Identifying patient-centered outcomes for children with cancer and their caregivers when they seek care in the emergency department.

BACKGROUND: Children with cancer have high utilization of the emergency department (ED), but little is known about which outcomes are most important to them and their caregivers when they seek care in the ED. PROCEDURE: A qualitative evaluation of ED experience for children with cancer and their caregivers was performed using self-reported interactive toolkits. Eligible participants included children with cancer (ages 11-19) and caregivers of children with cancer whose child received cancer therapy within the last year and had an ED visit within the last 2 years. Eligible participants received toolkits by mail and received incentives if they completed the toolkit. Toolkits were transcribed, thematically coded, and iteratively analyzed using Nvivo 11.0 software. RESULTS: There were 26 toolkits received-seven by children aged 11-17 years and 19 by caregivers (11 with children aged 2-7 years, eight with children aged 11-17 years). About half were from within 1 h of their treating institution. The most important outcomes to this population included system-level issues (eg, cleanliness of space, timeliness of evaluation) and oncology-provider- and ED-provider-level issues (eg, ability to access port-a-caths, quality of communication). Participants also identified outcomes that were within the control of the patient/caregiver, such as improving their sense of preparedness. CONCLUSION: The important outcomes to children with cancer and their caregivers when they seek care in the ED are distinct from current quality metrics. Future research should focus on the development and validation of a patient-centered outcomes tool.

Blood Sugar, Your Pancreas, and Unicorns: The Development of Health Education Materials for Youth With Prediabetes.

Background. The obesity epidemic has led to an increase in prediabetes in youth, causing a serious public health concern. Education on diabetes risk and initiation of lifestyle change are the primary treatment modalities. There are few existing age-appropriate health education tools to address diabetes prevention for high-risk youth. Aim. To develop an age-appropriate health education tool(s) to help youth better understand type 2 diabetes risk factors and the reversibility of risk. Method. Health education tool development took place in five phases: exploration, design, analysis, refinement, and process evaluation. Results. The project resulted in (1) booklet designed to increase knowledge of risk, (2) meme generator that mirrors the booklet graphics and allows youth to create their own meme based on their pancreas' current mood, (3) environmental posters for clinic, and (4) brief self-assessment that acts as a conversation starter for the health educators. Conclusion. Patients reported high likability and satisfaction with the health education tools, with the majority of patients giving the materials an "A" rating. The process evaluation indicated a high level of fidelity and related measures regarding how the health education tools were intended to be used and how they were actually used in the clinic setting.

Sonographic Prediction of Pediatric Renal Scarring With Full Parameter Normalization.

OBJECTIVES: To predict the chronic kidney disease (CKD) state for pediatric patients based on scaled renal cortical echogenicity. METHODS: Sonograms from a cohort of 26 patients, half of whom had stage 4 or 5 CKD, whereas the other half had normal renal function, were analyzed. For each patient image, a region of interest (ROI) was drawn around the renal cortex for comparison with an ROI drawn around the hepatic parenchyma. The latter ROI was shifted spatially to normalize the signal attenuations and time-gain compensations of the two organs' ROIs. Then the average pixel intensity of the renal ROI was divided by the corresponding hepatic value, resulting in scaled renal cortical echogenicity. RESULTS: The average scaled renal cortical echogenicity was higher for diseased than healthy kidneys by roughly a factor of 2 (2.01 [95% confidence interval, 1.62-2.40] versus 1.05 [95% confidence interval, 0.88-1.23] for normal kidneys). This difference was statistically significant (P < .001). CONCLUSIONS: Our results show that the pediatric CKD state correlates with rigorously calculated scaled renal cortical echogenicity.

"I Am Interested!": The Voices of the Community and Their Participation in Health Advisory Boards.

