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Arits A.H.M.M.,Maastricht University | Mosterd K.,Maastricht University | Essers B.A.B.,Maastricht University | Spoorenberg E.,Maastricht University | And 12 more authors.
The Lancet Oncology | Year: 2013

Background: Superficial basal-cell carcinoma is most commonly treated with topical non-surgical treatments, such as photodynamic therapy or topical creams. Photodynamic therapy is considered the preferable treatment, although this has not been previously tested in a randomised control trial. We assessed the effectiveness of photodynamic therapy compared with imiquimod or fluorouracil in patients with superficial basal-cell carcinoma. Methods: In this single blind, non-inferiority, randomised controlled multicentre trial, we enrolled patients with a histologically proven superficial basal-cell carcinoma at seven hospitals in the Netherlands. Patients were randomly assigned to receive treatment with methylaminolevulinate photodynamic therapy (MAL-PDT; two sessions with an interval of 1 week), imiquimod cream (once daily, five times a week for 6 weeks), or fluorouracil cream (twice daily for 4 weeks). Follow-up was at 3 and 12 months post-treatment. Data were collected by one observer who was blinded to the assigned treatment. The primary outcome was the proportion of patients free of tumour at both 3 and 12 month follow up. A pre-specified non-inferiority margin of 10% was used and modified intention-to-treat analyses were done. This trial is registered as an International Standard Randomised controlled trial (ISRCTN 79701845). Findings: 601 patients were randomised: 202 to receive MAL-PDT, 198 to receive imiquimod, and 201 to receive fluorouracil. A year after treatment, 52 of 196 patients treated with MAL-PDT, 31 of 189 treated with imiquimod, and 39 of 198 treated with fluorouracil had tumour residue or recurrence. The proportion of patients tumour-free at both 3 and 12 month follow-up was 72·8% (95% CI 66·8-79·4) for MAL-PDT, 83·4% (78·2-88·9) for imiquimod cream, and 80·1% (74·7-85·9) for fluorouracil cream. The difference between imiquimod and MAL-PDT was 10·6% (95% CI 1·5-19·5; p=0·021) and 7·3% (-1·9 to 16·5; p=0·120) between fluorouracil and MAL-PDT, and between fluorouracil and imiquimod was -3·3% (-11·6 to 5·0; p=0·435. For patients treated with MAL-PDT, moderate to severe pain and burning sensation were reported most often during the actual MAL-PDT session. For other local adverse reactions, local skin redness was most often reported as moderate or severe in all treatment groups. Patients treated with creams more often reported moderate to severe local swelling, erosion, crust formation, and itching of the skin than patients treated with MAL-PDT. In the MAL-PDT group no serious adverse events were reported. One patient treated with imiquimod and two patients treated with fluorouracil developed a local wound infection and needed additional treatment in the outpatient setting. Interpretation: Topical fluorouracil was non-inferior and imiquimod was superior to MAL-PDT for treatment of superficial basal-cell carcinoma. On the basis of these findings, imiquimod can be considered the preferred treatment, but all aspects affecting treatment choice should be weighted to select the best treatment for patients. Funding: Grant of the Netherlands Organization for Scientific Research ZONMW (08-82310-98-08626). © 2013 Elsevier Ltd.

Wilschut J.A.,Rotterdam University | Hol L.,Rotterdam University | Jansen J.B.,Elkerliek Hospital | Van Leerdam M.E.,Rotterdam University | And 4 more authors.
Gastroenterology | Year: 2011

Background & Aims: Two European randomized trials (N = 30,000) compared guaiac fecal occult blood testing with quantitative fecal immunochemical testing (FIT) and showed better attendance rates and test characteristics for FIT. We aimed to identify the most cost-effective FIT cutoff level for referral to colonoscopy based on data from these trials and allowing for differences in screening ages. Methods: We used the validated MIcrosimulation SCreening ANalysis (MISCAN)-Colon microsimulation model to estimate costs and effects of different screening strategies for FIT cutoff levels of 50, 75, 100, 150, and 200 ng/mL hemoglobin. For each cutoff level, screening strategies were assessed with various age ranges and screening intervals. We assumed sufficient colonoscopy capacity for all strategies. Results: At all cost levels, FIT screening was most effective with the 50 ng/mL cutoff level. The incremental cost-effectiveness ratio of biennial screening between ages 55 and 75 years using FIT at 50 ng/mL, for example, was 3900 euro per life year gained. Annual screening had an incremental cost-effectiveness ratio of 14,900 euro per life year gained, in combination with a wider age range (between ages 45 and 80 years). In the sensitivity analysis, 50 ng/mL remained the preferred cutoff level. Conclusions: FIT screening is more cost-effective at a cutoff level of 50 ng/mL than at higher cutoff levels. This supports the recommendation to use FIT at a cutoff level of 50 ng/mL, which is considerably lower than the values used in current practice. © 2011 AGA Institute.

