Effectiveness of a multicomponent self-management intervention for adults with epilepsy (ZMILE study): A randomized controlled trial.

BACKGROUND: The objective of the ZMILE study was to compare the effectiveness of a multicomponent self-management intervention (MCI) with care as usual (CAU) in adult patients with epilepsy (PWE) over a six-month period. METHODS: Participants (PWE & relative) were randomized into intervention or CAU groups. Self-report questionnaires were used to measure disease-specific self-efficacy as the primary outcome measure and general self-efficacy, adherence, seizure severity, emotional functioning, quality of life, proactive coping, and side-effects of antiepileptic drugs (AED) as secondary outcome measures. Instruments used at baseline and during a six-month follow-up period were the following: disease-specific self-efficacy (Epilepsy Self-Efficacy Scale [ESES], General Self-Efficacy Scale [GSES]); adherence (Medication Adherence Scale [MARS] and Medication Event Monitoring System [MEMS]); seizure severity (National Hospital Seizure Severity Scale [NHS3]); emotional well-being (Hospital Anxiety and Depression Scale [HADS]); quality of life (Quality of Life in Epilepsy [QOLIE-31P]); proactive coping (Utrecht Proactive Coping Competence [UPCC]); and side-effects of antiepileptic drugs [SIDAED]. Multilevel analyses were performed, and baseline differences were corrected by inclusion of covariates in the analyses. RESULTS: In total, 102 PWE were included in the study, 52 of whom were in the intervention group. On the SIDAED and on three of the quality of life subscales QOLIE-31P, a significant difference was found (p<0.05) in the intervention group. Self-efficacy, however, showed no significant differences between the MCI and the CAU groups. None of the other outcome measures showed any significant difference between the two groups. SIGNIFICANCE: Although we found no statistically significant difference in the primary outcome measure, disease-specific self-efficacy, this MCI could prove promising, since we found improvement in some domains of quality of life in epilepsy scale and a decrease in AED side-effects in the MCI group compared with the CAU group.

Whole liver CT texture analysis to predict the development of colorectal liver metastases-A multicentre study.

OBJECTIVES: CT texture analysis has shown promise to differentiate colorectal cancer patients with/without hepatic metastases. AIM: To investigate whether whole-liver CT texture analysis can also predict the development of colorectal liver metastases. MATERIAL AND METHODS: Retrospective multicentre study (n=165). Three subgroups were assessed: patients [A] without metastases (n=57), [B] with synchronous metastases (n=54) and [C] who developed metastases within ≤24 months (n=54). Whole-liver texture analysis was performed on primary staging CT. Mean grey-level intensity, entropy and uniformity were derived with different filters (σ0.5-2.5). Univariable logistic regression (group A vs. B) identified potentially predictive parameters, which were tested in multivariable analyses to predict development of metastases (group A vs. C), including subgroup analyses for early (≤6 months), intermediate (7-12 months) and late (13-24 months) metastases. RESULTS: Univariable analysis identified uniformity (σ0.5), sex, tumour site, nodal stage and carcinoembryonic antigen as potential predictors. Uniformity remained a significant predictor in multivariable analysis to predict early metastases (OR 0.56). None of the parameters could predict intermediate/late metastases. CONCLUSIONS: Whole-liver CT-texture analysis has potential to predict patients at risk of developing early liver metastases ≤6 months, but is not robust enough to identify patients at risk of developing metastases at later stage.

The Influence of Pre- and Postoperative Fear Avoidance Beliefs on Postoperative Pain and Disability in Patients With Lumbar Spinal Stenosis: Analysis of the Lumbar Spinal Outcome Study (LSOS) Data.

