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Importance: Preoperative chemo(radio)therapy is increasingly used in patients with localized pancreatic adenocarcinoma, leading to pathological complete response (pCR) in a small subset of patients. However, multicenter studies with in-depth data about pCR are lacking. Objective: To investigate the incidence, outcome, and risk factors of pCR after preoperative chemo(radio)therapy. Design, Setting, and Participants: This observational, international, multicenter cohort study assessed all consecutive patients with pathology-proven localized pancreatic adenocarcinoma who underwent resection after 2 or more cycles of chemotherapy (with or without radiotherapy) in 19 centers from 8 countries (January 1, 2010, to December 31, 2018). Data collection was performed from February 1, 2020, to April 30, 2022, and analyses from January 1, 2022, to December 31, 2023. Median follow-up was 19 months. Exposures: Preoperative chemotherapy (with or without radiotherapy) followed by resection. Main Outcomes and Measures: The incidence of pCR (defined as absence of vital tumor cells in the sampled pancreas specimen after resection), its association with OS from surgery, and factors associated with pCR. Factors associated with overall survival (OS) and pCR were investigated with Cox proportional hazards and logistic regression models, respectively. Results: Overall, 1758 patients (mean [SD] age, 64 [9] years; 879 [50.0%] male) were studied. The rate of pCR was 4.8% (n = 85), and pCR was associated with OS (hazard ratio, 0.46; 95% CI, 0.26-0.83). The 1-, 3-, and 5-year OS rates were 95%, 82%, and 63% in patients with pCR vs 80%, 46%, and 30% in patients without pCR, respectively (P < .001). Factors associated with pCR included preoperative multiagent chemotherapy other than (m)FOLFIRINOX ([modified] leucovorin calcium [folinic acid], fluorouracil, irinotecan hydrochloride, and oxaliplatin) (odds ratio [OR], 0.48; 95% CI, 0.26-0.87), preoperative conventional radiotherapy (OR, 2.03; 95% CI, 1.00-4.10), preoperative stereotactic body radiotherapy (OR, 8.91; 95% CI, 4.17-19.05), radiologic response (OR, 13.00; 95% CI, 7.02-24.08), and normal(ized) serum carbohydrate antigen 19-9 after preoperative therapy (OR, 3.76; 95% CI, 1.79-7.89). Conclusions and Relevance: This international, retrospective cohort study found that pCR occurred in 4.8% of patients with resected localized pancreatic adenocarcinoma after preoperative chemo(radio)therapy. Although pCR does not reflect cure, it is associated with improved OS, with a doubled 5-year OS of 63% compared with 30% in patients without pCR. Factors associated with pCR related to preoperative chemo(radio)therapy regimens and anatomical and biological disease response features may have implications for treatment strategies that require validation in prospective studies because they may not universally apply to all patients with pancreatic adenocarcinoma.
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Adenocarcinoma , Neoplasias Pancreáticas , Humanos , Neoplasias Pancreáticas/tratamento farmacológico , Neoplasias Pancreáticas/terapia , Neoplasias Pancreáticas/cirurgia , Neoplasias Pancreáticas/mortalidade , Masculino , Pessoa de Meia-Idade , Feminino , Adenocarcinoma/tratamento farmacológico , Adenocarcinoma/terapia , Adenocarcinoma/patologia , Idoso , Terapia Neoadjuvante/métodos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Resultado do Tratamento , Estudos de Coortes , Oxaliplatina/uso terapêutico , PancreatectomiaRESUMO
BACKGROUND: In 2012, the American Society of Anesthesiologists (ASA) published guidelines recommending against routine preoperative laboratory testing for low-risk patients to reduce unnecessary medical expenditures. The aim of this study was to assess the change in routine preoperative laboratory testing in low-risk versus higher-risk patients before and after release of these guidelines. METHODS: The ACS-NSQIP database, 2005-2018, was separated into low-risk versus higher-risk patients based upon a previously published stratification. The guideline implementation date was defined as January 2013. Changes in preoperative laboratory testing over time were compared between low- and higher-risk patients. A difference-in-differences model was applied. The primary outcome included any laboratory test obtained ≤90 days prior to surgery. RESULTS: Of 7,507,991 patients, 972,431 (13.0%) were defined as low-risk and 6,535,560 (87.0%) higher-risk. Use of any preoperative laboratory test declined in low-risk patients from 66.5% before to 59.6% after guidelines, a 6.9 percentage point reduction, versus 93.0%-91.9% in higher-risk patients, a 1.1 percentage point reduction (p < 0.0001, comparing percentage point reductions). After risk-adjustment, the adjusted odds ratio for having any preoperative laboratory test after versus before the guidelines was 0.77 (95% CI 0.76-0.78) in low-risk versus 0.93 (0.92-0.94) in higher-risk patients. In low-risk patients, lack of any preoperative testing was not associated with worse outcomes. CONCLUSIONS: While a majority of low-risk patients continue to receive preoperative laboratory testing not recommended by the ASA, there has been a decline after implementation of guidelines. Continued effort should be directed at the deimplementation of routine preoperative laboratory testing for low-risk patients.
