Procurement of shared data instruments for Research Electronic Data Capture (REDCap).

REDCap (Research Electronic Data Capture) is a web-based software solution and tool set that allows biomedical researchers to create secure online forms for data capture, management and analysis with minimal effort and training. The Shared Data Instrument Library (SDIL) is a relatively new component of REDCap that allows sharing of commonly used data collection instruments for immediate study use by research teams. Objectives of the SDIL project include: (1) facilitating reuse of data dictionaries and reducing duplication of effort; (2) promoting the use of validated data collection instruments, data standards and best practices; and (3) promoting research collaboration and data sharing. Instruments submitted to the library are reviewed by a library oversight committee, with rotating membership from multiple institutions, which ensures quality, relevance and legality of shared instruments. The design allows researchers to download the instruments in a consumable electronic format in the REDCap environment. At the time of this writing, the SDIL contains over 128 data collection instruments. Over 2500 instances of instruments have been downloaded by researchers at multiple institutions. In this paper we describe the library platform, provide detail about experience gained during the first 25months of sharing public domain instruments and provide evidence of impact for the SDIL across the REDCap consortium research community. We postulate that the shared library of instruments reduces the burden of adhering to sound data collection principles while promoting best practices.

Effect of the COVID-19 Pandemic on Musculoskeletal Care in the Emergency Room.

OBJECTIVE: Study the effect of the coronavirus disease (COVID-19) pandemic on emergency room (ER) utilization for musculoskeletal (MSK) complaints. METHODS: Data from ER encounters in a teaching hospital for years 2019 and 2020 were extracted from an electronic database. The ICD-10-CM codes were used to assign the primary diagnosis. Joinpoint regression was applied to a time-series to detect changes in daily encounters (all-cause and MSK). Total number and median daily encounters were calculated by year, sex, age groups, and diagnostic codes for each year. RESULTS: Overlapping intervals within March 2020 showed drops of 8.1 all-cause encounters per day (95% CI: 4.8-11.5), and 1.2 MSK encounters per day (95% CI: 0.8-1.7), resulting in net losses for the year of 33.2% for all-cause and 35.8% for MSK encounters. Reductions were observed for both sexes and all age groups. MSK codes with largest declines were low back pain, joint pain, and limb pain. CONCLUSION: The COVID-19 pandemic resulted in major reductions in all-cause and MSK encounters in the ER of an academic hospital probably due to governmental restrictions and a change in patients behaviors. Persistence of the observed reduction suggests that patients requiring ER services delayed seeking care for MSK and other health conditions.

Musculoskeletal Conditions in Older Men and Women: An Emergency Room Study.

OBJECTIVE: To study the utilization of emergency room (ER) services for health complaints of the musculoskeletal (MSK) system in older men and women. METHODS: Data from all medical encounters at the ER of a teaching hospital for calendar years 2016-2020 were extracted from an electronic database. MSK encounters were defined as those with ICD 10-CM M and S codes in the primary diagnosis field of the database. Frequency distributions were calculated by year, sex, and age group for MSK and all encounters. The most frequent codes used by sex and age groups were assessed. RESULTS: The number of unique patients with medical encounters at the ER during the five-year period was 94,346. There was a total of 220,153 encounters (median:1 encounter per patient; interquartile range:1-3). A 33.2% reduction in the number of encounters occurred in 2020 compared to 2019. The total number of unique patients in the 60 yr. and older group was 24,412 (25.9% of all unique patients). The total number of encounters in the group 60 yr. and older was 56,294 (25.6% of all encounters). Women accounted for 31,488 (56%) encounters in this age group. A total of 12,744 encounters (22.6%) in older adults involved the MSK system and this proportion decreased with increasing age. The most common MSK conditions included low back pain, pain in joints, and femoral fractures. CONCLUSION: Older adults with MSK health conditions represent a substantial portion of ER patients. Many MSK health conditions could be evaluated and treated in other health care settings.

Economic analysis of centralized vs. decentralized electronic data capture in multi-center clinical studies.

BACKGROUND: New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models. METHODS: We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models. MAIN OUTCOME MEASURES: The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers. RESULTS: Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models. CONCLUSION: Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs.

Home-based management of COVID-19 by identification of low-risk features.

