Cost-utility analysis of a structured medication review compared to usual care in Parkinson's disease.

PURPOSE: For controlling symptoms in Parkinson's disease (PD) together with treating additional comorbidities, patients often face complex medication regimens, with suboptimal adherence, drug-related problems, and diminished therapy efficacy as a common consequence. A medication review could potentially tackle these issues, among others by optimizing drug treatment. Even if no change in clinical outcomes is observed, this intervention might decrease health care costs by reducing drug-related problems and hospital admissions. This study aimed to gain more insight in the health benefits and costs of a structured medication review (SMR) in PD. METHODS: A cost-utility analysis was performed, based on a multicenter randomized controlled trial with 202 PD patients with polypharmacy. The intervention group received an SMR, whereas the control group received usual care. The intervention effect after 6 months of follow-up was presented as incremental quality-adjusted life years (QALY) using the EQ-5D-5L questionnaire. Costs were based on real-world data. Missing data was imputed using multiple imputation techniques. Bootstrapping was used to estimate the uncertainty in all health and economic outcomes. RESULTS: The QALY gain in the intervention group compared to the control group was - 0.011 (95% CI - 0.043; 0.020). Incremental costs were €433 (95% CI - 873; 1687). When adapting a willingness-to-pay threshold of €20,000/QALY and €80,000/QALY, the probability of SMRs being cost-effective was 18% and 30%, respectively. CONCLUSION: A community pharmacist-led SMR in PD patients in the current setting shows no apparent benefit and is not cost-effective after 6 months, compared to usual care. TRIAL REGISTRATION: Netherlands Trial Register, NL4360. Registered 17 March 2014.

Facilitators and Barriers of Adherence to Multi-Disease Exacerbation Action Plans in COPD Patients - A Qualitative Study.

Whereas exacerbation action plans to self-manage Chronic Obstructive Pulmonary Disease (COPD) significantly improve health outcomes, patients' adherence to those action plans is often poor. This study aimed to identify facilitators and barriers of adherence to tailored multi-disease exacerbation action plans. We also explored patients' perspectives toward disease management roles. Individual semi-structured interviews were conducted with a sample of COPD patients who completed a Dutch-Australian self-management intervention evaluating tailored exacerbation action plans for COPD and relevant comorbidities. Interviews were thematically analyzed using a deductive approach guided by the Capability, Opportunity and Motivation of Behavior (COM-B) model. In 2016, ten patients (5 Australian; 5 Dutch; 6 men; age 59-83 years) were interviewed at the end of their one-year follow-up. Facilitators of adherence included improved patients' comprehension of disease and treatment, positive feelings about the intervention, improved self-confidence, and professional support. Barriers included difficulties to recognize symptoms, dislike toward daily symptom monitoring, negative feelings about the intervention, negative mood state, and complexity of symptom diaries and action plans. Patients indicated three distinctive perspectives of their own and their healthcare professional's role in their disease management: 1) patients felt mainly responsible; 2) patients felt shared responsibility with their healthcare professional; and 3) patients felt not responsible as they perceived their healthcare professional to be mainly responsible. We successfully used the COM-B model as a guide to identify facilitators and barriers of patients' adherence to multi-disease exacerbation action plans. Improving patients' adherence in future self-management interventions by targeting specific facilitators or barriers should be considered.

Effect of physical exercise on cognitive function after chemotherapy in patients with breast cancer: a randomized controlled trial (PAM study).