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Guias de Prática Clínica como Assunto , Cuidados Pré-Operatórios , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Estados Unidos , Cuidados Pré-Operatórios/normas , Cuidados Pré-Operatórios/métodos , Sociedades Médicas , Medição de Risco/métodos , Idoso , Estudos Longitudinais , Fidelidade a Diretrizes/estatística & dados numéricos , Adulto , Testes Diagnósticos de Rotina/normasRESUMO
Background: Surgical diagnostic lung biopsy (DLB) is performed to guide the management of pulmonary disease with unclear etiology. However, the utilization of surgical DLB in critically ill patients remains unclear. The purpose of this study was to determine if patient preoperative disposition impacts complication rates after DLB. Methods: This was retrospective cohort study using electronic health record (EHR) data at one academic institution [2013-2021]. Patients who underwent DLB were identified using current procedural terminology (CPT) codes and cohorted based on preoperative disposition. The primary outcome was 30-day mortality; secondary outcomes were overall morbidity, individual complications, and changes to medical therapy. Complication rates were compared using chi-squared tests, Fisher's exact tests, or analysis of variance (ANOVA). Multivariable logistic regression was performed to generate risk-adjusted odds ratios (ORs) for each complication. Results: Of 285 patients, 238 (83.5%) presented from home, 26 (9.1%) from inpatient floor units, and 21 (7.4%) from intensive care units (ICUs). Patients requiring ICU had the highest 30-day rates of mortality, overall morbidity, and all individual complications (all P<0.05). After risk adjustment, non-ICU inpatients had higher odds of postoperative ventilator use, prolonged ventilation, and ICU need than outpatients (all P<0.05). Preoperative ICU disposition was associated with increased OR of 30-day mortality [OR, 70.92; 95% confidence interval (CI): 5.55-906.32] and overall morbidity (OR, 7.27; 95% CI: 1.93-27.42) compared to patients with other preoperative dispositions. There were no differences in changes to medical therapy between the cohorts. Conclusions: Patients requiring ICU before DLB had significantly higher risk-adjusted rates of mortality and postoperative complications than outpatients and other inpatients. A clear benefit from tissue diagnosis should be defined prior to performing DLB on critically ill patients.
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Patient-reported outcomes (PROs) are an underreported aspect of surgical recovery. The purpose of our study was to track PROs after robotic anatomic lung to determine the timing to recovery of baseline patient baseline quality of life. This was a prospective cohort study at an academic medical center (4/2021-12/2022). Patients who underwent robotic anatomic lung resection were asked to complete PROMIS-29 surveys at the preoperative clinic visit, postoperative clinic visit, 30 days and 90 days postoperatively via in-person and email-based electronic surveys. The PROPr score, a summary of health-related quality of life, and mental and physical health z-scores were estimated for each patient using published methods and compared by postoperative timing. 75 patients completed the preoperative survey and at least one postoperative survey; 56 completed postoperative clinic surveys, 54 completed 30-day postoperative surveys, and 40 completed 90-day postoperative surveys. All three PROMIS scores decreased between the preoperative and first postoperative visit (all p < 0.05). PROPr scores increased over time but remained significantly worse than baseline by 90 days (-0.08 difference between 90 days and preoperative, p = 0.02). While PROMIS summary z-scores for physical health remained - 0.29 lower at 90 days postoperatively, this did not reach statistical significance (p = 0.06). Mental health scores returned to baseline by 90 days postoperatively (p = 0.41). While some PROs returned to baseline by 90 days postoperatively, overall quality-of-life scores remained significantly below preoperative baselines. These findings are important to share with patients during the informed consent process to achieve patient centered care more effectively.
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Qualidade de Vida , Procedimentos Cirúrgicos Robóticos , Humanos , Estudos Prospectivos , Procedimentos Cirúrgicos Robóticos/métodos , Medidas de Resultados Relatados pelo Paciente , PulmãoRESUMO
OBJECTIVE: To estimate preoperative risk of postoperative infections using structured electronic health record (EHR) data. BACKGROUND: Surveillance and reporting of postoperative infections is primarily done through costly, labor-intensive manual chart reviews on a small sample of patients. Automated methods using statistical models applied to postoperative EHR data have shown promise to augment manual review as they can cover all operations in a timely manner. However, there are no specific models for risk-adjusting infectious complication rates using EHR data. METHODS: Preoperative EHR data from 30,639 patients (2013-2019) were linked to the American College of Surgeons National Surgical Quality Improvement Program preoperative data and postoperative infection outcomes data from 5 hospitals in the University of Colorado Health System. EHR data included diagnoses, procedures, operative variables, patient characteristics, and medications. Lasso and the knockoff filter were used to perform controlled variable selection. Outcomes included surgical site infection, urinary tract infection, sepsis/septic shock, and pneumonia up to 30 days postoperatively. RESULTS: Among >15,000 candidate predictors, 7 were chosen for the surgical site infection model and 6 for each of the urinary tract infection, sepsis, and pneumonia models. Important variables included preoperative presence of the specific outcome, wound classification, comorbidities, and American Society of Anesthesiologists physical status classification. The area under the receiver operating characteristic curve for each model ranged from 0.73 to 0.89. CONCLUSIONS: Parsimonious preoperative models for predicting postoperative infection risk using EHR data were developed and showed comparable performance to existing American College of Surgeons National Surgical Quality Improvement Program risk models that use manual chart review. These models can be used to estimate risk-adjusted postoperative infection rates applied to large volumes of EHR data in a timely manner.
