Face, Content, and Construct Validity of the Take-Home EoSim Augmented Reality Laparoscopy Simulator for Basic Laparoscopic Tasks.

Background: The eoSim® laparoscopic augmented reality (AR) simulator has instrument tracking capabilities that may be suitable for implementation in laparoscopic training. The objective is to assess face, content, and construct validity of this simulator for basic laparoscopic skills training. Methods: Participants were divided into three groups: novices (no training), intermediates (<50 laparoscopic procedures), and experts (>50 laparoscopic procedures). Three basic tasks were completed on the simulator: thread transfer (1), cyst dissection (2), and tube ligation (3). A questionnaire was completed on realism, didactic value, and usability of the simulator. Measured outcome parameters were as follows: time, distance, time off screen, average speed, acceleration, and smoothness. Results: Mean ± standard deviation scores on realism were positive (Task 1 or T1; 3.9 ± 0.7, P = .13, T2; 3.7 ± 0.7, P = .07, T3; 3.7 ± 0.07), as well as didactic value (T1; 3.9 ± 0.8, P = .71, T2; 3.9 ± 0.8, P = .31, T3; 4.0 ± 0.8, P = .40). Usability was valued the highest, with mean scores between 3.9 and 4.3 (T1; P = .71, T2; P = .80, T3; P = .85). Scores did not differ significantly between groups. Experts were significantly faster (Task 1; P < .001, Task 2; P = .042, Task 3: P < .001) with higher handling speed for tasks 2 and 3 (Task 1; P = .20, task 2; P = .034, task 3; P = .049). Results for other outcome parameters also indicated experts had better instrument control and efficiency than novices, although these differences did not reach statistical significance. Conclusions: The eoSim laparoscopic AR simulator is regarded as a realistic, accessible, and useful tool for the training of basic laparoscopic skills, with good face validity. Construct validity of the eoSim AR simulator was demonstrated on several core variables, but not all.

Anticyclic Citrullinated Peptide Antibodies and Rheumatoid Factor as Risk Factors for 10-year Cardiovascular Morbidity in Patients with Rheumatoid Arthritis: A Large Inception Cohort Study.

OBJECTIVE: To determine whether anticyclic citrullinated peptide antibodies (anti-CCP) and rheumatoid factor (RF) are risk factors for 10-year cardiovascular disease (CVD) in patients with rheumatoid arthritis (RA). METHODS: Analyses were performed using data from the Nijmegen early RA inception cohort, in which patients with newly diagnosed RA, consecutively included since 1985, were regularly followed up. Anti-CCP and RF were determined at baseline (diagnosis). Outcome was the first cardiovascular disease (CVD) event [ischemic heart disease, nonhemorrhagic cerebrovascular accident (CVA), or peripheral artery disease (PAD)] after baseline as retrieved from physician diagnosis. Fatality was checked against death certificates. Cox regression including correction for baseline confounders was performed to estimate the effect of anti-CCP, RF, and their interaction on 10-year CVD-free survival. RESULTS: Of 929 patients included, 628 were anti-CCP-positive and 697 were RF-positive. During followup, with a median of 7.5 years, 162 CV events were observed (101 ischemic heart disease, 45 CVA, and 16 PAD), of which 15 were fatal. The HRadjusted for anti-CCP was 1.17 (95% CI 0.82-1.67) and the HRadjusted for RF was 1.52 (95% CI 1.00-2.30). The association of RF positivity with CVD was even stronger in the anti-CCP-negative patients: HRadjusted 2.09 (95% CI 1.18-3.71). There was no significant interaction (p = 0.098) between anti-CCP and RF. CONCLUSION: Rather than anti-CCP, presence of RF was associated with CVD in this cohort of patients with RA.

The effect of disease duration and disease activity on the risk of cardiovascular disease in rheumatoid arthritis patients.

