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1.
Telemed J E Health ; 29(11): 1679-1687, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37036813

RESUMO

Introduction: Early detection and optimal resuscitation of critically ill sepsis patients may improve sepsis care delivery. The objective was to assess the feasibility of developing and implementing an end-to-end sepsis solution including early detection, monitoring, and teleconsultation. Methods: Prospective implementation of an end-to-end sepsis solution for potential sepsis patients presenting to a community hospital emergency department (ED) between 11 AM and 5 PM, Monday to Friday, during a 40-day period in 2019. Qualifying patients were compared with patients presenting at other times during the pilot screening period and to historic controls. Results: During the initial period, 203 patients met the screening criteria for potential sepsis; 77 patients (37.9%) had a primary diagnosis of sepsis, present on admission. Mean age was 60 ± 20 years; 50.7% were female; and 24 patients (11.8%) were primary sepsis, SEP-1 bundle eligible. Eighty of 203 (39.4%) had an initial lactate performed, mean, 2.7 ± 1.7 mmol/L. For the 24 primary sepsis, SEP-1 bundle eligible patients, 100% received antibiotics and intravenous fluid. Thirteen consults were performed on 12 patients; mean time from consult decision to beam in to the telemedicine robot was 7.3 ± 5.5 min; mean time from beam in to robot connection with the expert was 23.6 ± 13.2 s; mean consultation call time was 6.3 ± 4.3 min. Conclusions: In a convenience sample of patients with potential sepsis presenting to a community hospital ED, an end-to-end sepsis solution using early detection, tracking, and consultation was feasible and has the potential to improve sepsis detection and treatment.


Assuntos
Sepse , Telemedicina , Humanos , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Masculino , Estudos Prospectivos , Serviço Hospitalar de Emergência , Sepse/diagnóstico , Sepse/terapia , Ácido Láctico , Encaminhamento e Consulta
2.
Surg Endosc ; 36(9): 6688-6695, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35028734

RESUMO

INTRODUCTION: The objectives of this study were to identify consensus priority research questions according to members of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), and to explore differences in priorities according to specific membership subgroups. METHODS: A modified Delphi study was conducted including active members of SAGES. An initial list of research questions was compiled by members of 26 SAGES Committees and Task Forces, and was further refined by the SAGES Delphi Task Force. The questions were divided into five research categories: (1) Surgical Outcomes; (2) Education, Training, and Simulation; (3) Health Services Research; (4) New Technology; and (5) Artificial Intelligence. Delphi respondents were asked to rank each question with regards to its importance in the field of gastrointestinal and endoscopic surgery (1-low; 5-high). "Priority" was defined as a single-round mean score of ≥ 3.5, and "consensus" as a single-round standard deviation < 1.0. Subgroup analyses were performed according to a priori selected respondent characteristics. RESULTS: The total number of respondents for each round was: Round 1 (n = 407); Round 2 (n = 569); Round 3 (n = 273). In each round, the majority of respondents were male (Round 1: 77.4%; Round 2: 77.1%; Round 3: 76.7%), self-identified as academic (vs. community) surgeons (Round 1: 57.1%; Round 2: 61.1%; Round 3: 60.2%), and practiced in North America (Round 1: 71.8%; Round 2: 70.8%; Round 3: 75.9%). A total of 29 out of 122 research questions met criteria for both "priority" and "consensus"-Surgical Outcomes, n = 6; Education, Training, and Simulation, n = 9; Health Services Research, n = 5; New Technology, n = 5; and Artificial Intelligence, n = 4. CONCLUSIONS: Consensus priority research questions in gastrointestinal and endoscopic surgery were identified across five different research categories. These results can provide direction and areas of interest for funding and investigation for future studies.


Assuntos
Inteligência Artificial , Cirurgiões , Consenso , Técnica Delphi , Endoscopia , Feminino , Humanos , Masculino , Estados Unidos
3.
Ophthalmic Physiol Opt ; 42(4): 887-896, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35403738

RESUMO

INTRODUCTION: To establish the most appropriate curve fitting method to allow accurate comparison of defocus curves derived from intraocular lenses (IOLs). METHODS: Defocus curves were plotted in five IOL groups (monofocal, extended depth of focus, refractive bifocal, diffractive bifocal and trifocal). Polynomial curves from 2nd to 11th order and cubic splines were fitted. Goodness of fit (GOF) was assessed using five methods: least squares, coefficient of determination (R2adj ), Akaike information criteria (AIC), visual inspection and Snedecor and Cochran. Additional defocus steps at -2.25 D and -2.75 D were measured and compared to the calculated visual acuity (VA) values. Area under the defocus curve and range of focus were also compared. RESULTS: Goodness of fit demonstrated variable results, with more lenient methods such as R2adj leading to overfitting and conservative methods such as AIC resulting in underfitting. Furthermore, conservative methods diminished the inflection points resulting in an underestimation of VA. Polynomial of at least 8th order was required for comparison of area methods, but overfitted the EDoF and monofocal groups; the spline curve was consistent for all IOLs and methods. CONCLUSIONS: This study demonstrates the inherent difficulty of selecting a single polynomial function. The R2 method can be used cautiously along with visual inspection to guard against overfitting. Spline curves are suitable for all IOLs, guarding against the issues of overfitting. Therefore, for analysis of the defocus profile of IOLs, the fitting of a spline curves is advocated and should be used wherever possible.


