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1.
Int J Surg ; 109(5): 1489-1496, 2023 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-37132189

RESUMO

BACKGROUND: Standards for reporting surgical adverse events (AEs) vary widely within the scientific literature. Failure to adequately capture AEs hinders efforts to measure the safety of healthcare delivery and improve the quality of care. The aim of the present study is to assess the prevalence and typology of perioperative AE reporting guidelines among surgery and anesthesiology journals. MATERIALS AND METHODS: In November 2021, three independent reviewers queried journal lists from the SCImago Journal & Country Rank (SJR) portal (www.scimagojr.com), a bibliometric indicator database for surgery and anesthesiology academic journals. Journal characteristics were summarized using SCImago, a bibliometric indicator database extracted from Scopus journal data. Quartile 1 (Q1) was considered the top quartile and Q4 bottom quartile based on the journal impact factor. Journal author guidelines were collected to determine whether AE reporting recommendations were included and, if so, the preferred reporting procedures. RESULTS: Of 1409 journals queried, 655 (46.5%) recommended surgical AE reporting. Journals most likely to recommend AE reporting were: by category surgery (59.1%), urology (53.3%), and anesthesia (52.3%); in top SJR quartiles (i.e. more influential); by region, based in Western Europe (49.8%), North America (49.3%), and the Middle East (48.3%). CONCLUSIONS: Surgery and anesthesiology journals do not consistently require or provide recommendations on perioperative AE reporting. Journal guidelines regarding AE reporting should be standardized and are needed to improve the quality of surgical AE reporting with the ultimate goal of improving patient morbidity and mortality.


Assuntos
Anestesiologia , Humanos , Bibliometria , Fator de Impacto de Revistas , Europa (Continente) , Oriente Médio
2.
J Clin Med ; 12(7)2023 Mar 28.
Artigo em Inglês | MEDLINE | ID: mdl-37048631

RESUMO

BACKGROUND: Intraoperative adverse events (iAEs) are associated with adverse postoperative outcomes and cause a significant healthcare burden. However, a critical appraisal of iAEs is lacking. Considering the details of iAEs could benefit postoperative care. We comprehensively analyzed iAEs in a large series including all types of operations and their relation to postoperative complications. METHODS: All patients enrolled in the multicenter ClassIntra® validation study (NCT03009929) were included in this analysis. The surgical and anesthesia team prospectively recorded all iAEs. Two researchers, blinded to each other's ratings, appraised all recorded iAEs according to their origin into four categories: surgery, anesthesia, organization, or other, including subcategories such as organ injury, arrhythmia, or instrument failure. They further descriptively analyzed subcategories of all iAEs. Postoperative complications were assessed using the Comprehensive Complication Index (CCI®), a weighted sum of all postoperative complications according to the Clavien-Dindo classification. The association of iAE origins in addition to the severity grade of ClassIntra® on CCI® was assessed with a multivariable mixed-effects generalized linear regression analysis. RESULTS: Of 2520 included patients, 778 iAEs were recorded in 610 patients. The origin was surgical in 420 (54%), anesthesia in 283 (36%), organizational in 34 (4%), and other in 41 (5%) events. Bleeding (n = 217, 28%), hypotension (n = 118, 15%), and organ injury (n = 98, 13%) were the three most frequent subcategories in surgery and anesthesia, respectively. In the multivariable mixed-effect analysis, no significant association between the origin and CCI® was observed. CONCLUSION: Analyzing the type and origin of an iAE offers individualized and contextualized information. This detailed descriptive information can be used for targeted surveillance of intra- and postoperative care, even though the overall predictive value for postoperative events was not improved by adding the origin in addition to the severity grade.

