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OBJECTIVE: The aim of this study was to investigate the natural history of internal carotid artery (ICA) stenosis progression. METHODS: This single-institution retrospective cohort study analyzed patients diagnosed with ICA stenosis of 50% or greater on duplex ultrasound from 2015 to 2022. Subjects were drawn from our institutional Intersocietal Accreditation Commission-accredited noninterventional vascular laboratory database. Primary outcomes were incidences of disease progression, and stroke or revascularization after index study. Progression was defined as an increase in stenosis classification category. Imaging, demographic, and clinical data was obtained from our institutional electronic medical record via a database mining query. Cases were analyzed at the patient and artery levels, with severity corresponding to the greatest degree of ICA stenosis on index and follow-up studies. RESULTS: Of 577 arteries in 467 patients, mean cohort age was 73.5 ± 8.9 years at the time of the index study, and 45.0% (n = 210) were female. Patients were followed with duplex ultrasound for a mean of 42.2 ± 22.7 months. Of 577 arteries, 65.5% (n = 378) at the index imaging study had moderate (50%-69%) stenosis, 23.7% (n = 137) had severe (70%-99%) stenosis, and 10.7% (n = 62) were occluded. These three groups had significant differences in age, hypertension, hyperlipidemia prevalence, and proportion on best medical therapy. Of the 467-patient cohort, 56.5% (n = 264) were on best medical therapy, defined as smoking cessation, treatment with an antiplatelet agent, statin, and antihypertensive and glycemic agents as indicated. Mean time to progression for affected arteries was 28.0 ± 20.5 months. Of those arteries with nonocclusive disease at diagnosis, 21.3% (n = 123) progressed in their level of stenosis. Older age, diabetes, and a history of vasculitis were associated with stenosis progression, whereas antiplatelet agent use trended towards decreased progression rates. Of the 467 patients, 5.6% (n = 26) developed symptoms; of those, 38.5% (n = 10) had ischemic strokes, 26.9% (n = 7) had hemispheric transient ischemic attacks, 11.5% (n = 3) had amaurosis fugax, and 23.1% (n = 6) had other symptoms. A history of head and neck cancer was positively associated with symptom development. Of 577 affected arteries, 16.6% (n = 96) underwent intervention; 81% (n = 78) of interventions were for asymptomatic disease and 19% (n = 18) were for symptomatic disease. No patient-level factors were associated with risk of intervention. CONCLUSIONS: A significant number of carotid stenosis patients experience progression of disease. Physicians should consider long-term surveillance on all patients with carotid disease, with increased attention paid to those with risk factors for progression, particularly those with diabetes and a history of vasculitis.
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Estenose das Carótidas , Diabetes Mellitus , Vasculite , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Masculino , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/epidemiologia , Estenose das Carótidas/terapia , Estudos Retrospectivos , Constrição Patológica/complicações , Inibidores da Agregação Plaquetária , Artéria Carótida Interna/diagnóstico por imagem , Progressão da Doença , Ultrassonografia Doppler Dupla , Fatores de Risco , Vasculite/complicaçõesRESUMO
OBJECTIVE: Investigations into imaging modalities in the diagnosis of extracranial carotid artery occlusion (CAO) have raised questions about the inter-modality comparability of duplex ultrasound (DUS) and cross-sectional imaging (CSI). This study examines the relationship between DUS and CSI diagnoses of extracranial CAO. METHODS: This single-institution retrospective analysis studied patients with CAO diagnosed by DUS from 2010 to 2021. Patients were identified in our office-based accredited vascular laboratory database. Imaging and clinical data was obtained via our institutional electronic medical record. Primary outcome was discrepancy between DUS and CSI modalities. Secondary outcomes included incidence of stroke and intervention subsequent to CAO diagnosis. RESULTS: Of our 140-patient cohort, 95 patients (67.9%) had DUS follow-up (mean, 42.7 ± 31.3 months). At index duplex, 68.0% of individuals (n = 51) were asymptomatic. Seventy-five patients (53.6%) had CSI of the carotids after DUS CAO diagnosis; 18 (24%) underwent magnetic resonance imaging and 57 (76%) underwent computed tomography. Indications for CSI included follow-up of DUS findings of carotid stenosis/occlusion (44%), stroke/transient ischemic attack (16%), other symptoms (12%), preoperative evaluation (2.7%), unrelated pathology follow-up (9.3%), and outside institution imaging with unavailable indications (16%). When comparing patients with CSI and those without, there were no differences with regard to symptoms at diagnosis, prior neck interventions, or