Proposed CMS Data Access Changes May Hamper Health Services Research.

This Viewpoint discusses how proposed Centers for Medicare & Medicaid Services data access changes may impede health services research.

Perceptions of chemotherapy calendar creation among US pediatric oncologists.

BACKGROUND: An effective chemotherapy calendar system between the clinician and the patient/caregiver can improve patient-centered outcomes. There is lack of research on how chemotherapy calendars are created and what aspects are important to pediatric oncology physicians. PROCEDURE: In an online survey of pediatric oncology physicians, we evaluated institutional practices, perceptions of chemotherapy calendar creation, and desires for future tools. A total of 220 survey participants provided data (10.4% participant response rate) from 123 institutions (53.5% represented institutions). RESULTS: Participants indicated that 72% always or most of the time their institution provides a chemotherapy calendar, most commonly at the start of a new cycle (90%) or with a dosing change (68%). Factors such as the health literacy of the family, prior nonadherence, type of cancer, and desire of the family affected the creation decision. Advanced practice providers (45%) or nurse coordinator/navigators (43%) were most likely to create the chemotherapy calendar. No significant difference was found between the likelihood of creating a chemotherapy calendar and institutional size (p = .09) or physician years in practice (p = .26). Approximately 95% of participants indicated chemotherapy calendar creation software that improved ease and efficiency would be moderately to extremely useful. CONCLUSION: Future efforts should focus on co-design of an efficient and effective chemotherapy calendar by engaging with nursing and advanced practice providers along with caregivers of children with cancer.

Human-centered designed communication tools for obesity prevention in early life.

Objective: How we communicate about obesity is critical as treatment paradigms shift upstream. We previously identified parental perceptions, concerns, beliefs, and communication preferences about early life obesity risk. We engaged parents of children 0 to 24 months of age and pediatricians from Indianapolis, Indiana, USA in the co-design of messages and tools that can be used to facilitate parent/provider conversations about early life obesity prevention. Methods: From April to June 2021, we conducted a series of co-design workshops with parents of children ages 0 to 24 months and pediatricians to identify their preferences for communicating obesity prevention in the setting of a pediatric well visit. Human-centered design techniques, including affinity diagraming and model building, were used to inform key elements of a communication model and communication strategy messages. These elements were combined and refined to create prototype tools that were subsequently refined using stakeholder feedback. Results: Parent participants included 11 mothers and 2 fathers: 8 white, 4 black, and 1 Asian; median age 33 years with 38% reporting annual household incomes less than $50,000. Pediatricians included 7 female and 6 male providers; 69% white. Through an iterative process of co-design, we created an exam room poster that addresses common misconceptions about infant feeding, sleep and exercise, and a behavior change plan to foster parent/provider collaboration focused on achieving children's healthy weight. Conclusions: Our hands-on, collaborative approach may ultimately improve uptake, acceptability and usability of early life obesity interventions by ensuring that parents remain at the center of prevention efforts.

Evolving microbial patterns of acute mastoiditis in pediatric patients undergoing mastoidectomy.

