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INTRODUCTION: The majority of neck of femur (NOF) fracture patients are frail and at a higher risk of cardiac arrest. This makes discussion of treatment escalation vital to informed care. The optimal time for these discussions is prior to admission or trauma. However, when this has not occurred, it is vital that these discussions happen early in the patient's admission when family is often present and before further deterioration in their condition. We undertook a service evaluation to evaluate and discuss the effect of clinician education on improving rates of timely discussion amongst orthopaedic doctors. MATERIALS AND METHODS: The first cycle included 94 patients. Their notes were reviewed for presence of a ReSPECT (Recommend Summary Plan for Emergency Care and Treatment) form prior to operation and whether this it countersigned by a consultant. Following this, clinician education was undertaken and a re-audit was carried out involving 57 patients. RESULTS: ReSPECT form completion rates rose from 23% in cycle 1-32% in cycle 2 following intervention. The proportion which consultants signed rose from 41% to 56% following intervention. CONCLUSION: This project demonstrates how a basic education program can prove limited improvements in the rates of timely resuscitation discussions. We discuss a current lack in quality research into educational programs for discussion of treatment escalation for orthopaedic trainees. We suggest there is room to improve national best practice guidelines and training to ensure these discussions are carried out more frequently and to a better standard.
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Fraturas do Colo Femoral , Ortopedia , Fraturas do Colo Femoral/cirurgia , Hospitalização , HumanosRESUMO
INTRODUCTION: The popularity of day-case arthroplasty has been fuelled by focus on its cost effectiveness for the healthcare system. Safety concerns still remain. The aim of this review was to compare readmission rates after total joint arthroplasty for patients undergoing day-case surgery and for inpatients. METHODS: A comprehensive online search of databases was performed for all published articles in the English language evaluating readmission rates after total hip arthroplasty (THA) and total knee arthroplasty (TKA). Seventeen studies were deemed eligible and included in the meta-analysis. RESULTS: All studies included in the meta-analysis described readmission rates following THA/TKA. The readmission rate for day-case patients was 1.9% (n=124) whereas for inpatients, it was 2.0% (n=12,399). Compared with inpatient arthroplasty, day-case arthroplasty was associated with lower total readmission rates (odds ratio [OR]: 0.77, 95% confidence interval [CI]: 0.63-0.94, p=0.01). Furthermore, day-case surgery conferred a decrease in readmission rates for both THA (1.3% vs 7.0%) and TKA (2.7% vs 4.3%). Moreover, day-case THA and TKA were both associated with a decreased chance of readmission (OR: 0.27, 95% CI: 0.17-0.42, p<0.00001; and OR: 0.55, 95% CI: 0.42-0.72, p<0.00001 respectively). CONCLUSIONS: This review emphasises that with a thoughtful, designated protocol and with careful patient selection, day-case arthroplasty is a safe and effective option.
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Procedimentos Cirúrgicos Ambulatórios , Artroplastia de Quadril , Artroplastia do Joelho , Readmissão do Paciente/estatística & dados numéricos , Artroplastia de Quadril/efeitos adversos , Artroplastia do Joelho/efeitos adversos , Bases de Dados Factuais , Humanos , Resultado do TratamentoRESUMO
BACKGROUND: Cardiopulmonary exercise-testing (CPET) and the (Portsmouth) Physiological and Operative Severity Score for the enUmeration of Mortality and Morbidity ((P)-POSSUM) are used as pre-operative risk stratification and audit tools in general surgery, however, both have been demonstrated to have limitations in major hepatopancreatobiliary (HPB) surgery. MATERIALS AND METHODS: The aim of this review is to determine if CPET and (P)-POSSUM scoring systems accurately predict morbidity and mortality. Eligible articles were identified with an electronic database search. Analysis according to surgery type and tool used was performed. RESULTS: Twenty-five studies were included in the final review. POSSUM predicted morbidity demonstrated weighted O/E ratios of 0.75(95%CI0.57-0.97) in hepatic surgery and 0.85(95%CI0.8-0.9) in pancreatic surgery. P-POSSUM predicted mortality in pancreatic surgery demonstrated an O/E ratio of 0.75(95%CI0.27-2.13) and 0.94(95%CI0.57-1.55) in hepatic surgery. In both pancreatic and hepatic surgery an anaerobic threshold(AT) of between 9 0.5-11.5 ml/kg/min was predictive of post-operative complications, and in pancreatic surgery ventilatory equivalence of carbon dioxide(ËVE/ËVCO2) was predictive of 30-day mortality. CONCLUSION: POSSUM demonstrates an overall lack of predictive fit for morbidity, whilst CPET variables provide some predictive power for post-operative outcomes. Development of a new HPB specific risk prediction tool would be beneficial; the combination of parameters from POSSUM and CPET, alongside HPB specific markers could overcome current limitations.