hypertension. There was a significant difference between cross-sectionally imaged and non-imaged patients in anti-hypertensive medications (72% vs 53.8%; P = .04). Despite initial DUS diagnoses of carotid occlusion, 10 patients (13.3%) ultimately had CSI indicating patent carotids. Four of these 10 patients had stenoses of â¼99% (with 1 string sign), four of 70% to 99%, one of 50% to 69%, and one of less than 50% on CSI. The majority of patients (70%) had CSI within 1 month of the index ultrasound. There were no significant relationships between imaging discrepancies and body mass index, heart failure, upper body edema, carotid artery calcification, and neck hardware. Eight individuals (10.7%) underwent ipsilateral revascularization; 62.5% (n = 5) were carotid endarterectomy procedures, and the remaining three procedures were a transcervical carotid revascularization, subclavian to internal carotid artery bypass, and transfemoral carotid artery stenting. Eight patients (10.7%) underwent contralateral revascularization, with the same distribution of procedures as those ipsilateral to occlusions. Two of the 10 patients with discrepancies underwent carotid endarterectomy, and one underwent carotid stenting. CONCLUSIONS: In our experience, duplex diagnosis of CAO is associated with a greater than 10% discordance when compared with CSI. These patients may benefit from closer surveillance as well as confirmatory computed tomography or magnetic resonance angiography. Further work is needed to determine the optimal diagnostic modality for CAO.
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Doenças das Artérias Carótidas , Estenose das Carótidas , Endarterectomia das Carótidas , Acidente Vascular Cerebral , Humanos , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/cirurgia , Estudos Retrospectivos , Stents/efeitos adversos , Doenças das Artérias Carótidas/complicações , Endarterectomia das Carótidas/efeitos adversos , Artéria Carótida Interna/diagnóstico por imagem , Ultrassonografia Doppler Dupla , Artérias Carótidas , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/etiologia , Resultado do TratamentoRESUMO
OBJECTIVE: Although splenic artery aneurysms (SAAs) are the most common visceral aneurysm, there is a paucity of literature on the behavior of these entities. The objective of this study was to review the natural history of patients with SAA. METHODS: This single-institution, retrospective analysis studied patients with SAA diagnosed by computed tomography imaging between 2015 and 2019, identified by our institutional radiology database. Imaging, demographic, and clinical data were obtained via the electronic medical record. The growth rate was calculated for patients with radiologic follow-up. RESULTS: The cohort consisted of 853 patients with 890 SAAs, of whom 692 were female (81.2%). There were 37 women (5.3%) of childbearing age (15-50 years). The mean age at diagnosis was 70.9 years (range: 28-100 years). Frequently observed medical comorbidities included hypertension (70.2%), hypercholesterolemia (54.7%), and prior smoking (32.2%). Imaging indications included abdominal pain (37.3%), unrelated follow-up (28.0%), and follow-up of a previously noted visceral artery aneurysm (8.6%). The mean diameter at diagnosis was 13.3 ± 6.3 mm. Anatomic locations included the splenic hilum (36.0%), distal splenic artery (30.3%), midsplenic artery (23.9%), and proximal splenic artery (9.7%). Radiographically, the majority were saccular aneurysms (72.4%) with calcifications (88.5%). One patient (38-year-old woman) was initially diagnosed at the time of rupture of a 25 mm aneurysm; this patient underwent immediate endovascular intervention with no complications. The mean clinical follow-up among 812 patients was 4.1 ± 4.0 years, and the mean radiological follow-up among 514 patients was 3.8 ± 6.8 years. Of the latter, 122 patients (23.7%) experienced growth. Aneurysm growth rates for initial sizes <10 mm (n = 123), 10 to 19 mm (n = 353), 20 to 29 mm (n = 34), and >30 mm (n = 4) were 0.166 mm/y, 0.172 mm/y, 0.383 mm/y, and 0.246 mm/y, respectively. Of the entire cohort, 27 patients (3.2%) eventually underwent intervention (81.5% endovascular), with the most common indications including size/growth criteria (70.4%) and symptom development (18.5%). On multivariate analysis, only prior tobacco use was significantly associated with aneurysm growth (P = .028). CONCLUSIONS: The majority of SAAs in this cohort remained stable in size, with few patients requiring intervention over a mean follow-up of 4 years. Current guidelines recommending treatment of asymptomatic aneurysms >30 mm appear appropriate given their slow progression. Despite societal recommendations for intervention for all SAAs among women of childbearing age, only a minority underwent vascular surgical consultation and intervention in this series, indicating that these recommendations are likely not well known in the general medical community.
