Development of a prediction model for deep vein thrombosis in a retrospective cohort of patients with suspected deep vein thrombosis in primary care.

OBJECTIVE: Early and accurate prediction and diagnosis of deep vein thrombosis (DVT) is essential to allow for immediate treatment and reduce potential complications. However, all potentially strong risk factors have not been included in pretest probability assessments such as the Wells score. In addition, the Wells score might not be suitable for use in primary care because it was developed for secondary care. We hypothesized that the addition of more risk factors for DVT to existing diagnostic approaches could improve the prediction of DVT. METHODS: All consecutive patients suspected of having DVT from 2004 to 2016 in a primary care setting were included in our retrospective study. All the patients had undergone Wells score, D-dimer, and duplex ultrasound assessments. The available recorded data of the patients were used to develop a model to predict DVT. RESULTS: Of 3381 eligible patients, 489 (14.5%) had confirmed DVT. The developed model, which included the D-dimer level, Wells score, gender, anticoagulation use, age, and family history of venous thrombosis, was able to distinguish patients with DVT among those with suspected DVT with a sensitivity of 82% (95% confidence interval, 78%-86%) and specificity of 82% (95% confidence interval, 80%-83%). CONCLUSIONS: The proposed model was able to predict for the presence of DVT among all patients with suspected DVT in a primary care setting with reasonable accuracy. Further validation in prospective studies is required.

A risk score for iliofemoral patients with deep vein thrombosis.

OBJECTIVE: Deep vein thrombosis (DVT) is a common condition with a high risk of post-thrombotic morbidity, especially in patients with a proximal thrombus. Successful iliofemoral clot removal has been shown to decrease the severity of post-thrombotic syndrome. It is assumed that earlier thrombus lysis is associated with a better outcome. Generally, the earlier IFDVT is confirmed, the earlier thrombus lysis could be performed. d-Dimer levels and Wells score are currently used to assess the preduplex probability for DVT; however, some studies indicate that the d-dimer value varies depending on the thrombus extent and localization. Using d-dimer and other risk factors might facilitate development of a model selecting those with an increased risk of IFDVT that might benefit from early referral for additional analysis and adjunctive iliofemoral thrombectomy. METHODS: All consecutive adult patients from a retrospective cohort of STAR diagnostic center (primary care) in Rotterdam suspected of having DVT between September 2004 and August 2016 were assessed for this retrospective study. The diagnostic workup for DVT including Wells score and d-dimer were performed as well as complete duplex ultrasound examination. Patients with objective evidence of DVT were categorized according to thrombus localization using the Lower Extremity Thrombolysis classification. Logistic regression analysis was done for a model predicting IFDVT. The cut-off value of the model was determined using a receiver operating characteristic curve. RESULTS: A total of 3381 patients were eligible for study recruitment, of whom 489 (14.5%) had confirmed DVT. We developed a multivariate model (sensitivity of 77% and specificity of 82%; area under the curve, 0.90; 0.86-0.93) based on d-dimer, Wells score, age, and anticoagulation use, which is able to distinguish IFDVT patients from all patients suspected of DVT. CONCLUSIONS: This multivariate model adequately distinguishes IFDVT among all suspected DVT patients. Practically, this model could give each patient a preduplex risk score, which could be used to prioritize suspected IFDVT patients for an immediate imaging test to confirm or exclude IFDVT. Further validation studies are needed to confirm potential of this prediction model for IFDVT.

A multicenter, randomized, dose-finding study of mechanochemical ablation using ClariVein and liquid polidocanol for great saphenous vein incompetence.