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Pneumonia , Sepse , Choque Séptico , Humanos , Registros Eletrônicos de Saúde , Infecção da Ferida Cirúrgica/diagnóstico , Infecção da Ferida Cirúrgica/epidemiologia , Pneumonia/epidemiologia , Pneumonia/etiologia , Aprendizado de Máquina , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/epidemiologia , Fatores de Risco , Estudos RetrospectivosRESUMO
OBJECTIVE: The purpose of this study was to determine if an association between Social Vulnerability Index (SVI) and risk-adjusted complications exists in a broad spectrum of surgical patients. SUMMARY BACKGROUND DATA: Growing evidence supports the impact of social circumstances on surgical outcomes. SVI is a neighborhood-based measure accounting for sociodemographic factors putting communities at risk. METHODS: This was a multi-hospital, retrospective cohort study including a sample of patients within one healthcare system (2012-2017). Patient addresses were geocoded to determine census tract of residence and estimate SVI. Patients were grouped into low SVI (score<75) and high SVI (score≥75) cohorts. Perioperative variables and postoperative outcomes were tracked and compared using local ACS-NSQIP data. Multivariable logistic regression was performed to generate risk-adjusted odds ratios of postoperative complications in the high SVI cohort. RESULTS: Overall, 31,224 patients from five hospitals were included. Patients with high SVI were more likely to be racial minorities, have 12/18 medical comorbidities, have high ASA class, be functionally dependent, be treated at academic hospitals, and undergo emergency operations (all p â< â0.05). Patients with high SVI had significantly higher rates of 30-day mortality, overall morbidity, respiratory, cardiac and infectious complications, urinary tract infections, postoperative bleeding, non-home discharge, and unplanned readmissions (all p â< â0.05). After risk-adjustment, only the associations between high SVI and mortality and unplanned readmission became non-significant. CONCLUSIONS: High SVI was associated with multiple adverse outcomes even after risk adjustment for preoperative clinical factors. Targeted preventative interventions to mitigate risk of these specific complications should be considered in this high-risk population.
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Melhoria de Qualidade , Vulnerabilidade Social , Humanos , Estudos Retrospectivos , Complicações Pós-Operatórias/etiologia , Hemorragia Pós-OperatóriaRESUMO
CONTEXT: Scientific journals are the primary source for dissemination of research findings, and this process relies on rigorous editorial and peer-review. As part of continuing efforts by the Journal of Pain and Symptom Management (JPSM) to advance equity, diversity, and inclusion, JPSM's leadership requested an external evaluation of their publication decisions. OBJECTIVES: 1) Describe primary author characteristics associated with final decisions to accept or reject manuscripts submitted for publication; 2) Report on whether there are potential publication biases in the JPSM editorial or peer-review processes. METHODS: Data consisted of self-reported primary author demographic characteristics associated with manuscript submissions between June 18, 2020, and December 31, 2022. Characteristics included region of residence, race, gender, and ethnicity. A multiple logistic regression model was used to estimate adjusted odds of rejection for each author characteristic. RESULTS: A total of 1940 submissions were evaluated. Compared to authors residing in North America, authors residing in Asia had six-fold greater odds of rejection, authors residing in Europe had four-fold greater odds of rejection, and authors residing in other regions had two-fold greater odds of rejection. Female authors submitted 1.7 times more papers than males, but there was no difference in acceptance rates of their papers in adjusted analysis. CONCLUSION: In this analysis of publication decisions by the JPSM, there were differences in acceptance rates by region of residence, ethnicity, and race but not by gender. Asian authors and authors residing in regions outside of North America had greater odds of rejection compared to White or North American authors.
