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Background: Rich data on diverse patients and their treatments and outcomes within Electronic Health Record (EHR) systems can be used to generate real world evidence. A health recommender system (HRS) framework can be applied to a decision support system application to generate data summaries for similar patients during the clinical encounter to assist physicians and patients in making evidence-based shared treatment decisions., Objective: A human-centered design (HCD) process was used to develop a HRS for treatment decision support in orthopaedic medicine, the Informatics Consult for Individualized Treatment (I-C-IT) . We also evaluate the usability and utility of the system from the physician's perspective, focusing on elements of utility and shared decision-making in orthopaedic medicine., Methods: The HCD process for I-C-IT included 6 steps across three phases of analysis, design, and evaluation. A team of informaticians and comparative effectiveness researchers directly engaged with orthopaedic surgeon subject matter experts in a collaborative I-C-IT prototype design process. Ten orthopaedic surgeons participated in a mixed methods evaluation of the I-C-IT prototype that was produced., Results: The HCD process resulted in a prototype system, I-C-IT, with 14 data visualization elements and a set of design principles crucial for HRS for decision support. The overall standard system usability scale (SUS) score for the I-C-IT Webapp prototype was 88.75 indicating high usability. In addition, utility questions addressing shared decision-making found that 90% of orthopaedic surgeon respondents either strongly agreed or agreed that I-C-IT would help them make data informed decisions with their patients., Conclusion: The HCD process produced an HRS prototype that is capable of supporting orthopaedic surgeons and patients in their information needs during clinical encounters. Future research should focus on refining I-C-IT by incorporating patient feedback in future iterative cycles of system design and evaluation., Competing Interests: Competing interests: The authors declare that they have no competing interests. Additional Declarations: No competing interests reported.

Some of the most vexing issues with the COVID-19 pandemic were the inability of schools and work areas to track symptoms. Technology solutions to mitigate repercussions of the COVID-19 pandemic include tools that provide guidelines and interfaces to influence behavior, reduce exposure to the disease, and enable policy-driven avenues to return to a sense of normalcy (e.g., school and work). This presentation presents the implementation and early evaluation of a return-to-work COVID-19 symptom and risk assessment tool.

Background: The Health Information Technology for Economic and Clinical Health Act of 2009 was legislated to reduce health care costs, improve quality, and increase patient safety. Providers and organizations were incentivized to exhibit meaningful use of certified electronic health record (EHR) systems in order to achieve this objective. EHR adoption is an expensive investment, given the resources and capital that are invested. Due to the cost of the investment, a return on the EHR adoption investment is expected., Objective: This study performed a value analysis of EHRs. The objective of this study was to investigate the relationship between EHR adoption levels and financial and clinical outcomes by combining both financial and clinical outcomes into one conceptual model., Methods: We examined the multivariate relationships between different levels of EHR adoption and financial and clinical outcomes, along with the time variant control variables, using moderation analysis with a longitudinal fixed effects model. Since it is unknown as to when hospitals begin experiencing improvements in financial outcomes, additional analysis was conducted using a 1- or 2-year lag for profit margin ratios., Results: A total of 5768 hospital-year observations were analyzed over the course of 4 years. According to the results of the moderation analysis, as the readmission rate increases by 1 unit, the effect of a 1-unit increase in EHR adoption level on the operating margin decreases by 5.38%. Hospitals with higher readmission payment adjustment factors have lower penalties., Conclusions: This study fills the gap in the literature by evaluating individual relationships between EHR adoption levels and financial and clinical outcomes, in addition to evaluating the relationship between EHR adoption level and financial outcomes, with clinical outcomes as moderators. This study provided statistically significant evidence (P<.05), indicating that there is a relationship between EHR adoption level and operating margins when this relationship is moderated by readmission rates, meaning hospitals that have adopted EHRs could see a reduction in their readmission rates and an increase in operating margins. This finding could further be supported by evaluating more recent data to analyze whether hospitals increasing their level of EHR adoption would decrease readmission rates, resulting in an increase in operating margins. Hospitals would incur lower penalties as a result of improved readmission rates, which would contribute toward improved operating margins., (©Shikha Modi, Sue S Feldman, Eta S Berner, Benjamin Schooley, Allen Johnston. Originally published in JMIR Medical Informatics (https://medinform.jmir.org), 24.01.2024.)

