Diversifying Electronic Cohort Research at UCSF

A community-engaged contest to select and support a diverse "eCohort" at UCSF

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Hypospadias and Penile Problems in Children Including Observation Registry

Proposal Status: 

Hypospadias and Penile Problems in Children Including Observation Registry

Plain-language summary of proposal:

Hypospadias is a condition that occurs in boys where the urethral meatus, or opening where the urine comes out, is not in the typical position.  The current consensus among pediatric surgeons it to repair the hypospadias surgically within the first year of life so that the boy will be able to live his life with a “normal” penis.  Thus, hypospadias surgery is now one of the most common genital surgeries performed in children under 18 months of age.  Recently, however, doubt has been cast on the validity of this consensus view.  First, the complication rate of these surgeries is high, second, the risk of anesthesia is higher in these young children, and third, there are ethical questions regarding informed consent; i.e., the ability of a minor to consent to genital surgery for a non-life-threatening condition.

So, the question becomes:  Is living life with the penile meatus not in the typical position detrimental to a child’s and/or adult’s quality of life?  If it is not detrimental, then the obvious answer is that we should wait; surgery can be done when the child is older.  However, it is also important to ask this question among a diverse group of people, as different ethnicities and cultural backgrounds will most likely affect how this question is answered.  Certain groups of people may do better with early surgery, and others with surgery later in life.  This has never been studied before.    

Our hypothesis is that most hypospadias surgery is unnecessary in infants and small children, but the results will vary by ethnicity and cultural background.  One of the ways we will study this hypothesis is by seeking out adults with hypospadias who have never had surgery, and see how they fared in life.  Since almost all children in the past have had surgery for their hypospadias, the numbers of “non-surgically altered” hypospadias patients are quite small, so we will need to study a very large group of adult men to find these patients. The only way to recruit enough adult patients from diverse groups (to include people with different ethnicities, sexual preferences, gender identities) would be online, through electronic medical records, and with community involvement.      

We will create the first registry for hypospadias in the nation, and this will be the first time watchful waiting (non-operative treatment) of genital atypia will be evaluated scientifically, and the first time a large diverse group of adult non-operated patients can be studied.

Full proposal:

Mild penile disorders, such as distal hypospadias and its variants, are common and occur in approximately 1% of boys. More severe penile disorders, such as differences of sex development (DSD), are less common, but both hypospadias and DSD can have profound impacts on a child’s quality of life.  Most of these children receive surgery at a young age, usually before 18 months of age.  Hypospadias and chordee surgery are some of the most common genital surgeries performed in children under 18 months of age.  However, there is currently very little evidence that infant genital surgery has a beneficial effect in the long term. In the short term, surgery can create external genitalia that conform to parental and societal perceptions of what is considered normal, which is why the surgery is so common, but these perceived benefits can come at a cost to the child. There are some data that performing surgery early in life may have lower complication rates, but conversely, there are also data that show no difference in the complication rates between early and late surgery. However, there is a significant complication rate for early surgery, even for mild forms of childhood hypospadias; the complication rate has been reported to be up to 10%, and many of these patients may require more than one operation, and possibly have long term sequelae even into adulthood, including psychosexual sequelae. There are also new concerns about short term memory loss associated with general anesthesia in the first two years of life, and additionally, concerns about informed consent are arising that question the ability of the parents to make decisions regarding their child’s genitalia.  

Our hypothesis is that most of these surgeries are unnecessary in infants and small children, and children will have a normal quality of life (QOL) without surgery, and possibly an improved QOL, since the complication rate for penile surgery in infants is up to 10%.  There are two ways to test this hypothesis:  one is to offer select children non-surgical treatment at their first clinic appointment and then follow them prospectively through adulthood; the second is to find adults who have never had penile surgery for their atypical genitalia and see how they fared in life.  It is the second method that this proposal is most interested in, since this adult cohort can be identified and recruited online, or by reviewing EHR’s.  In fact, since DSD’s are a rare disorder, the only way to recruit enough adult patients from diverse groups (to include people with different ethnicities, sexual preferences, gender identities, ages, and different forms of DSD’s) would be online. 

We propose creating the first ever registry that includes non-operated patients with penile disorders (Hypospadias and Penile Problems in Children Including Observation Registry - HAPPIOR).  We will follow the patients prospectively giving us the ability to perform observational comparative studies as the data comes in. The HAPPIOR study will recruit new patients through urology clinics as the patients arrive, but more importantly, we will be able to develop a large diverse cohort by also recruiting patients utilizing electronic means such as EHR extraction, on-line social media and dedicated web sites, including community involvement.  Community involvement will be essential for not only recruitment, but for helping us to be certain that our approach is sensitive to that specific community. 

HAPPIOR will be the first registry for hypospadias and other penile anomalies in the nation, and the first time watchful waiting (non-operative treatment) of genital atypia will be able to be evaluated in a prospective fashion, and the first time a large diverse cohort of adult non-operated patients can be studied. Because of the potential for this study to change the timing of genital surgery – i.e., allowing the patient and not just the parent to participate in the decision-making process, we have the support of the Accord Alliance, a major patient advocacy group for children and adults with disorders of sex development (DSD) and an important advocacy group in the DSD community.   

This proposal addresses both aspects of the Diverse eCohort Research mission: developing a large cohort that can only be accomplished with online support, and creating that cohort so that it is diverse.  Diversity is essential in this type of research as different population groups (and sub-groups) have very different pre-conceived notions of what constitutes “normal” male genitalia.  For example, it is the authors experience that certain population groups are much more comfortable with the penile meatus being somewhat proximal, or of foreskin abnormalities, than those of other populations.  We will plan to recruit Spanish speaking patients to help study this hypothesis among that population, and we will also study other ethnicities.  We will also study variations in sub-groups among the different populations, such as sexual preference, gender identity, religious values, age, and others.

In the first year, this registry will initially include only patients seen and recruited by UCSF faculty, however, the goal is to eventually expand the registry to include other centers, and to develop a global initiative as well.  This current proposal, if chosen, would be used a pilot study for a larger NIH grant proposal used to extend the time period and the cohort.  A previous pilot study by the author was able to recruit 52 men with untreated penile anomalies by using a simple Facebook advertisement, so the author anticipates with a robust web presence, community involvement, and EHR extraction, this number can be increased to over 1000 in the first year.  Preliminary results would be able to be used immediately to show that non-surgical treatment is an option in these patients, and this information will be disseminated to the DSD community through advocacy groups such as the Accord Alliance.  In addition, the results will be shared with legislators to help them develop government proposals regarding genital surgery in children (there is a current non-binding resolution in California to ban genital surgery in children, and we would be proactive in making sure the legislatures base their final decisions on sound science).

Recruitment will be twofold.  We will recruit existing UCSF urology clinic patients into the HAPPIOR registry as they come in to clinic.  Additional patients will be recruited by electronic means (EHR extraction, Web).  This will be accomplished utilizing a UCSF online research platform per the eCohort proposal.  Local patients discovered by electronic means will be invited to the urology clinic for a routine patient appointment where data will be collected (including digital photography in patients under 2 years old), deidentified, and placed in the registry.  For non-local patients, data will be collected online, deidentified, and placed in the registry.  Inclusion criteria are any self-identifying male with hypospadias, chordee, megameatus, micropenis, bifid scrotum, penoscrotal transposition, or DSD.       

Appraisal tools will be based on age and include, but not be limited to:  The Penile Perception Score (PPS) (the PPS for adults and the PPPS for children and parents), the Sexual Health Inventory for Men (SHIM), the International Prostate Symptom Score (IPPS), and the Multidimensional Sexual Self Concept Questionnaire (MSSCQ).  QOL will be measured using more broad-based measures (e.g., The Multigroup Ethnic Identity Measure, the Index of Race Related Stress--Brief Version, and the World Health Organization Quality of Life--Brief Version) so as to control for the differences seen in QOL in different racial/ethnic populations.

Routine physical examination with measurements, and 3D digital photography in children under two years old, will also be performed in those patients seen in clinic.

This study has already been submitted to the UCSF IRB and has passed through the preliminary review phase and is awaiting final approval.  Our research team is self-supporting, i.e., not requiring salary support or direct funding from this opportunity.  However, if selected, after the one-year period of in-kind support, we will plan to keep the project active indefinitely, initially with internal funding (from the PI’s Medical Project fund) for one additional year.  After the first 2 years, we anticipate having convincing preliminary results and plan to extend the database to multiple institutions and locations utilizing external funding.

If chosen, this study will facilitate discovery of specific phenotype/outcome associations and measured versus perceived characteristics of genital anatomy in a large diverse cohort.  This project will act as a basis for a future long-term registry and will lead to observational studies that will finally determine the necessity and efficacy of early genital surgery in children.

Commenting is closed.

The Patient Cancer OUtreach, Navigation, Technology and Support (Patient COUNTS) Project: Addressing Care for Asian Americans with Cancer

Proposal Status: 

Summary. Cancer is the most common cause of death for Asian Americans, but many Asian American cancer patients do not receive appropriate treatment or survivorship care. To better address their needs, we will develop and test a culturally and linguistically tailored navigation program, Patients COUNTS. We will enroll 150 Asian American men and women recently diagnosed with colorectal, liver, or lung cancer. We will work with an Advisory Council comprised of members from the community and healthcare settings to ensure our platform is culturally relevant. Bilingual patient navigators will help patients: obtain appropriate clinical care, assist with logistical needs (e.g., transportation), and provide other support to address emotional, social, and stress-related needs. Patient COUNTS will use a multilingual (English, Chinese, Vietnamese) web-based patient portal to provide access to virtual or in-person patient navigation, cancer information and resources, and to assess patient-reported outcomes.


Background/Study Description. 

Asian Americans are the fastest growing racial group in the U.S. Two-thirds of Asian Americans speak a language other than English at home, and 31% do not speak English very well. Cancer is the most common cause of death for Asian Americans, but many Asian American cancer patients do not receive appropriate treatment or patient-centered survivorship care.

