Follow-up care of 12 months of patients with bladder cancer in Spain: A multicenter prospective cohort study.

The therapeutic approach of bladder cancer strongly determines its prognosis. We describe the treatments and outcomes for a Spanish cohort of patients with bladder cancer for the first 12 months after diagnosis and identify the factors that influenced the decision to undergo the treatment received. We conducted a multicenter, prospective, cohort study including primary bladder cancer patients during the first 12 months after diagnosis. The clinical outcomes were performance status (ECOG), adverse events and any cause of mortality. We stratified the analysis by factors that might influence the treatments received. We conducted univariate and multivariable logistic regression models to assess which patient and tumor characteristics were associated with receiving adjuvant treatment in the subgroup of noninvasive bladder cancer patients. In total, 314 patients were included (85% men; 53.8% >70 years) in 7 tertiary Spanish hospitals; 82.2% had a noninvasive urothelial bladder cancer (NMIBC). Patients received mostly surgery plus adjuvant therapy (67.7%). BCG (32.8% patients) was the most frequently administered adjuvant therapy, followed by intravesical chemotherapy (17.8% patients) and radiotherapy (10.8%). The variability of administered treatments among hospitals was low. Patients with NMIBC were more likely to receive adjuvant therapy if they had a higher educational level, some comorbidities and a high-grade tumor. The number of fully active patients (ECOG 0) significantly decreased during the first year of follow-up from 58% to 36 % (OR: 2.41, 95%CI 1.82-3.20); at 12-month follow-up 10.8% patients had died from any cause. In conclusion, most of the patients had a NMIBC. Surgery alone or plus adjuvant therapy were the commonest curative options of bladder cancer. BCG therapy was the adjuvant therapy most frequently administered. Higher educational level, presence of comorbidities and a high-grade tumor were associated with adjuvant therapy. Patient performance status was worsening over time. Almost 1 of 10 patients died during the first year of follow-up.

Follow-up care over 12 months of patients with prostate cancer in Spain: A multicenter prospective cohort study.

ABSTRACT: The therapeutic approach is crucial to prostate cancer prognosis. We describe treatments and outcomes for a Spanish cohort of patients with prostate cancer during the first 12 months after diagnosis and identify the factors that influenced the treatment they received.This multicenter prospective cohort study included patients with prostate cancer followed up for 12 months after diagnosis. Treatment was stratified by factors such as hospital, age group (<70 and ≥70 years), and D'Amico cancer risk classification. The outcomes were Eastern Cooperative Oncology Group (ECOG) performance status, adverse events (AEs), and mortality. The patient characteristics associated with the different treatment modalities were analyzed using multivariate logistic regression.We included 470 men from 7 Spanish tertiary hospitals (mean (standard deviation) age 67.8 (7.6) years), 373 (79.4%) of which received treatment (alone or in combination) as follows: surgery (n = 163; 34.7%); radiotherapy (RT) (n = 149; 31.7%); and hormone therapy (HT) (n = 142; 30.2%). The remaining patients (n = 97) were allocated to no treatment, that is, watchful waiting (14.0%) or active surveillance (5.7%). HT was the most frequently administered treatment during follow-up and RT plus HT was the most common therapeutic combination. Surgery was more frequent in patients aged <70, with lower histologic tumor grades, Gleason scores <7, and lower prostate-specific antigen levels; while RT was more frequent in patients aged ≥70 with histologic tumor grade 4, and higher ECOG scores. HT was more frequent in patients aged ≥70, with histologic tumor grades 3 to 4, Gleason score ≥8, ECOG ≥1, and higher prostate-specific antigen levels. The number of fully active patients (ECOG score 0) decreased significantly during follow-up, from 75.3% at diagnosis to 65.1% at 12 months (P < .001); 230 (48.9%) patients had at least 1 AE, and 12 (2.6%) patients died.Surgery or RT were the main curative options. A fifth of the patients received no treatment. Palliative HT was more frequently administered to older patients with higher tumor grades and higher Gleason scores. Close to half of the patients experienced an AE related to their treatment.

