Prospective Dutch colorectal cancer cohort: an infrastructure for long-term observational, prognostic, predictive and (randomized) intervention research.

BACKGROUND: Systematic evaluation and validation of new prognostic and predictive markers, technologies and interventions for colorectal cancer (CRC) is crucial for optimizing patients' outcomes. With only 5-15% of patients participating in clinical trials, generalizability of results is poor. Moreover, current trials often lack the capacity for post-hoc subgroup analyses. For this purpose, a large observational cohort study, serving as a multiple trial and biobanking facility, was set up by the Dutch Colorectal Cancer Group (DCCG). METHODS/DESIGN: The Prospective Dutch ColoRectal Cancer cohort is a prospective multidisciplinary nationwide observational cohort study in the Netherlands (yearly CRC incidence of 15 500). All CRC patients (stage I-IV) are eligible for inclusion, and longitudinal clinical data are registered. Patients give separate consent for the collection of blood and tumor tissue, filling out questionnaires, and broad randomization for studies according to the innovative cohort multiple randomized controlled trial design (cmRCT), serving as an alternative study design for the classic RCT. Objectives of the study include: 1) systematically collected long-term clinical data, patient-reported outcomes and biomaterials from daily CRC practice; and 2) to facilitate future basic, translational and clinical research including interventional and cost-effectiveness studies for both national and international research groups with short inclusion periods, even for studies with stringent inclusion criteria. RESULTS: Seven months after initiation 650 patients have been enrolled, eight centers participate, 15 centers await IRB approval and nine embedded cohort- or cmRCT-designed studies are currently recruiting patients. CONCLUSION: This cohort provides a unique multidisciplinary data, biobank, and patient-reported outcomes collection initiative, serving as an infrastructure for various kinds of research aiming to improve treatment outcomes in CRC patients. This comprehensive design may serve as an example for other tumor types.

Association between socioeconomic status, surgical treatment and mortality in patients with colorectal cancer.

BACKGROUND: High socioeconomic status is associated with better survival in colorectal cancer (CRC). This study investigated whether socioeconomic status is associated with differences in surgical treatment and mortality in patients with CRC. METHODS: Patients diagnosed with stage I-III CRC between 2005 and 2010 in the Eindhoven Cancer Registry area in the Netherlands were included. Socioeconomic status was determined at a neighbourhood level by combining the mean household income and the mean value of the housing. RESULTS: Some 4422 patients with colonic cancer and 2314 with rectal cancer were included. Patients with colonic cancer and high socioeconomic status were operated on with laparotomy (70·7 versus 77·6 per cent; P = 0·017), had laparoscopy converted to laparotomy (15·7 versus 29·5 per cent; P = 0·008) and developed anastomotic leakage or abscess (9·6 versus 12·6 per cent; P = 0·049) less frequently than patients with low socioeconomic status. These differences remained significant after adjustment for patient and tumour characteristics. In rectal cancer, patients with high socioeconomic status were more likely to undergo resection (96·3 versus 93·7 per cent; P = 0·083), but this was not significant in multivariable analysis (odds ratio (OR) 1·44, 95 per cent confidence interval 0·84 to 2·46). The difference in 30-day postoperative mortality in patients with colonic cancer and high and low socioeconomic status (3·6 versus 6·8 per cent; P < 0·001) was not significant after adjusting for age, co-morbidities, emergency surgery, and anastomotic leakage or abscess formation (OR 0·90, 0·51 to 1·57). CONCLUSION: Patients with CRC and high socioeconomic status have more favourable surgical treatment characteristics than patients with low socioeconomic status. The lower 30-day postoperative mortality found in patients with colonic cancer and high socioeconomic status is largely explained by patient and surgical factors.

The relationship between disease-related characteristics and conduction disturbances in ankylosing spondylitis.

OBJECTIVES: Ankylosing spondylitis (AS) is associated with an increased cardiovascular (CV) risk. Conduction disturbances (CD) may explain the CV burden, as they are independently associated with cardiac disease. The aim of this study was (i) to determine the prevalence of CD in AS, and (ii) to evaluate the relationship between CD and demographic and AS-related characteristics. METHODS: A rheumatological evaluation assessing demographic and AS-related characteristics and a resting standard 12-lead electrocardiogram (ECG) were performed in 131 consecutive AS patients. RESULTS: A first-degree atrioventricular (AV) block was found in six (4.6%) patients. One (0.8%) patient suffered from a complete right bundle branch block (RBBB) and one (0.8%) patient had a left anterior hemiblock. A prolonged QRS (pQRS) interval was observed in 38 (29.2%) patients, including those with a complete or incomplete BBB. Age, disease duration, and body mass index (BMI) were significantly associated with the PR interval, and male gender, disease duration, and the Bath Ankylosing Spondylitis Metrology Index (BASMI) with the QRS interval. In multivariate analyses, disease duration remained independently associated with both the PR and the QRS intervals. CONCLUSION: Intraventricular CD is highly prevalent in AS, particularly in patients with long-standing disease. Further research is needed to determine whether intraventricular CD contribute to the increased CV risk and long-term CV mortality in AS.