RESUMO
BACKGROUND: Some quality indicators of proper health care in patients with colorectal cancer have been established. AIMS: Our goal was to evaluate the relationship between performing of certain procedures or treatments, included as quality indicators, and some outcomes of indicators in the follow-up of colorectal cancer patients. METHODS: This was a prospective cohort study of patients diagnosed with colorectal cancer that underwent surgery and were followed at 1, 2, 3, and 5 years. CT scanning, colonoscopy, chemotherapy, and radiotherapy were evaluated in relation to various clinical outcomes and PROM changes over 5 years. Multivariable generalized linear mixed models were used to evaluate their effect on mortality, complications, recurrence, and PROM changes (HAD, EQ-5D, EORTC-Q30) at the next follow-up. RESULTS: CT scanning or colonoscopy was related to a decrease in the risk of dying, while chemotherapy at a specified moment was related to an increased risk. In the case of recurrence, CT scanning and chemotherapy showed statistically increased the risk, while all the procedures and treatments influenced complications. Regarding PROM scales, CT scanning, colonoscopy, and radiotherapy showed statistically significant results with respect to an increase in anxiety and decrease in quality of life measured by the EORTC. However, undergoing radiotherapy at a specified moment increased depression levels, and overall, receiving radiotherapy decreased the quality of life of the patients, as measured by the EuroQol-5d. CONCLUSIONS: After adjustment for sociodemographic factors, comorbidities, and severity of the disease, performing certain quality indicators of proper health care in patients with colorectal cancer was related to less mortality but higher adverse outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02488161.
Assuntos
Neoplasias Colorretais , Qualidade de Vida , Humanos , Estudos Prospectivos , Indicadores de Qualidade em Assistência à Saúde , Neoplasias Colorretais/terapia , Neoplasias Colorretais/diagnósticoRESUMO
Renal involvement in COVID-19 infection is varied and worsens its outcome and prognosis. However, the association of COVID-19 infection with glomerulonephritis is exceptional. We report a 46-year-old woman with COVID-19 who had an acute kidney injury and ANCA associated glomerulonephritis two weeks after the onset of the disease. The kidney biopsy showed a crescentic glomerulo-nephritis and the presence of anti-glomerular basement membrane antibodies (GBM-Abs). She was treated with steroids and oral cyclophosphamide with good response without requiring plasmapheresis. Plasma anti GBM-Abs were negative. This case suggests that the presence of anti-GBM-Abs in the kidney, was temporally related to COVID-19 pulmonary damage. The absence of plasma antibodies is probably due to transient production and glomerular adsorption, but with unknown pathogenic role.
Assuntos
Humanos , Feminino , Pessoa de Meia-Idade , COVID-19/complicações , Glomerulonefrite/complicações , Autoanticorpos , Membrana Basal/patologia , Anticorpos Anticitoplasma de NeutrófilosRESUMO
Renal involvement in COVID-19 infection is varied and worsens its outcome and prognosis. However, the association of COVID-19 infection with glomerulonephritis is exceptional. We report a 46-year-old woman with COVID-19 who had an acute kidney injury and ANCA associated glomerulonephritis two weeks after the onset of the disease. The kidney biopsy showed a crescentic glomerulo-nephritis and the presence of anti-glomerular basement membrane antibodies (GBM-Abs). She was treated with steroids and oral cyclophosphamide with good response without requiring plasmapheresis. Plasma anti GBM-Abs were negative. This case suggests that the presence of anti-GBM-Abs in the kidney, was temporally related to COVID-19 pulmonary damage. The absence of plasma antibodies is probably due to transient production and glomerular adsorption, but with unknown pathogenic role.