BACKGROUND: Up to 60% of breast cancer patients treated with chemotherapy is confronted with cognitive problems, which can have a significant impact on daily activities and quality of life (QoL). We investigated whether exercise training improves cognition in chemotherapy-exposed breast cancer patients 2-4 years after diagnosis. METHODS: Chemotherapy-exposed breast cancer patients, with both self-reported cognitive problems and lower than expected performance on neuropsychological tests, were randomized to an exercise or control group. The 6-month exercise intervention consisted of supervised aerobic and strength training (2 h/week), and Nordic/power walking (2 h/week). Our primary outcome was memory functioning (Hopkins Verbal Learning Test-Revised; HVLT-R). Secondary outcomes included online neuropsychological tests (Amsterdam Cognition Scan; ACS), self-reported cognition (MD Anderson Symptom Inventory for multiple myeloma; MDASI-MM), physical fitness (relative maximum oxygen uptake; VO2peak), fatigue (Multidimensional Fatigue Inventory), QoL (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; EORTC QLQ C-30), depression (Patient Health Questionnaire-9, Hospital Anxiety and Depression Scale; HADS), and anxiety (HADS). HVLT-R total recall was analyzed with a Fisher exact test for clinically relevant improvement (≥ 5 words). Other outcomes were analyzed using multiple regression analyses adjusted for baseline and stratification factors. RESULTS: We randomized 181 patients to the exercise (n = 91) or control group (n = 90). Two-third of the patients attended ≥ 80% of the exercise sessions, and physical fitness significantly improved compared to control patients (B VO2peak 1.4 ml/min/kg, 95%CI:0.6;2.2). No difference in favor of the intervention group was seen on the primary outcome. Significant beneficial intervention effects were found for self-reported cognitive functioning [MDASI-MM severity (B-0.7, 95% CI - 1.2; - 0.1)], fatigue, QoL, and depression. A hypothesis-driven analysis in highly fatigued patients showed positive exercise effects on tested cognitive functioning [ACS Reaction Time (B-26.8, 95% CI - 52.9; - 0.6) and ACS Wordlist Learning (B4.4, 95% CI 0.5; 8.3)]. CONCLUSIONS: A 6-month exercise intervention improved self-reported cognitive functioning, physical fitness, fatigue, QoL, and depression in chemotherapy-exposed breast cancer patients with cognitive problems. Tested cognitive functioning was not affected. However, subgroup analysis indicated a positive effect of exercise on tested cognitive functioning in highly fatigued patients. Trial Registration Netherlands Trial Registry: Trial NL5924 (NTR6104). Registered 24 October 2016, https://www.trialregister.nl/trial/5924 .

Functional or not functional; that's the question: Can we predict the diagnosis functional movement disorder based on associated features?

BACKGROUND AND PURPOSE: Functional movement disorders (FMDs) pose a diagnostic challenge for clinicians. Over the years several associated features have been shown to be suggestive for FMDs. Which features mentioned in the literature are discriminative between FMDs and non-FMDs were examined in a large cohort. In addition, a preliminary prediction model distinguishing these disorders was developed based on differentiating features. METHOD: Medical records of all consecutive patients who visited our hyperkinetic outpatient clinic from 2012 to 2019 were retrospectively reviewed and 12 associated features in FMDs versus non-FMDs were compared. An independent t test for age of onset and Pearson chi-squared analyses for all categorical variables were performed. Multivariate logistic regression analysis was performed to develop a preliminary predictive model for FMDs. RESULTS: A total of 874 patients were eligible for inclusion, of whom 320 had an FMD and 554 a non-FMD. Differentiating features between these groups were age of onset, sex, psychiatric history, family history, more than one motor phenotype, pain, fatigue, abrupt onset, waxing and waning over long term, and fluctuations during the day. Based on these a preliminary predictive model was computed with a discriminative value of 91%. DISCUSSION: Ten associated features are shown to be not only suggestive but also discriminative between hyperkinetic FMDs and non-FMDs. Clinicians can use these features to identify patients suspected for FMDs and can subsequently alert them to test for positive symptoms at examination. Although a first preliminary model has good predictive accuracy, further validation should be performed prospectively in a multi-center study.

Effect of the dr. Bart application on healthcare use and clinical outcomes in people with osteoarthritis of the knee and/or hip in the Netherlands; a randomized controlled trial.

OBJECTIVE: To evaluate the short-term effects of use of the dr. Bart app, compared to usual care, on the number of secondary health care consultations and clinical outcomes in people with knee/hip OA in the Netherlands. METHOD: A randomized controlled design involving participants ≥50 years with self-reported knee and/or hip OA recruited from the community. The number of secondary health care consultations (primary outcome) and secondary outcomes were assessed at baseline, 3 and 6 months via online questionnaires. Data were analyzed using longitudinal mixed models, corrected for baseline values. Due to the design of this study, blinding of participants and researchers was not possible. RESULTS: In total, 427 eligible participants were allocated to either the dr. Bart group (n = 214) or usual care (n = 213). We found no difference between groups in the number of secondary (i.e., orthopaedic surgeon, rheumatologist, or physician assistant) health care consultations (incidence rate ratio (IRR) 1.20 (95% CI: 0.67; 2.19)). We found positive treatment effects of the dr. Bart app on symptoms (2.6 (95% CI: 0.4; 4.9)), pain (3.5 (95% CI: 0.9; 6.0)), and activities of daily living (2.9 (95% CI: 0.2; 5.6)) on a 0-100 scale, higher score indicating less complaints, but not in any other secondary outcome. CONCLUSION: The dr. Bart app did not change the number of secondary health care consultations compared to usual care. However, we found small positive effects (not clinically relevant) on pain, symptoms, and activities of daily living in people with knee/hip OA. TRIAL REGISTRATION: Dutch Trial Register (Trial Number NTR6693/NL6505) (https://www.trialregister.nl/trial/6505).

