Eight-year follow-up of a randomized clinical trial comparing ultrasound-guided foam sclerotherapy with surgical stripping of the great saphenous vein.

BACKGROUND: This was an 8-year follow-up of an RCT comparing ultrasound-guided foam sclerotherapy (UGFS) with high ligation and surgical stripping (HL/S) of the great saphenous vein (GSV). METHODS: Patients were randomized to UGFS or HL/S of the GSV. The primary outcome was the recurrence of symptomatic GSV reflux. Secondary outcomes were patterns of reflux according to recurrent varices after surgery, Clinical Etiologic Anatomic Pathophysiologic (CEAP) classification, Venous Clinical Severity Score (VCSS) and EuroQol Five Dimensions (EQ-5D™) quality-of-life scores. RESULTS: Of 430 patients originally randomized (230 UGFS, 200 HL/S), 227 (52·8 per cent; 123 UGFS, 103 HL/S) were available for analysis after 8 years. The proportion of patients free from symptomatic GSV reflux at 8 years was lower after UGFS than HL/S (55·1 versus 72·1 per cent; P = 0·024). The rate of absence of GSV reflux, irrespective of venous symptoms, at 8 years was 33·1 and 49·7 per cent respectively (P = 0·009). More saphenofemoral junction (SFJ) failure (65·8 versus 41·7 per cent; P = 0·001) and recurrent reflux in the above-knee GSV (72·5 versus 20·4 per cent; P = 0·001) was evident in the UGFS group. The VCSS was worse than preoperative scores in both groups after 8 years; CEAP classification and EQ-5D® scores were similar in the two groups. CONCLUSION: Surgical stripping had a technically better outcome in terms of recurrence of GSV and SFJ reflux than UGFS in the long term. Long-term follow-up suggests significant clinical progression of venous disease measured by VCSS in both groups, but less after surgery. Registration number: NCT02304146 (http://www.clinicaltrials.gov).

Conservative versus surgical treatment of venous leg ulcers: 10-year follow up of a randomized, multicenter trial.

INTRODUCTION: Leg ulcers have a large socio-economic impact. Treatment modalities are either conservative or surgical. Conservative treatment involves local treatment and compression therapy. Surgical treatment of venous ulcers is based on correcting venous hypertension, by treating incompetent superficial, deep, and perforating veins. A prospective randomized multicenter trial comparing surgical treatment (combined superficial and perforating vein surgery) with ambulatory compression therapy was conducted during 1998 and 2001. This paper presents the results of a 10-year follow-up period of this trial. MATERIALS AND METHODS: All patients enrolled in the original prospective trial were approached and invited for additional examination and duplex ultrasound evaluation. Secondary, disease specific and generic quality-of-life (QoL) was assessed. Current ulcer state and recurrence during the follow-up period was assessed. RESULTS: After a mean of 97 months follow up, 80 (41%) out of 196 legs could be inspected. The incidence of "ulcer-free", the main outcome, was significantly (p = 0.007) higher in the surgical group (58.9%), compared to the conservative group (39.6%). Observed ulcer recurrence was 48.9% for the surgical group and 94.3% for the conservative group. The number of incompetent perforating veins appears to be a significant (p < 0.001) risk factor for not being ulcer-free. Disease specific QoL showed no significant difference between the surgical and conservative groups. CONCLUSIONS: The addition of surgical treatment in patients with venous ulceration leads to a significantly higher chance of being ulcer-free, than just ambulatory compression therapy. This effect persists after 10 years of follow up. The number of incompetent perforating veins has a significant effect on the ulcer-state and recurrence.

Quality-of-life in interventionally treated patients with post-thrombotic syndrome.