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BACKGROUND: Systemic inflammation is pivotal in the pathogenesis of cardiovascular disease. As inflammation can directly cause cardiomyocyte injury, we hypothesised that established systemic inflammation, as reflected by elevated preoperative neutrophil-lymphocyte ratio (NLR) >4, predisposes patients to perioperative myocardial injury. METHODS: We prospectively recruited 1652 patients aged ≥45 yr who underwent non-cardiac surgery in two UK centres. Serum high sensitivity troponin T (hsTnT) concentrations were measured on the first three postoperative days. Clinicians and investigators were blinded to the troponin results. The primary outcome was perioperative myocardial injury, defined as hsTnT≥14 ng L-1 within 3 days after surgery. We assessed whether myocardial injury was associated with preoperative NLR>4, activated reactive oxygen species (ROS) generation in circulating monocytes, or both. Multivariable logistic regression analysis explored associations between age, sex, NLR, Revised Cardiac Risk Index, individual leukocyte subsets, and myocardial injury. Flow cytometric quantification of ROS was done in 21 patients. Data are presented as n (%) or odds ratio (OR) with 95% confidence intervals. RESULTS: Preoperative NLR>4 was present in 239/1652 (14.5%) patients. Myocardial injury occurred in 405/1652 (24.5%) patients and was more common in patients with preoperative NLR>4 [OR: 2.56 (1.92-3.41); P<0.0001]. Myocardial injury was independently associated with lower absolute preoperative lymphocyte count [OR 1.80 (1.50-2.17); P<0.0001] and higher absolute preoperative monocyte count [OR 1.93 (1.12-3.30); P=0.017]. Monocyte ROS generation correlated with NLR (r=0.47; P=0.03). CONCLUSIONS: Preoperative NLR>4 is associated with perioperative myocardial injury, independent of conventional risk factors. Systemic inflammation may contribute to the development of perioperative myocardial injury. CLINICAL TRIAL REGISTRATION: NCT01842568.
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Traumatismos Cardíacos/etiologia , Procedimentos Cirúrgicos Operatórios/métodos , Síndrome de Resposta Inflamatória Sistêmica/complicações , Idoso , Estudos de Coortes , Feminino , Humanos , Complicações Intraoperatórias/etiologia , Contagem de Linfócitos , Masculino , Pessoa de Meia-Idade , Monócitos/metabolismo , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Espécies Reativas de Oxigênio/metabolismo , Fatores de Risco , Resultado do Tratamento , Troponina T/sangueRESUMO
BACKGROUND: Preservation of fertility in cancer patients of reproductive age is a concern for both the patient and the clinician. In this study, we aimed to study the effectiveness of laparoscopic ovarian transposition or ovariopexy in preserving ovarian function in women undergoing pelvic radiotherapy with or without chemotherapy for pelvic tumours. METHODS: The records of patients who underwent laparoscopic ovarian transposition or ovariopexy prior to pelvic radiation therapy between 2002 and 2018 were reviewed retrospectively. RESULTS: Thirty-nine women or adolescent girls with a diagnosis of cervical cancer (n=15), Hodgkin's lymphoma (n=6) or other types of pelvic tumours (n=18) were included in the study. The majority of patients had bilateral (n=25) or unilateral (n=8) ovarian transposition prior to radiotherapy. Nine out of 10 (90%) patients with soft tissue tumors, Ewing sarcoma or ependymoma, five out of seven (71.4%) patients with Hodgkin's lymphoma, two patients (100%) with rectal and anal cancer, and six out of 15 (40%) with cervical cancer retained ovarian function. Patients with cervical cancer, those who received concomitant chemotherapy and those older than 30 years were more likely to experience ovarian failure. Five patients conceived spontaneously and two women had four live births. CONCLUSION: Laparoscopic repositioning of the ovaries out of the radiation field in order to protect ovarian function in patients receiving radiotherapy appears to be effective in the majority of patients. The procedure seems safe and should be considered either as a sole procedure or in association with other fertility preservation methods prior to pelvic radiotherapy.
