Open Access Policy Articles

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The IUPUI Faculty Council adopted an open access policy on October 7th, 2014 (available from: https://openaccess.iupui.edu/policy). This policy shows IUPUI's commitment to disseminating the fruits of research and scholarship as widely as possible. Open access policies increase authors’ rights, readership and citation rates for scholarly articles. The opt out provision ensures that all faculty authors have the freedom to publish in the journal of their choice.

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Now showing 1 - 10 of 24121

The IeDEA harmonist data toolkit: A data quality and data sharing solution for a global HIV research consortium
(Elsevier, 2022) Lewis, Judith T.; Stephens, Jeremy; Musick, Beverly; Brown, Steven; Malateste, Karen; Ostinelli, Cam Ha Dao; Maxwell, Nicola; Jayathilake, Karu; Shi, Qiuhu; Brazier, Ellen; Kariminia, Azar; Hogan, Brenna; Duda, Stephany N.; Biostatistics and Health Data Science, School of Medicine
We describe the design, implementation, and impact of a data harmonization, data quality checking, and dynamic report generation application in an international observational HIV research network. The IeDEA Harmonist Data Toolkit is a web-based application written in the open source programming language R, employs the R/Shiny and RMarkdown packages, and leverages the REDCap data collection platform for data model definition and user authentication. The Toolkit performs data quality checks on uploaded datasets, checks for conformance with the network's common data model, displays the results both interactively and in downloadable reports, and stores approved datasets in secure cloud storage for retrieval by the requesting investigator. Including stakeholders and users in the design process was key to the successful adoption of the application. A survey of regional data managers as well as initial usage metrics indicate that the Toolkit saves time and results in improved data quality, with a 61% mean reduction in the number of error records in a dataset. The generalized application design allows the Toolkit to be easily adapted to other research networks.
The COVID-19 pandemic and associated rise in pediatric firearm injuries: A multi-institutional study
(Elsevier, 2022) Collings, Amelia T.; Farazi, Manzur; Van Arendonk, Kyle J.; Fallat, Mary E.; Minneci, Peter C.; Sato, Thomas T.; Speck, K. Elizabeth; Deans, Katherine J.; Falcone, Richard A., Jr.; Foley, David S.; Fraser, Jason D.; Gadepalli, Samir K.; Keller, Martin S.; Kotagal, Meera; Landman, Matthew P.; Leys, Charles M.; Markel, Troy A.; Rubalcava, Nathan; St. Peter, Shawn D.; Flynn-O’Brien, Katherine T.; Midwest Pediatric Surgery Consortium; Surgery, School of Medicine
Background: Firearm sales in the United States (U.S.) markedly increased during the COVID-19 pandemic. Our objective was to determine if firearm injuries in children were associated with stay-at-home orders (SHO) during the COVID-19 pandemic. We hypothesized there would be an increase in pediatric firearm injuries during SHO. Methods: This was a multi institutional, retrospective study of institutional trauma registries. Patients <18 years with traumatic injuries meeting National Trauma Data Bank (NTDB) criteria were included. A "COVID" cohort, defined as time from initiation of state SHO through September 30, 2020 was compared to "Historical" controls from an averaged period of corresponding dates in 2016-2019. An interrupted time series analysis (ITSA) was utilized to evaluate the association of the U.S. declaration of a national state of emergency with pediatric firearm injuries. Results: Nine Level I pediatric trauma centers were included, contributing 48,111 pediatric trauma patients, of which 1,090 patients (2.3%) suffered firearm injuries. There was a significant increase in the proportion of firearm injuries in the COVID cohort (COVID 3.04% vs. Historical 1.83%; p < 0.001). There was an increased cumulative burden of firearm injuries in 2020 compared to a historical average. ITSA showed an 87% increase in the observed rate of firearm injuries above expected after the declaration of a nationwide emergency (p < 0.001). Conclusion: The proportion of firearm injuries affecting children increased during the COVID-19 pandemic. The pandemic was associated with an increase in pediatric firearm injuries above expected rates based on historical patterns.