Background: The COVID-19 pandemic influenced many to consider methods to reduce human contact and ease the burden placed on health care workers. Conversational agents or chatbots are a set of technologies that may aid with these challenges. They may provide useful interactions for users, potentially reducing the health care worker burden while increasing user satisfaction. Research aims to understand these potential impacts of chatbots and conversational recommender systems and their associated design features., Objective: The objective of this study was to evaluate user perceptions of the helpfulness of an artificial intelligence chatbot that was offered free to the public in response to COVID-19. The chatbot engaged patients and provided educational information and the opportunity to report symptoms, understand personal risks, and receive referrals for care., Methods: A cross-sectional study design was used to analyze 82,222 chats collected from patients in South Carolina seeking services from the Prisma Health system. Chi-square tests and multinomial logistic regression analyses were conducted to assess the relationship between reported risk factors and perceived chat helpfulness using chats started between April 24, 2020, and April 21, 2022., Results: A total of 82,222 chat series were started with at least one question or response on record; 53,805 symptom checker questions with at least one COVID-19-related activity series were completed, with 5191 individuals clicking further to receive a virtual video visit and 2215 clicking further to make an appointment with a local physician. Patients who were aged >65 years (P<.001), reported comorbidities (P<.001), had been in contact with a person with COVID-19 in the last 14 days (P<.001), and responded to symptom checker questions that placed them at a higher risk of COVID-19 (P<.001) were 1.8 times more likely to report the chat as helpful than those who reported lower risk factors. Users who engaged with the chatbot to conduct a series of activities were more likely to find the chat helpful (P<.001), including seeking COVID-19 information (3.97-4.07 times), in-person appointments (2.46-1.99 times), telehealth appointments with a nearby provider (2.48-1.9 times), or vaccination (2.9-3.85 times) compared with those who did not perform any of these activities., Conclusions: Chatbots that are designed to target high-risk user groups and provide relevant actionable items may be perceived as a helpful approach to early contact with the health system for assessing communicable disease symptoms and follow-up care options at home before virtual or in-person contact with health care providers. The results identified and validated significant design factors for conversational recommender systems, including triangulating a high-risk target user population and providing relevant actionable items for users to choose from as part of user engagement., (©Akanksha Singh, Benjamin Schooley, Nitin Patel. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 14.12.2023.)

Background: A core set of requirements for designing AI-based Health Recommender Systems (HRS) is a thorough understanding of human factors in a decision-making process. Patient preferences regarding treatment outcomes can be one important human factor. For orthopaedic medicine, limited communication may occur between a patient and a provider during the short duration of a clinical visit, limiting the opportunity for the patient to express treatment outcome preferences (TOP). This may occur despite patient preferences having a significant impact on achieving patient satisfaction, shared decision making and treatment success. Inclusion of patient preferences during patient intake and/or during the early phases of patient contact and information gathering can lead to better treatment recommendations., Aim: We aim to explore patient treatment outcome preferences as significant human factors in treatment decision making in orthopedics. The goal of this research is to design, build, and test an app that collects baseline TOPs across orthopaedic outcomes and reports this information to providers during a clinical visit. This data may also be used to inform the design of HRSs for orthopaedic treatment decision making., Methods: We created a mobile app to collect TOPs using a direct weighting (DW) technique. We used a mixed methods approach to pilot test the app with 23 first-time orthopaedic visit patients presenting with joint pain and/or function deficiency by presenting the app for utilization and conducting qualitative interviews and quantitative surveys post utilization., Results: The study validated five core TOP domains, with most users dividing their 100-point DW allocation across 1-3 domains. The tool received moderate to high usability scores. Thematic analysis of patient interviews provides insights into TOPs that are important to patients, how they can be communicated effectively, and incorporated into a clinical visit with meaningful patient-provider communication that leads to shared decision making., Conclusion: Patient TOPs may be important human factors to consider in determining treatment options that may be helpful for automating patient treatment recommendations. We conclude that inclusion of patient TOPs to inform the design of HRSs results in creating more robust patient treatment profiles in the EHR thus enhancing opportunities for treatment recommendations and future AI applications., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Singh, Schooley, Floyd, Pill and Brooks.)

Background: The (GuideSafe™) Exposure Notification System (ENS) was built and deployed in (Alabama) for anonymous sending and receiving of COVID-19 exposure alerts to people who have been in close contact with someone who later reports a positive COVID-19 test. Little is known about how the demographic groups perceive recent privacy-preserving the ENS innovations, including their usability, usefulness, satisfaction, and continued interest in sharing COVID-19 exposure information. The purpose of this study was to investigate how users across the demographic groups perceive the sharing of exposure information with various types of organizations and to investigate how end-user perceptions of the ENS usability, usefulness, and satisfaction differ across the demographic groups within the context of a statewide deployment of an exposure notification system., Methods: A survey was administered to (state residents blinded for review) ( N = 1,049) to assess propensity to share COVID-19 infection data and evaluate end-user perceptions about usability, usefulness, and satisfaction with the (Alabama) ENS. The ANOVA and the Tukey's Honestly Significant Difference (HSD) post-hoc tests were conducted to assess the demographic group differences., Results: The ENS survey participants had a high awareness of contact tracing, exposure notifications, and the (GuideSafe™) ENS and reported having downloaded the app. Survey results revealed the majority of participants rated the app as useful ( n = 490, 79%), easy to use ( n = 490, 79%), and reported satisfaction with its use ( n = 546, 88%). Other results suggest that ethnicity and age may be important factors for trust in sharing exposure information., Conclusion: The (GuideSafe™) system was one integrated component of comprehensive education and work re-entry strategy across (Alabama) that reached a broad user base. Users across the different demographic groups perceive the sharing of information about their communicable disease exposures differently. Furthermore, demographic factors play a role in which types of organizations individuals are willing to share their communicable disease exposure information. Public health institutions, employers, schools, healthcare providers, and technology designers may want to consider these findings as they construct technologies and perform outreach campaigns aimed at reducing infection rates with the ENS and related technologies., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Schooley and Feldman.)