STUDY DESIGN: Prospective multicenter cohort study. OBJECTIVE: To evaluate the effect of pre- and postoperatively assessed fear avoidance beliefs (FAB) on pain and disability in patients with degenerative lumbar spinal stenosis (LSS) after decompression surgery. SUMMARY OF BACKGROUND DATA: To the present, the influence of pre- and postoperative FAB on the prognosis after surgery for LLS is still unclear. METHODS: Patients of the Swiss Lumbar Stenosis Outcome Study (LSOS) with confirmed LSS undergoing first-time decompression without fusion were enrolled in this study. The main outcome of this study was minimal clinically important difference (MCID) in spinal stenosis measure symptoms (pain) and function (disability) after 12 months. To analyze the influence of pre- and postoperatively assessed FAB on pain and disability we built simple and multiple logistic regression models. RESULTS: In this analysis of 234 patients undergoing decompression surgery for symptomatic degenerative LSS we found baseline FAB measured by the FAB physical activity subscale (FABQ-P) not to be associated with pain (OR 0.95; 95% CI: 0.55-1.67) and disability (OR 1.11; 95% CI: 0.64-1.92) at 12 months' follow-up. In the final multiple logistic regression models patients with high FABQ-P at 6 months (OR 0.46; 95% CI: 0.24-0.91) and high persistent FABQ-P at baseline and 6 months (OR 0.34, 95% CI: 0.16-0.73) were less likely to report a MCID for spinal stenosis measure symptoms at 12 months. Our analysis found a similar trend for disability; however, the results were not statistically significant. CONCLUSION: In elderly patients undergoing decompression surgery for symptomatic degenerative LSS preoperative fear avoidance beliefs were not a prognostic indicator for the outcome. Patients with FAB at 6 months and persistent FAB were less likely to experience clinically relevant improvement in pain at 12 months. Studies should address the importance of persistent postoperative FAB. LEVEL OF EVIDENCE: 3.

New ophthalmologic imaging techniques for detection and monitoring of neurodegenerative changes in diabetes: a systematic review.

Optical coherence tomography (OCT) of the retina and around the optic nerve head and corneal confocal microscopy (CCM) are non-invasive and repeatable techniques that can quantify ocular neurodegenerative changes in individuals with diabetes. We systematically reviewed studies of ocular neurodegenerative changes in adults with type 1 or type 2 diabetes and noted changes in the retina, the optic nerve head, and the cornea. Of the 30 studies that met our inclusion criteria, 14 used OCT and 16 used CCM to assess ocular neurodegenerative changes. Even in the absence of diabetic retinopathy, several layers in the retina and the mean retinal nerve fibre layer around the optic nerve head were significantly thinner (-5·36 µm [95% CI -7·13 to -3·58]) in individuals with type 2 diabetes compared with individuals without diabetes. In individuals with type 1 diabetes without retinopathy none of the intraretinal layer thicknesses were significantly reduced compared with individuals without diabetes. In the absence of diabetic polyneuropathy, individuals with type 2 diabetes had a lower nerve density (nerve branch density: -1·10/mm(2) [95% CI -4·22 to 2·02]), nerve fibre density: -5·80/mm(2) [-8·06 to -3·54], and nerve fibre length: -4·00 mm/mm(2) [-5·93 to -2·07]) in the subbasal nerve plexus of the cornea than individuals without diabetes. Individuals with type 1 diabetes without polyneuropathy also had a lower nerve density (nerve branch density: -7·74/mm(2) [95% CI -14·13 to -1·34], nerve fibre density: -2·68/mm(2) [-5·56 to 0·20]), and nerve fibre length: -2·58 mm/mm(2) [-3·94 to -1·21]). Ocular neurodegenerative changes are more evident when diabetic retinopathy or polyneuropathy is present. OCT and CCM are potentially useful, in addition to conventional clinical methods, to assess diabetic neurodegenerative changes. Additional research is needed to determine their incremental benefit and to standardise procedures before the application of OCT and CCM in daily practice.

Prevalence and Predictive Factors of Chronic Postsurgical Pain and Poor Global Recovery 1 Year After Outpatient Surgery.

OBJECTIVES: To prospectively describe the prevalence and predictive factors of chronic postsurgical pain (CPSP) and poor global recovery in a large outpatient population at a university hospital, 1 year after outpatient surgery. MATERIALS AND METHODS: A prospective longitudinal cohort study was performed. During 18 months, patients presenting for preoperative assessment were invited to participate. Outcome parameters were measured by using questionnaires at 3 timepoints: 1 week preoperatively, 4 days postoperatively, and 1 year postoperatively. A value of >3 on an 11-point numeric rating scale was considered to indicate moderate to severe pain. A score of ≤80% on the Global Surgical Recovery Index was defined as poor global recovery. RESULTS: A total of 908 patients were included. The prevalence of moderate to severe preoperative pain was 37.7%, acute postsurgical pain 26.7%, and CPSP 15.3%. Risk factors for the development of CPSP were surgical specialty, preoperative pain, preoperative analgesic use, acute postoperative pain, surgical fear, lack of optimism, and poor preoperative quality of life. The prevalence of poor global recovery was 22.3%. Risk factors for poor global recovery were recurrent surgery because of the same pathology, preoperative pain, preoperative analgesic use, surgical fear, lack of optimism, poor preoperative and acute postoperative quality of life, and follow-up surgery during the first postoperative year. DISCUSSION: Moderate to severe CPSP after outpatient surgery is common, and should not be underestimated. Patients at risk for developing CPSP can be identified during the preoperative phase.