Aspiración manual versus aspiración digital en el tratamiento inicial del neumotórax espontáneo primario: estudio AMVADI. Ensayo clínico aleatorizado / Manual versus digital aspiration for first-line treatment of primary spontaneous pneumothorax. The AMVADI study: a randomized clinical trial

INTRODUCCIÓN: La efectividad de la punción aspiración en el tratamiento inicial del neumotórax espontáneo primario ha sido ampliamente estudiada. El objetivo de este trabajo es comparar la aspiración digital frente a la manual en un ensayo clínico aleatorizado. MÉTODOS: Se ha diseñado un ensayo clínico aleatorizado paralelo con ratio 1:1 y evaluación ciega. El ensayo clínico se adapta al estándar del grupo CONSORT. El resultado primario se define como éxito inmediato e ingreso hospitalario, y los secundarios, como recidiva, reingreso, necesidad de cirugía y días de ingreso. Se realiza encuesta de satisfacción entre los profesionales que realizan los dos tipos de punción. RESULTADOS: Sesenta y siete pacientes han sido incluidos en el estudio (n = 36 grupo control, n = 31 grupo intervención) con un seguimiento del 100%. Ambos grupos presentan un éxito inmediato del 58%, evitándose el ingreso hospitalario. No se observan diferencias en cuanto a recidiva, reingreso, necesidad de cirugía o días de ingreso. El 80% del personal que realiza la técnica de punción prefiere la aspiración digital, siendo el 100% entre el personal que realiza más de 5 punciones al año. CONCLUSIONES: Tanto la punción aspiración manual como la digital ofrecen buenos resultados inmediatos que evitan ingresos hospitalarios; la aspiración digital es el método preferido por quienes realizan dicha técnica

INTRODUCTION: The effectiveness of needle aspiration in the initial treatment of primary spontaneous pneumothorax has been widely studied. The objective of this research was to compare digital with manual aspiration in a randomized clinical trial. METHODS: We designed a blinded parallel-group randomized clinical trial with a 1:1 allocation ratio. The clinical trial is reported in line with the guidelines of the CONSORT group. The primary outcome variables were immediate success and hospital admission, while the secondary outcome measures were relapse, re-admission and need for surgery, and length of hospital stay. A satisfaction survey was also carried out among clinicians who perform these 2 types of aspiration. RESULTS: A total of 67 patients were included in the study (n = 36, control group; n = 31, experimental group) with no losses to follow-up. In both groups, 58% of procedures were immediately successful, avoiding hospital admission. No differences were found in rates of relapse, re-admission, need for surgery, or length of hospital stay. Overall, 80% of clinicians who performed aspiration preferred the digital system, and this preference rose to 100% among clinicians who performed more than 5 procedures a year. CONCLUSIONS: Both manual and digital aspiration provide good immediate results avoiding hospital admission, while digital drainage is preferred by clinicians responsible for first-line treatment of pneumothorax

Current methods for development of rapid reviews about diagnostic tests: an international survey.

BACKGROUND: Rapid reviews (RRs) have emerged as an efficient alternative to time-consuming systematic reviews-they can help meet the demand for accelerated evidence synthesis to inform decision-making in healthcare. The synthesis of diagnostic evidence has important methodological challenges. Here, we performed an international survey to identify the current practice of producing RRs for diagnostic tests. METHODS: We developed and administered an online survey inviting institutions that perform RRs of diagnostic tests from all over the world. RESULTS: All participants (N = 25) reported the implementation of one or more methods to define the scope of the RR; however, only one strategy (defining a structured question) was used by ≥90% of participants. All participants used at least one methodological shortcut including the use of a previous review as a starting point (92%) and the use of limits on the search (96%). Parallelization and automation of review tasks were not extensively used (48 and 20%, respectively). CONCLUSION: Our survey indicates a greater use of shortcuts and limits for conducting diagnostic test RRs versus the results of a recent scoping review analyzing published RRs. Several shortcuts are used without knowing how their implementation affects the results of the evidence synthesis in the setting of diagnostic test reviews. Thus, a structured evaluation of the challenges and implications of the adoption of these RR methods is warranted.

Manual Versus Digital Aspiration for First-Line Treatment of Primary Spontaneous Pneumothorax. The AMVADI Study: A Randomized Clinical Trial. / Aspiración manual versus aspiración digital en el tratamiento inicial del neumotórax espontáneo primario: estudio AMVADI. Ensayo clínico aleatorizado.