To date, most HIE studies have investigated user perceptions of value prior to use. Few studies have assessed factors associated with the value of HIE through its actual use. This study investigates provider perceptions on HIE comparing those who had prior experience vs those who had no experience with it. In so doing, we identify six constructs: prior use, system complexity, system concerns, public/population health, care delivery, and provider performance. This study uses a mixed methods approach to data collection. From 15 interviews of medical community leaders, a survey was constructed and administered to 263 clinicians. Descriptive statistics and analysis of variance was used, along with Tukey HSD tests for multiple comparisons. Results indicated providers whom previously used HIE had more positive perceptions about its benefits in terms of system complexity ( p  = .001), care delivery ( p  = .000), population health ( p  = .003), and provider performance ( p  = .005); women providers were more positive in terms of system concerns ( p  = .000); patient care ( p  = .031), and population health ( p  = .009); providers age 44-55 were more positive than older and younger groups in terms of patient care ( p  = .032), population health ( p  = .021), and provider performance ( p  = .014); while differences also existed across professional license groups (physician, nurse, other license, admin (no license)) for all five constructs ( p  < .05); and type of organization setting (hospital, ambulatory clinic, medical office, other) for three constructs including system concerns ( p  = .017), population health ( p  = .018), and provider performance (p = .018). There were no statistically significant differences found between groups based on a provider's role in an organization (patient care, administration, teaching/research, other). Different provider perspectives about the value derived from HIE use exist depending on prior experience with HIE, age, gender, license (physician, nurse, other license, admin (no license)), and type of organization setting (hospital, ambulatory clinic, medical office, other). This study draws from the theory of planned behavior to understand factors related to physicians' perceptions about HIE value, serving as a departure point for more detailed investigations of provider perceptions and behavior in regard to future HIE use and promoting interoperability., Competing Interests: Conflict of InterestOn behalf of all authors, the corresponding author states that there is no conflict of interest., (© Springer Science+Business Media, LLC, part of Springer Nature 2020.)

Children in foster care face disproportionate rates of biopsychosocial challenges but social and extracurricular activities (SEAs) may support their healthy development. The Reasonable and Prudent Parenting Standard (RPPS), a 2014 federal policy, aims to increase access to these opportunities for children in foster care. Analyses of statutes from 50 US states and the District of Columbia (n = 51) revealed similarities and differences in state-level RPPS policy implementation. Building on these findings, researchers conducted semi-structured retrospective telephone interviews with foster parents across one southeastern state (n = 20) to identify local retrospective perspectives on RPPS implementation. Using thematic inductive coding two unique themes emerged about SEAs prior to RPPS: 1) negative social impacts and 2) complicated activity approval processes. Three unique themes emerged after RPPS: 1) empowerment, 2) implementation disparities and 3) resource recommendations. Policy implications include the need to support foster parents by increasing resources (funding, transportation, access), clarifying liability and clarifying motivation expectations.

Background: Although the incidence of breast cancer is lower in African-American women than in White women, African-American women have a decreased survival rate. The difference in survival rate may stem from poor endocrine therapy adherence, which increases breast cancer recurrence. Therefore, accessible and culturally sensitive interventions to increase endocrine therapy adherence are necessary., Objective: The purpose of this concurrent convergent mixed methods study was to provide further data to guide the development of the proposed culturally sensitive mHealth app, STORY+ for African-American women with breast cancer., Methods: We recruited 20 African-American women diagnosed with estrogen-positive breast cancer and currently prescribed endocrine therapy. We used a concurrent convergent data collection method to (1) assess the use of smartphones and computers related to health care and (2) identify foundational aspects to support endocrine therapy adherence for incorporation in a mobile health app., Results: Overwhelmingly, the participants preferred using smartphones to using computers for health care. Communicating with health care providers and pharmacies was the most frequent health care use of smartphones, followed by exercise tracking, and accessing the patient portal. We identified 4 aspects of adherence to endocrine therapy and smartphone use for incorporation in app development. The factors that emerged from the integrated qualitative and quantitative data were (1) willingness to use, (2) side effects, (3) social connection, and (4) beliefs about endocrine therapy., Conclusions: Further research is needed to develop a culturally sensitive app for African-American women with breast cancer to improve adherence to endocrine therapy. Our work strongly suggests that this population would use the app to connect with other African-American breast cancer survivors and manage endocrine therapy., (©Sara Donevant, Sue P Heiney, Cassandra Wineglass, Benjamin Schooley, Akanksha Singh, Jingxi Sheng. Originally published in JMIR Formative Research (https://formative.jmir.org), 11.06.2021.)