According to the Pew Internet Survey, Asian Americans were the most prolific users of the internet among all racial/ethnic groups, and use continues to increase over time among all sociodemographic groups. The 2016 California Health Interview Survey (adult questionnaire) data for Asian Americans in San Francisco show that 72% of Chinese and 85% of Vietnamese reported using the internet for health or medical information in the past year. In a prior case-control study of breast cancer among Asian Americans in the Bay Area, we found that 84% of breast cancer patients and 80% of controls reported using the internet daily or several times a week, and 66% of patients and 59% of controls reported that they would complete a health survey online. Although internet usage and willingness to complete a health survey online declined with increasing age, the rates were still high at 70% and 45% among those ages 56 and older among breast cancer patients and controls, respectively. In another prior study, we tested the use of an ecological momentary assessment (EMA) approach to collecting survey data from Asian American breast cancer patients and controls using short online surveys administered frequently over time to capture real-time exposure data, limiting issues with recall. This approach involved sending links via text of email to short online surveys on a periodic basis. All (100%) participants in this pilot test reported preferring this mode of research study engagement over traditional epidemiologic data collection approaches via telephone, in-person interviews, or mailed surveys.

Based on the community needs and findings from these surveys and preliminary studies, the Patient COUNTS Study will develop, implement, and evaluate an intervention to improve the quality of cancer care and support among Asian American colorectal, liver or lung cancer patients. Given the teams experience working with the Asian American community over the past 20 years, we expect that uptake and reception of using web-based platforms among Asian American cancer patients will be quite high. Thus, we feel that the time is right to test the feasibility and acceptability of a web-based program, focusing here on Chinese and Vietnamese patients, in addition to English-speaking Asian Americans.

The intervention, Patient COUNTS, is a patient-centered program that utilizes technology to identify newly diagnosed cancer patients, reaches out to them to offer information about cancer care, and, through navigation, helps patients obtain appropriate clinical care, assistance for logistical needs, and support for psychosocial stress. The Patient COUNTS intervention will use on-line communication tools such as a web-based patient portal and video conferencing to provide cancer information and resources, and patient navigation either virtually or in-person for these Asian American cancer patients who speak English, Chinese, or Vietnamese. We will assess the patient’s needs such as knowledge about guideline-based cancer treatment, logistical barriers, and psychosocial stress associated with cancer diagnosis. Either in-person or virtually, depending on the patient’s preference, we will be available to be present at the patient’s clinical visits to provide assistance as needed. We will provide patients access to curated online and community supportive services as needed to address issues raised by the patient. In addition, we will assess the feasibility of using the web-based patient portal to collect patient-generated health data on cancer survivorship outcomes including adherence to treatments, satisfaction with care, and quality of life.

The Patient COUNTS Study leverages the collective and synergistic expertise of a multi-disciplinary team comprising of community-based participatory researchers, clinicians, and cancer epidemiologists with two decades of experience collecting cancer data and conducting interventions with Asian Americans, and strong connections with community-based organizations and patient advocates. This innovative study will culminate in a culturally and linguistically appropriate cancer navigation program with great potential for adaptation and sustainability. The impact of the project on Asian American communities will be to: create a much-needed tool to coordinate medical and non-medical supportive services for Asian American cancer patients; connect them to community supportive services; and in the process of demystifying the treatment of cancer and providing practical solutions to problems associated with a cancer diagnosis, mobilize Asian American communities to confront the stigma and burden of cancer.

Study Sample. We plan to recruit a total of 150 patients through population-based recruitment of Asian Americans newly-diagnosed with colorectal, lung and liver cancer from the Greater Bay Area Cancer Registry (GBACR), a part of the statewide California Cancer Registry and the NCI Surveillance, Epidemiology, and End Results (SEER) Program. Eligible cases are defined as: self-identify as  Asian American; age 21 or older; reside in one of the nine GBACR counties at time of diagnosis and interview; speak and read English, Cantonese, Mandarin, or Vietnamese; has not yet completed treatment (may have begun treatment); and is willing to participate in a study that lasts up to 7 months, in order to complete data collection activities after the 6 months of follow-up. Given the focus of the study on patient navigation through the cancer treatment phase, we will focus on patients diagnosed with stages I-III cancer. Eligible patients will also need to have access to the internet. Study measures will include shared decision-making, provider-recommended treatments, treatment status (initiation, adherence), reasons for discontinuing treatment, satisfaction with care, and health-related quality of life (including cancer specific concerns and side-effects). In addition, sociodemographic data on participants will be collected.

Why seeking support for an online engagement platform that will help enroll diverse study participants.

For this study, we would like to create a platform that will operate as a secured cloud-based system and will be HIPAA compliant. Participants will register with name, email and/or cellular telephone number, and will then be identified within the system by a unique Study ID number. There will be separate portals for each cancer site so that content can be tailored to the specific cancer site. We will develop the site in English, Chinese, and Vietnamese. Prior to implementation of the Patient COUNTS intervention, we will conduct usability testing of the online portal with members of our Advisory Committee. We will aim for a literacy level of 8th grade in all languages. The core content will be the same for all languages, but we will culturally target each language group by adapting graphics, examples, idioms, tone, and other relevant communication characteristics. Since English speaking Asian Americans can comprise over 30 different national origin groups, the amount of targeting will have to be limited to commonly shared elements. We will work with our diverse Advisory Council to delineate these elements.

We envision an online portal that will include the following features/capabilities: multilingual content (English, Chinese, Vietnamese); electronic consenting; self-administered brief surveys (15 minutes each) at baseline (enrollment), 3 months, and 6 months [topics will include treatment, shared decision making; health-related quality of life]; personalized report/feedback from surveys; reports to navigators; cancer and survivorship information; and links to a curated list of credible resources, including local, community-based ones.

Through our Advisory Council and using two decades of experience in conducting community-engaged research and patient-centered research with Asian American communities, we will identify the key issues related to cancer care for Asian Americans and approaches to provide assistance for those issues in order to create an intervention that is culturally, linguistically, and societally appropriate. Because of the stakeholder-driven approach, the possibility for sustainability is also higher, particularly as we will interact with the San Francisco Cancer Initiative (sfcancer.org), an innovative communitywide effort to reduce the effect of cancer and cancer disparities in the city and county of San Francisco.

The Patient COUNTS Study has been selected for funding from the Bristol Meyers Squibb Foundation with support for 3 years, with a study start date of July 1, 2018. Per the study timeline, we have 18 months to develop and test the online portal, and will implement the online navigation intervention and evaluation in the subsequent 18 months. Upon completion of the funded study, we expect the technological infrastructure to remain. This includes the web portal and any educational materials developed for the project. Other elements, particularly the multi-lingual aspect and the involvement of the navigator, will need support to be maintained. We anticipate that SF CAN will help with this. We will also work with healthcare systems to identify the possibility of support. In addition, we will seek to pursue the model established by the California Smokers’ Quitline, which is available in multiple languages and originally supported by research funding, but is now supported by a variety of funders including the California Department of Public Health, Centers for Disease Control and Prevention, and Centers for Medicare & Medicaid Services.

Commenting is closed.

Computerized Assessment of Mental Status (CAMS): Using remote assessment to make mental health resources more accessible to underserved populations

Primary Author: Josh Woolley
Proposal Status: 

Computerized Assessment of Mental Status (CAMS): Using remote assessment to make mental health resources more accessible to underserved populations

The Problem

Every year, one in five adults in the U.S. experiences mental illness and over $190 billion in earnings are lost due to the disabling effects of serious mental illness. Members of racial and ethnic minorities face an even greater burden: they are less likely to have access to mental health services, more likely to use emergency rooms for their mental health care, and more likely to receive lower quality care. The overwhelming personal, social, and economic costs associated with mental illness, particularly in underserved communities, call for innovative approaches that address this critical gap in access. Remote assessment of mental health has the potential to transform mental health care delivery, but lack of robust assessment tools presents a major challenge to implementing scalable, cost-effective solutions.

The Solution

When a person seeks mental health care, the first thing clinicians do is a mental health status interview. Throughout this interview, the clinician looks for signs of mental health or illness by observing their behavior: the language they use, the quality of their voice, and how they move their face and body. Unfortunately, these mental health assessments are 1) expensive in terms of training and administration time, and 2) subjective, meaning that conclusions can vary by clinician and are vulnerable to implicit bias. To address these challenges, we have developed Computerized Assessment of Mental Status (CAMS), an easy-to-use, interactive, cloud-based application that extracts information about people’s behavior from video data in order to objectively assess their mental health status. CAMS has the potential to improve accessibility, precision, and cost-effectiveness of mental health care delivery, whether used for connecting first-time patients to the mental health resources they need, or monitoring people already in treatment.   

How it works

In CAMS, participants interact with a virtual assistant, responding to a series of questions and stimuli similar to what is used during in-person mental health assessments (Fig. 1). From these videos of rich social behavior, we extract three types of data: 1) natural language (what the participant says), 2) vocal signals (how they say it), and 3) visual signals (how they move their face and body). Together, these data provide information about a participant’s emotional state and thought process, providing a snapshot of their mental health. When compared to normed data matched on demographic variables, this snapshot can indicate mental health problems and the need for treatment. The more data we have to compare participants’ results to, the more accurate CAMS will be. To ensure that we are building a platform that will serve diverse communities it is critical that data from those populations are adequately represented in the CAMS data.  

 Fig. 1

Fig. 1. Data collection using CAMS. A virtual assistant guides the participant through a series of tasks designed to capture clinically relevant behavior. For example, participants are asked about the last time they felt really happy and what they are most worried about. Participants also watch a series of brief, emotionally evocative videos and answer questions about the videos as shown above. Throughout CAMS, video data of the participant is recorded using a phone’s built-in camera. 

The current proposal

Previous efforts to generalize mental health research to diverse communities, especially research using technology, have been largely ineffective due to lack of diverse populations used in the original research. By combining CAMS with the capabilities of the Eureka platform, our goal is to create a tool that can improve access and cost-effectiveness of mental health care for underserved communities. Enrolling a large number of people who are diverse with regards to race, ethnicity, SES, and age, is a priority for three reasons. First, the proposed project will provide a critical first test of the usability of CAMS in diverse populations, enabling us to identify ways CAMS can best serve a wide variety of communities. Second, the project will yield a large dataset that allows us to examine how behavior covaries with symptoms of mental illness and will be the basis for scientific publications that will have immediate impact on the field of mental health. Third, in the long term, the data we will collect in this project will be used in machine learning approaches to ensure that CAMS will be able to accurately assess the mental health status of people from diverse communities.  