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Dor , Masculino , Humanos , Feminino , Europa (Continente) , Modelos Logísticos , Análise MultivariadaRESUMO
OBJECTIVE: Inadvertent perioperative hypothermia has been associated with poor surgical outcomes. The purpose of this study was to evaluate the incidence and associated postoperative complications of inadvertent perioperative hypothermia in patients undergoing robotic-assisted thoracic surgery lung resections. METHODS: This was a single-center, retrospective cohort study evaluating all consecutive patients who underwent robotic-assisted thoracic surgery lung resection between January 1, 2021, and November 30, 2022. Temperatures were measured at 5 time points: preprocedure unit, anesthesia induction, 30 minutes postinduction, extubation, and recovery room arrival. Temperature changes were calculated at each interval. Adjusted and unadjusted comparison was performed between those who experienced varying levels of inadvertent perioperative hypothermia (Hypothermia I: <36 °C, Hypothermia II: <35.5 °C, and Hypothermia III: <35 °C) and those who did not. RESULTS: A total of 313 patients were included, and 201 (64.2%) lobectomies, 50 (16.0%) segmentectomies, and 62 (19.8%) wedge resections were performed. Across all patients, 291 (93.0%) had a temperature less than 36 °C, 195 (62.3%) had a temperature less than 35.5 °C, and 100 (31.9%) had a temperature less than 35.0 °C. Patients experienced significant temperature change at all intervals (P < .001), with the greatest loss occurring during the preprocedure interval (between leaving preprocedure unit and anesthesia induction). On adjusted analysis, patients who experienced inadvertent perioperative hypothermia less than 35.5 °C were older (odds ratio, 1.03; 95% CI, 1.01-1.05), had lower body mass index (odds ratio, 0.95; 95% CI, 0.87-0.98), and had increasing operative time (odds ratio, 1.00; 95% CI, 1.00-1.01). Patients who experienced inadvertent perioperative hypothermia had higher risk-adjusted rates of overall morbidity and infectious postoperative complications. CONCLUSIONS: The majority of patients undergoing robotic-assisted thoracic surgery lung resections experience some degree of inadvertent perioperative hypothermia and have associated increased rates of 30-day morbidity. Structured and interval-specific interventions should be implemented to decrease rates of inadvertent perioperative hypothermia and subsequent complications.
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BACKGROUND: There are persistent racial and ethnic health disparities in end-of-life health outcomes in the United States. African American patients are less likely than White patients to access palliative care, enroll in hospice care, have documented goals of care discussions with their healthcare providers, receive adequate symptom control, or die at home. We developed Community Health Worker Intervention for Disparities in Palliative Care (DeCIDE PC) to address these disparities. DeCIDE PC is an integrated community health worker (CHW) palliative care intervention that uses community health workers (CHWs) as care team members to enhance the receipt of palliative care for African Americans with advanced cancer. The overall objectives of this study are to (1) assess the effectiveness of the DeCIDE PC intervention in improving palliative care outcomes amongst African American patients with advanced solid organ malignancy and their informal caregivers, and (2) develop generalizable knowledge on how contextual factors influence implementation to facilitate dissemination, uptake, and sustainability of the intervention. METHODS: We will conduct a multicenter, randomized, assessor-blind, parallel-group, pragmatic, hybrid type 1 effectiveness-implementation trial at three cancer centers across the United States. The DeCIDE PC intervention will be delivered over 6 months with CHW support tailored to the individual needs of the patient and caregiver. The primary outcome will be advance care planning. The treatment effect will be modeled using logistic regression. The secondary outcomes are quality of life, quality of communication, hospice care utilization, and patient symptoms. DISCUSSION: We expect the DeCIDE PC intervention to improve integration of palliative care, reduce multilevel barriers to care, enhance clinic and patient linkage to resources, and ultimately improve palliative care outcomes for African American patients with advanced cancer. If found to be effective, the DeCIDE PC intervention may be a transformative model with the potential to guide large-scale adoption of promising strategies to improve palliative care use and decrease disparities in end-of-life care for African American patients with advanced cancer in the United States. TRIAL REGISTRATION: Registered on ClinicalTrials.gov (NCT05407844). First posted on June 7, 2022.
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Enfermagem de Cuidados Paliativos na Terminalidade da Vida , Assistência Terminal , Humanos , Cuidados Paliativos , Agentes Comunitários de Saúde , Qualidade de Vida , Morte , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como AssuntoRESUMO
BACKGROUND: The gold standard for detecting postoperative complications uses databases like the American College of Surgeons National Surgical Quality Improvement Program, a multi-centered database based on manual chart review. However, their limitations and costs have led many centers to discontinue participation. Novel techniques to detect postoperative complications must be developed and implemented with surgeon involvement, which is paramount to their adoption. We sought to assess surgeons' opinions of a newly developed postoperative complication detection tool, the Automated Surveillance of Postoperative Infections, within the contextual clinical environment. METHODS: This was a multi-site qualitative formative evaluation of surgeon perceptions of the Automated Surveillance of Postoperative Infections. We conducted semi-structured interviews and focus groups with surgeons and presented the Automated Surveillance of Postoperative Infections concept. Important domains and constructs, as categorized by Consolidated Framework for Implementation Research, were identified to support the successful adoption and implementation of the Automated Surveillance of Postoperative Infections. RESULTS: Twenty-four surgeons with 10 surgical subspecialties were interviewed. The following 4 main themes were found: (1) perception of the Automated Surveillance of Postoperative Infections tool-to provide important data that can improve and support clinical outcomes; (2) environment for implementation-description of factors to support or impede implementation; (3) adaptability of the Automated Surveillance of Postoperative Infections-to work with the complexity of surgical cases; and (4) the Automated Surveillance of Postoperative Infections report format and details. CONCLUSIONS: We successfully captured the perspectives and suggestions of surgeons to improve the Automated Surveillance of Postoperative Infections and potential barriers during the initial development phase. Barriers included fear of punitive action from reports and complex surgical cases. Facilitators identified were the need to improve clinical outcomes and organizational support. The results of this formative evaluation will be used to further develop Automated Surveillance of Postoperative Infections, starting with a prototype, the Automated Surveillance of Postoperative Infections 1.0.