Assuntos
COVID-19 , Glomerulonefrite , Feminino , Humanos , Pessoa de Meia-Idade , Anticorpos Anticitoplasma de Neutrófilos , COVID-19/complicações , Glomerulonefrite/complicações , Autoanticorpos , Membrana Basal/patologiaRESUMO
BACKGROUND: The aim of this study was to identify predictors of mortality in elderly patients undergoing colorectal cancer surgery and to develop a risk score. METHODS: This was an observational prospective cohort study. Individuals over 80 years diagnosed with colorectal cancer and treated surgically were recruited in 18 hospitals in the Spanish National Health Service, between June 2010 and December 2012, and were followed up 1, 2, 3, and 5 years after surgery. Sociodemographic and clinical data were collected. The primary outcomes were mortality at 2 and between 2 and 5 years after the index admission. RESULTS: The predictors of mortality 2 years after surgery were haemoglobin ≤ 10 g/dl and colon locations (HR 1.02; CI 0.51-2.02), ASA class of IV (HR 3.55; CI 1.91-6.58), residual tumour classification of R2 (HR 7.82; CI 3.11-19.62), TNM stage of III (HR 2.14; CI 1.23-3.72) or IV (HR 3.21; CI 1.47-7), LODDS of more than - 0.53 (HR 3.08; CI 1.62-5.86)) and complications during admission (HR 1.73; CI 1.07-2.80). Between 2 and 5 years of follow-up, the predictors were no tests performed within the first year of follow-up (HR 2.58; CI 1.21-5.46), any complication due to the treatment within the 2 years of follow-up (HR 2.47; CI 1.27-4.81), being between 85 and 89 and not having radiotherapy within the second year of follow-up (HR 1.60; CI 1.01-2.55), no colostomy closure within the 2 years of follow-up (HR 4.93; CI 1.48-16.41), medical complications (HR 1.61; CI 1.06-2.44), tumour recurrence within the 2 years of follow-up period (HR 3.19; CI 1.96-5.18), and readmissions at 1 or 2 years of follow-up after surgery (HR 1.44; CI 0.86-2.41). CONCLUSION: We have identified variables that, in our sample, predict mortality 2 and between 2 and 5 years after surgery for colorectal cancer older patients. We have also created risks scores, which could support the decision-making process. TRIAL REGISTRATION: ClinicalTrials.gov , NCT02488161 .
Assuntos
Neoplasias Colorretais , Medicina Estatal , Idoso , Neoplasias Colorretais/cirurgia , Humanos , Recidiva Local de Neoplasia/epidemiologia , Prognóstico , Estudos Prospectivos , Fatores de RiscoRESUMO
OBJECTIVE: To identify factors associated with early, intermediate or late recurrence colon cancer recurrence. METHODS: A total of 1,732 consecutive patients with colon cancer were recruited and followed for a period of 5 years. Recurrence at 1 year (early), from 1 to 2 (early), from 2 to 3 (intermediate) and from 3 to 5 years (late) was the main outcome measures. RESULTS: Predictors of early recurrence (AUC (95% CI):0.74 (0.70-0.78) were as follows: TNM stage II and III, more than one type of invasion, haemoglobin <10 g/dl, residual tumour (R1), ASA IV, log odds of positive lymph nodes ratio ≥-0.53, perforation, neoadjuvant chemotherapy, infectious complications within 1 year and CEA pre- and post-intervention. These factors remained significant for predicting intermediate (AUC [95% CI]: 0.72 [0.67-0.77]) and late (AUC [95% CI]: 0.68 [0.63-0.74]) recurrence, except for ASA class, log lymph node ratio, perforation and neoadjuvant chemotherapy. Additionally, laterality (left) and medical complications up to 2 years were significant. CONCLUSIONS: These risk factors show good predictive ability of early, intermediate and late recurrence, confirming factors established by guidelines and adding some others. They could serve to provide more appropriate and accurate treatment and follow-up tailored to patient characteristics.
Assuntos
Neoplasias do Colo , Neoplasias do Colo/patologia , Neoplasias do Colo/cirurgia , Humanos , Terapia Neoadjuvante , Recidiva Local de Neoplasia , Estadiamento de Neoplasias , Prognóstico , Estudos Prospectivos , Estudos Retrospectivos , Fatores de RiscoRESUMO
PURPOSE: To assess the impact of readmission and reoperation on colon or rectal cancer patients in clinical and patient-reported outcome measures (PROMs) and to identify predictors of these events up to 1 year after surgery. METHODS: Prospective cohort study of patients diagnosed with colon or rectal cancer who underwent surgery at 1 of 22 hospitals. Medical history, clinical parameters, and PROMs were evaluated as possible predictors. Multivariable multilevel logistic regression and survival models were used in the analyses to create the clinical prediction rules. Models were developed in a derivation sample and validated in a different sample. RESULTS: Readmission and reoperation were related to clinical outcomes and changes in some PROMs. Predictors of readmission in colon cancer were ASA class (odds ratio (OR) 4.5), TNM (OR for TNM III 3.24, TNM IV 4.55), evidence of residual tumor (R2) (OR 3.96), and medical (OR 1.96) and infectious (OR 2.01) complications within 30 days after surgery, while for rectal cancer, the predictors identified were age (OR 1.03), R2 (OR 6.48), infectious complications within 30 days (OR 2.29), hemoglobin (OR 3.26), lymph node ratio (OR 2.35), and surgical complications within 1 month (OR 3.04). Predictors of reoperation were TNM IV (OR 5.06), surgical complications within 30 days (OR 1.98), and type and site of tumor (OR 1.72) in colon cancer and being male (OR 1.52), age (OR 1.80), stoma (OR 1.87), and surgical complications within 1 month (OR 1.95) in rectal cancer. CONCLUSIONS: Our clinical prediction rule models are easy to use and could help to develop and implement interventions to reduce preventable readmissions and reoperations. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02488161 Identifier: NCT02488161.
