A discrete choice experiment to identify the most efficient quality indicators for the supervision of psychiatric hospitals.

BACKGROUND: In the Netherlands, health care is regulated by the Health and Youth Care Inspectorate. Forty-six indicators are used to prioritize supervision of psychiatric hospitals. The objective of this study is to define a smaller set of weighted indicators which reflects a consensus among inspectors about which aspects are most important for risk assessment. METHODS: The set of 46 indicators, complemented with missing information, was reduced to six indicators by means of interviews, group discussions and ranking among the inspectors. These indicators were used as attributes in a discrete choice experiment (DCE) to define their weights. RESULTS: Twenty-six inspectors defined the top four indicators suitable for the risk assessment of psychiatric hospitals. These are: the policy on prevention of compulsory treatment; the policy on dysfunctional professionals; the quality of internal research after a serious incident; and the implementation of multidisciplinary guidelines on suicidal behaviour. These indicators share the same importance with regard to risk assessment. The screening of somatic symptoms and the policy on integrated care are important indicators too, but less relevant. CONCLUSION: Through a DCE, we reduced the amount of information for risk assessment of psychiatric hospitals to six weighted indicators. Inspectors can use these indicators to prioritize their inspections.

Bowel Outcome Prediction After Traumatic Spinal Cord Injury: Longitudinal Cohort Study.

Background. Predicting functional outcomes after traumatic spinal cord injury (SCI) is essential for counseling, rehabilitation planning, and discharge. Moreover, the outcome prognosis is crucial for patient stratification when designing clinical trials. However, no valid prediction rule is currently available for bowel outcomes after a SCI. Objective. To generate a model for predicting the achievement of independent, reliable bowel management at 1 year after traumatic SCI. Methods. We performed multivariable logistic regression analyses of data for 1250 patients with traumatic SCIs that were included in the European Multicenter Study about Spinal Cord Injury. The resulting model was prospectively validated on data for 186 patients. As potential predictors, we evaluated age, sex, and variables from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and the Spinal Cord Independence Measure (SCIM), measured within 40 days of the injury. A positive outcome at 1 year post-SCI was assessed with item 7 of the SCIM. Results. The model relied on a single predictor, the ISNCSCI total motor score-that is, the sum of muscle strengths in 5 key muscle groups in each limb. The area under the receiver operating characteristics curve (aROC) was 0.837 (95% CI: 0.815-0.859). The prospective validation confirmed high predictive power: aROC = 0.817 (95% CI: 0.754-0.881). Conclusions. We generated a valid model for predicting independent, reliable bowel management at 1 year after traumatic SCI. Its application could improve counseling, optimize patient-tailored rehabilitation planning, and become crucial for appropriate patient stratification in future clinical trials.

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.

Prediction of bladder outcomes after ischemic spinal cord injury: A longitudinal cohort study from the European multicenter study about spinal cord injury.

OBJECTIVE: The recovery of bladder function after spinal cord injury (SCI) is of major importance for patients and caregivers. We recently developed prediction models of bladder outcomes (defined as the capacity of storing the urine and emptying completely the bladder) 1 year after a SCI of traumatic etiology and investigated if these models would also be applicable to patients with ischemic SCI. PATIENTS AND METHODS: From the European multicenter study about spinal cord injury (EMSCI), we extracted data of all ischemic SCI patients with available neurological and functional data (according to the International Standards for Neurological Classification of Spinal Cord Injury, ISNCSCI, and Spinal Cord Independence Measure, SCIM) within 40 days and bladder outcomes 1 year after ischemia. The model relies on three predictors: strength of the legs, the presence of sensation in the S3 dermatome, and the part of the SCIM assessing breathing and bladder and bowel control. A simplified model relying on leg strength only was also tested. Bladder outcomes were evaluated according to the score of item six of SCIM. RESULTS: In total 85 patients (56 males (66%), mean age 55 years) were included. Twenty-three patients (27%) showed complete bladder function recovery one year after ischemia. Both models showed a very good predictive power: the area under the receiver operating characteristics curve (aROC) of the two models was 0.825 and 0.822, respectively. CONCLUSIONS: Comparable to acute traumatic SCI, also in ischemic SCI the outcome of full bladder function recovery can be predicted by clinical scores, and prediction models of bladder outcomes may be applicable in clinical trials.