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Complicações Pós-Operatórias , Cirurgiões , Humanos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Bases de Dados Factuais , Medo , Grupos FocaisRESUMO
BACKGROUND: Outcomes for patients undergoing emergency thoracic operations have not been well described. This study was designed to compare postoperative outcomes among patients undergoing emergency versus nonemergency thoracic operations. METHODS: We retrospectively analyzed the American College of Surgeons National Surgical Quality Improvement Program database (2005-2018). We identified patients who underwent emergency thoracic operations using current procedural technology codes. Patients were then sorted into 1 of 4 cohorts: lung and chest wall, hiatal hernia, esophagus, and pericardium. Emergency versus nonemergency outcomes were compared. Univariate logistic regression was performed with "emergency status" as the independent variable and 30-day postoperative outcomes as the dependent variables. Multiple logistic regression models were performed to control for preoperative factors. RESULTS: Of 90,398 thoracic operations analyzed, 4,044 (4.5%) were emergency. Common emergency operations were pericardial window (n = 580, 10.2%), laparoscopic hiatal hernia repair (n = 366, 8.9%), thoracoscopic partial lung decortication (n = 334, 8.1%), thoracoscopic wedge resection (n = 301, 7.3%), thoracoscopic total lung decortication (n = 256, 6.2%), and open repair of hiatal hernia without mesh (n = 254, 6.2%). In all 4 cohorts, 30-day postoperative complications occurred more frequently after emergency surgery. After controlling for patient characteristics, 8 complications were more frequent after emergency lung and chest wall surgery, 5 complications were more frequent after emergency hiatal hernia surgery, and 3 complications were more frequent after emergency pericardium surgery. Risk-adjusted complications were not different after emergency esophageal surgery. CONCLUSION: Patients undergoing emergency thoracic operations have worse risk-adjusted outcomes than those undergoing nonemergency thoracic operations. Subset analysis is needed to determine what factors contribute to increased adverse outcomes in specific patient populations.
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Hérnia Hiatal , Laparoscopia , Cirurgia Torácica , Procedimentos Cirúrgicos Torácicos , Humanos , Estudos Retrospectivos , Hérnia Hiatal/cirurgia , Hérnia Hiatal/etiologia , Procedimentos Cirúrgicos Torácicos/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Herniorrafia/efeitos adversos , Laparoscopia/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: After surgical resection of pancreatic ductal adenocarcinoma, 14% of patients have lung-only recurrence. We hypothesize that in patients with isolated lung metastases from pancreatic ductal adenocarcinoma, pulmonary metastasectomy offers a survival benefit with minimal additional morbidity after resection. METHODS: This was a single-institution, retrospective study of patients who underwent definitive resection of pancreatic ductal adenocarcinoma and later developed isolated lung metastases between 2009 and 2021. Patients were included if they carried a diagnosis of pancreatic ductal adenocarcinoma, underwent pancreatic resection with curative intent, and subsequently developed lung metastases. Patients were excluded if they developed multiple sites of recurrence. RESULTS: We identified 39 patients with pancreatic ductal adenocarcinoma and isolated lung metastases, 14 of whom underwent pulmonary metastasectomy. During the study period, 31 (79%) patients died. Across all patients, there was an overall survival of 45.9 months, a disease-free interval of 22.8 months, and survival after recurrence of 22.5 months. Survival after recurrence was significantly longer in patients who underwent pulmonary metastasectomy than those who did not (30.8 months vs 18.6 months, P < .01). There was no difference in overall survival between groups. However, patients who underwent pulmonary metastasectomy were significantly more likely to be alive 3 years after their diagnosis (100.0% vs 64%, P = .02) and 2 years after recurrence (79% vs 32%, P < .01) than those in who did not undergo pulmonary metastasectomy. No mortalities occurred related to pulmonary metastasectomy, and procedure-related morbidity was 7%. CONCLUSION: Patients who underwent pulmonary metastasectomy for isolated pulmonary pancreatic ductal adenocarcinoma metastases had significantly longer survival after recurrence and clinically meaningful survival benefit with minimal additional morbidity after pulmonary resection.