Assuntos
Lentes Intraoculares , Lentes Intraoculares Multifocais , Humanos , Implante de Lente Intraocular/métodos , Satisfação do Paciente , Estudos Prospectivos , Desenho de Prótese , Refração Ocular
4.
Ann Surg ; 274(5): 821-828, 2021 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-34334637

RESUMO

OBJECTIVE: To define "best possible" outcomes for secondary bariatric surgery (BS). BACKGROUND: Management of poor response and of long-term complications after BS is complex and under-investigated. Indications and types of reoperations vary widely and postoperative complication rates are higher compared to primary BS. METHODS: Out of 44,884 BS performed in 18 high-volume centers from 4 continents between 06/2013-05/2019, 5,349 (12%) secondary BS cases were identified. Twenty-one outcome benchmarks were established in low-risk patients, defined as the 75th percentile of the median outcome values of centers. Benchmark cases had no previous laparotomy, diabetes, sleep apnea, cardiopathy, renal insufficiency, inflammatory bowel disease, immunosuppression, thromboembolic events, BMI> 50 kg/m2 or age> 65 years. RESULTS: The benchmark cohort included 3143 cases, mainly females (85%), aged 43.8 ±â€Š10 years, 8.4 ±â€Š5.3 years after primary BS, with a BMI 35.2 ±â€Š7 kg/m2. Main indications were insufficient weight loss (43%) and gastro-esophageal reflux disease/dysphagia (25%). 90-days postoperatively, 14.6% of benchmark patients presented ≥1 complication, mortality was 0.06% (n = 2). Significantly higher morbidity was observed in non-benchmark cases (OR 1.37) and after conversional/reversal or revisional procedures with gastrointestinal suture/stapling (OR 1.84). Benchmark cutoffs for conversional BS were ≤4.5% re-intervention, ≤8.3% re-operation 90-days postoperatively. At 2-years (IQR 1-3) 15.6% of benchmark patients required a reoperation. CONCLUSION: Secondary BS is safe, although postoperative morbidity exceeds the established benchmarks for primary BS. The excess morbidity is due to an increased risk of gastrointestinal leakage and higher need for intensive care. The considerable rate of tertiary BS warrants expertise and future research to optimize the management of non-success after BS.


Assuntos
Cirurgia Bariátrica/normas , Benchmarking/normas , Procedimentos Cirúrgicos Eletivos/normas , Laparoscopia/normas , Obesidade Mórbida/cirurgia , Adulto , Feminino , Seguimentos , Humanos , Masculino , Estudos Prospectivos , Reoperação
5.
Catheter Cardiovasc Interv ; 97(7): 1309-1317, 2021 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-32329200

RESUMO

OBJECTIVES: This study aimed to assess the impact of stent optimization by NC-balloon postdilatation (PD) during primary-PCI for STEMI with the use of coronary physiology and intracoronary imaging. METHODS: This was a prospective observational study (ClinicalTrials.gov:NCT02788396). Optical coherence tomography (OCT) and physiological measurements were performed immediately before and after PD with the operators blinded to all measurements. The index of microcirculatory resistance (IMR), coronary flow reserve (CFR) and fractional flow reserve (FFR) were measured. OCT analysis was performed for assessment of stent expansion, malapposition, in-stent plaque-thrombus prolapse (PTP) and stent-edge dissections (SED). The change in IMR before and after PD as a measure of microvascular injury was the primary objective of the study. RESULTS: Thirty-two STEMI patients undergoing primary-PCI had physiological measurements before and after PD. All patients received second-generation DES (diameter 3.1 ± 0.5 mm, length 29.9 ± 10.7 mm) and postdilatation with NC-balloons (diameter 3.6 ± 0.6 mm, inflation pressure 19.3 ± 2.0 atm). IMR (44.9 ± 25.6 vs. 48.8 ± 34.2, p = 0.26) and CFR (1.60 ± 0.89 vs. 1.58 ± 0.71, p = 0.87) did not change, while FFR increased after PD (0.91 ± 0.08 vs. 0.93 ± 0.06, p = 0.037). At an individual patient level, IMR increased in half of the cases. PD improved significantly absolute and relative stent expansion, reduced malapposition, and increased PTP. There was no difference in clinically relevant SED. CONCLUSION: In this exploratory, hypothesis-generating study, postdilatation during primary-PCI for STEMI improved stent expansion, apposition and post-PCI FFR, without a significant effect on coronary microcirculation overall. Nevertheless, IMR increased in a group of patients and larger studies are warranted to explore predictors of microcirculatory response to postdilatation.