Assuntos
Neoplasias Colorretais/cirurgia , Reoperação/estatística & dados numéricos , Adulto , Idoso , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Estatísticos , Razão de Chances , Readmissão do Paciente/estatística & dados numéricos , Complicações Pós-Operatórias/diagnóstico , Estudos Prospectivos , Fatores de RiscoRESUMO
PURPOSE: To identify and validate risk factors that contribute to prolonged length of hospital stay (LOS) in patients undergoing resection for colorectal cancer. METHODS: This prospective cohort study included 1955 patients admitted to 22 hospitals for primary resection of colorectal cancer. Multivariate analyses were used to identify and validate risk factors, randomizing patients into a derivation and a validation cohort. Multiple correspondence and cluster analysis were performed to identify clinical subtypes based on LOS. RESULTS: The strongest independent predictors of prolonged LOS were postoperative reintervention, surgical site infection, open surgery, and distant metastasis. The multiple correspondence and cluster analysis provided three groups of patients in relation to prolonged LOS: patients with the longest LOS included the highest percentage of patients with open surgery, distant metastasis, deep surgical site infections, emergency admissions, additional diagnostic factors, and highly contaminated surgical sites. Patients with prolonged LOS (> 14 days) were more likely to develop adverse outcomes within 30 days after discharge. CONCLUSIONS: Patients undergoing resection of colorectal cancer cluster into different groups based on LOS of the index admission. Those with prolonged LOS were more likely to develop adverse outcomes within 30 days after discharge. Some of the strongest independent predictors of prolonged LOS, such as surgical infections or open surgery, could be modified to reduce LOS and, in turn, other adverse outcomes. TRIAL REGISTRATION: NCT02488161.
Assuntos
Neoplasias do Colo/cirurgia , Procedimentos Cirúrgicos do Sistema Digestório/estatística & dados numéricos , Tempo de Internação/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Humanos , Masculino , Alta do Paciente , Período Pós-Operatório , Estudos Prospectivos , Fatores de Risco , Infecção da Ferida CirúrgicaRESUMO
OBJECTIVE: There is limited information on health service use or patient-reported outcomes when comparing the effectiveness of laparoscopic with that of open surgery. The aim was to compare the effectiveness of laparoscopic with that of open surgery up to 2 years after intervention in patients with colon cancer. METHODS: Prospective cohort study of patients with colon cancer who underwent surgery (laparoscopic or open surgery) between June 2010 and December 2012, at 22 hospitals. Main outcomes of the study were mortality, complications, reoperation, readmission, and patient-reported outcome measures (PROMs), as measured using the Hospital Anxiety and Depression Scale, Duke-UNC, EuroQol-5D, and European Organisation for Research and Treatment of Cancer-Q30 and Q29 at baseline, and 30 days and 1 and 2 years after surgery. Multivariable multilevel logistic regression and generalized linear models were used in analyses after adjusting for specific propensity scores developed for each outcome and time point. RESULTS: In the multivariable analysis, the complication rates up to 30 days (infectious, surgical, and medical) and 1 year (surgical), and readmission rate at 30 days and at 2 years were higher among patients who underwent open surgery than among those who underwent laparoscopic surgery. There were no differences between the two surgical approaches in all other parameters assessed and in changes of all PROMs. CONCLUSIONS: Though in most outcomes both surgical approaches provide similar results up to 2 years after intervention, still the rates of some complications and readmission, mainly up to 30 days, are higher in open surgery. CLINICALTRIALS. GOV IDENTIFIER: NCT02488161.
