Eastern Regional Meeting 2021

The proceedings contain 63 papers. The topics discussed include: doxorubicin cardiotoxicity in human organotypic cardiac slices is modulated by P38 MAPK inhibition in a sex- and isoform-specific manner;validation of a modified response evaluation criteria in solid tumors after stereotactic ablative radiosurgery for lung cancer;safer use of aspirin in older adults, need for a consensus;efficacy of facemasks in prevention of COVID-19: a systematic review;practice patterns of rapid influenza diagnostic test;equity and inclusion in patient centered outcomes research: lessons from the adaptable study at Montefiore site;a solution to decrease potentially inappropriate medications (PIM) use during hospitalization;predictors of misperceptions, risk perceptions, and personal risk perceptions about COVID-19 by country, education and income;cognitive function and the consumption of probiotic foods in older adults: an NHANES study;and registered dietitian nutritionist care impacts nutrition-related outcomes for patients with cancer in the outpatient setting.

HPR4 ISPOR HEOR Trends Over Time: What Is the Influence of Macro HTA Changes?

Objectives: To better understand the constantly evolving global perspectives on health economics and outcomes research (HEOR), ISPOR conducts surveys among its members and global leaders to capture key methodological and policy HEOR trends expected to significantly impact on health care decision-making. To summarise these trends over time and capture the potential impact of health technology assessment (HTA) processes, we conducted a review of ISPOR's HEOR trends and where we are to-date. Method(s): We systematically searched for trends published by ISPOR between 2018 and 2022 and extracted key information to understand the consistency of trends over time and the evolution of themes. This search was supplemented by identifying key HTA developments and related methodological movements in decision-making in the same period that may have impacted the ranking of trends across years. Results were synthesized qualitatively using infographics. Result(s): Overall, across the last 5 years, 11 different trends were identified. Real-world evidence appeared as the third most influential trend in 2019 and became the number one trend since 2020, whereas drug and healthcare pricing dropped from a key trend in 2018 to 6th position in 2022. Some trends (e.g., biosimilars) only appeared once, due to potentially limited interest or lack of new related methods, whereas other topics (e.g., health equity) regained attention during recent years. Latest research initiatives such as the GetReal Initiative in Europe, HTA collaborations with real-world data organisations (Flatiron), the rise of advanced methodologies (e.g., value-based frameworks) and the recent COVID-19 pandemic may have influenced the appearance, upgrade, or disruption of some of these trends, reflecting changes occurring in HEOR landscape and decision-making. Conclusion(s): Capturing HEOR trends through a representative organisation such as ISPOR is key to understanding past and potential future developments in methods and processes of health policy, considering the wider interplay of contextual and methodological advances.Copyright © 2022

Training the next generation of learning health system scientists.

Introduction: The learning health system (LHS) aligns science, informatics, incentives, stakeholders, and culture for continuous improvement and innovation. The Agency for Healthcare Research and Quality and the Patient-Centered Outcomes Research Institute designed a K12 initiative to grow the number of LHS scientists. We describe approaches developed by 11 funded centers of excellence (COEs) to promote partnerships between scholars and health system leaders and to provide mentored research training. Methods: Since 2018, the COEs have enlisted faculty, secured institutional resources, partnered with health systems, developed and implemented curricula, recruited scholars, and provided mentored training. Program directors for each COE provided descriptive data on program context, scholar characteristics, stakeholder engagement, scholar experiences with health system partnerships, roles following program completion, and key training challenges. Results: To date, the 11 COEs have partnered with health systems to train 110 scholars. Nine (82%) programs partner with a Veterans Affairs health system and 9 (82%) partner with safety net providers. Clinically trained scholars (n = 87; 79%) include 70 physicians and 17 scholars in other clinical disciplines. Non-clinicians (n = 29; 26%) represent diverse fields, dominated by population health sciences. Stakeholder engagement helps scholars understand health system and patient/family needs and priorities, enabling opportunities to conduct embedded research, improve outcomes, and grow skills in translating research methods and findings into practice. Challenges include supporting scholars through roadblocks that threaten to derail projects during their limited program time, ranging from delays in access to data to COVID-19-related impediments and shifts in organizational priorities. Conclusions: Four years into this novel training program, there is evidence of scholars' accomplishments, both in traditional academic terms and in terms of moving along career trajectories that hold the potential to lead and accelerate transformational health system change. Future LHS training efforts should focus on sustainability, including organizational support for scholar activities.

