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Digital therapeutics (DTx) are a somewhat novel class of US Food and Drug Administration-regulated software that help patients prevent, manage, or treat disease. Here, we use natural language processing to characterise registered DTx clinical trials and provide insights into the clinical development landscape for these novel therapeutics. We identified 449 DTx clinical trials, initiated or expected to be initiated between 2010 and 2030, from ClinicalTrials.gov using 27 search terms, and available data were analysed, including trial durations, locations, MeSH categories, enrolment, and sponsor types. Topic modelling of eligibility criteria, done with BERTopic, showed that DTx trials frequently exclude patients on the basis of age, comorbidities, pregnancy, language barriers, and digital determinants of health, including smartphone or data plan access. Our comprehensive overview of the DTx development landscape highlights challenges in designing inclusive DTx clinical trials and presents opportunities for clinicians and researchers to address these challenges. Finally, we provide an interactive dashboard for readers to conduct their own analyses.
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Ensaios Clínicos como Assunto , Processamento de Linguagem Natural , Humanos , Estados Unidos , United States Food and Drug AdministrationRESUMO
BACKGROUND: Electronic visits (e-visits) are billable, asynchronous patient-initiated messages that require at least five minutes of medical decision-making by a provider. Unequal use of patient portal tools like e-visits by certain patient populations may worsen health disparities. To date, no study has attempted to qualitatively assess perceptions of e-visits in older adults. OBJECTIVE: In this qualitative study, we aimed to understand patient perceptions of e-visits, including their perceived utility, barriers to use, and care implications, with a focus on vulnerable patient groups. METHODS: We conducted a qualitative study using in-depth structured individual interviews with patients from diverse backgrounds to assess their knowledge and perceptions surrounding e-visits as compared with unbilled portal messages and other visit types. We used content analysis to analyze interview data. RESULTS: We conducted 20 interviews, all in adults older than 65 years. We identified 4 overarching coding categories or themes. First, participants were generally accepting of the concept of e-visits and willing to try them. Second, nearly two-thirds of the participants voiced a preference for synchronous communication. Third, participants had specific concerns about the name "e-visit" and when to choose this type of visit in the patient portal. Fourth, some participants indicated discomfort using or accessing technology for e-visits. Financial barriers to the use of e-visits was not a common theme. CONCLUSIONS: Our findings suggest that older adults are generally accepting of the concept of e-visits, but uptake may be limited due to their preference for synchronous communication. We identified several opportunities to improve e-visit implementation.
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BACKGROUND: Hydroxychloroquine (HCQ) is commonly used for patients with autoimmune conditions. Long-term use of HCQ can cause retinal toxicity, but this risk can be reduced if high doses are avoided. OBJECTIVE: We developed and piloted an electronic health record-based dashboard to improve the safe prescribing of HCQ within the Veterans Health Administration (VHA). We observed pilot facilities over a 1-year period to determine whether they were able to improve the proportion of patients receiving inappropriate doses of HCQ. METHODS: Patients receiving HCQ were identified from the VHA corporate data warehouse. Using PowerBI (Microsoft Corp), we constructed a dashboard to display patient identifiers and the most recent HCQ dose and weight (flagged if ≥5.2 mg/kg/day). Six VHA pilot facilities were enlisted to test the dashboard and invited to participate in monthly webinars. We performed an interrupted time series analysis using synthetic controls to assess changes in the proportion of patients receiving HCQ ≥5.2 mg/kg/day between October 2020 and November 2021. RESULTS: At the start of the study period, we identified 18,525 total users of HCQ nationwide at 128 facilities in the VHA, including 1365 patients at the 6 pilot facilities. Nationwide, at baseline, 19.8% (3671/18,525) of patients were receiving high doses of HCQ. We observed significant improvements in the proportion of HCQ prescribed at doses ≥5.2 mg/kg/day among pilot facilities after the dashboard was deployed (-0.06; 95% CI -0.08 to -0.04). The difference in the postintervention linear trend for pilot versus synthetic controls was also significant (-0.06; 95% CI -0.08 to -0.05). CONCLUSIONS: The use of an electronic health record-based dashboard reduced the proportion of patients receiving higher than recommended doses of HCQ and significantly improved performance at 6 VHA facilities. National roll-out of the dashboard will enable further improvements in the safe prescribing of HCQ.