BACKGROUND: The purpose of the present study was to identify the ideal polidocanol (POL) concentration for mechanochemical ablation (MOCA) of the great saphenous vein (GSV) using the ClariVein system (Merit Medical, South Jordan, Utah). METHODS: We performed a multicenter, randomized, controlled, single-blind trial with a follow-up period of 6 months. Patients with symptomatic primary truncal GSV incompetence were randomized to MOCA + 2% POL liquid (2% group) or MOCA + 3% POL liquid (3% group). The primary outcome was technical success (TS), defined as an open part of the treated vein segment of ≤10 cm in length. The secondary outcomes were alternative TS, defined as ≥85% occlusion of the treated vein segment, postoperative pain, venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and short-form 36-item health survey questionnaire scores, and complications. RESULTS: From 2012 to 2018, 364 patients (375 limbs) were included, of which, 189 limbs were randomly allocated to the 2% group and 186 to the 3% group. The TS rate at 6 months was 69.8% in the 2% group vs 78.0% in the 3% group (P = .027). A higher overall TS rate was seen in GSVs of ≤5.9 mm compared with GSVs >5.9 mm (84.3% vs 59.5%, respectively; P < .001). The alternative TS rate at 6 months was 61.4% in the 2% group and 67.7% in the 3% group (P = .028). The venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and most short-form 36-item health survey questionnaire domains had improved in both groups (P < .002). Postprocedural pain was low. Two pulmonary embolisms and two deep vein thromboses were seen. Superficial venous thrombosis had occurred more often in the 3% group (18 vs 8 in the 2% group; P = .033). CONCLUSIONS: The results from the present study showed a higher success rate for MOCA with 3% POL liquid than for MOCA with 2% POL liquid at 6 months of follow-up. However, the difference in quality of life was not significant. Long-term follow-up studies are required to investigate whether these results will be sustained in the future.

A Survey on Voiding Complaints in Women Presenting at a Pelvic Care Center.

INTRODUCTION: This article reports the prevalence of self-reported voiding complaints and the relationship with other pelvic floor and bladder dysfunctions (PFD). MATERIALS AND METHODS: Women with a variety of PFDs were referred to the pelvic care center. A standardised questionnaire on 6 PFDs was used. Frequencies of patient characteristics, PFDs and voiding complaints were calculated. Cross tabulation was used to investigate correlations and Pearson correlation coefficients to reveal the strength of the association between PFDs and self-reported voiding complaints. RESULTS: Data of 4470 women were included. Prevalence of (self-reported) voiding Lower urinary tract symptoms was 59.5%. Incomplete bladder emptying is the most prevalent voiding complaint. Self-reported voiding complaints are weakly correlated to age (r = 0.15, p < 0.01) and have moderate correlation with self-reported recurrent urinary tract infections (r = 0.34, p < 0.01), pelvic floor, bladder and bowel complaints. However, the correlation between the feeling of incomplete bladder emptying and the presence of recurrent urinary tract infections is weak (r = 0.06, p = 0.02). CONCLUSION: Voiding complaints have a high prevalence and symptom bother in women visiting a pelvic care center.

Long-term effects of motherfit group therapy in pre-(MOTHERFIT1) and post-partum women (MOTHERFIT2) with stress urinary incontinence compared to care-as-usual: study protocol of two multi-centred, randomised controlled trials.