INTRODUCTION: The effectiveness of needle aspiration in the initial treatment of primary spontaneous pneumothorax has been widely studied. The objective of this research was to compare digital with manual aspiration in a randomized clinical trial. METHODS: We designed a blinded parallel-group randomized clinical trial with a 1:1 allocation ratio. The clinical trial is reported in line with the guidelines of the CONSORT group. The primary outcome variables were immediate success and hospital admission, while the secondary outcome measures were relapse, re-admission and need for surgery, and length of hospital stay. A satisfaction survey was also carried out among clinicians who perform these 2 types of aspiration. RESULTS: A total of 67 patients were included in the study (n=36, control group; n=31, experimental group) with no losses to follow-up. In both groups, 58% of procedures were immediately successful, avoiding hospital admission. No differences were found in rates of relapse, re-admission, need for surgery, or length of hospital stay. Overall, 80% of clinicians who performed aspiration preferred the digital system, and this preference rose to 100% among clinicians who performed more than 5procedures a year. CONCLUSIONS: Both manual and digital aspiration provide good immediate results avoiding hospital admission, while digital drainage is preferred by clinicians responsible for first-line treatment of pneumothorax.

Evaluation of the predictive value of the hematopoietic progenitor cell count using an automated hematology analyzer for CD34+ stem cell mobilization and apheresis product yield.

INTRODUCTION: We evaluated the value of hematopoietic progenitor cells (HPCs) counted in Sysmex XN analyzers to predict the mobilization and collection of CD34+ cells in apheresis for stem cell transplantation. METHODS: Eighty patients who underwent stem cell transplantation were enrolled (50 autologous and 30 allogeneic). In the autologous group, patients were considered poor mobilizers when the CD34+ count was <10 × 106 /L or <20 × 106 /L in patients with multiple myeloma who were going to undergo two transplants. ROC curves were generated, and HPC cutoffs were calculated. RESULTS: The correlation between the HPC and CD34+ cell counts was good. Two algorithms were proposed. In the first algorithm, samples collected the day before apheresis, negative and positive HPC cutoffs were selected to detect poor and good mobilization and, therefore, the need or not to administer plerixafor. In the second algorithm, samples collected pre-apheresis, the negative HPC cutoff was an indication to delay apheresis; an HPC higher than the optimal cutoff was an indication to start apheresis. When the HPC values were between these cutoffs, there was an indication to count CD34+ cells for a better decision-making. Finally, in samples collected pre-apheresis, HPC counts could be used to predict patients who would have poor CD34+ cell collections. In the allogeneic group, all the donors mobilized well, and very few needed two apheresis procedures. CONCLUSIONS: The HPC count is useful for decision-making in the management of patients subjected to apheresis procedures to collect peripheral blood stem cells.

Rapid reviews of medical tests used many similar methods to systematic reviews but key items were rarely reported: a scoping review.

BACKGROUND AND OBJECTIVES: Rapid reviews provide an efficient alternative to standard systematic reviews in response to a high priority or urgent need. Although rapid reviews of interventions have been extensively evaluated, little is known about the characteristics of rapid reviews of diagnostic evidence. STUDY DESIGN AND SETTING: We performed a scoping review for rapid reviews of medical tests published from 2013 to 2018. We extracted information on review characteristics and methods used to assess the evidence. RESULTS: We identified 191 rapid reviews. All reviews were developed within a short time (less than 12 months) and were relatively concise (less than 10 pages). The reviews involved multiple index tests (44%), multiple outcomes (88%), and several test applications (29%). Well-known methodological tailoring strategies were infrequently used. Although reporting of several key features was limited, we found that, in general, rapid reviews have similar characteristics to broader knowledge syntheses. CONCLUSION: Our scoping review is the first to describe the characteristics and methods of rapid reviews of diagnostic evidence. Future research should identify the most appropriate methods for performing rapid reviews of medical tests. Standards for reporting of rapid reviews are needed.

Results from the CLUES study: a cluster randomized trial for the evaluation of cardiovascular guideline implementation in primary care in Spain.