Walk and Talk Bereavement Support: Piloting an Innovative Service at Marie Curie Northern Ireland

Introduction At the advent of COVID-19 the bereavement support service in Belfast Hospice had to quickly adapt to new ways of working to ensure continued service provision, with counsellors transitioning to video-link platforms and telephone to facilitate client sessions. However, counsellors reported challenges building a rapport with clients online, and had concerns that the client's grief was compounded by loneliness and social isolation. In response, the Marie Curie walk and walk bereavement support project, in partnership with the National Trust, was proposed as an innovative solution. Taking traditional counselling sessions outdoors meant the counsellors could maintain adherence to COVID-19 guidance, while supporting the mental health and wellbeing of bereaved clients. Furthermore, nature therapy has been shown to enhance both physical and mental health, reducing symptoms of depression. Whilst there are studies that demonstrate the benefit of nature therapy for mental health outcomes, research is limited in bereavement care. Aims Supporting the mental health and wellbeing of bereaved clients. Methods A pilot Walk and Talk bereavement therapy brings together the skilful, compassionate counselling work of Marie Curie staff and volunteers in beautiful, restorative National Trust spaces. We plan to conduct semi-structured interviews with service users to explore their experience of walk and talk therapy. Results To date, the feedback received has been overwhelmingly positive, this is based on informal verbal feedback gathered by counsellors at the end of each session. Conclusions Despite the physical distancing barriers faced during COVID-19, staff and volunteers were able to overcome these challenges through innovation, creativity, and flexibility, to provide person-centred, compassionate bereavement care and support Impact Work is ongoing, but we hope to continue to develop the walk and talk bereavement service with the National Trust, to support the mental and physical health and wellbeing of people affected by dying, death and bereavement.