BACKGROUND: Stress urinary incontinence (SUI) is highly prevalent during pregnancy and after delivery. It is often associated with a failing pelvic floor, sphincteric and/or supportive system. Pelvic-floor-muscle training (PFMT) peri-partum has been proven effective for up to 1 year post-partum; however, its long-term effects are unknown. Group PFMT, given by a physiotherapist, has been proven to be as equally effective as individual therapy. Motherfit is a group-PFMT therapy with an emphasis on pelvic floor exercises, adherence and general fitness. Care-as-usual (CAU), if guideline driven, should, as first treatment option, consist of PFMT. Cost-effective strategies are of relevance, given the rise of health care costs. Motherfit group therapy has the potential to be cost-effective in women with urinary incontinence. Therefore, the objectives of the two current studies are: (1) to investigate whether intensive, supervised, pre-partum (MOTHERFIT1) or post-partum (MOTHERFIT2) pelvic-floor-muscle group therapy reduces 18-month post-partum severity of SUI compared to CAU and (2) whether MOTHERFIT1 OR MOTHERFIT 2 is more (cost-)effective compared to CAU. METHODS: Two multi-centred, randomised controlled trials (MOTHERFIT1, n = 150, MOTHERFIT2, n = 90) will be performed. Participants will be recruited by their midwife or gynaecologist during their routine check. Participants with SUI will receive either motherfit group therapy or CAU. Motherfit group therapy consists of eight group sessions of 60 min each, instructed and supervised by a registered pelvic physiotherapist. Motherfit group therapy includes instructions on pelvic floor anatomy and how to contract, relax and train the pelvic-floor muscles correctly and is combined with general physical exercises. Adherence during and after motherfit will be stimulated by reinforcement techniques and a mobile app. The primary outcome measure is the absence of self-reported SUI based on the severity sum score of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF) at 18 months post-partum. Secondary outcomes evaluate quality of life, subjective improvement and health care costs. DISCUSSION: The motherfit studies are, to our knowledge, the first studies that evaluate both long-term results and health care costs compared to CAU in pregnant and post-partum women with SUI. If motherfit is shown to be (cost-)effective, implementation in peri-partum care should be considered. TRIAL REGISTRATION: Netherlands Trial Register, ID: NL5816 . Registered on 18 July 2016.

Prevalence of anxiety and depressive symptoms and their association with pelvic floor dysfunctions-A cross sectional cohort study at a Pelvic Care Centre.

AIMS: Pelvic floor dysfunctions (PFDs), like voiding complaints, urinary and fecal incontinence, and prolapse, are prevalent and associated with decrease in quality of life. PFDs are often complex and multifactorial in origin showing interrelationships between different PFD and with affective conditions. The primary aim of this study is to describe the prevalence of affective complaints in a cohort of Pelvic Care Centre (PCC) patients. The secondary aim is to describe associations between PFDs and depression or anxiety. METHODS: A cross sectional cohort study at an University Hospital's PCC. First contact patients were included in a triage system and filled out questionnaires regarding pelvic floor complaints and Hospital Anxiety and Depression Scale (HADS) scores. Linear (dummy-) regression analysis of HADS scales was performed to test the effects of relevant clinical predictors related, and not directly related, to pelvic floor problems, and demographic characteristics of the patients. RESULTS: From 1862 eligible first-contact PCC patients, 1510 (mean age 57.1) had completed the questionnaire (352 missing, 18.9%). The prevalence of anxiety and depression complaints was 30.9% and 20.3%, respectively. The variance explained for depression score by PFDs was 0.12 and 0.074 for anxiety. CONCLUSIONS: Anxiety and depression are prevalent (30.9% and 20.3%, respectively) in a cohort of PFDs. PFDs can explain variance within anxiety and depression complaints. Corrected for other contributing variables, 12% of depression and 7.4% of anxiety was directly related to PFDs. We advocate a multidisciplinary approach, containing psychometric assessment for PFDs in order to obtain better diagnostic results and personalized treatment options.

Does sinus rhythm conversion after cardiac surgery affect postoperative health- related quality of life?