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BACKGROUND: Despite the increasing importance of cardiopulmonary exercise testing (CPET) for preoperative risk assessment, the reliability of CPET interpretation is unclear. We aimed to assess inter-observer reliability of preoperative CPET. METHODS: We conducted a prospective, multi-centre, observational study of preoperative CPET interpretation. Participants were professionals with previous experience or training in CPET, assessed by a standardized questionnaire. Each participant interpreted 100 tests using standardized software. The CPET variables of interest were oxygen consumption at the anaerobic threshold (AT) and peak oxygen consumption (VO2 peak). Inter-observer reliability was measured using intra-class correlation coefficient (ICC) with a random effects model. Results are presented as ICC with 95% confidence interval, where ICC of 1 represents perfect agreement and ICC of 0 represents no agreement. RESULTS: Participants included 8/28 (28.6%) clinical physiologists, 10 (35.7%) junior doctors, and 10 (35.7%) consultant doctors. The median previous experience was 140 (inter-quartile range 55-700) CPETs. After excluding the first 10 tests (acclimatization) for each participant and missing data, the primary analysis of AT and VO2 peak included 2125 and 2414 tests, respectively. Inter-observer agreement for numerical values of AT [ICC 0.83 (0.75-0.90)] and VO2 peak [ICC 0.88 (0.84-0.92)] was good. In a post hoc analysis, inter-observer agreement for identification of the presence of a reportable AT was excellent [ICC 0.93 (0.91-0.95)] and a reportable VO2 peak was moderate [0.73 (0.64-0.80)]. CONCLUSIONS: Inter-observer reliability of interpretation of numerical values of two commonly used CPET variables was good (>80%). However, inter-observer agreement regarding the presence of a reportable value was less consistent.
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Competência Clínica/estatística & dados numéricos , Teste de Esforço/métodos , Consumo de Oxigênio , Cuidados Pré-Operatórios/métodos , Limiar Anaeróbio , Estudos Transversais , Frequência Cardíaca , Humanos , Estudos Prospectivos , Reprodutibilidade dos TestesRESUMO
The approach to i.v. fluid therapy for hypovolaemia may significantly influence outcomes for patients who experience a systemic inflammatory response after sepsis, trauma, or major surgery. Currently, there is no single i.v. fluid agent that meets all the criteria for the ideal treatment for hypovolaemia. The physician must choose the best available agent(s) for each patient, and then decide when and how much to administer. Findings from large randomized trials suggest that some colloid-based fluids, particularly starch-based colloids, may be harmful in some situations, but it is unclear whether they should be withdrawn from use completely. Meanwhile, crystalloid fluids, such as saline 0.9% and Ringer's lactate, are more frequently used, but debate continues over which preparation is preferable. Perhaps most importantly, it remains unclear how to select the optimal dose of fluid in different patients and different clinical scenarios. There is good reason to believe that both inadequate and excessive i.v. fluid administration may lead to poor outcomes, including increased risk of infection and organ dysfunction, for hypovolaemic patients. In this review, we summarize the current knowledge on this topic and identify some key pitfalls and some areas of agreed best practice.
