A Novel Stakeholder Engagement Approach for Patient-centered Outcomes Research.

INTRODUCTION/OBJECTIVES: The engagement of patients and other stakeholders is a critical element in the design of patient-centered outcomes research studies. However, methodology for scalable engagement in research management particularly activities such as operationalization of principles and setting of priorities is not well-developed. The objective of this study is to describe a novel approach for scalable stakeholder engagement in research aligned with the Patient-Centered Outcomes Research Institute (PCORI) engagement principles, which was evaluated in a national clinical data research network. MATERIALS AND METHODS: Patient, patient advocate, clinician, and researcher stakeholders were recruited from clinical sites, as well as social media sites related to the 3 conditions of focus, heart failure, obesity, and Kawasaki disease. The engagement strategy was designed, implemented, and mapped to the PCORI engagement principles. Evaluation included internal assessment and quantitative measures of online engagement. RESULTS: We operationalized the PCORI principles with 12 stakeholder engagement strategies and convened stakeholder advisory boards and online research prioritization panels to determine research priorities in a rigorous, deliberative process. A total of 46 advisors (20 patients) and 339 panelists (159 patients) actively participated. There were not significant differences between patients and clinicians in level of online engagement. Nonetheless, while patients reported a slightly greater challenge with following online discussion, they overall had a more favorable opinion about use of the online format. DISCUSSION/CONCLUSION: An efficient way to engage large numbers of representative stakeholders in research is a necessary first step to assure the public of trustworthy use of data networks for health research. This paper describes a comprehensive approach to engagement in patient-centered outcomes research management that informs ongoing development of rigorous methodologies in this area.

Prevalence of Fetal Alcohol Spectrum Disorders in 4 US Communities.

Importance: Fetal alcohol spectrum disorders are costly, life-long disabilities. Older data suggested the prevalence of the disorder in the United States was 10 per 1000 children; however, there are few current estimates based on larger, diverse US population samples. Objective: To estimate the prevalence of fetal alcohol spectrum disorders, including fetal alcohol syndrome, partial fetal alcohol syndrome, and alcohol-related neurodevelopmental disorder, in 4 regions of the United States. Design, Setting, and Participants: Active case ascertainment methods using a cross-sectional design were used to assess children for fetal alcohol spectrum disorders between 2010 and 2016. Children were systematically assessed in the 4 domains that contribute to the fetal alcohol spectrum disorder continuum: dysmorphic features, physical growth, neurobehavioral development, and prenatal alcohol exposure. The settings were 4 communities in the Rocky Mountain, Midwestern, Southeastern, and Pacific Southwestern regions of the United States. First-grade children and their parents or guardians were enrolled. Exposures: Alcohol consumption during pregnancy. Main Outcomes and Measures: Prevalence of fetal alcohol spectrum disorders in the 4 communities was the main outcome. Conservative estimates for the prevalence of the disorder and 95% CIs were calculated using the eligible first-grade population as the denominator. Weighted prevalences and 95% CIs were also estimated, accounting for the sampling schemes and using data restricted to children who received a full evaluation. Results: A total of 6639 children were selected for participation from a population of 13 146 first-graders (boys, 51.9%; mean age, 6.7 years [SD, 0.41] and white maternal race, 79.3%). A total of 222 cases of fetal alcohol spectrum disorders were identified. The conservative prevalence estimates for fetal alcohol spectrum disorders ranged from 11.3 (95% CI, 7.8-15.8) to 50.0 (95% CI, 39.9-61.7) per 1000 children. The weighted prevalence estimates for fetal alcohol spectrum disorders ranged from 31.1 (95% CI, 16.1-54.0) to 98.5 (95% CI, 57.5-139.5) per 1000 children. Conclusions and Relevance: Estimated prevalence of fetal alcohol spectrum disorders among first-graders in 4 US communities ranged from 1.1% to 5.0% using a conservative approach. These findings may represent more accurate US prevalence estimates than previous studies but may not be generalizable to all communities.