3.
Ann Surg ; 278(5): e981-e987, 2023 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-36727743

RESUMO

OBJECTIVE: To assess the discrepancy between perioperative complications, prospectively recorded during a cohort study versus retrospectively from health records. BACKGROUND: Perioperative adverse events are relevant for patient outcome, but incomplete reporting is common. METHODS: Two physicians independently recorded all intraoperative adverse events according to ClassIntra and all postoperative complications according to the Clavien-Dindo classification based on all available health records. These retrospective assessments were compared with the number and severity of those prospectively assessed in the same patients during their inclusion in 1 center of a prospective multicenter cohort study. RESULTS: Interrater agreement between both physicians for retrospective recording was high [intraclass correlation coefficient: 0.89 (95% CI, 0.86, 0.91) for intraoperative and 0.88 (95% CI, 0.85, 0.90) for postoperative complications]. In 320 patients, the incidence rate was higher retrospectively than prospectively for any intraoperative complication (incidence rate ratio: 1.79; 95% CI, 1.50, 2.13) and for any postoperative complication (incidence rate ratio: 2.21; 95% CI, 1.90, 2.56). In 71 patients, the severity of the most severe intraoperative complication was higher in the retrospective than in the prospective data collection, whereas in 69 the grading was lower. In 106 patients, the severity of the most severe postoperative complication was higher in the retrospective than in the prospective data collection, whereas in 19 the grading was lower. CONCLUSIONS: There is a noticeable discrepancy in the number and severity of reported perioperative complications between these 2 data collection methods. On the basis of the double-blinded assessment of 2 independent raters, our study renders prospective underreporting more likely than retrospective overreporting.


Assuntos
Complicações Intraoperatórias , Complicações Pós-Operatórias , Humanos , Estudos Retrospectivos , Estudos de Coortes , Estudos Prospectivos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Intraoperatórias/epidemiologia
4.
Surgery ; 172(6): 1875-1876, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36283842
6.
BMJ Open ; 12(6): e059919, 2022 06 10.
Artigo em Inglês | MEDLINE | ID: mdl-35688587

RESUMO

INTRODUCTION: The use of Bispectral Index (BIS) monitors for assessing depth of sedation has led to a reduction in both the incidence of awareness and anaesthetic consumption in total intravenous anaesthesia. However, these monitors are vulnerable to artefacts. In addition to the processed number, the raw frontal electroencephalogram (EEG) can be displayed as a curve on the same monitor. Anaesthesia practitioners can learn to interpret the EEG in a short tutorial and may be quicker and more accurate thanBIS in assessing anaesthesia depth by recognising EEG patterns. We hypothesise that quality of recovery (QoR) in patients undergoing laparoscopic surgery is better, if propofol is titrated by anaesthesia practitioners able to interpret the EEG. METHODS AND ANALYSIS: This is a multicentre, double-blind (patients and outcome assessors) randomised controlled trial taking place in four Swiss hospitals. Patients aged 18 years or older undergoing laparoscopic procedures with general anaesthesia using propofol and anaesthesia practitioners with more than 2 years experience will be eligible. The primary study outcome is the difference in QoR 24 hours after surgery. Secondary outcomes are propofol consumption, incidence of postoperative nausea and vomiting (PONV) and postoperative delirium.QoR and propofol consumption are compared between both groups using a two-sample t-test. Fisher's exact test is used to compare the incidences of PONV and delirium. A total of 200 anaesthesia practitioners (and 200 patients) are required to have an 80% chance of detecting the minimum relevant difference for the QoR-15 as significant at the 5% level assuming a SD of 20. ETHICS AND DISSEMINATION: Ethical approval has been obtained from all responsible ethics committees (lead committee: Ethikkommission Nordwest- und Zentralschweiz, 16 January 2021). The findings of the trial will be published in a peer-reviewed journal, presented at international conferences, and may lead to a change in titrating propofol in clinical practice. TRIAL REGISTRATION NUMBER: www. CLINICALTRIALS: gov:NCT04105660.


Assuntos
Delírio , Laparoscopia , Propofol , Anestesia Geral/efeitos adversos , Delírio/etiologia , Eletroencefalografia , Humanos , Laparoscopia/efeitos adversos , Estudos Multicêntricos como Assunto , Náusea e Vômito Pós-Operatórios/induzido quimicamente , Propofol/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto
7.
Swiss Med Wkly ; 152: w30135, 2022 03 14.
Artigo em Inglês | MEDLINE | ID: mdl-35380180