Insight Into Rho Kinase Isoforms in Obesity and Energy Homeostasis
(Frontiers Media, 2022-06-13) Wei, Lei; Shi, Jianjian; Pediatrics, School of Medicine
Obesity and associated complications increasingly jeopardize global health and contribute to the rapidly rising prevalence of type 2 diabetes mellitus and obesity-related diseases. Developing novel methods for the prevention and treatment of excess body adipose tissue expansion can make a significant contribution to public health. Rho kinase is a Rho-associated coiled-coil-containing protein kinase (Rho kinase or ROCK). The ROCK family including ROCK1 and ROCK2 has recently emerged as a potential therapeutic target for the treatment of metabolic disorders. Up-regulated ROCK activity has been involved in the pathogenesis of all aspects of metabolic syndrome including obesity, insulin resistance, dyslipidemia and hypertension. The RhoA/ROCK-mediated actin cytoskeleton dynamics have been implicated in both white and beige adipogenesis. Studies using ROCK pan-inhibitors in animal models of obesity, diabetes, and associated complications have demonstrated beneficial outcomes. Studies via genetically modified animal models further established isoform-specific roles of ROCK in the pathogenesis of metabolic disorders including obesity. However, most reported studies have been focused on ROCK1 activity during the past decade. Due to the progress in developing ROCK2-selective inhibitors in recent years, a growing body of evidence indicates more attention should be devoted towards understanding ROCK2 isoform function in metabolism. Hence, studying individual ROCK isoforms to reveal their specific roles and principal mechanisms in white and beige adipogenesis, insulin sensitivity, energy balancing regulation, and obesity development will facilitate significant breakthroughs for systemic treatment with isoform-selective inhibitors. In this review, we give an overview of ROCK functions in the pathogenesis of obesity and insulin resistance with a particular focus on the current understanding of ROCK isoform signaling in white and beige adipogenesis, obesity and thermogenesis in adipose tissue and other major metabolic organs involved in energy homeostasis regulation.
The Reproducibility Movement in Psychology: Does Researcher Gender Affect How People Perceive Scientists With a Failed Replication?
(Frontiers Media, 2022-06-13) Ashburn-Nardo, Leslie; Moss-Racusin, Corinne A.; Smith, Jessi L.; Sanzari, Christina M.; Vescio, Theresa K.; Glick, Peter; Psychology, School of Science
The reproducibility movement in psychology has resulted in numerous highly publicized instances of replication failures. The goal of the present work was to investigate people’s reactions to a psychology replication failure vs. success, and to test whether a failure elicits harsher reactions when the researcher is a woman vs. a man. We examined these questions in a pre-registered experiment with a working adult sample, a conceptual replication of that experiment with a student sample, and an analysis of data compiled and posted by a psychology researcher on their public weblog with the stated goal to improve research replicability by rank-ordering psychology researchers by their “estimated false discovery risk.” Participants in the experiments were randomly assigned to read a news article describing a successful vs. failed replication attempt of original work from a male vs. female psychological scientist, and then completed measures of researcher competence, likability, integrity, perceptions of the research, and behavioral intentions for future interactions with the researcher. In both working adult and student samples, analyses consistently yielded large main effects of replication outcome, but no interaction with researcher gender. Likewise, the coding of weblog data posted in July 2021 indicated that 66.3% of the researchers scrutinized were men and 33.8% were women, and their rank-ordering was not correlated with researcher gender. The lack of support for our pre-registered gender-replication hypothesis is, at first glance, encouraging for women researchers’ careers; however, the substantial effect sizes we observed for replication outcome underscore the tremendous negative impact the reproducibility movement can have on psychologists’ careers. We discuss the implications of such negative perceptions and the possible downstream consequences for women in the field that are essential for future study.