Optimizing the Interdisciplinary Design of Adaptive Platform Trials

Adaptive platform trials (APTs) are often complex clinical trials that, ideally, are well suited to answer the motivating clinical questions effectively and efficiently, with the motivating clinical questions and associated treatment arms expected to evolve over time as evidence accumulates. Recently, APTs have played a pivotal role in informing public health policy by efficiently generating compelling evidence regarding the effectiveness of therapies for COVID-19. For APTs to be maximally effective in informing future public health policy, they must be carefully tailored to address the right clinical questions, with the right balance of size, scope, rigor, and flexibility. The design process requires input from clinical and statistical domain experts and often includes input from trial implementation personnel, ethicists, and patient representatives. The design process is inherently iterative, with proposed designs evaluated through trial simulation, the identification of strengths and weaknesses of the proposed design, and revision by the team to address weaknesses. This iterative design process requires effective communication and collaboration between the statistical and clinical domain experts. This session is intended to present a current best practice in facilitating and enhancing the collaborative design process for APTs, including how best to present simulation-based trial performance to the design team and ensure effective interdisciplinary communication. The speakers have extensive experience in leading the design of APTs across multiple therapeutic areas, in both academic and industry settings. The session will begin with a brief presentation by Dr. Lewis on the basic structure of an APT and the tasks and challenges associated with the multidisciplinary design process. The subsequent discussion will be organized by the following themes: (1) considerations in the selection of the study population and primary outcome metric;(2) selecting treatment domains and factors to be compared;(3) trial simulation and communication of performance metrics to both statistical and non-statistical team members;and (4) defining and calibrating interim decision rules. Each of the 4 panel members will outline a recommended approach to facilitating 1 of the 4 design tasks, with examples drawn from their experience. The remaining time (15 min) will be available for a panel question-and-answer period. At the end of the session, the audience will have an understanding of the general organization of, and a process for facilitating, the design process for an adaptive platform trial. Panel Members Roger J Lewis, MD, PhD, is a Senior Physician in the Los Angeles County Department of Health Services, Professor of Emergency Medicine at the David Geffen School of Medicine at UCLA, and the Senior Medical Scientist at Berry Consultants, LLC, a group that specializes in innovative clinical trial design. He is also the former Chair of the Department of Emergency Medicine at Harbor-UCLA Medical Center. Dr. Lewis' expertise centers on adaptive and Bayesian clinical trials, including platform trials;translational, clinical, health services and outcomes research methodology;data and safety monitoring boards, and the oversight of clinical trials. Dr. Lewis was elected to membership in the National Academy of Medicine in 2009. He has authored or coauthored over 270 original research publications, reviews, editorials, and chapters. Dr. Lewis is a Past President of the Society for Academic Emergency Medicine (SAEM) and served on the Board of Directors for the Society for Clinical Trials. He is a fellow of the American College of Emergency Physicians, the American Statistical Association, and the Society for Clinical Trials. Juliana Tolles, MD, MHS, is an Assistant Professor of Emergency Medicine at the Harbor-UCLA Medical Center and the David Geffen School of Medicine at UCLA, and a Medical and Statistical Scientist at Berry Consultants, LLC. Her academic research interests include emergency medical services, resuscitation medicine, and trau a care. She has authored several reviews for Journal of the American Medical Association (JAMA) on statistical methodology and has lectured nationally on research methodology for the Society for Academic Emergency Medicine Advanced Research Methodology Evaluation and Design (ARMED) course. She is also a co-investigator for the Strategies to Innovate Emergency Clinical Care Trials (SIREN) network Southern California site. Kert Viele, PhD, is a Director and Senior Statistical Scientist with Berry Consultants, where he leads Berry Consultants' research enterprise. He is a leader in clinical trial implementation of Bayesian hierarchical modeling, with expertise in platform and basket trials as well as clinical trials incorporating the use of historical information. Prior to joining Berry Consultants in 2010, he was a faculty member at the University of Kentucky, where he received the Provost's Award for Outstanding Teaching and was an investigator for NSF and NIH-funded research. He has developed over 100 custom Bayesian adaptive clinical trials for clients in industry, government, and academia, and currently serves on several data safety monitoring boards for randomized clinical trials. A former editor of the journal Bayesian Analysis, Dr. Viele is also an author of FACTS (Fixed and Adaptive Clinical Trial Simulator), clinical trial simulation software currently licensed to multiple pharmaceutical, academic, and government organizations. William Meurer, MD, MS, is an Associate Professor of Emergency Medicine and Neurology at the University of Michigan Health System. In addition, he serves as a Medical and Statistical Scientist for Berry Consultants, LLC. He works to improve the care of patients with acute neurological disease both through his work on the acute stroke team and as a researcher. His work in the field focuses on the design of clinical trials with adaptive and flexible components. In addition, he is a principal investigator of the National Institutes of Neurological Disorders and Stroke (NINDS) Clinical Trials Methodology Course (http:// neurotrials.training) and a co-investigator in the clinical coordinating center of the Strategies to Innovate Emergency Care Clinical Trials (SIREN) network- also funded by NIH). He was a co-investigator on the Adaptive Designs Accelerating Promising Treatments into Trials (ADAPT-IT) project, as part of the FDA Advancing Regulatory Science initiative with NIH.

"Black People Like Me": A virtual conference series to engage underserved patients with asthma in patient centered outcomes research.

BACKGROUND: In response to racial inequity in asthma, asthma-related research among diverse patients is vital. However, people from historically marginalized groups are underrepresented in clinical and patient-centered outcomes research (PCOR). The "Black People Like Me" (BPLM) virtual conference series was developed to: (1) engage Black patients with asthma and their caregivers in education and discussions about asthma, and (2) encourage involvement in PCOR. Education about COVID-19 and COVID-19 vaccination was also incorporated. METHODS: The Project Advisory Group consisting of Black patients, clergy, physicians, and a program evaluator met monthly to develop BPLM. The program consisted of free one-hour virtual sessions held monthly for 6 months. BPLM was promoted through the Allergy & Asthma Network website, emails, social media, and personal contacts with a recruitment goal of ≥ 100 Black patients with asthma or caregivers. Program evaluations, interactive polling questions during each session, and participant pre- and post-session tests were conducted. RESULTS: Sessions averaged 658 participants including Black patients, family members, caregivers, Black clergy, health care providers, and other concerned community. Overall, 77% of participants strongly agreed with satisfaction with the sessions. Pre- and post-tests demonstrated that participants exhibited growth in knowledge regarding asthma risk, PCOR, and PCOR research opportunities for patients, exhibited preexisting and sustained knowledge regarding COVID-19 vaccination and side effects, and demonstrated an increased sense of empowerment during healthcare visits. CONCLUSIONS: BPLM demonstrated that a virtual platform can successfully engage Black communities. Incorporating clergy and religious organizations was critical in developing the trust of the Black community towards BPLM.