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Aneurisma Roto , Artéria Esplênica , Humanos , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Adolescente , Adulto Jovem , Masculino , Seguimentos , Artéria Esplênica/diagnóstico por imagem , Artéria Esplênica/cirurgia , Aneurisma Roto/cirurgia , Estudos Retrospectivos , Resultado do TratamentoRESUMO
OBJECTIVE: The objective of this study was to investigate the administrative and clinical impacts of prior authorization (PA) processes in the office-based laboratory (OBL) setting. METHODS: This single-institution, retrospective analysis studied all OBL PAs pursued between January 2018 and March 2022. Case, PA, and coding information was obtained from the practice's scheduling database. RESULTS: Over the study period, 1854 OBL cases were scheduled; 8% (n = 146) required PA. Of these, 75% (n = 110) were for lower extremity arterial interventions, 19% (n = 27) were for deep venous interventions, and 6% (n = 9) were for other interventions. Of 146 PAs, 19% (n = 27) were initially denied but 74.1% (n = 7) of these were overturned on appeal. Deep venous procedures were initially denied, at 43.8% (n = 14), more often than were arterial procedures, at 11.8% (n = 13). Of 146 requested procedures, 4% (n = 6) were delayed due to pending PA determination by a mean 14.2 ± 18.3 working days. An additional 6% (n = 8) of procedures were performed in the interest of time before final determination. Of the seven terminally denied procedures, 57% (n = 4) were performed at cost to the practice based on clinical judgment. CONCLUSIONS: Using PA appeals mechanisms, while administratively onerous, resulted in the overturning of most initial denials.
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Autorização Prévia , Humanos , Estudos RetrospectivosRESUMO
OBJECTIVES: Carotid interventions are indicated for both patients with symptomatic and a subset of patients with severe asymptomatic carotid artery stenosis (CAS). Symptomatic CAS accounts for up to 12%-25% of overall carotid interventions, but predictors of symptomatic presentation remain poorly defined. The aim of this study was to identify factors associated with symptomatic CAS in our patient population. METHODS: Between January 2015 and February 2022, an institutional retrospective cohort study of prospectively collected data on patients undergoing interventions for CAS was performed. Procedures included carotid endarterectomy (CEA), transcarotid artery revascularization (TCAR), and transfemoral carotid artery stenting (TF-CAS). Demographic data, comorbidities, procedural details, and anatomic features from various imaging modalities were collected. Comparisons were made between symptomatic (symptoms within the prior 6 months) and asymptomatic patients. RESULTS: During the study period, 279 patients who underwent intervention for symptomatic CAS were paired with a randomly selected cohort of 300 patients who underwent intervention for asymptomatic CAS from a total patient cohort of 1143 patients undergoing interventions for asymptomatic CAS. Demographic data did not differ between groups. Patients with symptomatic CAS more frequently had prior TIA/stroke (>6 months remote to the current event), but less frequently had coronary artery disease or chronic kidney disease and were less likely to receive adequate medical management including antihypertensive agents, lipid-lowering agents, and anti-platelet therapy. On multivariate analysis, remote prior TIA/stroke and lack of anti-platelet therapy remained significant. Among symptomatic patients presenting with stroke, lack of anti-platelet therapy was associated with an overall larger area of parenchymal involvement. No difference was observed with single versus dual anti-platelet therapy. Furthermore, symptomatic patients were more likely to have ulcerated plaques (30.9% vs 18%, p < .001), and symptomatic patients with ulcerated plaques more frequently had less than 50% compared to moderate/severe CAS. Nine patients who presented with symptoms had mild CAS and underwent intervention. CONCLUSIONS: Symptomatic CAS was associated with a history of remote prior symptoms and lack of anti-platelet therapy at time of presentation. Furthermore, symptomatic patients not on anti-platelet agents were more likely to have a greater area of parenchymal involvement when presenting with stroke and symptomatic patients with ulcerated plaques were more likely to have mild CAS, suggesting the role of plaque instability in symptomatic presentation. These findings underscore the importance of appropriate medical management and adherence in all patients with CAS and perhaps a role for more frequent surveillance in those with potentially unstable plaque morphology.