Background: Adverse drug/device reactions (ADRs) can result in severe patient harm. We define very serious ADRs as being associated with severe toxicity, as measured on the Common Toxicity Criteria Adverse Events (CTCAE)) scale, following use of drugs or devices with large sales, large financial settlements, and large numbers of injured persons. We report on impacts on patients, clinicians, and manufacturers following very serious ADR reporting., Methods: We reviewed clinician identified very serious ADRs published between 1997 and 2019. Drugs and devices associated with reports of very serious ADRs were identified. Included drugs or devices had market removal discussed at Food and Drug Advisory (FDA) Advisory Committee meetings, were published by clinicians, had sales > $1 billion, were associated with CTCAE Grade 4 or 5 toxicity effects, and had either >$1 billion in settlements or >1,000 injured patients. Data sources included journals, Congressional transcripts, and news reports. We reviewed data on: 1) timing of ADR reports, Boxed warnings, and product withdrawals, and 2) patient, clinician, and manufacturer impacts. Binomial analysis was used to compare sales pre- and post-FDA Advisory Committee meetings., Findings: Twenty very serious ADRs involved fifteen drugs and one device. Legal settlements totaled $38.4 billion for 753,900 injured persons. Eleven of 18 clinicians (61%) reported harms, including verbal threats from manufacturer (five) and loss of a faculty position (one). Annual sales decreased 94% from $29.1 billion pre-FDA meeting to $4.9 billion afterwards ( p <0.0018). Manufacturers of four drugs paid $1.7 billion total in criminal fines for failing to inform the FDA and physicians about very serious ADRs. Following FDA approval, the median time to ADR reporting was 7.5 years (Interquartile range 3,13 years). Twelve drugs received Box warnings and one drug received a warning (median, 7.5 years following ADR reporting (IQR 5,11 years). Six drugs and 1 device were withdrawn from marketing (median, 5 years after ADR reporting (IQR 4,6 years))., Interpretation: Because very serious ADRs impacts are so large, policy makers should consider developing independently funded pharmacovigilance centers of excellence to assist with clinician investigations., Funding: This work received support from the National Cancer Institute (1R01 CA102713 (CLB), https://www.nih.gov/about-nih/what-we-do/nih-almanac/national-cancer-institute-nci; and two Pilot Project grants from the American Cancer Society's Institutional Grant Award to the University of South Carolina (IRG-13-043-01) https://www.cancer.org/ (SH; BS)., Competing Interests: Dr. Sartor reports grants and personal fees from AAA, personal fees from ASTELLAS, grants and personal fees from ASTRAZENECA, grants and personal fees from BAYER, personal fees from BLUE EARTH DIAGNOSTICS, INC., personal fees from EMD SERONO, grants and personal fees from ENDOCYTE, personal fees from PFIZER, grants and personal fees from PROGENICS, grants and personal fees from SANOFI, grants from INVITAE, grants and personal fees from MERCK, grants and personal fees from NOVARTIS, grants and personal fees from JANSSEN, personal fees from CONSTELLATION, personal fees from DENDREON, personal fees from BRISTOL-MYERS SQUIBB, grants from INNOCRIN, grants from SOTIO, other from NRG, other from NCI, personal fees from BRAVARIN NORDIC, personal fees from CLOVIS, personal fees from MYRIAD, personal fees from NORIA THERAPEUTICS, INC., personal fees from NOXOPHARM, personal fees from POINT BIOPHARMA, personal fees from TENEBIO, personal fees from THERAGNOSTICS, personal fees from TELIX, personal fees from CLARITY PHARMACUEITCALS, personal fees from Celegne, personal fees from FUSION, personal fees from ISOTOPEN TECHNOLOGIEN MEUNCHEN, during the conduct of the study. All other authors report no conflict., (© 2020 The Author(s).)

Background: Patient education delivered by a health care provider increases patients' understanding and adherence to medical instructions, which helps to improve patient health. Multiple challenges exist to delivering effective patient education to patients with multiple chronic conditions, including giving the necessary time, range, and types of learning materials, and assessing the level of understanding. To help overcome these challenges, it is important to study new electronic means to assist in patient education, such as the use of mobile devices, interactive media, 3-dimensional images, and multimedia educational content at the bedside., Objective: The goal of this study was to address the need for blended learning strategies combining technical and workflow integration of digital patient education systems for patients with chronic conditions within and across the regular process of care. Studies are needed to evaluate the utility and benefits of these technologies for providers and patients alike., Methods: A mixed-methods approach was employed including survey administration to 178 patients after they received digital patient education in person with a health care provider, and qualitative interviews with 16 nurse educators who used the mobile digital health education technology to deliver instruction to patients. Patient survey data were analyzed using chi-square statistical tests. Qualitative interviews were analyzed for user acceptance and perceived value themes., Results: Patients who were counseled using a blended digital health education approach reported improved understanding of educational content (P=.034) and chronic health conditions (P<.001), were more motivated to care for themselves at home (P<.001), were more likely to say that they felt capable of making health care decisions with their doctors (P<.001) and on their own (P=.001), and were more likely to report their intention to follow their doctor's instructions (P<.001) than were patients whose education was not computer-based. Nurse educators felt that the digital education system and content enhanced their education efforts and could be easily integrated into the outpatient clinical workflow., Conclusions: Patient education for individuals with chronic conditions may be more effective than traditional formats when provided in blended digital formats supervised by a health care provider., (©Benjamin Schooley, Akanksha Singh, Neşet Hikmet, Robert Brookshire, Nitin Patel. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 22.12.2020.)