To meet these goals, we propose to partner with community-based organizations and leverage the Eureka platform to gather video data via smartphones from a large diverse sample (N=2000) of adults using CAMS. Given the large target sample, we intend to recruit outside UCSF patient populations. In this entirely remote study, we would use the Eureka platform for online consenting, remote administration of mental health symptom self-report scales, and remote video data collection. There will be two assessment points at least six months apart during which self-reported symptoms (e.g. depression, psychosis) will be assessed and responses to CAMS will be video recorded. This repeated measures design will allow us to parse between-person and within-person variability in symptoms of mental illness and behavioral responses.  On the backend, we will use our suite of behavioral analysis tools (see Fig. 2) to identify behaviors that significantly relate to self-reported mental health symptoms and establish how these relationships may differ between diverse populations.  In the short term, these data will improve our understanding of how emotional and cognitive behavior relate to current and future symptoms of mental illness, and in the long term, will allow us to improve CAMS’ ability to bring much-needed mental health resources to diverse communities.  At this time, we will focus on English-speaking participants, but we are currently planning a Spanish language version of CAMS. 

 Fig. 2

Fig. 2.  Data extracted by CAMS. We analyze three types of data from participant videos to create a snapshot of mental health status.

Our team is led by Josh Woolley, a psychiatrist and Assistant Professor with extensive experience assessing social and emotional behavior in people with mental illness and designing and conducting clinical trials. He also has experience remotely recruiting participants with mental illness for online studies. Dr. Woolley has salary support through a Career Development Award and project funding through 2020. Dr. Bradley is a psychiatrist and VA Research Fellow with experience running clinical trials and recruiting participants with psychosis both within UCSF and across the Bay Area community. Dr. Anderson is a postdoctoral fellow in the UCSF department of psychiatry, and is an expert on the assessment of emotions. He has previously partnered with Bay Area organizations that make outdoors experiences more accessible to underserved communities to study how nature can improve the mental health of at-risk youth. Together, our team has salary support and grant funding to cover participant compensation, project coordination, and cloud-based data storage through December of 2020. We also re-submitted a National Science Foundation (NSF) grant, which received positive reviews, that would potentially fund CAMS for the next 5 years.  

Commenting is closed.

The Talking About Prostate Cancer (TAP) Study

Proposal Status: 

Research questions

Approximately 1 in 3 of prostate cancer diagnoses are classified as “low risk” and “very low risk” for disease progression and mortality. Active surveillance, that is, closely monitoring the course of disease, is a recommended management option for all men with very low risk and most men with low risk cancer. In the U.S., more than 100,000 men a year are estimated to be candidates for active surveillance, but only 40% of eligible men receive active surveillance. Despite the fact that prostate cancer is the most commonly diagnosed cancer in men among all major racial/ethnic groups, there is very little known about the determinants of active surveillance and outcomes across racial/ethnic groups.

The research questions for this study are:

1)    What are provider experiences with and perceptions of racial/ethnic differences in patients’ preferences regarding active surveillance?

2)    What are patient perspectives and ethnic/cultural/psychosocial beliefs regarding active surveillance?

3)    What is the influence of patient and contextual (family, social networks, institutional/provider, neighborhood) factors on use of active surveillance?

4)    What are patient-reported outcomes (PROs), including quality of life and physical, physiological, and psychosocial well-being, at various time points after prostate cancer diagnosis?

To address these questions, the Talking About Prostate Cancer (TAP) study will establish a diverse population-based cohort of low risk prostate cancer patients that can be followed for future research inquiries, including examination of disease progression.This study, conducted within a range of medical care settings, will enable us to understand the factors that drive differences in active surveillance referral and utilization. In identifying vulnerable sub-populations, study results will inform culturally-targeted clinic-level policies and practices regarding patient communication and counseling, and ultimately ensuring that all men, regardless of race/ethnicity or socioeconomic status (SES), have the opportunity to be fully informed about their treatment options and experience optimal wellness as a survivor.

An online engagement and data collection platform would allow this study to recruit and retain the diverse participants that are needed to answer the above research questions. Making data collection more efficient, streamlined, and culturally relevant will promote engagement from participants who are typically underrepresented in research projects. Finally, an online platform would facilitate the development of a diverse population-based cohort for future research studies.

The impact of the project on minority communities will be to: understand the unique factors that affect decision-making about treating prostate cancer; inform culturally-targeted clinic-level policies and practices directed towards improving patient communication and counseling; and ultimately, to support all men diagnosed with prostate cancer to make decisions about their treatment that will reflect the same positive outcomes across all racial/ethnic groups.

Study sample

This study will include a survey component among both prostate cancer patients and physicians in the Bay Area. We propose to use the Eureka platform only for the patient component of this study, thus, only the methods pertaining to patient participants are described here. Eligible patients will be identified through the Greater Bay Area Cancer Registry (GBACR), a part of the statewide California Cancer Registry and the NCI Surveillance, Epidemiology, End Results (SEER) Program since 1973. Using an early case ascertainment method to identify cases within 6-9 months after diagnosis, eligible patients are those newly-diagnosed with very low risk or low risk first primary invasive prostate cancer, ages 40-79 years and residing in one of the nine Greater Bay Area counties at diagnosis. This age range was selected because it represents 95% of all cases, and treatment decisions are less confounded by comorbidities and life expectancies. We will recruit all non-White ethnic groups and a 20% sample of NH Whites. Of approximately 4,700 cases of invasive prostate cancer reported each year in the catchment region, more than 40% (N approximately 1,900) have very low or low risk disease. These patients include both UCSF patients and non-UCSF patients. We plan to recruit patients who speak English, Spanish, Chinese (Mandarin and Cantonese), and Tagalog.


The main survey constructs are listed in the Table. Tumor characteristics will be ascertained from the GBACR. Most domains will be based on established items, adapted accordingly based on a qualitative phase of the study, which will inform the survey development.



Table. TAP Study patient survey constructs

Independent variables

Outcomes – dependent variables

  • Tumor characteristics
  • Individual risk factors
  • Demographic information
  • Social relationships
  • Social context
  • Institutional context
  • Decisional   & psychological factors
  • Treatment - active surveillance, definitive treatment   (radiation, radical prostatectomy)
  • Patient-reported outcomes
  • Prostate-specific quality of life and symptoms
  • Disease progression
  • Recurrence


We will conduct a baseline survey within 2-3 months of diagnosis when the men are making their decision regarding their initial treatment. Follow-up surveys will be administered at 12- and 24-months after the baseline survey (approximately 15- and 27-months after diagnosis), selected to capture relevant clinical events in the trajectory of treatment and surveillance, such as  PSA measurement at 6 months and biopsy at 12 months following diagnosis, and to capture changes in PROs.

We currently have a study website available in 3 languages (English, Spanish, Chinese) for patient recruitment (tapstudy.ucsf.edu). The Eureka platform would be an ideal solution for tailoring our website with culturally-relevant content that would encourage participation, easily incorporate electronic consent for this minimal-risk protocol, and provide a stable self-administered survey platform in 4 languages (English, Chinese, Spanish, Tagalog). The Eureka platform would also enable us to offer links to suveys via computers or apps and could be programmed to notify participants when surveys are ready and notify study staff of important data collection issues, completion of surveys, and non-response flags. Simple, tested, stable platforms for this type of research are critical to engaging diverse populations and retaining their participation in the future.


This research will be led by a multi-disciplinary team of collaborators with a productive history of research in prostate cancer, especially focused on disparities. The Principal Investigator, Dr. Scarlett Lin Gomez, Professor in the Department of Epidemiology and Biostatistics (DEB) and Member of the HDFCCC, is a cancer epidemiologist at UCSF with experience in disparities research focusing on multi-dimensional social and cultural determinants of health. Dr. Iona Cheng, Associate Professor in DEB and Member of the HDFCCC, is a molecular epidemiologist whose research focuses on understanding the role of genetic, molecular, lifestyle, and neighborhood factors in relation to cancer risk and outcomes, with much of her research focused on prostate cancer. Dr. Shariff-Marco, Associate Professor in DEB and Member of the HDFCCC, is trained in social and behavioral sciences and conducts epidemiologic and mixed methods research aimed at addressing the role of social determinants of health, including neighborhood determinants, as it relates to cancer disparities in racial/ethnic groups. Dr. Janet Shim is Professor in the Department of Social and Behavioral Sciences at UCSF, and brings expertise in sociology, psychology, qualitative and mixed methods research. Dr. Daphne Lichtensztajn is an epidemiologist with M.D. training, and is well-versed in cancer registry data, particularly clinical and diagnostic data on prostate cancer.  Additional study staff at UCSF include Mindy DeRouen, Laura Allen, Debora Oh, and Mei Chin Kuo.

Co-Investigators include urologic oncologists, Drs. James Brooks, Benjamin Chung, and John Leppert, from Stanford School of Medicine, and Drs. Peter Carroll and Matthew Cooperberg from UCSF; Dr. Robert Haile from Cedars-Sinai Medical Center; Weiva Sieh from Mt. Sinai; Qian Lu from MD Anderson; and Dominick Frosch from Palo Alto Medical Foundation Research Institute.

We have assembled a racially/ethnically-diverse 4-member patient advisory group to help with input on our survey measures, recruitment plans and website design. We will work with HDFCCC to engage with community partners to inform communities about the research, encourage participation, and distribute findings that could impact men’s experience of prostate cancer in the future (e.g., information sessions tailored to issues learned from the results of this study). 


This study is funded through the National Cancer Institute (R01CA211141) from August 2017-July 2022. The direct cost budget per year is about $500,000 (minus a 17% budget reduction applied by the NCI). The timing for the e-cohort initiative fits in well with our study as we are beginning the qualitative phase of the study and will begin the patient cohort recruitment in early 2019. Per our timeline, we will begin developing the survey for the patient cohort in upcoming months.

Commenting is closed.