Behavioral Changes Associated with a Disruptive New Student in the Classroom.

CASE: Marcus is a 10-year-old boy who was followed by his pediatrician for several years. She knows him as a socially engaged, active athlete, playing soccer and baseball, out-going, and a good student. He has been in good health without a significant medical history.At the beginning of this academic year, a new student was placed in Marcus's fourth grade class. This student is disruptive, impulsive, and abusive. He has frequent violent outbursts, yelling, kicking, and throwing objects, including recently throwing a desk across the room. The school has made efforts to manage this student. The teacher sets up behavior contracts, and the school has temporarily suspended the child; however, the school is unable to remove the child from the classroom. Many students, including Marcus, have been significantly affected by this disruption.Marcus describes the classroom environment as "tense." He reports he is never sure what is going to make the student "so mad." Over the last 3-4 months, Marcus developed nightmares, enuresis, and trichotillomania. The hair pulling is the most distressing feature for both Marcus and his parents. Marcus acknowledges that he is usually unaware of the behavior at first but then finds the sensation is relaxing. Afterward, he is typically embarrassed by the behavior. There is a family history of anxiety in both parents.He has been seeing a psychologist with some mild improvement in his enuresis. However, the hair pulling has not improved and has worsened. They were seeking additional advice regarding the next steps.

Cardiac Emergency Response Planning for Schools: A Policy Statement.

A sudden cardiac arrest in school or at a school event is potentially devastating to families and communities. An appropriate response to such an event-as promoted by developing, implementing, and practicing a cardiac emergency response plan (CERP)-can increase survival rates. Understanding that a trained lay-responder team within the school can make a difference in the crucial minutes between the time when the victim collapses and when emergency medical services arrive empowers school staff and can save lives. In 2015, the American Heart Association convened a group of stakeholders to develop tools to assist schools in developing CERPs. This article reviews the critical components of a CERP and a CERP team, the factors that should be taken into account when implementing the CERP, and recommendations for policy makers to support CERPs in schools.

Behavioral changes associated with a disruptive new student in the classroom.

CASE: Marcus is a 10-year-old boy who was followed by his pediatrician for several years. She knows him as a socially engaged, active athlete, playing soccer and baseball, out-going, and a good student. He has been in good health without a significant medical history.At the beginning of this academic year, a new student was placed in Marcus's fourth grade class. This student is disruptive, impulsive, and abusive. He has frequent violent outbursts, yelling, kicking, and throwing objects, including recently throwing a desk across the room. The school has made efforts to manage this student. The teacher sets up behavior contracts, and the school has temporarily suspended the child; however, the school is unable to remove the child from the classroom. Many students, including Marcus, have been significantly affected by this disruption.Marcus describes the classroom environment as "tense." He reports he is never sure what is going to make the student "so mad." Over the last 3-4 months, Marcus developed nightmares, enuresis, and trichotillomania. The hair pulling is the most distressing feature for both Marcus and his parents. Marcus acknowledges that he is usually unaware of the behavior at first but then finds the sensation is relaxing. Afterward, he is typically embarrassed by the behavior. There is a family history of anxiety in both parents.He has been seeing a psychologist with some mild improvement in his enuresis. However, the hair pulling has not improved and has worsened. They were seeking additional advice regarding the next steps.

Soliciting views of various communities on health research: a prelude to engagement in specific research projects.

BACKGROUND: Members of the public are increasingly engaged in health-service and biomedical research and provide input into the content of research, design and data sharing. As there is variation among different communities on how research is perceived, to engage all sectors of the general public research institutions need to customize their approach. OBJECTIVE: This paper explores how research institutions and community leaders can partner to determine the best ways to engage different sectors of the public in research. DESIGN: Following a literature review, a research institution engaged with four different sectors of the public through their respective representative community-based organizations (CBOs) by interviews with leaders, community member focus groups and a joint project. SETTING: San Diego and Imperial Counties, California, United States of America (USA). CONCLUSION: Before embarking on more specific research projects, investigators can gain valuable insights about different communities' attitudes to, and understanding of, health services and biomedical research by interacting directly with members of the community, collaborating with community leaders, and jointly identifying steps of engagement tailored to the community.