BACKGROUND: Covid-19 is a triphasic disorder characterized by a viral phase lasting 7-10 days from first onset of symptoms. In approximately 20% it is followed by a second stage heralded by elevation of pro-inflammatory markers such as ferritin, IL-6, CRP, LDH and D-dimers. We hypothesized that those with few abnormalities would have a low risk for progression to respiratory insufficiency and could be monitored at home without treatment. METHODS: Inclusion criteria included age >21, O2 saturation >90%. To be observed without treatment patients could not have >1 of the following: CRP > 10 mg/dL, high LDH, ferritin > 500 ng/ml, D-dimer > 1 mg/L, IL-6 > 10 pg/ml, absolute lymphocyte count <1,000, O2 sat <94%, or CT chest evidence of pneumonia. Primary endpoint: progression to respiratory failure. Secondary endpoint: 28-day survival. RESULTS: Of 208 entered, 132 were monitored without therapy. None progressed to respiratory failure or died. CONCLUSIONS: We have shown that our approach can identify cases who can safely be observed without treatment, thus avoiding expensive, potentially toxic therapies, and circumventing unnecessary, costly hospitalizations. These results support our hypothesis that after applying our criteria, 64% of Covid-19 cases can be monitored as outpatients without therapy.

Musculoskeletal Conditions in the Emergency Room: A Teaching Opportunity for Medical Students and Residents.

OBJECTIVE: Assess the potential value of an emergency room (ER) for the teaching of musculoskeletal (MSK) medicine to medical students and residents in training. METHODS: Data from all encounters to the ER of a teaching hospital for calendar years 2016-2019 were extracted from an electronic database. Encounters with ICD-10-CM M codes (MSK system) and S codes (injury) were selected (MSK encounters). Frequency distributions were calculated by year, sex, and age group for all encounters and MSK encounters. Annual distributions of encounters involving the shoulder, hip, knee, and ankle joints were assessed. RESULTS: The number of unique patients seen during the four-year period was 84,094, and the number of encounters was 187,829 (Median: 1 encounter; interquartile range: 1-2). The mean number of encounters per year was 46,957 (range: 45,311- 48,382). There was no seasonal variation. Most patients were women (45,868; 54.6%) and young (20 29 yr.) adults (15,012; 17.8%), and these groups generated the largest numbers of encounters (women: 108,799; 57.9%; young adults: 35,969; 19.1%). A total of 41,353 encounters (22.0% of all encounters) involved the MSK system. The shoulder, hip, knee, and ankle were involved in 2,768 (1.5%), 1,592 (0.8%), 3,082 (1.6%), and 1,718 (0.9%) encounters, respectively. The most common conditions for each joint were shoulder pain, femoral fracture, knee contusion, and ankle sprain. CONCLUSION: Our findings suggest that ER physicians should have broad knowledge of MSK conditions and injuries. An ER is an excellent location for the teaching of MSK medicine to medical students and residents of other training programs.

Single-Arm, Open-Label Phase 2 Trial of Preemptive Methylprednisolone to Avert Progression to Respiratory Failure in High-Risk Patients with COVID-19.

Introduction: Covid-19 is a triphasic disorder first typified by a viral phase that lasts from the first onset of symptoms until seven days later. This is followed by a second and third phase, initially characterized by the appearance of lung infiltrates, followed in 20% by respiratory failure. The second phase is usually heralded by an elevation of serologic inflammatory markers including CRP, ferritin, IL-6, LDH as well as D-dimers. Approximately 20% proceed to the second phase and are usually then treated with dexamethasone, provided they are oxygen-dependent since these are the only cases that benefit from dexamethasone. If we had objective criteria to predict this 20% that develop severe illness, they could preemptively be treated with steroids. In this exploratory study we investigated the early use of preemptive steroids in the setting of early disease, in high-risk non-oxygen dependent cases. Methods: Eligible patients were those 21 years or older with a diagnosis of Covid-19 and oxygen saturation ≥91%. For patients to be classified as high-risk, they had to exhibit two or more of the following abnormalities 7-10 days after first symptom: IL-6 ≥ 10 pg/ml, ferritin > 500 ng/ml, D-dimer > 1 mg/L (1,000 ng/ml), CRP > 10 mg/dL (100 mg/L), LDH above normal range lymphopenia (absolute lymphocyte count <1,000 /µL), oxygen saturation between 91-94%, or CT chest with evidence of ground glass infiltrates. Primary endpoint was progression to respiratory failure. CALL score method was used to predict the expected number of cases of respiratory failure. High risk patients received methylprednisolone (MPS) 80 mg IV daily x 5 days starting no earlier than seven days from first onset of symptoms. The primary endpoint was progression to hypoxemic respiratory failure defined as PaO2 <60 mm Hg or oxygen saturation ≤90%. Secondary endpoints included survival at 28 days from registration, admission to intensive care and live discharge from the hospital. Change in levels of inflammatory markers and length of hospitalization were also assessed. Results: In 76 patients, the expected number with respiratory failure was 30 (39.5%), yet only 4 (5.3%) developed that complication (p=.00001). Survival at 28 days was 98.6%.Improvement in inflammatory markers correlated with favorable outcome. Conclusions: Our results are encouraging and suggest that this approach is both effective and safe.

