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Within the Department of Medicine (DOM) in a large tertiary academic health care facility in midwestern United States, we have developed an educational offering that incorporates an academic writing program (AWP) blending the approaches of a writing accountability work group, a writing workshop, and didactic writing courses. The purpose of this AWP was to assist healthcare professionals (HCP) with their manuscript writing skills to enhance academic productivity. We report our evolving journey and experiences with this AWP. To date, it has been offered 3 times to 25 HCP over the course of 3 years. Among those responding to a post program follow up survey (N = 11), 8 (73%) indicated that they completed the project that they were working on during the AWP and went on to publish the manuscript (N = 5) or were in the process of submission (N = 2). Some indicated they has also gone on to present posters (N = 2) or were in the process of presenting posters (N = 2) or had received grants (N = 1) or were awaiting grant notice (N = 1). A number of attendees have continued to use and share the tools presented during the AWP. Based on input from attendees and increased requests for this AWP, this educational program has been deemed a success and expansion of this program is currently underway.
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Personal de Salud , Escritura , Humanos , Personal de Salud/educación , Centros Médicos AcadémicosRESUMEN
BACKGROUND: Over 30% of patients with COVID-19 have persistent symptoms that last beyond 30 days and referred to as Long COVID. Long COVID has been associated with a persistent elevation in peripheral cytokines including interleukin-6, interleukin-1ß, and tumor necrosis factor-α. This study reports cytokine profiles of patients in our clinic across SARS-COV-2 variant epochs. METHODS: The clinical cytokine panel was analyzed in patients with Long COVID during periods that were stratified according to variant epoch. The 4 variant epochs were defined as: (1) wild-type through alpha, (2) alpha/beta/gamma, (3) delta, and (4) omicron variants. RESULTS: A total of 390 patients had the clinical cytokine panel performed; the median age was 48 years (IQR 38-59) and 62% were female. Distribution by variant was wild-type and alpha, 50% (n = 196); alpha/beta/gamma, 7.9% (n = 31); delta, 18% (n = 72); and omicron, 23% (n = 91). Time to cytokine panel testing was significantly longer for the earlier epochs. Tumor necrosis factor-α (P < .001) and interleukin 1ß (P < .001) were significantly more elevated in the earlier epochs (median of 558 days in wild-type through Alpha epoch vs 263 days in omicron epoch, P < .001)). Nucleocapsid antibodies were consistently detected across epochs. DISCUSSION: When stratified by variant epoch, patients with early epoch Long COVID had persistently elevated peripheral pro-inflammatory cytokine levels when compared to later epoch Long COVID. Patients with Long COVID have similar clusters of symptoms across epochs, suggesting that the underlying pathology is independent of the peripheral cytokine signature.
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COVID-19 , Citocinas , SARS-CoV-2 , Humanos , Femenino , Persona de Mediana Edad , Masculino , Citocinas/sangre , COVID-19/inmunología , COVID-19/sangre , Adulto , SARS-CoV-2/inmunología , Síndrome Post Agudo de COVID-19 , Interleucina-1beta/sangre , Factor de Necrosis Tumoral alfa/sangre , Interleucina-6/sangreRESUMEN
BACKGROUND: In addition to the morbidity and mortality associated with acute infection, COVID-19 has been associated with persistent symptoms (>30 days), often referred to as Long COVID (LC). LC symptoms often cluster into phenotypes, resembling conditions such as fibromyalgia, postural orthostatic tachycardiac syndrome (POTS), and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). LC clinics have been established to best address the needs of LC patients and continuity of care. We developed a cross-sectional survey to assess treatment response through our LC Clinic (LCC). METHODS: A 25-question survey (1-10 Likert scale) was expert- and content-validated by LCC clinicians, patients, and patient advocates. The survey assessed LC symptoms and the helpfulness of different interventions, including medications and supplements. A total of 852 LCC patients were asked to complete the survey, with 536 (62.9%) responding. RESULTS: The mean time from associated COVID-19 infection to survey completion was 23.2 ± 6.4 months. The mean age of responders was 52.3 ± 14.1 (63% females). Self-reported symptoms were all significantly improved (P < .001) from the initial visit to the LCC (baseline) to the time of the follow-up survey. However, only 4.5% (24/536) of patients rated all symptoms low (1-2) at the time of the survey, indicating low levels of full recovery in our cohort. The patients rated numerous interventions as being helpful, including low-dose naltrexone (45/77; 58%), vagal nerve stimulation (18/34; 53%), and fisetin (28/44; 64%). CONCLUSIONS: Patients report general improvements in symptoms following the initial LCC visit, but complete recovery rates remain low at 23.2 ± 6.4 months.