Plasqui G.,Maastricht University | Boonen A.,Maastricht University | Geusens P.,Maastricht University | Kroot E.J.,Elkerliek Hospital | And 2 more authors.
Arthritis Care and Research | Year: 2012

Objective. Patients with ankylosing spondylitis (AS) are at risk for accelerated muscle loss and reduced physical activity. Accurate data are needed on body composition and physical activity in this patient group. The purpose of this study was to investigate body composition and objectively assessed physical activity in patients with AS. Methods. Twenty-five AS patients (15 men, mean ± SD age 48 ± 11 years) were compared with 25 healthy adults matched for age, sex, and body mass index. Body composition was measured using a 3-compartment model based on air-displacement plethysmography to assess body volume and deuterium dilution to assess total body water. The fat-free mass index (FFMI; fat-free mass divided by height squared) and the percent fat mass (%FM) were calculated. Daily physical activity was assessed for 7 days using a triaxial accelerometer and physical fitness with an incremental test until exertion on a bicycle ergometer. Blood samples were taken to determine C-reactive protein (CRP) level and tumor necrosis factor. Results. Accelerometer output (kilocounts/day) showed the same physical activity level for patients and controls (mean ± SD 319 ± 105 versus 326 ± 66). There was no difference in the FFMI or %FM between the patients and controls. Physical activity was positively related to the FFMI (partial R = 0.38, P = 0.01) and inversely related to CRP level (R =-0.39, P < 0.01), independent of group. CRP level was inversely related to the FFMI, but the effect was less strong than with physical activity (partial R =-0.31, P = 0.03). Conclusion. Daily physical activity may help preserve fat-free mass in patients with AS. © 2012, American College of Rheumatology.

Boons H.W.,Elkerliek Hospital | Goosen J.H.,Rijnstate Hospital | Van Grinsven S.,Rijnstate Hospital | Van Susante J.L.,Rijnstate Hospital | Van Loon C.J.,Rijnstate Hospital
Clinical Orthopaedics and Related Research | Year: 2012

Background: Four-part fractures of the proximal humerus account for 3% of all humeral fractures and are regarded as the most difficult fractures to treat in the elderly. Various authors recommend nonoperative treatment or hemiarthroplasty, but the literature is unclear regarding which provides better quality of life and function. Questions/purposes We therefore performed a randomized controlled trial to compare (1) function, (2) strength, and (3) pain and disability in patients 65 years and older with four-part humeral fractures treated either nonoperatively or with hemiarthroplasty. Methods: We randomly allocated 50 patients to one of the two approaches. There were no differences in patient demographics between the two groups. The Constant- Murley score was the primary outcome measure. Secondary outcome measures were the Simple Shoulder Test, abduction strength test as measured by a myometer, and VAS scores for pain and disability. All patients were assessed at 12 months. Results: We found no between-group differences in Constant-Murley and Simple Shoulder Test scores at 3- and 12-months followup. Abduction strength was better at 3 and 12 months in the nonoperatively treated group although the nonoperatively treated patients experienced more pain at 3 months; this difference could not be detected after 12 months. Conclusions: We observed no clear benefits in treating patients 65 years or older with four-part fractures of the proximal humerus with either hemiarthroplasty or nonoperative treatment. Level of Evidence: Level I, therapeutic study. See Instructions for Authors for a complete description of levels of evidence. © The Association of Bone and Joint Surgeons® 2012.

Van Der Aa H.P.A.,VU University Amsterdam | Comijs H.C.,VU University Amsterdam | Penninx B.W.J.H.,VU University Amsterdam | Van Rens G.H.M.B.,VU University Amsterdam | And 2 more authors.
Investigative Ophthalmology and Visual Science | Year: 2015

PURPOSE. We assessed the prevalence of subthreshold depression and anxiety, and major depressive, dysthymic, and anxiety disorders (panic disorder, agoraphobia, social phobia, and general anxiety disorder) in visually impaired older adults and compared these estimates with those of normally sighted peers. METHODS. Cross-sectional data were analyzed based on telephone interviews with visually impaired older adults aged ± 60 years (n = 615) with a visual acuity of ≥ 0.30 logMAR (20/40 Snellen) in the best eye from outpatient low vision rehabilitation centers, and face-to-face interviews with community-dwelling normally sighted peers (n = 1232). To determine prevalence rates, the normally sighted population was weighted on sex and age to fit the visually impaired population. Logistic regression analyses were used to compare the populations and to correct for confounders. RESULTS. The prevalence of major depressive disorder (5.4%) and anxiety disorders (7.5%), as well as the prevalence of subthreshold depression (32.2%) and subthreshold anxiety (15.6%), were significantly higher in visually impaired older adults compared to their normally sighted peers (P < 0.05). Agoraphobia and social phobia were the most prevalent anxiety disorders in visually impaired older adults. CONCLUSIONS. This study shows that depression and anxiety are major public health problems in visually impaired older adults. Research on psychotherapeutic and psychopharmacologic interventions to improve depression and anxiety in this population is warranted. (http:/?www.trialregister.nl number, NTR3296.) © 2015 The Association for Research in Vision and Ophthalmology, Inc.