Introduction: Researchers can often be challenged by meaningful efforts to involve the public and communities in research. Community and health advisory boards (HABs) offer an opportunity to create a fully intentional and honest relationship between researchers and the community. Objective: Most recently, the All Indiana (IN) for Health HAB had four openings and a call was published to our community of over 13,800 individuals in the All IN for Health newsletter. Four hundred eighty-eight individuals submitted applications to become part of the board. In what follows, we share the lessons in motivations and interests of individuals who responded. Methods: The application process included the following questions: What lived experiences and/or personal interests have motivated you to be involved in All IN for Health? Please explain why you are interested in being an All IN for HAB member. Our analysis approach was qualitative and centered on narrative research. Results: We organize the findings in two categories: Motivation and Interests. Individuals were motivated to participate based on family or friend diagnosis, personal diagnosis, roles as caregivers, desire to impact change and advocacy, role as health professional, and previous participation in research. Interests followed similar themes beginning with crediting their interest to a diagnosis. In addition, we categorized desire to share their experience, personal positionality, and previous research experience, and contributing to the education of student/trainee. Conclusion: By understanding motivations, we understand needs. This information can be used for other advisory boards, as well as recruitment into research participation and health care advocacy.

"Research Jam": Engaging patients and other stakeholders through human-centered design to improve translational research.

Effective stakeholder engagement increases research relevance and utility. Though published principles of community-based participatory research and patient-centered outcomes research offer guidance, few resources offer effective techniques to engage stakeholders and translate their engagement into improvements in research process and outcomes. The Indiana Clinical and Translational Sciences Institute (Indiana CTSI) is home to Research Jam (RJ), an interdisciplinary team of researchers, project management professionals, and design experts, that employs human-centered design (HCD) to engage stakeholders in the research process. Establishing HCD services at the Indiana CTSI has allowed for accessible and innovative stakeholder-engaged research. RJ offers services for stakeholder-informed study design, measurement, implementation, and dissemination. RJ's services are in demand to address research barriers pertaining to a diverse array of health topics and stakeholder groups. As a result, the RJ team has grown significantly with both institutional and extramural support. Researchers involved in RJ projects report that working with RJ helped them learn how to better engage with stakeholders in research and changed the way they approach working with stakeholders. RJ can serve as a potential model for effectively engaging stakeholders through HCD to improve translational research.

Preoperative localization of breast lesions: Comparing digital breast tomosynthesis-guided radioactive seed localization versus standard 2D stereotactic radioactive seed localization.

PURPOSE: To compare single seed digital breast tomosynthesis-guided radioseed localization (DBT-L) to standard 2D stereotactic-guided radioseed localization (SGL) of the breast. METHODS: A retrospective review of a large tertiary cancer center's database yielded 68 women who underwent preoperative DBT-L from March 2019-December 2019 and a matched cohort of 65 women who underwent SGL during the same period. The electronic medical record and radiology were reviewed for patient characteristics including breast density, exam technique, pre- and post-operative pathology, exam duration, and radiation dose to the patient. To compare margin outcomes between the groups, the chi-square test of independence was used; to compare continuous outcomes such as exam duration and total dose, the Wilcoxon rank sum test was used. RESULTS: DBT-L and SGL localization targets included biopsy marker (62/68, 91% vs 55/65, 85%), distortion (4/68, 6% vs 2/65, <3%), focal asymmetry (1/68 and 1/65, < 2% for both), calcifications (1/68, <2% vs 4/65, 6%), and anatomic landmarks (0% vs 3/65, 5%). 72% and 71% of localizations were performed for malignant pathology in the DBT-L and SGL groups, respectively. The median duration of DBT-L was 8.3 min vs 10.3 min for SGL, representing statistically significant time savings (p = 0.003). The median total organ dose of DBT-L was 8.6 mGy vs 10.4 mGy for SGL, representing statistically significant dose savings (p = 0.018). The incidence of positive margins at surgery was not statistically different between the groups (p = 0.26). CONCLUSION: DBT-L demonstrates both time and dose savings for the patient compared to SGL without compromising surgical outcome.

Identifying Patient-Centered Outcomes for Caregivers and Children With Musculoskeletal Infections.