The Visual Analog Scale detects exercise-induced bronchoconstriction in children with asthma.

Objective: Exercise-induced bronchoconstriction (EIB) is a specific morbidity of childhood asthma and an important sign of uncontrolled asthma. The occurrence of EIB is insufficiently identified by the Childhood Asthma Control Test (C-ACT) and Asthma Control Test (ACT). This study aimed to (1) evaluate the Visual Analog Scale (VAS) for dyspnea as a tool to detect EIB in asthmatic children and (2) assess the value of combining (C-)ACT outcomes with VAS scores. Methods: We measured EIB in 75 asthmatic children (mean age 10.8 years) with a standardized exercise challenge test (ECT) performed in cold and dry air. Children and parents reported VAS dyspnea scores before and after the ECT. Asthma control was assessed by the (C-)ACT. Results: Changes in VAS scores (ΔVAS) of children and parents correlated moderately with fall in forced expiratory volume in 1 second (FEV1), respectively rs=0.57 (p < .001) and rs=0.58 (p < .001). At a ΔVAS cutoff value of ≥3 in children, sensitivity and specificity for EIB were 80% and 79% (AUC 0.82). Out of 38 children diagnosed with EIB, 37 had a (C-)ACT score of ≤19 and/or a ΔVAS of ≥3, corresponding with a sensitivity of 97% and a negative predictive value of 96%. Conclusion: This study shows that the VAS could be an effective additional tool for diagnosing EIB in children. A reported difference in VAS scores of ≥3 after a standardized ECT combined with low (C-)ACT scores was highly effective in detecting and excluding EIB.

WEARCON: wearable home monitoring in children with asthma reveals a strong association with hospital based assessment of asthma control.

BACKGROUND: Asthma is one of the most common chronic diseases in childhood. Regular follow-up of physiological parameters in the home setting, in relation to asthma symptoms, can provide complementary quantitative insights into the dynamics of the asthma status. Despite considerable interest in asthma home-monitoring in children, there is a paucity of scientific evidence, especially on multi-parameter monitoring approaches. Therefore, the aim of this study is to investigate whether asthma control can be accurately assessed in the home situation by combining parameters from respiratory physiology sensors. METHODS: Sixty asthmatic and thirty non-asthmatic children were enrolled in the observational WEARCON-study. Asthma control was assessed according to GINA guidelines by the paediatrician. All children were also evaluated during a 2-week home-monitoring period with wearable devices; a physical activity tracker, a handheld spirometer, smart inhalers, and an ambulatory electrocardiography device to monitor heart and respiratory rate. Multiple logistic regression analysis was used to determine which diagnostic measures were associated with asthma control. RESULTS: 24 of the 27 uncontrolled asthmatic children and 29 of the 32 controlled asthmatic children could be accurately identified with this model. The final model showed that a larger variation in pre-exercise lung function (OR = 1.34 95%-CI 1.07-1.68), an earlier wake-up-time (OR = 1.05 95%-CI 1.01-1.10), more reliever use (OR = 1.11 95%-CI 1.03-1.19) and a longer respiratory rate recovery time (OR = 1.12 95%-CI 1.05-1.20) were significant contributors to the probability of having uncontrolled asthma. CONCLUSIONS: Home-monitoring of physiological parameters correlates with paediatrician assessed asthma control. The constructed multivariate model identifies 88.9% of all uncontrolled asthmatic children, indicating a high potential for monitoring of asthma control. This may allow healthcare professionals to assess asthma control at home. TRIAL REGISTRATION: Netherlands Trail Register, NL6087 . Registered 14 February 2017.

A randomized controlled efficacy study of the Medido medication dispenser in Parkinson's disease.