Assuntos
Reserva Fracionada de Fluxo Miocárdico , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Angiografia Coronária , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Humanos , Microcirculação , Intervenção Coronária Percutânea/efeitos adversos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Stents , Tomografia de Coerência Óptica , Resultado do Tratamento
6.
Nephrology (Carlton) ; 26(6): 522-529, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33650168

RESUMO

AIM: Renal supportive care (RSC) programs are used to manage non-dialysis end-stage kidney disease (ESKD) patients. The aim of this study was to analyse the impact of RSC programs on hospitalization and survival outcomes in these patients. METHODS: A retrospective, single-centre observational cohort study of non-dialysis ESKD patients was undertaken. Hospitalizations and survival from eGFR≤15 ml/min was compared between patients managed in an RSC program (RSC group) and patients receiving standard conservative therapy (non-RSC group). Local databases, physician letters and electronic medical records were used for data collection. Prevalent patients from 2013 to 2017 with eGFR ≤15 ml/min were included. Cox proportion hazard testing and generalized linear modelling was undertaken to adjust for confounders. RESULTS: A total of 172 patients were included (95 RSC; 75 non-RSC). The median age was 82 years [IQR 78-85], 46% were male, the median Charlson-comorbidity Index was 5 [IQR 4-7]. The RSC group had significantly lowered haemoglobin level (102 g/L vs. 111 g/L) and fewer English-speakers (34% vs. 44%). RSC was associated with the decreased number of days in hospital per year (estimated means 46.6 days [95% CI 21-67] vs. 83.2 days [95%CI 60.5-105.8]; p = .01) and decreased number of hospital admissions per year (estimated means 5.4 [95%CI 2.1-8.8] vs. 12.3 [95%CI 8.2-16.4]; p = .01) compared with non-RSC. Median overall survival from eGFR≤15 in the entire cohort was 735 days, with no significant difference between RSC and non-RSC groups (p = .9), both unadjusted and adjusted for confounders. CONCLUSION: RSC programs can significantly decrease the number and length of hospitalizations in conservatively managed ESKD patients.


Assuntos
Hospitalização/estatística & dados numéricos , Falência Renal Crônica/mortalidade , Falência Renal Crônica/terapia , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Humanos , Masculino , Estudos Retrospectivos , Taxa de Sobrevida , Resultado do Tratamento
7.
Ophthalmic Physiol Opt ; 41(2): 365-377, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33354812

RESUMO

PURPOSE: In the UK, most referrals to the hospital eye service (HES) originate from community optometrists (CO). This audit investigates the quality of referrals, replies, and communication between CO and the HES. METHODS: Optometric referrals and replies were extracted from three practices in England. If no reply letter was found, the records were searched at each local HES unit, and additional replies or records copied. De-identified referrals, replies and records were audited by a panel against established standards to evaluate whether the referrals were necessary, accurate and directed to the appropriate professional. The referral rate (RR) and referral reply rate (RRR) were calculated. RESULTS: A total of 459 de-identified referrals were extracted. The RR ranged from 3.6%-8.7%. The proportion of referred patients who were seen in the HES unit was 63%-76%. From the CO perspective, the proportion of referrals for which they received replies ranged from 26%-49%. Adjusting the number of referrals for cases when it would be reasonable to expect an HES reply, RRR becomes 38%-62%. Patients received a copy of the reply in 3%-21% of cases. Referrals were made to the appropriate service in over 95% of cases, were judged necessary in 93%-97% and were accurate in 81%-98% of cases. The referral reply addressed the reason for the referral in 93%-97% and was meaningful in 94%-99% of cases. The most common conditions referred were glaucoma, cataract, anterior segment lesions, and neurological/ocular motor anomalies. The CO/HES dyad (pairing) in the area with the lowest average household income had the highest RR. CONCLUSIONS: In contrast with the Royal College of Ophthalmologists/College of Optometrists joint statement on sharing patient information, CO referrals often do not elicit a reply to the referring CO. Replies from the HES to COs are important for patient care, benefitting patients and clinicians, and minimising unnecessary HES appointments.


Assuntos
Serviços de Saúde Comunitária/organização & administração , Glaucoma/diagnóstico , Serviços Hospitalares Compartilhados/organização & administração , Optometristas/provisão & distribuição , Encaminhamento e Consulta/organização & administração , Comunicação , Estudos Transversais , Inglaterra
8.
Ann Surg ; 272(1): 3-23, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32404658