Assuntos
Colectomia/métodos , Neoplasias do Colo/cirurgia , Procedimentos Cirúrgicos Eletivos/métodos , Laparoscopia/métodos , Pontuação de Propensão , Idoso , Neoplasias do Colo/mortalidade , Feminino , Seguimentos , Humanos , Tempo de Internação/tendências , Masculino , Estudos Prospectivos , Reoperação , Espanha/epidemiologia , Taxa de Sobrevida/tendências , Resultado do TratamentoRESUMO
BACKGROUND: Tools to aid in the prognosis assessment of colon cancer patients in terms of risk of mortality are needed. Goals of this study are to develop and validate clinical prediction rules for 1- and 2-year mortality in these patients. METHODS: This is a prospective cohort study of patients diagnosed with colon cancer who underwent surgery at 22 hospitals. The main outcomes were mortality at 1 and 2 years after surgery. Background, clinical parameters, and diagnostic tests findings were evaluated as possible predictors. Multivariable multilevel logistic regression and survival models were used in the analyses to create the clinical prediction rules. Models developed in the derivation sample were validated in another sample of the study. RESULTS: American Society of Anesthesiologists Physical Status Classification System (ASA), Charlson comorbidity index (> = 4), age (>75 years), residual tumor (R2), TNM stage IV and log of lymph nodes ratio (> = -0.53) were predictors of 1-year mortality (C-index (95% CI): 0.865 (0.792-0.938)). Adjuvant chemotherapy was an additional predictor. Again ASA, Charlson Index (> = 4), age (>75 years), log of lymph nodes ratio (> = -0.53), TNM, and residual tumor were predictors of 2-year mortality (C-index:0.821 (0.766-0.876). Chemotherapy was also an additional predictor. CONCLUSIONS: These clinical prediction rules show very good predictive abilities of one and two years survival and provide clinicians and patients with an easy and quick-to-use decision tool for use in the clinical decision process while the patient is still in the index admission.
Assuntos
Neoplasias do Colo/mortalidade , Modelos Biológicos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Neoplasias do Colo/terapia , Intervalo Livre de Doença , Feminino , Seguimentos , Humanos , Masculino , Valor Preditivo dos Testes , Estudos Prospectivos , Taxa de SobrevidaRESUMO
BACKGROUND: To validate and recalibrate the CR- POSSUM model and compared its discriminatory capacity with other European models such as POSSUM, P-POSSUM, AFC or IRCS to predict operative mortality in surgery for colorectal cancer. METHODS: Prospective multicenter cohort study from 22 hospitals in Spain. We included patients undergoing planned or urgent surgery for primary invasive colorectal cancers between June 2010 and December 2012 (N = 2749). Clinical data were gathered through medical chart review. We validated and recalibrated the predictive models using logistic regression techniques. To calculate the discriminatory power of each model, we estimated the areas under the curve - AUC (95% CI). We also assessed the calibration of the models by applying the Hosmer-Lemeshow test. RESULTS: In-hospital mortality was 1.5% and 30-day mortality, 1.7%. In the validation process, the discriminatory power of the CR-POSSUM for predicting in-hospital mortality was 73.6%. However, in the recalibration process, the AUCs improved slightly: the CR-POSSUM reached 75.5% (95% CI: 67.3-83.7). The discriminatory power of the CR-POSSUM for predicting 30-day mortality was 74.2% (95% CI: 67.1-81.2) after recalibration; among the other models the POSSUM had the greatest discriminatory power, with an AUC of 77.0% (95% CI: 68.9-85.2). The Hosmer-Lemeshow test showed good fit for all the recalibrated models. CONCLUSION: The CR-POSSUM and the other models showed moderate capacity to discriminate the risk of operative mortality in our context, where the actual operative mortality is low. Nevertheless the IRCS might better predict in-hospital mortality, with fewer variables, while the CR-POSSUM could be slightly better for predicting 30-day mortality. TRAIL REGISTRATION: Registered at: ClinicalTrials.gov Identifier: NCT02488161.