INTRODUCTION: New developments in the treatment of complex deep venous disease have become available in the last decade. Besides analysing patencies as a surrogate outcome for these treatments we analysed the Quality-of-Life (QoL) changes for successful and failed deep venous treatments. MATERIALS AND METHODS: Patients with proven venous occlusive disease, referred to our department of Venous Surgery at the Maastricht University Medical Centre, were included. After inclusion patients were treated by percutaneous transluminal angioplasty and stenting and when indicated endophlebectomy with an arteriovenous fistula. QoL was assessed with the disease specific VEINES-QOL/Sym and the generic Short-Form (SF)-36 questionnaires preoperatively at baseline and post-operatively after 3, 12 and 24 months. RESULTS: One hundred fifty-three interventions were analysed, showing a primary, assisted primary and secondary patency of respectively 65%, 78% and 89% at 24 months. The VEINES-QOL and Sym scores improved at 3, 12 and 24 months. The overall improvement at 24 months is 22.7 for QoL and 18.18 for Sym with respective p values of 0.013 and 0.016. The improvement of the VEINES-QOL and Sym scores after a successful (patent) treatment remained highly significant (QoL: p < 0.001, Sym: p = 0.004). Also the generic QoL (Short-Form 36v2) shows significant improvement after 12 months for physical functioning (p = 0.004) and role physical (p = 0.004) scales. CONCLUSIONS: The overall patencies of interventions for deep venous pathology are exceptionally good after two years. Concomitantly the VEINES-Sym and VEINES-QOL scores improve significantly for 3, 12, and 24 months when compared to the baseline (T0) after treatment. Successful interventions showed, as expected, a significant greater QoL improvement between T0 and T3, T12, T24 for both VEINES-QOL and VEINES-Sym scores when compared to the failed interventions. The one-year linear improvement of two SF-36 scales (PF and RP) is also significant.

PNE versus 1st stage tined lead procedure: a direct comparison to select the most sensitive test method to identify patients suitable for sacral neuromodulation therapy.

AIMS: To compare the patient's response rate to the Percutaneous Nerve Evaluation test (PNE) and the 1st stage tined-lead placement test (FSTLP) for sacral neuromodulation therapy (SNM). METHODS: Single center study on patients with refractory idiopathic overactive bladder syndrome (OAB) or non-obstructive urinary retention, screened with both PNE and FSTLP. Patients were followed prospectively and their response rate based on bladder diary after PNE was compared to that after FSTLP. More than 50% improvement in at least two relevant urinary symptoms was considered a positive response. A Wilcoxon paired test was done to compare the rates of the two screening options and logistic regression to determine possible associations. A follow-up was conducted to determine the long-term failure rate. RESULTS: One hundred patients were included (82 female, 69 OAB). The mean age was 55 years (SD 13). The positive response rate on PNE was 47%. FSTLP showed a 69% positive response rate, which was negatively related to age. The 22% gain in positive response was statistically significant (P < 0.001) and positively associated with female gender and younger age. All 69 patients with a positive response to FSTLP received SNM treatment. Failure rate after an average of 2 years was 2.9%. CONCLUSIONS: This study suggests that FSTLP may be a more sensitive screening method than PNE to identify patients eligible for SNM therapy, warranting randomized trials.

A prospective randomized multicenter comparison on health-related quality of life: the value of add-on arrhythmia surgery in patients with paroxysmal, permanent or persistent atrial fibrillation undergoing valvular and/or coronary bypass surgery.

INTRODUCTION: This is a multicenter, prospective, randomized controlled trial to determine the effect of add-on arrhythmia surgery on health-related quality of life during 1-year follow-up of cardiac surgery patients with atrial fibrillation. METHODS: 150 patients with documented atrial fibrillation were randomly assigned to undergo cardiac surgery with or without add-on surgery. Patients completed quality of life questionnaires, comprising the RAND 36-item Health Survey 1.0 (SF-36), Multidimensional Fatigue Inventory-20 (MFI-20) and EuroQoL (EQ-5D and VAS) at baseline and 3, 6, and 12 months following operation. RESULTS: 132 patients completed the questionnaires at a minimum of one time-point during follow-up. At baseline patient characteristics, operative data and health-related quality of life were comparable. At 12-month follow-up 62 patients were free of atrial fibrillation without significant differences between groups (P = 0.28). Conversion to SR occurred in 69.8% (37/53) of patients with paroxysmal AF, in 28.2% (11/39) of patients with permanent AF and in 44.4% (12/27) of patients in persistent AF. Cardiac surgery in general resulted in an overall improvement of the RAND SF-36 and the MFI-20. However, the EQ-5D showed a significant deterioration in the subscale Pain/Discomfort for both groups (P < 0.001), with a significant worse outcome for the control group (P = 0.006). CONCLUSIONS: Health-related quality of life in patients with paroxysmal, permanent and persistent atrial fibrillation improves after cardiac surgery regardless of giving add-on surgery or not, but this improvement is presumably more affected by treating the underlying heart disease than by restoring sinus rhythm.