Scoping review of children's and youth's outdoor play publications in Canada. / Examen de la portée des publications sur le jeu à l'extérieur chez les enfants et les jeunes au Canada.

INTRODUCTION: Since 2015, interest in the benefits of outdoor play for physical, emotional, social and environmental health, well-being and development has been growing in Canada and elsewhere. METHODS: This scoping review aims to answer the question, "How, and in what context, is children's and youth's outdoor play being studied in Canada?" Included were studies of any type on outdoor play published after September 2015 in English or French by authors from Canadian institutions or assessing Canadian children and/or youth. Articles retrieved from MEDLINE, CINAHL and Scopus by March 2021 were organized according to eight priority areas: health, well-being and development; outdoor play environments; safety and outdoor play; cross-sectoral connections; equity, diversity and inclusion; professional development; Indigenous Peoples and land-based outdoor play; and COVID-19. Within each priority, study design and measurement method were tallied. RESULTS: Of the 275 articles included, the most common priority area was health, wellbeing and development (n = 239). The least common priority areas were COVID-19 (n = 9) and Indigenous Peoples and land-based outdoor play (n = 14). Cross-sectional studies were the most common; the least common were rapid reviews. Sample sizes varied from one parent's reflections to 999 951 data points from health databases. More studies used subjective than objective measurement methods. Across priorities, physical health was the most examined outcome, and mental/emotional development the least. CONCLUSION: A wealth of knowledge on outdoor play in Canada has been produced since 2015. Further research is needed on the relationship between outdoor play and mental/emotional development among children and youth.

Amiodarone for the Treatment of Arrhythmias in COVID-19 Patients Does Not Increase the Risk of Pulmonary Fibrosis: A Retrospective Cohort Study.

Amiodarone is a class III antiarrhythmic medication used to treat atrial and ventricular tachyarrhythmias. Pulmonary fibrosis from amiodarone use is a well-documented side effect. Pre-COVID-19 pandemic studies have shown that amiodarone-induced pulmonary fibrosis occurs in 1%-5% of patients and usually occurs between 12 to 60 months after initiation. The risk factors associated with amiodarone-induced pulmonary fibrosis include a high total cumulative dose (treatment longer than two months) and high maintenance dose (>400 mg/day). COVID-19 infection is also a known risk factor for developing pulmonary fibrosis and occurs in approximately 2%-6% of patients after a moderate illness. This study aims to assess the incidence of amiodarone in COVID-19 pulmonary fibrosis (ACPF). This is a retrospective cohort study with 420 patients with COVID-19 diagnoses between March 2020 and March 2022, comparing two populations, COVID-19 patients with exposure to amiodarone (N=210) and COVID-19 patients without amiodarone exposure (N=210). In our study, pulmonary fibrosis occurred in 12.9% of patients in the amiodarone exposure group compared to 10.5% of patients in the COVID-19 control group (p=0.543). In multivariate logistic analysis, which controlled for clinical covariates, amiodarone use in COVID-19 patients did not increase the odds of developing pulmonary fibrosis (odds ratio (OR): 1.02, 95% confidence interval (CI): 0.52-2.00). The clinical factors associated with the development of pulmonary fibrosis in both groups included a history of preexisting interstitial lung disease (ILD) (p=0.001), exposure to prior radiation therapy (p=0.021), and higher severity of COVID-19 illness (p<0.001). In conclusion, our study found no evidence that amiodarone use in COVID-19 patients increased the odds of developing pulmonary fibrosis at six-month follow-up. However, long-term amiodarone usage in the COVID-19 population should be based on the physician's discretion.

Total knee arthroplasty in the outpatient vs inpatient settings: impact of site of care on early postoperative economic and clinical outcomes.