Assuntos
Neoplasias Colorretais/mortalidade , Neoplasias Colorretais/cirurgia , Mortalidade Hospitalar/tendências , Hospitais , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Hospitais/estatística & dados numéricos , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Prospectivos , Curva ROC , Reprodutibilidade dos Testes , Medição de Risco , Espanha/epidemiologiaRESUMO
PURPOSE: The delayed diagnosis of colorectal cancer (CRC) may be attributable to sociodemographic characteristics, to aspects of tumour histopathology or to the functioning of the health system. We seek to determine which of these factors most influences prolonged patient-attributable delay (PPAD) in the diagnosis and treatment of CRC. MATERIALS AND METHODS: A prospective, multicentre observational study was conducted in 22 Spanish hospitals. In total, 1,785 patients were recruited to the study between 2010 and 2012 and underwent elective or urgent surgery. PPAD is considered to occur when the time elapsed between a patient presenting the symptom and him/her seeking attention from the primary care physician or hospital emergency department exceeds 180 days. A bivariate analysis was performed to assess differences in variables segmented by tumour location and patient delay. Multivariate logistic regression analysis was performed on the outcome variable, PPAD. RESULTS: The rate of PPAD among this population was 12.1%. PPAD was significantly associated with altered bowel rhythm (odds ratio [OR], 1.36; 95% confidence interval [CI], 1.02 to 1.83) and with adenocarcinoma histology, in comparison with mucinous adenocarcinoma (OR, 2.03; 95% CI, 1.11 to 3.71). Other sociocultural factors and clinicopathological features were not independent predictors of PPAD. CONCLUSION: Many patients do not consider altered bowel rhythm an alarming symptom, warranting a visit to the doctor. PPAD could be reduced by improving health education, raising awareness of CRC-related symptoms.
Assuntos
Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/cirurgia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Diagnóstico Tardio , Procedimentos Cirúrgicos Eletivos , Tratamento de Emergência , Feminino , Humanos , Modelos Logísticos , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Fatores SexuaisRESUMO
PURPOSE: The goal of this study was to compare the effectiveness of laparoscopic with that of open surgery up to 2 years after intervention in patients with rectal cancer. METHODS: This is a prospective cohort study of patients with rectal cancer who underwent surgery (laparoscopic or open) between June 2010 and December 2012 in 22 acute hospitals. Main outcomes were mortality, complications, reoperation, readmission, and patient-reported outcome measures (PROMs), as measured using the EuroQol-5D (EQ-5D), European Organisation for Research and Treatment of Cancer (EORTC) QLQ-Q30 and Q29, the Barthel Index (BI), and the Duke-UNC Functional Social Support Questionnaire at baseline, 1 year, and 2 years after surgery. Multivariable multilevel logistic regression and generalized linear models were used in the analyses after adjusting for specific propensity scores developed for each outcome and time point. RESULTS: In the multivariable analysis, rates of some medical complications after surgery during admission (renal failure and paralytic ileus) and infectious (urinary tract infection, septic shock, and localized intra-abdominal infection) and at 1 year (renal and heart failure) were higher among patients who underwent open surgery than among those who underwent laparoscopic surgery. There were no differences between the two surgical approaches in all other parameters assessed at the different time points or in all PROMs evaluated. CONCLUSIONS: Laparoscopic surgery and open surgery provide quite similar results in patients with rectal cancer up to 2 years after intervention in most outcomes, though the rates of certain medical and infectious complications at admission and up to 1 year after the intervention were higher in open surgery.
Assuntos
Laparoscopia , Neoplasias Retais/cirurgia , Humanos , Análise Multivariada , Resultado do TratamentoRESUMO
BACKGROUND: We hypothesized that patients undergoing surgery for colorectal cancer (CRC) with COPD as a comorbidity would consume more resources and have worse in-hospital outcomes than similar patients without COPD. Therefore, we compared different aspects of the care process and short-term outcomes in patients undergoing surgery for CRC, with and without COPD. METHODS: This was a prospective study and it included patients from 22 hospitals located in Spain - 472 patients with COPD and 2,276 patients without COPD undergoing surgery for CRC. Clinical variables, postintervention intensive care unit (ICU) admission, use of invasive mechanical ventilation, and postintervention antibiotic treatment or blood transfusion were compared between the two groups. The reintervention rate, presence and type of complications, length of stay, and in-hospital mortality were also estimated. Hazard ratio (HR) for hospital mortality was estimated by Cox regression models. RESULTS: COPD was associated with higher rates of in-hospital complications, ICU admission, antibiotic treatment, reinterventions, and mortality. Moreover, after adjusting for other factors, COPD remained clearly associated with higher and earlier in-hospital mortality. CONCLUSION: To reduce in-hospital morbidity and mortality in patients undergoing surgery for CRC and with COPD as a comorbidity, several aspects of perioperative management should be optimized and attention should be given to the usual comorbidities in these patients.
