[Show abstract][Hide abstract] ABSTRACT: Little is known about the healthcare process for patients with prostate cancer, mainly because hospital-based data are not routinely published. The main objective of this study was to determine the clinical characteristics of prostate cancer patients, the, diagnostic process and the factors that might influence intervals from consultation to diagnosis and from diagnosis to treatment.
We conducted a multicentre, cohort study in seven hospitals in Spain. Patients' characteristics and diagnostic and therapeutic variables were obtained from hospital records and patients' structured interviews from October 2010 to September 2011. We used a multilevel logistic regression model to examine the association between patient care intervals and various variables influencing these intervals (age, BMI, educational level, ECOG, first specialist consultation, tumour stage, PSA, Gleason score, and presence of symptoms) and calculated the odds ratio (OR) and the interquartile range (IQR). To estimate the random inter-hospital variability, we used the median odds ratio (MOR).
470 patients with prostate cancer were included. Mean age was 67.8 (SD: 7.6) years and 75.4 % were physically active. Tumour size was classified as T1 in 41.0 % and as T2 in 40 % of patients, their median Gleason score was 6.0 (IQR:1.0), and 36.1 % had low risk cancer according to the D'Amico classification. The median interval between first consultation and diagnosis was 89 days (IQR:123.5) with no statistically significant variability between centres. Presence of symptoms was associated with a significantly longer interval between first consultation and diagnosis than no symptoms (OR:1.93, 95%CI 1.29-2.89). The median time between diagnosis and first treatment (therapeutic interval) was 75.0 days (IQR:78.0) and significant variability between centres was found (MOR:2.16, 95%CI 1.45-4.87). This interval was shorter in patients with a high PSA value (p = 0.012) and a high Gleason score (p = 0.026).
Most incident prostate cancer patients in Spain are diagnosed at an early stage of an adenocarcinoma. The period to complete the diagnostic process is approximately three months whereas the therapeutic intervals vary among centres and are shorter for patients with a worse prognosis. The presence of prostatic symptoms, PSA level, and Gleason score influence all the clinical intervals differently.
[Show abstract][Hide abstract] ABSTRACT: Systematic reviews of diagnostic validity have been proposed as the best methodological tool to integrate all the available evidence and to help physicians decide whether to use a given diagnostic test. These studies aim to synthesize the results obtained in different primary studies into a couple of indices, generally sensitivity and specificity, or into a summary receiver operating characteristic (ROC) curve. Although there is a certain parallelism with reviews about the efficacy of therapeutic interventions, reviews of diagnostic validity have certain peculiarities that add complexity to the analysis and interpretation of the results. This article emphasizes the methodological aspects that make it possible to critically assess the extent to which the results of a review of the validity of diagnostic tests are valid and provides rudimentary knowledge of the statistics necessary to understand the results.
[Show abstract][Hide abstract] ABSTRACT: There are limited data available about the role of sedation and analgesia during noninvasive positive pressure ventilation (NPPV). The objective of study was to estimate the effect of analgesic or sedative drugs on the failure of NPPV.
We studied patients who received at least 2 h of NPPV as first-line therapy in a prospective observational study carried out in 322 intensive care units from 30 countries. A marginal structural model (MSM) was used to analyze the association between the use of analgesic or sedative drugs and NPPV failure (defined as need for invasive mechanical ventilation).
842 patients were included in the analysis. Of these, 165 patients (19.6 %) received analgesic or sedative drugs at some time during NPPV; 33 of them received both. In the adjusted analysis, the use of analgesics (odds ratio 1.8, 95 % confidence interval 0.6-5.4) or sedatives (odds ratio 2.8, 95 % CI 0.85-9.4) alone was not associated with NPPV failure, but their combined use was associated with failure (odds ratio 5.7, 95 % CI 1.8-18.4).
Slightly less than 20 % of patients received analgesic or sedative drugs during NPPV, with no apparent effect on outcome when used alone. However, the simultaneous use of analgesics and sedatives may be associated with failure of NPPV.
