[Anal protrusion of a ventriculo-peritoneal shunt]. / Wat steekt daar uit de anus?

A 26-year-old female patient presented to our emergency department with anal protrusion of her ventriculo-peritoneal shunt. She had no complaints other than slight abdominal discomfort. Laboratory values were normal. Laparoscopy was performed, revealing that the shunt entered the colon mid-descedens. Here, the shunt was cut and the puncture site was closed with a suture. The patient recovered without complications.

Noninferiority of Posterior Cervical Foraminotomy vs Anterior Cervical Discectomy With Fusion for Procedural Success and Reduction in Arm Pain Among Patients With Cervical Radiculopathy at 1 Year: The FACET Randomized Clinical Trial.

Importance: The choice between posterior cervical foraminotomy (posterior surgery) and anterior cervical discectomy with fusion (anterior surgery) for cervical foraminal radiculopathy remains controversial. Objective: To investigate the noninferiority of posterior vs anterior surgery in patients with cervical foraminal radiculopathy with regard to clinical outcomes after 1 year. Design, Setting, and Participants: This multicenter investigator-blinded noninferiority randomized clinical trial was conducted from January 2016 to May 2020 with a total follow-up of 2 years. Patients were included from 9 hospitals in the Netherlands. Of 389 adult patients with 1-sided single-level cervical foraminal radiculopathy screened for eligibility, 124 declined to participate or did not meet eligibility criteria. Patients with pure axial neck pain without radicular pain were not eligible. Of 265 patients randomized (132 to posterior and 133 to anterior), 15 were lost to follow-up and 228 were included in the 1-year analysis (110 in posterior and 118 in anterior). Interventions: Patients were randomly assigned 1:1 to posterior foraminotomy or anterior cervical discectomy with fusion. Main Outcomes and Measures: Primary outcomes were proportion of success using Odom criteria and decrease in arm pain using a visual analogue scale from 0 to 100 with a noninferiority margin of 10% (assuming advantages with posterior surgery over anterior surgery that would justify a tolerable loss of efficacy of 10%). Secondary outcomes were neck pain, disability, quality of life, work status, treatment satisfaction, reoperations, and complications. Analyses were performed with 2-proportion z tests at 1-sided .05 significance levels with Bonferroni corrections. Results: Among 265 included patients, the mean (SD) age was 51.2 (8.3) years; 133 patients (50%) were female and 132 (50%) were male. Patients were randomly assigned to posterior (132) or anterior (133) surgery. The proportion of success was 0.88 (86 of 98) in the posterior surgery group and 0.76 (81 of 106) in the anterior surgery group (difference, -0.11 percentage points; 1-sided 95% CI, -0.01) and the between-group difference in arm pain was -2.8 (1-sided 95% CI, -9.4) at 1-year follow-up, indicating noninferiority of posterior surgery. Decrease in arm pain had a between-group difference of 3.4 (1-sided 95% CI, 11.8), crossing the noninferiority margin with 1.8 points. All secondary outcomes had 2-sided 95% CIs clustered around 0 with small between-group differences. Conclusions and Relevance: In this randomized clinical trial, posterior surgery was noninferior to anterior surgery for patients with cervical radiculopathy regarding success rate and arm pain at 1 year. Decrease in arm pain and secondary outcomes had small between-group differences. These results may be used to enhance shared decision-making. Trial Registration: Netherlands Trial Register Identifier: NTR5536.

Between-hospital variation in time to glioblastoma surgery: a report from the Quality Registry Neuro Surgery in the Netherlands.