BACKGROUND: The incidence of total knee arthroplasty (TKA) surgery performed in the outpatient setting has increased as a result of improved perioperative recovery protocols, bundled payments, and challenges brought by the coronavirus disease of 2019 (COVID-19) pandemic on health systems. This study evaluates early postoperative clinical and economic outcomes of patients treated in the inpatient vs outpatient setting using the Attune Knee System (AKS). METHODS: Patients with an elective, primary TKA implanted with the AKS, from Q4 2015 to Q1 2021, were identified within the Premier Healthcare Database. The index was defined as the admission date for inpatient cases and the service day for outpatient procedures. Inpatient and outpatient cases were matched on patient characteristics. Outcomes included 90-day all-cause readmissions, 90-day knee reoperations, and index- and 90-day costs of care. Generalized linear models were used to evaluate outcomes (Reoperation: binomial distribution; costs: Gamma distribution with log link). RESULTS: Before matching, 39,337 inpatient and 9,365 outpatient cases were identified, with greater comorbidities in the inpatient cohort. The outpatient cohort had a lower average Elixhauser Index (EI) compared to the inpatient cohort (1.94 (standard deviation (SD): 1.46) vs 2.17 (SD: 1.53), p < 0.001), and the rates for each individual comorbidities were also slightly lower in the outpatient compared to the inpatient cohorts. Post-match, 9,060 patients were retained in each cohort [mean age: ~ 67, EI = 1.9 (SD: 1.5), 40% male]. Post-match comorbidity rates were similar between inpatient and outpatient cohorts (outpatient EI: 1.94 (SD: 1.44)-inpatient EI: 1.96 (SD: 1.45), p = 0.3516): in both, 54.1% of patients had an EI between 1 and 2, and 5.1% had an EI ≥ 5. No differences were observed in 3-month reoperation rates (0.6% in outpatient, 0.7% in inpatient cohort). Index and post-index 90-day costs were lower in the outpatient vs inpatient cases [(savings for index-only costs: $2,295 (95% CI: $1,977-$2,614); 90 days post-index knee-related care only: $2,540 (95% CI: $2,205-$2,876); 90 days post-index all-cause care: $2,679 (95% CI: $2,322-$3,036)]. CONCLUSIONS: Compared to matched inpatient cases, outpatient TKA cases treated with AKS showed similar 90-day outcomes, at lower cost.

Unidos Hablemos de: Engaging Hispanic Patients in Patient Centered Outcomes Research and Clinical Effectiveness Research (PCOR/CER)

Rationale: Historically, Hispanics are underrepresented in research which reduces the generalizability of research findings. Patient engagement in research can support more relevant research through better alignment with patients' and clinicians' real-world needs and concerns. A virtual conference series for the Hispanic community was held to gain insights to better engage Hispanic patients in research. Methods: A Patient Advisory Group (PAG) comprised of Hispanic patients diagnosed with COVID-19 and/or asthma and a Faith-based leader developed a six-month virtual series (objectives, platform, theme, agendas, and identification of presenters), pre-and-post knowledge surveys, polling questions, and session evaluations. Based on the PAG feedback, messaging, promotion and handouts were offered in English and Spanish. Results: Between October 2021- March 2022, 2200 people attended over the 6 virtual sessions. Attendees identifying as Hispanic patients or caregivers increased by 6.7%, and 19% requested content in Spanish. Overall knowledge was gained for sessions 2-6. 66.4% of attendees agreed they would be willing to be a research subject in an asthma study, while 15.6% did not agree and 18% would if their doctor thought it was a good idea. When asked about willingness to be a patient partner/advisor for an asthma study, 77.6% agreed, while only 3.2% did not agree and the remaining 20% were either unsure or participation would depend on whether their doctor thought it was a good idea. Conclusions: This bilingual virtual series engaged patients/caregivers to learn about COVID-19 and asthma, and tools used to participate in research with the goal to increase representation of Hispanics in research.

Changes in Practice/Outcomes of Pediatric/Congenital Catheterization in Response to the First Wave of COVID.