Full-text · Article · May 2015 · Intensive Care Medicine
[Show abstract][Hide abstract] ABSTRACT: Multivariate logistic regression is a statistical method commonly used in several fields to build predictive models. A nomogram is a tool that provides graphical depictions of all variables in the model and enables the user to easily compute output probabilities. Our objective was to build a flexible and easy-to-use nomogram generator in Stata. The script works after arbitrary logit or logistic commands.
[Show abstract][Hide abstract] ABSTRACT: A major determinant of treatment offered to patients with non-small cell lung cancer (NSCLC) is their intrathoracic (mediastinal) nodal status. If the disease has not spread to the ipsilateral mediastinal nodes, subcarinal (N2) nodes, or both, and the patient is otherwise considered fit for surgery, resection is often the treatment of choice. Planning the optimal treatment is therefore critically dependent on accurate staging of the disease. PET-CT (positron emission tomography-computed tomography) is a non-invasive staging method of the mediastinum, which is increasingly available and used by lung cancer multidisciplinary teams. Although the non-invasive nature of PET-CT constitutes one of its major advantages, PET-CT may be suboptimal in detecting malignancy in normal-sized lymph nodes and in ruling out malignancy in patients with coexisting inflammatory or infectious diseases.
Full-text · Article · Nov 2014 · Cochrane database of systematic reviews (Online)
[Show abstract][Hide abstract] ABSTRACT: Objective: To assess whether sleep quality (SQ) at baseline is associated with improvement in pain and disability at three months.
Methods: 422 subacute and chronic patients with neck pain (NP) were recruited in 32 physiotherapy, primary care and specialized centers. NP, referred pain, disability, catastrophizing, depression and SQ were assessed through validated questionnaires, upon recruitment and 3 months later. Correlations between baseline scores were calculated through the Spearman’s coefficient. Improvements in NP, disability and SQ were defined as a reduction ≥30% of baseline score. Six estimative logistic regression models were developed to assess the association between baseline SQ and improvement of NP, baseline SQ and improvement of disability, baseline NP and improvement of SQ, baseline disability and improvement of SQ, the evolutions of NP and SQ, and the evolutions of disability and SQ.
Results: Most patients were subacute and mildly impaired. Regression models showed that: better SQ at baseline is associated with improvement of NP (OR [95%CI]= 0.91 [0.83:0.99]), but not disability (1.04 [0.95;1.13]); the improvement of SQ is associated with more severe NP at baseline (1.26 [1.07;1.49)], but not with baseline disability (0.99 [0.97;1.02]); and that improvement in SQ is associated with improvements in NP (3.48 [1.68; 7.20]), and disability (5.02 [2.39;10,11]).
Discussion: Neck pain is less likely to improve in patients with poorer sleep quality, irrespective of age, sex, catastrophizing, depression or treatments prescribed for NP. Future studies should confirm these results with more severely impaired patients.
No preview · Article · Aug 2014 · Clinical Journal of Pain
[Show abstract][Hide abstract] ABSTRACT: Background:
The presence of oligoclonal IgM bands (OCMB) in cerebrospinal fluid (CSF) is an unfavourable prognostic marker in multiple sclerosis. There is no commercial test to investigate OCMB status. However, a sensitive and specific isoelectrofocusing (IEF) and western blot method was described. We aimed to study the inter-centre reproducibility of this technique, a necessary condition for a reliable test to be incorporated into clinical practice.
The presence of OCMB was analysed by IEF and western blot with prior reduction of pentameric IgM. We assayed the reproducibility of this test in a blinded multicentre study performed in 13 university hospitals. Paired-CSF and serum samples from 52 neurological patients were assayed at every centre.
Global analysis rendered a concordance of 89.8% with a kappa value of 0.71.
These data indicate that OCMB detection by means of IEF and western blot with IgM reduction shows a good interlaboratory reproducibility and thus can be used in daily clinical setting.