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Carcinoma Ductal Pancreático , Neoplasias Pulmonares , Metastasectomia , Neoplasias Pancreáticas , Humanos , Estudos Retrospectivos , Taxa de Sobrevida , Pulmão/patologia , Recidiva Local de Neoplasia , Prognóstico , Intervalo Livre de Doença , Neoplasias PancreáticasRESUMO
BACKGROUND: Thirty-day mortality after outpatient surgery is unexpected and undesired. We investigated preoperative risk factors, operative variables, and postoperative complications associated with 30-day death after outpatient surgery. METHODS: Using the 2005 to 2018 American College of Surgeons National Surgical Quality Improvement Program database, we evaluated 30-day mortality rate trends over time after outpatient operations. We analyzed associations between 37 preoperative variables, operation time, hospital length of stay, and 9 postoperative complications with mortality rate using χ2 analyses for categorical data and tests for continuous data. We used forward selection logistic regression models to determine the best predictors of mortality preoperatively and postoperatively. We also separately analyzed mortality by age group. RESULTS: A total of 2,822,789 patients were included. The 30-day mortality rate did not change significantly over time (P = .34, Cochran-Armitage trend test), remaining steady at around 0.06%. The most significant preoperative predictors of mortality included the patient having disseminated cancer, decreased functional health status, increased American Society of Anesthesiology Physical Status classification, increased age, and ascites, accounting for 95.8% (0.837/0.874) of the full model c-index. The most significant postoperative complications associated with increased risk of mortality included having cardiac (26.95% yes vs 0.04% no), pulmonary (10.25% vs 0.04%), stroke (9.22% vs 0.06%), and renal (9.33% vs 0.06%) complications. Postoperative complications conferred a greater risk for mortality than preoperative variables. Mortality risk increased incrementally with age, particularly past age 80. CONCLUSION: The operative mortality rate after outpatient surgery has not changed over time. Patients over 80 years with disseminated cancer, decreased functional health status, or increased ASA class should generally be considered for inpatient surgery. However, there might be some circumstances where outpatient surgery could be considered.
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Procedimentos Cirúrgicos Ambulatórios , Pacientes Internados , Humanos , Estados Unidos/epidemiologia , Idoso de 80 Anos ou mais , Procedimentos Cirúrgicos Ambulatórios/efeitos adversos , Fatores de Risco , Modelos Logísticos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Melhoria de Qualidade , Estudos RetrospectivosRESUMO
BACKGROUND: Infectious disease exposures in early life are increasingly recognized as a risk factor for poor subsequent growth and neurodevelopment. We aimed to evaluate the association between cumulative illness with neurodevelopment and growth outcomes in a birth cohort of Guatemalan infants. METHODS: From June 2017 to July 2018, infants 0-3 months of age living in a resource-limited region of rural southwest Guatemala were enrolled and underwent weekly at-home surveillance for caregiver-reported cough, fever, and vomiting/diarrhea. They also underwent anthropometric assessments and neurodevelopmental testing with the Mullen Scales of Early Learning (MSEL) at enrollment, 6 months, and 1 year. RESULTS: Of 499 enrolled infants, 430 (86.2%) completed all study procedures and were included in the analysis. At 12-15 months of age, 140 (32.6%) infants had stunting (length-for-age Z [LAZ] score < -2 SD) and 72 (16.7%) had microcephaly (occipital-frontal circumference [OFC] < -2 SD). In multivariable analysis, greater cumulative instances of reported cough illness (beta = -0.08/illness-week, P = 0.06) and febrile illness (beta = -0.36/illness-week, P < 0.001) were marginally or significantly associated with lower MSEL Early Learning Composite (ELC) Score at 12-15 months, respectively; there was no association with any illness (cough, fever, and/or vomiting/diarrhea; P = 0.27) or with cumulative instances of diarrheal/vomiting illness alone ( P = 0.66). No association was shown between cumulative instances of illness and stunting or microcephaly at 12-15 months. CONCLUSIONS: These findings highlight the negative cumulative consequences of frequent febrile and respiratory illness on neurodevelopment during infancy. Future studies should explore pathogen-specific illnesses, host response associated with these syndromic illnesses, and their association with neurodevelopment.
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Microcefalia , Humanos , Lactente , Idoso de 80 Anos ou mais , Guatemala/epidemiologia , Tosse , Diarreia/epidemiologia , Transtornos do Crescimento/epidemiologia , VômitoRESUMO
BACKGROUND: Postoperative length of stay is a meaningful patient-centered outcome and an important determinant of healthcare costs. The Surgical Risk Preoperative Assessment System preoperatively predicts 12 postoperative adverse events using 8 preoperative variables, but its ability to predict postoperative length of stay has not been assessed. We aimed to determine whether the Surgical Risk Preoperative Assessment System variables could accurately predict postoperative length of stay up to 30 days in a broad inpatient surgical population. METHODS: This was a retrospective analysis of the American College of Surgeons' National Surgical Quality Improvement Program adult database from 2012 to 2018. A model using the Surgical Risk Preoperative Assessment System variables and a 28-variable "full" model, incorporating all available American College of Surgeons' National Surgical Quality Improvement Program preoperative nonlaboratory variables, were fit to the analytical cohort (2012-2018) using multiple linear regression and compared using model performance metrics. Internal chronological validation of the Surgical Risk Preoperative Assessment System model was conducted using training (2012-2017) and test (2018) datasets. RESULTS: We analyzed 3,295,028 procedures. The adjusted R2 for the Surgical Risk Preoperative Assessment System model fit to this cohort was 93.3% of that for the full model (0.347 vs 0.372). In the internal chronological validation of the Surgical Risk Preoperative Assessment System model, the adjusted R2 for the test dataset was 97.1% of that for the training dataset (0.3389 vs 0.3489). CONCLUSION: The parsimonious Surgical Risk Preoperative Assessment System model can preoperatively predict postoperative length of stay up to 30 days for inpatient surgical procedures almost as accurately as a model using all 28 American College of Surgeons' National Surgical Quality Improvement Program preoperative nonlaboratory variables and has shown acceptable internal chronological validation.