BACKGROUND: The implementation of evidence-based clinical practice guidelines (CPG) can improve patients care. To date, the impact of implementation strategies has not been evaluated in our context. This study is aimed to evaluate the effectiveness of a multifaceted tailored intervention targeting clinician education for the implementation of three cardiovascular risk-related CPGs (type 2 diabetes, hypertension and dyslipidemia) in primary care at the Basque Health Service compared with usual implementation. METHODS: We conducted a cluster randomized controlled trial in two urban districts with 43 primary care units (PCU). Data from all patients diagnosed with diabetes, hypertension and all those eligible for coronary risk (CR) assessment were included. In the control group, guidelines were introduced in the usual way (by email, intranet and clinical meetings). In the intervention group, the implementation also included a specific website and workshops. Primary endpoints were annual HbA1c testing (diabetes), annual general laboratory testing (hypertension) and annual CR assessment (dyslipidemia). Secondary endpoints were process, prescription and clinical endpoints related with guideline recommendations. Analysis was performed at a PCU level weighted by cluster size. RESULTS: Significant differences between groups were observed in primary outcomes in the dyslipidemia CPG: increased CR assessment for both women and men (weighted mean difference, WMD, 13.58 and 12.91%). No significant differences were observed in diabetes and hypertension CPGs primary outcomes. Regarding secondary endpoints, annual CR assessment was significantly higher in both diabetic and hypertensive patients in the intervention group (WMD 28.16 and 27.55%). Rates of CR assessment before starting new statin treatments also increased (WMD 23.09%), resulting in a lower rate of statin prescribing in low risk women. Diuretic prescribing was higher in the intervention group (WMD 20.59%). Clinical outcomes (HbA1c and blood pressure control) did not differ between groups. CONCLUSIONS: The multifaceted implementation proved to be effective to increase the CR assessment and to improve prescription, but ineffective to improve diabetes and hypertension related outcomes. In order to obtain real improvements when cardiovascular issues are tackled, perhaps other or additional interventions need to be implemented besides education of professionals. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN 88876909 (retrospectively registered on January 13, 2009).

Clinical interval and diagnostic characteristics in a cohort of bladder cancer patients in Spain: a multicenter observational study.

OBJECTIVE: We performed a cohort study in seven hospitals in Spain to determine the clinical characteristics of incident patients with bladder cancer, the diagnostic process, and the conditions that might affect health care interval times. RESULTS: 314 patients with bladder cancer were included, 70.3 (Standard Deviation [SD] 11.2) years old and 85.0% male. Clinical stage was T1 in 45.9% of patients. The median interval time between first consultation and diagnosis was of 104.0 days (Inter quartile range [IQR]:112.0; range from 0 to 986), being shorter for those patients who attended a hospital for their first consultation. The median interval time between diagnosis and first treatment was of 0.0 days (IQR: 0.0; range from 0 to 366), being longer when the patient had a pathologic tumor stage ≥ T2a.

Intra-rater reliability and agreement of various methods of measurement to assess dorsiflexion in the Weight Bearing Dorsiflexion Lunge Test (WBLT) among female athletes.

OBJECTIVES: To examine the intra-observer reliability and agreement between five methods of measurement for dorsiflexion during Weight Bearing Dorsiflexion Lunge Test and to assess the degree of agreement between three methods in female athletes. DESIGN: Repeated measurements study design. SETTING: Volleyball club. PARTICIPANTS: Twenty-five volleyball players. MAIN OUTCOME MEASUREMENTS: Dorsiflexion was evaluated using five methods: heel-wall distance, first toe-wall distance, inclinometer at tibia, inclinometer at Achilles tendon and the dorsiflexion angle obtained by a simple trigonometric function. For the statistical analysis, agreement was studied using the Bland-Altman method, the Standard Error of Measurement and the Minimum Detectable Change. Reliability analysis was performed using the Intraclass Correlation Coefficient. RESULTS: Measurement methods using the inclinometer had more than 6° of measurement error. The angle calculated by trigonometric function had 3.28° error. The reliability of inclinometer based methods had ICC values < 0.90. Distance based methods and trigonometric angle measurement had an ICC values > 0.90. Concerning the agreement between methods, there was from 1.93° to 14.42° bias, and from 4.24° to 7.96° random error. CONCLUSION: To assess DF angle in WBLT, the angle calculated by a trigonometric function is the most repeatable method. The methods of measurement cannot be used interchangeably.

Cancer risk in DM1 is sex-related and linked to miRNA-200/141 downregulation.