RESUMO

AIMS OF THE STUDY: Multimorbidity is a growing global health problem, resulting in an increased perioperative risk for surgical patients. Data on both the prevalence of multimorbidity and its impact on perioperative outcome are limited. The American Society of Anesthesiologists (ASA) classification uses only the single most severe systemic disease to define the ASA class and ignores multimorbidity. This study aimed to assess the number and type of all anaesthesia-relevant comorbidities and to analyse their impact on outcome and hospital costs. METHODS: This cohort study is nested in the ClassIntra® validation study and includes only patients enrolled at the University Hospital of Basel. Approximately 30 patients per surgical discipline undergoing any type of in-hospital surgery were followed up until hospital discharge to record all intra- and postoperative adverse events. In addition, the type and severity of all perioperatively relevant comorbidities were extracted from the electronic medical record according to a predefined list. The primary endpoint was the number of all anaesthesia-relevant comorbidities by ASA class. Using structural equation models, the direct and indirect effects of comorbidities on costs were estimated after adjustment for the ASA class and further relevant confounders and mediators. RESULTS: Of 320 enrolled patients, 27 were ASA I (8%), 150 ASA II (47%), 116 ASA III (36%) and 27 ASA IV (8%). The median number of comorbidities per patient was 5 (range 0-18), this number significantly increasing with higher ASA class: 1 comorbidity (95% CI 0.0-2.0) in ASA I, 4 comorbidities (3.8-4.2) in ASA II, 9 (8.1-9.9) in ASA III and 12 (10-14) in ASA IV patients. Independent of ASA class, each additional comorbidity increased hospital costs by EUR 1,198 (95% CI 288-2108) with almost identical proportions of direct and indirect effects. The number of anaesthesia-relevant comorbidities also increased postoperative complications and postoperative length of hospital stay. CONCLUSIONS: Multimorbidity in perioperative patients is highly prevalent and has a relevant impact on hospital costs, independent of the ASA class. Incorporating multimorbidity into the ASA classification might be warranted to improve its predictive ability and support adequate reimbursement.


Assuntos
Complicações Pós-Operatórias , Estudos de Coortes , Comorbidade , Humanos , Tempo de Internação , Complicações Pós-Operatórias/epidemiologia , Período Pós-Operatório , Estudos Retrospectivos
8.
Surgery ; 171(6): 1570-1579, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35177252

RESUMO

BACKGROUND: Intraoperative adverse events (iAEs) are frequent in visceral surgery, but severity and related postoperative outcome are poorly investigated. A novel classification of intraoperative adverse events, ClassIntra, includes surgical and anesthesiologic intraoperative adverse events using 5 severity grades and showed a high criterion and construct validity across all surgical disciplines. ClassIntra was studied for reproducibility in a prespecified group of patients undergoing visceral surgery. METHODS: iAEs were recorded in all patients enrolled in the ClassIntra validation study (NCT03009929). Postoperative complications were assessed daily according to the Clavien-Dindo classification. Results of the visceral group were compared with those of the non-visceral group and the full cohort. The risk-adjusted association between most severe intra and postoperative complications was investigated in a multivariable proportional odds model. Second, risk-adjusted association between ClassIntra grade and Comprehensive Complication Index, and postoperative length of stay was investigated. RESULTS: In total, 1,270 out of 2,520 patients (50%) underwent visceral surgery. Compared with the nonvisceral group and full cohort, more intraoperative (337/1270 [27%] vs 273/1250 [22%] vs 610/2520 [24%] patients) and postoperative complications (457/1270 [36%] vs 381/1250 [30%] vs 838/2520 [33%] patients) occurred. The risk for a more severe postoperative complication increased with each ClassIntra grade (odds ratio [95% confidence interval] I vs 0 1.10 [0.73 to 1.66], II vs 0 1.69 [1.10 to 2.60], III vs 0 2.31 [1.21 to 4.41], IV vs 0 2.35 [0.69 to 8.06]). Accordingly, CCI and postoperative length of stay increased with each ClassIntra grade in the visceral group, comparable with the nonvisceral and full cohort. CONCLUSION: Consistent results for the association of intraoperative adverse events and patient outcomes render ClassIntra a valuable instrument in visceral surgery.