Oudejans I.,Elkerliek Hospital | Oudejans I.,University Utrecht | Mosterd A.,University Utrecht | Mosterd A.,Meander Medical Center | And 2 more authors.
Journal of Cardiac Failure | Year: 2012

Background: Elderly heart failure (HF) patients frequently have multiple comorbidities. The prognostic impact of combined comorbidities is poorly quantified in these patients. We assessed the impact of comorbidities on 3-year mortality in geriatric outpatients with newly diagnosed HF. Methods and Results: Of 93 geriatric outpatients with HF (mean age 82.7 years, 36.6% men), 52 patients (55.9%) died within 3 years after HF was diagnosed. Comorbidity was measured with the Charlson Comorbidity Index (CCI). Age- and gender-adjusted hazard ratio (HR) for 3-year mortality was 1.6 (95% confidence interval [CI] 0.9-3.2) for patients with 3-4 CCI points and 3.2 (95% CI 1.5-6.8) for those with >4 CCI points, compared with 1-2 CCI points. After adjustment for age, gender, left ventricular ejection fraction (LVEF), and N-terminal pro-B-type natriuretic peptide, CCI remained predictive of death (CCI 3-4: HR 1.5 (95% CI 0.7-2.9); CCI >4: HR 4.0 (95% CI 1.9-8.8)). In addition to age and gender, the c-statistics for CCI and LVEF were similar (0.63 [95% CI 0.55-0.70] and 0.64 [95% CI 0.56-0.72], respectively). Conclusions: The majority of geriatric outpatients with new HF die within 3 years. Comorbidity, summarized in the CCI, is the strongest independent predictor of mortality. © 2012 Elsevier Inc. All rights reserved.

Gondrie M.J.A.,University Utrecht | Mali W.P.T.M.,University Utrecht | Jacobs P.C.,University Utrecht | Oen A.L.,Elkerliek Hospital | Van Der Graaf Y.,University Utrecht
Radiology | Year: 2010

Purpose: To predict cardiovascular disease (CVD) in a clinical care population by using prevalent subclinical ancillary aortic findings detected on chest computed tomographic (CT) images. Materials and Methods: The study was approved by the medical ethics committee of the primary participating facility and the institutional review boards of all other participating centers. From a total of 6975 patients who underwent diagnostic contrast material-enhanced chest CT for noncardiovascular indications, a representative sample population of 817 patients plus 347 patients who experienced a cardiovascular event during a mean follow-up period of 17 months were assigned visual scores for ancillary aortic abnormalities - on a scale of 0-8 for calcifications, a scale of 0-4 for plaques, a scale of 0-4 for irregularities, and a scale of 0-1 for elongation. Four Cox proportional hazard models incorporating different sum scores for the aortic abnormalities plus age, sex, and chest CT indication were compared for discrimination and calibration. The prediction model that performed best was chosen and externally validated. Results: Each aortic abnormality was highly predictive, and all models performed well(c index range, 0.70-0.72; goodness-of-fit P value range, .45-.76). The prediction model incorporating the sum score for aortic calcifications was chosen owing to its good performance(c index, 0.72; goodness-of-fit P =.47) and its applicability to nonenhanced CT scanning. Validation of this model in an external data set also revealed good performance(c index, 0.71; goodness-of-fit P =.25; sensitivity, 46%; specificity, 76%). Conclusion: A derived prediction model incorporating ancillary aortic findings detected on routine diagnostic CT images complements established risk scores and may help to identify patients at high risk for CVD. Timely application of preventative measures may ultimately reduce the number or severity of CVD events. © RSNA, 2010.

Pijls B.G.,Elkerliek Hospital | Werner P.H.,Elkerliek Hospital | Eggen P.J.,Elkerliek Hospital
Journal of Orthopaedic Trauma | Year: 2011