RESUMO

BACKGROUND: BDI is the most common serious complication of laparoscopic cholecystectomy. To address this problem, a multi-society consensus conference was held to develop evidenced-based recommendations for safe cholecystectomy and prevention of BDI. METHODS: Literature reviews were conducted for 18 key questions across 6 broad topics around cholecystectomy directed by a steering group and subject experts from 5 surgical societies (Society of Gastrointestinal and Endoscopic Surgeons, Americas Hepato-Pancreato-Biliary Association, International Hepato-Pancreato-Biliary Association, Society for Surgery of the Alimentary Tract, and European Association for Endoscopic Surgery). Evidence-based recommendations were formulated using the grading of recommendations assessment, development, and evaluation methodology. When evidence-based recommendations could not be made, expert opinion was documented. A number of recommendations for future research were also documented. Recommendations were presented at a consensus meeting in October 2018 and were voted on by an international panel of 25 experts with greater than 80% agreement considered consensus. RESULTS: Consensus was reached on 17 of 18 questions by the guideline development group and expert panel with high concordance from audience participation. Most recommendations were conditional due to low certainty of evidence. Strong recommendations were made for (1) use of intraoperative biliary imaging for uncertainty of anatomy or suspicion of biliary injury; and (2) referral of patients with confirmed or suspected BDI to an experienced surgeon/multispecialty hepatobiliary team. CONCLUSIONS: These consensus recommendations should provide guidance to surgeons, training programs, hospitals, and professional societies for strategies that have the potential to reduce BDIs and positively impact patient outcomes. Development of clinical and educational research initiatives based on these recommendations may drive further improvement in the quality of surgical care for patients undergoing cholecystectomy.


Assuntos
Ductos Biliares/lesões , Colecistectomia Laparoscópica/normas , Doença Iatrogênica/prevenção & controle , Complicações Intraoperatórias/prevenção & controle , Humanos , Fatores de Risco
9.
Catheter Cardiovasc Interv ; 96(1): E8-E16, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-31498964

RESUMO

OBJECTIVES: We sought to evaluate mortality predictors and the role of new-generation drug-eluting stents (NG-DES) in stent thrombosis (ST) management. BACKGROUND: No data are available regarding the outcome of patients with ST after interventional management that includes exclusively NG-DES. METHODS: Patients with definite ST of DES or BMS who underwent urgent/emergent angiography between 2015 and 2018 at our institution were considered for the study. After excluding patients who achieved TIMI-flow<2 after intervention or received an old-generation stent, 131 patients were included. Management classification was stent or non-stent treatment (medical management, thromboaspiration, balloon-angioplasty). Follow-up was performed to document all-cause death (ACD) and target-lesion-revascularization (TLR) that was used for censorship. RESULTS: Mode of presentation was STEMI in 88% and UA/NSTEMI in 12%. Type of ST was early, late, and very late in 11, 4, and 85%, respectively. Eighty four patients received stent and 47 non-stent treatment. After 926 ± 34 days, 21 ACDs, 7 TLRs and no cases of definite, recurrent ST were observed. Univariate predictors of in-hospital mortality were LVEF and presentation with shock or cardiac arrest. For patients discharged alive, non-stent treatment (HR 4.2, p = .01), TIMI-2 flow (HR 7.4, p = .002) and GFR < 60 mL/min (HR 3.8, p = .01) were independent predictors of ACD. The stent-treatment group had significantly better ACD-free survival after discharge, both unadjusted (p = .022) and adjusted (p = .018). CONCLUSIONS: After ST management, different predictors were observed for in-hospital mortality and mortality in patients discharged alive. The better outcome with NG-DES treatment is a novel observation, warranting further studies to elucidate if it is associated with stent-related or patient-related factors.


Assuntos
Angioplastia Coronária com Balão , Fármacos Cardiovasculares/uso terapêutico , Trombose Coronária/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Trombectomia , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Fármacos Cardiovasculares/efeitos adversos , Trombose Coronária/diagnóstico por imagem , Trombose Coronária/etiologia , Trombose Coronária/mortalidade , Inglaterra , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Alta do Paciente , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Recidiva , Sistema de Registros , Retratamento , Medição de Risco , Fatores de Risco , Trombectomia/efeitos adversos , Trombectomia/mortalidade , Fatores de Tempo , Resultado do Tratamento
10.
Surg Endosc ; 34(7): 2827-2855, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32399938

RESUMO

BACKGROUND: Bile duct injury (BDI) is the most common serious complication of laparoscopic cholecystectomy. To address this problem, a multi-society consensus conference was held to develop evidenced-based recommendations for safe cholecystectomy and prevention of BDI. METHODS: Literature reviews were conducted for 18 key questions across six broad topics around cholecystectomy directed by a steering group and subject experts from five surgical societies (SAGES, AHPBA IHPBA, SSAT, and EAES). Evidence-based recommendations were formulated using the GRADE methodology. When evidence-based recommendations could not be made, expert opinion was documented. A number of recommendations for future research were also documented. Recommendations were presented at a consensus meeting in October 2018 and were voted on by an international panel of 25 experts with greater than 80% agreement considered consensus. RESULTS: Consensus was reached on 17 of 18 questions by the Guideline Development Group (GDG) and expert panel with high concordance from audience participation. Most recommendations were conditional due to low certainty of evidence. Strong recommendations were made for (1) use of intraoperative biliary imaging for uncertainty of anatomy or suspicion of biliary injury; and (2) referral of patients with confirmed or suspected BDI to an experienced surgeon/multispecialty hepatobiliary team. CONCLUSION: These consensus recommendations should provide guidance to surgeons, training programs, hospitals, and professional societies for strategies that have the potential to reduce BDIs and positively impact patient outcomes. Development of clinical and educational research initiatives based on these recommendations may drive further improvement in the quality of surgical care for patients undergoing cholecystectomy.