Medications at school: disposing of pharmaceutical waste.

BACKGROUND: This project quantified and categorized medications left unclaimed by students at the end of the school year. It determined the feasibility of a model medication disposal program and assessed school nurses' perceptions of environmentally responsible medication disposal. METHODS: At a large urban school district all unclaimed medications were collected at the end of a school year to determine the extent and nature of this problem. Nurses documented unclaimed medications and transported them to a central district location. An environmentally responsible medication disposal program, consisting of sealed containers bound for a local hospital's disposal system, was implemented. RESULTS: In a school district of approximately 133,000 students, there were 926 different medications abandoned at the end of a school year brought to a central disposal area. Nurses complied with the newly implemented protocol. Information collected from nurses indicates acceptance of the program. Disposal of unclaimed medications at a central location, use of secured containers, and transportation to a hospital for environmentally responsible disposal proved to be feasible and acceptable to the staff. CONCLUSIONS: Unclaimed medications at school each year pose a potentially huge environmental risk when disposed of improperly. It is feasible to implement an environmentally responsible medication disposal protocol at schools.

Case study in designing a research fundamentals curriculum for community health workers: a university-community clinic collaboration.

Community health workers (CHWs) are increasingly incorporated into research teams. Training them in research methodology and ethics, while relating these themes to a community's characteristics, may help to better integrate these health promotion personnel into research teams. An interactive training course on research fundamentals for CHWs was designed and implemented jointly by a community agency serving a primarily Latino, rural population and an academic health center. A focus group of community members and input from community leaders comprised a community-based participatory research model to create three 3-hour interactive training sessions. The resulting curriculum was interactive and successfully stimulated dialogue between trainees and academic researchers. By choosing course activities that elicited community-specific responses into each session's discussion, researchers learned about the community as much as the training course educated CHWs about research. The approach is readily adaptable, making it useful to other communities where CHWs are part of the health system.

Is Medication Information for Children with Autism Spectrum Disorder Monitored and Coordinated Across Professionals? Findings from a Teacher Survey.

Prescription medications are commonly used for children with autism spectrum disorder (ASD), however, there is little research regarding how the effect of medication is monitored across settings once prescribed. The present study addressed this issue for children with ASD in school by administering a questionnaire to teachers of students with ASD who were and were not being given medication. Specifically, the questionnaire assessed the teachers' knowledge about whether the child was being given medication, and whether behavior changes or side effects were being communicated in any way to the child's family and prescribing physician. The results showed that for children who were being given medication, fewer than half of the teachers reported knowing the child was being given medication. For those children who were not being given medication, only 53% of the teachers reported correct information for their students. Of the teachers who knew their students were being given medication, all reported that they were not conferring with the child's prescribing physician regarding behavioral observations or side effects. Whether teachers are blind to the medication types and dosage the students are being given or not, some type of communication to physicians about the children's behavior at school is important. Given the importance of monitoring medication for children with ASD, implications for system change, for professionals and for funding agencies are discussed.

Students with chronic diseases: nature of school physician support.