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.

A Trial-Based Economic Evaluation Comparing Spinal Cord Stimulation With Best Medical Treatment in Painful Diabetic Peripheral Neuropathy.

The objective was to perform an economic evaluation comparing spinal cord stimulation (SCS) in combination with best medical treatment (BMT) with BMT in painful diabetic peripheral neuropathy patients. Alongside a prospective 2-center randomized controlled trial, involving 36 painful diabetic peripheral neuropathy patients with severe lower limb pain not responding to conventional therapy, an economic evaluation was performed. Incremental cost-effectiveness ratios were based on: 1) societal costs and quality-adjusted life years (QALYs), and 2) direct health care costs and the number of successfully treated patients, respectively, both with a time horizon of 12 months. Bootstrap and secondary analyses were performed to address uncertainty. Total societal cost amounted to €26,539.18 versus €5,313.45 per patient in the SCS and BMT group, respectively. QALYs were .58 versus .36 and the number of successfully treated patients was 55% versus 7% for the SCS and BMT group, respectively. This resulted in incremental cost-effectiveness ratios of €94,159.56 per QALY and €34,518.85 per successfully treated patient, respectively. Bootstrap analyses showed that the probability of SCS being cost-effective ranges from 0 to 46% with willingness to pay threshold values ranging between €20,000 and €80,000 for a QALY. Secondary analyses showed that cost-effectiveness of SCS became more favorable after correcting for baseline cost imbalance between the 2 groups, extending the depreciation period of SCS material to 4 years, and extrapolation of the data up to 4 years. Although SCS was considerably more effective compared with BMT, the substantial initial investment that is required resulted in SCS not being cost-effective in the short term. Cost-effectiveness results were sensitive to baseline cost imbalances between the groups and the depreciation period of the SCS material. PERSPECTIVE: Painful diabetic peripheral neuropathy is a common complication of diabetes mellitus and the humanistic and economic burden is high. This article presents the cost-effectiveness of SCS in patients suffering from painful diabetic peripheral neuropathy from a societal and health care perspective with a time horizon of 12 months.

Arterial stiffness and decline of renal function in a primary care population.

Arterial stiffness is an important pathophysiological factor linking cardiovascular disease and kidney disease. Controversy exists as to whether arterial stiffness causes renal function decline, or kidney dysfunction leads to stiffening or whether the association is mutual. We aimed to investigate the longitudinal association between arterial stiffness and annual rate of renal function decline. We prospectively investigated in a primary care population whether carotid-femoral pulse wave velocity (PWV) was associated with estimated glomerular filtration rate (eGFR) and annual decline in eGFR in participants aged ⩾40 years without overt kidney disease. Baseline data on PWV and eGFR were available for 587 participants; follow-up measurements with a mean duration of 5.6 years were available for 222 patients. PWV, female gender and mean arterial pressure were independently associated with eGFR at baseline, although age confounded this association. More importantly, baseline PWV, age and eGFR were independent predictors of renal function decline. Stratification for age showed that the effect of PWV on rate of eGFR decline was amplified with advancing age. On the other hand, baseline eGFR did not determine annual change in PWV, suggesting a unidirectional association between arterial stiffness and eGFR. Arterial stiffness amplifies age-related renal function decline, suggesting that arterial stiffness plays a causal role in the development of renal damage, at least at later stages of age-related renal function decline, possibly through impaired renal autoregulation and increased arterial blood pressure pulsatility.

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.

Prediction of Bladder Outcomes after Traumatic Spinal Cord Injury: A Longitudinal Cohort Study.