BACKGROUND: We investigated the impact and the predictive value of sinus rhythm at 12 months (SR12) on subscales of three different HrQoL questionnaires: SF-36., EuroQoL and MFI 20. METHODS: Data of 125 cardiac surgery patients with pre-operative AF from our previous randomized trial were used. Based on their rhythm outcome patients were divided in two groups: SR12 or AF at 12 months follow up (non-SR12). All questionnaires were self-administered pre-operatively and at 3 months, 6 months and 12 months after surgery. RESULTS: Synus rhytm at 12 months was predictive of improvement of SF36- mental score (MS, p = 0.021), Euro-QoL-MS (p = 0.009), VAS (p = 0.006), and MFI 20-MS (p = 0.009). We failed to find any significant interactions between SR12 and any of the other significant risk factors: age <65 years, paroxysmal type of AF and preoperative AF duration <12 months. In contrast, SR12 was not significant in predicting physical score (PS) subscales of any of the questionnaires (all, p > 0.05) which were predicted by age <65 years (SF36-PS, p = 0.029) by paroxysmal type of AF and age <65 years (Euro-QoL-PS, p = 0.017 and p = 0.04, respectively) and by AF duration <12 months, paroxysmal type of AF and age < 65 years (MFI 20-PS, p = 0.019, p = 0.020 and p = 0.015, respectively). CONCLUSIONS: Specific mental-related HrQoL scales are much more sensitive to sinus rhythm conversion. Sinus rithm mantainance shows significant effects on mental scores independently of other cofactors. Successful conversion to sinus rhythm after surgical ablation during cardiac surgery does not significantly affect phisical health related quality of life during 1 year follow up.

The relation between clinical scores and quality-of-life in long-term follow-up.

INTRODUCTION: Quality-of-life and severity scores are both popular measures in medicine. For deep venous obstruction, the VEINES-QOL/Sym and venous clinical severity score (VCSS) are widely used. Combining a patient-reported outcome with a clinical severity score should give a more sensitive outcome for treatment results. To establish and compare their suitability for deep venous disease, we compared the outcomes of both scores in a group of patients who were interventionally treated for deep venous disease. METHODS: The venous clinical severity scores and VEINES-QOL/Sym scores of a group of patients who had received interventional treatment for deep venous obstruction more than 12 months ago were compared at T0 and T12. RESULTS: Both the Spearman's rho and Pearson's r show a very weak, negative correlation (statistically significant (p ≤ 0.05)), between the venous clinical severity score and VEINES-QOL at T12 and between the venous clinical severity score and the VEINES-SYM at both T0 and T12. T0 VCSS-VSYM: rho = -0.219 (p = 0.052), r = -0.236 (p = 0.037), T12 VCSS-VQOL: rho = -0.459 (p = 0.007), r = -0.379 (p = 0.030), T12 VCSS-VSYM: rho = -0.463 (p = 0.007), r = -0.432 (p = 0.012). This negative correlation was not statistically (p ≥ 0.05) confirmed for T0 VCSS-VSYM. CONCLUSION: The physician-scored venous clinical severity score of patients treated for deep venous obstruction does not correlate well with their self-reported quality-of-life and symptom scores.

Erythrocytapheresis versus phlebotomy in the maintenance treatment of HFE hemochromatosis patients: results from a randomized crossover trial.

BACKGROUND: Phlebotomy is standard maintenance treatment of patients with hereditary hemochromatosis (HH). Erythrocytapheresis, which selectively removes red blood cells, provides a new, potentially more effective treatment option. Our aim was to evaluate the effectiveness of erythrocytapheresis over phlebotomy for maintenance therapy in patients with HH. STUDY DESIGN AND METHODS: We conducted a two-treatment-arms, randomized, crossover clinical trial, involving 46 patients, treated for 1 year with either erythrocytapheresis or phlebotomy to keep the ferritin level at not more than 50 µg/L. After 1 year, patients were switched to the other treatment modality. Primary endpoint was the number of treatment procedures per treatment year. Secondary endpoints were intertreatment intervals, several aspects of health-related quality of life, costs, and patient discomfort as well as preference for one of both treatments. RESULTS: The mean number of required treatment procedures per treatment year was significantly higher using phlebotomy versus erythrocytapheresis (3.3 vs. 1.9; mean difference, 1.4; 95% confidence interval, 1.1-1.7). The median intertreatment time was 2.3 times longer for erythrocytapheresis. There was no significant difference in overall health assessed by SF-36 and EQ-5D, respectively, between both treatments arms. The number of self-reported swollen joints was significantly higher during phlebotomy treatment. The mean treatment costs of one treatment year were 235€ for phlebotomy versus 511€ for erythrocytapheresis. Eighty percent of patients preferred erythrocytapheresis as treatment method. CONCLUSION: Erythrocytapheresis significantly reduced the number of treatment procedures per treatment year, although the mean treatment costs per year are higher in our health care system. It is the preferred treatment for the majority of patients.

