Central Venous Catheter Complications during Home Parenteral Nutrition: A Prospective Pilot Study of 481 Patients with More than 30,000 Catheter Days

Background: Home parenteral nutrition (HPN) has been shown to delay deterioration in cancer patients with malnutrition. Its risk-benefit ratio, however, is determined by the threat of central venous catheter (CVC) complications. Only few prospective studies on this subject exist, most of them based on small samples. The objective of this study was to provide reliable estimates of incidence rates of CVC complications in everyday HPN patient care in Germany. Patients and Methods: Aiming for a large prospective cohort study, we cooperated with a service provider caring for HPN patients nationwide. Between July 1 and November 30, 2006, all consecutive adult patients with more than 10 infusion days and no previous history of HPN were recruited. Follow-up ended on January 31, 2007. Data were collected in a standardised way by the provider's staff. To prevent underreporting, we used computer-assisted telephone interviews with medical caregivers as a provider-independent data source. Results: 481 patients met the inclusion criteria, contributing a total of 31,337 catheter days. 52 patients experienced a total of 63 CVC complications, resulting in an incidence rate of 2.01 CVC complications per 1,000 catheter days including 1.02 CVC infections per 1,000 catheter days. Conclusion: HPN administration can be safely performed with a relatively low rate of CVC complications

Risk of advanced colorectal neoplasia according to age and gender.

Colorectal cancer (CRC) is one of the leading causes of cancer related morbidity and death. Despite the fact that the mean age at diagnosis of CRC is lower in men, screening by colonoscopy or fecal occult blood test (FOBT) is initiated at same age in both genders. The prevalence of the common CRC precursor lesion, advanced adenoma, is well documented only in the screening population. The purpose of this study was to assess the risk of advanced adenoma at ages below screening age. We analyzed data from a census of 625,918 outpatient colonoscopies performed in adults in Bavaria between 2006 and 2008. A logistic regression model to determine gender- and age-specific risk of advanced neoplasia was developed. Advanced neoplasia was found in 16,740 women (4.6%) and 22,684 men (8.6%). Male sex was associated with an overall increased risk of advanced neoplasia (odds ratio 1.95; 95% confidence interval, CI, 1.91 to 2.00). At any age and in any indication group, more colonoscopies were needed in women than in men to detect advanced adenoma or cancer. At age 75 14.8 (95% CI, 14.4-15.2) screening, 18.2 (95% CI, 17.7-18.7) diagnostic, and 7.9 (95% CI, 7.6-8.2) colonoscopies to follow up on a positive FOBT (FOBT colonoscopies) were needed to find advanced adenoma in women. At age 50 39.0 (95% CI, 38.0-40.0) diagnostic, and 16.3 (95% CI, 15.7-16.9) FOBT colonoscopies were needed. Comparable numbers were reached 20 and 10 years earlier in men than in women, respectively. At any age and independent of the indication for colonoscopy, men are at higher risk of having advanced neoplasia diagnosed upon colonoscopy than women. This suggests that starting screening earlier in life in men than in women might result in a relevant increase in the detection of asymptomatic preneoplastic and neoplastic colonic lesions

Chronic low back pain: a prospective study with 4 to 15 years follow-up after a multidisciplinary biopsychosocial rehabilitation program