Telehealth innovations in health education and training.

Telehealth applications are increasingly important in many areas of health education and training. In addition, they will play a vital role in biomedical research and research training by facilitating remote collaborations and providing access to expensive/remote instrumentation. In order to fulfill their true potential to leverage education, training, and research activities, innovations in telehealth applications should be fostered across a range of technology fronts, including online, on-demand computational models for simulation; simplified interfaces for software and hardware; software frameworks for simulations; portable telepresence systems; artificial intelligence applications to be applied when simulated human patients are not options; and the development of more simulator applications. This article presents the results of discussion on potential areas of future development, barries to overcome, and suggestions to translate the promise of telehealth applications into a transformed environment of training, education, and research in the health sciences.

Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.

The role of translational research in addressing health disparities: a conceptual framework.

Translational research has tremendous potential as a tool to reduce health disparities in the United States, but a lack of common understanding about the scope of this dynamic, multidisciplinary approach to research has limited its use. The term "translational research" is often associated with the phrase "bench to bedside," but the expedited movement of biomedical advances from the laboratory to clinical trials is only the first phase of the translational process. The second phase of translation, wherein innovations are moved from the bedside to real-world practice, is equally important, but it receives far less attention. Due in part to this imbalance, tremendous amounts of money and effort are spent expanding the boundaries of understanding and investigating the molecular underpinnings of disease and illness, while far fewer resources are devoted to improving the mechanisms by which those advances will be used to actually improve health outcomes. To foster awareness of the complete translational process and understanding of its value, we have developed two complementary models that provide a unifying conceptual framework for translational research. Specifically, these models integrate many elements of the National Institutes of Health roadmap for the future of medical research and provide a salient conceptualization of how a wide range of research endeavors from different disciplines can be used harmoniously to make progress toward achieving two overarching goals of Healthy People 2010--increasing the quality and years of healthy life and eliminating health disparities.

Addressing health disparities through multi-institutional, multidisciplinary collaboratories.

The national research leadership has recently become aware of the tremendous potential of translational research as an approach to address health disparities. The Research Centers in Minority Institutions (RCMI) Translational Research Network (RTRN) is a research network that supports multi-institutional, multidisciplinary collaboration with a focus on key diseases and conditions for which disproportionately adverse racial and ethnic health disparities exist. The RTRN is designed to facilitate the movement of scientific advances across the translational research spectrum by providing researchers at different institutions with the infrastructure and tools necessary to collaborate on interdisciplinary and transdisciplinary research projects relating to specific health outcomes for which major racial/ethnic disparities exist. In the past, the difficulty of overcoming the restrictions imposed by time and space have made it difficult to carry out this type of large-scale, multilevel collaboration efficiently. To address this formidable challenge, the RTRN will deploy a translational research cluster system that uses "cyber workspaces" to bring researchers with similar interests together by using online collaboratory technology. These virtual meeting environments will provide a number of tools, including videoconferences (seminars, works in progress, meetings); project management tools (WebCT, Microsoft Share Point); and posting areas for projects, concepts, and other research and educational activities. This technology will help enhance access to resources across institutions with a common mission, minimize many of the logistical hurdles that impede intellectual exchange, streamline the planning and implementation of innovative interdisciplinary research, and assess the use of protocols and practices to assist researchers in interacting across and within cyber workspaces.

An ethno-medical perspective on research participation: a qualitative pilot study.

BACKGROUND: Recruitment of racial/ethnic minorities for clinical research continues to be problematic, yet critical to ensuring that research data will be applicable to diverse populations. There is a paucity of information about culturally appropriate methods for recruiting and retaining racial/ethnic minorities in research. OBJECTIVE: To cross-culturally assess perceptions of research participation by African American and immigrant Latinos living in the inner-city community of Watts, Los Angeles, California, using qualitative methods. DESIGN: Focus groups using ethnically matched moderators were convened with African American and immigrant Latino participants. Discussion was facilitated using a script that focused on perceived "feelings" and "perceptions" about research. Discussions were audiotaped, transcribed, and analyzed using manual and computerized statistically based software (mixed) methods. RESULTS: African Americans and immigrant Latinos shared several barriers and motivators to research. However, they also reported barriers and motivators to research that were distinct to each group. Latinos were more interested in healthcare and health information, and African Americans were more concerned with issues of trust and quality of care. Most participants said they would participate in research if they were better informed, or if they or a family member had an illness. Improving communication was reported as being important for motivating participation in clinical research. Overall, socioecologically and socioeconomically based domains were shared, whereas historically and/or socioculturally based domains were distinct. CONCLUSIONS: Using an ethno-medical science model, we demonstrated that it is possible to identify shared barriers and motivators to research participation between 2 distinct cultural groups. This approach can be useful in developing targeted community-based strategies to increase minority participation in clinical trials.