No preview · Article · Aug 2014 · Clinica Chimica Acta
[Show abstract][Hide abstract] ABSTRACT: Background
This paper examines the Willingness to Pay (WTP) for a quality-adjusted life year (QALY) expressed by people who attended the healthcare system as well as the association of attitude towards risk and other personal characteristics with their response.
Health-state preferences, measured by EuroQol (EQ-5D-3L), were combined with WTP for recovering a perfect health state. WTP was assessed using close-ended, iterative bidding, contingent valuation method. Data on demographic and socioeconomic characteristics, as well as usage of health services by the subjects were collected. The attitude towards risk was evaluated by collecting risky behaviors data, by the subject’s self-evaluation, and through lottery games.
Six hundred and sixty two subjects participated and 449 stated a utility inferior to 1. WTP/QALY ratios varied significantly when payments with personal money (mean €10,119; median €673) or through taxes (mean €28,187; median €915) were suggested. Family income, area income, higher education level, greater use of healthcare services, and the number of co-inhabitants were associated with greater WTP/QALY ratios. Age and female gender were associated with lower WTP/QALY ratios. Risk inclination was independently associated with a greater WTP/QALY when “out of pocket” payments were suggested. Clear discrepancies were demonstrated between linearity and neutrality towards risk assumptions and experimental results.
WTP/QALY ratios vary noticeably based on demographic and socioeconomic characteristics of the subject, but also on their attitude towards risk. Knowing the expression of preferences by patients from this outcome measurement can be of interest for health service planning.
Full-text · Article · Jul 2014 · BMC Health Services Research
[Show abstract][Hide abstract] ABSTRACT: Diffuse large B-cell lymphoma (DLBCL) is an aggressive non-Hodgkin lymphoma with marked biologic heterogeneity. We analyzed 100 cases of DLBCL to evaluate the prognostic value of immunohistochemical markers derived from the gene expression profiling-defined cell origin signature, including MYC, BCL2, BCL6, and FOXP1 protein expression. We also investigated genetic alterations in BCL2, BCL6, MYC and FOXP1 using fluorescence in situ hybridization and assessed their prognostic significance. BCL6 rearrangements were detected in 29% of cases, and BCL6 gene alteration (rearrangement and/or amplification) was associated with the non-germinal center B subtype (non-GCB). BCL2 translocation was associated with the GCB phenotype, and BCL2 protein expression was associated with the translocation and/or amplification of 18q21. MYC rearrangements were detected in 15% of cases, and MYC protein expression was observed in 29% of cases. FOXP1 expression, mainly of the non-GCB subtype, was demonstrated in 37% of cases. Co-expression of the MYC and BCL2 proteins, with non-GCB subtype predominance, was observed in 21% of cases. We detected an association between high FOXP1 expression and a high proliferation rate as well as a significant positive correlation between MYC overexpression and FOXP1 overexpression. MYC, BCL2 and FOXP1 expression were significant predictors of overall survival. The co-expression of MYC and BCL2 confers a poorer clinical outcome than MYC or BCL2 expression alone, whereas cases negative for both markers had the best outcomes. Our study confirms that DLBCL, characterized by the co-expression of MYC and BCL2 proteins, has a poor prognosis and establishes a significant positive correlation with MYC and FOXP1 over-expression in this entity.
[Show abstract][Hide abstract] ABSTRACT: Objectives:
The aim of this study was to describe 8-year results from post-implementation surveillance of neuroreflexotherapy (NRT), a health technology proven effective for treating neck and back pain.
Post-implementation surveillance included all patients undergoing NRT across five regions within the Spanish National Health Service (SNHS). Validated methods were used to assess pain, disability, adverse events, use of health resources, and patient satisfaction. Logistic regression models were developed to identify the variables associated with the risk of a pain episode requiring more than one NRT intervention. The number of relapses among discharged patients during the 8-year period was calculated.