BACKGROUND: Multidisciplinary biopsychosocial rehabilitation (MBR) in patients with chronic low back pain (CLBP) is superior to less intensive treatments for at least one year, but the long-term course of the disease is largely unknown. The primary aim of this study was to describe the long-term course of an MBR in relation to pain, disability, and quality of life from the beginning of an MBR to between 4 to 15 years after participation. The secondary aim was to explore the long-term course of an MBR in relation to physiological outcomes of functioning. METHODS: This was a observational study conducted at a university hospital. The cohort consisted of participants of a 3-week, CLBP-specific MBR program between August 2001 and January 2013. The North American Spine Society questionnaire (NASS) pain and disability scale was the primary patient -reported outcome measure (PROM). The NASS neurogenic symptoms scale and the Short-Form 36 (SF-36) health survey were secondary PROMs. Patients were assessed before entry to the MBR (T0), at entry (T1), at discharge (T2) and 4 to 15 years after discharge (T3). Effects were quantified by effect size (ES). Score differences were tested for significance using parametric or non-parametric tests and linear mixed models. RESULTS: Of 299 consecutive patients from the MBR program, 229 could be contacted. Of these, 84 declined participation, five did not meet the inclusion criteria, and 26 had incomplete data. Thus, 114 patients were included. The mean follow-up time was 9.2 years. At T3, patients exhibited beneficial effects for NASS pain and disability with a moderate ES (ES = 0.63; p < 0.001). The NASS neurogenic symptoms scale was stable. The SF-36 scales showed an improvement in the bodily pain domain (ES = 1.02; p < 0.001), but no significant changes for physical functioning, physical role, general health, vitality, social functioning, emotional role, or mental health. The physical health component summary was improved (ES = 0.40, p = 0.002), and the mental health summary was unchanged. The linear mixed model analysis confirmed improvements in pain and disability between T1 and T3 (p = 0.010). CONCLUSIONS: The results of this study suggest that there is a long-term benefit of MBR participation in patients with CLBP

An external control of validity of the German EuroQol-5D questionnaire

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Comparison of two surgical methods for the treatment of CIN: classical LLETZ (large-loop excision of the transformation zone) versus isolated resection of the colposcopic apparent lesion - study protocol for a randomized controlled trial.

Background In compliance with national and international guidelines, non-pregnant women with cervical intraepithelial neoplasia grade 3 should be treated by cervical conization. According to the definition of the large loop excision of the transformation zone (LLETZ) operation, the lesion needs to be resected, including the transformation zone. It is well known from the literature that the cone size directly correlates with the risk of preterm delivery in the course of a future pregnancy. Thus, it would be highly desirable to keep the cone dimension as small as possible while maintaining the same level of oncological safety. Methods/Design The aim of this study is to analyze whether resection of the lesion only, without additional excision of the transformation zone, is equally as effective as the classical LLETZ operation regarding oncological outcome. We are performing this prospective, patient-blinded multicenter trial by randomly assigning women who need to undergo a LLETZ operation for cervical intraepithelial neoplasia grade 3 to either of the following two groups at a ratio of 1:1: (1) additional resection of the transformation zone or (2) resection of the lesion only. To evaluate equal oncological outcome, we are performing human papillomavirus (HPV) tests 6 and 12 months postoperatively. The study is designed to consider the lesion-only operation as oncologically not inferior if the rate of HPV high-risk test results is not higher than 5 % compared with the HPV high-risk rate of women undergoing the classical LLETZ operation. Discussion In case that non-inferiority of the “lesion-only” method can be demonstrated, this operation should eventually become standard treatment for all women at childbearing age due to the reduction in risk of preterm delivery. Trial registration German Clinical Trials Register (DRKS) Identifier: DRKS00006169 webcite. Date of registration: 30 July 2014

Incidence and predictors of immediate complications following perioperative non-obstetric epidural punctures

Background: Epidural Anesthesia (EA) is a well-established procedure. The aim of the present study was to evaluate the incidence of immediate complications following epidural puncture, such as sanguineous puncture, accidental dural perforation, unsuccessful catheter placement or insufficient analgesia and to identify patient and maneuver related risk factors. Methods: A total of 7958 non-obstetrical EA were analyzed. The risk of each complication was calculated according to the preconditions and the level of puncture. For probabilistic evaluation we used a logistic regression model with forward selection. Results: The risk of sanguineous puncture (n = 247, 3.1%) increases with both the patient's age (P = 0.013) and the more caudal the approach (P &lt; 0.01). Dural perforation (n = 123, 1.6%) was found to be influenced only by advanced age (P = 0.019). Unsuccessful catheter placement (n = 68, 0.94%) occurred more often in smaller individuals (P < 0.001) and at lower lumbar sites (P < 0.01). Amongst all cases with successful catheter placement a (partial) insufficient analgesia was found in 692 cases (8.8%). This risk of insufficient analgesia decreased with patient's age (P < 0.01), being least likely for punctures of the lower thoracic spine (P < 0.001). Conclusions: Compared to more cranial levels, EA of the lower spine is associated with an increased risk of sanguineous and unsuccessful puncture. Insufficient analgesia more often accompanies high thoracic and low lumbar approaches. The risk of a sanguineous puncture increases in elderly patients. Gender, weight and body mass index seem to have no influence on the investigated complications