BACKGROUND: Complex medication schedules in Parkinson's disease (PD) result in lower therapy adherence, which contributes to suboptimal therapy and clinical deterioration. Medication reminder systems might improve therapy adherence and subsequently improve symptoms of PD. This randomized controlled study assessed the effect of the electronic medication dispenser Medido on physical disability in PD, as a proxy for changes in therapy adherence.x METHODS: Eighty-seven patients were randomized into the Medido group or control group. The primary outcome of physical disability was measured by the AMC Linear Disability Scale (ALDS). Secondary outcomes were quality of life (QoL) (PDQ-39), health status (EQ5D-5L, VAS), non-motor symptoms (NMS-Quest), and QoL of the caregiver (PDQ-carer). Measurements were performed at baseline, and after 3 and 6 months follow-up. RESULTS: When using the Medido, a non-significant improvement of 3.0 points (95% CI -5.6;11.6) was seen in ALDS. The exploratory subgroup Hoehn & Yahr classification (H&Y) > 2.5 improved significantly on ALDS with 14.7 points (95% CI -28.5;-0.9, p = 0.029 for group x time interaction). QoL deteriorated with 1.0 point in PDQ-39 (p = 0.01 for group x time interaction) in favor of the control group. Non-significant differences were observed for VAS (0.4 points, p = 0.057) and NMS-Quest (1.3 points, p = 0.095) in favor of the Medido group. No changes over time were observed in EQ5D-5L and PDQ-carer. CONCLUSIONS: Based on these data, no firm conclusion can be drawn, but use of the Medido medication dispenser may result in a clinical improvement of physical disability and seems particularly appropriate for more severe patients. TRIAL REGISTRATION: NTR3917 . Registered 19 March 2013.

Comparing the 2007 and 2011 GOLD Classifications as Predictors of all-Cause Mortality and Morbidity in COPD.

To better classify patients with chronic obstructive pulmonary disease (COPD) for prognostic purposes and to tailor treatment, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2007 classification was revised in 2011. The primary aim of the current data analyses was to evaluate the accuracy of the GOLD 2007 and 2011 GOLD classifications to predict all-cause mortality and morbidity in a well-described COPD cohort. The prognostic values of both GOLD classifications, expressed as the C-statistic, were assessed in the Cohort of Mortality and Inflammation in COPD (COMIC) study of 795 COPD patients, with a follow-up of 3 years. Outcomes were all-cause mortality and morbidity. Morbidity was defined as time until first COPD-related hospitalisation and time until first community-acquired pneumonia (CAP). The prognostic value of the GOLD 2011 classification was compared between symptom classification based on the modified Medical Research Council (mMRC) score and the Clinical COPD Questionnaire (CCQ) scores with two different thresholds. Although the GOLD 2011 CCQ classification had the highest accuracy to predict mortality and morbidity in our study, the C-statistics differed only numerically. Furthermore, our study showed that the instrument used to determine the level of symptoms in the GOLD 2011 classification has not only important consequences on the mortality prognosis, but also affects the morbidity prognosis in COPD. Therefore, patients' estimated prognosis could alter when different types of tools are used to evaluate the prognosis.

Use of three-dimensional computed tomography overlay for real-time cryoballoon ablation in atrial fibrillation reduces radiation dose and contrast dye.

AIMS: Cryoballoon pulmonary vein (PV) isolation in patients with atrial fibrillation has proven to be effective in short-term and long-term follow-up. To visualise the PV anatomy, pre-ablation contrast pulmonary venography is commonly performed. Three-dimensional (3D) computed tomography (CT) overlay is a new technique creating a live 3D image of the left atrium by integrating a previously obtained CT scan during fluoroscopy. To evaluate the benefits of 3D CT overlay during cryoballoon ablation, we studied the use of 3D CT overlay versus contrast pulmonary venography in a randomised fashion in patients with paroxysmal atrial fibrillation undergoing cryoballoon PV isolation. METHODS AND RESULTS: Between October 2012 and June 2013, 30 patients accepted for PV isolation were randomised to cryoballoon PV isolation using either 3D CT overlay or contrast pulmonary venography. All patients underwent a pre-procedural cardiac CT for evaluation of the anatomy of the left atrium (LA) and the PVs. In the 3D CT overlay group, a 3D reconstruction of the LA and PVs was made. An overlay of the CT reconstruction was then projected over live fluoroscopy. Patients in the contrast pulmonary venography group received significantly more contrast agent (77.1 ± 21.2 cc vs 40.1 ± 17.6 cc, p < 0.001) and radiation (43.0 ± 21.9 Gy.cm2 vs 28.41 ± 11.7 Gy.cm2, p = 0.04) than subjects in the 3D CT overlay group. There was no difference in total procedure time, fluoroscopy time and the amount of cryoapplications between the two groups. CONCLUSION: The use of 3D CT overlay decreases radiation and contrast dye exposure and can assist in guiding cryoballoon-based PV isolation.