Prevalence and Genetic Profile of Duchene and Becker Muscular Dystrophy in Puerto Rico.

BACKGROUND: Duchenne and Becker Muscular Dystrophy (DMD and BMD, respectively), are common forms of inherited muscle disease. Information regarding the epidemiology of these conditions, including genotype, is still sparse. OBJECTIVE: To establish the prevalence and genetic profile of DMD and BMD in Puerto Rico. METHODS: We collected data from medical records in all Muscular Dystrophy Association (MDA) clinics in Puerto Rico in order to estimate the prevalence of DMD and BMD and to describe the genotypic profile of these patients. Patients selected for data analysis matched "definite", "probable" and "possible" case definitions as established by MD STARnet. RESULTS: A total of 141 patients matched the inclusion criteria, with 64.5% and 35.5% being categorized into DMD and BMD, respectively. DMD and BMD prevalence in Puerto Rico was estimated at 5.18 and 2.84 per 100,000 males, respectively. Deletion was the most common form of mutation (66.7%) in the dystrophin gene, with exons in segment 45 to 47 being the most frequently affected. CONCLUSIONS: This is the first report of the prevalence and genetic profile characteristics of DMD and BMD in Puerto Rico. Prevalence of DMD was similar to that reported worldwide, while prevalence of BMD was higher. Genetic profile was consistent with that reported in the literature.

SalHUD--A Graphical Interface to Public Health Data in Puerto Rico.

PURPOSE: This paper describes SalHUD, a prototype web-based application for visualizing health data from Puerto Rico. Our initial focus was to provide interactive maps displaying years of potential life lost (YPLL). METHODS: The public-use mortality file for year 2008 was downloaded from the Puerto Rico Institute of Statistics website. Data was processed with R, Python and EpiInfo to calculate years of potential life lost for the leading causes of death on each of the 78 municipalities in the island. Death records were classified according to ICD-10 codes. YPLL for each municipality was integrated into AtlasPR, a D3 Javascript map library. Additional Javascript, HTML and CSS programing was required to display maps as a web-based interface. RESULTS: YPLL for all municipalities are displayed on a map of Puerto Rico for each of the ten leading causes of death and for all causes combined, so users may dynamically explore the impact of premature mortality. DISCUSSION: This work is the first step in providing the general public in Puerto Rico with user-friendly, interactive, visual access to public health data that is usually published in numerical, text-based media.

Use of Medicare services by elderly residents of Puerto Rico.

OBJECTIVES: We describe hospitalization rates among Medicare beneficiaries resident in Puerto Rico compared to beneficiaries in the mainland U.S., in 1999. METHODS: A cross-sectional analysis using Medicare Denominator and hospitalization files. RESULTS: The rate ratio (PR/U.S.) of age, gender-adjusted hospitalizations among elderly Medicare beneficiaries with Part A coverage was 0.78, compared with 0.92 among beneficiaries with both Part A and Part B coverage. Among the latter, the rate ratios were 0.78 for surgical admissions, 1.08 for low-variation medical conditions, and 0.97 for high variation medical conditions. They were higher for younger elderly beneficiaries. CONCLUSIONS: Rates of hospitalization in Puerto Rico may be lower, the same or exceed those of the mainland U.S. depending on the age of the beneficiary and the type of hospitalization.

Anaerobic power and muscle strength in human immunodeficiency virus-positive preadolescents.