Assuntos
Procedimentos Cirúrgicos do Sistema Digestório , Complicações Pós-Operatórias , Estudos Clínicos como Assunto , Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , Humanos , Complicações Intraoperatórias/epidemiologia , Complicações Intraoperatórias/etiologia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Período Pós-Operatório , Reprodutibilidade dos Testes , Estudos Retrospectivos
9.
Med Teach ; 44(6): 672-678, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35021934

RESUMO

INTRODUCTION: As competency-based curricula get increasing attention in postgraduate medical education, Entrustable Professional Activities (EPAs) are gaining in popularity. The aim of this survey was to determine the use of EPAs in anesthesiology training programs across Europe and North America. METHODS: A survey was developed and distributed to anesthesiology residency training program directors in Switzerland, Germany, Austria, Netherlands, USA and Canada. A convergent design mixed-methods approach was used to analyze both quantitative and qualitative data. RESULTS: The survey response rate was 38% (108 of 284). Seven percent of respondents used EPAs for making entrustment decisions. Fifty-three percent of institutions have not implemented any specific system to make such decisions. The majority of respondents agree that EPAs should become an integral part of the training of residents in anesthesiology as they are universal and easy to use. CONCLUSION: Although recommended by several national societies, EPAs are used in few anesthesiology training programs. Over half of responding programs have no specific system for making entrustment decisions. Although several countries are adopting or planning to adopt EPAs and national societies are recommending the use of EPAs as a framework in their competency-based programs, few are yet using these to make "competence" decisions.


Assuntos
Anestesiologia , Internato e Residência , Anestesiologia/educação , Competência Clínica , Educação Baseada em Competências/métodos , Currículo , Humanos , Inquéritos e Questionários
10.
Trials ; 22(1): 744, 2021 Oct 26.
Artigo em Inglês | MEDLINE | ID: mdl-34702332

RESUMO

BACKGROUND: Muscle relaxants are routinely used during anesthesia to facilitate endotracheal intubation and to optimize surgical conditions. However, controversy remains about the required depth of neuromuscular block (NMB) needed for optimal surgical working conditions and how this relates to other outcomes. For instance, a deep neuromuscular block yields superior surgical working conditions compared to a standard NMB in laparoscopic surgery, however, a robust association to other (safety) outcomes has not yet been established. METHODS: Trial design: an international multicenter randomized controlled double-blind strategy trial. Trial population: 922 patients planned for elective, laparoscopic or robotic, abdominal surgery. INTERVENTION: Patients will be randomized to a deep NMB (post-tetanic count 1-2 twitches) or standard care (single-dose muscle relaxant administration at induction and repeated only if warranted by surgical team). Main trial endpoints: Primary endpoint is the difference in incidence of intraoperative adverse events during laparoscopic surgery graded according to ClassIntra® classification (i.e., ClassIntra® grade ≥ 2) between both groups. Secondary endpoints include the surgical working conditions, 30-day postoperative complications, and patients' quality of recovery. DISCUSSION: This trial was designed to analyze the effect of deep neuromuscular block compared to standard neuromuscular block on intra- and postoperative adverse events in patients undergoing laparoscopic surgery. TRIAL REGISTRATION: ClinicalTrials.gov NCT04124757 (EURO-RELAX); registration URL: https://clinicaltrials.gov/ct2/show/NCT04124757 , registered on October 11th, 2019.


Assuntos
Laparoscopia , Bloqueio Neuromuscular , Método Duplo-Cego , Humanos , Laparoscopia/efeitos adversos , Bloqueio Neuromuscular/efeitos adversos
11.
Swiss Med Wkly ; 151: w20550, 2021 08 02.
Artigo em Inglês | MEDLINE | ID: mdl-34375986