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Pacientes Internados , Complicações Pós-Operatórias , Adulto , Humanos , Tempo de Internação , Estudos Retrospectivos , Fatores de Risco , Complicações Pós-Operatórias/epidemiologia , Medição de Risco/métodosRESUMO
BACKGROUND: Cardiac surgery prediction models and outcomes from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) have not been reported. The authors sought to develop preoperative prediction models and estimates of postoperative outcomes for cardiac surgery using the ACS-NSQIP and compare these to the Society of Thoracic Surgeons Adult Cardiac Surgery Database (STS-ACSD). METHODS: In a retrospective analysis of the ACS-NSQIP data (2007-2018), cardiac operations were identified using cardiac surgeon primary specialty and sorted into cohorts of coronary artery bypass grafting (CABG) only, valve surgery only, and valve+CABG operations using CPT codes. Prediction models were created using backward selection of the 28 non-laboratory preoperative variables in ACS-NSQIP. Rates of nine postoperative outcomes and performance statistics of these models were compared to published STS 2018 data. RESULTS: Of 28 912 cardiac surgery patients, 18 139 (62.8%) were CABG only, 7872 (27.2%) were valve only, and 2901 (10.0%) were valve+CABG. Most outcome rates were similar between the ACS-NSQIP and STS-ACSD, except for lower rates of prolonged ventilation and composite morbidity and higher reoperation rates in ACS-NSQIP (all P <0.0001). For all 27 comparisons (9 outcomes × 3 operation groups), the c-indices for the ACS-NSQIP models were lower by an average of ~0.05 than the reported STS models. CONCLUSIONS: The ACS-NSQIP preoperative risk models for cardiac surgery were almost as accurate as the STS-ACSD models. Slight differences in c-indexes could be due to more predictor variables in STS-ACSD models or the use of more disease- and operation-specific risk variables in the STS-ACSD models.
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Procedimentos Cirúrgicos Cardíacos , Cirurgia Torácica , Adulto , Humanos , Estudos de Coortes , Estudos Retrospectivos , Melhoria de Qualidade , Sociedades Médicas , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Bases de Dados Factuais , Medição de RiscoRESUMO
BACKGROUND: The role of curative-intent resection and perioperative chemotherapy for nonmetastatic pancreatic neuroendocrine carcinoma (PanNEC) remains unclear due to their biological aggressiveness and rarity. This study aimed to evaluate the association of resection and perioperative chemotherapy with overall survival for nonmetastatic PanNEC. STUDY DESIGN: Patients with localized (cT1-3, M0), small- and large-cell PanNEC were identified in the National Cancer Database from 2004 to 2017. The changing trends in terms of the annual proportions of resection and adjuvant chemotherapy were assessed. The survival of patients who received resection and those who received adjuvant chemotherapy were investigated using Kaplan-Meier estimates and Cox regression models. RESULTS: In total, 199 patients with localized small- and large-cell PanNEC were identified; 50.3% of those were resected, and 45.0% of the resected patients received adjuvant chemotherapy. Rate of resection and adjuvant treatment has trended upward since 2011. The resected group was younger, was more often treated at academic institutions, had more distal tumors, and had a lower number of small-cell PanNEC. The median overall survival was longer in the resected group compared to the unresected group (29.4 months vs 8.6 months, p < 0.001). Resection was associated with improved survival in a multivariable Cox regression model adjusting for preoperative factors (adjusted hazard ratio 0.58, 95% CI 0.37 to 0.92), while adjuvant therapy was not. CONCLUSIONS: This nationwide retrospective study suggests that resection is associated with improved survival in patients with localized PanNEC. The role of adjuvant chemotherapy needs more investigation.