Asian Pacific Islander And Cardiovascular Disease Outcomes: A Prospective Study (PANDA Study)

Primary Author: Priscilla Hsue
Proposal Status: 

Asian Americans are among the fastest growing ethnic groups in the United States, projected to comprise nearly 40 million individuals by 20601 in six main subgroups: Chinese, Filipino, Japanese, Korean, Vietnamese, and Indian (U.S. Census Bureau 2015).1 The San Francisco Bay Area has one of the largest and most diverse Asian populations in America, approaching 2 million individuals in its five core counties (San Francisco, San Mateo, Santa Clara, Alameda, and Contra Costa). Individuals age 65 and older are projected to compose 30% of the growing Asian American community in Santa Clara County by 2060—the highest proportion of seniors in any ethnic category—indicating an urgent need to understand and improve cardiovascular health in this population and each of its subgroups.2

The cardiovascular health of Asian Americans has been less thoroughly investigated than that of other ethnic groups3, but observational studies indicate that rates of cardiovascular diseases (CVD) vary considerably between each subgroup of national origin.4 Prior studies show that Asian Americans exhibit elevated rates of type II diabetes and that Korean-, Japanese-, and Filipino-Americans are at especially high risk, with local diabetes prevalence of 16%, 13%, and 13%, respectively.2, 4 Incidence of diabetes and metabolic syndrome5 increases at lower body mass index (BMI) in Asian Americans than in other ethnic groups, causing an observed diabetes prevalence that is 60% higher than non-Hispanic whites after adjustment for BMI.6 Dyslipidemia, a major risk factor for heart attack or stroke, occurs at higher rates among Asian Americans in Northern California, varying considerably between each subgroup and likely exacerbated by lower rates of treatment than among non-Hispanic whites.7, 8 Prediction of cardiovascular disease risk among Asian Americans is notably less accurate, since the Framingham Risk Score and other risk calculators may poorly model disease incidence and therefore require ethnic-specific refinements to improve applicability to this population and its subgroups.3

Several trends have highlighted the critical need for a better understanding of the mechanisms underlying CVD risk in this population. A recent study in Los Angeles County found that rates of hypertension among Asian Americans increased by 18% between 2005 and 2015 and noted an especially high prevalence among Filipinos (32.7%) and Vietnamese (35.1%).9 Diabetes prevalence has also risen, especially among Filipinos, and presents at lower BMI than non-Hispanic whites.10 Although subgroup-specific data is limited, studies of total Asian Americans have shown that proportionate mortality for many cardiovascular diseases is elevated and rates of health improvement are slower than among non-Hispanic whites.11

In order to understand these divergences in cardiovascular risk, we propose a prospective cohort study that will evaluate the underlying mechanisms of elevated CVD in Asian Americans. The purpose of this proposal is to initiate an internet-enhanced research project using the Eureka Mobile Health platform at Zuckerberg San Francisco General Hospital (ZSFG) and UCSF in order to build the foundation of our cohort and obtain critical preliminary data for NIH grant proposals along with data to advocate for possible donor/philanthropic support in the near future. Our group will adapt the well-established infrastructure that allows us to undertake cardiovascular research within the diverse HIV/AIDS community at ZSFG to study the unique mechanisms underlying CVD in the Asian American population with the ultimate goal of improving cardiovascular health. 

Study Design: Initial Cohort of Chinese- and Filipino-Americans in San Francisco

We plan to follow a model similar to the Mediators of Atherosclerosis in South Asians Living in America (MASALA) Study at UCSF, which is an ongoing prospective cohort study of cardiovascular health specifically among Indian- and Pakistani-Americans.12 We will leverage existing research infrastructure established by Dr. Priscilla Hsue at Zuckerberg San Francisco General, which she uses to conduct many prospective studies and clinical trials in individuals with HIV. This project will be covered initially using Dr. Hsue’s discretionary funds for preliminary data in order to demonstrate feasibility of recruitment and study design. After completing this initial study, we plan to apply for NIH grants to support a larger cohort study utilizing the same infrastructure provided by Eureka Mobile Health platform.

We will begin with an initial cohort of 50 Chinese-Americans and 50 Filipino-Americans recruited through UCSF, SFGH, and local community partners such as North East Medical Services (NEMS), the Chinatown Public Health Clinic, the Asian Health Institute, and the Asian American Research Center on Health. Potential participants will be screened according to 1) Chinese or Filipino ancestry, defined by ≥3 grandparents born in China/Taiwan or the Philippines, respectively; 2) age between 40 and 79 years; 3) ability to speak and/or read English, Cantonese, Mandarin, or Tagalog. Individuals will be excluded from our study according to the same criteria used in the Multi-Ethnic Study of Atherosclerosis (MESA) and MASALA studies12; namely, we will not enroll those with prior history of major adverse cardiovascular events, ongoing cancer diagnosis, life expectancy under 5 years due to any illness, impaired cognitive capacity, or plans to leave the study region.13

After enrollment, our study team will use the Eureka Mobile Health platform to administer a detailed questionnaire gathering information about dietary habits, lifestyle factors, medical history, and socioeconomic circumstances for each participant. Given the unique challenges faced by our population of interest, we will also assess culturally relevant topics like primary language, country/province of origin, timeline of residence in the United States, use of traditional medicine, effects of discrimination,14, 15 and other measures of acculturation that are known to affect health outcomes in ethnic minority populations.16 A baseline visit at ZSFG will include vitals and anthropometric measurements. We will also draw and store blood from participants for future testing of genomic, metabolomic, proteomic, and inflammatory markers.

Individuals will be recruited to use the KardiaMobile home EKG monitor, which has been shown to accurately detect atrial fibrillation burden in recent studies.17 These participants will also receive home monitoring devices for blood pressure and Ziopatch monitoring.  All participants will use the monitoring devices for 6 months. We will link output data from each of these mobile devices with the questionnaire data mentioned above using the Eureka Mobile Health platform. Previous studies have shown that usage of home monitoring or smartphone engagement devices positively influences rates of diagnosis18-20 and improves treatment compliance, healthy behavioral modifications, and utilization of healthcare resources.21-23 Interventions that increase access, diagnosis, and treatment are especially important in the Asian American population, since previous studies have shown reduced access to healthcare within some Asian subgroups.24, 25

Our primary goal is to provide better insight into risk factors and develop interventional modalities for improving Asian American cardiovascular health. This initial cohort will also allow us to gather critical preliminary data for a future grant submission to support a larger cohort study. With expanded funding, we hope to assess lipids, inflammatory markers, and metabolic measurements alongside genetic profiling, proteomics, and other newer markers of cardiovascular health such as clonal hematopoiesis of indeterminate potential (CHIP). In order to probe the underlying mechanism of CVD in the Asian population, we plan to evaluate coronary artery calcium and plaque burden using CT angiography, along with assessment of carotid intima media thickness to evaluate vascular disease.  We plan to assess the association between clinical characteristics gathered using the Eureka Mobile Health platform and these imaging indices in order to better understand the pathophysiology underlying increased CV risk in Asian American individuals.  As a corollary to this work, we hope to establish a center of cardiovascular excellence for the Asian American population, which can provide clinical care for Asians with underlying CVD.  In addition, this clinic could serve as the impetus for launching implementation studies in the future aimed at risk reduction including smoking cessation, BP control, lipid control, diet and exercise.  Importantly, our research effort and clinical center would also provide significant research and clinical opportunities for trainees in the future. 



1.            Colby SL and Ortman JM. Projections of the size and composition of the US population: 2014 to 2060: Population estimates and projections. 2017.

2.            Santa Clara County Public Health. Asian and Pacific Islander Health Assessment: Executive Summary. 2017.

3.            Palaniappan LP, Araneta MRG, Assimes TL, Barrett-Connor EL, Carnethon MR, Criqui MH, Fung GL, Narayan KV, Patel H and Taylor-Piliae RE. Call to action: cardiovascular disease in Asian Americans: a science advisory from the American Heart Association. Circulation. 2010;122:1242-1252.

4.            Hastings KG, Jose PO, Kapphahn KI, Frank AT, Goldstein BA, Thompson CA, Eggleston K, Cullen MR and Palaniappan LP. Leading Causes of Death among Asian American Subgroups (2003-2011). PLoS One. 2015;10:e0124341.

5.            Palaniappan LP, Wong EC, Shin JJ, Fortmann SP and Lauderdale DS. Asian Americans have greater prevalence of metabolic syndrome despite lower body mass index. International journal of obesity (2005). 2011;35:393-400.

6.            McNeely MJ and Boyko EJ. Type 2 diabetes prevalence in Asian Americans: results of a national health survey. Diabetes Care. 2004;27:66-69.

7.            Zhao B, Jose PO, Pu J, Chung S, Ancheta IB, Fortmann SP and Palaniappan LP. Racial/ethnic differences in hypertension prevalence, treatment, and control for outpatients in northern California 2010-2012. American journal of hypertension. 2015;28:631-9.

8.            Frank AT, Zhao B, Jose PO, Azar KM, Fortmann SP and Palaniappan LP. Racial/ethnic differences in dyslipidemia patterns. Circulation. 2014;129:570-9.

9.            Du Y, Shih M, Lightstone AS and Baldwin S. Hypertension among Asians in Los Angeles County: Findings from a multiyear survey. Preventive medicine reports. 2017;6:302-306.

10.          Shih M, Du Y, Lightstone AS, Simon PA and Wang MC. Stemming the tide: rising diabetes prevalence and ethnic subgroup variation among Asians in Los Angeles County. Preventive medicine. 2014;63:90-5.

11.          Jose PO, Frank AT, Kapphahn KI, Goldstein BA, Eggleston K, Hastings KG, Cullen MR and Palaniappan LP. Cardiovascular disease mortality in Asian Americans. J Am Coll Cardiol. 2014;64:2486-94.

12.          Kanaya AM, Kandula N, Herrington D, Budoff MJ, Hulley S, Vittinghoff E and Liu K. Mediators of Atherosclerosis in South Asians Living in America (MASALA) study: objectives, methods, and cohort description. Clinical cardiology. 2013;36:713-720.

13.          Bild DE, Bluemke DA, Burke GL, Detrano R, Diez Roux AV, Folsom AR, Greenland P, Jacob DR, Jr., Kronmal R, Liu K, Nelson JC, O'Leary D, Saad MF, Shea S, Szklo M and Tracy RP. Multi-Ethnic Study of Atherosclerosis: objectives and design. Am J Epidemiol. 2002;156:871-81.

14.          Gee GC, Spencer MS, Chen J and Takeuchi D. A nationwide study of discrimination and chronic health conditions among Asian Americans. American journal of public health. 2007;97:1275-82.

15.          Chae DH, Takeuchi DT, Barbeau EM, Bennett GG, Lindsey JC, Stoddard AM and Krieger N. Alcohol disorders among Asian Americans: associations with unfair treatment, racial/ethnic discrimination, and ethnic identification (the national Latino and Asian Americans study, 2002-2003). Journal of epidemiology and community health. 2008;62:973-9.