RESUMO

OBJECTIVES: Patients with severe COVID-19 may be at risk of longer term sequelae. Long-term clinical, immunological, pulmonary and radiological outcomes of patients treated with anti-inflammatory drugs are lacking. METHODS: In this single-centre prospective cohort study, we assessed 90-day clinical, immunological, pulmonary and radiological outcomes of hospitalised patients with severe COVID-19 treated with tocilizumab from March 2020 to May 2020. Criteria for tocilizumab administration were oxygen saturation <93%, respiratory rate >30/min, C-reactive protein levels >75 mg/l, extensive area of ground-glass opacities or progression on computed tomography (CT). Descriptive analyses were performed using StataIC 16. RESULTS: Between March 2020 and May 2020, 50 (27%) of 186 hospitalised patients had severe COVID-19 and were treated with tocilizumab. Of these, 52% were hospitalised on the intensive care unit (ICU) and 12% died. Eleven (22%) patients developed at least one microbiologically confirmed super-infection, of which 91% occurred on ICU. Median duration of hospitalisation was 15 days (interquartile range [IQR] 10–24) with 24 days (IQR 14–32) in ICU patients and 10 days (IQR 7–15) in non-ICU patients. At day 90, 41 of 44 survivors (93%) were outpatients. No long-term adverse events or late-onset infections were identified after acute hospital care. High SARS-CoV-2 antibody titres were found in all but one patient, who was pretreated with rituximab. Pulmonary function tests showed no obstructive patterns, but restrictive patterns in two (5.7%) and impaired diffusion capacities for carbon monoxide in 11 (31%) of 35 patients, which predominated in prior ICU patients. Twenty-one of 35 (60%) CT-scans at day 90 showed residual abnormalities, with similar distributions between prior ICU and non-ICU patients. CONCLUSIONS: In this cohort of severe COVID-19 patients, no tocilizumab-related long-term adverse events or late-onset infections were identified. Although chest CT abnormalities were highly prevalent at day 90, the majority of patients showed normal lung function. TRIAL REGISTRATION: ClinicalTrials.gov NCT04351503.


Assuntos
Tratamento Farmacológico da COVID-19 , Anticorpos Monoclonais Humanizados , Estudos de Coortes , Humanos , Estudos Prospectivos , SARS-CoV-2
12.
Klin Monbl Augenheilkd ; 238(4): 510-520, 2021 Apr.
Artigo em Alemão | MEDLINE | ID: mdl-33930927

RESUMO

BACKGROUND: To the best of our knowledge, there is no validated classification to assess intraoperative adverse events (iAEs) in ophthalmic surgery. ClassIntra is a newly developed classification for surgery- and anaesthesia-related iAEs that has been recently validated in various surgical disciplines, but not in ophthalmic surgery. We aim to assess the validity and practicability of ClassIntra in patients undergoing ophthalmic surgery. METHODS: A consecutive sample of in-hospital patients undergoing any type of ophthalmic surgery was included in this single-centre prospective cohort study. iAEs were classified using ClassIntra, consisting of 5 severity grades according to the symptoms of the patient and the required treatment. All patients were followed for two weeks to record all postoperative adverse events according to Clavien-Dindo. The primary endpoint was the risk-adjusted association between the most severe iAE and the weighted sum of all postoperative adverse events within the two-week follow-up using the Comprehensive Complication Index (CCI). In addition, ophthalmologists and anaesthesiologists were asked to complete an online survey assessing the severity of iAEs for 10 fictitious clinical case scenarios. Reliability was assessed by comparing the clinicians' ratings to the prespecified benchmark rating of the study team. RESULTS: In this study, 100 in-hospital patients with an average age of 64 years (SD 15) were included. The majority of all patients were ASA II (n = 53, 53%) or III (n = 42, 42%). Thirty-two iAEs were recorded in 22 patients (17 grade I, 12 grade II, 3 grade III). Ninety-four postoperative adverse events occurred in 50 patients (44 grade I, 36 grade II, 14 grade IIIa). We found a mean difference in CCI of 2,1 (95% confidence interval [CI] - 2,5 to 6,8) per one unit increase in severity grades of ClassIntra. Fifty ophthalmologists and anaesthesiologists completed the online survey (response rate 54%). The intraclass correlation coefficient was 0,79 (95% CI 0,64 to 0,94). CONCLUSIONS: The application of ClassIntra during daily routine in ophthalmic surgery showed the usefulness and practicability of this classification for the standardised assessment of intraoperative adverse events. Although construct validity could not be demonstrated, the good reliability in the survey's rating underlines the criterion validity of this newly developed classification in ophthalmic surgery.