OBJECTIVES:: The purpose of this study is to evaluate a consecutive series of proximally porous-coated hemiarthroplasty for the treatment of severe proximal humeral fractures with special emphasis on aseptic loosening and functional outcome. DESIGN:: Observational cohort of a consecutive series of a single prosthetic design. SETTING:: Orthopaedic clinic, nonacademic institutional hospital. PATIENTS/PARTICIPANTS:: All patients (n = 30) treated with hemiarthroplasty for severe fractures of the proximal humerus with informed consent and at least 1 year follow-up were included. Follow-up averaged 37 months (range, 13-62 months). INTERVENTION:: Uncemented proximally porous-coated hemiarthroplasty. MAIN OUTCOME MEASUREMENTS:: We evaluated clinical and radiologic aseptic loosening, Constant score, patient satisfaction and visual analog scale score, range of motion, radiologic parameters such as head-to-tuberosity distance, lateral projection, and lateral offset. RESULTS:: The overall Constant score was 68 (standard deviation [SD] 18), the mean patient satisfaction 7.1 (SD 1.8), and the average visual analog scale score 3.7 (SD 2.5). We observed no cases of radiographic tilting or subsidence. In 17 cases (57%), radiolucent lines 1.0 mm or less were observed in less than three zones. None of the cases met the criteria for radiographic loosening. No revision was performed for aseptic loosening. The average head-to-tuberosity distance was 7.6 (SD 8.7 mm). We found that traumatic neurologic deficit and head-to-tuberosity distance significantly influenced Constant score. Lateral projection significantly correlated with Constant score, active forward flexion, and abduction. CONCLUSIONS:: Proximally porous-coated hemiarthroplasty is a valuable alternative alongside cemented hemiarthroplasty for the treatment of severe fractures of the proximal humerus. The radiographic finding of increased lateral projection was associated with an improved range of motion. Copyright © 2011 by Lippincott Williams & Wilkins.

Pijls B.G.C.W.,Elkerliek Hospital | Werner P.H.,Elkerliek Hospital | Eggen P.J.M.G.,Elkerliek Hospital
Journal of Shoulder and Elbow Surgery | Year: 2010

Hypothesis: We hypothesize that the sling technique provides better long term tuberosity fixation in hemiarthroplasty for severe fractures of the proximal humerus. Background: After hemiarthroplasty for proximal humeral fractures, problems exist with deterioration of shoulder function by secondary displacement of the initially fixated humeral tuberosities. This study evaluated a new technique for fixation of the greater and lesser tuberosities in uncemented hemiarthroplasties in severely displaced 3- or 4-part proximal humeral fractures. Materials and methods: A consecutive series of 31 uncemented hemiarthroplasties using the new sling technique to repair the tuberosities was evaluated clinically and radiographically with special emphasis on the head-to-tuberosity distance (HTD). A historical cohort of 10 similar uncemented hemiarthroplasties was the control group in which the drill-hole technique was used for fixation of the humeral tuberosities. Results: The sling technique had an overall better tuberosity positioning in terms of HTD compared with the drill-hole technique (8 vs 1 mm; P = .025, U test). There were significantly more normal HTD values in the sling-technique group (81% vs 44%; P = .032, χ2 test). In the anatomic HTD group, the Constant score (70 vs 52; P = .009), patient satisfaction (7.1 vs 5.7; P = .038), and visual analog scale score (3.2 vs 5.2; P = .025) were statistically significantly superior compared with the nonanatomic HTD group. Conclusion and Discussion: The sling technique for tuberosity fixation seems to provide solid fixation. In this study, anatomic HTD fixation was associated with significantly better functional outcome, patient satisfaction, and pain scores. © 2010 Journal of Shoulder and Elbow Surgery Board of Trustees.

Gondrie M.J.A.,University Utrecht | Van Der Graaf Y.,University Utrecht | Jacobs P.C.,University Utrecht | Oen A.L.,Elkerliek Hospital | Mali W.P.Th.M.,University Utrecht
European Radiology | Year: 2011

Objectives: This study aims to investigate the prognostic value of incidental aortic valve calcification (AVC), mitral valve calcification (MVC) and mitral annular calcification (MAC) for cardiovascular events and non-rheumatic valve disease in particular on routine diagnostic chest CT. Methods: The study followed a case-cohort design. 10410 patients undergoing chest CT were followed for a median period of 17 months. Patients referred for cardiovascular disease were excluded. A random sample of 1285 subjects and the subjects who experienced an endpoint were graded for valve calcification by three reviewers. Cox-proportional hazard analysis was performed to evaluate the prognostic value. Results: 515 cardiovascular events were ascertained. Compared with patients with no valve calcification, patients with severe AVC, MVC or MAC had respectively 2.03 (1.48-2.78), 2.08 (1.04-4.19) and 1.53 (1.13-2.08) increased risks of experiencing an event during follow-up. For valve endpoints the hazard ratios were respectively 14.57 (5.19-40.53), 8.78 (2.33-33.13) and 2.43 (1.18-4.98). Conclusion: Incidental heart valve calcification, detected on routine chest CT is an independent predictor of future cardiovascular events. The study emphasises how incidental imaging findings can contribute to clinical care. It is a step in the process of composing an evidence-based approach in the reporting of incidental subclinical findings. © 2010 The Author(s).

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