Background: Musculoskeletal infections (MSKI), including osteomyelitis and septic arthritis, are among the most common invasive infections in children and have the potential to cause significant morbidity. Guidelines have been developed to optimize care based on clinician-developed endpoints. Patient-centered outcomes have not been defined for children with MSKI. This study identified outcomes most important to caregivers and patients with MSKI. Methods: This was a single-center prospective qualitative study of children 6 months to 18 years of age hospitalized with MSKI from November 2019 to September 2021. Using design-research methods, patients and caregivers participated in interviews and/or completed journals to describe their experiences during acute infection and recovery from MSKI. Results: A total of 51 patient/caregivers were approached to participate in the study, 35 of whom declined to participate, resulting in 8 interviews conducted and 14 journals collected from 16 patient/caregivers. From these, a journey map was created highlighting points of stress during the onset of symptoms, through hospitalization, and returning home with new challenges. In addition, patient-centered outcomes were identified. For caregivers, these included managing mental health, managing responsibilities, and receiving support. Both caregivers and patients shared the importance of understanding of treatment plans and responsibilities. For patients, improving mental and physical health was important. Conclusions: Management of children with MSKI is complex and requires a multidisciplinary team approach. Validation of the outcomes identified and development of a measurement tool are needed. Addressing the patient-centered outcomes we identified in this study can greatly improve the holistic care of children with MSKI.

Diabetes Prevention in Adolescents: Co-design Study Using Human-Centered Design Methodologies.

BACKGROUND: The rise in pediatric obesity and its accompanying condition, type 2 diabetes (T2D), is a serious public health concern. T2D in adolescents is associated with poor health outcomes and decreased life expectancy. Effective diabetes prevention strategies for high-risk adolescents and their families are urgently needed. OBJECTIVE: The aim of this study was to co-design a diabetes prevention program for adolescents by using human-centered design methodologies. METHODS: We partnered with at-risk adolescents, parents, and professionals with expertise in diabetes prevention or those working with adolescents to conduct a series of human-centered design research sessions to co-design a diabetes prevention intervention for youth and their families. In order to do so, we needed to (1) better understand environmental factors that inhibit/promote recommended lifestyle changes to decrease T2D risk, (2) elucidate desired program characteristics, and (3) explore improved activation in diabetes prevention programs. RESULTS: Financial resources, limited access to healthy foods, safe places for physical activity, and competing priorities pose barriers to adopting lifestyle changes. Adolescents and their parents desire interactive, hands-on learning experiences that incorporate a sense of fun, play, and community in diabetes prevention programs. CONCLUSIONS: The findings of this study highlight important insights of 3 specific stakeholder groups regarding diabetes prevention and lifestyle changes. The findings of this study demonstrate that, with appropriate methods and facilitation, adolescents, parents, and professionals can be empowered to co-design diabetes prevention programs.

Methicillin-Resistant Staphylococcus aureus Eradication and Decolonization in Children Study (Part 2): Patient- and Parent-Centered Outcomes of Decolonization.

BACKGROUND: Skin and soft tissue infections (SSTIs) due to community-acquired methicillin-resistant Staphylococcus aureus (MRSA) can lead to a number of significant known medical outcomes including hospitalization, surgical procedures such as incision and drainage (I&D), and the need for decolonization procedures to remove the bacteria from the skin and nose and prevent recurrent infection. Little research has been done to understand patient and caregiver-centered outcomes associated with the successful treatment of MRSA infection. OBJECTIVE: This study aimed to uncover MRSA decolonization outcomes that are important to patients and their parents in order to create a set of prototype measures for use in the MRSA Eradication and Decolonization in Children (MEDiC) study. METHODS: A 4-hour, human-centered design (HCD) workshop was held with 5 adolescents (aged 10-18 years) who had experienced an I&D procedure and 11 parents of children who had experienced an I&D procedure. The workshop explored the patient and family experience with skin infection to uncover patient-centered outcomes of MRSA treatment. The research team analyzed the audio and artifacts created during the workshop and coded for thematic similarity. The final themes represent patient-centered outcome domains to be measured in the MEDiC comparative effectiveness trial. RESULTS: The workshop identified 9 outcomes of importance to patients and their parents: fewer MRSA outbreaks, improved emotional health, improved self-perception, decreased social stigma, increased amount of free time, increased control over free time, fewer days of school or work missed, decreased physical pain and discomfort, and decreased financial burden. CONCLUSIONS: This study represents an innovative HCD approach to engaging patients and families with lived experience with MRSA SSTIs in the study design and trial development to determine meaningful patient-centered outcomes. We were able to identify 9 major recurrent themes. These themes were used to develop the primary and secondary outcome measures for MEDiC, a prospectively enrolling comparative effectiveness trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT02127658; https://clinicaltrials.gov/ct2/show/NCT02127658.