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Carcinoma Neuroendócrino , Neoplasias Pancreáticas , Humanos , Estudos Retrospectivos , Carcinoma Neuroendócrino/cirurgia , Carcinoma Neuroendócrino/tratamento farmacológico , Terapia Combinada , Quimioterapia Adjuvante , Modelos de Riscos Proporcionais , Estadiamento de Neoplasias , Neoplasias Pancreáticas/cirurgia , Neoplasias Pancreáticas/tratamento farmacológicoRESUMO
BACKGROUND: Children with medical complexity (CMC) often rely upon the use of multiple medications to sustain quality of life and control substantial symptom burden. Pediatric polypharmacy (≥ 5 concurrent medications) is prevalent and increases the risk of medication-related problems (MRPs). Although MRPs are associated with pediatric morbidity and healthcare utilization, polypharmacy is infrequently assessed during routine clinical care for CMC. The aim of this randomized controlled trial is to determine if a structured pharmacist-led Pediatric Medication Therapy Management (pMTM) intervention reduces MRP counts, as well as the secondary outcomes of symptom burden and acute healthcare utilization. METHODS: This is a hybrid type 2 randomized controlled trial assessing the effectiveness of pMTM compared to usual care in a large, patient-centered medical home for CMC. Eligible patients include all children ages 2-18 years old, with ≥ 1 complex chronic condition, and with ≥ 5 active medications, as well as their English-speaking primary caregivers. Child participants and their primary parental caregivers will be randomized to pMTM or usual care before a non-acute primary care visit and followed for 90 days. Using generalized linear models, the overall effectiveness of the intervention will be evaluated using total MRP counts at 90 days following pMTM intervention or usual care visit. Following attrition, a total of 296 CMC will contribute measurements at 90 days, which provides > 90% power to detect a clinically significant 1.0 reduction in total MRPs with an alpha level of 0.05. Secondary outcomes include Parent-Reported Outcomes of Symptoms (PRO-Sx) symptom burden scores and acute healthcare visit counts. Program replication costs will be assessed using time-driven activity-based scoring. DISCUSSION: This pMTM trial aims to test hypotheses that a patient-centered medication optimization intervention delivered by pediatric pharmacists will result in lower MRP counts, stable or improved symptom burdens, and fewer cumulative acute healthcare encounters at 90 days following pMTM compared to usual care. The results of this trial will be used to quantify medication-related outcomes, safety, and value for a high-utilization group of CMC, and outcomes may elucidate the role of integrated pharmacist services as a key component of outpatient complex care programs for this priority pediatric population. TRIAL REGISTRATION: This trial was prospectively registered at clinicaltrials.gov (NCT05761847) on Feb 25, 2023.
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Conduta do Tratamento Medicamentoso , Polimedicação , Humanos , Criança , Pré-Escolar , Adolescente , Qualidade de Vida , Assistência Centrada no Paciente/métodosRESUMO
BACKGROUND: The number of obese surgical patients continues to grow, and yet obesity's association with surgical outcomes is not totally clear. This study examined the association between obesity and surgical outcomes across a broad surgical population using a very large sample size. METHODS: This was an analysis of the 2012 to 2018 American College of Surgeons National Surgical Quality Improvement database, including all patients from 9 surgical specialties (general, gynecology, neurosurgery, orthopedics, otolaryngology, plastics, thoracic, urology, and vascular). Preoperative characteristics and postoperative outcomes were compared by body mass index class (normal weight 18.5-24.9 kg/m2, overweight 25.0-29.9, obese class I 30.0-34.9, obese II 35.0-39.9, obese III ≥40). Adjusted odds ratios were computed for adverse outcomes by body mass index class. RESULTS: A total of 5,572,019 patients were included; 44.6% were obese. Median operative times were marginally higher for obese patients (89 vs 83 minutes, P < .001). Compared to normal weight patients, overweight and obese patients in classes I, II, and III all had higher adjusted odds of developing infection, venous thromboembolism, and renal complications, but they did not exhibit elevated odds of other postoperative complications (mortality, overall morbidity, pulmonary, urinary tract infection, cardiac, bleeding, stroke, unplanned readmission, or discharge not home (except for class III patients). CONCLUSION: Obesity was associated with increased odds of postoperative infection, venous thromboembolism, and renal but not the other American College of Surgeons National Surgical Quality Improvement complications. Obese patients need to be carefully managed for these complications.
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Cirurgiões , Tromboembolia Venosa , Humanos , Estados Unidos/epidemiologia , Sobrepeso/complicações , Fatores de Risco , Melhoria de Qualidade , Obesidade/complicações , Obesidade/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Índice de Massa Corporal , Estudos RetrospectivosRESUMO
INTRODUCTION: The purpose of this study was to determine whether the work relative value unit (workRVU) of a patient's operation can be useful as a measure of surgical complexity for the risk adjustment of surgical outcomes. METHODS: We retrospectively analyzed the American College of Surgeon's National Surgical Quality Improvement Program database (2005-2018). We examined the associations of workRVU of the patient's primary operation with preoperative patient characteristics and associations with postoperative complications. We performed forward selection multiple logistic regression analysis to determine the predictive importance of workRVU. We then generated prediction models using patient characteristics with and without workRVU and compared c-indexes to assess workRVU's additive predictive value. RESULTS: 7,507,991 operations were included. Patients who were underweight, functionally dependent, transferred from an acute care hospital, had higher American Society of Anesthesiologists class or who had medical comorbidities had operations with higher workRVU (all P < 0.0001). The subspecialties with the highest workRVU were neurosurgery (mean = 22.2), thoracic surgery (mean = 21.1), and vascular surgery (mean = 18.8) (P < 0.0001). For all postoperative complications, mean workRVU was higher for patients with the complication than those without (all P < 0.0001). For eight of 12 postoperative complications, workRVU entered the logistic regression models as a predictor variable in the 1st to 4th steps. Addition of workRVU as a preoperative predictive variable improved the c-index of the prediction models. CONCLUSIONS: WorkRVU was associated with sicker patients and patients experiencing postoperative complications and was an important predictor of postoperative complications. When added to a prediction model including patient characteristics, it only marginally improved prediction. This is possibly because workRVU is associated with patient characteristics.