Background: The Coronavirus disease 2019 (COVID-19) pandemic has posed tremendous stress on the health care system. Its effects on pediatric/congenital catheterization program practice and performance have not been described. Objectives: To evaluate how case volumes, risk-profile, and outcomes of pediatric/congenital catheterization procedures changed in response to the first wave of COVID-19 and after that wave. Methods: A multicenter retrospective observational study was performed using Congenital Cardiac Catheterization Project on Outcomes Registry (C3PO) data to study changes in volume, case mix, and outcomes (high-severity adverse events [HSAEs]) during the first wave of COVID (March 1, 2020, to May 31, 2020) in comparison to the period prior to (January 1, 2019, to February 28, 2020) and after (June 1, 2020, to December 31, 2020) the first wave. Multivariable analyses adjusting for case type, hemodynamic vulnerability, and age group were performed. Hospital responses to the first wave were captured with an electronic study instrument. Results: During the study period, 12,557 cases were performed at 14 C3PO hospitals (with 8% performed during the first wave of COVID and 32% in the postperiod). Center case volumes decreased from a median 32.1 cases/mo (interquartile range: 20.7-49.0) before COVID to 22 cases/mo (interquartile range: 13-31) during the first wave (P = 0.001). The proportion of cases with risk factors for HSAE increased during the first wave, specifically proportions of infants and neonates (P < 0.001) and subjects with renal insufficiency (P = 0.02), recent cardiac surgery (P < 0.001), and a higher hemodynamic vulnerability score (P = 0.02). The observed HSAE risk did not change significantly (P = 0.13). In multivariable analyses, odds of HSAE during the first wave of COVID (odds ratio: 0.75) appeared to be lower than that before COVID, but the difference was not significant (P = 0.09). Conclusion: Despite increased case-mix complexity, C3PO programs maintained, if not improved, their performance in terms of HSAE. Exploratory analyses of practice changes may inform future harm-reduction efforts.

Post-COVID-19 Assessment of Physical, Psychological, and Socio-Economic Impact on a General Population of Patients From Odisha, India.

AIM:  This prospective cross-sectional study evaluated the physical, psychological, and socioeconomic impacts of post-COVID-19 conditions (PCC) in a generalized population from Odisha, India. MATERIALS AND METHODS:  The study protocol and clinical record form (CRF) were approved by the Institutional Ethics Committee. Those above 18 years and of all genders who had recovered in the last six months, whether hospitalized or not hospitalized after the COVID-19 diagnosis, were included in our study. RESULTS:  A total of 198 persons with a median age of 41 years (18-87 years) were enrolled at the post-Covid clinic. For COVID-19 management, 91 persons (46%) were hospitalized, and the remaining 107 (54%) were non-hospitalized. Five dominant clusters of physical symptoms were present - fatigue (82.8%), cough (54%), breathing difficulty (54%), pain in the body (53%), and sleeplessness (51%). The psychological issues faced were fear (41.6%), worry (40.4%), depression (31.8%), and anger (30.3%). The median monthly income in Indian Rupees (INR) for pre-Covid versus post-Covid was 30,000 versus 25,000, effectively a loss of 16.6% in the family income. Adverse impacts on health and economic conditions were observed in 31.3% and 20.7%, respectively. CONCLUSION: Post-Covid clinics can be a resource-appropriate health system approach for nearly 20% of the pandemic survivors with a low gross domestic product (GDP) per capita.

Developing patient-centered outcomes research infrastructure in a rural community through patient and stakeholder engagement and education during the COVID-19 pandemic.

In addition to facing numerous healthcare disparities, rural America is chronically underrepresented in clinical research. This gap was made more evident during the COVID-19 pandemic. St Lawrence Health, located in rural Upstate New York, established its Clinical and Rural Health Research Department in 2015 to help close this gap. The research department then launched the DISRUPTS (Developing InfraStructure for Research to Utilize Patient-centered Techniques at St Lawrence Health System) program to build the infrastructure to conduct Patient-Centered Outcomes Research (PCOR). Together with a diverse committee, the team used proven methods and frameworks to develop a model for engagement, content creation, and education delivery that was successfully used to create educational programs on PCOR and COVID-19. The resulting DISRUPTS webinars had a combined total of over 450 live attendees and over 1,110 views on recordings. Furthermore, nearly one-third of those who participated in the COVID-19 vaccines webinar indicated they were more likely to receive a COVID-19 vaccine after taking part. DISRUPTS can serve as an important model for other rural communities that aim to increase access to and engagement in PCOR, and which hope to improve outreach and education efforts in their communities.

How Useful Are Digital Health Terms for Outcomes Research? An ISPOR Special Interest Group Report.