Assuntos
Ductos Biliares/lesões , Colecistectomia Laparoscópica/efeitos adversos , Colecistectomia Laparoscópica/métodos , Complicações Intraoperatórias/prevenção & controle , Humanos , Complicações Intraoperatórias/etiologia , Cirurgiões
11.
World J Surg ; 44(3): 696-703, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31659411

RESUMO

BACKGROUND: Simulation-based care pathway approach (CPA) training is a novel approach in surgical education. The objective of the present study was to determine whether CPA was feasible for training surgical residents and could improve efficiency in patients' management. A common disease was chosen: acute appendicitis. METHODS: All five junior residents of our department were trained in CPA: preoperative CPA consisted in virtual patients (VPs) presenting with acute right iliac fossa pain; intraoperative CPA involved a virtual competency-based curriculum for laparoscopic appendectomy (LAPP); finally, post-operative VP were reviewed after LAPP. Thirty-eight patients undergoing appendectomy were prospectively included before (n = 21) and after (n = 17) the training. All demographic and perioperative data were prospectively collected from their medical records, and time taken from admission to management was measured. RESULTS: All residents had performed less than 10 LAPP as primary operator. Pre- and intraoperative data were comparable between pretraining and post-training patients. Times to liquid and solid diet were significantly reduced after training [7 h (2-20) vs. 4 (4-6); P = 0.004, and 17 h (4-48) vs. 6 (4-24); P = 0.005] without changing post-operative morbidity [4 (19%) vs. 0 (0); P = 0.11] and length of stay [48 h (30-264) vs. 44 (21-145); P = 0.22]. CONCLUSIONS: CPA training is feasible in abdominal surgery. In the current study, it improved patients' management in terms of earlier oral intake.


Assuntos
Apendicectomia/educação , Serviço Hospitalar de Emergência/economia , Laparoscopia/educação , Treinamento por Simulação/métodos , Adolescente , Adulto , Apendicite/cirurgia , Currículo , Feminino , Humanos , Masculino , Estudos Prospectivos
12.
Br J Cancer ; 120(2): 172-182, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30568294

RESUMO

BACKGROUND: This randomised, double-blind study compared PF-05280014 (a trastuzumab biosimilar) with reference trastuzumab (Herceptin®) sourced from the European Union (trastuzumab-EU), when each was given with paclitaxel as first-line treatment for HER2-positive metastatic breast cancer. METHODS: Between 4 April 2014 and 22 January 2016, 707 participants were randomised 1:1 to receive intravenous PF-05280014 plus paclitaxel (PF-05280014 group; n = 352) or trastuzumab-EU plus paclitaxel (trastuzumab-EU group; n = 355). PF-05280014 or trastuzumab-EU was administered weekly (first dose 4 mg/kg, subsequent doses 2 mg/kg), with the option to change to a 3-weekly regimen (6 mg/kg) from Week 33. Treatment with PF-05280014 or trastuzumab-EU could continue until disease progression. Paclitaxel (starting dose 80 mg/m2) was administered on Days 1, 8 and 15 of 28-day cycles for at least six cycles or until maximal benefit of response. The primary endpoint was objective response rate (ORR), evaluating responses achieved by Week 25 and confirmed by Week 33, based on blinded central radiology review. RESULTS: The risk ratio for ORR was 0.940 (95% CI: 0.842-1.049). The 95% CI fell within the pre-specified equivalence margin of 0.80-1.25. ORR was 62.5% (95% CI: 57.2-67.6%) in the PF-05280014 group and 66.5% (95% CI: 61.3-71.4%) in the trastuzumab-EU group. As of data cut-off on 11 January 2017 (using data up to 378 days post-randomisation), there were no notable differences between groups in progression-free survival (median: 12.16 months in the PF-05280014 group vs. 12.06 months in the trastuzumab-EU group; 1-year rate: 54% vs. 51%) or overall survival (median: not reached in either group; 1-year rate: 89.31% vs. 87.36%). Safety outcomes and immunogenicity were similar between the treatment groups. CONCLUSION: When given as first-line treatment for HER2-positive metastatic breast cancer, PF-05280014 plus paclitaxel demonstrated equivalence to trastuzumab-EU plus paclitaxel in terms of ORR. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01989676.