16.          Fox M, Thayer Z and Wadhwa PD. Assessment of acculturation in minority health research. Social science & medicine (1982). 2017;176:123-132.

17.          Bumgarner JM, Lambert CT, Hussein AA, Cantillon DJ, Baranowski B, Wolski K, Lindsay BD, Wazni OM and Tarakji KG. Smartwatch Algorithm for Automated Detection of Atrial Fibrillation. J Am Coll Cardiol. 2018;71:2381-2388.

18.          Steinhubl SR, Waalen J, Edwards AM, Ariniello LM, Mehta RR, Ebner GS, Carter C, Baca-Motes K, Felicione E, Sarich T and Topol EJ. Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation: The mSToPS Randomized Clinical Trial. Jama. 2018;320:146-155.

19.          Halcox JPJ, Wareham K, Cardew A, Gilmore M, Barry JP, Phillips C and Gravenor MB. Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF Study. Circulation. 2017;136:1784-1794.

20.          Chan NY and Choy CC. Screening for atrial fibrillation in 13 122 Hong Kong citizens with smartphone electrocardiogram. Heart. 2017;103:24-31.

21.          Hurling R, Catt M, Boni MD, Fairley BW, Hurst T, Murray P, Richardson A and Sodhi JS. Using internet and mobile phone technology to deliver an automated physical activity program: randomized controlled trial. Journal of medical Internet research. 2007;9:e7.

22.          Kim BH and Glanz K. Text messaging to motivate walking in older African Americans: a randomized controlled trial. American journal of preventive medicine. 2013;44:71-5.

23.          Hartmann-Boyce J, Stead LF, Cahill K and Lancaster T. Efficacy of interventions to combat tobacco addiction: Cochrane update of 2013 reviews. Addiction (Abingdon, England). 2014;109:1414-25.

24.          Ye J, Mack D, Fry-Johnson Y and Parker K. Health care access and utilization among US-born and foreign-born Asian Americans. Journal of immigrant and minority health. 2012;14:731-7.

25.          Chen J, Vargas-Bustamante A and Ortega AN. Health care expenditures among Asian American subgroups. Medical care research and review : MCRR. 2013;70:310-29.

Commenting is closed.

Pilot Test & Feasibility of a Digital Lifestyle Cohort of Diverse Individuals with Cancer

Proposal Status: 

PLAIN LANGUAGE SUMMARY - A common question that people ask after they find out they have cancer is: “What can I do to keep the cancer from spreading or coming back?” Our study aims to find answers for the millions of people worldwide who live with cancer. We will use the Internet to collect information on individual characteristics (such as age, race, where people live, who they live with, education, etc), cancer care and other diseases, and about daily life (for example, what people eat, how much they exercise and sleep, if they use any natural products or supplements or meditate, what their religious beliefs are, etc). If we can enroll a diverse group of people and follow them for several years, we will examine if different lifestyle practices lead to better cancer outcomes or can improve how people feel. To start, we will enroll people with prostate, bladder, and colorectal cancer. We will share what we learn on our website, for participants and the general public. 

RESEARCH QUESTION -  Our goal is to study if diet, exercise, and other lifestyle factors can improve quality-of-life (QOL), prognosis, and overall health of people living with cancer. Given the heterogeneous nature of cancer, we hypothesize that customizing lifestyle recommendations and tools to patients’ cancer site, socio-demographics, culture, treatments, tumor features, habits, and preferences will maximize uptake and benefit. To support this goal, we are building a novel technology-enhanced cohort that will collect detailed data on diet, exercise, sedentary habits, complementary alternative medicine practices, spiritual beliefs, sleep quality, socio-demographics, immigration history, co-morbidities, and other factors. We will follow participants for general and cancer-specific QOL and clinical outcomes (e.g., treatment-specific progression, metastasis, death) through long-term periodic medical chart review and National Death Index and cancer registry searches. These rich data will support multiple research studies across a broad range of topics. We will start by pilot testing the feasibility and acceptability of our recruitment methods, study format (digital), survey questions, and request for long-term follow-up among 300 diverse individuals with prostate, bladder, or colorectal cancer. We anticipate making iterative improvements after this pilot phase, and that through collaboration, the cohort will be comprised of sub-cohorts of thousands of individuals with various cancer types in the future.

This study will address two major gaps in the medical literature – the lack of data on lifestyle habits after a cancer diagnosis and its impact on subsequent QOL and clinical outcomes; and the lack of diversity in cohorts that have collected comprehensive lifestyle data. In the US, African Americans (AA) have the highest death rate and shortest survival of any racial and ethnic group for most cancer types. Approximately 190,000 AAs are diagnosed with cancer annually. There are extremely limited data on the impact of lifestyle factors on psychosocial and clinical outcomes in AAs with cancer. Thus, focused study on post-diagnostic lifestyle factors, and its influences on cancer outcomes, in particular among AA’s, is warranted.

This cohort was approved in 2016 to be built by the UCSF Health ePeople team on the Eureka Research Platform (Eureka) (NIH-funded 5U2CEB021881-02). A digital cohort has several potential advantages, such as reduced infrastructure costs and labor. However, a limitation may be the generalizability, due to the “digital divide”- i.e., inequity with regards to access to or use of the Internet and information and communication technology, based on age, education, income, or race. Thus, it is important to pilot test the feasibility and acceptability of this digital cohort in diverse groups, and collect data on barriers and facilitators to participation, for iterative improvements. Thus, we propose to address the following questions:

1. What is the feasibility and acceptability of a digital lifestyle cohort in adults with prostate, bladder, or colorectal cancer using online (e.g., email blasts, website ads, etc) or print-based (e.g., mass mailings using cancer registry or APEX queries, brochures in clinics, etc) recruitment methods? We will analyze response, enrollment, and survey completion rates overall and by socio-demographic factors. We will query participants on ways to improve the online study, assess the ability to obtain electronic vs. paper medical records, and assess feasibility of consent for long-term follow-up.

2. What are the best ways to engage and enroll older adults and under-represented groups into a digital cohort? We will develop and test methods for outreach to and enrollment of older adults and diverse populations, including AA’s. Based on experience, we anticipate the potential need for in-person assistance to engage and educate some groups about clinical research and the study, prior to enrollment, and for technology support. With this proposal, we welcome the opportunity to work with experts on community outreach and enrollment of under-represented populations.

STUDY SAMPLEWe aim to enroll ~200 men with prostate, and 50 individuals with bladder and 50 with colorectal cancer (Ntotal~300). Individuals will be over 18, need to have access to the Internet, and consent to medical record follow-up, and completion of online surveys (see Table 1). We welcome the opportunity to translate our materials into other languages, including Spanish, Chinese, Tagalog, and Russian. This study will be open to individuals managed anywhere, including UCSF. For the initial pilot, we will not restrict enrollment based on disease status or clinical criteria, and will collect data on such clinical parameters for future planning.

We also welcome the opportunity to collaborate with community partners and other researchers to add other measures that gather data on individual, structural, and environmental barriers to physical activity and healthy nutrition. For example, we may add questions about adverse life course events or utilize tools to map out the communities with regards to how conducive they are to support exercise and healthy food choices.

We are initiating the study in the proposed cancer sites, given the public health burden and our team’s experience. Prostate cancer is the 2nd most common cancer in men worldwide. In US men, it is the most commonly diagnosed cancer and second-leading cause of cancer death, with 164,690 new diagnoses and 29,430 deaths estimated to occur in 2018. There are ~2.8 million men living with prostate cancer in the US. AA men experience the highest burden of prostate cancer worldwide, with 74% higher incidence and twice the mortality compared to whites. 140,250 new cases and 50,630 deaths due to colorectal cancer are estimated to occur in 2018. 1.2 million people live with colorectal in the US (the third most common cancer among US cancer survivors). Bladder cancer is the 4th most common cancer in men, and 81,190 new diagnoses and 17,240 bladder cancer deaths will occur in 2018.

Table 1. Proposed Surveys & Source of Surveys to be Administered on Eureka Platform*


Survey Source

Socio-Demographics, Smoking


Medical History, Family History

CaPSURE & Health Professionals Follow-up Study

Diet, Exercise/Sedentary habits

Harvard cohorts and CHARRED



Sleep Quality

Pittsburg Sleep Quality Index 

Memory / Cognition

Nurses’ Health Study

General & Cancer specific QOL

SF-12 & Patient Reported Outcome Measurement Information Systems Depression & Anxiety

Cancer specific QOL & Anxiety

e.g., EPIC-26, QLQ-C30, & MAX-PC

*Each survey will be administered ~annually, though some may be less frequent (e.g., diet asked every 4 years), while others may be more frequent (cancer-specific quality of life, every 6 months). Surveys administration will be staggered such that participants are pinged ~ quarterly.

OUR TEAM - Our team has outstanding experience in recruitment, enrollment, and follow-up of people with cancer, including diverse populations. For each of our initial proposed cancer types, we have an epidemiologist and a clinician co-lead (Drs. June Chan & Peter Carroll, prostate cancer; Drs. Stacey Kenfield & Sima Porten, bladder cancer; Drs. Erin Van Blarigan & Alan Venook, colorectal cancer). We have also engaged leaders in cancer health disparities research, Drs. Rena Pasick and Nynikka Palmer. Drs. Chan, Kenfield, and Van Blarigan are cancer epidemiologists and have led and implemented multiple cohorts and randomized clinical trials of individuals with prostate or colorectal cancer. Drs. Carroll and Venook lead the prostate and gastrointestinal cancer programs (respectively) of the Helen Diller Family Comprehensive Cancer Center (HDFCCC); and each has long-standing experience in clinical trials, patient enrollment, and outcomes research. Dr. Porten specializes in bladder cancer and is the Associate Chair for Diversity & Academic Affairs in the Dept. of Urology. Dr. Pasick has conducted cancer disparities research for ~30 years, including multi-ethnic, multi-lingual studies with AA, Latino, Chinese, Vietnamese, and Filipino adults on cancer screening and genetic counseling for hereditary cancers. Previously, as Director of the UCSF HDFCCC’s Office of Community Engagement, she established a network of 70+ AA churches in four Bay Area counties, leading to changes in church policies and practices related to diet and health. Dr. Nynikka Palmer has a National Cancer Institute (NCI) K01 award to address inequities in quality of care among AAs with prostate cancer, and established and runs a support group for AA men with prostate cancer in Oakland. Drs. Pasick and Palmer co-lead the first of its kind county-wide initiative to eliminate the mortality disparity in prostate cancer among AA men via community-based education and screening and a multiple health system quality collaborative (San Francisco Cancer Initiative, SF CAN). Mr. Ghilamichael Andemeskel is a graduate of the SF BUILD program, former Vice President of the Black Student Union and founder of the first Black Unity Center at San Francisco State University, and is currently an outreach coordinator for Dr. Chan’s clinical studies on prostate cancer. Our team has worked (or is currently working) with the following community leaders: Mr. A. Perkins, former Director of the Alameda County Public Health Dept. and prostate cancer advocate; Mr. M. Shaw, Director of the Alameda Health Department's Urban Male Health Initiative; Mr. S. Rosenfeld, Marin County prostate cancer support group leader; and Drs. B. Breyer and S. Blashko, clinical urology leaders of Zuckerberg San Francisco General Hospital and Highland Hospital, Oakland, respectively. Additionally, thru Mr. Andemeskel’s efforts, our team has recently begun to engage with multiple community partners, including SF CAN Wellness Warriors, American Cancer Society, San Francisco National Association for the Advancement of Colored People, and multiple community organizations focused on addressing systemic issues facing African American communities in Oakland and San Francisco.

