[Show abstract][Hide abstract] ABSTRACT: Cost-effectiveness analyses (CEAs) of behavioral interventions typically use physical outcome criteria. However, any progress in cognitive antecedents of behavior change may be seen as a beneficial outcome of an intervention. The aim of this study is to explore the feasibility and validity of incorporating cognitive parameters of behavior change in CEAs. The CEA from a randomized controlled trial on smoking cessation was reanalyzed. First, relevant cognitive antecedents of behavior change in this dataset were identified. Then, transition probabilities between combined states of smoking and cognitions at 6 weeks and corresponding 6 months smoking status were obtained from the dataset. These rates were extrapolated to the period from 6 to 12 months in a decision analytic model. Simulated results were compared with the 12 months’ observed cost-effectiveness results. Self-efficacy was the strongest time-varying predictor of smoking cessation. Twelve months’ observed CEA results for the multiple tailoring intervention versus usual care showed €3188 had to be paid for each additional quitter versus €10,600 in the simulated model. The simulated CEA showed largely similar but somewhat more conservative results. Using self-efficacy to enhance the estimation of the true behavioral outcome seems a feasible and valid way to estimate future cost-effectiveness.
[Show abstract][Hide abstract] ABSTRACT: The aim of this paper is to identify which domains of health-related quality of life (HRQoL) are most important for patients with chronic obstructive pulmonary disease (COPD), from the perspective of healthcare professionals (HCPs).
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. 11/2014;
[Show abstract][Hide abstract] ABSTRACT: Aims: Drug-eluting stents (DES) were first used on-label - in simple patients with low clinical risk and easily accessible lesions. Currently, DES are increasingly used off-label - in complex patients undergoing percutaneous coronary interventions (PCI) with historically higher event risk. Therefore, our aim was to investigate whether patients with off-label indications for DES use had similar outcomes compared to patients who were treated for on-label indications only. We analysed two-year follow-up data of 1,387 TWENTE trial patients, treated with second-generation everolimus-eluting XIENCE V or zotarolimus-eluting Resolute stents, and compared off-label vs. on-label DES use with regard to the following clinical endpoints: cardiac death, myocardial infarction (MI), periprocedural MI (≤48 hrs), and target vessel revascularisation (TVR). Patients with off-label DES use (n=1,033; 74.5%) had more diabetes (22.9% vs. 17.5%; p=0.032), previous MI (35.9% vs. 22.3%; p<0.001), type B2/C lesions (84.7% vs. 62.7%; p<0.001), and acute coronary syndromes (57.8% vs. 33.3%; p<0.001). Nevertheless, cardiac death and TVR rates were similar to those of patients with on-label DES use (p>0.8). Following off-label DES use, there was a higher incidence of PMI (5.0% vs. 1.4%; p=0.003), of which only 1.1% reached creatine kinase levels >5x the upper limit of normal (ULN). Despite differences in risk profile, patients with off-label DES use did not differ from patients with on-label DES use in clinical endpoints other than periprocedural MI. These largely positive findings underline the favourable safety profile of second-generation DES.
[Show abstract][Hide abstract] ABSTRACT: To analyze the incidence and prognostic factors of ipsilateral breast tumor recurrence (IBTR) after breast-conserving therapy (BCT) in a large, population-based, single-center study with long-term follow-up.
International journal of radiation oncology, biology, physics 08/2014; 89(5):1006-14. · 4.59 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Severe childhood obesity has become a major health problem, and effective, evidence-based interventions are needed. The relative effectiveness of inpatient compared with ambulatory treatment remains unknown.
[Show abstract][Hide abstract] ABSTRACT: Background
Numerous instruments are available to measure HRQoL in patients with COPD, covering a wide array of domains ranging from symptoms such as dyspnea, cough and wheezing, to social and emotional functioning. Currently no information or guide is available yet to aid the selection of domains for a particular study or disease population. The aim of this paper is to identify which domains of health-related quality of life (HRQoL) are most important with respect to Chronic Obstructive Pulmonary Disease (COPD), from the patient perspective.Methods
Twenty-one Dutch patients with Chronic Obstructive Pulmonary Disease (COPD) were asked to describe important domains impacted by COPD freely; second, they were presented with cues (domains from the Patient-Reported Outcomes Measurement Information System (PROMIS) framework) and were asked to select the domains that were most relevant to them. During the interview, the patients were asked to indicate in which way the selected domains impact their lives. Both the answers to the open question, and the patient statements motivating nomination of PROMIS domains were coded into themes.ResultsThe most relevant (sub)domains of HRQoL for patients with COPD were: physical health (fatigue, physical functioning), social health (instrumental support, ability to participate in social roles and activities, companionship, and emotional support), and coping with COPD.Conclusion
We identified which domains of HRQoL are most important to patients with COPD. One of these (coping with COPD) is not explicitly covered by PROMIS, or by traditional questionnaires that are used to measure HRQoL in COPD.
