Island completed a self-administered survey 1.5-4.0 years after the storm. Multivariable logistic regressions were performed to determine the relationship between sociodemographic characteristics and flood exposure. Participants (n = 1231) residing in areas of the lowest two quartiles of median household income experienced flooding the most often (FEMA/self-reported: <$40,298: 65.3%/42.0%, $40,298-$67,188: 43.3%/32.1%), and these areas contained the highest proportions of non-White participants (<$40,298: 39.1%, $40,298-$67,188: 36.6%) and those with ≤high school education (<$40,298: 35.5%, $40,298-$67,188: 33.6%). Both self-report (p < 0.05) and FEMA (p < 0.05) flood measures indicated that older participants were more likely to live in a household exposed to flooding, while those living in higher-income areas had decreased likelihood of flooding (p < 0.0001). Socioeconomic and age disparities were present in exposure to flooding during Hurricane Sandy. Future disaster preparedness responses must understand flooding from an environmental justice perspective to create effective strategies that minimize disproportionate exposure and its adverse outcomes.

The Impact of Dementia on Cancer Treatment Decision-Making, Cancer Treatment, and Mortality: A Mixed Studies Review.

Dementia and cancer occur commonly in older adults. Yet, little is known about the effect of dementia on cancer treatment and outcomes in patients diagnosed with cancer, and no guidelines exist. We performed a mixed studies review to assess the current knowledge and gaps on the impact of dementia on cancer treatment decision-making, cancer treatment, and mortality. A search in PubMed, Medline, and PsycINFO identified 55 studies on older adults with a dementia diagnosis before a cancer diagnosis and/or comorbid cancer and dementia published in English from January 2004 to February 2020. We described variability using range in quantitative estimates, ie, odds ratios (ORs), hazard ratios (HRs), and risk ratios (RR) when appropriate and performed narrative review of qualitative data. Patients with dementia were more likely to receive no curative treatment (including hospice or palliative care) (OR, HR, and RR range = 0.40-4.4, n = 8), while less likely to receive chemotherapy (OR and HR range = 0.11-0.68, n = 8), radiation (OR range = 0.24-0.56, n = 2), and surgery (OR range = 0.30-1.3, n = 4). Older adults with cancer and dementia had higher mortality than those with cancer alone (HR and OR range = 0.92-5.8, n = 33). Summarized findings from qualitative studies consistently revealed that clinicians, caregivers, and patients tended to prefer less aggressive care and gave higher priority to quality of life over life expectancy for those with dementia. Current practices in treatment-decision making for patients with both cancer and dementia are inconsistent. There is an urgent need for treatment guidelines for this growing patient population that considers patient and caregiver perspectives.