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OBJECTIVES: Generative artificial intelligence (AI) has emerged as a promising tool to engage with patients. The objective of this study was to assess the quality of AI responses to common patient questions regarding vascular surgery disease processes. METHODS: OpenAI's ChatGPT-3.5 and Google Bard were queried with 24 mock patient questions spanning seven vascular surgery disease domains. Six experienced vascular surgery faculty at a tertiary academic center independently graded AI responses on their accuracy (rated 1-4 from completely inaccurate to completely accurate), completeness (rated 1-4 from totally incomplete to totally complete), and appropriateness (binary). Responses were also evaluated with three readability scales. RESULTS: ChatGPT responses were rated, on average, more accurate than Bard responses (3.08 ± 0.33 vs 2.82 ± 0.40, p < .01). ChatGPT responses were scored, on average, more complete than Bard responses (2.98 ± 0.34 vs 2.62 ± 0.36, p < .01). Most ChatGPT responses (75.0%, n = 18) and almost half of Bard responses (45.8%, n = 11) were unanimously deemed appropriate. Almost one-third of Bard responses (29.2%, n = 7) were deemed inappropriate by at least two reviewers (29.2%), and two Bard responses (8.4%) were considered inappropriate by the majority. The mean Flesch Reading Ease, Flesch-Kincaid Grade Level, and Gunning Fog Index of ChatGPT responses were 29.4 ± 10.8, 14.5 ± 2.2, and 17.7 ± 3.1, respectively, indicating that responses were readable with a post-secondary education. Bard's mean readability scores were 58.9 ± 10.5, 8.2 ± 1.7, and 11.0 ± 2.0, respectively, indicating that responses were readable with a high-school education (p < .0001 for three metrics). ChatGPT's mean response length (332 ± 79 words) was higher than Bard's mean response length (183 ± 53 words, p < .001). There was no difference in the accuracy, completeness, readability, or response length of ChatGPT or Bard between disease domains (p > .05 for all analyses). CONCLUSIONS: AI offers a novel means of educating patients that avoids the inundation of information from "Dr Google" and the time barriers of physician-patient encounters. ChatGPT provides largely valid, though imperfect, responses to myriad patient questions at the expense of readability. While Bard responses are more readable and concise, their quality is poorer. Further research is warranted to better understand failure points for large language models in vascular surgery patient education.
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OBJECTIVE: The existing renal artery aneurysm (RAA) literature is largely composed of reports of patients who underwent intervention. The objective of this study was to review the natural history of RAA. METHODS: This single-institution retrospective analysis studied all patients with RAA diagnosed by computed tomography imaging between 2015 and 2019, identified by our institutional radiology database. Imaging, demographic, and clinical data were obtained via the electronic medical record. He growth rate was calculated for all patients with radiological follow-up. RESULTS: The cohort consists of 331 patients with 338 RAAs. Most patients were female (61.3%), with 11 (3.3%) of childbearing age. The mean age at diagnosis was 71.5 years (range, 24-99 years). Medical comorbidities included hypertension (73.7%), prior smoking (34.4%), and connective tissue disease (3.9%). Imaging indications included abdominal pain (33.5%), unrelated follow-up (29.6%), and follow-up of an RAA initially diagnosed before the study period (10.7%). Right RAA (61.9%) was more common than left (35.1%); 3% of patients had bilateral RAA. The mean diameter at diagnosis was 12.9 ± 5.9 mm. Size distribution included lesions measuring less than <15 mm (69.9%), 15 to 25 mm (27.1%), and more than 25 mm (3.0%). Anatomic locations included the distal RA (26.7%), renal hilum (42.4%), and mid-RA (13.1%). The majority were true aneurysms (98%); of these, 72.3% were fusiform and 27.7% were saccular. Additional characteristics included calcification (82.2%), thrombus (15.9%), and dissection (0.9%). Associated findings included aortic atherosclerosis (65.6%), additional visceral aneurysms (7.3%), and abdominal aortic aneurysm (5.7%). The mean clinical follow-up among 281 patients was 41.0 ± 24.0 months. The mean radiological follow-up among 137 patients was 26.0 ± 21.4 months. Of these, 43 patients (31.4%) experienced growth, with mean growth rate of 0.23 ± 4.7 mm/year; the remainder remained stable in size. Eight patients eventually underwent intervention (5 endovascular), with the most common indications including size criteria (4/8) and symptom development (3/8). No