Assuntos
Anticorpos Monoclonais Humanizados/administração & dosagem , Neoplasias da Mama/tratamento farmacológico , Receptor ErbB-2/genética , Trastuzumab/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticorpos Monoclonais Humanizados/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Medicamentos Biossimilares , Neoplasias da Mama/genética , Neoplasias da Mama/patologia , Intervalo Livre de Doença , Método Duplo-Cego , Feminino , Humanos , Estimativa de Kaplan-Meier , Pessoa de Meia-Idade , Metástase Neoplásica , Paclitaxel/administração & dosagem , Paclitaxel/efeitos adversos , Trastuzumab/efeitos adversos , Trastuzumab/química
13.
Surg Endosc ; 33(1): 1-7, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30421077

RESUMO

INTRODUCTION: Closed social media groups (CSMG), including closed Facebook® groups, are online communities providing physicians with platforms to collaborate privately via text, images, videos, and live streaming in real time and optimize patient care. CSMG platforms represent a novel paradigm in online learning and education, so it is imperative to ensure that the public and patients trust the physicians using these platforms. Informed consent is an essential aspect of establishing this trust. With the launch of several of its own CSMG, Society of Gastrointestinal and Endoscopic Surgeons (SAGES) sought to define its position on CSMG platforms and provide an informed consent template for educating and protecting patients, surgeons, and institutions. METHODS: A review of the literature (2012-2018) discussing the informed consent process for posting clinical scenarios, photography, and/or videography on social media was performed. Pertinent articles and exemplary legal counsel-approved CSMG policies and informed consent forms were reviewed by members of the SAGES Facebook® Task Force. RESULTS: Eleven articles and two institutional CSMG policies discussing key components of the informed consent process, including patient transparency and confidentiality, provider-patient partnerships, ethics, and education were included. Using this information and expert opinion, a SAGES-approved statement and informed consent template were formulated. CONCLUSIONS: SAGES endorses the professional use of medical and surgical CSMG platforms for education, patient care optimization, and dissemination of clinical information. Despite the growing use of social media as an integral tool for surgical practice and education, issues of informed consent still exist and remain the responsibility of the physician contributor. Responsible, ethical, and compliant use of CSMG platforms is essential. Surgeons and patients embracing CSMG for quality improvement and optimized outcomes should be legally protected. SAGES foresees the use of this type of platform continuing to grow.


Assuntos
Procedimentos Cirúrgicos do Sistema Digestório/educação , Educação Médica Continuada/métodos , Endoscopia/educação , Consentimento Livre e Esclarecido , Privacidade , Encaminhamento e Consulta/organização & administração , Mídias Sociais , Sociedades Médicas , Confidencialidade , Humanos , Cirurgiões
14.
Ann Surg ; 267(1): 26-34, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28562397

RESUMO

: A workshop on "Simulation Research in Gastrointestinal and Urologic Care: Challenges and Opportunities" was held at the National Institutes of Health in June 2016. The purpose of the workshop was to examine the extent to which simulation approaches have been used by skilled proceduralists (not trainees) caring for patients with gastrointestinal and urologic diseases. The current status of research findings in the use and effectiveness of simulation applications was reviewed, and numerous knowledge gaps and research needs were identified by the faculty and the attendees. The paradigm of "deliberate practice," rather than mere repetition, and the value of coaching by experts was stressed by those who have adopted simulation in music and sports. Models that are most useful for the adoption of simulation by expert clinicians have yet to be fully validated. Initial studies on the impact of simulation on safety and error reduction have demonstrated its value in the training domain, but the role of simulation as a strategy for increased procedural safety remains uncertain in the world of the expert practitioner. Although the basic requirements for experienced physicians to acquire new skills have been explored, the widespread availability of such resources is an unrealized goal, and there is a need for well-designed outcome studies to establish the role of simulation in improving the quality of health care.


Assuntos
Bioengenharia/educação , Pesquisa Biomédica/educação , Simulação por Computador , Educação Médica/métodos , National Institute of Biomedical Imaging and Bioengineering (U.S.) , National Institute of Diabetes and Digestive and Kidney Diseases (U.S.) , Docentes , Humanos , Estados Unidos
15.
J Surg Res ; 223: 149-154, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29433867

RESUMO

BACKGROUND: Academic research is an integral part of general surgery training. Despite the recent research curriculum requirements of the Accreditation Council for Graduate Medical Education, there is perceived lack of research structure for residents. The aim of this study was to identify research opportunities, structure, and academic outputs during general surgical United States (US) residency. METHODS: A Web-based review of all accredited general surgery US residency programs was undertaken. Individual websites were reviewed for resident research duration, type, and structure. Research outputs, departmental projects, and availability of faculty supervisors were also identified. RESULTS: Data were available for 242 general surgery residency programs of which 137 (56.6%) offer dedicated research years, ranging from 1 to 4 years, and 30 (12.4%) programs mandate such time as required. One hundred forty-two (58.7%) programs mentioned opportunities in clinical research, 129 (53.3%) in basic sciences, 29 (12.0%) in health services and outcomes-based research, and 15 (6.2%) in education. Advanced degrees were mentioned by 38 (15.7%) programs, the majority being Master of Public Health, Master of Business Administration, or Doctor of Philosophy. Nineteen (7.9%) programs mentioned research structure, mostly qualitative in description. Thirty-four (14.0%) programs provided examples of resident presentations or publications, and 25 (10.3%) mentioned a resident research day. One hundred ninety-nine (82.2%) programs offered a list of faculty supervisors and 129 (53.3%) listed examples of department research projects. CONCLUSIONS: Although research opportunities are ample within surgical US residency training, programs should consider the opportunity to offer varied types of research, with the potential to pursue an advanced degree. Finally, guidelines should be developed with regard to resident research structure, process, and outcomes.