Between January 1, 2004, and June 30, 2012, 9,023 patients (median age: 53 years), presenting 11,384 subacute (25.2 percent) and chronic (74.8 percent), neck or back pain episodes, were discharged after receiving NRT. Spinal pain improved in 89 percent of cases, 83 percent abandoned drugs, and 0.02 percent required spine surgery. The only adverse event was skin discomfort (8.0 percent of patients). Number of patient complaints was 0, and answers to a standardized questionnaire reflected a high degree of satisfaction (response rate: 76.7 percent). Of the pain episodes, 18.9 percent required more than one NRT intervention; logistic regression models identified the variables associated with this. Over the 8-year period, the proportion of discharged patients referred for treatment due to relapse at the same level for neck, thoracic, and low back pain, was 16.4 percent, 6.5 percent, and 14.5 percent respectively.
Post-marketing surveillance for a non-pharmacological technology is feasible within the SNHS. These results support generalizing NRT across the entire SNHS under the current validated application conditions.
Full-text · Article · May 2014 · International Journal of Technology Assessment in Health Care
[Show abstract][Hide abstract] ABSTRACT: Cancer stem cells (CSCs) are a subset of tumor cells with capacity to self-renew and generate the diverse cells that make up the tumor. The aim of this study is to evaluate the prognostic value of CSCs in a highly homogeneous population of stage II colon cancer.
One hundred stage II colon cancer patients treated by the same surgical team between 1977 and 2005 were retrospectively analyzed. None of the patients received adjuvant chemotherapy. Inmunohistochemistry expression of CD133, NANOG and CK20 was scored, using four levels: <10%, 11-25%, 26-50% and >50% positivity. Kaplan-Meier analysis and log rank test were used to compare survival.
The average patient age was 68 years (patients were between 45-92 years of age) and median follow up was 5.8 years. There was recurrent disease in 17 (17%); CD133 expression (defined by >10% positivity) was shown in 60% of the tumors, in 95% for NANOG and 78% for CK20. No correlation was found among expression levels of CD133, NANOG or CK20 and relapse-free survival (RFS) or overall survival (OS). However, a statistical significant correlation was found between established pathological prognostic factors and RFS and OS.
Stem Cell quantification defined by CD133 and NANOG expression has no correlation with RFS or OS in this cohort of Stage II colon cancer.
[Show abstract][Hide abstract] ABSTRACT: Purpose:
To explore the perceptions of people with low back pain (LBP) treated within the Spanish National Health Service, and their experience while undergoing a new evidence-based treatment ("neuroreflexotherapy").
A focus group (FG) study was conducted. Participants were divided into five groups according to whether they: suffered from subacute versus chronic LBP; had undergone one versus several neuroreflexotherapy procedures; showed a clinically relevant improvement in pain and disability according to validated measuring instruments, and reported it. Thirty-two patients were selected by purposive sampling. Content analysis was undertaken by two researchers who had no contact with the clinicians.
Subacute and chronic LBP curtails daily activities, reduces quality of life (QoL) and self-esteem, and is experienced as a stigma. Patients want to be treated with respect and empathy by clinicians who refrain from judging them. New treatments trigger hope, but also fear and mistrust. Most patients experiencing a clinically relevant improvement resume daily activities, and report improvement in QoL, self-esteem and emotional wellbeing.
Southern European LBP patients have similar perceptions to those in other cultural settings. LBP jeopardizes patients' QoL and self-esteem. When pain improves significantly, patients are happy to acknowledge it and resume their normal life. Implications for Rehabilitation People with low back pain (LBP) want to be treated with respect and empathy by clinicians who inspire confidence and refrain from judging them. When faced with a new evidence based treatment, people with subacute and chronic LBP are hopeful, but apprehensive. Most of those who experience a clinically meaningful improvement after treatment are happy to acknowledge it and resume an active and fulfilling life. People who report no improvements after being treated, should be believed.
No preview · Article · Dec 2013 · Disability and Rehabilitation
[Show abstract][Hide abstract] ABSTRACT: The objective of this study was to assess the association between severe disc degeneration (DD) and low back pain (LBP).