FUTURE PLANS - This initial pilot will be supported via philanthropic funds of Drs. Carroll & Chan in the Dept. of Urology. We are committed to launching and sustaining the cohort through 2020 and beyond, by applying for grants from NCI and Dept. of Defense. Build-out of the cohort will be guided by the pilot, though we anticipate expanding the scope of the study through mailings via state cancer registries, collaboration with international health-focused philanthropic organizations such as Movember and Prostate Cancer Foundation (whose leaders have already expressed support for digital advertising), and outreach to community networks.

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The Saving Our Ladies from Early Births and Reducing Stress (SOLARS) Cohort Study: Leveraging the Eureka Platform

Proposal Status: 


Summary:  Preterm birth is leading cause of death and disability in infants and children. Black and Latina women are at increased risk for preterm delivery compared to White women. While psychological stress has been shown to be associated with preterm birth, the mechanisms through which psychological stress causes preterm birth are unclear. The Saving Our Ladies from Early Births and Reducing Stress (SOLARS) study focuses on expanding our understanding of the relationship between psychological stress and preterm birth in 1,000 Black and Latina women in San Francisco, Oakland, and Fresno. The study has two primary research questions that examine the impact of individual, molecular, and social factors on psychological stress and preterm birth. The first question focuses on understanding patterns in all women in the study and the second focuses specifically on understanding why some women with high levels of psychological stress deliver preterm and some do not.

Introduction: More than one in ten Black and Latina pregnant women will have an infant born prematurely – that is, before 37 completed weeks of gestation. Infants born prematurely are at substantially increased risk for death within the first year of life and are more likely to have short- and long-term developmental and health challenges including, for example, intellectual delay, attention deficit hyperactivity disorder (ADHD), and asthma.

Rates of preterm birth in Black and Latina women have consistently been found to be 20 to 100% higher than in White women. Some data suggests that higher rates of preterm birth in women of color may be due to higher levels of stress – including higher levels of acute stress, accumulated lifetime exposure to stress, racism associated stress, and post-traumatic stress. Support for this explanation is driven by consistent findings showing an association between preterm birth and these different types of stress as measured by surveys, questionnaires and interviews.

Although studies have demonstrated specific links between multiple types of stress and preterm birth in women of color, what underlies this relationship remains unclear from a mechanistic point of view. For example, although cortisol is a key measure of biological stress, studies that have looked at the relationship between cortisol and preterm birth in women with both high and low levels of psychological stress have not observed a consistent link with preterm birth. The Saving Our Ladies from Early Births and Reducing Stress (SOLARS) study, funded by the UCSF California Preterm Birth initiative, is a prospective cohort study focused on expanding our understanding of the relationship between psychological stress, molecular signaling, and preterm birth in Black and Latina women in San Francisco, Oakland and Fresno.

Research questions: The SOLARS study focuses on two primary research aims including: 1) Evaluating whether individual, molecular, and social factors moderate or mediate the relationship between psychological stress and preterm birth in Black and Latina women (Aim 1); And, 2) Exploring the interrelationships of demographic, psychosocial, obstetric, and molecular risk and protective factors with preterm birth in Black and Latina women with high levels of psychological stress (Aim 2). Within Aim 1 we test three hypotheses: 1a, tests the hypotheses that social and individual risk and protective factors moderate the relationship between psychological stress and PTB;  Aim 1b, tests the hypothesis that individually-measured psychological resilience moderates the relationship between psychological stress and preterm birth; Aim 1c tests the hypothesis that molecular factors mediate the relationship between psychological stress and preterm birth. Whereas Aim 1 focuses on hypothesis testing, Aim 2 leverages advanced statistical techniques (i.e. machine learning) to determine whether or not there are factors within or across pregnancy that are associated with or predict  preterm birth in women with high levels of psychological stress. We believe that addressing these aims will lead to novel and actionable information that could eventually be translated into interventions for increasing gestational age and decreasing preterm birth in Black and Latina women in the geographies of focus and more broadly. In addition, we believe these efforts will contribute key data and biological resources for expanded and ongoing studies aimed at improving birth and developmental outcomes for women and children of color.

Addressing the SOLARS research aims requires intense work with participants and study partners throughout pregnancy and afterwards and includes the collection of survey data throughout pregnancy through the first year of life as well as biospecimens and hospital record data. Integration of the SOLARS study into the Eureka platform offers the opportunity to maximize engagement with women and study partners and we believe, could facilitate a more rapid cycling between discovery to interventions. In addition, use of the platform would offer the opportunity for developing nested studies that focus on other technologies including, for example, wearable activity and sleep tracking devices and contraction monitoring devices. In addition, leverage of the platform would eventually allow us to include more study sites across the United States and even worldwide as the effort progresses.

Study Sample: The SOLARS study will enroll 1,000 (500 Black and 500 Latina) women and their infants in San Francisco, Oakland and Fresno. The study pilot which aimed to assess methods for recruitment and retention and the acceptability of methods and measures among participants was conducted in March 2018-August 2018. We expect the full study to launch in the Fall of 2018 with enrollment extending over a three-year period (through 2021) and the full study extending through June 2023. Women are enrolled before 21 completed weeks of gestation at both UCSF and non-UCSF sites in all three geographies. All women included are self-identified as Black or Latina, are 18 years or older, are English and/or Spanish speaking, live or work full-time in one of the three geographies, and are expected to express a willingness to participate in all survey, biospecimen, and medical record review components of the study at all study time points in the prenatal period until the infant is one year of age. Women are not eligible for the study if they have active bipolar disorder or psychosis, if they are pregnant with a multiple gestation, if they are serving as birth surrogates, or if their pregnancy resulted from assisted reproductive technology.

Measurements: Participants complete online surveys and contribute biospecimens at up to 4 time points during pregnancy (11-14, 15-20, 24-26, 30-32). After birth, women complete surveys at 5-6 weeks, 6-months, and 12-months postpartum. Postpartum biospecimen collection is done at 5-6 weeks and 6-months. Hospital record review is done for all women from 1-year prior to pregnancy through 1-year after birth and for infants from birth through 12-months postpartum. Survey items focus on multiple components of psychological stress (e.g. childhood events, chronic strain, racism/discrimination), neighborhood and sociocultural factors (e.g. available healthcare, crime, poverty), individual factors (e.g. age, clinical factors, substance use/abuse), resiliency (e.g. mastery, self-efficacy, positive affect), and the current health status of the woman and infant (e.g. recent maternal and/or infant diagnoses). Required maternal biospecimen collection across time points include blood, urine and saliva. Molecular measures in biospecimens across time points include measures of the direct molecular stress response (cortisol and corticotropin-releasing hormone), measures of the immune response (cytokines, chemokines) and measures of placental health and growth (e.g. pregnancy-associated-protein-plasma protein A, nerve growth factor). We will also measure telomere length and target genetic markers (SNPs) with known associations to stress and/or preterm birth as well as lipids, proteins, metabolites and epigenetic signals in order to explore whether these pathways yield any useful information related to the link between stress and preterm birth. It is our belief that the Eureka platform would help facilitate all the survey measurement and hospital record review components of the study as well as online enrollment across sites and data visualization. We also believe that the Eureka platform might provide real-time specimen tracking capability across sites and might eventually provide a seamless way to share data with participants and partners.

Team: It is important to note that SOLARS study was designed from a reproductive justice perspective.This study was conceptualized, designed, and executed in a deeply engaged way with women of color serving in key leadership positions throughout the project. Project coordinators, graduate student researchers, and research assistants have been intentionally chosen to maximize the success of recruiting medically underserved women of color. We believe the integrity of the science and the quality of the data and their analyses are impacted by who, how, and why data are being collected.

The SOLARS team includes investigators across several schools and departments at UCSF and also includes investigators at UC Berkeley, UCSD, Stanford University, the University of Iowa, Cincinnati Children’s Hospital, and Fresno State University. The Primary Investigator on the study is Laura Jelliffe-Pawlowski, PhD – Director of Discovery and Precision Health within the UCSF California Preterm Birth Initiative. Dr. Jelliffe-Pawlowski has worked in the field of preterm birth for nearly two decades and is also the Mother of a daughter born preterm. Brittany Chambers, PhD, is one of two Co-Primary Investigators on the study and is an Assistant Professor in Epidemiology & Biostatistics at UCSF. Dr. Chambers’ research focuses on understanding the links between racism and preterm birth. Anu Gomez, PhD, is the other Co-Primary Investigator on the study and is an Assistant Professor in Sociology in the UC Berkeley School of Sociology. Dr. Gomez’ research focuses on understanding women’s contraception choices and on better understanding the reproductive experiences of Latina women.