patient developed rupture. On multivariate analysis, obesity (P = .04) was significantly associated with growth. An initial diameter of more than 25 mm was significantly associated with subsequent intervention (P = .006), but was not significantly associated with growth. Four of five RAAs with an initial diameter 30 mm or greater did not undergo intervention. The mean clinical follow-up for these patients was 24 months; none developed rupture and two remained stable in size. CONCLUSIONS: This large institutional cohort found that the majority of RAAs remained stable in size, with few patients meeting indications for repair based on societal guidelines. Current guidelines recommending intervention for asymptomatic aneurysms more than 30 mm seem to be appropriate given their slow progression.
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Aneurisma , Nefropatias , Masculino , Humanos , Feminino , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Artéria Renal/diagnóstico por imagem , Estudos Retrospectivos , Resultado do Tratamento , Procedimentos Cirúrgicos Vasculares/métodos , Aneurisma/diagnóstico por imagem , Aneurisma/epidemiologia , Aneurisma/terapia , Tomografia Computadorizada por Raios XRESUMO
BACKGROUND: There is a paucity of literature on the natural history of extracranial carotid artery occlusion (CAO). This study reviews the natural history of this patient cohort. METHODS: This single-institution retrospective analysis studied patients with CAO diagnosed by duplex ultrasound between 2010 and 2021. Patients were identified by searching our office-based Intersocietal Accreditation Commission accredited vascular laboratory database. Imaging and clinical data were obtained via our institutional electronic medical record. Outcomes of interest included ipsilateral stroke, attributable neurologic symptoms, and ipsilateral intervention after diagnosis. RESULTS: The full duplex database consisted of 5,523 patients who underwent carotid artery duplex examination during the study period. The CAO cohort consisted of 139 patients; incidence of CAO was 2.5%. Mean age at diagnosis was 69.7 years; 31.4% were female. Hypertension (72.7%), hyperlipidemia (64.7%), and prior smoking (43.9%) were the most common comorbid conditions. Of the CAO cohort, 61.3% (n = 85) of patients were asymptomatic at diagnosis; 38.8% (n = 54) were diagnosed after a stroke or transient ischemic attack occurring within 6 months prior to diagnosis, with 21.6% occurring ipsilateral to the CAO and 10.1% occurring contralateral to the CAO. 7.2% (n = 10) had unclear symptoms or laterality at presentation. Of the CAO cohort, 95 patients (68.3%) had duplex imaging follow-up (mean 42.7 ± 31.3 months). Of those with follow-up studies, 7 patients (5.0%) developed subsequent stroke ipsilateral to the CAO with mean occurrence 27.8 ± 39.0 months postdiagnosis. In addition, 5 patients (3.6%) developed other related symptoms, including global hypoperfusion (2.4%) and transient ischemic attack (1.2%). Of those, 95 patients with follow-up duplex ultrasound imaging, 6 (4.3%) underwent eventual ipsilateral intervention, including carotid endarterectomy (n = 4), transfemoral carotid artery stent (n = 1), and carotid bypass (n = 1), with mean occurrence 17.7 ± 23.7 months postdiagnosis. The aggregate rate of ipsilateral cerebrovascular accident, attributable neurologic symptoms, or ipsilateral intervention was 11.5%. Of 95 patients with follow-up duplex ultrasound imaging, 5 underwent subsequent duplex studies demonstrating ipsilateral patency, resulting in a 5.3% discrepancy rate between sequential duplex studies. All 6 patients undergoing intervention received periprocedural cross-sectional imaging (magnetic resonance angiography or computed tomography angiography). In 5 of these 6 patients, cross-sectional demonstrated severe stenosis rather than CAO, disputing prior duplex ultrasound findings. CONCLUSIONS: In this large, institutional cohort of patients with a CAO diagnosis on duplex ultrasound, a clinically meaningful subset of patients experienced cerebrovascular accident, related symptoms, or intervention. We also found a notable rate of temporal duplex discrepancies among patients with CAO diagnoses and discrepancies between CAO diagnosis per duplex ultrasound and findings on cross-sectional imaging for those patients who underwent intervention. These results suggest that use of a single duplex ultrasound as a sole diagnostic tool in CAO may not be sufficient and that physicians should consider close duplex ultrasound surveillance of these patients, potentially in conjunction with additional confirmatory imaging modalities. Further investigation into optimal workup and surveillance protocols for CAO is needed.