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Hidratação/métodos , Derivados de Hidroxietil Amido/uso terapêutico , Hipovolemia/tratamento farmacológico , Substitutos do Plasma/uso terapêutico , Solução de Ringer/uso terapêutico , Administração Intravenosa , Coloides , Humanos , Derivados de Hidroxietil Amido/administração & dosagem , Soluções Isotônicas , Substitutos do Plasma/administração & dosagem , Solução de Ringer/administração & dosagemRESUMO
Background: The 100 mm visual analog scale (VAS) score is widely used to measure pain intensity after surgery. Despite this widespread use, it is unclear what constitutes the minimal clinically important difference (MCID); that is, what minimal change in score would indicate a meaningful change in a patient's pain status. Methods: We enrolled a sequential, unselected cohort of patients recovering from surgery and used a VAS to quantify pain intensity. We compared changes in the VAS with a global rating-of-change questionnaire using an anchor-based method and three distribution-based methods (0.3 sd , standard error of the measurement, and 5% range). We then averaged the change estimates to determine the MCID for the pain VAS. The patient acceptable symptom state (PASS) was defined as the 25th centile of the VAS corresponding to a positive patient response to having made a good recovery from surgery. Results: We enrolled 224 patients at the first postoperative visit, and 219 of these were available for a second interview. The VAS scores improved significantly between the first two interviews. Triangulation of distribution and anchor-based methods resulted in an MCID of 9.9 for the pain VAS, and a PASS of 33. Conclusions: Analgesic interventions that provide a change of 10 for the 100 mm pain VAS signify a clinically important improvement or deterioration, and a VAS of 33 or less signifies acceptable pain control (i.e. a responder), after surgery.
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Dor Aguda/diagnóstico , Diferença Mínima Clinicamente Importante , Medição da Dor/métodos , Dor Pós-Operatória/diagnóstico , Satisfação do Paciente/estatística & dados numéricos , Escala Visual Analógica , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Procedimentos Cirúrgicos Operatórios , Inquéritos e Questionários , Adulto JovemRESUMO
BACKGROUND: Stroke volume variation (SVV) and pulse pressure variation (PPV), termed dynamic markers of preload responsiveness, may predict the response to i.v. fluid in critically ill patients. However, the predictive accuracy of these variables during gastrointestinal surgery remains uncertain. METHODS: Observational study of patients aged ≥50 yr undergoing major gastrointestinal surgery, enrolled in the OPTIMISE trial. Patients received six 250 ml fluid challenges with i.v. colloid solution (three during and three after surgery), while SVV and PPV were measured using the LiDCOrapid monitor (LiDCO Ltd, UK). Fluid responsiveness was defined as a stroke volume increase ≥10%. Area under the receiver operating characteristic curve was calculated with 95% confidence intervals. Adjustment for covariates was performed by regression modelling and a clustering method was used to adjust for intra-patient correlation. RESULTS: One hundred patients were recruited between August 2010 and October 2012. Five hundred and fifty-six fluid challenges were administered and 159 (28.6%) were associated with increased stroke volume. The predictive value of both variables was poor during surgery [SVV 0.69 (0.63-0.77); PPV 0.70 (0.62-0.77)], and also after surgery [SVV 0.69 (0.63-0.78); PPV 0.64 (0.56-0.73)]. The findings were similar when analysed according to whether patients were mechanically ventilated [SVV 0.68 (0.63-0.77); PPV 0.69 (0.61-0.77)] or breathing spontaneously [SVV 0.69 (0.61-0.77); PPV 0.63 (0.56-0.72)]. Predictive value improved slightly in a sensitivity analysis excluding outlier values of SVV and PPV. CONCLUSIONS: In this study, the predictive accuracy of SVV and PPV for fluid responsiveness was insufficient to recommend for routine clinical use during or after major gastrointestinal surgery.