Faecal calprotectin in suspected paediatric inflammatory bowel disease.

OBJECTIVES: The diagnostic accuracy of faecal calprotectin (FC) concentration for paediatric inflammatory bowel disease (IBD) is well described at the population level, but not at the individual level. We reassessed the diagnostic accuracy of FC in children with suspected IBD and developed an individual risk prediction rule using individual patient data. METHODS: MEDLINE, EMBASE, DARE, and MEDION databases were searched to identify cohort studies evaluating the diagnostic performance of FC in paediatric patients suspected of having IBD. A standard study-level meta-analysis was performed. In an individual patient data meta-analysis, we reanalysed the diagnostic accuracy on a merged patient dataset. Using logistic regression analysis we investigated whether and how the FC value and patient characteristics influence the diagnostic precision. A prediction rule was derived for use in clinical practice and implemented in a spreadsheet calculator. RESULTS: According to the study-level meta-analysis (9 studies, describing 853 patients), FC has a high overall sensitivity of 0.97 (95% confidence interval [CI] 0.92-0.99) and a specificity of 0.70 (0.59-0.79) for diagnosing IBD. In the patient-level pooled analysis of 742 patients from 8 diagnostic accuracy studies, we calculated that at an FC cutoff level of 50 µg/g there would be 17% (95% CI 15-20) false-positive and 2% (1-3) false-negative results. The final logistic regression model was based on individual data of 545 patients and included both FC level and age. The area under the receiver operating characteristic curve of this derived prediction model was 0.92 (95% CI 0.89-0.94). CONCLUSIONS: In high-prevalence circumstances, FC can be used as a noninvasive biomarker of paediatric IBD with only a small risk of missing cases. To quantify the individual patients' risk, we developed a simple prediction model based on FC concentration and age. Although the derived prediction rule cannot substitute the clinical diagnostic process, it can help in selecting patients for endoscopic evaluation.

Intraoperative magnetic resonance imaging versus standard neuronavigation for the neurosurgical treatment of glioblastoma: A randomized controlled trial.

BACKGROUND: Although the added value of increasing extent of glioblastoma resection is still debated, multiple technologies can assist neurosurgeons in attempting to achieve this goal. Intraoperative magnetic resonance imaging (iMRI) might be helpful in this context, but to date only one randomized trial exists. METHODS: We included 14 adults with a supratentorial tumor suspect for glioblastoma and an indication for gross total resection in this randomized controlled trial of which the interim analysis is presented here. Participants were assigned to either ultra-low-field strength iMRI-guided surgery (0.15 Tesla) or to conventional neuronavigation-guided surgery (cNN). Primary endpoint was residual tumor volume (RTV) percentage. Secondary endpoints were clinical performance, health-related quality of life (HRQOL) and survival. RESULTS: Median RTV in the cNN group is 6.5% with an interquartile range of 2.5-14.75%. Median RTV in the iMRI group is 13% with an interquartile range of 3.75-27.75%. A Mann-Whitney test showed no statistically significant difference between these groups (P =0.28). Median survival in the cNN group is 472 days, with an interquartile range of 244-619 days. Median survival in the iMRI group is 396 days, with an interquartile range of 191-599 days (P =0.81). Clinical performance did not differ either. For HRQOL only descriptive statistics were applied due to a limited sample size. CONCLUSION: This interim analysis of a randomized trial on iMRI-guided glioblastoma resection compared with cNN-guided glioblastoma resection does not show an advantage with respect to extent of resection, clinical performance, and survival for the iMRI group. Ultra-low-field strength iMRI does not seem to be cost-effective compared with cNN, although the lack of a valid endpoint for neurosurgical studies evaluating extent of glioblastoma resection is a limitation of our study and previous volumetry-based studies on this topic.