Assuntos
Hospitais , Complicações Intraoperatórias , Humanos , Complicações Intraoperatórias/epidemiologia , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Período Pós-Operatório , Estudos Prospectivos , Reprodutibilidade dos Testes
13.
Eur J Anaesthesiol ; 38(7): 751-757, 2021 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-33259453

RESUMO

BACKGROUND: Ryanodine receptor type 1 (RYR1) sequence variants are pathogenic for malignant hyperthermia. Variant carriers have a subtle increase in resting myoplasmic calcium concentration compared with nonaffected individuals, but whether this has metabolic effects in daily life is unknown. OBJECTIVES: We analysed the potential effect of malignant hyperthermia-pathogenic RYR1 sequence variants on BMI as a single factor. Due to the heterogeneity of genetic variants predisposing to malignant hyperthermia, and to incomplete information about their regional distribution, we describe the prevalence of RYR1 variants in our population. DESIGN: A retrospective cohort study. SETTING: A single University hospital. PATIENTS: Patients from malignant hyperthermia families with pathogenic RYR1 sequence variants were selected if BMI was available. OUTCOME MEASURES: BMI values were compared amongst malignant hyperthermia susceptible (MHS) and malignant hyperthermia-negative individuals using hierarchical multivariable analyses adjusted for age and sex and considering family clustering. Variant prevalence was calculated. RESULTS: The study included 281 individuals from 42 unrelated malignant hyperthermia families, 109 of whom were MHS and carriers of the familial RYR1 sequence variants. Median [IQR] BMI in MHS individuals with pathogenic RYR1 variants was 22.5 kg m-2 [21.3 to 25.6 kg m-2]. In malignant hyperthermia-negative individuals without variants, median BMI was 23.4 kg m-2 [21.0 to 26.3 kg m-2]. Using multivariable regression adjusted for age and sex, the mean difference was -0.73 (95% CI -1.51 to 0.05). No carrier of a pathogenic RYR1 sequence variant was found to have BMI higher than 30 kg m-2. Only 10 RYR1 variants from the list of the European MH Group were found in our cohort, the most common being p.Val2168Met (39% of families), p.Arg2336His (24%) and p.Arg614Cys (12%). CONCLUSION: The observed tendency towards lower BMI values in carriers of malignant hyperthermia-pathogenic RYR1 sequence variants points to a possible protective effect on obesity. This study confirms regional differences of the prevalence of malignant hyperthermia-pathogenic RYR1 sequence variants, with just three variants covering 75% of Swiss MHS families. TRIAL REGISTRATION: This manuscript is based on a retrospective analysis.


Assuntos
Hipertermia Maligna , Canal de Liberação de Cálcio do Receptor de Rianodina , Índice de Massa Corporal , Estudos de Coortes , Humanos , Hipertermia , Hipertermia Maligna/diagnóstico , Hipertermia Maligna/epidemiologia , Hipertermia Maligna/genética , Mutação , Estudos Retrospectivos , Canal de Liberação de Cálcio do Receptor de Rianodina/genética , Suíça/epidemiologia
14.
Lancet ; 396(10252): 665-666, 2020 09 05.
Artigo em Inglês | MEDLINE | ID: mdl-32891204
15.
BMJ ; 370: m2917, 2020 08 25.
Artigo em Inglês | MEDLINE | ID: mdl-32843333

RESUMO

OBJECTIVE: To prospectively assess the construct and criterion validity of ClassIntra version 1.0, a newly developed classification for assessing intraoperative adverse events. DESIGN: International, multicentre cohort study. SETTING: 18 secondary and tertiary centres from 12 countries in Europe, Oceania, and North America. PARTICIPANTS: The cohort study included a representative sample of 2520 patients in hospital having any type of surgery, followed up until discharge. A follow-up to assess mortality at 30 days was performed in 2372 patients (94%). A survey was sent to a representative sample of 163 surgeons and anaesthetists from participating centres. MAIN OUTCOME MEASURES: Intraoperative complications were assessed according to ClassIntra. Postoperative complications were assessed daily until discharge from hospital with the Clavien-Dindo classification. The primary endpoint was construct validity by investigating the risk adjusted association between the most severe intraoperative and postoperative complications, measured in a multivariable hierarchical proportional odds model. For criterion validity, inter-rater reliability was evaluated in a survey of 10 fictitious case scenarios describing intraoperative complications. RESULTS: Of 2520 patients enrolled, 610 (24%) experienced at least one intraoperative adverse event and 838 (33%) at least one postoperative complication. Multivariable analysis showed a gradual increase in risk for a more severe postoperative complication with increasing grade of ClassIntra: ClassIntra grade I versus grade 0, odds ratio 0.99 (95% confidence interval 0.69 to 1.42); grade II versus grade 0, 1.39 (0.97 to 2.00); grade III versus grade 0, 2.62 (1.31 to 5.26); and grade IV versus grade 0, 3.81 (1.19 to 12.2). ClassIntra showed high criterion validity with an intraclass correlation coefficient of 0.76 (95% confidence interval 0.59 to 0.91) in the survey (response rate 83%). CONCLUSIONS: ClassIntra is the first prospectively validated classification for assessing intraoperative adverse events in a standardised way, linking them to postoperative complications with the well established Clavien-Dindo classification. ClassIntra can be incorporated into routine practice in perioperative surgical safety checklists, or used as a monitoring and outcome reporting tool for different surgical disciplines. Future studies should investigate whether the tool is useful to stratify patients to the appropriate postoperative care, to enhance the quality of surgical interventions, and to improve long term outcomes of surgical patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT03009929.