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Pressão Sanguínea , Procedimentos Cirúrgicos do Sistema Digestório , Hidratação , Volume Sistólico , Idoso , Idoso de 80 Anos ou mais , Feminino , Hidratação/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Curva ROCRESUMO
OBJECTIVE: Since 2003, over 2000 cases of lymphogranuloma venereum (LGV) have been diagnosed in the U.K. in men who have sex with men (MSM). Most cases present with proctitis, but there are limited data on how to differentiate clinically between LGV and other pathology. We analysed the clinical presentations of rectal LGV in MSM to identify clinical characteristics predictive of LGV proctitis and produced a clinical prediction model. DESIGN: A prospective multicentre case-control study was conducted at six U.K. hospitals from 2008 to 2010. Cases of rectal LGV were compared with controls with rectal symptoms but without LGV. METHODS: Data from 98 LGV cases and 81 controls were collected from patients and clinicians using computer-assisted self-interviews and clinical report forms. Univariate and multivariate logistic regression was used to compare symptoms and signs. Clinical prediction models for LGV were compared using receiver operating curves. RESULTS: Tenesmus, constipation, anal discharge and weight loss were significantly more common in cases than controls. In multivariate analysis, tenesmus and constipation alone were suggestive of LGV (OR 2.98, 95% CI 0.99 to 8.98 and 2.87, 95% CI 1.01 to 8.15, respectively) and that tenesmus alone or in combination with constipation was a significant predictor of LGV (OR 6.97, 95% CI 2.71 to 17.92). The best clinical prediction was having one or more of tenesmus, constipation and exudate on proctoscopy, with a sensitivity of 77% and specificity of 65%. CONCLUSIONS: This study indicates that tenesmus alone or in combination with constipation makes a diagnosis of LGV in MSM presenting with rectal symptoms more likely.
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Constipação Intestinal/etiologia , Homossexualidade Masculina , Linfogranuloma Venéreo/diagnóstico , Dor/etiologia , Doenças Retais/diagnóstico , Redução de Peso , Adulto , Estudos de Casos e Controles , Hemorragia Gastrointestinal/etiologia , Infecções por HIV/complicações , Humanos , Modelos Logísticos , Linfogranuloma Venéreo/complicações , Linfogranuloma Venéreo/fisiopatologia , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Proctite/etiologia , Proctoscopia , Estudos Prospectivos , Doenças Retais/complicações , Doenças Retais/fisiopatologia , Sensibilidade e Especificidade , Reino UnidoRESUMO
BACKGROUND: After treatment, patients with active cancer face a considerable burden from the effects of both the disease and its treatment. The Palliative Rehabilitation Program (prp) is designed to ameliorate disease effects and to improve the patient's functioning. The present study evaluated predictors of program completion and changes in functioning, symptoms, and well-being after the program. METHODS: The program received referrals for 173 patients who had finished anticancer therapy. Of those 173 patients, 116 with advanced cancer were eligible and enrolled in the 8-week interprofessional prp; 67 completed it. Measures of physical, nutritional, social, and psychological functioning were evaluated at entry to the program and at completion. RESULTS: Participants experienced significant improvements in physical performance (p < 0.000), nutrition (p = 0.001), symptom severity (p = 0.005 to 0.001), symptom interference with functioning (p = 0.003 to 0.001), fatigue (p = 0.001), and physical endurance, mobility, and balance or function (p = 0.001 to 0.001). Reasons that participants did not complete the prp were disease progression, geographic inaccessibility, being too well (program not challenging enough), death, and personal or unknown reasons. A normal level of C-reactive protein (<10 mg/L, p = 0.029) was a predictor of program completion. CONCLUSIONS: Patients living with advanced cancers who underwent the interprofessional prp experienced significant improvement in functioning across several domains. Program completion can be predicted by a normal level of C-reactive protein.