OBJECTIVE: Describe the incidence of cancer in a large cohort of patients with myotonic dystrophy type 1 (DM1) and to unravel the underlying molecular mechanisms. METHODS: Standardized incidence ratios (SIRs) were calculated in the Gipuzkoa DM1 cohort (1985-2013), dividing observed numbers by expected numbers for all cancers combined and stratified by sex. An estimation of the expected incidence was achieved by multiplying the age- and sex-specific incidence rates from the Basque population cancer registry by the person-years observed in the study cohort. Large-scale gene expression of peripheral blood mononuclear cell samples derived from 10 individuals with DM1 (5 men, 5 women) and 10 healthy matched controls was analyzed by the Human Gene 1.0 ST Affymetrix microarray. RESULTS: During 18,796 person-years of follow-up, corresponding to 424 patients with DM1, we observed 70 cancers in 62 patients giving a 1.81-fold risk (95% confidence interval [CI] 1.37-2.36), which was stronger in women than in men. Ovary (SIR 8.33, 95% CI 1.72-24.31) and endometrium (SIR 6.86, 95% CI 2.23-16.02) in women and thyroid (SIR 23.33, 95% CI 9.38-48.08) and brain (SIR 9.80, 95% CI 3.18-22.88) in both sexes were tumor sites with significantly higher risks in DM1. There were differences in gene expression between healthy controls and patients with DM1 and between men and women with DM1; all patients with DM1 combined and female patients with DM1 displayed significant downregulation of the microRNA (miRNA)-200c/141 tumor suppressor family. CONCLUSIONS: Oncologic risk is increased in DM1, especially in women and for gynecologic, brain, and thyroid cancer. Expression of the miRNA-200/miRNA-141 tumor suppressor family is decreased in women with DM1.

DianaHealth.com, an On-Line Database Containing Appraisals of the Clinical Value and Appropriateness of Healthcare Interventions: Database Development and Retrospective Analysis.

OBJECTIVE: To describe the development of a novel on-line database aimed to serve as a source of information concerning healthcare interventions appraised for their clinical value and appropriateness by several initiatives worldwide, and to present a retrospective analysis of the appraisals already included in the database. METHODS AND FINDINGS: Database development and a retrospective analysis. The database DianaHealth.com is already on-line and it is regularly updated, independent, open access and available in English and Spanish. Initiatives are identified in medical news, in article references, and by contacting experts in the field. We include appraisals in the form of clinical recommendations, expert analyses, conclusions from systematic reviews, and original research that label any health care intervention as low-value or inappropriate. We obtain the information necessary to classify the appraisals according to type of intervention, specialties involved, publication year, authoring initiative, and key words. The database is accessible through a search engine which retrieves a list of appraisals and a link to the website where they were published. DianaHealth.com also provides a brief description of the initiatives and a section where users can report new appraisals or suggest new initiatives. From January 2014 to July 2015, the on-line database included 2940 appraisals from 22 initiatives: eleven campaigns gathering clinical recommendations from scientific societies, five sets of conclusions from literature review, three sets of recommendations from guidelines, two collections of articles on low clinical value in medical journals, and an initiative of our own. CONCLUSIONS: We have developed an open access on-line database of appraisals about healthcare interventions considered of low clinical value or inappropriate. DianaHealth.com could help physicians and other stakeholders make better decisions concerning patient care and healthcare systems sustainability. Future efforts should be focused on assessing the impact of these appraisals in the clinical practice.

Design Characteristics Influence Performance of Clinical Prediction Rules in Validation: A Meta-Epidemiological Study.