BACKGROUND: Neurogenic bladder dysfunction represents one of the most common and devastating sequelae of traumatic spinal cord injury (SCI). As early prediction of bladder outcomes is essential to counsel patients and to plan neurourological management, we aimed to develop and validate a model to predict urinary continence and complete bladder emptying 1 y after traumatic SCI. METHODS AND FINDINGS: Using multivariate logistic regression analysis from the data of 1,250 patients with traumatic SCI included in the European Multicenter Spinal Cord Injury study, we developed two prediction models of urinary continence and complete bladder emptying 1 y after traumatic SCI and performed an external validation in 111 patients. As predictors, we evaluated age, gender, and all variables of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and of the Spinal Cord Independence Measure (SCIM). Urinary continence and complete bladder emptying 1 y after SCI were assessed through item 6 of SCIM. The full model relies on lower extremity motor score (LEMS), light-touch sensation in the S3 dermatome of ISNCSI, and SCIM subscale respiration and sphincter management: the area under the receiver operating characteristics curve (aROC) was 0.936 (95% confidence interval [CI]: 0.922-0.951). The simplified model is based on LEMS only: the aROC was 0.912 (95% CI: 0.895-0.930). External validation of the full and simplified models confirmed the excellent predictive power: the aROCs were 0.965 (95% CI: 0.934-0.996) and 0.972 (95% CI 0.943-0.999), respectively. This study is limited by the substantial number of patients with a missing 1-y outcome and by differences between derivation and validation cohort. CONCLUSIONS: Our study provides two simple and reliable models to predict urinary continence and complete bladder emptying 1 y after traumatic SCI. Early prediction of bladder function might optimize counselling and patient-tailored rehabilitative interventions and improve patient stratification in future clinical trials.

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.

Phosphodiesterase 5 inhibitors for the treatment of erectile dysfunction: a trade-off network meta-analysis.

CONTEXT: Erectile dysfunction (ED) is a major health care problem worldwide and phosphodiesterase 5 inhibitors (PDE5Is) are the pharmacological treatment of choice. However, the optimal PDE5I for ED treatment is not known. OBJECTIVE: To investigate trade-offs between efficacy and adverse events for various PDE5Is in treating ED. EVIDENCE ACQUISITION: A review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement. Medline, Scopus, reference lists of relevant articles, and systematic reviews were searched. Eligible studies were randomized controlled trials comparing at least one PDE5I for treating ED with placebo or another PDE5I. EVIDENCE SYNTHESIS: We included 82 trials (47 626 patients) for efficacy analysis and 72 trials (20 325 patients) for adverse event analysis. In the trade-off analysis of starting dosages, sildenafil 50mg had the greatest efficacy but also had the highest rate of overall adverse events. Tadalafil 10mg had intermediate efficacy but had the lowest overall rate of all adverse events. Vardenafil 10mg and avanafil 100mg had similar overall adverse events than sildenafil 50mg but a markedly lower global efficacy. Udenafil 100mg had similar global efficacy to that of tadalafil 10mg but its overall adverse event rates were higher. CONCLUSIONS: This is the first trade-off analysis of the different PDE5Is currently available. For individuals who prioritize high efficacy, sildenafil 50mg appears to be the treatment of choice. Men wishing to optimize tolerability should take tadalafil 10mg or switch to udenafil 100mg in the case of insufficient efficacy. PATIENT SUMMARY: For patients with erectile dysfunction who wish to prioritize high efficacy, sildenafil 50mg appears to be the treatment of choice. Men who wish to optimize tolerability should take tadalafil 10mg or switch to udenafil 100mg in the case of insufficient efficacy.

On the interplay of microvasculature, parenchyma, and memory in type 2 diabetes.

OBJECTIVE: Type 2 diabetes is associated with accelerated cognitive decline, especially regarding memory for which the hippocampus plays an essential role. The pathophysiological mechanisms still remain to be elucidated. The purpose of this study is to examine whether hippocampal microvascular and microstructural changes are related to type 2 diabetes (based on status or based on fasting blood glucose [FBG] levels) and verbal memory performance. RESEARCH DESIGN AND METHODS: Thirty-nine participants with type 2 diabetes (64.5 ± 6.1 years old) and 34 participants without type 2 diabetes (58.3 ± 9.2 years old) underwent detailed cognitive assessments and 3-Tesla MRI using intravoxel incoherent motion (IVIM) MRI. Multivariate regression analyses controlling for age, sex, education level, BMI, systolic blood pressure, hematocrit level, and relative hippocampal volume were performed to examine associations between hippocampal IVIM measures, type 2 diabetes (status and FBG), and memory performance. RESULTS: For the microvasculature, blood perfusion volume (f) was larger in participants with type 2 diabetes, f and blood flow (fD*) increased with higher FBG levels, and microvascular pseudodiffusion (D*) and fD*, which are indicative of altered microvasculature, were higher in participants with both relatively high FBG levels and low memory performance. In addition, fD* increased with lower memory performance. For the parenchymal microstructure, the diffusion (D), indicative of injured microstructure, was higher with reduced memory performance. CONCLUSIONS: In addition to the parenchymal microstructure, especially the microvascular properties of the hippocampus are altered in participants with both type 2 diabetes and memory problems and possibly hint at an underlying vascular mechanism.