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BACKGROUND: Cancer can affect many dimensions of a patient's life, and in turn, it should be targeted using a multimodal approach. We tested the extent to which an interdisciplinary nutrition-rehabilitation program can improve the well-being of patients with advanced cancer. METHODS: Between January 10, 2007, and September 29, 2010, 188 patients with advanced cancer enrolled in the 10-12-week program. Body weight, physical function, symptom severity, fatigue dimensions, distress level, coping ability, and overall quality of life were assessed at the start and end of the program. RESULTS: Of the enrolled patients, 70% completed the program. Patients experienced strong improvements in the physical and activity dimensions of fatigue (effect sizes: 0.8-1.1). They also experienced moderate reductions in the severity of weakness, depression, nervousness, shortness of breath, and distress (effect sizes: 0.5-0.7), and moderate improvements in Six Minute Walk Test distance, maximal gait speed, coping ability, and quality of life (effect sizes: 0.5-0.7) Furthermore, 77% of patients either maintained or increased their body weight. CONCLUSIONS: Interdisciplinary nutrition-rehabilitation can be advantageous for patients with advanced cancer and should be considered an integrated part of standard palliative care.
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BACKGROUND: For evidence-based medical practice, well-defined risk scoring systems are essential to identify patients with a poor prognosis. The objective of this study was to develop a prognostic score, the Montreal prognostic score (MPS), to improve prognostication of patients with incurable non-small cell lung cancer (NSCLC) in everyday practice. METHODS: A training cohort (TC) and a confirmatory cohort (CC) of newly diagnosed patients with NSCLC planning to receive chemotherapy were used to develop the MPS. Stage and clinically available biomarkers were entered into a Cox model and risk weights were estimated. C-statistics were used to test the accuracy. RESULTS: The TC consisted of 258 patients and the CC consisted of 433 patients. Montreal prognostic score classified patients into three distinct groups with median survivals of 2.5 months (95% confidence interval (CI): 1.8, 4.2), 8.2 months (95% CI: 7.0, 9.4) and 18.2 months (95% CI: 14.0, 27.5), respectively (log-rank, P<0.001). Overall, the C-statistics were 0.691 (95% CI: 0.685, 0.697) for the TC and 0.665 (95% CI: 0.661, 0.670) for the CC. CONCLUSION: The MPS, by classifying patients into three well-defined prognostic groups, provides valuable information, which physicians could use to better inform their patients about treatment options, especially the best timing to involve palliative care teams.
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Biomarcadores Tumorais/análise , Carcinoma Pulmonar de Células não Pequenas/diagnóstico , Neoplasias Pulmonares/diagnóstico , Idoso , Biomarcadores Tumorais/metabolismo , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/metabolismo , Carcinoma Pulmonar de Células não Pequenas/patologia , Estudos de Coortes , Feminino , Humanos , Estimativa de Kaplan-Meier , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/metabolismo , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade , Prognóstico , Reprodutibilidade dos Testes , Estudos Retrospectivos , Índice de Gravidade de Doença , Taxa de SobrevidaRESUMO
A chronic inflammatory state (CIS) commonly accompanies advanced cancers. Elements of a CIS include aberrant immune system activity and changes in hypothalamic-neuroendocrine control mechanisms. The end result is stimulation of tumour growth and metastases. In addition to tumour stimulation, cancer symptoms may be enhanced. While for most symptoms correlation with a CIS remains tenuous, clearly a CIS is linked to the aetiology of the cancer anorexia-cachexia syndrome. To date clinical studies aimed at a CIS are modest, but the increased understanding of the partnership of a CIS, cancer progression and anorexia-cachexia must lead to targeting a CIS in concert with conventional efforts to directly destroy tumour tissue.