The EU, the USA, and Japan account for the majority of biological pharmacotherapy use worldwide. Biosimilar regulatory approval pathways were authorised in the EU (2006), in Japan (2009), and in the USA (2015), to facilitate approval of biological drugs that are highly similar to reference products and to encourage market competition. Between 2007 and 2020, 33 biosimilars for oncology were approved by the European Medicines Agency (EMA), 16 by the US Food and Drug Administration (FDA), and ten by the Japan Pharmaceuticals and Medical Devices Agency (PMDA). Some of these approved applications were initially rejected because of manufacturing concerns (four of 36 [11%] with the EMA, seven of 16 [44%] with the FDA, none of ten for the PMDA). Median times from initial regulatory submission before approval of oncology biosimilars were 1·5 years (EMA), 1·3 years (FDA), and 0·9 years (PMDA). Pharmacists can substitute biosimilars for reference biologics in some EU countries, but not in the USA or Japan. US regulation prohibits substitution, unless the biosimilar has been approved as interchangeable, a designation not yet achieved for any biosimilar in the USA. Japan does not permit biosimilar substitution, as prescribers must include the product name on each prescription and that specific product must be given to the patient. Policy Reviews published in 2014 and 2016 in The Lancet Oncology focused on premarket and postmarket policies for oncology biosimilars before most of these drugs received regulatory approval. In this Policy Review from the Southern Network on Adverse Reactions, we identify factors preventing the effective launch of oncology biosimilars. Introduction to the market has been more challenging with therapeutic than for supportive care oncology biosimilars. Addressing region-specific competition barriers and educational needs would improve the regulatory approval process and market launches for these biologics, therefore expanding patient access to these products in the EU, the USA, and Japan., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Erythropoisis stimulating agent (ESA) use was addressed in Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) meetings between 2004 and 2008. FDA safety-focused regulatory actions occurred in 2007 and 2008. In 2007, black box warnings advised of early death and venous thromboembolism (VTE) risks with ESAs in oncology. In 2010, a Risk Evaluation Strategies (REMS) was initiated, with cancer patient consent that mortality and VTE risks were noted with ESAs. We report warnings and REMS impacts on ESA utilization among Veterans Administration (VA) cancer patients with chemotherapy-induced anemia (CIA). Data were from Veterans Affairs database (2003-2012). Epoetin and darbepoetin use were primary outcomes. Segmented linear regression was used to estimate changes in ESA use levels and trends, clinical appropriateness, and adverse events (VTEs) among chemotherapy-treated cancer patients. To estimate changes in level of drug prescription rate after policy actions, model-specific indicator variables as covariates based on specific actions were included. ESA use fell by 95% and 90% from 2005, for epoetin and darbepoetin, from 22% and 11%, respectively, to 1% and 1%, respectively, among cancer patients with CIA, respectively (p<0.01). Following REMS in 2010, mean hematocrit levels at ESA initiation decreased from 30% to 21% (p<0.01). Black box warnings preceded decreased ESA use among VA cancer patients with CIA. REMS was followed by reduced hematocrit levels at ESA initiation. Our findings contrast with privately- insured and Medicaid insured cancer patient data on chemotherapy-induced anemia where ESA use decreased to 3% to 7% by 2010-2012. By 2012, the era of ESA administration to VA to cancer patients had ended but the warnings remain relevant and significant. In 2019, oncology/hematology national guidelines (ASCO/ASH) recommend that cancer patients with chemotherapy-induced anemia should receive ESAs or red blood cell transfusions after risk-benefit evaluation., Competing Interests: The authors have read the journal’s policy and have the following competing interests to declare: LB is a paid employee of Oncology Analytics in Plantation, Florida (https://www.oncologyanalytics.com/). There are no patents, products in development or marketed products associated with this research to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Erythropoiesis-stimulating agents (ESAs) are available to treat chemotherapy-induced anemia (CIA). In 2007-2008, regulatory notifications advised of venous thromboembolism and mortality risks while the Center for Medicare and Medicaid Services' restricted ESA initiation to patients with hemoglobin <10 g/dl. In 2010, a Risk Evaluation and Mitigation Strategies required consent prior to administration. We evaluated ESA utilization from 2003 to 2012 and obtained private health insurer claims data for persons with lung, colorectal, or breast cancer from 2001 to 2012. ESA use for CIA was determined by an ESA claim after chemotherapy, up to 6 months after treatment. We identified 839,948 commercially insured patients, including 24,785 patients with ESA-treated CIA (3.2%). Darbepoetin use increased 3.9-fold from 2003 to 2007 (12.3% to 48.7%) and then decreased 95% to 2.6% by 2012. Epoetin use decreased 90% from 2003 to 2012 (30.3% to 3.1%). Between 2003 and 2012, mean epoetin dosing decreased 0.8-fold (244,979 in 2003 vs. 196,216 units in 2012), but increased 1.8-fold for darbepoetin-treated CIA (262 in 2003 to 467 μg in 2012). Among CIA patients, transfusions were low (4.5%) in 2002-2007, then increased 2.2-fold between 2008 and 2012. Safety initiatives between 2007 and 2010 facilitated reductions in ESA use combined with changes in coverage. These data show the efficacy of regulatory efforts, publication of adverse events and changes in reimbursement in reducing use of ESAs. Future studies are warranted to optimize deimplementation strategies to improve patient safety., (© 2020 UICC.)

Technology based patient education and adherence approaches are increasingly utilized to instruct and remind patients to prepare correctly for medical procedures. This study examines the interaction between two primary factors: patterns of patient adherence to challenging medical preparation procedures; and the demonstrated, measurable potential for cloud-based multi-media information technology (IT) interventions to improve patient adherence. An IT artifact was developed through prior design science research to serve information, reminders, and online video instruction modules to patients. The application was tested with 297 patients who were assessed clinically by physicians. Results indicate modest potential (43.4% relative improvement) for the IT-based approach for improving patient adherence to endoscopy preparations. Purposively designed cloud-based applications hold promise for aiding patients with complex medical procedure preparation. Health care provider involvement in the design and evaluation of a patient application may be an effective strategy to produce medical evidence and encourage the adoption of adherence apps., Competing Interests: No potential conflict of interest was reported by the authors., (© Operational Research Society 2019.)