OBJECTIVE: To investigate the microbial patterns and clinical outcomes of pediatric patients undergoing mastoidectomy for acute coalescent mastoiditis and to identify factors associated with poor outcomes and/or prolonged treatment. STUDY DESIGN: Monocentric retrospective cohort study. SETTING: Tertiary referral pediatric hospital in Indiana. METHODS: By cross-referencing database data from the Pediatric Health Information System (PHIS) querying for all inpatient stays (patients younger than eighteen) with a diagnostic code of mastoiditis between January 1st, 2010 and August 31, 2019, and the electronic health record (Cerner) for Riley Hospital for Children, 46 patients with mastoidectomy were included. A two-tailed T-test was used to evaluate continuous parametric data. Statistical significance was determined as P < 0.05. For continuous variables, data was analyzed using continuous logistic regression. A criteria of p > 0.1 was used for inclusion in the multivariate regression. RESULTS: Inclusion criteria was met by 46 patients. From 2010 to 2019, S. pyogenes and S. pneumoniae were the most common bacteria, each isolated in 11 of 42 bacterial isolates (26.2%). There was no growth in 35.4% (17/48) of intra-operative wound cultures. On univariate analysis, patients with negative cultures had longer length of hospital stay (LOS) (7.7 days [6.5] vs. 4.3 [2.8]; p = 0.018) as well as higher rates of PICC (peripherally inserted central catheter) placement (53.3% vs. 19.4%; p = 0.021). There was a statistically significant difference in terms of gender (p = 0.021), with 15 males and 16 females in the positive culture cohort and 13 males and 2 females in the negative culture cohort. On multivariate analysis, which included gender, PICC placement, both intracranial and extracranial complications, duration of antibiotics, and LOS, female gender was the only significant predictor of positive culture status (p = 0.039). CONCLUSION: S. pyogenes and S. pneumoniae were the predominant etiologic agents in acute coalescent mastoiditis between 2010 and 2019, and negative wound cultures were associated with worse clinical outcomes.

Understanding caregiver burden with accessing sickle cell care in the Midwest and their perspective on telemedicine.

BACKGROUND: Survival for children with sickle cell disease (SCD) has improved significantly. However, patients with SCD still encounter several impediments to accessing adequate healthcare. Rural and medically underserved areas, such as parts of the Midwest, can exacerbate these barriers, separating children with SCD from subspecialists even further. Telemedicine has been a means to close these gaps in care for children with other special healthcare needs, but few studies have discussed how caregivers of children with SCD perceive its use. METHODS: The objective of this study is to understand the experiences of caregivers of pediatric SCD patients in a geographically diverse area in the Midwest in accessing care, and their perspectives of telemedicine. Caregivers of children with SCD completed an 88-item survey via a secured REDCap link either in-person or via secure text. Descriptive statistics (means, medians, ranges, frequencies) were performed for all responses. Univariate chi square tests were performed to analyze associations, particularly with telemedicine responses. RESULTS: The survey was completed by 101 caregivers. Nearly 20% of families traveled more than 1 hour to reach the comprehensive SCD center. Other than their SCD provider, caregivers reported their child having at least 2 other healthcare providers. Most barriers caregivers identified were financial or resource based. Almost a quarter of caregivers expressed feeling as though these barriers impacted their and/or their child's mental health. Ease of access to team members, as well as scheduling, were common facilitators of care cited by caregivers. The majority were willing to participate in telemedicine visits, regardless of how far they lived from the SCD center, though many noted aspects requiring adaptation. CONCLUSION: This cross-sectional study describes barriers to care experienced by caregivers of children with SCD, regardless of proximity to an SCD center, as well as caregiver perceptions of the usefulness and acceptability of telemedicine for SCD care.

Building a prototype of a continence goal-selection tool for children with spina bifida: Patient, parental and urology provider recommendations.