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Anorexia/etiologia , Caquexia/etiologia , Inflamação/complicações , Neoplasias/complicações , Doença Crônica , Progressão da Doença , Humanos , PrognósticoRESUMO
BACKGROUND: A pilot study (NCT00316563) to determine if delta-9-tetrahydrocannabinol (THC) can improve taste and smell (chemosensory) perception as well as appetite, caloric intake, and quality of life (QOL) for cancer patients with chemosensory alterations. PATIENTS AND METHODS: Adult advanced cancer patients, with poor appetite and chemosensory alterations, were recruited from two sites and randomized in a double-blinded manner to receive either THC (2.5 mg, Marinol(®); Solvay Pharma Inc., n = 24) or placebo oral capsules (n = 22) twice daily for 18 days. Twenty-one patients completed the trial. At baseline and posttreatment, patients completed a panel of patient-reported outcomes: Taste and Smell Survey, 3-day food record, appetite and macronutrient preference assessments, QOL questionnaire, and an interview. RESULTS: THC and placebo groups were comparable at baseline. Compared with placebo, THC-treated patients reported improved (P = 0.026) and enhanced (P < 0.001) chemosensory perception and food 'tasted better' (P = 0.04). Premeal appetite (P = 0.05) and proportion of calories consumed as protein increased compared with placebo (P = 0.008). THC-treated patients reported increased quality of sleep (P = 0.025) and relaxation (P = 0.045). QOL scores and total caloric intake were improved in both THC and placebo groups. CONCLUSIONS: THC may be useful in the palliation of chemosensory alterations and to improve food enjoyment for cancer patients.
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Dronabinol/uso terapêutico , Neoplasias/tratamento farmacológico , Neoplasias/fisiopatologia , Percepção Olfatória/efeitos dos fármacos , Cuidados Paliativos/métodos , Percepção Gustatória/efeitos dos fármacos , Idoso , Método Duplo-Cego , Dronabinol/efeitos adversos , Feminino , Humanos , Masculino , Projetos Piloto , Placebos , Qualidade de VidaRESUMO
BACKGROUND: Accurate prediction of outcome in advanced non-small-cell lung cancer (NSCLC) remains challenging. Even within the same stage and treatment group, survival and response to treatment vary. We set out to determine the predictive value of inflammatory markers C-reactive protein (CRP) and white blood cells (WBCS) in patients with advanced NSCLC. PATIENTS AND METHODS: Patients were assigned a prognostic index (PI): 0 for crp 10 mg/L or less and WBCS 11x109/L or less, 1 if one of the two markers was elevated, and 2 if both markers were elevated. We then used chest computed tomography (CT) imaging to evaluate response after 2 cycles of chemotherapy treatment. RESULTS: Of 134 patients, 46 had a PI of 0; 60, a PI of 1; and 28, a PI of 2. Disease progressed in 41 patients. Progression was significantly more frequent among patients with a PI of 2 (p = 0.008). Median survival was 20.0 months for the PI 0 group, 10.4 months for the PI 1 group, and 7.9 months for the PI 2 group (p < 0.001). The PI was the only significant prognostic factor for survival even after adjustment for performance status, smoking, and weight loss (hazard ratio: 1.57; 95% confidence interval: 1.2 to 2.14; p = 0.004). CONCLUSIONS: Inflammatory state correlates significantly with both chemotherapy response and survival in stage IV NSCLC. The PI may provide additional guidance for therapeutic decision-making.
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BACKGROUND: C-reactive protein (CRP) is gaining credibility as a prognostic factor in different cancers. Cox's proportional hazard (PH) model is usually used to assess prognostic factors. However, this model imposes a priori assumptions, which are rarely tested, that (1) the hazard ratio associated with each prognostic factor remains constant across the follow-up (PH assumption) and (2) the relationship between a continuous predictor and the logarithm of the mortality hazard is linear (linearity assumption). METHODS: We tested these two assumptions of the Cox's PH model for CRP, using a flexible statistical model, while adjusting for other known prognostic factors, in a cohort of 269 patients newly diagnosed with non-small cell lung cancer (NSCLC). RESULTS: In the Cox's PH model, high CRP increased the risk of death (HR=1.11 per each doubling of CRP value, 95% CI: 1.03-1.20, P=0.008). However, both the PH assumption (P=0.033) and the linearity assumption (P=0.015) were rejected for CRP, measured at the initiation of chemotherapy, which kept its prognostic value for approximately 18 months. CONCLUSION: Our analysis shows that flexible modeling provides new insights regarding the value of CRP as a prognostic factor in NSCLC and that Cox's PH model underestimates early risks associated with high CRP.