Impact of diabetes on medical costs in the pre- and postoperative year of lower extremity amputations in Belgium.

AIMS: To compare the medical costs of individuals undergoing lower extremity amputation (LEA) in Belgium with those of amputation-free individuals. METHODS: Belgian citizens undergoing LEAs in 2014 were identified. The median costs per capita in euros for the 12 months preceding and following minor and major LEAs were compared with those of matched amputation-free individuals. RESULTS: A total of 3324 Belgian citizens underwent LEAs (2295 minor, 1029 major), 2130 of them had diabetes. The comparison group included 31,716 individuals. Amputation was associated with high medical costs (individuals with diabetes: major LEA €49,735, minor LEA €24,243, no LEA €2,877 in the year preceding amputation; €45,740, €21,445 and €2,284, respectively, in the post-amputation year). Significantly higher costs were observed in the individuals with (versus without) diabetes in all groups. This difference diminished with higher amputation levels. Individuals undergoing multiple LEAs generated higher costs (individuals with diabetes: €39,313-€89,563 when LEAs preceded index amputation; €46,629-€92,877 when LEAs followed index amputation). Individuals dying in the year after a major LEA generated remarkably lower costs. CONCLUSIONS: LEA-related medical costs were high. Diabetes significantly impacted costs, but differences in costs diminished with higher amputation levels. Individuals with multiple amputations generated the highest costs.

Development and Validation of an Open-Source Grading Tool for Outcome Assessment in Limbal Stem Cell Treatment.

PURPOSE: To design a grading system and validate an open-source tool to improve objective quantification and follow-up of limbal stem cell deficiency (LSCD) after treatment. METHODS: A custom-made web-based grading system was developed for grading stem cell deficient eyes, termed the "Vascularisation, Haze, and Integrity" tool. For validation purposes, 60 corneal slit-lamp images of 30 limbal stem cell deficient eyes were graded by 3 groups of examiners: 3 corneal specialists (group A), 3 ophthalmologists with an expertise other than cornea (group B), and 3 nonclinicians (group C). The intragrader and intergrader agreement was evaluated using Fleiss weighted kappa coefficients and concurrent assessment of interrater and intrarater reliability (IRR) coefficients. RESULTS: The overall intergrader agreement was 0.78, 0.61, and 0.42 for superficial corneal vascularization, corneal haze, and epithelial integrity, respectively. All groups had good agreement for the vascularization parameter with the highest intergrader reliability in group A (IRR = 0.80) and the lowest in group C (IRR = 0.72). When assessing "haze," there was good agreement in groups A (IRR = 0.75) and B (IRR = 0.76) but low agreement in group C (IRR = 0.37). CONCLUSIONS: We report the development and evaluation of a novel method for grading results of limbal stem cell deficient eyes after treatment and provide this system as a free, open-source online tool. The grading tool offers an easy and standardized way of assessing the corneal surface in patients with LSCD, enables evaluation of progression over time, reduces assessment bias, and-if adopted universally-will harmonize outcome being reported between groups.

Oral health screening: feasibility and reliability of the oral health assessment tool as used by speech pathologists.

BACKGROUND: The aim of this study was to investigate the feasibility and reliability of the Oral Health Assessment Tool (OHAT) as used by speech pathologists, to become part of a comprehensive clinical swallowing examination. METHODS: A multicentre study in 132 elderly subjects was conducted by speech pathologists. The inter-rater, test-retest and intra-rater reliabilities of the OHAT were assessed in R statistics, version 3.0.1. Intraclass correlation coefficients (ICCs) were used for the total OHAT, and Kappa statistics were used for the individual categories. RESULTS: Total OHAT scores showed good inter-rater (ICC = 0.96), intra-rater (ICC ≥ 0.95) and test-retest (ICC ≥ 0.78) agreement. The inter-rater Kappa statistics were almost perfect (κ ≥ 0.83) for seven of the eight individual categories of the OHAT and perfect for 'dental pain' (κ = 1.00). The test-retest Kappa statistics indicated excellent agreement for 'natural teeth' and 'dentures' (κ ≥ 0.86). The intra-rater per cent agreement was excellent for all categories except 'gums and tissues'. CONCLUSIONS: This is the first study to examine the feasibility and reliability of the OHAT as used by speech pathologists. As the results showed both good feasibility and reliability, the OHAT has the potential to add to the clinical swallowing examination. However, future research investigating actual referral strategies and adaptation of care strategies following assessment with OHAT is needed.