OBJECTIVE: Disease duration and disease activity may be associated with an increased risk of cardiovascular disease (CVD) in rheumatoid arthritis (RA). The objectives of this study were to investigate (1) the relationship between duration of inflammation and the development of CVD in RA patients and (2) the relationship between RA disease activity over time and CVD in patients with RA. METHODS: RA patients with a follow-up of ≥6 months in the Nijmegen early RA cohort without prior CVD were included. Disease activity over time was calculated using the time-averaged  28 joint disease activity score (DAS28) for each patient. Kaplan-Meier survival analysis and Cox proportional hazards regression were used for the analyses. RESULTS: During follow-up of the 855 patients that were included, 154 CV events occurred. The course of hazards over time did not indicate a change in the risk of CVD over the course of RA (disease duration), which is also reflected by the absence of a deflection in the survival curves. The survival distributions did not differ between patients with a disease duration of <10 years or >10 years (Log-rank test: p=0.82). Time-averaged DAS28 was significantly associated with CVD (p=0.002) after correction for confounders. CONCLUSIONS: Disease duration does not appear to independently affect the risk of CVD. The risk of CVD in RA patients was not increased after 10 years of disease duration compared with the first 10 years. Disease activity over time may contribute to the risk of CVD.

Serum samples that have been stored long-term (>10 years) can be used as a suitable data source for developing cardiovascular risk prediction models in large observational rheumatoid arthritis cohorts.

OBJECTIVE: There is an unmet need for a specific cardiovascular risk (CV) algorithm for rheumatoid arthritis (RA) patients. Lipoprotein data are often not available in RA cohorts but could be obtained from frozen blood samples. The objective of this study was to estimate the storage effect on lipoproteins in long-term (>10 years) frozen serum samples. METHODS: Data were used from an inception RA cohort. Multiple serum samples from 152 patients were analyzed for lipoproteins, being frozen for 1-26 years at -20°C. Storage effect on lipoproteins was estimated using longitudinal regression analyses and a lipid decay correction factor was developed. Clinical impact of the storage effect on lipoproteins was assessed by calculating the number of patients reclassified to another CV risk group according to the SCORE risk calculator after applying the decay correction factor. RESULTS: There was a significant effect of storage time on total cholesterol (TC) (P<0.001) and high density lipoprotein cholesterol (HDL-c) levels (P<0.001), not LDL-c (P=0.83). The lipid decay correction factor was 0.03 mmol/L and 0.024 mmol/L per additional year of storage for TC and HDL-c, respectively. The TC:HDL ratio decreased after correction for storage effect. After correction, only 5% of patients were reclassified to another CV risk group. CONCLUSION: A modest storage decay effect on lipoproteins was found that is unlikely to significantly affect CV risk stratification. Serum samples that have been stored long-term (>10 years) can be used to obtain valid lipid levels for developing CV risk prediction models in RA cohorts, even without applying a decay correction factor.

The cost-effectiveness of substituting physicians with diabetes nurse specialists: a randomized controlled trial with 2-year follow-up.

AIMS: To evaluate the cost-effectiveness of an intervention substituting physicians with nurse specialists. BACKGROUND: Increasing populations of people with diabetes in most Western countries require creative solutions that give high-quality chronic care while controlling costs. Instigating nurse specialists as a substitute for physicians yields positive results in this area. Research about such interventions in a hospital-based setting is limited. METHODS: This paper is a report of a study of a randomized, non-blinded clinical trial including people with diabetes mellitus types 1 and 2. In the intervention group nurse specialists were the central carers, providing care that conformed to a preset protocol. Patients were included between 2004 and 2007. Costs, quality of life and adverse events were measured, cost-effect ratios and incremental cost-effect ratios were calculated based on health-resource utilization rates, corresponding market prices and national tariffs from 2007. RESULTS: Health related quality of life scores did not differ significantly between the control and the intervention group. In the intervention group, fewer patients were hospitalized and fewer side effects from drugs were reported compared to controls. Nurse specialists as central care givers generated a modest reduction in costs per quality adjusted life year gained compared to usual care. CONCLUSION: Nurse specialists give diabetes care that is similar to care provided by physicians in terms of quality of life and economic value. Instigating a nurse specialist as central carer yields opportunities to generate cost savings. Developing interventions which also focus on prevention of complications is recommended when aiming for long-term organisational cost savings.