A case-control study was conducted with 304 subjects, aged 35-50, recruited in routine clinical practice across six hospitals; 240 cases (chronic LBP patients with a median pain duration of 46 months) and 64 controls (asymptomatic subjects without any lifetime history of significant LBP). The following variables were assessed once, using previously validated methods: gender, age, body mass index (BMI), lifetime smoking exposure, degree of physical activity, severity of LBP, disability, and findings on magnetic resonance (MRI) (disc degeneration, Modic changes (MC), disc protrusion/hernia, annular tears, spinal stenosis, and spondylolisthesis). Radiologists who interpreted MRI were blinded to the subjects' characteristics. A multivariate logistic regression model assessed the association between severe DD and chronic LBP, adjusting for gender, age, BMI, physical activity, MC, disc protrusion/hernia, and spinal stenosis.
Severe DD at ≥1 level was found in 46.9 % of the controls and 65.8 % of the cases. Crude odds ratio (95 % CI), for suffering chronic LBP when having severe DD, was 2.06 (1.05; 4.06). After adjusting for "MC" and "disc protrusion/hernia," it was 1.81 (0.81; 4.05).
The association between severe DD and LBP ceases to be significant when adjusted for MC and disc protrusion/hernia. These results do not support that DD as a major cause of chronic LBP.
[Show abstract][Hide abstract] ABSTRACT: In the context of shared decision-making, a valid estimation of the probability that a given patient will improve after a specific treatment is valuable.
To develop models that predict the improvement of spinal pain, referred pain, and disability in patients with subacute or chronic neck or low back pain undergoing a conservative treatment.
Analysis of data from a prospective registry in routine practice.
All patients who had been discharged after receiving a conservative treatment within the Spanish National Health Service (SNHS) (n=8,778).
Spinal pain, referred pain, and disability were assessed before the conservative treatment and at discharge by the use of previously validated methods.
Improvement in spinal pain, referred pain, and disability was defined as a reduction in score greater than the minimal clinically important change. A predictive model that included demographic, clinical, and work-related variables was developed for each outcome using multivariate logistic regression. Missing data were addressed using multiple imputation. Discrimination and calibration were assessed for each model. The models were validated by bootstrap, and nomograms were developed.
The following variables showed a predictive value in the three models: baseline scores for pain and disability, pain duration, having undergone X-ray, having undergone spine surgery, and receiving financial assistance for neck or low back pain. Discrimination of the three models ranged from slight to moderate, and calibration was good.
A registry in routine practice can be used to develop models that estimate the probability of improvement for each individual patient undergoing a specific form of treatment. Generalizing this approach to other treatments can be valuable for shared decision making.
No preview · Article · Oct 2013 · The spine journal: official journal of the North American Spine Society
[Show abstract][Hide abstract] ABSTRACT: We reviewed publications with two main objectives: to describe how survival analyses are reported across medical journal specialties and to evaluate changes in reporting across periods and journal specialties.
Systematic review of clinical research articles published in 1991 and 2007, in 13 high-impact medical journals.
The number of articles performing survival analysis published in 1991 (104) and 2007 (240) doubled (17% vs. 33.5%; P = 0.000), although not uniformly across specialties. The percentage of studies using regression models and the number of patients included also increased. The presentation of results improved, although only the reporting of precision of effect estimates reached satisfactory levels (53.1% in 1991 vs. 94.2% in 2007; P = 0.000). Quality of reporting also varied across specialties; for example, cardiology articles were less likely than oncology ones to discuss sample size estimation (odds ratio = 0.12; 95% confidence interval: 0.05, 0.30). We also detected an interaction effect between period and specialty regarding the likelihood of reporting precision of curves and precision of effect estimates.
The application of survival analysis to medical research data is increasing, whereas improvement in reporting quality is slow. We propose a list of minimum requirements for improved application and description of survival analysis.
No preview · Article · Sep 2013 · Journal of clinical epidemiology