Methicillin-Resistant Staphylococcus aureus Eradication and Decolonization in Children Study (Part 1): Development of a Decolonization Toolkit With Patient and Parent Advisors.

BACKGROUND: Community-acquired methicillin-resistant Staphylococcus aureus (MRSA) skin and soft tissue infections affect many healthy children. A significant number of these children are hospitalized and require surgical incision and drainage (I&D). Once sent home, these children and families are asked to complete burdensome home decolonization and hygiene procedures in an effort to prevent the high rate of recurrent infections. OBJECTIVE: This component of the Methicillin-resistant Staphylococcus aureus Eradication and Decolonization in Children (MEDiC) study aimed to develop a toolkit to assist MEDiC study participants in completing MRSA decolonization and hygiene procedures at home (the MEDiC kit). METHODS: In all, 5 adolescents (aged 10-18 years) who had undergone an I&D procedure for a skin infection and 11 parents of children who had undergone an I&D procedure for a skin infection were engaged in a 4-hour group workshop using a human-centered design approach. The topics covered in this workshop and analyzed for this paper were (1) attitudes about MRSA decolonization procedures and (2) barriers to the implementation of MRSA decolonization and hygiene procedures. The team analyzed the audio and artifacts created during the workshop and synthesized their findings to inform the creation of the MEDiC kit. RESULTS: The workshop activities uncovered barriers to successful completion of the decolonization and hygiene procedures: lack of step-by-step instruction, lack of proper tools in the home, concerns about adverse events, lack of control over some aspects of the hygiene procedures, and general difficulty coordinating all the procedures. Many of these could be addressed as part of the MEDiC kit. In addition, the workshop revealed that effective communication about decolonization would have to address concerns about the effects of bleach, provide detailed information, give reasons for the specific decolonization and hygiene protocol steps, and include step-by-step instructions (preferably through video). CONCLUSIONS: Through direct engagement with patients and families, we were able to better understand how to support families in implementing MRSA decolonization and hygiene protocols. In addition, we were able to better understand how to communicate about MRSA decolonization and hygiene protocols. With this knowledge, we created a robust toolkit that uses patient-driven language and visuals to help support patients and families through the implementation of these protocols. TRIAL REGISTRATION: ClinicalTrials.gov NCT02127658; https://clinicaltrials.gov/ct2/show/NCT02127658.

Flow alteration-ecology relationships in Ozark Highland streams: Consequences for fish, crayfish and macroinvertebrate assemblages.

We examined flow alteration-ecology relationships in benthic macroinvertebrate, fish, and crayfish assemblages in Ozark Highland streams, USA, over two years with contrasting environmental conditions, a drought year (2012) and a flood year (2013). We hypothesized that: 1) there would be temporal variation in flow alteration-ecology relationships between the two years, 2) flow alteration-ecology relationships would be stronger during the drought year vs the flood year, and 3) fish assemblages would show the strongest relationships with flow alteration. We used a quantitative richest-targeted habitat (RTH) method and a qualitative multi-habitat (QMH) method to collect macroinvertebrates at 16 USGS gaged sites during both years. We used backpack electrofishing to sample fish and crayfish at 17 sites in 2012 and 11 sites in 2013. We used redundancy analysis to relate biological response metrics, including richness, diversity, density, and community-based metrics, to flow alteration. We found temporal variation in flow alteration-ecology relationships for all taxa, and that relationships differed greatly between assemblages. We found relationships were stronger for macroinvertebrates during the drought year but not for other assemblages, and that fish assemblage relationships were not stronger than the invertebrate taxa. Magnitude of average flow, frequency of high flow, magnitude of high flow, and duration of high flow were the most important categories of flow alteration metrics across taxa. Alteration of high and average flows was more important than alteration of low flows. Of 32 important flow alteration metrics across years and assemblages, 19 were significantly altered relative to expected values. Ecological responses differed substantially between drought and flood years, and this is likely to be exacerbated with predicted climate change scenarios. Differences in flow alteration-ecology relationships among taxonomic groups and temporal variation in relationships illustrate that a complex suite of variables should be considered for effective conservation of stream communities related to flow alteration.