BACKGROUND: Many new clinical prediction rules are derived and validated. But the design and reporting quality of clinical prediction research has been less than optimal. We aimed to assess whether design characteristics of validation studies were associated with the overestimation of clinical prediction rules' performance. We also aimed to evaluate whether validation studies clearly reported important methodological characteristics. METHODS: Electronic databases were searched for systematic reviews of clinical prediction rule studies published between 2006 and 2010. Data were extracted from the eligible validation studies included in the systematic reviews. A meta-analytic meta-epidemiological approach was used to assess the influence of design characteristics on predictive performance. From each validation study, it was assessed whether 7 design and 7 reporting characteristics were properly described. RESULTS: A total of 287 validation studies of clinical prediction rule were collected from 15 systematic reviews (31 meta-analyses). Validation studies using case-control design produced a summary diagnostic odds ratio (DOR) 2.2 times (95% CI: 1.2-4.3) larger than validation studies using cohort design and unclear design. When differential verification was used, the summary DOR was overestimated by twofold (95% CI: 1.2 -3.1) compared to complete, partial and unclear verification. The summary RDOR of validation studies with inadequate sample size was 1.9 (95% CI: 1.2 -3.1) compared to studies with adequate sample size. Study site, reliability, and clinical prediction rule was adequately described in 10.1%, 9.4%, and 7.0% of validation studies respectively. CONCLUSION: Validation studies with design shortcomings may overestimate the performance of clinical prediction rules. The quality of reporting among studies validating clinical prediction rules needs to be improved.

Lack of concordance amongst measurements of individual anaerobic threshold and maximal lactate steady state on a cycle ergometer.

INTRODUCTION: The calculation of exertion intensity, in which a change is produced in the metabolic processes which provide the energy to maintain physical work, has been defined as the anaerobic threshold (AT). The direct calculation of maximal lactate steady state (MLSS) would require exertion intensities over a long period of time and with sufficient rest periods which would prove significantly difficult for daily practice. Many protocols have been used for the indirect calculation of MLSS. OBJECTIVES: The aim of this study is to determine if the results of measurements with 12 different AT calculation methods and calculation software [Keul, Simon, Stegmann, Bunc, Dickhuth (TKM and WLa), Dmax, Freiburg, Geiger-Hille, Log-Log, Lactate Minimum] can be used interchangeably, including the method of the fixed threshold of Mader/OBLA's 4 mmol/l and then to compare them with the direct measurement of MLSS. METHODS: There were two parts to this research. Phase 1: results from 162 exertion tests chosen at random from the 1560 tests. Phase 2: sixteen athletes (n = 16) carried out different tests on five consecutive days. RESULTS: There was very high concordance among all the methods [intraclass correlation coefficient (ICC) > 0.90], except Log-Log in relation to the Stegamnn, Dmax, Dickhuth-WLa and Geiger-Hille. The Dickhuth-TKM showed a high tendency towards concordance, with Dmax (2.2 W) and Dickhuth-WLa (0.1 W). The Dickhuth-TKM method presented a high tendency to concordance with Dickhuth-WLa (0.5 W), Freiburg (7.4 W), MLSS (2.0 W), Bunc (8.9 W), Dmax (0.1 W). The calculation of MLSS power showed a high tendency to concordance, with Dickhuth-TKM (2 W), Dmax (2.1 W), Dickhuth-WLa (1.5 W). CONCLUSION: The fixed threshold of 4 mmol/l or OBLA produces slightly different and higher results than those obtained with all the methods analyzed, including MLSS, meaning an overestimation of power in the individual anaerobic threshold. The Dickhuth-TKM, Dmax and Dickhuth-WLa methods defined a high concordance on a cycle ergometer. Dickhuth-TKM, Dmax, Dickhuth-WLa described a high concordance with the power calculated to know the MLSS.

Standard and fenestrated endograft sizing in EVAR planning: Description and validation of a semi-automated 3D software.

An abdominal aortic aneurysm (AAA) is a pathological dilation of the abdominal aorta that may lead to a rupture with fatal consequences. Endovascular aneurysm repair (EVAR) is a minimally invasive surgical procedure consisting of the deployment and fixation of a stent-graft that isolates the damaged vessel wall from blood circulation. The technique requires adequate endovascular device sizing, which may be performed by vascular analysis and quantification on Computerized Tomography Angiography (CTA) scans. This paper presents a novel 3D CTA image-based software for AAA inspection and EVAR sizing, eVida Vascular, which allows fast and accurate 3D endograft sizing for standard and fenestrated endografts. We provide a description of the system and its innovations, including the underlying vascular image analysis and visualization technology, functional modules and user interaction. Furthermore, an experimental validation of the tool is described, assessing the degree of agreement with a commercial, clinically validated software, when comparing measurements obtained for standard endograft sizing in a group of 14 patients.

Clinical intervals and diagnostic characteristics in a cohort of prostate cancer patients in Spain: a multicentre observational study.