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OBJECTIVE: Using the American College of Rheumatology Rheumatology Informatics System for Effectiveness (RISE) registry, our objective was to examine performance on rheumatoid arthritis (RA) quality measures and to assess the association between practice characteristics and changes in performance over time among participating practices. METHODS: We analyzed data from practices enrolled in RISE between January 1, 2015 and December 31, 2017. Eight quality measures in the areas of RA disease management, cardiovascular risk reduction, and patient safety were examined. Variability in performance was evaluated at the practice level. Multivariate linear models were used to predict change in measure performance by year and to determine the effect of practice characteristics on change in performance over time. RESULTS: Data from 59,986 patients from 54 practices were examined. The mean ± SD age was 62 ± 14 years, 77% were female, 69% were Caucasian, and most patients were seen in a single-specialty group practice (46%). The average performance on measures related to RA treatments was consistently high (>90%) across the study period. Measures related to RA functional status and disease activity assessment had the greatest improvements over time (8.4% and 13.0% increase per year, respectively; P < 0.001). Single-specialty group practices had the fastest rates of improvement over time across all measures. CONCLUSION: Among practices participating in RISE between 2015 and 2017, performance on most RA quality measures improved. Single-specialty group practices saw the fastest rates of improvement over time. Identification of workflow patterns leading to dramatic improvements in quality of care will help guide process redesign to address gaps in priority areas, such as tuberculosis screening and blood pressure control.
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Artrite Reumatoide/terapia , Indicadores de Qualidade em Assistência à Saúde/estatística & dados numéricos , Sistema de Registros , Reumatologia/estatística & dados numéricos , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reumatologia/normasRESUMO
OBJECTIVE: The study sought to describe the contributions of clinical informatics (CI) fellows to their institutions' coronavirus disease 2019 (COVID-19) response. MATERIALS AND METHODS: We designed a survey to capture key domains of health informatics and perceptions regarding fellows' application of their CI skills. We also conducted detailed interviews with select fellows and described their specific projects in a brief case series. RESULTS: Forty-one of the 99 CI fellows responded to our survey. Seventy-five percent agreed that they were "able to apply clinical informatics training and interest to the COVID-19 response." The most common project types were telemedicine (63%), reporting and analytics (49%), and electronic health record builds and governance (32%). Telehealth projects included training providers on existing telehealth tools, building entirely new virtual clinics for video triage of COVID-19 patients, and pioneering workflows and implementation of brand-new emergency department and inpatient video visit types. Analytics projects included reports and dashboards for institutional leadership, as well as developing digital contact tracing tools. For electronic health record builds, fellows directly contributed to note templates with embedded screening and testing guidance, adding COVID-19 tests to order sets, and validating clinical triage workflows. DISCUSSION: Fellows were engaged in projects that span the breadth of the CI specialty and were able to make system-wide contributions in line with their educational milestones. CONCLUSIONS: CI fellows contributed meaningfully and rapidly to their institutions' response to the COVID-19 pandemic.
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COVID-19 , Educação de Pós-Graduação em Medicina , Aplicações da Informática Médica , Informática Médica , COVID-19/epidemiologia , Visualização de Dados , Registros Eletrônicos de Saúde , Bolsas de Estudo , Humanos , Entrevistas como Assunto , Liderança , Informática Médica/educação , Informática em Saúde Pública , Inquéritos e Questionários , Telemedicina , Estados UnidosRESUMO
OBJECTIVE: Patient-reported outcomes (PROs) are an integral part of treat-to-target approaches in managing rheumatoid arthritis (RA). In clinical practice, however, routine collection, documentation, and discussion of PROs with patients are highly variable. The RISE LC (Rheumatology Informatics System for Effectiveness Learning Collaborative) was established to develop and share best practices in PRO collection and use across adult rheumatology practices in the United States METHODS: The goals of the RISE LC were developed through site surveys and in-person meetings. Participants completed a baseline survey on PRO collection and use in their practices. RISE LC learning sessions focused on improving communication around PROs with patients and enhancing shared decision-making in treatment plans. During the coronavirus disease 2019 (COVID-19) pandemic, the RISE LC pivoted to adapt PRO tools for telehealth. RESULTS: At baseline, all responding sites (n = 15) had established workflows for collecting PROs. Most sites used paper forms alone. PRO documentation in electronic health records was variable, with only half of the sites using structured data fields. To standardize and improve the use of PROs, participants iteratively developed a Clinical Disease Activity Index-based RA Disease Activity Communication Tool to solicit treatment goals and improve shared decision-making across sites. The COVID-19 pandemic necessitated developing a tool to gauge PROs via telehealth. CONCLUSION: The RISE LC is a continuous, structured method for implementing strategies to improve PRO collection and use in rheumatological care, initially adapting from the Learning Collaborative model and extending to include features of a learning network. Future directions include measuring the impact of standardized PRO collection and discussion on shared decision-making and RA outcomes.