Serum 25(OH)D response to vitamin D3 supplementation: a meta-regression analysis.

OBJECTIVE: The aim of this study was to review factors that influence serum 25(OH)D when patients are given vitamin D supplements. METHODS: From a comprehensive search of all randomized controlled clinical trials with vitamin D3 supplementation available on PubMed up to November 2011, we selected 33 with 43 treatment arms that included at least 30 adult participants. The achieved pooled mean difference (PMD) and 95% confidence intervals (CIs) were calculated using the random-effects models. Meta-regression and subgroup analyses were performed for prespecified factors, including dose, duration, baseline serum 25(OH)D, and age. RESULTS: With a mean baseline serum 25(OH)D of 50.4 nmol/L, PMD was 37 nmol/L (95% CI, 33-41) with significant heterogeneity among studies. Dose (slope: 0.006; P < 0.001), trial duration (slope: 0.21; P < 0.001), baseline serum 25(OH)D (slope: -0.19; P < 0.001), and age (slope: 0.42; P < 0.001) independently influenced vitamin D response. Similar results were found in studies with a mean baseline serum 25(OH)D <50 nmol/L. In subgroup analyses, the PMD was higher with doses ≥800 IU/d (39.3 nmol/L) after 6 to 12 mo (41.7 nmol/L), with baseline 25(OH)D <50 nmol/L (39.6 nmol/L), and in adults aged >80 y (40.5 nmol/L). CONCLUSION: This meta regression indicates that a higher increase in serum levels of 25(OH)D in adults is found with a dose of ≥800 IU/d, after at least 6 to 12 mo, and even when baseline 25(OH)D is low and in adults >80 y.

Application of an electronic nose in the diagnosis of head and neck cancer.

OBJECTIVES/HYPOTHESIS: Electronic nose (E-nose) technology has various applications such as the monitoring of air quality and the detection of explosive and chemical agents. We studied the diagnostic accuracy of volatile organic compounds (VOC) pattern analysis in exhaled breath by means of an E-nose in patients with head and neck squamous cell carcinoma (HNSCC). STUDY DESIGN: Cohort study. Exhaled breath samples from patients with HNSCC were analyzed by using an E-Nose. METHODS: Thirty-six patients diagnosed with HNSCC exhaled into a 5-litre Tedlar bag. The control group consisted of 23 patients visiting the outpatient clinic for other (benign) conditions. Air samples were analyzed using an E-nose. RESULTS: Logistic regression showed a significant difference (P < 0.05) in VOC resistance patterns between patients diagnosed with HNSCC and the control group, with a sensitivity of 90% and a corresponding specificity of 80%. CONCLUSIONS: E-nose application holds a promising potential for application in the diagnosis of HNSCC due to its rapid, simple, and noninvasive nature. LEVEL OF EVIDENCE: 3b.

Good results in postoperative and hematogenous deep infections of 89 stable total hip and knee replacements with retention of prosthesis and local antibiotics.

BACKGROUND: Deep postoperative and hematogenous prosthesis infections may be treated with retention of the prosthesis, if the prosthesis is stable. How long the infection may be present to preclude a good result is unclear. PATIENTS AND METHODS: We retrospectively studied 89 deep-infected stable prostheses from 69 total hip replacements and 20 total knee replacements. There were 83 early or delayed postoperative infections and 6 hematogenous. In the postoperative infections, treatment had started 12 days to 2 years after implantation. In the hematogenous infections, symptoms had been present for 6 to 9 days. The patients had been treated with debridement, prosthesis retention, systemic antibiotics, and local antibiotics: gentamicin-PMMA beads or gentamicin collagen fleeces. The minimum follow-up time was 1.5 years. We investigated how the result of the treatment had been influenced by the length of the period the infection was present, and by other variables such as host characteristics, infection stage, and type of bacteria. RESULTS: In postoperative infections, the risk of failure increased with a longer postoperative interval: from 0.2 (95% CI: 0.1-0.3) if the treatment had started ≥ 4 weeks postoperatively to 0.5 (CI: 0.2-0.8) if it had started at ≥ 8 weeks. The relative risk for success was 0.6 (CI: 0.3-0.95) if the treatment had started ≥ 8 weeks. In the hematogenous group, 5 of 6 infections had been treated successfully. INTERPRETATION: A longer delay before the start of the treatment caused an increased failure rate, but this must be weighed against the advantage of keeping the prosthesis. We consider a failure rate of < 50% to be acceptable, and we therefore advocate keeping the prosthesis for up to 8 weeks postoperatively, and in hematogenous infections with a short duration of symptoms.