Oncology-associated adverse drug/device reactions can be fatal. Some clinicians who treat single patients with severe oncology-associated toxicities have researched case series and published this information. We investigated motivations and experiences of select individuals leading such efforts. Clinicians treating individual patients who developed oncology-associated serious adverse drug events were asked to participate. Inclusion criteria included having index patient information, reporting case series, and being collaborative with investigators from two National Institutes of Health funded pharmacovigilance networks. Thirty-minute interviews addressed investigational motivation, feedback from pharmaceutical manufacturers, FDA personnel, and academic leadership, and recommendations for improving pharmacovigilance. Responses were analyzed using constant comparative methods of qualitative analysis. Overall, 18 clinicians met inclusion criteria and 14 interviewees are included. Primary motivations were scientific curiosity, expressed by six clinicians. A less common theme was public health related (three clinicians). Six clinicians received feedback characterized as supportive from academic leaders, while four clinicians received feedback characterized as negative. Three clinicians reported that following the case series publication they were invited to speak at academic institutions worldwide. Responses from pharmaceutical manufacturers were characterized as negative by 12 clinicians. One clinician's wife called the post-reporting time the "Maalox month," while another clinician reported that the manufacturer collaboratively offered to identify additional cases of the toxicity. Responses from FDA employees were characterized as collaborative for two clinicians, neutral for five clinicians, unresponsive for negative by six clinicians. Three clinicians endorsed developing improved reporting mechanisms for individual physicians, while 11 clinicians endorsed safety activities that should be undertaken by persons other than a motivated clinician who personally treats a patient with a severe adverse drug/device reaction. Our study provides some of the first reports of clinician motivations and experiences with reporting serious or potentially fatal oncology-associated adverse drug or device reactions. Overall, it appears that negative feedback from pharmaceutical manufacturers and mixed feedback from the academic community and/or the FDA were reported. Big data, registries, Data Safety Monitoring Boards, and pharmacogenetic studies may facilitate improved pharmacovigilance efforts for oncology-associated adverse drug reactions. These initiatives overcome concerns related to complacency, indifference, ignorance, and system-level problems as barriers to documenting and reporting adverse drug events- barriers that have been previously reported for clinician reporting of serious adverse drug reactions., Competing Interests: The authors have declared that no competing interests exist.

Empowering and engaging youth in advocacy and participatory action research (PAR) for healthy community environments is an emerging approach to reducing the childhood obesity epidemic. Technology is a promising strategy for engaging youth in such efforts. The Community Park Audit Tool (CPAT) is user-friendly tool for evaluating the ability of parks to promote youth physical activity. Recently an electronic version of the tool (eCPAT) was developed and validated. The purpose of this study was to explore the use of eCPAT mobile technology on youth empowerment and advocacy. This study examined tool usability, youths' technology access, use, and readiness for PAR efforts, effectiveness of mobile technology on youth empowerment and advocacy, interaction effects between tool format and regular technology use, and tool format preferences. Youth ages 11-18 years were recruited and randomized into one of three study conditions: Control (no audit), paper (CPAT), and mobile technology (eCPAT). Intervention youth completed two park audits using assigned format. A subsample of youth in the Control group completed both CPAT and eCPAT audits for comparison. Independent samples t -tests and MANCOVAs explored differences in post-project levels of tool usability and empowerment and advocacy scores between groups. Multivariate linear regression analysis explored the interaction between Control, Paper, or eCPAT group membership and mean technology use in predicting empowerment and advocacy. Youth ( n = 124) completed pre and post surveys. The majority of youth had access to technology (smartphone 77.4%, tablet/iPad 67.7%). Youth used mobile technology at least once a day to use apps ( M = 7.8, SD = 3.2), browse the web ( M = 6.3, SD = 3.3), and search for information ( M = 6.3, SD = 3.5). Youth were also ready and willing to use technology for PAR ( M = 3.42-3.59). No main or interaction effects were found for post-project levels of youth empowerment or advocacy. However, the eCPAT tool had high usability scores, was better liked, and was preferred by youth over paper-pencil methods. Mobile technologies are ubiquitous and a preferred strategy among youth for engagement in community change. Future studies should explore mobile technology as a potential strategy for engaging youth in ongoing PAR efforts to achieve successful engagement and advocacy in community healthy environmental change.

Purpose: The US Food and Drug Administration (FDA) has approved epoetin and darbepoetin for chemotherapy-induced anemia (CIA). Approved epoetin and darbepoetin dosing schedules were three times per week and weekly, respectively, although off-label, less frequent scheduling was common. In 2004, 2007, and 2008, a US Food and Drug Administration Advisory Committees warned of risks associated with erythropoiesis-stimulating agents. During this period, lawsuits alleging illegal darbepoetin marketing practices have concluded, resulting in $1.1 billion in fines and settlements and one criminal conviction. No prior study, to our knowledge, has reported on the use of darbepoetin versus epoetin for CIA., Methods: We evaluated the dosing, utilization, and costs of erythropoiesis-stimulating agents among 3,761 South Carolina Medicaid patients with CIA., Results: Epoetin and darbepoetin utilization rates were 22% and 28% in 2003, 10% and 33% in 2007, and 3% and 7% in 2010, respectively. Mean per-patient per-administration epoetin and darbepoetin doses were 40,983 IU and 191 µg, respectively, in 2003 and 47,753 IU and 369 µg, respectively, in 2010. Mean monthly patient costs for epoetin and darbepoetin were $1,030 and $981, respectively, in 2003 and $932 and $1,352, respectively, in 2010. Epoetin use decreased steadily between 2002 and 2010; darbepoetin use increased steadily between 2003 and 2007 and then decreased steadily thereafter. Per-patient dosing of darbepoetin, but not epoetin, increased steadily between 2003 and 2010, and monthly per-patient epoetin costs decreased 3% while the per-patients costs of darbepoetin increased 30% between 2003 and 2010., Conclusion: To our knowledge, our findings are the first data reporting on epoetin versus darbepoetin use for CIA and support recently concluded lawsuits involving allegations of illegal marketing practices of the manufacturer of darbepoetin.