OBJECTIVES: This study aimed to review definitions of digital health and understand their relevance for health outcomes research. Four umbrella terms (digital health, electronic health, mobile health, and telehealth/telemedicine) were summarized in this article. METHODS: PubMed/MEDLINE, Embase, Cochrane Library, and EconLit were searched from January 2015 to May 2020 for systematic reviews containing key Medical Subject Headings terms for digital health (n = 38) and synonyms of "definition." Independent pairs of reviewers performed each stage of the review, with reconciliation by a third reviewer if required. A single reviewer consolidated each definition for consistency. We performed text analysis via word clouds and computed document frequency-and inverse corpus frequency scores. RESULTS: The search retrieved 2610 records with 545 articles (20.9%) taken forward for full-text review. Of these, 39.3% (214 of 545) were eligible for data extraction, of which 134 full-text articles were retained for this analysis containing 142 unique definitions of umbrella terms (digital health [n = 4], electronic health [n = 36], mobile health [n = 50], and telehealth/telemedicine [n = 52]). Seminal definitions exist but have increasingly been adapted over time and new definitions were created. Nevertheless, the most characteristic words extracted from the definitions via the text analyses still showed considerable overlap between the 4 umbrella terms. CONCLUSIONS: To focus evidence summaries for outcomes research purposes, umbrella terms should be accompanied by Medical Subject Headings terms reflecting population, intervention, comparator, outcome, timing, and setting. Ultimately a functional classification system is needed to create standardized terminology for digital health interventions denoting the domains of patient-level effects and outcomes.

Vital best practices for antiracist patient engagement in AYA oncology research and advocacy: A Delphi study of BIPOC AYA experts

Background: In the thick of the ongoing global crises of the COVID-19 pandemic, uprisings against anti-Black racism and police brutality, and anti-Asian racism and violence, Black, indigenous, and people of color (BIPOC) adolescent and young adult (AYA) cancer patients may be particularly vulnerable and exploited. Whilst embroiled in sociopolitical complexity, BIPOC AYAs are increasingly called upon to contribute as patient advocates in AYA oncology research and advocacy. Researchers, clinicians, and advocates in AYA oncology must dismantle long-standing racism and create meaningful structural change. The purpose of this study is to derive vital best practices for implementing antiracist patient engagement in AYA oncology research and advocacy that are co-developed by BIPOC AYA cancer patients and oncology professionals. Methods: We utilized a modified Delphi technique with a panel of BIPOC AYA cancer patients (n = 32) to build consensus opinions on professional recommendations from a prior study (Cheung et al., 2021), and to generate antiracist best practices in patient engagement. The Delphi study was comprised of three consecutive and iterative survey rounds over the course of 8 months in 2021;participants were BIPOC AYAs diagnosed with cancer between ages 15-36 years. Results: Results detail best practices for the implementation of antiracist patient engagement across all research activities within the Patient-Centered Outcomes Research Institute's (PCORI) Framework for Patient Engagement. For example, BIPOC AYAs agreed with oncology professionals' high priority recommendation for including BIPOC AYAs at the highest levels of decision making in research topic selection. As such, a best practice is for researchers to ensure that such representatives not only hold BIPOC AYA identity, but also hold direct experience with the particular oncology diagnosis, issue, or other outcome of interest. Additionally, BIPOC AYAs concurred with oncology professionals' high priority for “transparency, honesty, and trust” as a core principle for best practices in patient engagement. They further explained that trustworthy relationships are especially important when collaborating with teens and young adults, who are developmentally just coming into their own. When describing successful experiences of inclusion, participants ranked “build collaborative relationships with BIPOC AYA communities and listen to patients not usually heard” and “recruit a diverse range of BIPOC patients and let them give actual input into the study” as the highest priority best practices. Conclusions: Findings from this study are instructional for AYA oncology researchers, clinicians, and advocates to prevent harmful tokenism and implement genuine antiracist inclusion to advance health equity. Future research should investigate best practices within unique clinical settings.

Gastrointestinal prophylaxis for COVID-19: an illustration of severe bias arising from inappropriate comparators in observational studies.