Co-Investigators across UCSF include Dr. Larry Rand who is also the Primary Investigator of the UCSF California Preterm Birth Initiative, Drs. Monica McLemore, Elena Flowers, Kord Korber and Anatol Sucher in the School Nursing, Drs. Elizabeth Rogers and Matt Pantell in the Department of Pediatrics, Drs. Nancy Adler, Elissa Epel, and Jen Felder in the Department of Psychiatry, Dr. Nisha Parikh in the Department of Cardiology, and Dr. Charles McCulloch in the Department of Epidemiology & Biostatistics. This UCSF team works with closely with co-investigators at other institutions (Mike Snyder, PhD, at Stanford University, Christina Chambers, PhD at UCSD, Kelli Ryckman, PhD at the University of Iowa, Lou Muglia, MD, PhD, at Cincinnati Children’s Hospital, and Tania Pacheco, PhD at Fresno  State University). This transdisciplinary team also partners closely with women with lived experience and with community based organizations and clinics in San Francisco, Oakland and Fresno. The SOLARS team has a long-standing and ongoing relationship with the Community Advisory Board (CAB) of the California Preterm Birth Initiative. This CAB is composed mostly of Black and Latina women from San Francisco, Oakland and Fresno. All of the women on the CAB have either had a child with preterm birth or work closely with women at increased risk for preterm birth. These women have provided key input and suggestions at all phases of the SOLARS study and it is anticipated that they will remain involved as the study progresses. The study team also works closely with several organizations that serve low income women in one or more of the geographies of focus (e.g. Black Infant Health, La Clinica De La Raza). These partners assist with recruitment of women through their programs and provide feedback on study materials and methods.

Funding and Sustainability: The SOLARS study is funded by the UCSF California Preterm Birth Initiative. The UCSF Preterm Birth Initiative was funded by at $100 million gift from Marc and Lynn Benioff and Bill and Melinda Gates in 2015 and includes both a California arm and an East Africa arm. The California arm of the initiative will provide funding to the SOLARS project through fiscal year 2022-2023. Investigators are also seeking funding through the NIH and other entities to augment initiative costs and expand on the established research goals and infrastructure. It is also notable that the Eureka platform might eventually allow us to include women in Africa and other global locations in the study.


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Improving access to chronic urticaria care by creating an online engagement platform accessible to diverse patient populations

Primary Author: Iris Otani
Proposal Status: 


To evaluate whether an online engagement platform for chronic hives / urticaria (CU) accessible to diverse patient populations and focused on symptom tracking, assessment of psychiatric comorbidities, and clinician feedback improves immediate and long-term CU symptom control.

Background and Problem

Urticaria or hives is a common affliction that affects 25% of the general population. A subset of patients with urticaria develop chronic urticaria (CU), which has an estimated prevalence of 0.5-5% and incidence of 1.4% per year in the general population and is characterized by recurrent pruritic hives and/or painful angioedema for six weeks or more. The biology of CU is not well-understood, although a subset of patients may have an autoimmune basis to their CU.  

CU has a significant detrimental impact on quality of life as CU disrupts patients’ activities of daily living, work, and sleep. Indeed, one-third to one-half of CU patients experience depression and anxiety, and the health status of CU patients is comparable to coronary artery disease patients awaiting bypass surgery. Many patients do not receive adequate psychosocial care.

Achieving symptom control during the first year after CU onset is recommended, as data suggest that early symptom control is associated with improved long-term symptom control. Unfortunately, despite the fact that there are effective CU therapies available, achieving early symptom control remains one of the biggest challenges in CU.

Cultural and linguistic barriers prevent patients from receiving the frequent clinician feedback needed for symptom assessment and treatment. Another significant barrier to achieving early symptom control is inadequate access to allergists. Patients report 3-6 month wait times to be seen at allergy clinics (UCSF, other academic centers, and private practices). This wait period encroaches on that early time period when achieving symptom control is critical. After patients have been seen by an allergist, distance can prevent patients from receiving the frequent follow-up needed for symptom assessment and treatment.

Proposed Solution

An online engagement platform with symptom tracking and clinician feedback would address the major barriers to adequate care – distance, cultural and linguistic barriers, and insufficient access to allergists. It would allow allergists to manage a diverse population of patients remotely and enable early symptom control critical for long-term treatment success. Existing apps created through the American College of Dermatology, Genentech/Novartis, and eResearchTechnology are only available in English and are not adequate for meaningful patient follow-up.

One emphasis will be on creating a platform with a culturally and linguistically appropriate design such that non-English-speaking patients from diverse cultural backgrounds can be included in the study cohort. We will start by conceptualizing the initial platform design with existing symptom and quality-of-life measurement tools that have been translated into Chinese and Spanish and have been validated in Chinese and Latin@ populations. From there, we plan to use semi-structured interviews of chronic hive patients in our clinics (initially English-speaking and Chinese-speaking) to guide platform design so that it is tailored to cultural and linguistic needs. If our initial pilot studies are successful, our plan is to expand the platform to include culturally and linguistically appropriate tools for Spanish-speaking Latin@ patients. In this way, we hope to potentially adapt existing symptom and quality-of-life measurement tools to culturally diverse populations. 

Our proposed platform and studies would assess the cultural appropriateness of smartphone-based health data and best strategies for patient engagement across diverse populations.

A CU cohort lends itself well to this type of platform.

  1. There are well-validated tools to measure symptoms. The Urticaria Activity Score (UAS-7) and Itch Severity Scale (ISS) are recommended for use in routine practice and in clinical trials to measure disease severity. Symptom tracking allows patients to better identify non-allergic triggers and specific physical triggers, which affect 25% of patients with CU.
  2. There are validated quality of life tools such as the Chronic Urticaria Quality of Life Questionnaire (CU-Q2OL) and Dermatology Life Quality Index (DLQI).
  3. CU therapies are known to be effective in up to 97% of patients, and the main difficulty with symptom control is access to care and adequate follow-up. Therefore, an online platform that enables early access and frequent follow-up is primed for success.

Validated CU tools have been translated into multiple languages and studied in diverse populations, which supports the creation of a platform with a culturally and linguistically appropriate design and function.

There are tools that have been translated into Chinese and studied in Chinese populations. There are also tools that we would need to translate and do field testing in our population to make sure they are understandable and reliable. We have outlined these tools below. We would ask for community partner input (patients, allergists, primary care physicians) to determine which tools would be preferred for use in the app. Lulu Tsao, who is fluent in English and Chinese, will conduct semi-structured interviews with Chinese and Chinese-American patients to gauge their interest in an app, how they would want to use an app (symptoms, messaging, photos), and whether they would want recommendations from an allergist via an app.

  1. The UAS has been used in research studies in both mainland China and Taiwan. It was used in a cross-sectional survey of about 3000 patients in tertiary hospitals in different provinces.
  2. The DLQI has also been used for Chinese patients and an official Chinese (traditional and simplified) version is available online. This version was studied among 148 patients with CU in Taiwan and found to have high reliability.
  3. The Urticaria Control Test (UCT) is available in 30 languages and consists of only 4 questions, although the translated versions are not readily available.
  4. The CU-Q20L has not been translated or validated in Chinese populations, and translation and field testing with our population is needed to make sure it is understandable and reliable.

If an initial pilot in a Chinese-speaking population is successful, our plan is to also expand the platform to include Spanish-speaking patients. At that point, similar review of existing symptom and quality of life scoring tools and discussions with the appropriate community partners will be undertaken to determine which tools are most suitable for this patient population. In terms of already validated tools, the UAS and UAS7 were validated by researchers in Spain in a multicenter study of 166 patients and found to have good internal consistency, reliability, and sensitivity to change.

Chinese UAS7

Spanish UAS7


Ideally, the Eureka Research Platform would be used for the following aspects of the online platform. Features within each section are listed in order of highest to lowest priority.

A. Electronic consent
  1. Study enrollment
  2. Medical release form: On enrollment, patients will specify which providers they would like to keep informed about their hive treatment and sign a medical release form to grant these providers HIPAA-compliant access to a report of their work-up and treatment plans.
  3. Omalizumab (advanced CU treatment) consent form: This capability will prevent delays in care that occur when medication orders cannot be processed because patients cannot come to clinic to sign consent.

B. Symptom tracking: As there are pros and cons to each of the tools described, we will work with community partners to determine which tools will be used in the platform.

  1. UAS / UAS-7: Allow patients to track their symptoms daily, or even multiple times a day, a request made by users of current apps.
  2. Record hive triggers: Allow patients to track and identify non-allergic and physical triggers for urticaria.
  3. PHQ-2 / PHQ-9: Use depression screening tools to identify patients who could benefit from timely referral to psychology or psychiatry as appropriate. Up to 50% of patients with CU are affected by depression but many of them do not seek treatment. If possible, collaboration with existing online therapy apps would be ideal.
  4. Quality of life reports: Incorporate CU-specific quality of life surveys (CU-Q2OL, DLQI) to assess CU wellness over time.
  5. Smartphone-based reminders: Patients can opt in for reminders to submit their daily scores and response to medications.

C. Store patient-generated health data

  1. Data storage (photos of hives, photos of medication, pre-populated symptom lists, and speech-text interfaces) that reduces the need for real-time translation would improve patient-provider engagement and facilitate shared decision-making. It would clarify what treatments non-English-speaking patients are using.
  2. Having a report of patient-generated health data that can be recorded by patients from diverse cultural and language backgrounds would allow patients and providers to better engage in meaningful shared decision-making.

D. Facilitate communication between patients and allergists

  1. It would be ideal if allergists could remotely access the patient-reported data for their patients. This would allow patients to share their symptom and quality of life scores and update their allergist about what prescription, over-the-counter, and herbal medications they are taking. The allergist would take this data and recommend medication changes if necessary. A platform that could interface with Epic would streamline provider workflow, but it would be understandable if that feature is not a possibility.
  2. If allergists can’t access the patient-reported data unless the patient comes to clinic, the platform would still be helpful in terms of decreasing cultural and language barriers between the patient and the provider, because the app would store patient-generated health data (symptom-tracking data, medication use data, and possible triggers for the hives) that could be reviewed during the appointment. However, in this case the app would not help in terms of eliminating distance and time barriers for patients.

E. Facilitate data transfer between patients, allergists, and PCP providers

  1. The platform would generate a report of patients' work-up and treatment plans that can be faxed to their primary care providers for the allergy office.
  2. The platform would also serve as an updated physical “medical file” that the patient could show any provider during in-person clinic visits. As such, especially if the platform could interface with Epic, this study would also be an exploration into whether smartphone-based health data owned and carried by patients is indeed an effective way to store health data so that it is accessible by patients and their providers.