Introduction: Burnout among emergency medical practitioners and personnel negatively affects career satisfaction and job performance and can lead to mental health issues, including anxiety, depression, and suicide., Purpose: This study investigated the relationship between the perceptions of burnout and job satisfaction of those working in two different hospital's emergency departments assessing the effect of burnout dimensions and additional factors (age, position, marital status, annual income, employment type, gender, patient encounters, and household economic well-being) on job satisfaction. This study addresses a gap in the literature of the relationships between a) burnout and job satisfaction of emergency department's health care personnel (physicians, nurses, technicians) and b) the factors that are associated with emergency department employees' job satisfaction., Method: A cross-sectional survey of two hundred and fifty participants was interviewed, using validated instruments (the Maslach Burnout Scale and the Minnesota Satisfaction Questionnaire). Participants include 38 physicians, 89 nurses, and 84 medical technicians, and 39 information technicians. The Maslach Burnout Inventory Scale, which assesses emotional exhaustion (EE), depersonalization (DP) and personal accomplishment (PA), and the Minnesota Satisfaction Questionnaire (MSQ), which assesses intrinsic satisfaction (IS), extrinsic satisfaction (ES) and overall satisfaction (OS), were used for data collection., Results: Study findings indicate that significant relationship exists between burnout and job satisfaction; annual income and household economic-well-being had a positive association with job satisfaction, whereas gender, age, education, marital status had no significant effect on any form of satisfaction. Moreover, this study reveals that emotional exhaustion (EE) is a significant predictor of all three dimensions of job satisfaction while depersonalization (DP) had no significant showing., Conclusion: Results of this study suggest that it is not yet clear which factors are salient contributors in demonstrating the relationship between burnout and job satisfaction. This study may draw attention to a better understanding of this relationship will help enable health care administrators to design and implement tools to help increase job satisfaction and decrease burnout as a combined goal rather than treat each issue separately., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Creation of mobile technology environmental audit tools can provide a more interactive way for youth to engage with communities and facilitate participation in health promotion efforts. This study describes the development and validity and reliability testing of an electronic version of the Community Park Audit Tool (eCPAT). eCPAT consists of 149 items and incorporates a variety of technology benefits. Criterion-related validity and inter-rater reliability were evaluated using data from 52 youth across 47 parks in Greenville County, SC. A large portion of items (>70 %) demonstrated either fair or moderate to perfect validity and reliability. All but six items demonstrated excellent percent agreement. The eCPAT app is a user-friendly tool that provides a comprehensive assessment of park environments. Given the proliferation of smartphones, tablets, and other electronic devices among both adolescents and adults, the eCPAT app has potential to be distributed and used widely for a variety of health promotion purposes., Competing Interests: Compliance with ethical standards This study occurred in collaboration with Greenville County Parks, Recreation, and Tourism; the City of Greenville Parks and Recreation Department; and LiveWell Greenville and was approved by the Institutional Review Board (IRB) at the University of South Carolina.

Objective: Health information technology investments continue to increase while the value derived from their implementation and use is mixed. Mobile device adoption into practice is a recent trend that has increased dramatically and formal studies are needed to investigate consequent benefits and challenges. The objective of this study is to evaluate practitioner perceptions of improvements in productivity, provider-patient communications, care provision, technology usability and other outcomes following the adoption and use of a tablet computer connected to electronic health information resources., Methods: A pilot program was initiated in June 2013 to evaluate the effect of mobile tablet computers at one health provider organization in the southeast United States. Providers were asked to volunteer for the evaluation and were each given a mobile tablet computer. A total of 42 inpatient and outpatient providers were interviewed in 2015 using a survey style questionnaire that utilized yes/no, Likert-style, and open ended questions. Each had previously used an electronic health record (EHR) system a minimum of one year outside of residency, and were regular users of personal mobile devices. Each used a mobile tablet computer in the context of their practice connected to the health system EHR., Results: The survey results indicate that more than half of providers perceive the use of the tablet device as having a positive effect on patient communications, patient education, patient's perception of the provider, time spent interacting with patients, provider productivity, process of care, satisfaction with EHR when used together with the device, and care provision. Providers also reported feeling comfortable using the device (82.9%), would recommend the device to colleagues (69.2%), did not experience increased information security and privacy concerns (95%), and noted significant reductions in EHR login times (64.1%). Less than 25% of participants reported negative impacts on any of these areas as well as on time spent on order submission, note completion time, overall workload, patient satisfaction with care experience and patient outcomes. Gender, number of years in practice, practice type (general practitioner vs. specialist), and service type (inpatient/outpatient) were found to have a significant effect on perceptions of patient satisfaction, care process, and provider productivity., Conclusions: Providers found positive gains from utilizing mobile devices in overall productivity, improved communications with their patients, the process of care, and technology efficiencies when used in combination with EHR and other health information resources. Demographic and health care work environment play a role in how mobile technologies are integrated into practice by providers., (Copyright © 2016. Published by Elsevier Ireland Ltd.)