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COVID-19 , Síndrome Post Agudo de COVID-19 , Humanos , Estudios Transversales , COVID-19/terapia , Persona de Mediana Edad , Femenino , Masculino , Adulto , Encuestas y Cuestionarios , Estudios Longitudinales , Progresión de la Enfermedad , SARS-CoV-2 , AncianoRESUMEN
Background: Residency is a time of personal and professional growth. Resident assessment and feedback are an integral part of that process. However, assessment may be influenced by various types of bias, including gender bias. Women are less likely than men to be identified by their professional titles in many settings. The use of professional titles for residents in written assessments is unknown and may be a marker of bias. Objective: To assess for differences and trends regarding the use of professional and personal titles in formal resident assessments related to gender-based resident-faculty pairs. Methods: Electronic assessments of postgraduate year 1 (PGY1) internal medicine residents from the 2019-2020 academic year were used. Professional title use was analyzed, as it relates to resident-faculty gendered dyads, among other variables. The primary outcome of professional title usage was split into a binary variable by professional versus other titles and analyzed using logistic regression and random-effects model. Results: We analyzed 1,363 unique electronic assessments (37.8% from female faculty). Female residents were more likely to be addressed by a professional title than their male colleagues (odds ratio [OR], 1.7; confidence interval [CI], 1.2-2.4; p = 0.02). We found no difference in professional title usage based on resident-faculty gendered dyads. After adjusting for repeated faculty and resident encounters with random-effects model, secondary analysis found no significant difference in evaluation of word count between gendered dyads. Conclusions: The analysis found no significant difference in professional title usage based on resident-faculty dyads. In our analysis, female residents were significantly more likely to have their professional title used on assessments than male residents.
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Background: To study the effects of the Reflect, Inspire, Strengthen, and Empower (RISE) 2.0 Program designed for professional development of women staff. Topics included emotional intelligence, appreciative coaching, resilience, and strategic career development. Methods: The RISE 2.0 program was held between September 2020 and February 2021. After each session, program satisfaction surveys were sent to evaluate whether session objectives were met. Professional network, professional mentor, and professional goals were surveyed at the introductory session and at 1 month after the program ended. Survey data about leadership self-efficacy, motivation to lead, and well-being were collected at the introductory session (baseline) and at months 1 and 3 to evaluate the sustainability of program outcomes. Results: Of the 71 notified, 41 (58%) committed to the program. Results increased for having a robust professional network from baseline to month 1 for very good (7.3% to 13.3%) and excellent (19.5% to 40%). Those who responded favorably to setting and attaining ambitious goals increased from 78.1% to 93.3%. For leadership self-efficacy, all except 2 respondents reported an increase in ratings from baseline to month 3. Motivation to lead changed only slightly. Well-being scores fluctuated as affected by daily needs and fulfillment. For 10 of 15 respondents, well-being increased overall from baseline to month 1 or 3, from month 1 to 3. Conclusions: Based on participant evaluations and feedback, the RISE 2.0 program received positive responses overall in achieving its learning goals. The program exhibited promise in fostering career advancement and leadership development, particularly when assessed using indicators predictive of successful leadership, such as self-efficacy, motivation to lead, and overall wellbeing.