Prevalence and triage of first contact pelvic floor dysfunction complaints in male patients referred to a Pelvic Care Centre.

AIMS: (i) To describe and analyse pelvic floor dysfunction symptoms in men referred to a Pelvic Care Centre (PCC). (ii) To describe the triage process of the same patients based on response to a first-contact interview. METHODS: Triage started with a telephone interview using previously constructed questions, asking for six types of PF complaints during the preceding 6 months. If present, complaint severity was registered on a 0-10 scale. Next, these first-contact complaints were used to describe patient case mix profiles using cross-tabular analysis. Later on, at first PCC visit, an intake questionnaire regarding specific PF health problem(s) was filled out. This procedure contributed to a firm baseline characterization of the individual patient profile and a clinically valid allocation to structured, predefined assessment and treatment. RESULTS: From 2005 to 2013 985 first-time patients (mean age 58.2 years (SD 15.3) have been referred to the PCC. Most frequently mentioned complaints: voiding dysfunctions (73.9%), urinary incontinence (29.5%), sexual problems (16.6%), faecal incontinence (13.9%), constipation (9.6%), and prolapse (0.3%). A first appointment to a single specialist was determined in 805 (81.7%) patients, in 137 (13.9%) consultation of >1 specialist. Data analysis revealed higher-order interactions between PF complaints, suggesting patient profile complexity and patient population heterogeneity. CONCLUSIONS: One out of seven PCC patients showed multifactorial problems, needing >1 specialist. PF complaints either turned out to stand alone or cluster with others, or even to strengthen, weaken, nullify or inverse relationships. Neurourol. Urodynam. 35:487-491, 2016. © 2015 Wiley Periodicals, Inc.

Prevalence and triage of first-contact complaints on pelvic floor dysfunctions in female patients at a Pelvic Care Centre.

AIMS: (i) To describe and analyse pelvic floor dysfunction symptoms in women referred to a Pelvic Care Centre (PCC). (ii) To describe the triage process of the same patients based on response to a first-contact interview. METHODS: Triage started with a telephone interview using previously constructed questions, asking for seven types of PF complaints during the preceding 6 months. If present, complaint severity was registered on a 0-10 scale. Next, these first-contact complaints were used to describe patient case mix profiles using cross-tabular analysis. Later on, at first PCC visit, an intake questionnaire containing questions on specific PF health problem(s) was filled out. This procedure contributed to a firm baseline characterization of the individual patient profile and a clinically valid allocation to structured, predefined assessment, and treatment. RESULTS: From 2005 to 2013, 4473 first-time patients (mean age 56.9 (SD 16.2) have been referred to the PCC. Most frequently mentioned complaints: voiding dysfunction (59.5%), urinary incontinence (46.6%), prolapse (41.1%), fecal incontinence (15.1%), constipation (12.6%), and sexual problems (4.6%). A first appointment to a single specialist was determined in 3.110 (69.5%) patients, in 1.192 (26.7%) consultation of >1 specialist. Data analysis revealed higher-order interactions between PF complaints, suggesting patient profile complexity and patient population heterogeneity. CONCLUSIONS: More than one out of four PCC patients showed multifactorial problems, needing >1 specialist. PF complaints either turned out to stand alone or cluster with others, or even to strengthen, weaken, nullify, or inverse relationships. Neurourol. Urodynam. 35:503-508, 2016. © 2015 Wiley Periodicals, Inc.

Factors influencing postpartum women's willingness to participate in a preventive pelvic floor muscle training program: a web-based survey.