Assuntos
Neoplasias Colorretais/cirurgia , Recursos em Saúde/estatística & dados numéricos , Pulmão/fisiopatologia , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/uso terapêutico , Transfusão de Sangue/estatística & dados numéricos , Distribuição de Qui-Quadrado , Neoplasias Colorretais/mortalidade , Neoplasias Colorretais/patologia , Comorbidade , Feminino , Mortalidade Hospitalar , Humanos , Unidades de Terapia Intensiva , Estimativa de Kaplan-Meier , Tempo de Internação , Modelos Logísticos , Masculino , Admissão do Paciente , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/terapia , Modelos de Riscos Proporcionais , Estudos Prospectivos , Doença Pulmonar Obstrutiva Crônica/mortalidade , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Doença Pulmonar Obstrutiva Crônica/terapia , Respiração Artificial/estatística & dados numéricos , Fatores de Risco , Espanha/epidemiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
A prospective study was performed of patients diagnosed with colorectal cancer (CRC), distinguishing between colonic and rectal location, to determine the factors that may provoke a delay in the first treatment (DFT) provided.2749 patients diagnosed with CRC were studied. The study population was recruited between June 2010 and December 2012. DFT is defined as time elapsed between diagnosis and first treatment exceeding 30 days.Excessive treatment delay was recorded in 65.5% of the cases, and was more prevalent among rectal cancer patients. Independent predictor variables of DFT in colon cancer patients were a low level of education, small tumour, ex-smoker, asymptomatic at diagnosis and following the application of screening. Among rectal cancer patients, the corresponding factors were primary school education and being asymptomatic.We conclude that treatment delay in CRC patients is affected not only by clinicopathological factors, but also by sociocultural ones. Greater attention should be paid by the healthcare provider to social groups with less formal education, in order to optimise treatment attention.
Assuntos
Neoplasias Colorretais/epidemiologia , Tempo para o Tratamento , Idoso , Biomarcadores Tumorais , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/terapia , Diagnóstico Tardio , Análise Fatorial , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Gradação de Tumores , Metástase Neoplásica , Estadiamento de Neoplasias , Razão de Chances , Fatores de Risco , Fatores SocioeconômicosRESUMO
BACKGROUND: Colorectal cancers are one of the most common forms of malignancy worldwide. But two significant areas of research less studied deserve attention: health services use and development of patient stratification risk tools for these patients. DESIGN: a prospective multicenter cohort study with a follow up period of up to 5 years after surgical intervention. Participant centers: 22 hospitals representing six autonomous communities of Spain. Participants/Study population: Patients diagnosed with colorectal cancer that have undergone surgical intervention and have consented to participate in the study between June 2010 and December 2012. Variables collected include pre-intervention background, sociodemographic parameters, hospital admission records, biological and clinical parameters, treatment information, and outcomes up to 5 years after surgical intervention. Patients completed the following questionnaires prior to surgery and in the follow up period: EuroQol-5D, EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer quality of life questionnaire) and QLQ-CR29 (module for colorectal cancer), the Duke Functional Social Support Questionnaire, the Hospital Anxiety and Depression Scale, and the Barthel Index. The main endpoints of the study are mortality, tumor recurrence, major complications, readmissions, and changes in health-related quality of life at 30 days and at 1, 2, 3 and 5 years after surgical intervention. STATISTICAL ANALYSIS: In relation to the different endpoints, predictive models will be used by means of multivariate logistic models, Cox or linear mixed-effects regression models. Simulation models for the prediction of discrete events in the long term will also be used, and an economic evaluation of different treatment strategies will be performed through the use of generalized linear models. DISCUSSION: The identification of potential risk factors for adverse events may help clinicians in the clinical decision making process. Also, the follow up by 5 years of this large cohort of patients may provide useful information to answer different health services research questions. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02488161 . Registration date: June 16, 2015.
Assuntos
Neoplasias Colorretais/terapia , Pesquisa sobre Serviços de Saúde , Humanos , Estudos Observacionais como Assunto , Estudos Prospectivos , Qualidade de Vida , Resultado do TratamentoRESUMO
Fungal peritonitis is a major complication of peritoneal dialysis associated with high mortality. Most survivors have a high rate of abandonment of peritoneal dialysis. We report a case of fungal peritonitis due to an unusual agent. An 83 year-old woman, with a history of type 2 diabetes mellitus and multiple episodes of bacterial peritonitis associated to technical flaws in the implementation of automated peritoneal dialysis, was admitted due to abdominal pain and cloudy peritoneal fluid. Rhodotorula mucilaginosa was identified in the peritoneal fluid by MALDI-TOF. She was treated with catheter removal and oral posaconazole for 14 days showing clinical resolution and non-recurrence.
