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In order to better understand how young adult literature (YAL) is used in secondary English teacher education, this study examines course syllabi submitted by researchers recently published in "The ALAN Review." Using a framework built on Bakhtin's work, this article analyzes course objectives and goals for inherent social discourses to examine how syllabi establish practices to support student learning. The syllabi studied provided support for an understanding of how YAL fits into teacher education. The goal was to use Bakhtin's theories to analyze these syllabi to build a foundational understanding of how the discourses of education influence course design. Data were organized into four categories. The first examines the discourses of how YAL is used to teach English education methods. The second is to use YAL to understand discourses of critical education, social justice, and diversity. The third examines discourses on defining YAL and/or adolescence/adolescents. The fourth examines discourses on reflective practice. In the findings section, individual objectives and goals are analyzed so that an understanding of how these discourses meet at sites of tension allows for a discussion on how YAL is being used, and how might it be developed in the future.

Jeffrey M Cochran,1 Hui Fang,2 Christophe Le Gallo,3 Timothy Peters-Strickland,4 Jean-Pierre Lindenmayer,5 J Corey Reuteman-Fowler6 1Medical & Real World Data Analytics, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 2Biostatistics, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 3Clinical Programming, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 4PPD, Inc., Wilmington, NC, USA; 5Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA; 6Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USACorrespondence: Jeffrey M Cochran, Medical & Real World Data Analytics, Otsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center, Princeton, NJ, 08540, USA, Tel +1 609 535 9035, Email Jeffrey.Cochran@otsuka-us.comPurpose: A recent, phase 3b, mirror-image clinical trial of outpatients with schizophrenia found that use of aripiprazole tablets with sensor (AS; Abilify MyCite®, comprising an ingestible event-marker sensor embedded in aripiprazole tablets, wearable sensor patches, and a smartphone application) reduced the incidence of psychiatric hospitalizations relative to oral standard-of-care antipsychotics. This analysis explored the relationship between AS engagement by participants and changes in participant performance and symptom-severity measures assessed by clinical raters.Participants and Methods: This post hoc analysis used prospectively collected clinical data from a phase 3b clinical trial (NCT03892889). Outpatients had schizophrenia, were aged 18– 65 years, and had ≥ 1 psychiatric hospitalization in the previous 48 months. Participants were grouped by study completion status and a k-means clustering algorithm based on AS utilization, resulting in 3 groups: discontinued (discontinued AS before month 3 of the study); moderate engagement (completed 3 months, used AS intermittently); and high engagement (completed 3 months, used AS regularly). Baseline to end-of-study differences for the Clinical Global Impression Scale (Severity of Illness and Improvement of Illness scales), Personal and Social Performance Scale, and Positive and Negative Syndrome Scale were calculated.Results: A total of 277 outpatients were enrolled (discontinued, n = 164; moderate engagement, n = 63; high engagement, n = 50). All groups experienced symptom improvement from baseline to end-of-study, with significant changes in the more-engaged groups. Highly engaged participants showed significant improvement for all clinical scores and subscores (all P < 0.05) and demonstrated significantly more improvement in symptoms than participants with less engagement.Conclusion: Participants who completed 3 months of the study and had higher AS engagement experienced significantly greater improvement in their end-of-study clinical assessments versus participants who did not complete 3 months. Improvement may be related to more-consistent medication intake and better engagement with a digital health system.Keywords: digital medicine, medication ingestion, treatment utilization, Positive and Negative Syndrome Scale

J Corey Fowler,1 Nathan Cope,2 Jonathan Knights,3 Hui Fang,4 Taisa Skubiak,5 Sukhi S Shergill,6 Peter Phiri,7 Shanaya Rathod,7 Timothy Peters-Strickland1 1Global Clinical Development, CNS and Digital Medicine, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, 08540, USA; 2Program Management, Otsuka Pharmaceutical Europe Ltd., Wexham, SL3 6PJ, UK; 3Data Insights and Analytics, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, 08540, USA; 4Biostatistics, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, 08540, USA; 5Clinical Management, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, 08540, USA; 6Institute of Psychiatry, Psychology and Neuroscience, King’s College London and South London and Maudsley NHS Foundation Trust, London, SE5 8AF, UK; 7Southern Health NHS Foundation Trust, Moorgreen Hospital, Clinical Trials Facility, Research Department, Southampton, SO30 3JB, UKCorrespondence: J Corey FowlerOtsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center, Princeton, NJ, 08540, USATel +1 919 475 4823Email corey.fowler@otsuka-us.comPurpose: Symptoms of psychotic disorders can complicate efforts to accurately evaluate patients’ medication ingestion. The digital medicine system (DMS), composed of antipsychotic medication co-encapsulated with an ingestible sensor, wearable sensor patches, and a smartphone application, was developed to objectively measure medication ingestion. We assessed performance and acceptance of the DMS in subjects with psychotic disorders.Methods: This was an 8-week open-label, single-arm, multicenter, Phase 4 pragmatic study (NCT 03568500; EudraCT #2017-004602-17). Eligible adults were diagnosed with schizophrenia, schizoaffective disorder, or first-episode psychosis; were receiving aripiprazole, quetiapine, olanzapine, or risperidone; and could use the DMS with the application downloaded on a personal smartphone. The primary endpoint was good patch coverage, defined as the proportion of days over the assessment period where ≥ 80.0% of patch data was available, or an ingestion was detected. Exploratory endpoints included a survey on user satisfaction, used to assess acceptance of the DMS. Safety analyses included the incidence of treatment-emergent adverse events (TEAEs).Results: From May 25, 2018 to March 22, 2019, 55 subjects were screened and 44 were enrolled. Good patch coverage was achieved on 63.4% of days assessed and the DMS generated an adherence metric of ≥ 80.0%, reflecting the percentage of ingestion events expected when good patch coverage was reported. Most subjects (53.5%) were satisfied with the DMS. Medical device skin irritations were the only TEAEs reported.Conclusion: The DMS had sufficient performance in, and acceptance from, subjects with psychotic disorders and was generally well tolerated.Keywords: digital medicine, antipsychotic, digital health, medication adherence