OBJECTIVE: Pregnancy and delivery are the most prominent risk factors for the onset of pelvic floor injuries and - later-on - urinary incontinence. Supervised pelvic floor muscle training during and after pregnancy is proven effective for the prevention of urinary incontinence on the short term. However, only a minority of women do participate in preventive pelvic floor muscle training programs. Our aim was to analyze willingness to participate (WTP) in an intensive preventive pelvic floor muscle training (PFMT) program and influencing factors, from the perspective of postpartum women, for participation. STUDY DESIGN: We included 169 three-month postpartum women in a web-based survey in the Netherlands. Demographic and clinical characteristics, knowledge and experience with PFMT and preconditions for actual WTP were assessed. Main outcome measures were frequencies and percentages for categorical data. Cross tabulations were used to explore the relationship between WTP and various independent categorical variables. A linear regression analysis was done to analyze which variables are associated with WTP. RESULTS: A response rate of 64% (n=169) was achieved. 31% of the women was WTP, 41% was hesitating, 12% already participated in PFMT and 15% was not interested (at all). No statistically significant association was found between WTP and risk or prognostic pelvic floor dysfunction factors. Women already having symptoms of pelvic floor dysfunction such as incontinence and pelvic organ prolapse symptoms were more WTP (p=0.010, p=0.001, respectively) as were women perceiving better general health (p<0.001). Preconditions for women to participate were program costs, and travel time not exceeding 15min. CONCLUSIONS: From the perspective of postpartum women, there is room for improvement of preventive pelvic floor management. Further research should focus on strategies to tackle major barriers and to introduce facilitators for postpartum women to participate in PFMT programs.

An overview of the most commonly used venous quality of life and clinical outcome measurements.

BACKGROUND: Modern medicine should no longer rely solely on technical success to evaluate treatments. The treatment of venous disease has seen many new developments, insights, and treatment modalities. Combining clinical scores with quality of life (QoL) outcome measurements is becoming the new norm for evaluation of treatments. Many different outcome assessment instruments are currently available, indicating a lack of consensus. METHODS: We set out to find the most reliable and comprehensive scoring instrument for clinical and QoL measurement in venous disease. In this review, we focus on the eight most widely used instruments. For clinical assessment, these are the Clinical, Etiologic, Anatomic, and Pathologic (CEAP) classification, Villalta scale, and Venous Clinical Severity Score (VCSS); for generic QoL, the 36-Item Short Form Health Survey (SF-36) and EQ-5D questionnaires; and for disease-specific QoL, the Aberdeen Varicose Vein Questionnaire (AVVQ), Chronic Venous Insufficiency Questionnaire (CIVIQ), and VEnous INsufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) questionnaire. Each instrument is reviewed. CONCLUSIONS: For the accurate evaluation of treatment outcomes, socioeconomic, QoL, and clinical aspects must be assessed. None of the available disease-specific instruments is suited to use in uniform outcome measurement for the whole spectrum of venous disease. A new combined QoL and clinical instrument is needed to validly assess and compare the outcomes of venous treatments. The VEINES-QOL/Sym is currently the most valid instrument to assess disease-specific QoL.

Introducing an integrated intermediate care unit improves ICU utilization: a prospective intervention study.

BACKGROUND: Improvement of appropriate bed use and access to intensive care (ICU) beds is essential in optimizing utilization of ICU capacity. The introduction of an intermediate care unit (IMC) integrated in the ICU care may improve this utilization. METHOD: In a before-after prospective intervention study in a university hospital mixed ICU, the impact of introducing a six-bed mixed IMC unit supervised and staffed by ICU physicians was investigated. Changes in ICU utilization (length of stay, frequency of mechanical ventilation use), nursing workload assessed byTISS-28 score, as well as inappropriate bed use, accessibility of the ICU (number of referrals), and clinical outcome indicators (readmission and mortality rates) were measured. RESULTS: During 17 months, data of 1027 ICU patients were collected. ICU utilization improved significantly with an increased appropriate use of ICU beds. However, the number of referrals, readmissions to the ICU and mortality rates did not decrease after the IMC was opened. CONCLUSION: The IMC contributed to a more appropriate use of ICU facilities and did result in a significant increase in mean nursing workload at the ICU.