Health and Quality of Life Outcomes 07/2014; 12(1):106. · 2.27 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Inhaled corticosteroids and bronchodilators, which are pivotal to the management of respiratory diseases, are delivered by numerous devices, including pressurized metered-dose inhalers and dry-powder inhalers. However, patient adherence to these medications is suboptimal and incorrect inhaler technique is endemic, meaning that insufficient drug quantities are frequently delivered to the lungs. Genuair(®) (Almirall SA, Spain) is a novel, breath-actuated, multidose dry-powder inhaler designed to achieve reliable and effective delivery of inhaled medicines - including aclidinium bromide - to patients with chronic obstructive pulmonary disease. In addition to describing Genuair's design, which incorporates multiple feedback mechanisms in order to confirm effective medication uptake, this article discusses the performance characteristics of the inhaler, its efficiency in terms of drug deposition and the results of recent patient preference and satisfaction studies.
[Show abstract][Hide abstract] ABSTRACT: In patients with locally advanced rectal cancer treated with neoadjuvant chemoradiation followed by rectal resection, postoperative morbidity is a significant clinical problem. Pathologic complete tumour response seems to give the best prognosis in the long term. Little is known about the factors that are associated with postoperative complications and pathologic complete response. The aim of this retrospective study was to identify and describe these factors.
Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract. 06/2014;
[Show abstract][Hide abstract] ABSTRACT: Although upper eyelid blepharoplasty is one of the most frequently performed facial plastic surgical procedures, there is no consensus of opinion about the effect of an upper eyelid blepharoplasty on the position of the eyebrows in a general population.
Journal of plastic, reconstructive & aesthetic surgery : JPRAS. 05/2014;
[Show abstract][Hide abstract] ABSTRACT: To evaluate the safety and efficacy of 2 novel drug-eluting stents (DES) with biodegradable polymer-based coatings versus a durable coating DES.
BIO-RESORT is an investigator-initiated, prospective, patient-blinded, randomized multicenter trial in 3540 Dutch all-comers with various clinical syndromes, requiring percutaneous coronary interventions (PCI) with DES implantation. Randomization (stratified for diabetes mellitus) is being performed in a 1:1:1 ratio between ORSIRO sirolimus-eluting stent with circumferential biodegradable coating, SYNERGY everolimus-eluting stent with abluminal biodegradable coating, and RESOLUTE INTEGRITY zotarolimus-eluting stent with durable coating. The primary endpoint is the incidence of the composite endpoint target vessel failure at 1 year, consisting of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Power calculation assumes a target vessel failure rate of 8.5% with a 3.5% non-inferiority margin, giving the study a power of 85% (α level .025 adjusted for multiple testing). The impact of diabetes mellitus on post-PCI outcome will be evaluated. The first patient was enrolled on December 21, 2012.
BIO-RESORT is a large, prospective, randomized, multicenter trial with three arms, comparing two DES with biodegradable coatings versus a reference DES with a durable coating in 3540 all-comers. The trial will provide novel insights into the clinical outcome of modern DES and will address the impact of known and so far undetected diabetes mellitus on post-PCI outcome.
American heart journal 04/2014; 167(4):445-51. · 4.65 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The mesenteric circulation has an extensive collateral network. Therefore, stenosis in one or more mesenteric arteries does not necessarily lead to symptoms. The objective of this study was to determine the effect of collateral flow on celiac artery (CA) and superior mesenteric artery (SMA) duplex parameters.
Between 1999 and 2007, a cohort of 228 patients analyzed for suspected chronic mesenteric syndrome was studied. Stenosis of the mesenteric vessels and collateral flow patterns were identified on angiography and categorized. The effect of stenosis in one mesenteric vessel and the presence of collaterals from the other unaffected vessel was examined in both the CA and SMA.