Assessing Progress Toward the Vision of a Comprehensive, Shared Electronic Care Plan: Scoping Review
(JMIR, 2022-06-10) Norton, Jenna M.; Ip, Alex; Ruggiano, Nicole; Abidogun, Tolulope; Camara, Djibril Souleymane; Fu, Helen; Hose, Bat-Zion; Miran, Saadia; Hsiao, Chun-Ju; Wang, Jing; Bierman, Arlene S.; Epidemiology, School of Public Health
Background: Care plans are central to effective care delivery for people with multiple chronic conditions. But existing care plans-which typically are difficult to share across care settings and care team members-poorly serve people with multiple chronic conditions, who often receive care from numerous clinicians in multiple care settings. Comprehensive, shared electronic care (e-care) plans are dynamic electronic tools that facilitate care coordination and address the totality of health and social needs across care contexts. They have emerged as a potential way to improve care for individuals with multiple chronic conditions. Objective: To review the landscape of e-care plans and care plan-related initiatives that could allow the creation of a comprehensive, shared e-care plan and inform a joint initiative by the National Institutes of Health and the Agency for Healthcare Research and Quality to develop e-care planning tools for people with multiple chronic conditions. Methods: We conducted a scoping review, searching literature from 2015 to June 2020 using Scopus, Clinical Key, and PubMed; we also searched the gray literature. To identify initiatives potentially missing from this search, we interviewed expert informants. Relevant data were then identified and extracted in a structured format for data synthesis and analysis using an expanded typology of care plans adapted to our study context. The extracted data included (1) the perspective of the initiatives; (2) their scope, (3) network, and (4) context; (5) their use of open syntax standards; and (6) their use of open semantic standards. Results: We identified 7 projects for e-care plans and 3 projects for health care data standards. Each project provided critical infrastructure that could be leveraged to promote the vision of a comprehensive, shared e-care plan. All the e-care plan projects supported both broad goals and specific behaviors; 1 project supported a network of professionals across clinical, community, and home-based networks; 4 projects included social determinants of health. Most projects specified an open syntax standard, but only 3 specified open semantic standards. Conclusions: A comprehensive, shared, interoperable e-care plan has the potential to greatly improve the coordination of care for individuals with multiple chronic conditions across multiple care settings. The need for such a plan is heightened in the wake of the ongoing COVID-19 pandemic. While none of the existing care plan projects meet all the criteria for an optimal e-care plan, they all provide critical infrastructure that can be leveraged as we advance toward the vision of a comprehensive, shared e-care plan. However, critical gaps must be addressed in order to achieve this vision.
Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials
(American Diabetes Association, 2022) Tuttle, Katherine R.; Levin, Adeera; Nangaku, Masaomi; Kadowaki, Takashi; Agarwal, Rajiv; Hauske, Sibylle J.; Elsäßer, Amelie; Ritter, Ivana; Steubl, Dominik; Wanner, Christoph; Wheeler, David C.; Medicine, School of Medicine
Objective: To assess the safety of empagliflozin in patients with type 2 diabetes and moderate to severe chronic kidney disease (CKD) (category G3-4) enrolled in clinical trials. Research design and methods: This analysis pooled data from 19 randomized, placebo-controlled, phase 1-4 clinical trials and 1 randomized, placebo-controlled extension study in which patients received empagliflozin 10 mg or 25 mg daily. Time to first occurrence of adverse events (AEs) was evaluated using Kaplan-Meier analysis and multivariable Cox regression models. Results: Among a total of 15,081 patients who received at least one study drug dose, 1,522, 722, and 123 were classified as having G3A, G3B, and G4 CKD, respectively, at baseline. Demographic and clinical characteristics were similar between treatment groups across CKD categories. Rates of serious AEs, AEs leading to discontinuation, and events of special interest (including lower limb amputations and acute renal failure [ARF]) were also similar between empagliflozin and placebo across CKD subgroups. In adjusted Cox regression analyses, risks for volume depletion and ARF were similar for empagliflozin and placebo in the combined group with CKD categories G3B and G4 and the G3A group. Notably lower risks were observed in both groups for hyperkalemia (hazard ratio 0.59 [95% CI 0.37-0.96, P = 0.0323] and 0.48 [0.26-0.91, P = 0.0243], respectively) and edema (0.47 [0.33-0.68, P < 0.0001] and 0.44 [0.28-0.68, P = 0.0002], respectively). Conclusions: Use of empagliflozin in patients with type 2 diabetes and advanced CKD raised no new safety concerns and may have beneficial effects on the development of hyperkalemia and edema.