Adherence to safety guidelines on paediatric procedural sedation: the results of a nationwide survey under general paediatricians in The Netherlands.

OBJECTIVES: Following two fatal accidents during paediatric procedural sedation (PS), the authors investigated the level of adherence to established safety standards on PS in a nationwide cohort of fully trained general paediatricians, entrusted with PS. STUDY DESIGN AND METHODS: Sample survey Safety guidelines on PS were split into four domains ("Presedation Assessment", "Monitoring during PS", "Recovery after PS" and "Facilities and Competences for Emergencies and Rescue"). Each domain was operationalised into sub-domains and items. Items were presented within a questionnaire list as procedural points of attention on which respondents could give their personal adherence score. Percentages of full adherence were calculated. Non-adherence was defined as gradual deviation from full adherence. After factor and reliability analysis, observed scores were summed up to scales, and results were transformed to a 0-10 report mark (RM). An RM of ≥9 is considered as a satisfactory level of adherence while an RM <6 is considered as unacceptably low. RESULTS: Full adherence was rare. For most (sub) domains, only a minority of respondents achieved a satisfactory level of adherence. Large numbers of respondents had scores below 6. CONCLUSIONS: Potentially unsafe PS practices are common under Dutch general paediatricians, despite the availability of guidelines. The design of guidelines should include a goal-directed plan for implementation including training, initiatives for continuous quality assurance and improvement and repeated measurements of adherence to guidelines.

Factors associated with percutaneous nerve evaluation and permanent sacral nerve modulation outcome in patients with fecal incontinence.

PURPOSE: Sacral nerve modulation is an established treatment for fecal incontinence. Little is known about predictive factors for successful percutaneous nerve evaluation (or test stimulation) and permanent sacral nerve modulation outcome. The purpose of this retrospective study was to discover predictive factors associated with temporary and permanent stimulation. METHODS: We analyzed data from test stimulations performed in patients with fecal incontinence from March 2000 until May 2007. Successful outcome was defined as >50% improvement of incontinence episodes in three weeks. Patients with a successful test stimulation were eligible for permanent sacral nerve modulation implantation. All patients who subsequently had permanent sacral nerve modulation were analyzed. Logistic regression was used to determine the predictive power of baseline demographics and diagnostic variables. RESULTS: Test stimulations were performed in 245 patients (226 females; mean age, 56.6 (standard deviation, 12.8) years). Our analysis showed that older age (P = 0.014), external anal sphincter defects (P = 0.005), and repeated procedures after initial failure (P = 0.001) were significantly related to failure. One hundred seventy-three patients (70.6%) were eligible for permanent sacral nerve modulation implantation. The analysis showed no significant predictive factors related to permanent sacral nerve modulation. CONCLUSION: Three predictive factors were negatively associated with the outcome of test stimulation: older age, repeated procedures, and a defect in the external anal sphincter. These factors may indicate lower chances of success for test stimulation but do not exclude patients from sacral nerve modulation treatment. Although assessed in a selected patient group, no factors were predictive of the outcome of permanent stimulation.

Why women do not accept randomisation for place of birth: feasibility of a RCT in The Netherlands.

OBJECTIVE: The purpose of this study was to investigate why low-risk nulliparae were not willing to participate in a randomised controlled trial (RCT) of place of birth. DESIGN: Prospective study. SETTING: The Netherlands. POPULATION: All low-risk nulliparous women starting their pregnancy under midwife. METHODS: A questionnaire for 107 nulliparae who were willing to participate in a cohort study on place of birth, but at an earlier stage in their pregnancy declined to participate in a RCT of place of birth. This questionnaire included 12 items on a 4-point Likert scale but was not subjected to formal validation. MAIN OUTCOME MEASURE: Reasons why nulliparae did not accept randomisation of place of birth. RESULTS: The most important reason why women refused participation in the trial was that they had already chosen their place of birth before they were asked to participate at 12 weeks of pregnancy. From their answers, it became clear that pregnant women strongly value their autonomy of choice. The decision not to participate in the trial was not influenced by the information given by the midwife and the additional written information. CONCLUSIONS: Factors that prevent randomisation for place of birth are difficult to influence. There is a need to explore why there is such certainty of view among women having their first child. Until we have an understanding of why women select information to make these choices and why women are reluctant to participate in trials that challenge choice, it may well be impossible to mount a trial of place of birth.