Incidence and predictors of immediate complications following perioperative non-obstetric epidural punctures

Background: Epidural Anesthesia (EA) is a well-established procedure. The aim of the present study was to evaluate the incidence of immediate complications following epidural puncture, such as sanguineous puncture, accidental dural perforation, unsuccessful catheter placement or insufficient analgesia and to identify patient and maneuver related risk factors. Methods: A total of 7958 non-obstetrical EA were analyzed. The risk of each complication was calculated according to the preconditions and the level of puncture. For probabilistic evaluation we used a logistic regression model with forward selection. Results: The risk of sanguineous puncture (n = 247, 3.1%) increases with both the patient's age (P = 0.013) and the more caudal the approach (P &lt; 0.01). Dural perforation (n = 123, 1.6%) was found to be influenced only by advanced age (P = 0.019). Unsuccessful catheter placement (n = 68, 0.94%) occurred more often in smaller individuals (P < 0.001) and at lower lumbar sites (P < 0.01). Amongst all cases with successful catheter placement a (partial) insufficient analgesia was found in 692 cases (8.8%). This risk of insufficient analgesia decreased with patient's age (P < 0.01), being least likely for punctures of the lower thoracic spine (P < 0.001). Conclusions: Compared to more cranial levels, EA of the lower spine is associated with an increased risk of sanguineous and unsuccessful puncture. Insufficient analgesia more often accompanies high thoracic and low lumbar approaches. The risk of a sanguineous puncture increases in elderly patients. Gender, weight and body mass index seem to have no influence on the investigated complications

Variables predicting weaning outcome in prolonged mechanically ventilated tracheotomized patients: a retrospective study

Background: Several studies have assessed predictors of weaning and extubation outcome in short-term mechanically ventilated patients, but there are only few studies on predictors of weaning from prolonged mechanical ventilation. Methods: Retrospective, single-center, observational study at a specialized national weaning center in Germany. Patients' medical records were reviewed to obtain data on demographics, comorbidities, respiratory indices, and the result of a prospectively documented, standardized spontaneous breathing trial (SBT) upon admission to the weaning center. Respiratory indices assessed were the ventilatory ratio (VR) and parameters derived from calculated mechanical power (MP). Predictors associated with failure of prolonged weaning and failure of the SBT were assessed using a binary logistic regression model. Results: A total of 263 prolonged mechanically ventilated, tracheotomized patients, treated over a 5-year period were analyzed. After 3 weeks of mechanical ventilation, patients with unsuccessful weaning failed a SBT more frequently and showed significantly increased values for inspiratory positive airway pressure, driving pressure, VR, absolute MP, and MP normalized to predicted body weight and dynamic lung-thorax compliance (LTC-MP). In the logistic regression analyses, variables independently correlated with weaning failure were female gender (adjusted odds ratio 0.532 95% CI 0.291-0.973; p = 0.040), obesity (body mass index ≥ 30 kg/m2) (2.595 1.210-5.562; p = 0.014), COPD (3.209 1.563-6.589; p = 0.002), LTC-MP (3.470 1.067-11.284; p = 0.039), PaCO2 on mechanical ventilation (1.101 95% CI 1.034-1.173; p = 0.003), and failure of the SBT (4.702 2.250-9.825; p < 0.001). In addition, female gender (0.401 0.216-0.745; p = 0.004), LTC-MP (3.017 1.027-8.862; p = 0.046), and PaCO2 on mechanical ventilation (1.157 1.083-1.235; p < 0.001) were independent risk factors for an unsuccessful SBT. Conclusions In the present study, the derived predictors of weaning point to a crucial role of the workload imposed on respiratory muscles during spontaneous breathing. Mechanical power normalized to lung-thorax compliance was independently correlated with weaning outcome and may identify patients at high risk for weaning failure