INTRODUCTION: No tools exist to help children with spina bifida (SB) describe their incontinence concerns and to help their providers account for them when evaluating management success. Our aim was to understand patients', parents', and clinicians' preferences about how a SB continence goal-selection tool (MyGoal-C) should look and function, and to create a tool prototype. METHODS: We used a qualitative research approach integrated with human-centered design methods. We recruited children with SB (8-17 years old), parents ( ≥ 18 years old) of children with SB (8-17 years old) in clinic and online, and urology healthcare providers at our institution. We surveyed children and parents, and conducted parent and provider Zoom-based prototyping sessions to iteratively design the app. Design researchers analyzed online activities using affinity diagramming, group analysis and modeling activities. Provider sessions were analyzed with qualitative thematic analysis based on grounded theory. Recruitment continued until saturation was reached. RESULTS: Thirteen children with SB participated (median age: 10 years old, 4 female, 9 shunted, 10 using bladder catheterizations). Thirty-seven parents participated (33 mothers, median age: 43 years old). Children and parents unanimously recommended an app and their comments generated 6 major theme domains: goal-setting process, in-app content, working toward goals, urology provider check-in, app customization, and using big data to improve future functionality. Twenty-one of the parents participated in 3 prototyping sessions with 6 breakout groups. The remaining 16 parents and 13 children then completed the Prototype Testing Survey, leading to a refined prototype and a visual flow map of the app experience (Figure). Feedback from 11 urology healthcare providers (7 female, 6 advanced practice providers) generated 8 themes: patient engagement/autonomy, clearly displaying results, integration into clinic workflow, not increasing clinical staff burden, potential clinician bias, parental involvement, limitations of the app, and future app adaptation. These cumulative data allowed for a construction of a final app prototype. COMMENT: Findings of our study lay the foundation for creating a goal-selection app that meets preferences and needs of children, parents, and providers. Next steps involve building the app, testing its usability and assessing it prospectively in a clinical setting. CONCLUSIONS: Children with SB and parents preferred an app to help them set and track continence goals. All stakeholders, including urology providers, offered complementary and mutually reinforcing feedback to guide the creation of an app prototype that would ultimately be integrated into a clinic visit.

In-person classroom instruction and risk of SARS-CoV-2 infection among undergraduates at Indiana University, Fall 2020.

Objective: To examine how in-person classroom instruction was related to risk of SARS-CoV-2 infection in undergraduate students. Participants: Indiana University undergraduate students (n = 69,606) enrolled in Fall 2020, when courses with in-person and remote instruction options were available. Methods: Students participated weekly in mandatory SARS-CoV-2 RT-PCR asymptomatic testing by random selection, supplemented with symptomatic testing as needed. We used log-binomial regression models to estimate the association between number of in-person credit hours and the risk of SARS-CoV-2 infection over the course of the semester. Results: Overall 5,786 SARS-CoV-2 cases were observed. Increased in-person credit hour exposures were not associated with increased risk of SARS-CoV-2 overall [aRR (95% CI): 0.98 (0.97,0.99)], nor within specific subgroups (Greek affiliation and class). Conclusions: In-person instruction did not appear to increase SARS-CoV-2 transmission in a university setting with rigorous protective measures in place, prior to mass vaccine rollout and prior to delta variant emergence.

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.

A patient- and parent-centered approach to urinary and fecal incontinence in children and adolescents with spina bifida: understanding experiences in the context of other competing care issues.

INTRODUCTION: Despite significant and known challenges to urinary and fecal incontinence (UI and FI, respectively) among children with spina bifida (SB) and their families, few studies have identified patient-centered measures and approaches to assessing them. This study represents the first stage of a larger study to develop a patient-centered goal-setting tool to guide incontinence management (Figure). Our aim was to understand patient experiences of UI and FI, and what goals should be included in the tool. METHODS: We used a qualitative research approach integrated with human-centered design methods. We recruited, in clinic and online, children with SB (8-17 years old) and parents (>=18 years old) of children with SB (8-17 years old). Online activities were analyzed by four experienced design researchers using affinity diagramming, group analysis and modeling activities (mind maps, challenge maps, experience maps). Recruitment and thematic qualitative analysis continued until saturation was reached. RESULTS: Seventeen children with SB participated (9 female, 12 shunted, 13 using bladder catheterizations, 6 using Malone antegrade continence enema, median age: 15 years old). Fifteen parents participated (13 mothers/2 fathers, median age: 42 years old), including six mother-child dyads. Five major themes each were identified for UI and FI experiences: (1) negative emotional impact of incontinence, (2) unpredictability of incontinence, (3) challenging/unpleasant incontinence management, (4) inconvenient/unreliable incontinence management, (5) UI management having unpleasant complications and FI putting much responsibility on parents. We identified six UI goal domains and five FI goal domains. Four overlapping domains included: accidents, independence, interruptions at school and social/friends. Unique domains were: urinary tract infections (UI), catheterizations (UI) and enemas (FI). COMMENT: Findings of our study improve our understanding of children's and parents' experiences associated with incontinence in SB and potential continence goals. CONCLUSIONS: Children with SB experience incontinence as distressing and unpredictable. Incontinence management can be challenging and unreliable. Patient-centered continence goals cluster in domains, indicating how incontinence intermeshes with other life areas and offering potential approaches to structure continence goals in a goals-selection tool.