OBJECTIVE: Patients with glioblastoma are often scheduled for urgent elective surgery. Currently, the impact of the waiting period until glioblastoma surgery is undetermined. In this national quality registry study, the authors determined the wait times until surgery for patients with glioblastoma, the risk factors associated with wait times, and the risk-standardized variation in time to surgery between Dutch hospitals. The associations between time to surgery and patient outcomes were also explored. METHODS: Data from all 4589 patients who underwent first-time glioblastoma surgery between 2014 and 2019 in the Netherlands were collected by 13 hospitals in the Quality Registry Neuro Surgery. Time to surgery comprised 1) the time from first MR scan to surgery (MTS), and 2) the time from first neurosurgical consultation to surgery (CTS). Long MTS was defined as more than 21 days and long CTS as more than 14 days. Potential risk factors were analyzed in multivariable logistic regression models. The standardized rate of long time to surgery was analyzed using funnel plots. Patient outcomes including Karnofsky Performance Scale (KPS) score change, complications, and survival were analyzed by multivariable logistic regression and proportional hazards models. RESULTS: The median overall MTS and CTS were 18 and 9 days, respectively. Overall, 2576 patients (56%) had an MTS within 3 weeks and 3069 (67%) had a CTS within 2 weeks. Long MTS was significantly associated with older age, higher preoperative KPS score, higher American Society of Anesthesiologists comorbidity class, season, lower hospital case volume, university affiliation, and resection. Long CTS was significantly associated with higher baseline KPS score, university affiliation, resection, more recent year of treatment, and season. In funnel plots, considerable practice variation was observed between hospitals in patients with long times to surgery. Fewer patients with KPS score improvement were observed after a long time until resection. Long CTS was associated with longer survival. Complications and KPS score decline were not associated with time to surgery. CONCLUSIONS: Considerable between-hospital variation among Dutch hospitals was observed in the time to glioblastoma surgery. A long time to resection impeded KPS score improvement, and therefore, patients who may improve should be identified for more urgent resection. Longer survival was observed in patients selected for longer time until surgery after neurosurgical consultation (CTS).

Between-hospital variation in rates of complications and decline of patient performance after glioblastoma surgery in the dutch Quality Registry Neuro Surgery.

INTRODUCTION: For decisions on glioblastoma surgery, the risk of complications and decline in performance is decisive. In this study, we determine the rate of complications and performance decline after resections and biopsies in a national quality registry, their risk factors and the risk-standardized variation between institutions. METHODS: Data from all 3288 adults with first-time glioblastoma surgery at 13 hospitals were obtained from a prospective population-based Quality Registry Neuro Surgery in the Netherlands between 2013 and 2017. Patients were stratified by biopsies and resections. Complications were categorized as Clavien-Dindo grades II and higher. Performance decline was considered a deterioration of more than 10 Karnofsky points at 6 weeks. Risk factors were evaluated in multivariable logistic regression analysis. Patient-specific expected and observed complications and performance declines were summarized for institutions and analyzed in funnel plots. RESULTS: For 2271 resections, the overall complication rate was 20 % and 16 % declined in performance. For 1017 biopsies, the overall complication rate was 11 % and 30 % declined in performance. Patient-related characteristics were significant risk factors for complications and performance decline, i.e. higher age, lower baseline Karnofsky, higher ASA classification, and the surgical procedure. Hospital characteristics, i.e. case volume, university affiliation and biopsy percentage, were not. In three institutes the observed complication rate was significantly less than expected. In one institute significantly more performance declines were observed than expected, and in one institute significantly less. CONCLUSIONS: Patient characteristics, but not case volume, were risk factors for complications and performance decline after glioblastoma surgery. After risk-standardization, hospitals varied in complications and performance declines.

Between-hospital variation in mortality and survival after glioblastoma surgery in the Dutch Quality Registry for Neuro Surgery.