Suitability of pharmacokinetic models for dynamic contrast-enhanced MRI of abdominal aortic aneurysm vessel wall: a comparison.

PURPOSE: Increased microvascularization of the abdominal aortic aneurysm (AAA) vessel wall has been related to AAA progression and rupture. The aim of this study was to compare the suitability of three pharmacokinetic models to describe AAA vessel wall enhancement using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). MATERIALS AND METHODS: Patients with AAA underwent DCE-MRI at 1.5 Tesla. The volume transfer constant (K(trans) ), which reflects microvascular flow, permeability and surface area, was calculated by fitting the blood and aneurysm vessel wall gadolinium concentration curves. The relative fit errors, parameter uncertainties and parameter reproducibilities for the Patlak, Tofts and Extended Tofts model were compared to find the most suitable model. Scan-rescan reproducibility was assessed using the interclass correlation coefficient and coefficient of variation (CV). Further, the relationship between K(trans) and AAA size was investigated. RESULTS: DCE-MRI examinations from thirty-nine patients (mean age±SD: 72±6 years; M/F: 35/4) with an mean AAA maximal diameter of 49±6 mm could be included for pharmacokinetic analysis. Relative fit uncertainties for K(trans) based on the Patlak model (17%) were significantly lower compared to the Tofts (37%) and Extended Tofts model (42%) (p<0.001). K(trans) scan-rescan reproducibility for the Patlak model (ICC = 0.61 and CV = 22%) was comparable with the Tofts (ICC = 0.61, CV = 23%) and Extended Tofts model (ICC = 0.76, CV = 22%). K(trans) was positively correlated with maximal AAA diameter (Spearman's ρ = 0.38, p = 0.02) using the Patlak model. CONCLUSION: Using the presented imaging protocol, the Patlak model is most suited to describe DCE-MRI data of the AAA vessel wall with good K(trans) scan-rescan reproducibility.

Diagnostic radiation exposure in children with spinal dysraphism: an estimation of the cumulative effective dose in a cohort of 135 children from The Netherlands.

OBJECTIVE: Based on the assumption that children with spinal dysraphism are exposed to a large amount of ionising radiation for diagnostic purposes, our objective was to estimate this exposure, expressed in cumulative effective dose. DESIGN: Retrospective cohort study. SETTINGS: The Netherlands. PATIENTS: 135 patients with spinal dysraphism and under 18 years of age treated at our institution between 1991 and 2010. RESULTS: A total of 5874 radiological procedures were assessed of which 2916 (49.6%) involved ionising radiation. Mean cumulative effective dose of a child with spinal dysraphism during childhood was 23 mSv, while the individual cumulative effective dose ranged from 0.1 to 103 mSv. Although direct radiography accounted for 81.7% of examinations, the largest contributors to the cumulative effective dose were fluoroscopic examinations (40.4% of total cumulative effective dose). CONCLUSIONS: Exposure to ionising radiation and associated cancer risk were lower than expected. Nevertheless, the use of ionising radiation should always be justified and the medical benefits should outweigh the risk of health detriment, especially in children.

Individual patient data meta-analysis of diagnostic studies: opportunities and challenges.

Individual patient data meta-analyses using the raw data from primary diagnostic accuracy studies are taking hold in systematic reviews evaluating tests. Conventional reviews and meta-analyses that summarise study-level data on test accuracy (sensitivity and specificity) have several disadvantages. The most fundamental limitation of this approach is that it estimates the rates of test result-given disease (sensitivity is probability of positive test result-given disease is present; and specificity is probability of negative test result-given disease is absent). This may be addressed by summarising predictive values, but estimating accuracy for individual tests without consideration of other tests in the test chains that make up everyday diagnostic work-ups remain a problem. To inform clinical practice it is essential that test evaluation generates information about probability of disease given test results, and that it does so in view of the preceding contribution to diagnosis of other tests, for example, symptoms and signs. A multivariable (logistic regression) framework generates disease probabilities taking into account the important factors that play a role in diagnosis. Most primary accuracy studies lack statistical power to do this, particularly because of the small absolute number of disease events per test included in the diagnostic work. Synthesis using their raw data can overcome this problem, but meta-analysts will have limited success if there are difficulties in obtaining the large majority of valid studies, without 'missing' data on the tests relevant in clinical decision-making. Successful individual patient data meta-analyses create the opportunity to calculate directly and reliably disease probabilities corresponding with realistic chains of tests, thereby making outputs of reviews of test accuracy clinically applicable.