A prospective randomized controlled trial on the incidence and predictors of late-phase postoperative atrial fibrillation up to 30 days and the preventive value of biatrial pacing.

BACKGROUND: Postoperative atrial fibrillation (POAF) is considered to be a transient arrhythmia in the first week after cardiac surgery. OBJECTIVE: To determine the 30-day incidence and predictors of POAF and the value of postoperative overdrive biatrial pacing in the prevention of POAF. METHODS: Patients (n = 148) without a history of atrial fibrillation undergoing aortic valve replacement or coronary artery bypass graft (CABG) were randomized into a pacing group (n = 75) and a control group. Patients were treated with standardized sotalol postoperatively. Rhythm was continuously monitored for 30 days by a transtelephonic event recorder. RESULTS: POAF occurred in 73 (49.3%) patients, of whom 60 (40.5%) patients showed POAF during postoperative days (PODs) 0-5 and 37 (25%) patients during PODs 6-30. Prolonged aortic cross-clamp time was an important univariate predictor of 30-day and of late POAF (PODs 6-30; P = .017 and P = .03, respectively). Best-fit model analysis using 15 predetermined risk factors for POAF showed different positive interactive effects for early POAF (ie, baseline C-reactive protein levels with a history of myocardial infarction or low body mass index) and late POAF (ie, high body mass index, diabetes mellitus, baseline C-reactive protein, early POAF, creatinine levels, type of operation, smoking, and male gender). Biatrial pacing reduced the late POAF incidence in patients with aortic cross-clamp time >50 minutes (P = .006). CONCLUSION: POAF is not limited to the first week after cardiac surgery but also occurs frequently in the postoperative month. It is desirable to regularly follow patients with POAF for atrial fibrillation recurrences after discharge.

Depression, psychological distress, and quality of life in patients with cardioverter defibrillator with or without cardiac resynchronization therapy.

Congestive heart failure is frequent and leads to reduced exercise capacity, reduced quality of life (QoL), and depression in many patients. Cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillators (ICD) offer therapeutic options and may have an impact on QoL and depression. This study was performed to evaluate physical and mental health in patients undergoing ICD or combined CRT/ICD-implantation (CRT-D). Echocardiography, spiroergometry, and psychometric questionnaires [Beck Depression Inventory, General World Health Organization Five Well-being Index (WHO-5), Brief Symptom Inventory and 36-item Short Form (SF-36)] were obtained in 39 patients (ICD: 17, CRT-D: 22) at baseline and 6-month follow-up (FU) after device implantation. CRT-D patients had a higher NYHA class and broader left bundle branch block than ICD patients at baseline. At FU, ejection fraction (EF), peak oxygen uptake, and NYHA class improved significantly in CRT-D patients but remained unchanged in ICD patients. Patients with CRT-D implantation showed higher levels of depressive symptoms, psychological distress, and impairment in QoL at baseline and FU compared to ICD patients. These impairments remained mostly unchanged in all patients after 6 months. Overall, these findings imply that there is a need for careful assessment and treatment of psychological distress and depression in ICD and CRT-D patients in the course of device implantation as psychological burden seems to persist irrespective of physical improvement.

Consumer satisfaction among patients and their general practitioners about involving nurse specialists in primary care for patients with urinary incontinence.