PURPOSE: Standards for surgical decisions are unavailable, hence treatment decisions can be personalized, but also introduce variation in treatment and outcome. National registrations seek to monitor healthcare quality. The goal of the study is to measure between-hospital variation in risk-standardized survival outcome after glioblastoma surgery and to explore the association between survival and hospital characteristics in conjunction with patient-related risk factors. METHODS: Data of 2,409 adults with first-time glioblastoma surgery at 14 hospitals were obtained from a comprehensive, prospective population-based Quality Registry Neuro Surgery in The Netherlands between 2011 and 2014. We compared the observed survival with patient-specific risk-standardized expected early (30-day) mortality and late (2-year) survival, based on age, performance, and treatment year. We analyzed funnel plots, logistic regression and proportional hazards models. RESULTS: Overall 30-day mortality was 5.2% and overall 2-year survival was 13.5%. Median survival varied between 4.8 and 14.9 months among hospitals, and biopsy percentages ranged between 16 and 73%. One hospital had lower than expected early mortality, and four hospitals had lower than expected late survival. Higher case volume was related with lower early mortality (P = 0.031). Patient-related risk factors (lower age; better performance; more recent years of treatment) were significantly associated with longer overall survival. Of the hospital characteristics, longer overall survival was associated with lower biopsy percentage (HR 2.09, 1.34-3.26, P = 0.001), and not with academic setting, nor with case volume. CONCLUSIONS: Hospitals vary more in late survival than early mortality after glioblastoma surgery. Widely varying biopsy percentages indicate treatment variation. Patient-related factors have a stronger association with overall survival than hospital-related factors.

Porcine fetal ventral mesencephalic cells are targets for primed xenoreactive human T cells.

Xenotransplantation of porcine fetal ventral mesencephalic (pfVM) cells to overcome the dopamine shortage in the striatum of patients with Parkinson's disease seems a viable alternative to allotransplantion of human fetal donor tissue, especially because the latter is complicated by both practical and ethical issues. There is, however, little known about the xenospecific immune responses involved in such an intracerebral xenotransplantation. The aim of our study was to investigate whether (1) naive human peripheral blood mononuclear cells (PMBC) display cytotoxicity against pfVM cells of E28 pig fetuses, and (2) priming of human PBMC by xenogeneic antigen presenting cells (APC) modulates pfVM-directed cellular cytotoxicity. For this purpose fresh PMBC from nine individual donors were primed by incubation with either irradiated pfVM cells or porcine spleen cells (PSC) as APC in the presence of IL-2 for 1 week before assessing cytotoxicity in a 51Cr release assay. Also, direct NK reactivity and antibody-dependent cellular cytotoxicity (ADCC) of fresh PMBC against pfVM cells was assessed. No direct cytotoxicity of naive cells (either NK reactivity or ADCC) against pfVM cells could be determined. Only PMBC primed with PSC were capable of lysing pfVM cells. PBMC primed with pfVM cells did not show cytolytic capacity towards pfVM. Interestingly, large differences in xenospecific T-cell responses exist between individual donor PBMC. Thus, human T cells are capable of killing pfVM cells in a xenoreactive response, but only after priming by donor APC. The large interindividual differences between human donors in their xenoreactive response may influence patient selection for xenotransplantation and chances of graft survival for individual patients.

Individual human serum differs in the amount of antibodies with affinity for pig fetal ventral mesencephalic cells and the ability to lyse these cells by complement activation.

Xenografting pig fetal ventral mesencephalic (pfVM) cells to repair the dopamine deficit in patients with Parkinson's disease is the focus of both experimental and clinical investigations. Although there have been marked advances in the experimental and even clinical application of these xenogeneic transplantations, questions regarding the host's xenospecific immune response remain unanswered. It has been shown that human serum is able to lyse pfVM tissue by both anti-gal-gal and non-anti-gal-gal antibodies by complement activation. The aim of this study was to investigate whether interindividual differences exist in the levels of pfVM cell-specific IgM and IgG subclass antibodies, their ability to lyse pfVM cells in vitro and the relationship between both. Pig fetal VM cells were incubated with heat-inactivated serum from 10 different individuals and binding of IgM antibodies and IgG subclass antibodies to pfVM cells was analyzed by flow cytometry. The ability to lyse pfVM cells was analyzed exposing 51Cr-labeled pfVM cells to fresh serum or isolated IgM and IgG from the same individuals and subsequent determination of released 51Cr from lysed cells. Strong differences were found between individuals in the levels of pfVM cell-specific IgM antibodies: antibody levels differed up to 40-fold. pfVM-specific IgG1 and IgG2 levels were only detectable in a few individuals. The ability to lyse pfVM cells ranged from negligible lysis up to 66.5% specific lysis. There was a strong correlation between the levels of individual pfVM-specific IgM antibodies and the ability to lyse pfVM cells in vitro. Isolated IgM, but not IgG, was able to lyse pfVM cells in the presence of complement. In conclusion, the interindividual differences in the levels of IgM with affinity for pfVM cells and their ability to lyse pfVM cells in vitro are considerable. Only few individuals possessed IgG1 and IgG2 subclass antibodies with affinity for pfVM. These findings may influence patient selection for porcine transplants and chances of graft survival in individual patients.