Randomized comparison between the cemented Scientific Hip Prosthesis and Omnifit: 2-year DEXA and minimum 10-year clinical follow-up.

Radiostereometry (RSA) of the cemented Scientific Hip Prosthesis (SHP) reported excessive migration and predicted high failure rates. In a prospective randomized clinical trial we compared minimum 10 years results of the SHP (n=38) with the Omnifit-stem (n=37). Two-year bone remodelling, compared with dual energy x-ray absorptiometry and assessed in regions of interest A-D based on the 7 Gruen zones, showed better periprosthetic bone preservation around the SHP in all but one regions (P<.05). At 10 years Harris Hip Score was better for the SHP (P=.0001) but Oxford Hip Score was the same (P=.79). There were no revisions in either group, but radiographic loosening was definite in 1 SHP and 1 Omnifit. Based on earlier RSA studies, the rough surface finish of the SHP was expected to cause cement abrasion, osteolysis and inferior survival. However our clinical and remodelling results could not confirm these expectations, suggesting that the link of early migration and mid-term clinical results is not sufficiently clear for the SHP.

Spinal cord stimulation for complex regional pain syndrome type I: a prospective cohort study with long-term follow-up.

OBJECTIVES: Spinal cord stimulation (SCS) is an effective treatment for intractable complex regional pain syndrome type I pain. Long-term data are scarce on effectiveness, degree of pain relief, predictors, and complications. MATERIALS AND METHODS: From 1997 to 2008, 84 consecutive patients who received an implanted SCS system after positive test stimulation were included in the prospective study. Treatment effectiveness was assessed annually as measured by mean visual analog scale pain scores and with the Patients Global Impression of Change scale. Treatment success was defined as at least 30% mean pain relief at end point and treatment failure as explantation of the system. A Cox regression determined if baseline factors were associated with both these outcomes. RESULTS: During 11 years, 41% (95% CI: 27-55) of the patients experience at least 30% pain relief at assessment end point. During 12 years of follow-up 63% (95%CI: 41-85) of the implanted patients still use their SCS device at measured end point. Pain relief of at least 50% one week following test stimulation is associated with a higher probability of long-term treatment success. In 51 patients, 122 reinterventions were performed over 12 years; 13 were due to complications, 44 to battery changes, and 65 reinterventions were equipment related. CONCLUSION: SCS provides an effective long-term pain treatment for 63% (95%CI: 41-85) of implanted patients. Forty-one percent (95%CI: 27-55) of SCS treated patients have at least 30% pain reduction at measurement end point. The number of reinterventions after implantation due to equipment-related problems, battery changes, and complications is 122 over 12 years of follow-up. Sixty-one percent (N = 51) of the patients had at least one reintervention. Mean pain relief of at least 50% (visual analog scale) one week after the test stimulation is associated with long-term treatment success.

Efficacy and adverse events of antimuscarinics for treating overactive bladder: network meta-analyses.