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Pragmatic randomized clinical trials (pRCTs) have a unique set of considerations for data and safety monitoring. Because of their unconventional trial designs coupled with collection of multilevel data and implementation outcomes in real-world settings, thoughtful consideration is needed on the presentation of the trial design and accruing data to facilitate review and decision-making by the trial's data and safety monitoring board (DSMB). To our knowledge, there is limited information available in practical guidelines for generalists and medical general practitioners on what to monitor and to report to the DSMB during the conduct of pRCTs and what the DSMB should focus on in its review of reports. This article discusses these matters in the context of 3 case studies focusing on a set of critical data and safety monitoring questions that would be of interest to the generalist conducting pRCTs. In considering these questions, we provide tabular and graphical illustrations of how data can be presented to the DSMB while drawing attention to those areas that the DSMB should focus on in its review of the trial. The strategies and viewpoints discussed herein provide practical guidelines and can serve as a resource for the generalist conducting pRCTs.
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Comités de Monitoreo de Datos de Ensayos Clínicos , Humanos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Electronic massagers have gained popularity for their non-invasive and cost-effective approach to healthcare. However, existing electronic massagers require manual manipulation, leading to inconsistency. OBJECTIVE: To investigate the feasibility and acceptability of the Electronic Massager-Expert Manipulative Massage Automation (EMMA) among the American population. METHODS: A single-arm pilot study was conducted at Mayo Clinic Rochester campus. Participants received massage therapy with the EMMA treatment model and completed a demographics and Satisfaction Survey Questionnaire. Data were collected using REDCap, and statistical analysis was performed. RESULTS: Twenty healthy volunteers (13 women, 7 men; median age, 47 years) participated and completed the intervention within 2 weeks. No adverse events were reported. Overall, the acceptability and satisfaction of massage utilizing EMMA were high, with all participants finding the study worthwhile, willing to participate again, and willing to recommend the study to others. Regarding the overall experience, 65.0% reported a better-than-expected experience. Responses to open-ended post-treatment questions showed that most participants enjoyed the warmth (35%), pressure (25%), and relaxation (20%) provided by EMMA, with the majority suggesting no changes or improvements were needed. However, some participants expressed a desire for an expanded massage area (20%). CONCLUSIONS: This study suggests that the EMMA massager has high acceptability and satisfaction among healthy volunteers, thus demonstrating its feasibility. However, further research is needed to optimize EMMA and assess its clinical effectiveness.
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Masaje , Satisfacción Personal , Masculino , Humanos , Femenino , Persona de Mediana Edad , Proyectos Piloto , Estudios de Factibilidad , Resultado del TratamientoRESUMEN
This commentary offers the reader an alternative to mentoring through the use of PODCASTS. By providing the listener with an understanding of the challenges and opportunities for self-reflection and sharing of experiences by the interviewees, we are impacting the listener attitudes and future goals through lessons learned.
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Tutoría , Humanos , Donaciones , Evaluación de Programas y Proyectos de Salud , Mentores , DocentesRESUMEN
Objective: To determine whether a postdischarge video visit with patients, conducted by hospital medicine advanced practice providers, improves adherence to hospital discharge recommendations. Patients and Methods: We conducted a single-institution 2-site randomized clinical trial with 1:1 assignment to intervention vs control, with enrollment from August 10, 2020, to June 23, 2022. Hospital medicine patients discharged home or to an assisted living facility were randomized to a video visit 2-5 days postdischarge in addition to usual care (intervention) vs usual care (control). During the video visit, advanced practice providers reviewed discharge recommendations. Both intervention and control groups received telephone follow-up 3-6 days postdischarge to ascertain the primary outcome of adherence to all discharge recommendations for new and chronic medication management, self-management and action plan, and home support. Results: Among 1190 participants (594 intervention; 596 control), the primary outcome was ascertained in 768 participants (314 intervention; 454 control). In intervention vs control, there was no difference in the proportion of participants with the primary outcome (76.7% vs 72.5%; P=.19) or in the individual domains of the primary outcome: new and chronic medication management (94.1% vs 92.8%; P=.50), self-management and action plan (76.5% vs 71.5%; P=.18), and home support (94.1% vs 94.3%; P=.94). Women receiving intervention vs control had higher adherence to recommendations (odds ratio, 1.77; 95% CI, 1.08-2.91). Conclusion: In hospital medicine patients, a postdischarge video visit did not improve adherence to discharge recommendations. Potential gender differences in adherence require further investigation.Clinicaltrials.gov number, NCT04547803.