Predictive value of aspects of the Transtheoretical Model on smoking cessation in a community-based, large-group cognitive behavioral program.

OBJECTIVE: To evaluate the predictive value of aspects of the Transtheoretical Model (TTM) of behavior change as applied to smoking cessation in a large-group, community-based cognitive-behavioral intervention. RESEARCH APPROACH: Cognitive-behavioral intervention followed by 3-month assessment of smoking status. SETTING: Regional Outpatient Cancer Centre. STUDY PARTICIPANTS: A total of 2069 participants in smoking cessation clinics held between 1992 and 1999. INTERVENTION: Eight 90-min sessions over 4 months utilizing education, self-monitoring, a group quit date, and behaviour modification techniques. MAIN OUTCOME MEASURES: Cessation rates at 3 months postquit date. Differences between successful and unsuccessful participants on the baseline TTM variables of: stages of change, processes of change, decisional balance and situational temptations, as well as of precessation demographic, smoking history, and smoking behavior variables. RESULTS: Nonsmokers at 3 months endorsed using more of only one of the processes of change (Reinforcement Management) more than smokers prior to starting the program. They also endorsed more Cons of Smoking and had a more negative Decisional Balance score. When the variables of tobacco tolerance on the Fagerstrom Test for Nicotine Dependence (FTND), marital status, association with the Cancer Centre, and amount of vigorous exercise were first entered in a logistic regression model, Reinforcement Management and Cons of Smoking continued to be predictive of smoking cessation success, but again none of the other TTM variables added explanatory power. CONCLUSIONS: TTM variables measured prior to program attendance added little predictive value for cessation outcome beyond that explained by demographic and smoking history variables. Future studies may benefit from reassessing the TTM variables at the quit date and the 3-month assessment of smoking status to evaluate how the program impacted these variables.

The addition of social support to a community-based large-group behavioral smoking cessation intervention: improved cessation rates and gender differences.

OBJECTIVE: To determine the effects on cessation rates of adding a partner support group component to a large-group community-based behavioral smoking cessation program. METHODS: During the past eight smoking cessation programs at the Tom Baker Cancer Centre in Calgary, Alberta, Canada, separate support group sessions were offered for support persons of prospective quitters. Six hundred smokers brought 156 support people with them to the groups. Cessation rates were calculated at 3, 6, and 12 months postquit. RESULTS: Those smokers who had support people attending at least one of the support group sessions had higher cessation rates at 3, 6, and 12 months (56%, 46%, and 43%) compared to those without a support person in attendance (36%, 35%, 32%). This effect was especially strong for men, with 3-, 6-, and 12-month cessation rates for those with support of 58%, 54%, and 56%, compared to 52%, 41%, and 36% in the women with support. For men without a support person, the rates were 34%, 35%, and 33%, compared to 38%, 35%, and 31% in women without support. This indicates that although support was initially effective for women, it had no effect on sustained abstinence. CONCLUSIONS: The addition of a support person group to a large-group behavioral smoking cessation program was effective in improving 3-month cessation rates in both men and women, but over 1-year of follow-up support was only associated with greater sustained abstinence in men.