La peritonitis fúngica es una complicación mayor de la diálisis peritoneal, con una alta mortalidad asociada y la mayoría de los sobrevivientes presentan una alta tasa de abandono de diálisis peritoneal como terapia de reemplazo renal. Se presenta un caso de peritonitis fúngica por un agente infrecuente. Mujer de 83 años, diabética con múltiples episodios de peritonitis bacteriana asociada a fallas técnicas en la ejecución de diálisis peritoneal automatizada, ingresa por cuadro clínico de dolor abdominal y líquido peritoneal turbio. Se confirmó la presencia de Rhodotorula mucilaginosa en líquido peritoneal mediante MALDI-TOF. Fue tratada con retiro del catéter y posaconazol oral por 14 días, presentando una evolución favorable.
Assuntos
Humanos , Feminino , Idoso de 80 Anos ou mais , Peritonite/microbiologia , Rhodotorula/isolamento & purificação , Diálise Peritoneal/efeitos adversos , Febre Familiar do Mediterrâneo/terapia , Fatores de Tempo , Triazóis/uso terapêutico , Diálise Peritoneal/métodos , Infecções Relacionadas a Cateter/microbiologia , Infecções Relacionadas a Cateter/terapia , Antifúngicos/uso terapêuticoRESUMO
BACKGROUND: This is an update of a review previously published in 2009. Chronic angina and advanced forms of coronary disease are increasingly more frequent. In spite of the improvement in the efficacy of available revascularization treatments, a subgroup of patients continue suffering from refractory angina. Transmyocardial laser revascularization (TMLR) has been proposed to improve the clinical situation of these patients. OBJECTIVES: To assess the effects (both benefits and harms) of TMLR versus optimal medical treatment in people with refractory angina who are not candidates for percutaneous coronary angioplasty or coronary artery bypass graft, in alleviating angina severity, reducing mortality and improving ejection fraction. SEARCH METHODS: We searched the following resources up to June 2014: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the metaRegister of Controlled Trials database, ClinicalTrials.gov, and the WHO International Clinical Trials Registry. We applied no languages restrictions. We also checked reference lists of relevant papers. SELECTION CRITERIA: We selected studies if they fulfilled the following criteria: randomized controlled trials (RCTs) of TMLR, by thoracotomy, in patients with Canadian Cardiovascular Society or New York Heart Association angina grade III-IV who were excluded from other revascularization procedures. DATA COLLECTION AND ANALYSIS: Three authors independently extracted data for each trial about the population and interventions compared and assessed the risk of bias of the studies, evaluating randomisation sequence generation, allocation concealment, blinding (of participants, personnel and outcome assessors), incomplete outcome data, selective outcome reporting, and other potential sources of bias. MAIN RESULTS: From a total of 502 references, we retrieved 47 papers for more detailed evaluation. We selected 20 papers, reporting data from seven studies, which included 1137 participants, of which 559 were randomized to TMLR. Participants and professionals were not blinded, which suggests high risk of performance bias. Overall, 43.8% of participants in the treatment group decreased two angina classes, as compared with 14.8% in the control group: odds ratio (OR) 4.63, 95% confidence interval (CI) 3.43 to 6.25), and heterogeneity was present. Mortality by intention-to-treat analysis was similar in both groups at 30 days (4.0% in the TMLR group and 3.5% in the control group), and one year (12.2% in the TMLR group and 11.9% in the control group). However, the 30-day mortality as-treated was 6.8% in the TMLR group and 0.8% in the control group (pooled OR was 3.76, 95% CI 1.63 to 8.66), mainly due to a higher mortality in participants crossing from standard treatment to TMLR. The assessment of subjective outcomes, such as improvement in angina, was affected by a high risk of bias and this may explain the differences found. Other adverse events such as myocardial infarction, arrhythmias or heart failure, were not considered in this review, as they were not predefined outcomes in trials design and they show a high inconsistency across studies. No new trials on transmyocardial laser revascularization have been published in the last ten years and it is very unlikely that new research will be undertaken in this field. AUTHORS' CONCLUSIONS: This review shows that risks associated with TMLR outweigh the potential clinical benefits. Subjective outcomes are subject to high risk of bias and no differences were found in survival, but a significant increase in postoperative mortality and other safety outcomes suggests that the procedure may pose unacceptable risks.