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OBJECTIVE: The Coronavirus Disease-19 (COVID-19) pandemic caused a decline in hospitalist wellness. The COVID-19 pandemic has evolved, and new outbreaks (i.e. Mpox) have challenged healthcare systems. The objective of the study was to assess changes in hospitalist wellness and guide interventions. METHODS: We surveyed hospitalists (physicians and advanced practice providers [APPs]), in May 2021 and September 2022, at a healthcare system's 16 hospitals in four US states using PROMIS® measures for global well-being, anxiety, social isolation, and emotional support. We compared wellness score between survey periods; in the September 2022 survey, we compared wellness scores between APPs and physicians and evaluated the associations of demographic and hospital characteristics with wellness using logistic (global well-being) and linear (anxiety, social isolation, emotional support) regression models. RESULTS: In May 2021 vs. September 2022, respondents showed no statistical difference in top global well-being for mental health (68.4% vs. 57.4%) and social activities and relationships (43.8% vs. 44.3%), anxiety (mean difference: +0.8), social isolation (mean difference: +0.5), and emotional support (mean difference: -1.0) (all, p ≥ 0.05). In September 2022, in logistic regression models, APPs, compared with physicians, had lower odds for top (excellent or very good) global well-being mental health (odds ratio [95% CI], 0.31 [0.13-0.76]; p < 0.05). In linear regression models, age <40 vs. ≥40 years was associated with higher anxiety (estimate ± standard error, 2.43 ± 1.05; p < 0.05), and concern about contracting COVID-19 at work was associated with higher anxiety (3.74 ± 1.10; p < 0.01) and social isolation (3.82 ± 1.21; p < 0.01). None of the characteristics showed association with change in emotional support. In September 2022, there was low concern for contracting Mpox in the community (4.6%) or at work (10.0%). CONCLUSION: In hospitalists, concern about contracting COVID-19 at work was associated with higher anxiety and social isolation. The unchanged wellness scores between survey periods identified opportunities for intervention. Mpox had apparently minor impact on wellness.
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COVID-19 , Médicos Hospitalarios , Mpox , Humanos , COVID-19/epidemiología , Pandemias , Ansiedad/epidemiología , Ansiedad/psicología , Brotes de Enfermedades , Aislamiento SocialRESUMEN
Objectives: Our aim was to examine the relationship between weight concerns (WC) and smoking cessation. Methods: WC was assessed before smoking cessation treatment in 671 adult patients who completed a 12-month follow-up visit at the Centre for Tobacco-Dependent, Prague, Czech Republic, from 2013 through 2019. We evaluated the abstinence rate at 12-month follow-up. Results: Among 669 patients with baseline WC (mean age, 43.4 years), 47% were women (145/306) and 21% were men (78/363). No association existed between WC and abstinence at 12 months. Smokers with obesity had increased fear of gaining weight (34% versus 24% of overweight and 23% of healthy-weight smokers) (p=.034) and were less confident in their ability to maintain their current weight (36% versus 55% of overweight smokers and 59% of healthy- weight smokers) (p<.001). Conclusions: Many smokers are concerned about gaining weight after stopping smoking, but in this cohort of patients, having WC was not associated with 12-month abstinence, but obesity or overweight was related to being afraid of postcessation weight-gain and low confidence for maintaining weight. Practitioners should be aware of the prevalence of WC in those stopping smoking and should address concerns, such as poor motivation and low confidence about managing their weight.