BACKGROUND: To educate children with chronic diseases in the least restrictive environment, schools must prevent, recognize, and react appropriately to symptom exacerbations. Schools are often pushed to their limits of knowledge, resources, and comfort level. This study determined the health conditions of students for whom districts seek school physician consultation and the nature of school physician consultants' involvement. METHODS: A retrospective record review was performed on 250 of the most recent records of school-elicited referrals from an academic center that provides physician consultation to school districts. Referrals were sent from 8 school districts in southern California (July 1996 to October 2006). Data collected were nature of student's special health need, the school physician consultant's intervention required to satisfy schools' needs, student grade level, enrollment in special education, and health-related excessive absenteeism. RESULTS: No single chronic condition, symptom, or special health care need predominated. Six types of school physician consultant activities were used to overcome hurdles schools faced when accommodating students with special health care needs. The 3 most common were direct communication with students' own physicians (70% of students), recommending an appropriate level of school health services when this was a matter of controversy (42%), and formulating portions of students' individualized school health plans (38%). CONCLUSIONS: A portion of students with special health care needs benefited from district referral to a school physician consultant. Whether some of these referrals can be avoided if school personnel and students' own physicians are supported and trained to communicate more effectively with one another needs to be explored.

Obesity and student performance at school.

To review the state of research on the association between obesity among school-aged children and academic outcomes, the authors reviewed published studies investigating obesity, school performance, and rates of student absenteeism. A table with brief descriptions of each study's research methodology and outcomes is included. Research demonstrates that overweight and obesity are associated with poorer levels of academic achievement. Data on the association of child overweight or obesity with levels of attendance are too sparse to draw conclusions.

Childhood asthma and student performance at school.

To better understand what is known about the association between childhood asthma, school attendance, and academic outcomes, the authors reviewed published studies investigating this topic. Tables with brief descriptions of each study's research methodology and outcomes are included. Research reveals evidence that rates of absenteeism are higher among students with asthma. The exact magnitude of absenteeism is difficult to ascertain. However, the studies have helped to identify characteristics of children with asthma that are most likely to be associated with the highest absenteeism rates. Some interventions to improve rates of absenteeism among school-aged children with asthma show promise, but it cannot yet be concluded that students who adhere to medical routines for controlling asthma will as a result increase their rates of attendance. Studies thus far have shown that there is either only a weak or nonexistent association between asthma and school achievement. Further studies are required to verify if certain subpopulations of children with asthma (eg, those with severe and ongoing symptoms, those with disturbed sleep, kindergarten children) are at higher risk for poor school achievement.

Sleep and student performance at school.

To review the state of research on the association between sleep among school-aged children and academic outcomes, the authors reviewed published studies investigating sleep, school performance, and cognitive and achievement tests. Tables with brief descriptions of each study's research methods and outcomes are included. Research reveals a high prevalence among school-aged children of suboptimal amounts of sleep and poor sleep quality. Research demonstrates that suboptimal sleep affects how well students are able to learn and how it may adversely affect school performance. Recommendations for further research are discussed.

Chronic health conditions and student performance at school.

To review the state of research on the association between common chronic health conditions and academic outcomes, the authors reviewed published studies investigating the association of school attendance, cognitive ability, and achievement with a number of chronic diseases. Tables with brief descriptions of each study's research methods and outcomes are included. Research reveals evidence that diabetes, sickle cell anemia, and epilepsy affect student achievement and ability. Levels of academic deficiency and specific areas of cognitive impairment are not as well understood. Many chronic conditions are not well researched. Suggestions for further research and recommendations for educators and health practitioners are provided.

Nutrition and student performance at school.

This article reviews research from published studies on the association between nutrition among school-aged children and their performance in school and on tests of cognitive functioning. Each reviewed article is accompanied by a brief description of its research methodology and outcomes. Articles are separated into 4 categories: food insufficiency, iron deficiency and supplementation, deficiency and supplementation of micronutrients, and the importance of breakfast. Research shows that children with iron deficiencies sufficient to cause anemia are at a disadvantage academically. Their cognitive performance seems to improve with iron therapy. A similar association and improvement with therapy is not found with either zinc or iodine deficiency, according to the reviewed articles. There is no evidence that population-wide vitamin and mineral supplementation will lead to improved academic performance. Food insufficiency is a serious problem affecting children's ability to learn, but its relevance to US populations needs to be better understood. Research indicates that school breakfast programs seem to improve attendance rates and decrease tardiness. Among severely undernourished populations, school breakfast programs seem to improve academic performance and cognitive functioning.