Assuntos
Pesquisa Biomédica , Cirurgia Geral/educação , Internet , Internato e Residência , Humanos
16.
Eur J Vasc Endovasc Surg ; 56(4): 583-590, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30131277

RESUMO

OBJECTIVE/BACKGROUND: This study aimed to determine the cost-effectiveness of a PROficiency based StePwise Endovascular Curricular Training (PROSPECT) program, including e-learning and hands on virtual reality simulation. METHODS: A prospective, single blinded, randomised controlled trial (RCT) was carried out to evaluate the impact of a PROSPECT training program on real life operative performance. Under supervision, all subjects performed two endovascular interventions on patients with symptomatic iliac and/or superficial femoral artery stenosis. Primary outcomes were technical performance (Global Rating Scale, Examiner Checklist), operative metrics, and patient outcomes, adjusted for case difficulty and the trainee's experience. Additionally, an analysis of costs and savings related to implementation of this endovascular training program was performed. Thirty-two general surgery trainees were randomised into three groups: group 1 (n = 11) received e-learning and simulation training (PROSPECT program); group 2 (n = 10) only had access to e-learning; group 3 (n = 11) did not receive supplementary education besides clinical training. Developmental cost, implementation cost, training time cost, and the operational cost of PROSPECT were determined. Time spent studying and practicing was converted to indirect saving of operating time. The costs of logistics, faculty time supervising simulation sessions, and 30 day complication rates were registered. Sensitivity analysis was performed to assess the robustness of the results. RESULTS: Fifty-eight peripheral endovascular interventions, performed by 29 surgical trainees (three dropouts) were included in this RCT from October 2014 to February 2016. Annual costs from the perspective of the hospital were €6589 for curriculum design, €31,484 for implementation, and €1143 in operational costs. Per trainee, simulation based training until proficiency cost €3806. In comparison, if endovascular proficiency levels were obtained with conventional training only, this may have cost €5001 per trainee. CONCLUSION: Simulation based training in endovascular procedures may be cost saving, because training occurs outside the angiosuite. It is possible that cost savings are underestimated as, in contrast to the literature, prevented costs related to complications could not be defined.


Assuntos
Competência Clínica , Simulação por Computador , Procedimentos Endovasculares/educação , Ensino , Instrução por Computador , Currículo , Humanos , Duração da Cirurgia , Estudos Prospectivos
17.
Surg Endosc ; 32(7): 3041-3045, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29313125

RESUMO

BACKGROUND: Small seed grants strongly impact academic careers, result in future funding, and lead to increased involvement in surgical societies. We hypothesize that, in accordance with the SAGES Research and Career Development committee mission, there has been a shift in grant support from senior faculty to residents and junior faculty. We hypothesize that these junior physician-researchers are subsequently remaining involved with SAGES and advancing within their academic institutions. METHODS: All current and previous SAGES grant recipients were surveyed through Survey Monkey™. Questions included current academic status and status at time of grant, ensuing funding, publication and presentation of grant, and impact on career. Results were verified through a Medline query. SAGES database was examined for involvement within the society. Respondent data were compared to 2009 data. RESULTS: One hundred and ninety four grants were awarded to 167 recipients. Of those, 75 investigators responded for a response rate 44.9%. 32% were trainees, 43% assistant professors, 16% associate professors, 3% full professors, 3% professors with tenure, and 3% in private practice. This is a shift from 2009 data with a considerable increase in funding of trainees by 19% and assistant professors by 10% and a decrease in funding of associate professors by 5% and professors by 10%. 41% of responders who were awarded the grant as assistant or associate professors had advanced to full professor and 99% were currently in academic medicine. Eighty-two percent indicated that they had completed their project and 93% believed that the award helped their career. All responders remained active in SAGES. CONCLUSION: SAGES has chosen to reallocate an increased percentage of grant money to more junior faculty members and residents. It appears that these grants may play a role in keeping recipients interested in the academic surgical realm and involved in the society while simultaneously helping them advance in faculty rank.


Assuntos
Docentes de Medicina/economia , Organização do Financiamento/economia , Gastroenterologia , Editoração/economia , Sociedades Médicas , Cirurgiões/economia , Humanos , Estados Unidos
18.
Surg Endosc ; 32(5): 2175-2183, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29556977