The Effect of Unenhanced MRI on the Surgeons' Decision-Making Process in Females with Suspected Appendicitis.

BACKGROUND: This prospective study evaluated the impact of the results of unenhanced magnetic resonance imaging (MRI) on the surgeon's diagnosis of acute appendicitis in potentially fertile females. METHODS: 112 female patients, aged 12-55, with suspected appendicitis underwent MRI of the abdomen. At three defined intervals; admission and clinical re-evaluation before and after revealing the MRI results, the surgeon recorded the attendance of each patient in operative treatment, observation or discharge. Appendicitis was confirmed or declined by pathology or by telephone follow-up in case of non-intervention. FINDINGS: Appendicitis was confirmed in 29 of 112 patients. At admission the surgeon's disposition had a sensitivity of 97 % and specificity of 29 %. After knowing the MRI results, sensitivity was 97 % and specificity 64 %. The sensitivity and specificity of MRI alone were 89 and 100 %, with a negative and positive predictive value of 96 and 100 %, respectively. CONCLUSION: We believe that MRI should perhaps be standard in all female patients during their reproductive years with suspected appendicitis. It avoids an operation in 32 % of cases and allows earlier planning for patients with an equivocal clinical picture. Trial number: OND1292733 (Narcis.nl).

Safety and Tolerability of Nebulized Amoxicillin-Clavulanic Acid in Patients with COPD (STONAC 1 and STONAC 2).

The safety and tolerability of nebulized amoxicillin clavulanic acid were determined in patients with stable COPD and during severe exacerbations of COPD. Nine stable COPD patients received doses ranging from 50:10 mg up to 300:60 mg amoxicillin clavulanic acid and eight patients hospitalised for a COPD exacerbation received fixed doses 200/40 mg twice daily. Safety was evaluated by spirometry before and after inhalation. Tolerability was evaluated by questionnaire. Plasma and expectorated sputum samples were assayed for amoxicillin content. Seventeen patients underwent in total 100 nebulizations with amoxicillin clavulanic acid. In this safety and tolerability study no clinically relevant deteriorations in FEV1 were observed. Nebulized amoxicillin clavulanic acid produces sputum concentrations well above the Minimal Inhibiting Concentration of 90% for potential pathogenic micro-organisms, with low concentrations in the central compartment (low systemic exposure). Based on spirometry and reported side effects, inhalation of nebulized amoxicillin clavulanic acid seems to be safe and well tolerated, both in stable patients with COPD as in those experiencing a severe exacerbation. Levels of amoxicillin were adequate.

Chronic fatigue syndrome in women assessed with combined cardiac magnetic resonance imaging.

OBJECTIVE: In chronic fatigue syndrome (CFS), only a few imaging and histopathological studies have previously assessed either cardiac dimensions/function or myocardial tissue, suggesting smaller left ventricular (LV) dimensions, LV wall motion abnormalities and occasionally viral persistence that may lead to cardiomyopathy. The present study with cardiac magnetic resonance (CMR) imaging is the first to use a contrast-enhanced approach to assess cardiac involvement, including tissue characterisation of the LV wall. METHODS: CMR measurements of 12 female CFS patients were compared with data of 36 age-matched, healthy female controls. With cine imaging, LV volumes, ejection fraction (EF), mass, and wall motion abnormalities were assessed. T2-weighted images were analysed for increased signal intensity, reflecting oedema (i. e. inflammation). In addition, the presence of contrast enhancement, reflecting fibrosis (i. e. myocardial damage), was analysed. RESULTS: When comparing CFS patients and healthy controls, LVEF (57.9 ± 4.3 % vs. 63.7 ± 3.7 %; p < 0.01), end-diastolic diameter (44 ± 3.7 mm vs. 49 ± 3.7 mm; p < 0.01), as well as body surface area corrected LV end-diastolic volume (77.5 ± 6.2 ml/m2 vs. 86.0 ± 9.3 ml/m2; p < 0.01), stroke volume (44.9 ± 4.5 ml/m2 vs. 54.9 ± 6.3 ml/m2; p < 0.001), and mass (39.8 ± 6.5 g/m2 vs. 49.6 ± 7.1 g/m2; p = 0.02) were significantly lower in patients. Wall motion abnormalities were observed in four patients and contrast enhancement (fibrosis) in three; none of the controls showed wall motion abnormalities or contrast enhancement. None of the patients or controls showed increased signal intensity on the T2-weighted images. CONCLUSION: In patients with CFS, CMR demonstrated lower LV dimensions and a mildly reduced LV function. The presence of myocardial fibrosis in some CFS patients suggests that CMR assessment of cardiac involvement is warranted as part of the scientific exploration, which may imply serial non-invasive examinations.