OBJECTIVES: We aimed to use setting-appropriate comparisons to estimate the effects of different gastrointestinal (GI) prophylaxis pharmacotherapies for patients hospitalized with COVID-19 and setting-inappropriate comparisons to illustrate how improper design choices could result in biased results. STUDY DESIGN AND SETTING: We identified 3,804 hospitalized patients aged ≥ 18 years with COVID-19 from March to November 2020. We compared the effects of different gastroprotective agents on clinical improvement of COVID-19, as measured by a published severity scale. We used propensity score-based fine-stratification for confounding adjustment. Based on guidelines, we prespecified comparisons between agents with clinical equipoise and inappropriate comparisons of users vs. nonusers of GI prophylaxis in the intensive care unit (ICU). RESULTS: No benefit was detected when comparing oral famotidine to omeprazole in patients treated in the general ward or ICUs. We also found no associations when comparing intravenous famotidine to intravenous pantoprazole. For inappropriate comparisons of users vs. nonusers in the ICU, the probability of improvement was reduced by 32%-45% in famotidine users and 21%-48% in omeprazole or pantoprazole users. CONCLUSION: We found no evidence that GI prophylaxis improved outcomes for patients hospitalized with COVID-19 in setting-appropriate comparisons. An improper comparator choice can lead to spurious associations in critically ill patients.

Lung transplantation from controlled donation after circulatory death using simultaneous abdominal normothermic regional perfusion: A single center experience.

Despite the benefits of abdominal normothermic regional perfusion (A-NRP) for abdominal grafts in controlled donation after circulatory death (cDCD), there is limited information on the effect of A-NRP on the quality of the cDCD lungs. We aimed to study the effect of A-NRP in lungs obtained from cDCD and its impact on recipients´ outcomes. This is a study comparing outcomes of lung transplants (LT) from cDCD donors (September 2014 to December 2021) obtained using A-NRP as the abdominal preservation method. As controls, all lung recipients transplanted from donors after brain death (DBD) were considered. The primary outcomes were lung recipient 3-month, 1-year, and 5-year survival. A total of 269 LT were performed (60 cDCD and 209 DBD). There was no difference in survival at 3 months (98.3% cDCD vs. 93.7% DBD), 1 year (90.9% vs. 87.2%), and 5 years (68.7% vs. 69%). LT from the cDCD group had a higher rate of primary graft dysfunction grade 3 at 72 h (10% vs. 3.4%; p <  .001). This is the largest experience ever reported with the use of A-NRP combined with lung retrieval in cDCD donors. This combined method is safe for lung grafts presenting short-term survival outcomes equivalent to those transplanted through DBD.

Characterizing Telehealth Utilization from Administrative Claims in the US Using a Standardized Definition

Objectives: In response to the disruption of in-person healthcare visits during the Covid-19 pandemic in the US, public and private payers expanded their coverage and reimbursement for telehealth (TH) services starting March 2020. To account for this new driver of healthcare resource utilization, we created a standardized definition of TH utilization from administrative claims to improve research quality. We used this definition to investigate trends in TH utilization in a large US commercially insured/Medicare Advantage/Supplement population. Methods: Administrative claims from 1/1/2006 to 8/31/2021 from the HealthCore Integrated Research Database® were used to identify TH claims. We defined TH based on outpatient claims containing at least one of the following TH designations (not mutually exclusive): place of service codes, CPT codes, CPT modifiers, and certain Tax IDs from known telehealth providers. Coding patterns and TH utilization over time were evaluated. All analyses were descriptive. Results: Over the 15-year period, 57% of TH claims occurred in 2020 and an additional 39% in 2021 (through August). In 2019/2020/2021, the share of outpatient claims designated as TH was 0.1%/4.8%/4.4%. Utilization was slightly higher among commercially-insured compared to Medicare Advantage/Supplement patients (5.0% vs. 3.9% in 2020). Most TH use was identified via CPT modifier codes (80%), followed by place of service codes (53%). Evaluation & management visits and specialist physician services each accounted for approximately 45% of all TH claims. Approximately 8% of TH claims were for audio-only visits based on submitted codes. Conclusions: We created a standardized algorithm to identify TH using claims data. Consistent with prior reports, TH utilization increased substantially following onset of the Covid-19 pandemic in conjunction with increased coverage and reimbursement for the service. Incorporation of TH utilization via this algorithm is an essential tool for all health economic and outcomes research studies evaluating time periods from 2020 and beyond.