Malaria care in infants aged under six months in Uganda: an area of unmet needs!

BACKGROUND: Little information exists on malaria burden, artemisinin-based combination therapy (ACT) use, and malaria care provided to infants under six months of age. The perception that malaria may be rare in this age group has led to lack of clinical trials and evidence-based treatment guidelines. The objective of this study was to identify malaria parasitemia positivity rate (MPPR) among patients under six months, and practices and predictors of malaria diagnosis and treatment in this population. METHODS: Cross-sectional data collected from October 2010 to September 2011 on 25,997 individual outpatients aged <6 months from 36 health facilities across Uganda were analysed. FINDINGS: Malaria was suspected in 18,415 (70.8%) patients, of whom 7,785 (42.3%) were tested for malaria. Of those tested, the MPPR was 36.1%, with 63.9% testing negative, of which 1,545 (31.1%) were prescribed an antimalarial. Among children <5kgs, off-label prescription of ACT was high (104/285, 36.5%). Younger age (1-6 days, aOR=0.47, p=0.01; 7-31 days, aOR=0.43, p<0.001; and 1-2 months, aOR=0.61, p<0.001), pneumonia (aOR=0.78, p=0.01) or cough/cold (aOR=0.65, p<0.001) diagnosis, and fever (aOR=0.56, p=0.01) reduced the odds of receiving a malaria test. Fever (aOR=2.22, p<0.001), anemia diagnosis (aOR=3.51, p=0.01), consulting midwives (aOR=3.58, p=0.04) and other less skilled providers (aOR=4.75, p<0.001) relative to medical officers, consulting at hospitals (aOR=3.31, p=0.03), visiting health facilities in a medium-high malaria transmission area (aOR=2.20, p<0.001), and visiting during antimalarial (aOR=1.82, p=0.04) or antibiotic (aOR=2.23, p=0.04) shortages increased the odds of prescribing an antimalarial despite a negative malaria test result. CONCLUSIONS: We found high malaria suspicion but low testing rates in outpatient children aged <6 months. Among those tested, MPPR was high. Despite a negative malaria test result, many infants were prescribed antimalarials. Off-label ACT prescription was common in children weighing <5kgs. Evidence-based malaria guidelines for infants weighing <5 kilograms and aged <6 months are urgently needed.

Cost-effectiveness of contemporary vascular closure devices for the prevention of vascular complications after percutaneous coronary interventions in an all-comers PCI population.

AIMS: The present observational case-control study assessed the cost-effectiveness of contemporary vascular closure devices (VCDs) for the prevention of vascular complications in an all-comers transfemoral percutaneous coronary intervention (PCI) population. METHODS AND RESULTS: A total of 8,292 consecutive PCI patients were enrolled from a single-centre prospective registry from January 2005 to December 2010. VCDs were available from July 2007 and, from that time point, VCDs were implanted in 1,780 of the 5,394 patients (33%). Vascular complications occurred in 221 (2.7%) patients. The use of VCDs was independently associated with a 53% risk reduction (OR 0.47, 95% CI: 0.3-0.7) in vascular complications (3.0% vs. 1.5%) and with a 65% risk reduction (IRR 0.37, 95% CI: 0.32-0.43) in the post-PCI length of hospital stay (LOS) (mean 2.8 vs. 1.5 days). Mainly due to the reduced LOS, the patients with VCDs accrued vascular direct medical costs (VCD, diagnosis and treatment of vascular complications, post-PCI LOS) that were on average 498€ less than those accrued by the non-VCD patients. The cost-effectiveness was present across all vascular risk profiles. CONCLUSIONS: In this large, all-comers transfemoral PCI population, the use of VCDs was independently associated with a reduction in the rate of vascular complications and the post-PCI length of hospital stay and proved to be cost-saving across all vascular risk profiles.

Transesophageal echocardiography for cardiac thromboembolic risk assessment in patients with severe, symptomatic aortic valve stenosis referred for potential transcatheter aortic valve implantation.