Bilateral breast cancer, synchronous and metachronous; differences and outcome.

The aims of this study were twofold: to analyze the incidence of patients having synchronous or metachronous bilateral invasive breast cancer (SBBC and MBBC) and to assess the characteristics and outcome compared to those having unilateral breast cancer (UBC). The used data were obtained from our prospective population-based cohort study which had been started in 1983. Bilateral breast cancer (BBC) was categorized as SBBC (≤3 months of the first primary) or MBBC (>3 months after the first primary). The incidence of SBBC was 1% and that of MBBC 7.0 %. Patients with UBC showed more ductal carcinoma compared to patients with BBC. MBBC status was an independent significant predictor of local failure (HR 1.9; 95% CI 1.3-2.7). SBBC status was an independent predictor of distant metastases (HR 2.6; 95% CI 1.4-4.5). Overall survival (OS) was better for MBBC (HR 0.6; 95% CI 0.4-0.8) and worse for SBBC (HR 2.3; 95% CI 1.5-3.6) compared to UBC. We noted: (1) MBBC showed a significant higher local failure compared to UBC, (2) SBBC, compared to MBBC and UBC had a significant higher distant metastases rate, (3) disease-specific survival and OS were significantly worse for SBBC compared to UBC and MBBC, and (4) that the OS for MBBC compared to UBC, was significantly better.

The impact of discussing exercise test results of young asthmatic children on adherence to maintenance medication.

OBJECTIVE: Parents' awareness of their child's asthma may improve by discussing an exercise challenge test (ECT) result with them. We investigated the influence of discussing an ECT result with parents on adherence to inhaled maintenance medication, parental illness perceptions and medication beliefs in young asthmatic children. METHODS: A total of 79 children, 4-7 years old and enrolled in our standard comprehensive asthma care program, performed an ECT to assess exercise induced bronchoconstriction (EIB). The result of the ECT was immediately discussed with the parents. Median medication adherence level was measured with electronic medication loggers from six weeks before the ECT till six weeks afterwards. Parental beliefs about medicines and illness perceptions were measured with the Beliefs about Medicines Questionnaire (BMQ) and the Brief Illness Perceptions Questionnaire (B-IPQ). RESULTS: The median baseline adherence level was high (83%) and showed a small significant decline after the ECT. There was no significant difference in the decrease in median adherence level between the children with or without EIB. Most parents (82.1%) showed a positive necessity-concern ratio at baseline, as measured with the BMQ. There was no clinical relevant change in medication concerns and necessity scores or in illness perceptions. CONCLUSION: Discussing ECT results with parents does not modify median adherence levels to inhaled maintenance medication nor medication beliefs of highly adherent young asthmatic children who are already enrolled in a comprehensive asthma care program.

Long Term Results of Kissing Stents in the Aortic Bifurcation.

BACKGROUND: To evaluate the long-term outcome after aortoiliac kissing stent placement and to analyze variables, which potentially influence the outcome of endovascular reconstruction of the aortic bifurcation. METHODS: All patients treated with aortoiliac kissing stents at our institution between April 1995 and August 2011 were retrospectively identified from a prospective single-center database. Data regarding patient characteristics (age, gender, smoking, cardio- and cerebrovascular risk factors, hyperlipidaemia, diabetes mellitus and use of antihypertensive medication), symptoms, pre-interventional examination and imaging, procedural details and follow-up were retrieved. Patency rates were calculated with Kaplan-Meier analysis. Factors affecting the patency were determined with Cox uni- and multivariate analysis. RESULTS: A total of 215 patients (63% men, mean age 61 ±â€ˆ10 years) were included. The median follow-up period was 31 (IQR 47.1) months. Primary, primary assisted, and secondary patency rates were 97%, 97%, and 99%, respectively, at one month; 92%, 95% and 94% at four months; 75%, 86%, and 91% at two years; 70%, 81%, and 91% at 5 years; and 67%, 81%, and 91% at ten years. Younger age and previous aortoiliac treatment were predictors for reduced primary and primary assisted patency. Smoking, previous aortoiliac intervention, TASC C and D lesions were predictors for reduced secondary patency. CONCLUSIONS: Reconstruction of the aortoiliac bifurcation with kissing stents is feasible, safe and effective in all types of lesions with satisfying long term patencies. TASC C and D lesions are associated with a higher occlusion rate. Younger age and previous aortoiliac interventions are predictors for reduced primary and primary assisted patency.