OBJECTIVE: To determine the anaerobic power and muscle strength of preadolescents with human immunodeficiency virus (HIV). DESIGN: Cross-sectional design. SETTING: Human performance laboratory at the University District Hospital at the Puerto Rico Medical Center. PARTICIPANTS: Fifteen preadolescents (8 girls and 7 boys) with a classification of HIV A and B attending an investigational treatment program at the University Pediatric Hospital. Fifteen seronegative control subjects matched by age and gender also were included. MAIN OUTCOME MEASURES: The power of the lower extremities was measured with use of the Wingate Anaerobic Power Test on a MONARK cycle ergometer (mean power in watts). Local muscle strength of the dominant knee extensors (peak torque/body weight × 100) was tested with an isokinetic dynamometer set at 60 deg/s. Statistical analysis was performed with the Wilcoxon signed-rank test, and statistical significance was accepted at an α level of <.05. RESULTS: No significant differences between the control group and study group were detected on muscle strength testing. The study group presented a lower anaerobic power (mean power) compared with control subjects (P = .04). CONCLUSIONS: This exploratory study suggests that HIV-infected preadolescents present lower anaerobic power compared with uninfected control subjects. Our findings of impaired anaerobic capacity can have clinical implications in this population because most of the activities of daily living, such as play, leisure, and sport activities, are short term and high intensity (anaerobic) in nature.

Prevalence of tuberculin reacting and prevalence of risk factors for the development of active tuberculosis in a nursing home in Puerto Rico

A total of 91 nursing home patients were evaluated to determine the prevalence of tuberculous infection and the prevalence of risk factors for active TB in those with positive tuberculin reactions. Overall prevalence rate for positive PPD was 42.9 percent No association was found between revalence of positive PPD and time since admission to the nursing home. The most prevalent risk factors for active TB among PPD positive patients were diabetes mellitus (38.5percent), being 10 percent below ideal body weight (25.6 percent), chest X ray with fibrotic changes (13.2 percent), and carcinoma of oropharynx (5.1 percent). Twenty-one patients (53.8 percent) of patients with positive test) met criteria for prophylactic treatment with isoniazid. This study detected a high prevalence of positive PPD reactions in this nursing home population and a high prevalence of risk factors for the development of active TB in the group with positive reaction to PPD. Due to the high risk for the development of active tuberculosis in this population, aggressive screening and preventive therapy are mandatory

Prevalence of tuberculin reactivity and risk factors for the development of active tuberculosis admission to a nursing home

A total of 118 nursing home admissions were studied to determine the prevalence of M. tuberculosis infection and the prevalence of risk factors for the development of active tuberculosis. The overall prevalence of positive tests was 22.5 per cent. The most prevalent risk factors for development of active tuberculosis were diabetes mellitus (42.4 per cent), being more than 10 per cent below ideal body weight (41.5 per cent), and alcohol abuse (12.7 per cent). Thirty-four percent of admissions had albumin levels below 3.5 g/dl. No associations were found when logistic regression was used to determine the impact of age and poor nutritional status on the prevalence of positive PPD tests on admission. These results show a substantial difference between the prevalence of positive PPD tests found upon nursing home admissions (22.5 per cent) and the prevalence found previously among residents in the same in nursing home (42.9 per cent).

Factores asociados a la admisión hospitalaria en una población geriátrica / Factors associated with the hospitalary admission of a geriatric population

El estudio investiga los patrones de utilización hospitalaria en personas mayores de 64 años. La determinación de deficiencia intelectual y discapacidad de 1,353 personas mayores de 64 años y acogidos a Medicare fue obtenida de un censo de la población mayor de 59 año realizado en el municipio de Gurabo, Puerto Rico, entre 1987 y 1988. Examinando los datos de hospitalización del programa Medicare en Puerto Rico se encontró que un total de 105 de estas personas fueron hospitalizadas por lo menos una vez durante ese período de tiempo. Para el grupo con deficiencia intelectual y discapacidad la tasa de hospitalización fue de 13.5%. Los que presentan solamente discapacidad tuvieron una tasa de 9.4%. El grupo con deficiencia intelectual solamente tuvo una tasa de 8.8%. La menor tasa de 6,8%, correspondió a los sujetos sin deficiencia intelectual ni discapacidad. Estos datos sugieren una relación entre la presencia de dichas disfunciones y la probabilidad de ser hospitalizado. No obstante, es necesaria más investigación para dilucidar si dicho efecto es independiente de la edad

Differences in patient mix: a partial explanation for the excessive medicare mortality observed in some Pueto Rican hospitals

Data from a census in a Puerto Rican community were used to retrospectively compare patients admitted to government hospitals in terms of demographic variables, mental status and functional status in the community prior to admission. A total of 268 patients admitted to a hospital at least once during the study period were identified. Patients admitted to government hospitals were poorer, less educated, less functional and had a higher level of mental impairment. However, in comparison to private hospitals, stratified analysis showed consistently higher in-hospital mortality rates among patients admitted to government hospitals when other variables were taken into account