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Sobrepeso , Adulto , Masculino , Humanos , Femenino , Índice de Masa Corporal , Peso Corporal , Obesidad , Aumento de PesoRESUMEN
BACKGROUND: Tuina has gained widespread attention and utilization for the management of chronic nonspecific low back pain (CNLBP). However, evidence-based guidance for choosing accurate and appropriate outcome measures of Tuina is lacking. The objective of this study is to systematically synthesize the existing outcome measures reported in randomized controlled trials (RCTs) evaluating Tuina therapy in CNLBP. METHODS: Electronic literature searches were conducted in multiple English and Chinese databases from their inception to May 2022. RCTs were included if they involved clinical outcome measures in Tuina treatment for patients with CNLBP. Outcome instruments for each study were extracted and analyzed. Evidence from included studies were assessed using the Cochrane risk-of-bias tool. RESULTS: Of the 735 identified articles, 17 articles with 1628 participants were included. Measurement domains in these RCTs were mainly reported in terms of pain (94%) and physical activity (71%), followed by safety (41%), Chinese medicine outcome (35%), and quality of life (12%). Moreover, several limitations with existing outcomes were reported, including lack of emphasis on the evaluation of quality of life, inadequate safety monitoring, as well as insufficient and vague Chinese medicine outcome measures. All trials were deemed to be of poor methodological quality. CONCLUSION: Pain and physical disability were the most frequently studied outcome domains in CNLBP treated by Tuina therapy. More rigorous and high-quality trials with appropriately selected outcome measures are needed in the future.
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Dolor Crónico , Dolor de la Región Lumbar , Humanos , Dolor de la Región Lumbar/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto , Evaluación de Resultado en la Atención de Salud , Medicina Tradicional China , Masaje , Dolor Crónico/terapiaRESUMEN
INTRODUCTION/OBJECTIVES: A culture of joy in the workplace supports well-being, but less is known about the effect of a shared experience on well-being and burnout in a health care setting. This pilot study investigated personal well-being and occupational burnout among primary care staff who participated in a 3-month virtual book club. METHODS: In December 2021, health care workers from a primary care practice were invited to participate in a 3-month virtual book club. Participants were emailed a preintervention survey with questions regarding well-being and burnout, the pandemic's influence on emotional health, and demographic information. The book club met virtually every month from January 2022 through March 2022. After the March 2022 book club meeting, a paired postintervention survey was sent to participants with additional questions regarding their participation in the book club. Well-being and burnout were measured with the 11-point Well-Being Index, and the pandemic's influence on emotional health was assessed with the 64-point Pandemic Emotional Impact Scale. RESULTS: Of 12 book club participants, 9 participants (6 physicians and 3 nurses) completed surveys before and after the intervention. Postintervention improvement in the median score of the Pandemic Emotional Impact Scale was significant (7 points, P = .04). Although Well-Being Index results uniformly favored improved well-being after book club participation, the median improvement of 1 point was not significant (P = .69). CONCLUSIONS: Social connection through a virtual workplace activity such as a book club may contribute to well-being and may decrease occupational burnout.
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Agotamiento Profesional , COVID-19 , Humanos , Pandemias , Agotamiento Profesional/epidemiología , Agotamiento Profesional/psicología , Proyectos Piloto , Personal de Salud/psicología , Lugar de Trabajo/psicología , Encuestas y CuestionariosRESUMEN
OBJECTIVE: The purpose of this feasibility pilot study was to evaluate safety and adherence of a wearable brain sensing wellness device designed to reduce stress among healthcare professionals (HCP). METHODS: A total of 40 HCP were invited to participate in an open-label pilot study. Participants were asked to use a brain sensing wearable device (MUSE-S™) on a daily basis to reduce their stress, for a total of 90 days. Total study participation duration was 180 days. Study enrollment began in August 2021 and ended December 2021. The exploratory outcomes included stress, depression, sleep, burn-out, resilience, quality of life, and cognition. RESULTS: Among the 40 HCP in study, the majority were female (85%), white (87.5%) and with an average age of 41.3 ± 11.0 years (SD). Participants used the wearable device an average of 23.8 times over a 30-day period with a mean duration of 5.8 min with each use. Study results demonstrate the positive impact of guided mindfulness using the wearable device MUSE-S™ and its accompanying application (APP). A statistically significant improvement was found for a reduction in stress (P < .001) and improvement in resilience (P = .02), quality of life (P = .003), and cognition (P < .001). The majority (91.9%) of the participants indicated they felt more relaxed after using the device, and 73% indicated they would continue to use this device at end-of-study. No adverse effects were reported. CONCLUSION: Study results show that 3 to 10 min of guided meditation during work hours through the use of a brain sensing wearable device is safe and acceptable, with associated health benefits for HCP.