Isosorbide dinitrate ointment vs botulinum toxin A (Dysport) as the primary treatment for chronic anal fissure: a randomized multicentre study.

AIM: Nitric oxide donors, such as isosorbide dinitrate ointment (ISDN), are considered as first-choice agents in the treatment of chronic anal fissure. Injection with botulinum toxin A in the internal anal sphincter is often used as a second-line therapy, although it may give better results and fewer side effects than nitric oxide donors. The aim of this randomized clinical trial was to investigate whether botulinum toxin A (Dysport) is more effective than ISDN in the primary treatment of chronic anal fissure. METHOD: From April 2005 until October 2009, 60 patients (32 men) with a median age of 42 (25-82) years were randomized to receive either ISDN 10 mg/ml (1%) (n = 33) or injection with 60 units of Dysport (n = 27). The primary end-point was the percentage of complete fissure healing after 8 weeks. RESULTS: After a median of 9 weeks complete fissure healing was noted in 18 of 27 patients in the Dysport group and in 11 of 33 patients in the ISDN group (P = 0.010). Absolute improvement of pain scores after 9 weeks was similar in both groups (P = 0.733). Patients treated with Dysport had fewer side effects than patients treated with ISDN (P = 0.028). Of the patients with a healed fissure, 28% of the Dysport group and 50% of the ISDN group had a recurrence within 1 year (P = 0.286; hazard ratio 2.08; 95% CI = 0.54-7.97). CONCLUSION: Dysport is more effective than ISDN ointment and has fewer side effects in the primary treatment of chronic anal fissure. The recurrence rate within 1 year in both treatment groups is high.

Timing of radiotherapy in breast-conserving therapy: a large prospective cohort study of node-negative breast cancer patients without adjuvant systemic therapy.

BACKGROUND: To investigate the issue of timing of radiation therapy (RT) after lumpectomy in relation to recurrences and outcome. METHODS: Analysis was done on 1107 breast-conserving therapies (BCT) with 1070 women, all without lymph node metastasis and without any adjuvant systemic therapy. Timing was defined as time from lumpectomy till RT. Patients were categorised into tertiles: <45 days, 45-56 days, and 57-112 days. RESULTS: Local control did not show a difference between the tertiles. The distant metastasis-free survival as well as the disease-specific survival showed a decreased outcome starting the RT to early after the lumpectomy. CONCLUSION: The results of this cohort study further refines the hypothesis that timing of RT in BCT might have an impact on outcome. It suggests that a randomised trial in timing of RT in BCT seems necessary to give a definite answer.

Mixture randomized item-response modeling: a smoking behavior validation study.

Misleading response behavior is expected in medical settings where incriminating behavior is negatively related to the recovery from a disease. In the present study, lung patients feel social and professional pressure concerning smoking and experience questions about smoking behavior as sensitive and tend to conceal embarrassing or threatening information. The randomized item-response survey method is expected to improve the accuracy of self-reports as individual item responses are masked and only randomized item responses are observed. We explored the validation of the randomized item-response technique in a unique experimental study. Therefore, we administered a new multi-item measure assessing smoking behavior by using a treatment-control design (randomized response (RR) or direct questioning). After the questionnaire, we administered a breath test by using a carbon monoxide (CO) monitor to determine the smoking status of the patient. We used the response data to measure the individual smoking behavior by using a mixture item-response model. It is shown that the detected smokers scored significantly higher in the RR condition compared with the directly questioned condition. We proposed a Bayesian latent variable framework to evaluate the diagnostic test accuracy of the questionnaire using the randomized-response technique, which is based on the posterior densities of the subject's smoking behavior scores together with the breath test measurements. For different diagnostic test thresholds, we obtained moderate posterior mean estimates of sensitivity and specificity by observing a limited number of discrete randomized item responses.