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Doenças das Artérias Carótidas , Estenose das Carótidas , Ataque Isquêmico Transitório , Acidente Vascular Cerebral , Humanos , Feminino , Idoso , Masculino , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/terapia , Estenose das Carótidas/complicações , Ataque Isquêmico Transitório/diagnóstico por imagem , Ataque Isquêmico Transitório/etiologia , Estudos Retrospectivos , Resultado do Tratamento , Doenças das Artérias Carótidas/complicações , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Artérias CarótidasRESUMO
PURPOSE: Effective treatment of diabetic foot ulcers (DFUs) involves a multidisciplinary treatment plan to promote wound healing and prevent complications. Given the lack of consensus data on the factors affecting patient adherence, a systematic review was performed to identify and classify factors according to the WHO Dimensions of Adherence to Long-Term Therapies. METHODS: Six hundred and forty-three articles from PubMed, Embase, and Scopus were reviewed. The inclusion criteria included qualitative and quantitative studies which discussed factors affecting patient adherence to DFU treatment, had study populations that comprised patients with either prior history of or existing DFU, and had either prior history of DFU treatment or were currently receiving treatment. Factors, and associated measures of adherence, were extracted and organized according to the WHO Dimensions of Adherence to Long-Term Therapies. RESULTS: Seven quantitative and eight qualitative studies were included. Eleven patient-related factors, seven condition-related factors, three therapy-related factors, five socioeconomic factors, and five health system-related factors were investigated by the included studies. The largest proportion of factors studied was patient-related, such as patient insight on DFU treatment, patient motivation, and patient perception of DFU treatment. There was notable overlap in the range of discussed factors across various domains, in the socioeconomic (including social support, income, social and cultural acceptability of DFU therapy, cost) and therapy-related domains (including duration of treatment, offloading footwear, and reminder devices). Different studies found that specific factors, such as gender and patients having a low internal locus of control, had differing effects on adherence on different cohorts. CONCLUSION: Current literature presents heterogeneous findings regarding factors affecting patient adherence. It would be useful for future studies to categorize factors as such to provide more comprehensive understanding and personalized care to patients. Further research can be done to explore how significant factors can be addressed universally across different cohort populations in different cultural and socioeconomic contexts.
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Objective: Wound image analysis tools hold promise in helping patients to monitor their wounds. We aim to perform a novel feasibility study on the efficacy of a patient-owned wound surveillance system for diabetic foot ulcer (DFU) care. Methods: This two-institutional, prospective, single-arm pilot study examined patients with DFU. An artificial intelligence-enabled image analysis app calculating the wound surface area was installed and patients or caregivers were instructed to take pictures of wounds during dressing changes. Patients were followed until wound deterioration, wound healing, or wound stability at 6 months occurred and the outcomes of interest included study adherence, algorithm performance, and user experience. Results: Between January 2021 and December 2021, 39 patients were enrolled in the study, with a mean age of 61.6 ± 8.6 years, and 69% (n = 27) of subjects were male. All patients had documented diabetes and 85% (n = 33) of them had peripheral arterial disease. A mean follow-up for those completing the study was 12.0 ± 8.5 weeks. At the conclusion of the study, 80% of patients (n = 20) had primary wound healing whilst 20% (n = 5) had wound deterioration. The study completion rate was 64% (n = 25). Usage of the app for surveillance of DFU healing, as compared to physician evaluation, yielded a sensitivity of 100%, specificity of 20%, positive predictive value of 83%, and negative predictive value of 100%. Of those who provided user experience feedback, 59% (n = 10) felt the app was easy to use, 47% (n = 8) would recommend the wound analysis app to others but only 6% would pay for the app out of pocket (n = 1). Conclusion: Implementation of a patient-owned wound surveillance system is feasible. Most patients were able to effectively monitor wounds using a smartphone app-based solution. The image analysis algorithm demonstrates strong performance in identifying wound healing and is capable of detecting deterioration prior to interval evaluation by a physician. Patients generally found the app easy to use but were reluctant to pay for the use of the solution out of pocket.