Assuntos
Complicações Intraoperatórias/classificação , Complicações Pós-Operatórias/classificação , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Criança , Pré-Escolar , Feminino , Humanos , Complicações Intraoperatórias/epidemiologia , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Reprodutibilidade dos Testes , Procedimentos Cirúrgicos Operatórios/estatística & dados numéricos , Inquéritos e Questionários , Adulto Jovem
17.
BMC Geriatr ; 18(1): 222, 2018 09 21.
Artigo em Inglês | MEDLINE | ID: mdl-30241509

RESUMO

BACKGROUND: The relevance of femoral neck fractures (FNFs) increases with the ageing of numerous societies, injury-related decline is observed in many patients. Treatment strategies have evolved towards primary joint replacement, but the impact of different approaches remains a matter of debate. The aim of this trial was to evaluate the benefit of an anterior minimally-invasive (AMIS) compared to a lateral Hardinge (LAT) approach for hemiarthroplasty in these oftentimes frail patients. METHODS: Four hundred thirty-nine patients were screened during the 44-months trial, aiming at the evaluation of 150 patients > 60 yrs. of age. Eligible patients were randomised using an online-tool with completely random assignment. As primary endpoint, early mobility, a predictor for long-term outcomes, was evaluated at 3 weeks via the "Timed up and go" test (TUG). Secondary endpoints included the Functional Independence Measure (FIM), pain, complications, one-year mobility and mortality. RESULTS: A total of 190 patients were randomised; both groups were comparable at baseline, with a predominance for frailty-associated factors in the AMIS-group. At 3 weeks, 146 patients were assessed for the primary outcome. There was a reduction in the median duration of TUG performance of 21.5% (CI [- 41.2,4.7], p = 0.104) in the AMIS-arm (i.e., improved mobility). This reduction was more pronounced in patients with signs of frailty or cognitive impairment. FIM scores increased on average by 6.7 points (CI [0.5-12.8], p = 0.037), pain measured on a 10-point visual analogue scale decreased on average by 0.7 points (CI: [- 1.4,0.0], p = 0.064). The requirement for blood transfusion was lower in the AMIS- group, the rate of complications comparable, with a higher rate of soft tissue complications in the LAT-group. The mortality was higher in the AMIS-group. CONCLUSION: These results, similar to previous reports, support the concept that in elderly patients at risk of frailty, the AMIS approach for hemiarthroplasty can be beneficial, since early mobilisation and pain reduction potentially reduce deconditioning, morbidity and loss of independence. The results are, however, influenced by a plethora of factors. Only improvements in every aspect of the therapeutic chain can lead to optimisation of treatment and improve outcomes in this growing patient population. TRIAL REGISTRATION: www.clinicaltrials.gov : NCT01408693 (registered August 3rd 2011).