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Atención Plena , Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Proyectos Piloto , Atención Plena/métodos , Calidad de Vida , Pandemias , Alprostadil , Personal de Salud , EncéfaloRESUMEN
Objective: To evaluate indications for gabapentinoid prescription at an academic medical center. Patients and Methods: We retrospectively reviewed patients aged 18 years or older who were prescribed gabapentinoids (gabapentin or pregabalin) during the 2019 calendar year at an academic medical center in the US Midwest. Patient demographic characteristics, indications for gabapentinoid prescription, and prescribing clinician specialities were abstracted from a random sample, and the findings were extrapolated to the overall cohort. Results: A total of 6205 prescriptions for gabapentinoids were initially identified. In the random sample of prescriptions (n=721), 89.5% were for gabapentin and 10.5% were for pregabalin. More women than men were prescribed gabapentinoids, and the mean ± SD patient age was 58.6±16.9 years. The top 5 indications for gabapentinoid prescriptions were neuropathic pain, musculoskeletal pain, restless legs syndrome, anxiety, and headache. A majority (66.7%) of prescriptions had substantial-to-modest evidence, but 29.0% of prescriptions had conflicting or insufficient evidence. Conclusion: To our knowledge, this study is one of the first to manually review clinical notes from multiple clinical specialities to ascertain indications for gabapentinoid prescriptions. Although most prescriptions had modest evidence to support their use, a high percentage of gabapentinoid prescriptions were issued for indications not supported by robust evidence. This suggests that prescribers are gravitating toward gabapentinoid use for reasons that are currently not fully understood. Clinician intent for off-label gabapentinoid prescriptions at the point of care should be further studied to understand the factors that lead to these clinical decisions.
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BACKGROUND: The COVID-19 pandemic has led to increased burnout and staff turnover for health care providers (HCPs). The purpose of this pilot study was to evaluate the safety and acceptability of a Stress Resilience Program (SRP) for reducing perceived stress and improving resilience among HCPs during a pandemic. METHOD: Of the 12 HCPs expressing interest in the study, 10 were enrolled in this study. Participants attended three in-person visits (consent/screen, baseline, and end-of-study). The SRP consisted of education related to resilience enhancement and a breathing device (BreatherFit®) for combined respiratory muscle training (cRMT). Participants completed 4 weeks of cRMT and applied situational breathing strategies as needed. Outcomes measured were changes in stress (PSS-10), resilience (BRS), depression (PRIME-MD), and sleep (PSQI and Oura Ring®). FINDINGS: The majority of participants were male (60%) and White (60%) with an average age of 39.7 years. Changes from baseline to end-of-treatment indicated a positive trend with significant stress reduction (-3.2 ± 3.9, p = .028) and nonsignificant depression reduction (-0.5 ± 0.7, p = .05). Resilience was high at baseline and continued to stay high during the study with a nonsignificant increase at end-of-study (+0.07 ± 0.7, p = .77). No changes in overall sleep scores were noted. All participants agreed the study was worthwhile, 80% indicated they would repeat the experience, while 90% indicated they would recommend the study to others. CONCLUSION/APPLICATION TO PRACTICE: Because of its size and portability, SRP is an easily applicable and promising option for reducing stress among HCPs during a high-stress period, such as a pandemic. Larger studies are needed.