Redefining the clinical phenotypes of non-dystrophic myotonic syndromes.

OBJECTIVE: To redefine phenotypical characteristics for both chloride (ClCh) and sodium channelopathies (NaCh) in non-dystrophic myotonic syndromes (NDM). METHODS: In a cross-sectional, nationwide study, standardised interviews and clinical bedside tests were performed in 62 genetically confirmed NDM patients, 32 ClCh and 30 NaCh. RESULTS: Standardised interviews revealed that ClCh reported a higher frequency of muscle weakness (75 vs 36.7%; p<0.01), the warm-up phenomenon (100 vs 46.7%; p<0.001), and difficulties in standing up quickly (90.6 vs 50.0%; p<0.001), running (90.6% vs 66.7; p<0.05) and climbing stairs (90.6 vs 63.3%; p = 0.01). Patients with NaCh reported an earlier onset (4.4 vs 9.6 years; p<0.001), and higher frequencies of paradoxical (50.0 vs 0%; p<0.001) and painful myotonia (56.7 vs 28.1%; p<0.05). Standardised clinical bedside tests showed a higher incidence and longer relaxation times of myotonia in the leg muscles for ClCh (100 vs 60%; mean duration of chair tests 12.5 vs 6.3 s; p<0.001), and in eyelid muscles for NaCh (96.7 vs 46.9%; mean relaxation time of 19.2 vs 4.3 s; p<0.001). Transient paresis was only observed in ClCh (62.5%) and paradoxical myotonia only in NaCh (30.0%). Multivariate logistic regression analyses allowed clinical guidelines to be proposed for genetic testing. CONCLUSION: This study redefined the phenotypical characteristics of NDM in both ClCh and NaCh. The clinical guidelines proposed may help clinicians working in outpatient clinics to perform a focused genetic analysis of either CLCN1 or SCN4A.

Effects of Macroplastique Implantation System for stress urinary incontinence and urethral hypermobility in women.

A study was carried out to evaluate efficacy of Macroplastique(R) (MPQ) Implantation System (MIS) in women with urodynamic stress urinary incontinence (SUI) and urethral hypermobility after an unsuccessful conservative treatment. This is a prospective randomized controlled trial in women without previous incontinence surgery. Twenty-four women received MPQ. Twenty-one controls underwent a pelvic floor muscle exercises home program. Follow-up was at 3 months and the MPQ group also at 12 months. At 3 months, pad usage decreased significantly more in the MPQ group than in the control group (p = 0.015). According to physician and patient self-assessment, respectively, 71% and 63% women in the MPQ group were considered cured or markedly improved. This was significantly higher compared to controls. There was a significant higher increase of Incontinence Quality-of-Life questionnaire score in the MPQ group compared to controls (p = 0.017). Improvements in MPQ group at 3 months are sustained to 12 months. Adverse events were mild and transient. MIS is an acceptable option for women with SUI and urethral hypermobility.

How do patients with urinary incontinence perceive care given by their general practitioner? A cross-sectional study.

BACKGROUND: Urinary incontinence (UI) is a widespread problem, affecting quality of life and leading to high costs, mainly caused by incontinence pads. It seems that, despite guidelines, many UI patients get pads from their general practitioner (GP) without adequate diagnostics or treatment. OBJECTIVES: To assess what further treatment UI patients receive from their GP next to pads and to measure patient satisfaction with care. METHODS: A postal survey among UI patients who started pad use in the past 12 months. MAIN OUTCOME: Satisfaction with UI care. RESULTS: We analysed 208 questionnaires. 29.3% of pad users had no direct contact with their GP for a pad prescription. Of 147 UI patients who visited their GP 50.3% only got pads. 25% of patients was not satisfied with the information on UI received from their GP, especially younger patients, women, less healthy patients and patients with urgency UI. CONCLUSIONS: Dutch UI patients using pads experience suboptimal GP care and management. Factors identified through patient feedback should be used to improve quality of care for UI in primary care.

Perceptions of facial aesthetics in surgical patients with basal cell carcinoma.