Timothy Peters-Strickland,1 Ross A Baker,2 Pedro Such,3 Peter Zhang,4 Jessica J Madera21Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 2Global Medical Affairs, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 3Medical Affairs Psychiatry, H. Lundbeck A/S, Valby, Denmark; 4Biostatistics, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USAObjective: To evaluate the effect of aripiprazole once-monthly 400 mg (AOM 400; Abilify Maintena®,) on personal and social functioning in patients with schizophrenia in both the acute treatment and maintenance therapy settings.Methods: Post hoc analyses were conducted on data from Study 291 (NCT01663532), a 12-week, randomized, double-blind, placebo-controlled trial conducted in patients who were experiencing an acute psychotic episode, and Study 248 (NCT00731549), a 52-week open-label extension of two randomized, controlled trials of AOM 400 as maintenance therapy. Assessment of functioning was made using the Personal and Social Performance (PSP) scale. In Study 291, results were stratified by age (≤35 years or >35 years).Results: In Study 291, 340 patients were included in the analysis (n=168 randomized to AOM 400 [n=49 aged ≤35 years, n=119 aged >35 years]; n=172 randomized to placebo [n=54 aged ≤35 years, n=118 aged >35 years]). In Study 248, 1,081 patients entered the open-label maintenance phase and 858 completed the study. In Study 291, AOM 400, compared with placebo, resulted in a significant increase (improvement) in PSP scores based on LSM (SE) changes from baseline to Week 12 in patients aged ≤35 years (20.6 [1.9] for AOM 400 vs 9.5 [2.4] for placebo; P=0.001) and a numerically (but not significantly) larger increase in PSP scores in patients aged >35 years (16.1 [1.7] for AOM 400 vs 12.5 [1.9] for placebo; P=0.093). Improvements in both age groups met criteria for a minimally important clinical difference (7–10 points). In Study 248, AOM 400 resulted in either numerical improvements (increases) from baseline in PSP total score or maintenance of stable baseline values throughout the study.Conclusion: AOM 400 was effective in improving personal and social functioning during acute treatment and maintaining function during long-term treatment.Keywords: aripiprazole, long-acting injectable, antipsychotics, schizophrenia, patient function, psychosocial function

Timothy Peters-Strickland,1 Ainslie Hatch,2 Anke Adenwala,3 Katie Atkinson,4 Benjamin Bartfeld5 1Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 2Clinical Sciences, Digital Medicine, Otsuka America Pharmaceutical, Inc., Princeton, NJ, USA; 3Biostatistics, GfK Custom Research, LLC, Chicago, IL, USA; 4Human Factors Engineering, Proteus Digital Health, Redwood, CA, USA; 5Industrial Design Specialist, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA Background: The digital medicine system (DMS), a drug–device combination developed for patients with serious mental illness, integrates adherence measurement with pharmacologic treatment by embedding an ingestible sensor in a pill, allowing for information sharing among patients, health care providers (HCPs), and caregivers via a mobile interface. Studies conducted during the DMS development process aimed to minimize cognitive burden and use-related risks and demonstrated effective use of the technology. Methods: Human factors (HF) studies assessed the system’s safe and effective use by the intended users for the intended uses. The patient interface was tested in six formative HF studies followed by a validation study. The HCP/caregiver interface was tested in one study before validation. All tasks critical to safety or necessary for effective use were included. Formative studies identified use-related risks and the causes of use problems to guide design modification. Validation of the patient and HCP/caregiver interfaces assessed risks of the final product. Results: During the patient formative studies, design improvements were made to address problems and mitigate risks thought to be associated with a suboptimal system design or patient understanding of the system. In the validation study of the patient interface, 35 patients attempted 23 performance tasks, for a total of 805 attempts; 783/805 attempts were completed with success. One close call, 15 failures, and 6 difficulties occurred on these user tasks; only 3 of these were on a critical task. Residual risks resistant to mitigation were found to be of low severity based on the US Food and Drug Administration 2016 guidance. Conclusion: The final design of the DMS reflects input by the intended user populations through a comprehensive development methodology. In alignment with the US Food and Drug Administration goals for HF studies, the system was found to be safe and effective for the intended users, uses, and use environments. Keywords: digital medicine system, drug–device combination, schizophrenia, bipolar disorder, major depressive disorder, aripiprazole, serious mental illness, usability