CONTEXT: Millions of people worldwide experience overactive bladder (OAB), and antimuscarinics are the pharmacologic treatment of choice. Several conventional meta-analyses have been published, but they fail to quantify efficacy and adverse events across drugs, dosages, formulations, and pharmaceutical forms. OBJECTIVE: To perform two network meta-analyses summarizing the efficacy and adverse events of antimuscarinics in the treatment of OAB. EVIDENCE ACQUISITION: Medline and Scopus searches, previous systematic reviews, conference abstracts, book chapters, and the reference lists of relevant articles were searched. Trialists were contacted. Eligible studies were randomized trials that compared at least one antimuscarinic for treating OAB with placebo or with another antimuscarinic, and that reported efficacy and/or adverse event outcomes. Efficacy was assessed for six outcomes (perception of cure or improvement, urgency episodes per 24h, leakage episodes per 24h, urgency incontinence episodes per 24h, micturitions per 24h, and nocturia episodes per 24h). Adverse events were assessed in seven categories according to the Common Terminology Criteria for Adverse Events. Across all outcomes, a summary efficacy and an adverse event score were computed. Two authors independently extracted data. EVIDENCE SYNTHESIS: For the comparison of the efficacy, 76 trials enrolling 38 662 patients were included; for adverse events, 90 trials enrolling 39 919 patients were included. In the subset of studies reporting on treatments and dosages as used in clinical practice, 40 mg/d trospium chloride, 100mg/g per day oxybutynin topical gel, and 4 mg/d fesoterodine had the best efficacy, while higher dosages of orally administered oxybutynin and propiverine had the least favorable relationship of efficacy and adverse events. CONCLUSIONS: This is the first study allowing trade-offs between efficacy and adverse events of various drugs and dosages in the treatment of patients with OAB. Differences among the various antimuscarinics call for careful, patient-centered management in which regimen changes should be considered.

Prediction of proliferative vitreoretinopathy after retinal detachment surgery: potential of biomarker profiling.

PURPOSE: To investigate the potential of a combined assessment of clinical risk factors and biomarker profiling in the prediction of proliferative vitreoretinopathy (PVR) after retinal detachment surgery. DESIGN: Retrospective case-control study. METHODS: Multiplex bead-based immunoassays were used for the simultaneous measurement of 50 biomarkers in subretinal fluid samples obtained from patients who underwent scleral buckling surgery for primary rhegmatogenous retinal detachment (RRD). Of 306 samples that were collected and stored in our BioBank, we selected 21 samples from patients in whom a redetachment developed as a result of PVR within 3 months after reattachment surgery for primary RRD (PVR group). These were compared with age-, sex-, and storage time-matched RRD samples from 54 patients with an uncomplicated postoperative course after primary RRD repair (RRD group). RESULTS: Preoperative PVR was the only clinical variable that was an independent predictor of postoperative PVR development (P = .035) and resulted in an area under the receiver operating characteristic curve of 0.67 (95% confidence interval, 0.51 to 0.83). The addition of the biomarkers chemokine (C-C motif) ligand 22, interleukin-3, and macrophage migration inhibitory factor improved the model significantly (P < .001) and resulted in an area under the receiver operating characteristic curve of 0.93 (95% confidence interval, 0.82 to 1.04). A sensitivity of 94.1% and a specificity of 94.2% were reached, using a cutoff value of 5%. CONCLUSIONS: In combination with preoperative PVR grade, the measurement of a single biomarker or a small multibiomarker panel shows great potential and may predict postoperative PVR development after primary RRD in a highly sensitive and specific manner.

Optical detection of peripheral nerves: an in vivo human study.

BACKGROUND AND OBJECTIVES: A critical challenge encountered in interventional pain medicine procedures is to accurately and efficiently identify transitions to peripheral nerve targets. Current methods, which include ultrasound guidance and nerve stimulation, are not perfect. In this pilot study, we investigated the feasibility of identifying tissue transitions encountered during insertions toward peripheral nerve targets using optical spectroscopy. METHODS: Using a custom needle stylet with integrated optical fibers, ultrasound-guided insertions toward peripheral nerves were performed in 20 patients, with the stylet positioned in the cannula of a 20-gauge stimulation needle. Six different peripheral nerves were represented in the study, with 1 insertion per patient. During each insertion, optical reflectance spectra were acquired with the needle tip in subcutaneous fat, skeletal muscle, and at the nerve target region. Differences in the spectra were quantified with 2 parameters that provide contrast for lipid and hemoglobin, respectively. RESULTS: The transition of the needle tip from subcutaneous fat to muscle was associated with lower lipid parameter values (P = 0.003) and higher hemoglobin parameter values (P = 0.023). The transition of the needle tip from the muscle to the nerve target region was associated with higher lipid parameter values (P = 0.008). CONCLUSIONS: The results indicate that the spectroscopic information provided by the needle stylet could potentially allow for reliable identification of transitions from subcutaneous fat to skeletal muscle and from the muscle to the nerve target region during peripheral nerve blocks.