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Machine learning applications promise to augment clinical capabilities and at least 64 models have already been approved by the US Food and Drug Administration. These tools are developed, shared, and used in an environment in which regulations and market forces remain immature. An important consideration when evaluating this environment is the introduction of open-source solutions in which innovations are freely shared; such solutions have long been a facet of digital culture. We discuss the feasibility and implications of open-source machine learning in a health care infrastructure built upon proprietary information. The decreased cost of development as compared to drugs and devices, a longstanding culture of open-source products in other industries, and the beginnings of machine learning-friendly regulatory pathways together allow for the development and deployment of open-source machine learning models. Such tools have distinct advantages including enhanced product integrity, customizability, and lower cost, leading to increased access. However, significant questions regarding engineering concerns about implementation infrastructure and model safety, a lack of incentives from intellectual property protection, and nebulous liability rules significantly complicate the ability to develop such open-source models. Ultimately, the reconciliation of open-source machine learning and the proprietary information-driven health care environment requires that policymakers, regulators, and health care organizations actively craft a conducive market in which innovative developers will continue to both work and collaborate.
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OBJECTIVES: Predictive studies play important roles in the development of models informing care for patients with COVID-19. Our concern is that studies producing ill-performing models may lead to inappropriate clinical decision-making. Thus, our objective is to summarise and characterise performance of prognostic models for COVID-19 on external data. METHODS: We performed a validation of parsimonious prognostic models for patients with COVID-19 from a literature search for published and preprint articles. Ten models meeting inclusion criteria were either (a) externally validated with our data against the model variables and weights or (b) rebuilt using original features if no weights were provided. Nine studies had internally or externally validated models on cohorts of between 18 and 320 inpatients with COVID-19. One model used cross-validation. Our external validation cohort consisted of 4444 patients with COVID-19 hospitalised between 1 March and 27 May 2020. RESULTS: Most models failed validation when applied to our institution's data. Included studies reported an average validation area under the receiver-operator curve (AUROC) of 0.828. Models applied with reported features averaged an AUROC of 0.66 when validated on our data. Models rebuilt with the same features averaged an AUROC of 0.755 when validated on our data. In both cases, models did not validate against their studies' reported AUROC values. DISCUSSION: Published and preprint prognostic models for patients infected with COVID-19 performed substantially worse when applied to external data. Further inquiry is required to elucidate mechanisms underlying performance deviations. CONCLUSIONS: Clinicians should employ caution when applying models for clinical prediction without careful validation on local data.
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COVID-19 , Modelos Teóricos , Área Sob a Curva , COVID-19/diagnóstico , Humanos , PrognósticoRESUMO
The COVID-19 pandemic has challenged front-line clinical decision-making, leading to numerous published prognostic tools. However, few models have been prospectively validated and none report implementation in practice. Here, we use 3345 retrospective and 474 prospective hospitalizations to develop and validate a parsimonious model to identify patients with favorable outcomes within 96 h of a prediction, based on real-time lab values, vital signs, and oxygen support variables. In retrospective and prospective validation, the model achieves high average precision (88.6% 95% CI: [88.4-88.7] and 90.8% [90.8-90.8]) and discrimination (95.1% [95.1-95.2] and 86.8% [86.8-86.9]) respectively. We implemented and integrated the model into the EHR, achieving a positive predictive value of 93.3% with 41% sensitivity. Preliminary results suggest clinicians are adopting these scores into their clinical workflows.