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.

Efficacy and adverse events of aflibercept, ranibizumab and bevacizumab in age-related macular degeneration: a trade-off analysis.

TOPIC: To quantify the gain in visual acuity and serious side effects of ranibizumab, bevacizumab and aflibercept in age-related macular degeneration (AMD). CLINICAL RELEVANCE: There is an ongoing debate about the optimal treatment of AMD with these three antivascular endothelial growth factor (anti-VEGF) treatments. METHODS: Network meta-analyses. (Pre)Medline, EMBASE, SCOPUS, Cochrane Library (until April 2013), Science Citation Index and reference lists were searched for placebo-controlled randomised trials or head-to-head comparisons. Outcomes were 1-year follow-up data of visual acuity (letters gained) and serious (vascular death, any death, stroke, myocardial infarction, transient ischaemic attack) and thrombotic events. Two investigators independently assessed eligibility and quality of included studies and extracted data. RESULTS: 11 trials (enrolling 8341 patients) assessing five active treatments were included. Compared with placebo, all anti-VEGF treatments had a significantly higher percentage of letters gained: ranibizumab 0.3 mg 2.39% (95% CI 1.59 to 3.19; p<0.001), ranibizumab 0.5 mg 3.56% (95% CI 2.58 to 4.13; p<0.001), bevacizumab 1.25 mg 2.14% (95% CI 0.47 to 3.82; p=0.012), aflibercept 0.5 mg 2.91% (95% CI 0.99 to 4.82; p=0.003) and aflibercept 2 mg 3.44% (95% CI 1.73 to 5.14; p<0.001). Compared with placebo, serious side effects were higher in all other treatments: ranibizumab 0.3 mg 4.41% (95% CI 3.42 to 5.40; p<0.001), ranibizumab 0.5 mg 5.33% (95% CI 4.37 to 6.30; p<0.001), bevacizumab 1.25 mg 5.58% (95% CI 3.567 to 7.60; p<0.001), aflibercept 0.5 mg 5.65% (95% CI (3.28 to 8.02; p<0.001) and aflibercept 2 mg 5.29% (95% CI 3.18 to 7.39; p<0.001). Compared with placebo, systemic thrombotic events also occurred more often in all other treatments. CONCLUSIONS: The study revealed only a modest superiority of aflibercept 2 mg and ranibizumab 0.5 mg over other formulations and dosages.

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.

Controlled-release oxycodone versus naproxen at home after ambulatory surgery: a randomized controlled trial.

BACKGROUND: Strong opioids in the home setting after ambulatory surgery have rarely been studied for fear of hazardous adverse effects such as respiratory depression. OBJECTIVES: We compared the efficacy of paracetamol/controlled-release (CR) oxycodone and paracetamol/naproxen for treatment of acute postoperative pain at home after ambulatory surgery. Secondary outcomes were adverse effects of study medication, treatment satisfaction, and postoperative analgesic compliance. METHODS: Patients undergoing ambulatory knee arthroscopy or inguinal hernia repair surgery (n = 105) were randomized into 3 groups: Group1 paracetamol/naproxen (n = 35), Group 2 paracetamol/CR oxycodone for 24 hours (n = 35), and Group 3 paracetamol/CR oxycodone for 48 hours (n = 35). Pain intensity at movement and at rest using a visual analog scale as well as satisfaction with postoperative analgesia and side effects were recorded for up to 48 hours postoperatively. Compliance with study medication was also assessed. RESULTS: For pain at movement and at rest, no significant differences were found between the paracetamol/naproxen group and either the paracetamol/CR oxycodone for 24 hours group (ß = 2.6 [4.9]; P = 0.597) or the paracetamol/CR oxycodone for 48 hours (ß = -1.7 [5.1]; P = 0.736). No major adverse effects of study medication were registered and satisfaction with postoperative pain treatment was high in all groups. Compliance was comparable across the groups. Despite clear instructions, 8 patients with the lowest pain scores did not use any of the prescribed pain medication. CONCLUSIONS: Paracetamol/CR oxycodone and paracetamol/naproxen are equally effective in treatment of acute postoperative pain at home after ambulatory surgery with comparable patient satisfaction level. We suggest paracetamol/CR oxycodone to be a valuable alternative for the current paracetamol/naproxen gold standard, particularly in patients with a contraindication for nonsteroidal anti-inflammatory drugs. ClinicalTrials.gov identifier: NCT02152592.

Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: a prospective two-center randomized controlled trial.

OBJECTIVE: Painful diabetic peripheral neuropathy (PDPN) is a common complication of diabetes mellitus. Unfortunately, pharmacological treatment is often partially effective or accompanied by unacceptable side effects, and new treatments are urgently needed. Small observational studies suggested that spinal cord stimulation (SCS) may have positive effects. RESEARCH DESIGN AND METHODS: We performed a multicenter randomized clinical trial in 36 PDPN patients with severe lower limb pain not responding to conventional therapy. Twenty-two patients were randomly assigned to SCS in combination with the best medical treatment (BMT) (SCS group) and 14 to BMT only (BMT group). The SCS system was implanted only if trial stimulation was successful. Treatment success was defined as ≥50% pain relief during daytime or nighttime or "(very) much improved" for pain and sleep on the patient global impression of change (PGIC) scale at 6 months. RESULTS: Trial stimulation was successful in 77% of the SCS patients. Treatment success was observed in 59% of the SCS and in 7% of the BMT patients (P < 0.01). Pain relief during daytime and during nighttime was reported by 41 and 36% in the SCS group and 0 and 7% in the BMT group, respectively (P < 0.05). Pain and sleep were "(very) much improved" in 55 and 36% in the SCS group, whereas no changes were seen in the BMT group, respectively (P < 0.001 and P < 0.05). One SCS patient died because of a subdural hematoma. CONCLUSIONS: Treatment success was shown in 59% of patients with PDPN who were treated with SCS over a 6-month period, although this treatment is not without risks.

Protocol for a randomized, placebo-controlled, double-blind clinical trial investigating sacral neuromodulation for neurogenic lower urinary tract dysfunction.

BACKGROUND: Sacral neuromodulation has become a well-established and widely accepted treatment for refractory non-neurogenic lower urinary tract dysfunction, but its value in patients with a neurological cause is unclear. Although there is evidence indicating that sacral neuromodulation may be effective and safe for treating neurogenic lower urinary tract dysfunction, the number of investigated patients is low and there is a lack of randomized controlled trials. METHODS AND DESIGN: This study is a prospective, randomized, placebo-controlled, double-blind multicenter trial including 4 sacral neuromodulation referral centers in Switzerland. Patients with refractory neurogenic lower urinary tract dysfunction are enrolled. After minimally invasive bilateral tined lead placement into the sacral foramina S3 and/or S4, patients undergo prolonged sacral neuromodulation testing for 3-6 weeks. In case of successful (defined as improvement of at least 50% in key bladder diary variables (i.e. number of voids and/or number of leakages, post void residual) compared to baseline values) prolonged sacral neuromodulation testing, the neuromodulator is implanted in the upper buttock. After a 2 months post-implantation phase when the neuromodulator is turned ON to optimize the effectiveness of neuromodulation using sub-sensory threshold stimulation, the patients are randomized in a 1:1 allocation in sacral neuromodulation ON or OFF. At the end of the 2 months double-blind sacral neuromodulation phase, the patients have a neuro-urological re-evaluation, unblinding takes place, and the neuromodulator is turned ON in all patients. The primary outcome measure is success of sacral neuromodulation, secondary outcome measures are adverse events, urodynamic parameters, questionnaires, and costs of sacral neuromodulation. DISCUSSION: It is of utmost importance to know whether the minimally invasive and completely reversible sacral neuromodulation would be a valuable treatment option for patients with refractory neurogenic lower urinary tract dysfunction. If this type of treatment is effective in the neurological population, it would revolutionize the management of neurogenic lower urinary tract dysfunction. TRIAL REGISTRATION NUMBER: http://www.clinicaltrials.gov; Identifier: NCT02165774.