Human-centered Design of a Health Recommender System for Orthopaedic Shoulder Treatment.

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.

Value of Electronic Health Records Measured Using Financial and Clinical Outcomes: Quantitative Study.

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.

Evaluation of a COVID-19 Risk Tool.

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.

Effects of User-Reported Risk Factors and Follow-Up Care Activities on Satisfaction With a COVID-19 Chatbot: Cross-Sectional Study.

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.

Corrigendum: User perceptions about sharing exposure notification information for communicable diseases.

[This corrects the article DOI: 10.3389/fdgth.2022.926683.].

Predictors of COVID-19 From a Statewide Digital Symptom and Risk Assessment Tool: Cross-Sectional Study.

BACKGROUND: Some of the most vexing issues with the COVID-19 pandemic were the inability of facilities and events, such as schools and work areas, to track symptoms to mitigate the spread of the disease. To combat these challenges, many turned to the implementation of technology. 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. This paper presents the implementation and early evaluation of a return-to-work COVID-19 symptom and risk assessment tool. The system was implemented across 34 institutions of health and education in Alabama, including more than 174,000 users with over 4 million total uses and more than 86,000 reports of exposure risk between July 2020 and April 2021. OBJECTIVE: This study aimed to explore the usage of technology, specifically a COVID-19 symptom and risk assessment tool, to mitigate exposure to COVID-19 within public spaces. More specifically, the objective was to assess the relationship between user-reported symptoms and exposure via a mobile health app, with confirmed COVID-19 cases reported by the Alabama Department of Public Health (ADPH). METHODS: This cross-sectional study evaluated the relationship between confirmed COVID-19 cases and user-reported COVID-19 symptoms and exposure reported through the Healthcheck web-based mobile application. A dependent variable for confirmed COVID-19 cases in Alabama was obtained from ADPH. Independent variables (ie, health symptoms and exposure) were collected through Healthcheck survey data and included measures assessing COVID-19-related risk levels and symptoms. Multiple linear regression was used to examine the relationship between ADPH-confirmed diagnosis of COVID-19 and self-reported health symptoms and exposure via Healthcheck that were analyzed across the state population but not connected at the individual patient level. RESULTS: Regression analysis showed that the self-reported information collected by Healthcheck significantly affects the number of COVID-19-confirmed cases. The results demonstrate that the average number of confirmed COVID-19 cases increased by 5 (high risk: ß=5.10; P=.001), decreased by 24 (sore throat: ß=-24.03; P=.001), and increased by 21 (nausea or vomiting: ß=21.67; P=.02) per day for every additional self-report of symptoms by Healthcheck survey respondents. Congestion or runny nose was the most frequently reported symptom. Sore throat, low risk, high risk, nausea, or vomiting were all statistically significant factors. CONCLUSIONS: The use of technology allowed organizations to remotely track a population as it is related to COVID-19. Healthcheck was a platform that aided in symptom tracking, risk assessment, and evaluation of status for admitting individuals into public spaces for people in the Alabama area. The confirmed relationship between symptom and exposure self-reporting using an app and population-wide confirmed cases suggests that further investigation is needed to determine the opportunity for such apps to mitigate disease spread at a community and individual level.

Patient preferences as human factors for health data recommender systems and shared decision making in orthopaedic practice.

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.

User perceptions about sharing exposure notification information for communicable diseases.

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.

Impact of Provider Prior Use of HIE on System Complexity, Performance, Patient Care, Quality and System Concerns.

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.

Perceptions of Endocrine Therapy in African-American Breast Cancer Survivors: Mixed Methods Study.

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.

Consequences to patients, clinicians, and manufacturers when very serious adverse drug reactions are identified (1997-2019): A qualitative analysis from the Southern Network on Adverse Reactions (SONAR).

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).

Youth in Foster Care and the Reasonable and Prudent Parenting Standard.

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.

Integrated Digital Patient Education at the Bedside for Patients with Chronic Conditions: Observational Study.

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.

Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions.

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.

End of an era of administering erythropoiesis stimulating agents among Veterans Administration cancer patients with chemotherapy-induced anemia.

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.

End of an era for erythropoiesis-stimulating agents in oncology.

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.

Introduction to "health informatics, healthcare quality and safety, and healthcare simulation: the new triad to advance healthcare operations".

This special themed international issue explores the multiple facets of health informatics, healthcare quality and safety, and healthcare simulation from different parts of the world. The papers in this issue fall into two broad themes. The first theme uses the intersection to address better management of care including physical design layout. The second theme examines innovative uses of the triad to prevent critical and non-critical safety events. The collection of papers culminates with a position paper reporting on the interdependence that is emerging as an important triad for research and practice within medical education, system development and testing, and teamwork and communication and concludes with reducing imprecision and factual errors in handoffs. Findings from the special collection of papers can inform managers and leaders on advancing operations in healthcare settings.

Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions.

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.

Cloud-based multi-media systems for patient education and adherence: a pilot study to explore patient compliance with colonoscopy procedure preparation.

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.

Consumer perceptions of health IT utilization and benefits.

OBJECTIVES: The objective of this article is to examine consumer perceptions of health information technology (health IT) utilization and benefits through an integrated conceptual framework. MATERIALS AND METHODS: This article employs an integrated conceptual framework to examine consumer perceptions of health IT. A consumer survey yielded 1125 completed responses. A factor-based scale was developed for each sub-construct. Bivariate analysis using χ2 tests was performed to determine differences in the percentage of respondents who agreed with each sub-construct based on whether their physician used an electronic health record (EHR) system. Multivariable logistic regression that controlled for demographic characteristics of respondents was performed to determine adjusted odds of agreeing with selected opinions of health information exchange (HIE). RESULTS: Results indicate that respondents whose physicians used an EHR system were significantly more likely to agree that there was a perceived benefit with HIE and to care provided; that the patient should have control over the record; that they trust the physician and security of the medical information; that they understand the need for HIE, and that HIE must be easy to use. DISCUSSION: The results suggest that consumers who have experienced the use of one technology in the healthcare setting can recognize the potential benefit of another technology. Race/ethnicity, gender, and education played some role in respondents' views of EHRs and HIE, more specifically, non-Hispanic African American participants indicated lower levels of trust in HIE when compared with non-Hispanic Whites. CONCLUSION: This cross-sectional survey indicated that physician use of EHRs significantly increases the odds of consumers' seeing perceived benefits of HIE and understanding the need for HIE.