BACKGROUND: 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. METHODS: 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). RESULTS: 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). CONCLUSIONS: 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.

Gender and plasma iron biomarkers, but not HFE gene mutations, increase the risk of colorectal cancer and polyps.

A cohort study of patients included in the Basque Country colorectal cancer (CRC) screening programme was carried out to assess the risk of adenomatous polyps and CRC (P-CRC) associated with HFE gene mutations, with gender and with iron biomarkers (serum ferritin (SF), iron (Fe) and transferrin saturation index (TSI)). Among 432 included patients (mean age 59.8 years), 263 were men (60.9 %) and 169 women (39.1 %). P-CRC were identified in 221 patients (51.2 %) and no polyps (NP) in 211 patients (48.8 %). HFE mutations were identified in 43.8 % of the patients. C282Y/wt genotypic frequency was 6.8 % in the P-CRC group and 1.4 % in the NP group (p < 0.05). The allelic frequency was 3.8 versus 1.2 % (p < 0.05). For laboratory, all three iron biomarkers showed a statistically significant difference: mean Fe, 91.29 ± 34 for P-CRC and 80.81 ± 30.59 for NP group. Mean TSI for P-CRC was 24.95 ± 8.90 and 22.74 ± 8.79 for NP group. Mean SF 308.09 ± 536.32 for P-CRC and 177.55 ± 159.95 for NP group. In a multivariate logistic regression analysis, only male gender (odds ratio (OR) = 2.04, 1.29-3.22), SF (OR = 1.001, 1.0004-1.003) and Fe (OR = 1.01, 1.004-1.02) were related with the presence of CRC and adenoma. Men gender and raised serum iron biomarkers increase the risk of P-CRC.

Quality of life in patients with non-muscle-invasive bladder cancer: one-year results of a multicentre prospective cohort study.

OBJECTIVE: Few studies describe the effect of non-muscle-invasive bladder cancer (NMIBC) on health-related quality of life (HRQL), although patients are mostly diagnosed at this stage of the disease. Taking into account this current evidence gap and the high incidence rates in Spain, we aimed to describe the evolution over time of HRQL in Spanish patients with NMIBC and to examine the clinical and treatment-related factors associated with HRQL change during the first year of management. METHODS AND MATERIALS: Observational multicenter prospective inception cohort study conducted in urology departments of 7 Spanish hospitals. A consecutive sample of 244 patients with anatomopathologically confirmed NMIBC, recruited from October 2010 to September 2011, was followed during the diagnostic process, and 6 and 12 months later. HRQL was assessed by generic and disease-specific instruments: the Short Form-36 (covering physical and mental health) and the Bladder Cancer Index, measuring urinary, bowel, and sexual domains (summary scores: 0-100). Bivariate analysis was performed and generalized estimating equation models were constructed to assess HRQL score change. RESULTS: Almost 52% of the patients were diagnosed at stage I, and 84% were men. The number of patients treated only with transurethral resection (TUR) was 144, and 82 also received intravesical therapy with bacillus Calmette-Guérin (BCG) or mitomycin C. Mental health was significantly worse than Short Form-36 reference norms at diagnosis (mean of 49.7 vs. 53.3, 95% CI: 52.5-54.2). Urinary domain improved significantly from diagnosis (85.2, 95% CI: 82.9-87.4) to 12-month evaluation (90.2, 95% CI: 87.7-92.8), whereas sexual domain showed deterioration from 56.4 (95% CI: 52.8-59.9) to 53.7 (95% CI: 50.0-57.4). Adjusted HRQL score changes from baseline to 12-month follow-up estimated with generalized estimating equation models showed improvement on the following parameters: urinary domain after TUR with or without intravesical therapy (+3.9, 95% CI: 0.1-7.7), bowel domain among patients treated with TUR and BCG (+7.0, 95% CI: 2.4-11.5), and sexual domain among those treated with TUR and mitomycin C (+13.1, 95% CI: 5.9-20.2). CONCLUSIONS: For the first time, a distinctive HRQL pattern of bladder cancer treatment benefits emerges for TUR alone, and in combination with BCG or mitomycin C, which deserves further research. Treatment differences cannot be interpreted in terms of efficacy but can be useful to generate hypotheses to test in future studies.