FAM83A is a potential biomarker for breast cancer initiation
(Springer, 2022-02-19) Marino, Natascia; German, Rana; Podicheti, Ram; Rockey, Pam; Sandusky, George E.; Temm, Constance J.; Nakshatri, Harikrishna; Addison, Rebekah J.; Selman, Bryce; Althouse, Sandra K.; Storniolo , Anna Maria V.; Medicine, School of Medicine
Background Family with sequence similarity 83 member A (FAM83A) presents oncogenic properties in several cancers including breast cancer. Recently, we reported FAM83A overexpression in normal breast tissues from women at high risk of breast cancer. We now hypothesize that FAM83A is a key factor in breast cancer initiation. Methods Immunohistochemical staining was used to evaluate FAM83A protein levels in both a normal breast tissue microarray (TMA, N = 411) and a breast tumor TMA (N = 349). EGFR staining and its correlation with FAM83A expression were also assessed. Lentivirus-mediated manipulation of FAM83A expression in primary and hTERT-immortalized breast epithelial cells was employed. Biological and molecular alterations upon FAM83A overexpression/downregulation and FAM83A’s interaction partners were investigated. Results TMA analysis revealed a 1.5-fold increase in FAM83A expression level in breast cancer cases as compared with normal breast tissues (p < 0.0001). FAM83A protein expression was directly correlated with EGFR level in both normal and breast cancer tissues. In in vitro assays, exogenous expression of FAM83A in either primary or immortalized breast epithelial cells promoted cell viability and proliferation. Additionally, Ingenuity Pathway Analysis (IPA) revealed that FAM83A overexpression in primary cells affected the expression of genes involved in cellular morphology and metabolism. Mass spectrometry analysis identified DDX3X and LAMB3 as potential FAM83A interaction partners in primary cells, while we detected FAM83A interaction with cytoskeleton reorganization factors, including LIMA1, MYH10, PLEC, MYL6 in the immortalized cells. Conclusions This study shows that FAM83A promotes metabolic activation in primary breast epithelial cells and cell proliferation in both primary and immortalized cells. These findings support its role in early breast oncogenesis.