Studies on the topic of burnout measure the effects of emotional exhaustion (EE), depersonalization (DP) (negative or cynical attitudes toward work), and reduced sense of personal accomplishment (PA). While the prevalence of burnout in practicing emergency medicine (EM) professionals has been studied, little is known of the prevalence and factors across physicians, nurses, technicians, and health information technicians working for the same institution. The aim of this study was to assess burnout differences across EM professional types.The total population of 250 EM professionals at 2 public urban hospitals in Turkey were surveyed using the Maslach Burnout Inventory and basic social- and work-related demographics. Descriptive statistics, ANOVA, and additional post hoc tests were computed.Findings show that EE and DP scores were high across all occupational groups, while scores on PA were low. There was a statistically significant difference between nurses and medical technicians (P < 0.05) for EE; and between physicians and both nurses and medical technicians (P < 0.05) for PA; while no group differences were found for DP. Age, gender, economic well-being, and income level were all significant; while patient load and marital status showed no significance.Burnout can be high across occupational groups in the emergency department. Burnout is important for EM administrators to assess across human resources. Statistically significant differences across socio-demographic groups vary across occupational groups. However, differences between occupational groups may not be explained effectively by the demographic factors assessed in this or other prior studies. Rather, the factors associated with burnout are incomplete and require further institutional, cultural, and organizational analyses including differentiating between job tasks carried out by each EM job type., Competing Interests: The authors have no funding and conflicts of interest to disclose.

The purpose of this case study was to evaluate the information systems, personnel, and processes involved in mobile mammography settings, and offer recommendations to improve efficiency and satisfaction among patients and staff. Data includes on-site observations, interviews, and an electronic medical record review of a hospital who offers both mobile and fixed facility mammography services to their community. The optimal expectations for the process of mobile mammography from multiple perspectives were defined as (1) patient receives mammogram the day of their visit, (2) patient has efficient intake process with little wait time, (3) follow-up is completed and timely, (4) site contact and van staff are satisfied with van visit and choose to schedule future visits, and (5) the MMU is able to assess its performance and set goals for improvement. Challenges that prevent the realization of those expectations include a low patient pre-registration rate, difficulty obtaining required physician orders, frequent information system downtime/Internet connectivity issues, ill-defined organizational communication/roles, insufficient site host/patient education, and disparate organizational and information systems. Our recommendations include employing a dedicated mobile mammography team for end-to-end oversight, mitigating for system connectivity issues, allowing for patient self-referrals, integrating scheduling and registration processes, and a focused approach to educating site hosts and respective patients about expectations for the day of the visit. The MMU is an important community resource; we recommend simple process improvements and information flow improvements to further enable the MMU׳s goals., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Many studies have provided evidence of the importance of quality provider-patient communications and have suggested improvements to patient understanding by using video-based instruction., Objective: The objective of this study was to understand how mobile information technology assisted video and three-dimensional (3D) image instruction, provided by a health care worker, influences two categories of outcome: (1) patient understanding of information about their condition and detailed medical discharge instructions; and (2) patient perceptions and attitudes toward their health care providers, which included physicians, nurses, and staff. We hypothesize that video and 3D image instruction, provided on a mobile, tablet hardware platform, will improve patient understanding about the diagnostic testing, diagnoses, procedures, medications, and health topics provided to them. We also propose that use of the tablet/video combination will result in improved attitudinal evaluation by patients of their providers and the treatment plan., Methods: This study evaluated a hospital clinic-based trial (patient N=284) of video and 3D image instruction, provided on a mobile, tablet hardware platform, and its potential to improve patient understanding about the diagnostic testing, diagnoses, procedures, medications, and health topics provided to them., Results: Results showed strong evidence that the system was perceived as helpful for improving patient understanding, and that it improved communication between physicians and patients (P<.001). The advanced age of some patients had no effect on their perceptions of the tablet-based mediation. Physician comments provided useful insights on effective use of such systems in the future. Implications for further development and future research are discussed., Conclusions: This study added to the body of evidence that computer-assisted video instructional systems for patients can improve patient understanding of medical instructions from their health care providers and assist with patient compliance. In addition, such systems can be appealing to both patient and provider.

This exploratory study was conducted to determine if the postoperative course is different for women undergoing robotic-assisted total abdominal hysterectomy (TAH) compared to women undergoing traditional (open) TAH. This study adds to the evidence regarding potential benefits and complications of robotic-assisted gynecologic surgery, and identifies specific areas for further research.

Pick's disease is a progressive illness that affects brain function, eventually causing loss of verbal skills and problem-solving abilities. Pick's disease accounts for 5% of all dementias. The most common symptoms involve personality, behavior, and language changes. Diagnosis can be difficult; a differential diagnosis often requires several years. Frequently, the disorder is initially diagnosed as stress, depression, or Alzheimer's disease. A magnetic resonance imaging scan will show atrophied portions of the frontal and temporal lobes. One of the most difficult aspects of care for someone with Pick's disease is communication. The communication styles of nurses can alleviate the anxiety experienced by a person with Pick's disease. Nurses should try different strategies as an approach to communicating and caring for someone with Pick's disease, remembering that each person suffering from dementia is different. Pick's disease can be emotionally devastating to the families of those who develop this disease. Working with families confronting the disability of a loved one is perhaps the greatest challenge for nurses. Nurses have the responsibility of educating the primary caregiver about nutrition, skin protection, incontinence care, safety, and end-of-life decisions.