Creation of a Decision Support Tool for Expectant Parents Facing Threatened Periviable Delivery: Application of a User-Centered Design Approach.

BACKGROUND: Shared decision-making (SDM) is optimal in the context of periviable delivery, where the decision to pursue life-support measures or palliation is both preference sensitive and value laden. We sought to develop a decision support tool (DST) prototype to facilitate SDM by utilizing a user-centered design research approach. METHODS: We convened four patient and provider advisory boards with women and their partners who had experienced a surviving or non-surviving periviable delivery, pregnant women who had not experienced a prior preterm birth, and obstetric providers. Each 2-h session involved design research activities to generate ideas and facilitate sharing of values, goals, and attitudes. Participant feedback shaped the design of three prototypes (a tablet application, family story videos, and a virtual reality experience) to be tested in a final session. RESULTS: Ninety-five individuals (48 mothers/partners; 47 providers) from two hospitals participated. Most participants agreed that the prototypes should include factual, unbiased outcomes and probabilities. Mothers and support partners also desired comprehensive explanations of delivery and care options, while providers wanted a tool to ease communication, help elicit values, and share patient experiences. Participants ultimately favored the tablet application and suggested that it include family testimonial videos. CONCLUSION: Our results suggest that a DST that combines unbiased information and understandable outcomes with family testimonials would be meaningful for periviable SDM. User-centered design was found to be a useful method for creating a DST prototype that may lead to improved effectiveness, usability, uptake, and dissemination in the future, by leveraging the expertise of a wide range of stakeholders.

Assessment of the Effects of Pediatric Attention Deficit Hyperactivity Disorder on Family Stress and Well-Being: Development of the IMPACT 1.0 Scale.

Medications may lessen core symptoms of attention deficit hyperactivity disorder (ADHD), yet families continue to report stress and have a low quality of life. Primary care providers manage almost half of all children with ADHD but do not have a brief measure to assess ADHD impacts on family in the context of everyday family life. The IMPACT (Impact Measure of Parenting-Related ADHD Challenges and Treatment) 1.0 Scale was codeveloped with input from parent advisors and administered to 79 parents of children with ADHD. Exploratory factor analysis, correlations with validated instruments, and test-retest reliability were examined. Exploratory factor analysis resulted in 4 subscales (Misbehavior, Siblings, Time, School), which demonstrated moderate to high test-retest reliability. Scale domains were related to severity and change in ADHD symptoms. Significant correlations were found between IMPACT scores, adaptive functioning in the home, and ADHD-related quality of life. The IMPACT 1.0 Scale provides a novel, reliable, and valid method to assess family impact of ADHD.

Phase I of the Detecting and Evaluating Childhood Anxiety and Depression Effectively in Subspecialties (DECADES) Study: Development of an Integrated Mental Health Care Model for Pediatric Gastroenterology.

BACKGROUND: Children with gastrointestinal symptoms have a very high rate of anxiety and depression. Rapid identification of comorbid anxiety and depression is essential for effective treatment of a wide variety of functional gastrointestinal disorders. OBJECTIVE: The objective of our study was to determine patient and parent attitudes toward depression, anxiety, and mental health screening during gastroenterology (GI) visits and to determine patient and parent preferences for communication of results and referral to mental health providers after a positive screen. METHODS: We augmented standard qualitative group session methods with patient-centered design methods to assess patient and parent preferences. We used a variety of specific design methods in these sessions, including card sorting, projective methods, experience mapping, and constructive methods. RESULTS: Overall, 11 families (11 patients and 14 parents) participated in 2 group sessions. Overall, patients and their parents found integrated mental health care to be acceptable in the subspecialty setting. Patients' primary concerns were for the privacy and confidentiality of their screening results. Patients and their parents emphasized the importance of mental health services not interfering with the GI visit and collaboration between the GI physician, psychologist, and primary care provider. CONCLUSIONS: Patients and their families are open to integrated mental health care in the pediatric subspecialty clinic. The next phase of the DECADES study will translate patient and parent preferences into an integrated mental health care system and test its efficacy in the pediatric GI office.