Assuntos
Angina Pectoris/terapia , Terapia a Laser/métodos , Revascularização Miocárdica/métodos , Angina Pectoris/mortalidade , Humanos , Terapia a Laser/efeitos adversos , Terapia a Laser/mortalidade , Revascularização Miocárdica/efeitos adversos , Revascularização Miocárdica/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto , ToracotomiaRESUMO
PURPOSE: To develop and validate a clinical score to predict visual acuity (VA) and functional changes after phacoemulsification on the basis of readily obtainable preoperative history data and patient assessment. DESIGN: Prospective follow-up study. PARTICIPANTS: A sample of 5512 patients on waiting lists for phacoemulsification at 17 hospitals in Spain. METHODS: Data were obtained at the baseline examination from the 5512 patients. The patients were divided randomly into 2 subgroups: derivation (n = 3285; 60%) and validation (n = 2227; 40%). The preoperative predictors of postoperative gains in VA and visual function index 14 (VF-14) were determined by multivariate logistic regression analysis and implemented using a prediction score. MAIN OUTCOME MEASURES: Probability of postoperative improvement in VA and VF-14 scores. The cutoff points were established for each outcome on the basis of the minimal clinically important difference values. RESULTS: The predictive variables for VA gain were the baseline VA, patient age, ocular comorbidity, and surgical complexity. Regarding the VF-14, the predictive factors were the preoperative VF-14, the eye with the better VA, and the surgical complexity. In the multivariate logistic model in the derivation sample, the final VA and VF-14 scores ranged from 0 to 44 and from 0 and 24, respectively. Receiver operating characteristic curves were developed in the derivation and validation samples, and no statistical significance was found when their areas under the curve were compared. Areas under the curve ranged from 65% to 80%. Both scores had a positive predictive value from 74% to 85%. CONCLUSIONS: Newly developed and validated clinical prediction scores may assist physicians and patients in decision making about the expected outcomes and benefits of cataract surgery.
Assuntos
Facoemulsificação , Pseudofacia/fisiopatologia , Perfil de Impacto da Doença , Acuidade Visual/fisiologia , Idoso , Idoso de 80 Anos ou mais , Área Sob a Curva , Feminino , Seguimentos , Humanos , Implante de Lente Intraocular , Masculino , Valor Preditivo dos Testes , Estudos Prospectivos , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Chronic angina and advanced forms of coronary disease are increasingly more frequent. Although the improved efficacy of available revascularization treatments, a subgroup of patients present with refractory angina. Transmyocardial laser revascularization (TMLR) has been proposed to improve the clinical situation of these patients. OBJECTIVES: To assess the efficacy and safety of TMLR versus optimal medical treatment in patients with refractory angina in alleviating the severity of angina and improving survivorship and heart function. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials on The Cochrane Library (Issue 2 2007), MEDLINE (January 2006 to June 2007), EMBASE ( 2004 to June 2007) and ongoing studies were sought using the metaRegister of Controlled Trials database (mRCT) and ClinicalTrials.gov databases. No languages restrictions were applied. Reference lists of relevant papers were also checked. SELECTION CRITERIA: Studies were selected if they fulfilled the following criteria: randomized controlled trials of TMLR, by thoracotomy, in patients with angina grade III-IV who were excluded from other revascularization procedures. From a total of 181 references, 20 papers were selected, reporting data from seven studies. DATA COLLECTION AND ANALYSIS: Two reviewers abstracted data from selected papers; . The reviewers performed independently both quality assessment and data extraction. Selected studies present methodological weaknesses. None of them fulfilled all the quality criteria. MAIN RESULTS: Seven studies (1137 participants of which 559 randomized to TMLR) were included. Overall, 43.8 % of patients in the treatment group decreased two angina classes as compared with 14.8 % in the control group, odds ratio (OR) of 4.63 (95% confidence interval (CI) 3.43 to 6.25), and heterogeneity was statistically significant. Mortality by intention-to-treat analysis at both 30 days (4.0 % in the TMLR group and 3.5 % in the control group) and 1 year (12.2 % in the TMLR group and 11.9 % in the control group) was similar in both groups. The 30-days mortality as treated was 6.8% in TMLR group and 0.8% in the control group, showing a statistically significant difference. The pooled OR was 3.76 (95% CI 1.63 to 8.66), because of the higher mortality in patients crossing from standard treatment to TMLR. AUTHORS' CONCLUSIONS: There is insufficient evidence to conclude that the clinical benefits of TMLR outweigh the potential risks. The procedure is associated with a significant early mortality.