A human-centered designed outreach strategy for a youth contraception navigator program.

Objective: To identify key elements of an outreach strategy for a youth contraception navigator program designed to help young people overcome barriers to contraception access. Methods: A human-centered design approach was used to engage adolescents aged 15-17 in co-design sessions. Human-centered design techniques, such as affinity diagramming and model building were used to inform key elements of the communication model and the final outreach strategy messages. Results: Messages focused on the individual, normalizing talking about birth control, acknowledging the challenges to obtaining birth control, explaining how the navigator program works resonate with young people. Having images of diverse participants, offering information about birth control, and showing images of reputable sources will enhance trust. Conclusions: A name (IN Control) and key elements of an outreach strategy were determined for the navigator program. It is important to work with key stakeholders and co-design the optimal strategy and messages to assure that the intended audience is reached, and the desired behavior change is achieved. Innovation: Human-centered design techniques can be used to provide insight into programmatic outreach strategies for a contraception navigator program to increase their impact and ultimate success.

Communicating Risk for Obesity in Early Life: Engaging Parents Using Human-Centered Design Methodologies.

Objective: Pediatricians are well positioned to discuss early life obesity risk, but optimal methods of communication should account for parent preferences. To help inform communication strategies focused on early life obesity prevention, we employed human-centered design methodologies to identify parental perceptions, concerns, beliefs, and communication preferences about early life obesity risk. Methods: We conducted a series of virtual human-centered design research sessions with 31 parents of infants <24 months old. Parents were recruited with a human intelligence task posted on Amazon's Mechanical Turk, via social media postings on Facebook and Reddit, and from local community organizations. Human-centered design techniques included individual short-answer activities derived from personas and empathy maps as well as group discussion. Results: Parents welcomed a conversation about infant weight and obesity risk, but concerns about health were expressed in relation to the future. Tone, context, and collaboration emerged as important for obesity prevention discussions. Framing the conversation around healthy changes for the entire family to prevent adverse impacts of excess weight may be more effective than focusing on weight loss. Conclusions: Our human-centered design approach provides a model for developing and refining messages and materials aimed at increasing parent/provider communication about early life obesity prevention. Motivating families to engage in obesity prevention may require pediatricians and other health professionals to frame the conversation within the context of other developmental milestones, involve the entire family, and provide practical strategies for behavioral change.

Developing a Youth Contraception Navigator Program: A Human-Centered Design Approach.

PURPOSE: To determine key elements of a contraception navigator program that provides a personalized approach to overcoming patient-specific barriers by a trained navigator in central Indiana. METHODS: A human-centered design approach was used to engage adolescents and community stakeholders in co-design sessions. Sessions incorporated techniques, such as divergent brainwriting and journey maps, which led to the exploration of various themes that were ultimately used to inform key elements of the contraception navigator program. RESULTS: Adolescents aged 15-17 years (N = 35) and community stakeholders (N = 11) participated in co-design sessions. Analysis verified that the process of obtaining contraception for pregnancy prevention could be intimidating for young people. The importance of language, the presence of stigma, and the knowledge of side effects were all discussed. Essential elements of a contraceptive navigator program included building trust to ultimately co-create a plan that can overcome patient-specific barriers. Having a variety of communication methods available, as well as contraceptive side-effect support, will be essential. DISCUSSION: Using human-centered design techniques to engage adolescent and community stakeholders can help inform the development of a contraceptive navigator program. A trusted navigator that can address patient-specific barriers to contraception access both before and after contraception is obtained is a key element identified by stakeholders.

Caregiver experiences with accessing sickle cell care and the use of telemedicine.