Assuntos
Nádegas/cirurgia , Fraturas do Colo Femoral/cirurgia , Hemiartroplastia/métodos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Músculo Esquelético/cirurgia , Idoso , Idoso de 80 Anos ou mais , Artroplastia de Quadril/métodos , Artroplastia de Quadril/normas , Feminino , Fraturas do Colo Femoral/diagnóstico , Seguimentos , Hemiartroplastia/normas , Humanos , Masculino , Procedimentos Cirúrgicos Minimamente Invasivos/normas , Estudos Prospectivos , Resultado do Tratamento
18.
Pancreas ; 47(1): 55-64, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29215538

RESUMO

OBJECTIVES: The aims of this study were to assess whether copeptin, pro-atrial natriuretic peptide, proadrenomedullin, and cortisol are associated with disease severity in patients with acute pancreatitis (AP) and to compare their ability in predicting organ failure or death. METHODS: From April 2011 to January 2015, 142 patients with AP were included in this prospective single-center study and observed for 4 days. Disease severity was rated by the Atlanta 1992 and 2012 criteria and organ failure by the modified Marshall score. The aforementioned laboratory markers, C-reactive protein, and procalcitonin were measured. RESULTS: Patients with moderate to severe AP showed significantly higher plasma concentrations of all biomarkers than did those with mild AP. Overall, 30 organ failures or deaths occurred. All biomarkers except cortisol had only modest discriminatory ability, with areas under the receiver operating characteristic curve (AUCs) between 0.44 and 0.66. Cortisol showed an AUC of 0.78 compared with the Acute Physiology and Chronic Health Evaluation II score with an AUC of 0.75. CONCLUSIONS: Cortisol was the best predictor of organ failure or death. All biomarkers were associated with disease severity to a similar degree as C-reactive protein, the criterion-standard marker in AP. Further studies are warranted to define their clinical role.


Assuntos
Biomarcadores/sangue , Hidrocortisona/sangue , Avaliação de Resultados em Cuidados de Saúde/métodos , Pancreatite/sangue , Doença Aguda , Adulto , Idoso , Idoso de 80 Anos ou mais , Doenças Cardiovasculares/sangue , Doenças Cardiovasculares/diagnóstico , Feminino , Humanos , Inflamação/sangue , Inflamação/diagnóstico , Masculino , Pessoa de Meia-Idade , Neurotransmissores/sangue , Pancreatite/diagnóstico , Prognóstico , Estudos Prospectivos , Curva ROC
20.
Swiss Med Wkly ; 147: w14472, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28871577

RESUMO

BACKGROUND: Right-sided retroperitoneoscopic living donor nephrectomy (LDN) has been shown to be safe for the donor but it is unknown whether the short renal vein is associated with complications or an impaired long-term outcome in the recipient. METHODS: In this retrospective cohort study, consecutive transplant recipients after retroperitoneoscopic LDN were enrolled. Complications occurring within 1 year were classified according to the Clavien-Dindo Classification for Surgical Complications and analysed using multivariable logistic regression. Predictors of 1-year creatinine clearance were analysed with multivariable linear regression. Cox proportional hazard models were used to analyse graft survival. RESULTS: Of the 251 recipients, 193 (77%) received a left kidney and 58 (23%) a right kidney. Surgical complications of Clavien-Dindo grade 3 or higher were comparable in recipients of right and left kidneys (33% vs 29%, odds ratio 0.98, 95% confidence interval [CI] 0.50, 1.94). The occurrence of a surgical complication had a significant impact on creatinine clearance at 1 year (decrease of 6 ml/min/m2, p = 0.016). Vascular complications in right kidneys were more common but were all corrected without impact on graft survival. One-year graft-survival was similar in recipients of right (98.3%) and left (96.9%) kidneys, as was creatinine clearance one year after transplantation (mean difference 3.3 ml/min/m2, 95% CI -1.5, 8.1; p = 0.175). After a median follow-up of 5 years, neither the side (hazard ratio 1.56, 95% CI 0.67, 3.63) nor surgical complications (hazard ratio 1.44, 95% CI 0.65, 3.19) were associated with graft failure. CONCLUSION: Right retroperitoneoscopic LDN does not compromise the outcome of transplantation. Surgical complications, long-term graft function and graft survival were comparable in right and left kidneys.


Assuntos
Sobrevivência de Enxerto , Transplante de Rim/estatística & dados numéricos , Doadores Vivos , Nefrectomia/métodos , Complicações Pós-Operatórias , Creatinina/análise , Feminino , Humanos , Rim , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
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