BACKGROUND: Urinary incontinence (UI) is a very common problem, but existing guidelines on UI are not followed. To bring care in line with guidelines, we planned an intervention to involve nurse specialists on UI in primary care and assessed this in a randomised controlled trial. Alongside this intervention, we assessed consumer satisfaction among patients and general practitioners (GPs). METHODS: Patients' satisfaction with the care provided by either nurse specialists (intervention group) or GPs (control group), respectively, was measured with a self-completed questionnaire. GPs' views on the involvement of nurse specialists were measured in a structured telephone interview. RESULTS: The patient satisfaction score on the care offered by nurse specialists was 8.4 (scale 1-10), vs. 6.7 for care-as-usual by GPs. Over 85% of patients would recommend nurse specialist care to their best friends and 77% of the GPs considered the role of the nurse specialist to be beneficial, giving it a mean score of 7.2. CONCLUSIONS: Although the sample was relatively small and the stability of the results only provisionally established, substituting UI care from GP to nurse specialist appears to be welcomed by both patients and GPs. Small changes like giving additional UI-specific information and devoting more attention to UI (which had been given little attention before) would provide a simple instrument to stimulate patients to change their behaviour in the right direction.

The ciprofloxacin target AUC : MIC ratio is not reached in hospitalized patients with the recommended dosing regimens.

AIM: The aim of this study was to determine the ciprofloxacin serum concentrations in hospitalized patients and to determine which percentage reached the efficacy target of AUC : MIC > 125. Additionally, the influence of demographic anthropomorphic and clinical parameters on the pharmacokinetics and pharmacodynamics of ciprofloxacin were investigated. METHODS: In serum of 80 hospitalized patients ciprofloxacin concentrations were measured with reverse phase high performance liquid chromatography with fluorescence detection. The ciprofloxacin dose was 400-1200 mg day(-1) i.v. in two or three doses depending on renal function and causative bacteria. Pharmacokinetic parameters were calculated with maximum a posteriori Bayesian estimation (MW\PHARM 3.60). A two compartment open model was used. RESULTS: Mean (± SD) age was 66 (± 17) years, the mean clearance corrected for bodyweight was 0.24 l h(-1) kg(-1) and the mean AUC was 49 mg l(-1) h. Ciprofloxacin clearance and thus AUC were associated with both age and serum creatinine. Of all patients, 21% and 75% of the patients, did not reach the proposed ciprofloxacin AUC : MIC > 125 target with MICs of 0.25 and 0.5 mg l(-1), respectively. A computer simulated increase in the daily dose from 800 mg to 1200 mg, decreased these percentages to 1% and 37%, respectively. CONCLUSION: A substantial proportion of the hospitalized patients did not reach the target ciprofloxacin AUC : MIC and are suboptimally dosed with recommended doses. Taking into account the increasing resistance to ciprofloxacin worldwide, a ciprofloxacin dose of 1200 mg i.v. daily in patients with normal renal function is necessary to reach the targeted AUC : MIC > 125.

Effect of supervised exercise therapy for intermittent claudication in patients with diabetes mellitus.

BACKGROUND: Primary treatment for patients with intermittent claudication is exercise therapy. Diabetes mellitus (DM) is a frequently occurring comorbidity in patients with intermittent claudication, and in these patients, exercise tolerance is decreased. However, there is little literature about the increase in walking distance after supervised exercise therapy (SET) in patients with both intermittent claudication and DM. The objective of this study was to determine the effectiveness of SET for intermittent claudication in patients with DM. METHODS: Consecutive patients with intermittent claudication who started SET were included. Exclusion criteria were Rutherford stage 4 to 6 and the inability to perform the standardized treadmill test. SET was administered according to the guidelines of the Royal Dutch Society for Physiotherapy. At baseline and at 1, 3, and 6 months of follow-up, a standardized treadmill exercise test was performed. The primary outcome measurement was the absolute claudication distance (ACD). RESULTS: We included 775 patients, of whom 230 had DM (29.7%). At 6 months of follow-up, data of 440 patients were available. Both ACD at baseline and at 6 months of follow-up were significantly lower in patients with DM (P < 0.001). However, increase in ACD after 6 months of SET did not differ significantly (P = 0.48) between the DM group and the non-DM group (270 m and 400 m, respectively). CONCLUSION: In conclusion, SET for patients with intermittent claudication is equally effective in improving walking distance for both patients with and without DM, although ACD remains lower in patients with DM.