PROTOCOL: Barriers and facilitators to stakeholder engagement in health guideline development: A qualitative evidence synthesis
(Wiley, 2022-04-25) Magwood, Olivia; Riddle, Alison; Petkovic, Jennifer; Lytvyn, Lyubov; Khabsa, Joanne; Atwere, Pearl; Akl, Elie A.; Campbell, Pauline; Welch, Vivian; Smith, Maureen; Mustafa, Reem A.; Limburg, Heather; Dans, Leonila F.; Skoetz, Nicole; Grant, Sean; Concannon, Tom; Tugwell, Peter; Social and Behavioral Sciences, School of Public Health
Background: There is a need for the development of comprehensive, global, evidence-based guidance for stakeholder engagement in guideline development. Stakeholders are any individual or group who is responsible for or affected by health- and healthcare-related decisions. This includes patients, the public, providers of health care and policymakers for example. As part of the guidance development process, Multi-Stakeholder Engagement (MuSE) Consortium set out to conduct four concurrent systematic reviews to summarise the evidence on: (1) existing guidance for stakeholder engagement in guideline development, (2) barriers and facilitators to stakeholder engagement in guideline development, (3) managing conflicts of interest in stakeholder engagement in guideline development and (4) measuring the impact of stakeholder engagement in guideline development. This protocol addresses the second systematic review in the series. Objectives: The objective of this review is to identify and synthesise the existing evidence on barriers and facilitators to stakeholder engagement in health guideline development. We will address this objective through two research questions: (1) What are the barriers to multi-stakeholder engagement in health guideline development across any of the 18 steps of the GIN-McMaster checklist? (2) What are the facilitators to multi-stakeholder engagement in health guideline development across any of the 18 steps of the GIN-McMaster checklist? Search methods: A comprehensive search strategy will be developed and peer-reviewed in consultation with a medical librarian. We will search the following databases: MEDLINE, Cumulative Index to Nursing & Allied Health Literature (CINAHL), EMBASE, PsycInfo, Scopus, and Sociological Abstracts. To identify grey literature, we will search the websites of agencies who actively engage stakeholder groups such as the AHRQ, Canadian Institutes of Health Research (CIHR) Strategy for Patient-Oriented Research (SPOR), INVOLVE, the National Institute for Health and Care Excellence (NICE) and the PCORI. We will also search the websites of guideline-producing agencies, such as the American Academy of Pediatrics, Australia's National Health Medical Research Council (NHMRC) and the WHO. We will invite members of the team to suggest grey literature sources and we plan to broaden the search by soliciting suggestions via social media, such as Twitter. Selection criteria: We will include empirical qualitative and mixed-method primary research studies which qualitatively report on the barriers or facilitators to stakeholder engagement in health guideline development. The population of interest is stakeholders in health guideline development. Building on previous work, we have identified 13 types of stakeholders whose input can enhance the relevance and uptake of guidelines: Patients, caregivers and patient advocates; Public; Providers of health care; Payers of health services; Payers of research; Policy makers; Program managers; Product makers; Purchasers; Principal investigators and their research teams; and Peer-review editors/publishers. Eligible studies must describe stakeholder engagement at any of the following steps of the GIN-McMaster Checklist for Guideline Development. Data collection and analysis: All identified citations from electronic databases will be imported into Covidence software for screening and selection. Documents identified through our grey literature search will be managed and screened using an Excel spreadsheet. A two-part study selection process will be used for all identified citations: (1) a title and abstract review and (2) full-text review. At each stage, teams of two review authors will independently assess all potential studies in duplicate using a priori inclusion and exclusion criteria. Data will be extracted by two review authors independently and in duplicate according to a standardised data extraction form. Main results: The results of this review will be used to inform the development of guidance for multi-stakeholder engagement in guideline development and implementation. This guidance will be official GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group guidance. The GRADE system is internationally recognised as a standard for guideline development. The findings of this review will assist organisations who develop healthcare, public health and health policy guidelines, such as the World Health Organization, to involve multiple stakeholders in the guideline development process to ensure the development of relevant, high quality and transparent guidelines.