Alex Kopelowicz,1 Ross A Baker,2 Cathy Zhao,2 Claudette Brewer,3 Erica Lawson,3 Timothy Peters-Strickland2 1David Geffen School of Medicine, University of California, Los Angeles, CA, 2Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ, 3Otsuka Pharmaceutical Development and Commercialization Inc., Rockville, MD, USA Background: Medication nonadherence is common in the treatment of serious mental illness (SMI) and leads to poor outcomes. The digital medicine system (DMS) objectively measures adherence with oral aripiprazole in near-real time, allowing recognition of adherence issues. This pilot study evaluated the functionality of an integrated call center in optimizing the use of the DMS. Materials and methods: An 8-week, open-label, single-arm trial at four US sites enrolled adults with bipolar I disorder, major depressive disorder, and schizophrenia on stable oral aripiprazole doses and willing to use the DMS (oral aripiprazole + ingestible event marker [IEM], IEM-detecting skin patch, and software application). Integrated call-center functionality was assessed based on numbers and types of calls. Ingestion adherence with prescribed treatment (aripiprazole + IEM) during good patch wear and proportion of time with good patch wear (days with ≥80% patch data or detected IEM) were also assessed. Results: All enrolled patients (n=49) used the DMS and were included in analyses; disease duration overall approached 10 years. For a duration of 8 weeks, 136 calls were made by patients, and a comparable 160 calls were made to patients, demonstrating interactive communication. The mean (SD) number of calls made by patients was 2.8 (3.5). Approximately half of the inbound calls made by patients occurred during the first 2 weeks and were software application- or patch-related. Mean ingestion adherence was 88.6%, and corresponding good patch wear occurred on 80.1% of study days. Conclusion: In this pilot study, the integrated call center facilitated DMS implementation in patients with SMI on stable doses of oral aripiprazole. In clinical practice, the call center and the DMS will facilitate objective measurement of adherence and potentially improve rates of adherence in patients with SMI. Keywords: schizophrenia, bipolar I disorder, major depressive disorder, digital medicine, adherence

Sonal Batra,1 Ross A Baker,2 Tao Wang,3 Felicia Forma,4 Faith DiBiasi,3 Timothy Peters-Strickland5 1Department of Psychiatry, Rutgers Robert Wood Johnson Medical School, Piscataway, 2Global Medical Affairs, Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ, 3Medical Affairs, Otsuka Pharmaceutical Development and Commercialization Inc., Rockville, MD, 4Health Economics and Outcomes Management, 5Global Clinical Development, Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ, USA Background: As the capabilities and reach of technology have expanded, there is an accompanying proliferation of digital technologies developed for use in the care of patients with mental illness. The objective of this review was to systematically search published literature to identify currently available health technologies and their intended uses for patients with serious mental illness.Materials and methods: The Medline, Embase, and BIOSIS Previews electronic databases were searched to identify peer-reviewed English language articles that reported the use of digital, mobile, and other advanced technology in patients with schizophrenia/schizoaffective disorder, bipolar disorder, and major depressive disorder. Eligible studies were systematically reviewed based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.Results: Eighteen studies that met the inclusion criteria were identified. Digital health technologies (DHTs) assessed in the selected studies included mobile applications (apps), digital medicine, digital personal health records, and an electronic pill container. Smartphone apps accounted for the largest share of DHTs. The intended uses of DHTs could be broadly classified as monitoring to gain a better understanding of illness, clinical assessment, and intervention. Overall, studies indicated high usability/feasibility and efficacy/effectiveness, with several reporting validity against established clinical scales. Users were generally engaged with the DHT, and mobile assessments were deemed helpful in monitoring disease symptoms.Conclusion: Rapidly proliferating digital technologies seem to be feasible for short-term use in patients with serious mental illness; nevertheless, long-term effectiveness data from naturalistic studies will help demonstrate their usefulness and facilitate their adoption and integration into the mental health-care system. Keywords: serious mental illness, health technology, mHealth, smartphone applications, digital medicine

: In order to better understand how young adult literature (YAL) is used in secondary English teacher education, this study examines course syllabi submitted by researchers recently published in The ALAN Review. Using a framework built on Bakhtin's work, this article analyzes course objectives and goals for inherent social discourses to examine how syllabi establish practices to support student learning. The syllabi studied provided support for an understanding of how YAL fits into teacher education. The goal was to use Bakhtin's theories to analyze these syllabi to build a foundational understanding of how the discourses of education influence course design. Data were organized into four categories. The first examines the discourses of how YAL is used to teach English education methods. The second is to use YAL to understand discourses of critical education, social justice, and diversity. The third examines discourses on defining YAL and/or adolescence/adolescents. The fourth examines discourses on reflective practice. In the findings section, individual objectives and goals are analyzed so that an understanding of how these discourses meet at sites of tension allows for a discussion on how YAL is being used, and how might it be developed in the future [ABSTRACT FROM AUTHOR]