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Classical Hodgkin's lymphoma (CHL) presenting with exclusively pulmonary symptoms is very unusual. We report two cases of CHL with atypical clinical presentations mimicking pulmonary infections. The first case represents a stage IV CHL with secondary lung involvement, and the second case demonstrates a very rare case of CHL with isolated lung involvement, also known as primary pulmonary Hodgkin's lymphoma. The second patient was initially misdiagnosed and treated with six months of antibiotics before the correct diagnosis was made by a lung biopsy. Both patients received chemotherapy; one patient achieved complete remission and the other achieved near-complete remission.
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Doença de Hodgkin/diagnóstico , Doença de Hodgkin/patologia , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/patologia , Adulto , Antineoplásicos/uso terapêutico , Broncoscopia , Técnicas Citológicas , Histocitoquímica , Doença de Hodgkin/diagnóstico por imagem , Doença de Hodgkin/tratamento farmacológico , Humanos , Imuno-Histoquímica , Antígeno Ki-1/análise , Antígenos Comuns de Leucócito/análise , Neoplasias Pulmonares/diagnóstico por imagem , Neoplasias Pulmonares/tratamento farmacológico , Masculino , Microscopia , Tomografia por Raios X , Resultado do TratamentoRESUMO
BACKGROUND AND OBJECTIVES: Recent legislative and regulatory initiatives have emphasized preventive medicine and team-based health care delivery and education. Influenced by these initiatives, the investigators created an interprofessional teaching clinic to provide preventive care services (PCS) structured around Medicare's Annual Wellness Visit (AWV). The primary objective of this pilot study was to determine if PCS status improved for participating patients. METHODS: AWV-naïve Medicare beneficiaries aged 66--74 years were recruited for the interprofessional teaching clinic, which involved physicians, pharmacists, and nurses. Patients were screened for 11 PCS variables, underwent medication review, and received recommendations to address identified PCS deficiencies prior to completing a satisfaction survey. Follow-up telephone visits were completed to determine recommendation outcomes and final PCS status for each variable. Descriptive statistics were used to characterize patients, the medication review, PCS status, and satisfaction scores. McNemar tests were used to assess the PCS status of patients before and after participation, and Fisher's Exact tests were used to compare baseline PCS status between the pilot cohort and a comparator group. RESULTS: Thirty-four patients were enrolled in the pilot intervention, and one patient was lost to follow-up. Ninety-one percent (10/11) of PCS variables improved following participation. Significant improvements were observed for pneumococcal vaccination, mammography screening, fecal occult blood testing, and bone mineral density scanning. Patient satisfaction was high (mean scores for all items ?4.7). CONCLUSIONS: This interprofessional teaching clinic provides a promising mechanism to improve patients' PCS status, medication utilization, and satisfaction while training students to function effectively as a team.
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Comunicação Interdisciplinar , Educação de Pacientes como Assunto , Serviços Preventivos de Saúde/estatística & dados numéricos , Idoso , Feminino , Humanos , Masculino , Medicare , Projetos Piloto , Avaliação de Programas e Projetos de Saúde , Inquéritos e Questionários , Texas , Estados UnidosRESUMO
Background. Brachial neuritis (BN) is a rare inflammatory condition of peripheral nerves, usually involving the cervicobrachial plexus. These patients present with sudden onset of shoulder and arm pain that evolves into muscle weakness and atrophy.. Case Report. A 33-year-old woman presented with a 1-month history of diffuse pain in her thorax. She had no trauma or inciting incident prior to the onset of this pain and was initially treated for muscle spasms. The patient was seen in the emergency room multiple times and was treated with several courses of antibiotics for pneumonia on the basis of clinical symptoms and abnormal x-rays. The pleuritic chest pain persisted for at least 4 months, and the patient was eventually admitted for worsening pain and dyspnea. On physical examination, crackles were heard at both lung bases, and chest inspection revealed increased expansion in the upper thorax but poor expansion of the lower thorax and mild paradoxical respiration. "Sniff" test revealed no motion of the left hemidiaphragm and reduced motion on the right hemidiaphragm. Her computed tomography scan revealed bilateral atelectasis, more severe at the left base. She reported no symptoms involving her joints or skin or abdomen. Her presentation and clinical course are best explained by BN with a bilateral diaphragmatic weakness. However, she had a positive ANA, RF, anti-RNP antibody, and anti SS-A. Conclusion. Patients with BN can present with diffuse thoracic pain, pleuritic chest pain, and diaphragmatic weakness. Our patient may represent a case of connective tissue disease presenting with brachial plexus neuritis.