F. Linkage to EHR

  1. We could connect treatment response in our cohort to clinical data, such as autoantibody levels, to better understand the biology of CU.

Partnership with community advisors will be integral to the success of our proposed engagement platform for CU patients. As one of the highlights of our proposed platform is that it will be accessible by diverse populations, it is imperative that we work with community partners to gauge their interest in our project and to ask for their input regarding the platform.  

  1. Primary care physicians at UCSF
  2. Primary care physicians in the San Francisco Bay Area
  3. Primary care physicians who work at clinics focused on care for patients of Chinese backgrounds (Chinatown Public Health Center in SFHN, Chinese Hospital, etc.)
  4. Chinese traditional medicine and acupuncture clinics in San Francisco
  5. Local organizations such as Asian Alliance for Health, Asian Health Institute, Chinese Community Health Resource Center, and Southeast Asia Research Institute.
  6. Patients with chronic hives
    1. English-speaking
    2. Chinese-speaking
    3. Spanish-speaking, if initial pilot with Chinese-speaking population is successful
We would like to ask primary care physicians:
  1. What can we do to make this engagement platform useful for your patients and for you?
  2. Do you think that it will be helpful to broaden recruitment to chronic hive patients who are not referred to allergy practices?
  3. What outcome measures would you be interested in knowing?

We would like to ask traditional medicine and acupuncture clinics about their current practices and how they might be integrated into our platform. Patients are increasingly interested in the role of complementary and alternative medicine (CAM) in treating atopic conditions such as hives. It is also important to improve our understanding of how patients, particularly Asian patients, perceive and use CAM. 

Chronic hives may be of particular interest to Asian-American health organizations because chronic hives can be associated with chronic infections, such as H. pylori and hepatitis B and C, which are more prevalent among Asian populations. If of interest to primary care providers, we could discuss integration of outreach and education about these chronic infections in Asian populations with chronic hives.
We would like to ask patients with chronic hives:
  1. What can we do to make this engagement platform useful for you?
  2. Which symptom-tracking and quality-of-life tools would you want in the platform?
  3. We would also discuss any specific culturally important aspects of care that patients would like integrated into an engagement platform.
Study Cohort
The study cohort would consist of patients referred to the UCSF Allergy/Immunology clinic for hives who have smartphones to access the platform. Our goal is to then work with community partners (primary care physicians, patients, community allergists) and offer this app as a means to accessing allergy care for hives with a UCSF Allergy Clinic provider.
Study Plan
Our plan is to use qualitative feedback from current chronic hive patients in our clinic to guide platform design and function. Then, we will perform initial feasibility pilot studies in English-speaking and Chinese-speaking patients. If the initial pilot study is successful and community partners show interest, we can obtain qualitative feedback from current Spanish-speaking Latin@ chronic hive patients to tailor the platform design and function to the Latin@ population and perform a feasibility pilot study with Spanish-speaking patients. Our long-term goal is to perform a randomized clinical trial with a non-intervention group.
Creating the platform:
We will start by conceptualizing the initial platform design with existing symptom and quality-of-life measurement tools that have been translated into Chinese and have been validated in Chinese-speaking populations. From there, we plan to use semi-structured interviews of chronic hive patients in our clinics (initially English-speaking and Chinese-speaking) to guide platform design so that it is tailored to cultural and linguistic needs.
Feasibility pilot study:
After creating the platform, we will do an initial feasibility pilot study where the patients will serve as their own control. We will do two separate feasibility pilot studies, one for English-speaking patients and one for Chinese-speaking patients.
Primary aim: 
  1. Is there a clinically relevant difference at week 8 in the Urticaria Activity Score (UAS7) compared to baseline?

Secondary research aims:

  1. Investigate if there are clinically relevant differences between baseline and week 8 for other measurement outcomes requested by community partners, such as quality of life
  2. Obtain Kaplan-Meier estimates of the distribution of time to first minimum important difference (MID) response in UAS7 (i.e. time to a reduction from baseline in ≥ 10 points) to estimate the median time to MID.
  3. Compare the two language cohorts to identify differences in frequency of using the platform, frequency of messaging, or effect on UAS outcome that are potentially related to language accessibility

We expect to enroll 17 patients to detect a mean change in UAS7 at 8 weeks from baseline of 11 points (standard deviation 9 points) with 90% statistical power. This is based on a paired t-test, alpha of 0.05. A total of 34 patients will be recruited, 17 in each subgroup (English-speaking and Chinese-speaking patients). We would be able to enroll this number of patients within three months given the volume of hive patients we see. The minimal clinically important difference for the UAS7 is 10-11 points, and the standard deviation of the mean UAS7 at baseline in CU studies is 9 points. If we are able to combine the two cohorts, Asian speaking and English speaking, and/or enroll 20 people in each subgroup, we will explore the trajectory over time using a linear mixed-effects regression model.

As stated, if the initial pilot study is successful and community partners show interest, we will obtain qualitative feedback from current Spanish-speaking Latin@ chronic hive patients to tailor the platform design and function to the Latin@ population and perform a feasibility pilot study with Spanish-speaking patients.

Next steps: Randomized control trial (RCT)

If the feasibility studies are successful in showing a clinically relevant difference at week 8 in the Urticaria Activity Score (UAS7) compared to baseline, our long-term goal is to conduct a randomized controlled clinical trial (RCT) with a non-intervention group. The intervention arm would consist of patients treated by allergy providers who offer the platform, and the control arm would consist of patients treated by allergy providers who do not offer the platform and track patient symptom scores using paper forms and analog patient diaries. The clinic scheduler will randomize patients referred for hives to the intervention or control arm. Prior to starting the RCT, we will work with a biostatistician to finalize the study design and statistical analyses pending community partner input and outcomes of initial feasibility studies.

 Next steps: RCT Primary Aim

  1. Is there a clinically relevant difference at week 8 in the UAS7 between the intervention and the control group?

 Next steps: RCT secondary research questions:

  1. Does an online platform allow patients to engage sooner with an allergist after initial referral to Allergy is placed? 
  2. Compared to routine care (in-person visits), does an online platform for self-directed symptom tracking and clinician engagement achieve symptom control more quickly?
  3. Does achieving symptom control in the first 12 weeks after symptom onset result in increased likelihood of remission (complete control of symptoms without treatment) at 6 months, 1 year, 2 years, and 3 years after symptom onset?
  4. Are improvements in symptom control associated with improvements in the Chronic Urticaria Quality of Life Questionnaire (CU-Q2OL)?
Study team
Our study team would include allergists in the UCSF Allergy/Immunology clinic who have CU patients, including fellows and attendings. Allergists offer the platform to patients with CU who meet the above criteria. We can also reach out via phone or Epic to patients who have already been referred to our clinic for urticaria but not yet had a visit to see if they are interested in enrolling. The main PI would be Dr. Iris Otani who specializes in treatment of patients with CU in our clinic. The main project lead would be Lulu Tsao, an internal medicine resident with interest in developing technology solutions for diverse patient populations. Lulu previously worked on an asthma inhaler-game app interface for children at a federally qualified health center. We do not anticipate needing funding support for the first year beyond that provided by the Diverse eCohort team. In terms of sustainability through Fall 2020 and beyond, once an online platform has been created, we would be able to continue enrolling patients with CU as part of our clinic workflow. We will continue collecting data through the platform and will apply for funding for statistical assistance, technical maintenance, and any translation services from grants such as the Pilot for Junior Investigators in Basic and Clinical/Translation Sciences through the CSTI, and junior faculty grants through the ACAAI and AAAAI.
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  2. Deza G, Ricketti PA, Giménez-Arnau AM, Casale TB. Emerging Biomarkers and Therapeutic Pipelines for Chronic Spontaneous Urticaria. J Allergy Clin Immunol Pract. 2018 Jul - Aug;6(4):1108-1117.
  3. Zuberbier T, Bernstein JA. A Comparison of the United States and International Perspective on Chronic Urticaria Guidelines. J Allergy Clin Immunol Pract. 2018 Jul - Aug;6(4):1144-1151. Epub 2018 May 18.
  4. Hawro T, Ohanyan T, Schoepke N, Metz M, Peveling-Oberhag A, Staubach P, Maurer M, Weller K. The Urticaria Activity Score-Validity, Reliability, and Responsiveness. J Allergy Clin Immunol Pract. 2018 Jul - Aug;6(4):1185-1190.e1. Epub 2017 Nov 8.
  5. Greenberger PA. Chronic Urticaria: new management options. World Allergy Organ J. 2014 Nov 5;7(1):31.
  6. Bernstein JA et. al. The diagnosis and management of acute and chronic urticaria: 2014 update. J Allergy Clin Immunol. 2014 May;133(5):1270-7.
  7. Vietri J et. al. Effect of chronic urticaria on US patients: analysis of the National Health and Wellness Survey.Ann Allergy Asthma Immunol. 2015 Oct;115(4):306-11.
  8. Zhong H, Song Z, Chen W, Li H, He L, Gao T, Fang H, Guo Z, Xv J, Yu B, Gao X, Xie H, Gu H, Luo D, Chen X, Lei T, Gu J, Cheng B, Duan Y, Xv A, Zhu X, Hao F. Chronic urticaria in Chinese population: a hospital-based multicenter epidemiological study. Allergy 2014; 69: 359–364.
  9. Liu JB, Yao MZ, Si AL, Xiong LK, Zhou H. Life quality of Chinese patients with chronic urticaria as assessed by the dermatology life quality index. J Eur Acad Dermatol Venereol. 2012 Oct;26(10):1252-7. doi: 10.1111/j.1468-3083.2011.04277.x. Epub 2011 Sep 29.
  10. Balañá M, Valero A, Giménez Arnau A, Ferrer M, Jauregui I, Ballesteros C; study group of EVALUAS. Validation of The Spanish Version of The Urticaria Activity Score (Uas) and Its Use Over One Week (Uas7).Value Health. 2015 Nov;18(7):A426. doi: 10.1016/j.jval.2015.09.584. Epub 2015 Oct 20. *note this was for Novartis.
Existing Apps
  1. Chronic Hives by the American Academy of Dermatology. https://www.aad.org/members/aad-apps/chronic-urticaria-for-public.
  2. CIU Tracker. https://itunes.apple.com/us/app/ciu-tracker/id977990786?mt=8
  3. Target My Hives. http://myhives.com/en/

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