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COVID-19 , Resiliencia Psicológica , Humanos , Masculino , Femenino , Adulto , Pandemias/prevención & control , Proyectos Piloto , Personal de SaludRESUMEN
OBJECTIVE: To compare the clinicians' characteristics of "high adopters" and "low adopters" of an artificial intelligence (AI)-enabled electrocardiogram (ECG) algorithm that alerted for possible low left ventricular ejection fraction (EF) and the subsequent effectiveness of detecting patients with low EF. METHODS: Clinicians in 48 practice sites of a US Midwest health system were cluster-randomized by the care team to usual care or to receive a notification that suggested ordering an echocardiogram in patients flagged as potentially having low EF based on an AI-ECG algorithm. Enrollment was between June 26, 2019, and July 30, 2019; participation concluded on March 31, 2020. This report is focused on those clinicians randomized to receive the notification of the AI-ECG algorithm. At the patient level, data were analyzed for the proportion of patients with positive AI-ECG results. Adoption was defined as the clinician order of an echocardiogram after prompted by the alert. RESULTS: A total of 165 clinicians and 11,573 patients were included in this analysis. Among patients with positive AI-ECG, high adopters (n=41) were twice as likely to diagnose patients with low EF (33.9%) vs low adopters, n=124, (16.9%); odds ratio, 1.62; 95% CI, 1.21 to 2.17). High adopters were more often advanced practice providers (eg, nurse practitioners and physician assistants) vs physicians, Family Medicine vs Internal Medicine specialty, and tended to have less complex patients. CONCLUSION: Clinicians who most frequently followed the recommendations of an AI tool were twice as likely to diagnose low EF. Those clinicians with less complex patients were more likely to be high adopters. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT04000087.
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Inteligencia Artificial , Disfunción Ventricular Izquierda , Humanos , Volumen Sistólico , Función Ventricular Izquierda , Disfunción Ventricular Izquierda/diagnóstico , Electrocardiografía/métodos , Atención Primaria de SaludRESUMEN
Objective: To evaluate the safety and effectiveness of combination varenicline with lorcaserin in preventing post-cessation weight gain. Participants and Methods: We conducted a randomized (varenicline for 12 weeks + lorcaserin for 24 weeks vs varenicline for 12 weeks + placebo for 24 weeks) phase II clinical study to obtain preliminary data on the safety and effectiveness of combination varenicline and lorcaserin in preventing post-cessation weight gain in overweight and obese smokers. Eighty-four overweight and obese (body mass index [BMI], 27-40 kg/m2) cigarette smokers were randomized before study termination (lorcaserin: n=40; placebo: n=44). The primary outcomes were weight and waist circumference (WC) changes at 12 and 24 weeks in smokers meeting criteria for prolonged smoking abstinence. Results: Thirty-nine participants met criteria for prolonged smoking abstinence at 12 weeks (46%) and 21 at 24 weeks (25%). No significant treatment effect was observed at 12 weeks with lorcaserin compared with placebo (weight difference, -0.7 kg; 90% CI, -2.6 to 1.1 kg; P=.51; WC difference, -1.9 cm; 90% CI, -4.2 to 0.5 cm; P=.18; or BMI difference, -0.4 kg/m2; 90% CI, -1.1 to 0.3 kg/m2; P=.33). No significant treatment effect was observed between lorcaserin at 24 weeks compared with placebo (weight, 1.4 kg; 90% CI, -3.8 to 6.7 kg; P=.65; WC, -0.9 cm; 90% CI, -5.8 to 4.0 cm; P=.75; or BMI 0.29 kg/m2; 90% CI, -1.5 to 2.12 kg/m2; P=.79). Conclusion: Weight gain and WC increases after prolonged smoking abstinence were not reduced using combination varenicline and lorcaserin. The results do not support further research in the obese and weight-concerned smoking population using lorcaserin or similar drugs. Trial Registration: clinicaltrials.gov Identifier: NCT02412631.