Codesigned Shared Decision-Making Diabetes Management Plan Tool for Adolescents With Type 1 Diabetes Mellitus and Their Parents: Prototype Development and Pilot Test.

BACKGROUND: Adolescents with type 1 diabetes mellitus have difficulty achieving optimal glycemic control, partly due to competing priorities that interfere with diabetes self-care. Often, significant diabetes-related family conflict occurs, and adolescents' thoughts and feelings about diabetes management may be disregarded. Patient-centered diabetes outcomes may be better when adolescents feel engaged in the decision-making process. OBJECTIVE: The objective of our study was to codesign a clinic intervention using shared decision making for addressing diabetes self-care with an adolescent patient and parent advisory board. METHODS: The patient and parent advisory board consisted of 6 adolescents (teens) between the ages 12 and 18 years with type 1 diabetes mellitus and their parents recruited through our institution's Pediatric Diabetes Program. Teens and parents provided informed consent and participated in 1 or both of 2 patient and parent advisory board sessions, lasting 3 to 4 hours each. Session 1 topics were (1) patient-centered outcomes related to quality of life, parent-teen shared diabetes management, and shared family experiences; and (2) implementation and acceptability of a patient-centered diabetes care plan intervention where shared decision making was used. We analyzed audio recordings, notes, and other materials to identify and extract ideas relevant to the development of a patient-centered diabetes management plan. These data were visually coded into similar themes. We used the information to develop a prototype for a diabetes management plan tool that we pilot tested during session 2. RESULTS: Session 1 identified 6 principal patient-centered quality-of-life measurement domains: stress, fear and worry, mealtime struggles, assumptions and judgments, feeling abnormal, and conflict. We determined 2 objectives to be principally important for a diabetes management plan intervention: (1) focusing the intervention on diabetes distress and conflict resolution strategies, and (2) working toward a verbalized common goal. In session 2, we created the diabetes management plan tool according to these findings and will use it in a clinical trial with the aim of assisting with patient-centered goal setting. CONCLUSIONS: Patients with type 1 diabetes mellitus can be effectively engaged and involved in patient-centered research design. Teens with type 1 diabetes mellitus prioritize reducing family conflict and fitting into their social milieu over health outcomes at this time in their lives. It is important to acknowledge this when designing interventions to improve health outcomes in teens with type 1 diabetes mellitus.

Implementation of a journal prototype for pregnant and parenting adolescents.

Teenage pregnancy and childbearing remain pressing public health issues that have garnered attention from public health officials and social services agencies. This paper reports on the initial implementation and formative evaluation of a journaling program used as a means of communicating health information to pregnant and parenting adolescents (young women age 15-19) while also providing participants with a means of self-expression. The journaling prototype was implemented in a community-based agency in the Midwest by Family Support Specialists (FSSs) who made home visits on a monthly basis to assist pregnant and parenting adolescents (n=52) with successful family planning and public health education. A mixed method approach of qualitative (analysis of journals, field notes, and responses of semi-structured interviews with FSSs) and quantitative (questionnaires from pregnant and parenting adolescent respondents) data with purposive sampling was employed to evaluate the implementation of the journaling intervention. Twenty of the 52 study participants were pregnant when the journaling intervention was implemented, while 32 were not pregnant, but recently had a child and were currently parenting. Two core themes emerged from analysis of the data after the implementation of the journals: (1) usefulness of the journal and responsiveness to participants' information needs and (2) functionality challenges. The results offer practical starting points to tailor the implementation of journaling in other contexts. Further, areas for improvement emerged regarding the distribution timeline for the journal and the content of the journal itself. As such, we discuss the lessons learned through this collaborative project and suggest opportunities for future phases of the journal intervention.