BACKGROUND: Sickle cell disease (SCD) is associated with a wide range of complications. However, a multitude of barriers prevent SCD patients from receiving adequate healthcare, including difficulties with transportation and lack of provider knowledge about disease sequelae. Importantly, studies have demonstrated the benefits of telemedicine in addressing barriers to healthcare. While previous studies have identified barriers to care through quantitative methods, few studies have explored barriers which affect the pediatric SCD patient population in the Midwest, wherein the geographical landscape can prohibit healthcare access. Furthermore, few studies have established acceptability of telemedicine among caregivers and patients with SCD. METHODS: This study aims to increase understanding of barriers to care and perceptions of telemedicine by caregivers of pediatric SCD patients in a medically under-resourced area in the Midwest. Researchers conducted semi-structured interviews with caregivers of children with SCD. The interviews were audio-recorded and transcribed. Thematic analyses were performed. RESULTS: Researchers interviewed 16 caregivers of 15 children with SCD. Thematic analyses of the interview transcripts revealed four broad themes regarding caregiver burden/stress, both facilitators and barriers to SCD healthcare, and general thoughts on the acceptability/usefulness of telemedicine. CONCLUSION: This qualitative study describes common burdens faced by caregivers of SCD, barriers to and facilitators of SCD care in the Midwest, and caregiver perceptions of the usefulness and efficacy of telemedicine for SCD care.

Outpatient Opioid Prescriptions are Associated With Future Substance Use Disorders and Overdose Following Adolescent Trauma.

OBJECTIVE: This study aims to determine if outpatient opioid prescriptions are associated with future SUD diagnoses and overdose in injured adolescents 5 years following hospital discharge. SUMMARY OF BACKGROUND DATA: Approximately, 1 in 8 adolescents are diagnosed with an SUD and 1 in 10 experience an overdose in the 5 years following injury. State laws have become more restrictive on opioid prescribing by acute care providers for treating pain, however, prescriptions from other outpatient providers are still often obtained. METHODS: This was a retrospective cohort study of patients ages 12-18 admitted to 2 level I trauma centers. Demographic and clinical data contained in trauma registries were linked to a regional database containing 5 years of electronic health records and prescription data. Regression models assessed whether number of outpatient opioid prescription fills after discharge at different time points in recovery were associated with a new SUD diagnosis or overdose, while controlling for demographic and injury characteristics, and depression and posttraumatic stress disorder diagnoses. RESULTS: We linked 669 patients (90.9%) from trauma registries to a regional health information exchange database. Each prescription opioid refill in the first 3 months after discharge increased the likelihood of new SUD diagnoses by 55% (odds ratio: 1.55, confidence interval: 1.04-2.32). Odds of overdose increased with ongoing opioid use over 2-4 years post-discharge ( P = 0.016-0.025). CONCLUSIONS: Short-term outpatient opioid prescribing over the first few months of recovery had the largest effect on developing an SUD, while long-term prescription use over multiple years was associated with a future overdose.

Patient and Parent Well-Being and Satisfaction With Diabetes Care During a Comparative Trial of Mobile Self-Monitoring Blood Glucose Technology and Family-Centered Goal Setting.

Patient engagement in the process of developing a diabetes treatment plan is associated with person-centered care and improved treatment outcomes. The objective of the present study was to evaluate the self-reported patient and parent-centered satisfaction and well-being outcomes associated with the three treatment strategies utilized in a comparative effectiveness trial of technology-enhanced blood glucose monitoring and family-centered goal setting. We evaluated data from 97 adolescent-parent pairs at baseline and 6-months during the randomized intervention. Measures included: Problem Areas in Diabetes (PAID) child and parent scales, pediatric diabetes-related quality of life, sleep quality, and satisfaction with diabetes management. Inclusion criteria were 1) ages 12-18 years, 2) a T1D diagnosis for at least six months and 3) parent/caregiver participation. Longitudinal changes in survey responses were measured at 6 months from baseline. Differences between and within participant groups were evaluated using ANOVA. The average age of youth participants was 14.8 ± 1.6 years with half of the participants being female (49.5%). The predominant ethnicity/race was Non-Hispanic (89.9%) and white (85.9%). We found that youth perceived 1) greater of diabetes-related communication when using a meter capable of transmitting data electronically, 2) increased engagement with diabetes self-management when using family-centered goal setting, and 3) worse sleep quality when using both strategies together (technology-enhanced meter and family-centered goal setting). Throughout the study, scores for self-reported satisfaction with diabetes management were higher in youth than parents. This suggests that patients and parents have different goals and expectations regarding their diabetes care management and care delivery. Our data suggest that youth with diabetes value communication via technology and patient-centered goal setting. Strategies to align youth and parent expectations with the goal of improving satisfaction could be utilized as a strategy to improve partnerships in diabetes care management.