Stroke is a devastating complication after transcatheter aortic valve implantation (TAVI) and might partially be related to cardiac embolization. The aim of this single-center prospective study was to determine the incidence of intracardiac thrombi and left atrial spontaneous echo contrast (SEC), both known predictors of cardiac embolic stroke, in patients referred for potential TAVI. One hundred four consecutive patients with severe symptomatic aortic valve stenosis and at high or very high risk for surgery were included and underwent transesophageal echocardiography. In 11 patients (10.6%), intracardiac thrombi were detected, and 25 patients (24%) showed dense grade 2 SEC. Atrial fibrillation (p <0.0001), diastolic dysfunction (p = 0.0005), and atrial size (p = 0.0038) were related to the presence of intracardiac thrombus and/or dense SEC on multivariate analysis. In conclusion, the incidence of intracardiac thrombi and dense SEC in (very) high-risk patients with severe aortic valve stenosis referred for potential TAVI is high and can accurately be detected using transesophageal echocardiography. Systematic thromboembolic evaluation using transesophageal echocardiography is thus recommended in patients referred for TAVI.

Diagnostic performance of 3D SPACE for comprehensive knee joint assessment at 3 T.

OBJECTIVE: To assess the diagnostic performance of 3D sampling perfection with application-optimised contrasts using variable flip-angle evolution (SPACE) turbo spin-echo (TSE) sequences compared to 2D TSE for comprehensive knee assessment at 3 T. METHODS: From January to July 2011, isotropic 3D SPACE was added to a 2D knee protocol at 3 T. Forty patients underwent subsequent arthroscopy. Three readers independently assessed MR images for meniscus, anterior cruciate ligament (ACL) and cartilage lesions. Readers 1 and 2 evaluated 3D and 2D data at separate sittings; reader 3 interpreted the complete exam including 3D and 2D sequences. Accuracies were calculated using arthroscopy as reference standard. McNemar's test (p < 0.05) was used to compare 3D and 2D techniques. RESULTS: The highest diagnostic yield was obtained by reader 3 (accuracies ≥88 %). For the medial meniscus, readers performed better with the 2D technique than with 3D SPACE (accuracies 85-88 % vs. 78-80 %, respectively) (p > 0.05). For the lateral meniscus and ACL, 3D and 2D techniques had similar performance (accuracies ≥93 %). For cartilage lesions, 3D SPACE had significantly lower specificity (p = 0.0156) than the 2D protocol for one reader. CONCLUSION: The conventional 2D TSE acquisition is more reliable than 3D SPACE for comprehensive assessment of the knee at 3.0 T. MAIN MESSAGES: • 3D SPACE is a valuable component of a knee MR protocol at 3 T. • 3D SPACE cannot be used as a single sequence in the MR evaluation of the knee at 3 T. • Knee MR protocols at 3 T should include both 2D and 3D TSE sequences.

Systematic review of the literature on nitinol prostheses in surgery for otosclerosis: assessment of the adequacy of statistical power.

OBJECTIVE: To perform a systematic review of observational studies reporting hearing outcome in primary stapes surgery where a heat-crimping prosthesis was used. DATA SOURCES: Medline, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, TRIP database, Clinical Trials Registry, ISI Web of Knowledge, and Web of Science. The search was performed on January 1, 2010, including articles published ahead of print. No language restrictions. STUDY SELECTION: Inclusion criteria for qualitative synthesis were a population of otosclerosis patients, intervention being primary stapes surgery with a nickel titanium alloy (Nitinol) heat-crimping prosthesis, and hearing outcome. Inclusion criteria for quantitative analysis: application of audiometry guidelines of the American Academy of Otolaryngology-Head and Neck Surgery Committee on Hearing and Equilibrium for evaluation of conductive hearing loss. DATA EXTRACTION: Strategy and reporting based on Cochrane, Quality of Reporting of Meta-analyses, and Meta-analysis of Observational Studies in Epidemiology statements. A bias assessment tool was developed according to Cochrane guidelines. DATA SYNTHESIS: A quantitative synthesis was performed, but because of the heterogeneity in postoperative follow-up periods and outcome measures reported, we were not able to pool these data. A sample size analysis was performed to indicate the sample needed to demonstrate a statistically significant difference in hearing outcome between both interventions. Hearing outcome superiority of the Nitinol heat-crimping prosthesis over manually crimping prosthesis types was not demonstrated. CONCLUSION: Superiority could probably not be demonstrated because of insufficient sample size. Research addressing technical improvements in stapes surgery should agree on a base sample size able to detect the smallest difference that is clinically important or accept the null hypothesis. With data gathered in the Common Otology Database as basis, a sample size of at least 413 patients is needed in both the intervention and the control group. Other clinical outcome measures also should be explored.