RESUMO

BACKGROUND: Laparoscopic cholecystectomy (LC), one of the most commonly performed surgical procedures, remains associated with significant major morbidity including bile leak and bile duct injury (BDI). The effect of changes in practice over time, and of interventions to improve patient safety, on morbidity rates is not well understood. The aim of this review was to describe current incidence rates and trends for BDI and other complications during and after LC, and to identify risk factors and preventative measures associated with morbidity and BDI. METHODS: PubMed, MEDLINE, and Web of Science database searches and data extraction were conducted for studies which reported individual complications and complication rates following laparoscopic cholecystectomy in a representative population. Outcomes data were pooled. Meta-regression analysis was performed to assess factors associated with conversion, morbidity, and BDI rates. RESULTS: One hundred and fifty-one studies reporting outcomes for 505,292 patients were included in the final quantitative synthesis. Overall morbidity, BDI, and mortality rates were 1.6-5.3%, 0.32-0.52%, and 0.08-0.14%, respectively. Reported BDI rates reduced over time (1994-1999: 0.69(0.52-0.84)% versus 2010-2015 0.22(0.02-0.40)%, p = 0.011). Meta-regression analysis suggested higher conversion rates in developed versus developing countries (4.7 vs. 3.4%), though a greater degree of reporting bias was present in these studies, with no other significant associations identified. CONCLUSIONS: Overall, trends suggest a reduction in BDI over time with unchanged morbidity and mortality rates. However, data and reporting are heterogenous. Establishment of international outcomes registries should be considered.


Assuntos
Ductos Biliares/cirurgia , Colecistectomia Laparoscópica , Fidelidade a Diretrizes/normas , Segurança do Paciente/normas , Complicações Pós-Operatórias , Ductos Biliares/lesões , Colecistectomia Laparoscópica/efeitos adversos , Colecistectomia Laparoscópica/métodos , Análise de Dados , Bases de Dados Factuais , Humanos , Complicações Pós-Operatórias/cirurgia , Guias de Prática Clínica como Assunto
19.
J Clin Gastroenterol ; 2017 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-28562441

RESUMO

A workshop on ''Simulation Research in Gastrointestinal and Urologic Care: Challenges and Opportunities'' was held at the National Institutes of Health in June 2016. The purpose of the workshop was to examine the extent to which simulation approaches have been used by skilled proceduralists (not trainees) caring for patients with gastrointestinal and urologic diseases. The current status of research findings in the use and effectiveness of simulation applications was reviewed, and numerous knowledge gaps and research needs were identified by the faculty and the attendees. The paradigm of ''deliberate practice,'' rather than mere repetition, and the value of coaching by experts was stressed by those who have adopted simulation in music and sports. Models that are most useful for the adoption of simulation by expert clinicians have yet to be fully validated. Initial studies on the impact of simulation on safety and error reduction have demonstrated its value in the training domain, but the role of simulation as a strategy for increased procedural safety remains uncertain in the world of the expert practitioner. Although the basic requirements for experienced physicians to acquire new skills have been explored, the widespread availability of such resources is an unrealized goal, and there is a need for well-designed outcome studies to establish the role of simulation in improving the quality of health care.

20.
Surg Endosc ; 31(6): 2474-2482, 2017 06.
Artigo em Inglês | MEDLINE | ID: mdl-27655379

RESUMO

BACKGROUND: Substantial evidence in the scientific literature supports the use of simulation for surgical education. However, curricula lack for complex laparoscopic procedures in gynecology. The objective was to evaluate the validity of a program that reproduces key specific components of a laparoscopic hysterectomy (LH) procedure until colpotomy on a virtual reality (VR) simulator and to develop an evidence-based and stepwise training curriculum. METHODS: This prospective cohort study was conducted in a Marseille teaching hospital. Forty participants were enrolled and were divided into experienced (senior surgeons who had performed more than 100 LH; n = 8), intermediate (surgical trainees who had performed 2-10 LH; n = 8) and inexperienced (n = 24) groups. Baselines were assessed on a validated basic task. Participants were tested for the LH procedure on a high-fidelity VR simulator. Validity evidence was proposed as the ability to differentiate between the three levels of experience. Inexperienced subjects performed ten repetitions for learning curve analysis. Proficiency measures were based on experienced surgeons' performances. Outcome measures were simulator-derived metrics and Objective Structured Assessment of Technical Skills (OSATS) scores. RESULTS: Quantitative analysis found significant inter-group differences between experienced intermediate and inexperienced groups for time (1369, 2385 and 3370 s; p < 0.001), number of movements (2033, 3195 and 4056; p = 0.001), path length (3390, 4526 and 5749 cm; p = 0.002), idle time (357, 654 and 747 s; p = 0.001), respect for tissue (24, 40 and 84; p = 0.01) and number of bladder injuries (0.13, 0 and 4.27; p < 0.001). Learning curves plateaued at the 2nd to 6th repetition. Further qualitative analysis found significant inter-group OSATS score differences at first repetition (22, 15 and 8, respectively; p < 0.001) and second repetition (25.5, 19.5 and 14; p < 0.001). CONCLUSIONS: The VR program for LH accrued validity evidence and allowed the development of a training curriculum using a structured scientific methodology.


Assuntos
Educação Médica Continuada/métodos , Histerectomia/educação , Laparoscopia/educação , Curva de Aprendizado , Realidade Virtual , Adulto , Competência Clínica , Currículo/normas , Prática Clínica Baseada em Evidências , Feminino , Ginecologia/educação , Humanos , Histerectomia/métodos , Masculino , Pessoa de Meia-Idade , Desenvolvimento de Programas , Estudos Prospectivos
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