Comparison of a trauma comorbidity index with other measures of comorbidities to estimate risk of trauma mortality.

BACKGROUND: Comorbidities influence the outcomes of injured patients, yet a lack of consensus exists regarding how to quantify that association. This study details the development and internal validation of a trauma comorbidity index (TCI) designed for use with trauma registry data and compares its performance to other existing measures to estimate the association between comorbidities and mortality. METHODS: Indiana state trauma registry data (2013-2015) were used to compare the TCI with the Charlson and Elixhauser comorbidity indices, a count of comorbidities, and comorbidities as separate variables. The TCI approach utilized a randomly selected training cohort and was internally validated in a distinct testing cohort. The C-statistic of the adjusted models was tested using each comorbidity measure in the testing cohort to assess model discrimination. C-statistics were compared using a Wald test, and stratified analyses were performed based on predicted risk of mortality. Multiple imputation was used to address missing data. RESULTS: The study included 84,903 patients (50% each in training and testing cohorts). The Indiana TCI model demonstrated no significant difference between testing and training cohorts (p = 0.33). It produced a C-statistic of 0.924 in the testing cohort, which was significantly greater than that of models using the other indices (p < 0.05). The C-statistics of models using the Indiana TCI and the inclusion of comorbidities as separate variables-the method used by the American College of Surgeons Trauma Quality Improvement Program-were comparable (p = 0.11) but use of the TCI approach reduced the number of comorbidity-related variables in the mortality model from 19 to one. CONCLUSIONS: When examining trauma mortality, the TCI approach using Indiana state trauma registry data demonstrated superior model discrimination and/or parsimony compared to other measures of comorbidities.

Aerosol generation during cadaveric simulation of otologic surgery and live cochlear implantation.

OBJECTIVE: The risk of SARS-CoV-2 transmission to healthcare workers through airborne aerosolization during otologic surgery has not been characterized. The objective of this study was to describe and quantify the aerosol generation during common otologic procedures in both cadaveric surgical simulation and live patient surgery. METHODS: The number concentrations of generated aerosols in the particle size range of 0.30 to 10.0 µm were quantified using an optical particle sizer during both a cadaveric simulation of routine otologic procedures as well as cochlear implant surgery on live patients in the operating room. RESULTS: In the cadaveric simulation, temporalis fascia graft harvest using cold techniques (without electrocautery) (n = 4) did not generate aerosols above baseline concentrations. Tympanoplasty (n = 3) and mastoidectomy (n = 3) both produced statistically significant increases in concentrations of aerosols (P < 0.05), predominantly submicron particles (< 1.0 µm). High-speed, powered drilling of the temporal bone during mastoidectomy with a Multi Flute cutting burr resulted in higher peak concentrations and greater number of spikes in aerosols than with a diamond burr. In the operating room, spikes in aerosols occurred during both cochlear implant surgeries. CONCLUSION: In the cadaveric simulation, temporalis fascia graft harvest without electrocautery did not generate aerosol levels above baseline, while significant aerosol levels were generated during mastoidectomy and to a much less degree during tympanoplasty. Aerosol spikes were appreciated during cochlear implantation surgery in live patients. LEVEL OF EVIDENCE: 2.