Stenosis of the CA resulted in a significantly higher peak systolic velocity (PSV) and end-diastolic velocity in the normal SMA without stenosis. This was also found for the CA without stenosis in the presence of a stenosis of the SMA. An incremental effect of the severity of the CA stenosis was found with a mean SMA PSV of 158 cm/s when normal and 259 cm/s when occluded. The presence of collaterals had a clear effect on duplex parameters of the angiographically normal SMA. In the presence of collaterals and a 70% CA stenosis, the PSV in the normal SMA was significantly higher (P = .025).
This study shows that stenosis in either the CA or SMA increases flow velocities in the other unaffected mesenteric artery. This increase was correlated with the presence of collaterals. Collaterals and stenoses in one of the mesenteric arteries may lead to mimicking or overgrading of stenosis in the other mesenteric artery.
Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 03/2014; · 3.52 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: 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 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.
In the period April 2005 until October 2009, 60 patients (32 male) 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 Dysport(®) (n=27). The primary endpoint was the percentage complete fissure healing after 8 weeks.
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 one year (p=0.286; HR 2.08; 95% CI=0.54-7.97).
Dysport(®) is more effective with fewer side effects than ISDN ointment in the primary treatment of chronic anal fissure. The recurrence rates within one year in both treatment groups is high. This article is protected by copyright. All rights reserved.
[Show abstract][Hide abstract] ABSTRACT: Aims: To investigate the prognostic value of coronary dominance for various adverse clinical events following the implantation of drug-eluting stents. Methods and results: We assessed two-year follow-up data of 1,387 patients from the randomised TWENTE trial. Based on the origin of the posterior descending coronary artery, coronary circulation was categorised into left and non-left dominance (i.e., right and balanced). Target vessel-related myocardial infarction (MI) was defined according to the updated Academic Research Consortium (ARC) definition (2x upper reference limit of creatine kinase [CK], confirmed by CK-MB elevation), and periprocedural MI (PMI) as MI ≤48 hours following PCI. One hundred and thirty-six patients (9.8%) had left and 1,251 (90.2%) non-left dominance. Target lesions were more frequently located in dominant arteries (p<0.005). Left dominance was associated with more severe calcifications (p=0.006) and more bifurcation lesions (p=0.031). Non-left dominance tended to be less frequent in men (p=0.09). Left coronary dominance was associated with more target vessel-related MI (14 [10.3%] vs. 62 [5.0%], p=0.009). Left dominance independently predicted PMI (adjusted HR 2.19, 95% CI: 1.15-4.15, p=0.017), while no difference in other clinical endpoints was observed between dominance groups. Conclusions: In the population of the TWENTE trial, we observed a higher incidence of periprocedural myocardial infarction in patients who had left coronary dominance.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 02/2014; · 3.17 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Microvolt T-wave alternans (MTWA) is an electrocardiographic marker for predicting sudden cardiac death. In this study, we aimed to study the relation between MTWA and scar assessed with cardiac magnetic resonance imaging (CMR) in patients with ischemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM). Sixty-eight patients with positive or negative MTWA and analysable CMR examination were included. Using CMR and the delayed enhancement technique, left ventricular ejection fraction (LVEF), volumes, wall motion and scar characteristics were assessed. Overall, positive MTWA (n = 40) was related to male gender (p = 0.04), lower LVEF (p = 0.04) and increased left ventricular end-diastolic volume (LVEDV) (p < 0.01). After multivariate analysis, male gender (p = 0.01) and lower LVEF remained significant (p = 0.02). Scar characteristics (presence, transmurality, and scar score) were not related to MTWA (all p > 0.5). In the patients with ICM (n = 40) scar was detected in 38. Positive MTWA (n = 18) was related to higher LVEDV (p = 0.05). In patients with DCM (n = 28), scar was detected in 11. Trends were found between positive MTWA (n = 15) and male gender (p = 0.10), lower LVEF (p = 0.10), and higher LVEDV (p = 0.09). In both subgroups, the presence, transmurality or extent of scar was not related to MTWA (all p > 0.45). In this small study, neither in patients with ICM or DCM a relation was found between the occurrence of MTWA and the presence, transmurality or extent of myocardial scar. Overall there was a significant relation between heart failure remodeling parameters and positive MTWA.
The international journal of cardiovascular imaging 02/2014; · 2.15 Impact Factor