Artificial Intelligence Methods and Artificial Intelligence-Enabled Metrics for Surgical Education: A Multidisciplinary Consensus
(Wolters Kluwer, 2022) Vedula, S. Swaroop; Ghazi, Ahmed; Collins, Justin W.; Pugh, Carla; Stefanidis, Dimitrios; Meireles, Ozanan; Hung, Andrew J.; Schwaitzberg, Steven; Levy, Jeffrey S.; Sachdeva, Ajit K.; Collaborative for Advanced Assessment of Robotic Surgical Skills; Surgery, School of Medicine
Background: Artificial intelligence (AI) methods and AI-enabled metrics hold tremendous potential to advance surgical education. Our objective was to generate consensus guidance on specific needs for AI methods and AI-enabled metrics for surgical education. Study design: The study included a systematic literature search, a virtual conference, and a 3-round Delphi survey of 40 representative multidisciplinary stakeholders with domain expertise selected through purposeful sampling. The accelerated Delphi process was completed within 10 days. The survey covered overall utility, anticipated future (10-year time horizon), and applications for surgical training, assessment, and feedback. Consensus was agreement among 80% or more respondents. We coded survey questions into 11 themes and descriptively analyzed the responses. Results: The respondents included surgeons (40%), engineers (15%), affiliates of industry (27.5%), professional societies (7.5%), regulatory agencies (7.5%), and a lawyer (2.5%). The survey included 155 questions; consensus was achieved on 136 (87.7%). The panel listed 6 deliverables each for AI-enhanced learning curve analytics and surgical skill assessment. For feedback, the panel identified 10 priority deliverables spanning 2-year (n = 2), 5-year (n = 4), and 10-year (n = 4) timeframes. Within 2 years, the panel expects development of methods to recognize anatomy in images of the surgical field and to provide surgeons with performance feedback immediately after an operation. The panel also identified 5 essential that should be included in operative performance reports for surgeons. Conclusions: The Delphi panel consensus provides a specific, bold, and forward-looking roadmap for AI methods and AI-enabled metrics for surgical education.
Association Between Parental Leave and Ophthalmology Resident Physician Performance
(American Medical Association, 2022-11-01) Huh, Dana D.; Wang , Jiangxia; Fliotsos , Michael J.; Beal , Casey J.; Boente , Charline S.; Wisely , C. Ellis; De Andrade , Lindsay M.; Lorch , Alice C.; Ramanathan , Saras; Reinoso, Maria A.; Swamy, Ramya N.; Waxman , Evan L.; Woreta, Fasika A.; Srikumaran, Divya; Ophthalmology, School of Medicine
Importance Although parental leave is essential in enhancing resident wellness and fostering inclusive workplace environments, residents may often feel discouraged from using parental leave owing to perceived stigma and concerns about possible negative effects on their training. Objective To examine parental leave usage across multiple institutions and compare residency performance metrics between residents who took parental leave vs their peers who did not take leave. Design, Setting, and Participants This was a retrospective cross-sectional analysis conducted from April 1, 2020, to July 28, 2022, of educational records. Multicenter data were obtained from 10 Accreditation Council for Graduate Medical Education (ACGME)–accredited ophthalmology programs across the US. Included ophthalmology residents graduated between 2015 and 2019. Data were analyzed from August 15, 2021, to July 25, 2022. Exposures Performance metrics of residents who used parental leave during residency were compared with those of residents who did not take parental leave. Main Outcomes and Measures Measures of performance included the Ophthalmic Knowledge Assessment Program (OKAP) scores, ACGME milestones scores, board examination pass rates, research activity, and surgical volumes. Results Of the 283 ophthalmology residents (149 male [52.7%]) included in the study, 44 (15.5%) took a median (IQR) parental leave of 4.5 (2-6) weeks. There were no differences in average OKAP percentiles, research activity, average ACGME milestones scores, or surgical volume between residents who took parental leave and those who did not. Residents who pursued fellowship were less likely to have taken parental leave (odds ratio [OR], 0.43; 95% CI, 0.27-0.68; P < .001), and residents who practiced in private settings after residency were more likely to have taken parental leave (OR, 3.56; 95% CI, 1.79-7.08; P < .001). When stratified by sex, no differences were identified in performance between female residents who took parental leave compared with residents who did not take leave, except a mild surgical number difference in 1 subspecialty category of keratorefractive procedures (difference in median values, −2; 95% CI, −3.7 to −0.3; P = .03). Conclusions and Relevance In this multicenter cross-sectional study, no differences in performance metrics were identified between residents taking parental leave compared with their peers. These findings may provide reassurance to trainees and program directors regarding the unlikelihood, on average, that taking adequate parental leave will affect performance metrics adversely.

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