BACKGROUND: Basal cell carcinoma (BCC) is a non-melanoma form of skin cancer that is frequently localized within the cervicofacial area. So far, little research is available on how patients perceive their facial aesthetics after surgical treatment for BCC. OBJECTIVES: To analyse (i) if there was a statistically significant improvement over time with regard to the perceived facial aesthetics of surgical patients; (ii) if there was a significant difference between primary and recurrent BCC patients; and (iii) between patients who had Mohs micrographic surgery (MMS) or surgical excision (SE). To assess (iv) which baseline perceptions and/or clinical parameters may predict the evaluation of facial aesthetics at 6 months after surgery. METHODS: Parallel to a clinical trial, a survey was carried out in which patients were asked, by means of a newly developed disease-specific questionnaire, about perceptions with regard to their facial aesthetics before and after surgery. RESULTS: Aesthetic perceptions of all surgical patients improved over time. There was no statistically significant difference on facial aesthetics between the group with a primary or recurrent BCC and patients treated with MMS or SE. Results also showed that the evaluation of postsurgical facial aesthetics can be predicted by both visibility of the tumour and preoperative perceptions. CONCLUSION: It is recommended to administer preoperatively a short questionnaire in which perceptions related to facial aesthetics are included. In doing so, physicians will become more familiar with the aesthetic problems patients might have regarding their afflicted facial site. Ultimately, it may help physicians in deciding whether patients will benefit from additional cosmetic procedures after surgery.

Predictors of mortality: a comparison between two burn wound treatment policies.

Retrospective review of outcomes and experiences of a single burn centre between two time periods during which a new wound care technique was employed after the first period. The time period was divided into two: 1977-1984 and 1984-1990. Due to the use of cerium nitrate-silver sulphadiazine, the introduction of serial excision and grafting became possible in the second time period. Multivariate risk-analysis was done by logistic regression analysis. The mortality rate decreased from 13.7% (1997-1983) to 4.7% (1984-1990). Results of multiple logistic regression analysis indicate that the change in periods was advantageous for patients with >50% TBSA, within the age group, 0 to 30 years. Obviously, the care which a patient receives has improved significantly. Many developments occurred simultaneously and it appears impossible to conclude that only the use of cerium nitrate-silver sulphadiazine was the reason for improved survival. Nevertheless, the use of cerium nitrate-silver sulphadiazine enables sequential excision and grafting and in consequence allows for many of these developments to occur.

The effects of insole configurations on forefoot plantar pressure and walking convenience in diabetic patients with neuropathic feet.

BACKGROUND: The aim of this study was to evaluate the effects of insole configurations on plantar pressures and on walking convenience in patients with diabetic neuropathy. METHODS: Twelve different insole configurations were constructed for each of 20 patients with diabetic neuropathy. For this, different combinations of a metatarsal dome, varus and valgus wedges and arch supports with different heights were added on a fitted basic insole. Foot orthoses were evaluated while patients walked on a treadmill. Plantar pressure was measured with a Pedar Insole-system. Walking convenience was scored on a 10-point scale. FINDINGS: For the central and medial regions, plantar pressure reductions (up to 36% and 39%, respectively) were found when using a dome, standard and extra supports. The largest reductions were achieved with combination of a dome and extra support. There were no statistically significant pressure reducing effects of the insole configurations in the big toe and lateral regions, except for the effect of the combination extra support/varus wedge (21%), and for a dome (10%), respectively. The basic insole and a standard support received the best ratings for walking convenience and gradually worsened by adding extra support, a varus wedge and a dome. INTERPRETATION: A dome and the supports reduce plantar pressure in the central and medial forefoot. The combination of a dome and extra support seems to be the best choice for the construction of insoles. The results of this study are a step towards developing an evidence-based algorithm for the construction of optimal orthoses in therapeutic shoe design.

Histopathological characteristics of metastasizing squamous cell carcinoma of the skin and lips.

AIMS: The reported incidence of metastasis from squamous cell carcinoma (SCC) of the skin and lip varies between 0.5% and 16%. Clinical and histopathological criteria have been proposed to identify tumours that may have an increased risk of metastasis. The aim of this study was to define such high-risk tumours, especially since the incidence of SCC of the skin is increasing. METHODS AND RESULTS: Histopathological features of metastasized skin and lip tumours and a matched group of non-metastasizing tumours were reassessed. Characteristics studied were: tumour width, excision margins, histological subtype, Clark level, Breslow depth, tumour differentiation, inflammation, perineural and angio-invasive growth, ulceration and desmoplasia. Data were statistically analysed separately for skin and labial lesions. Desmoplasia, Clark level, Breslow depth, maximum diameter, angio-invasion, grading, perineural invasion, plasma cells and eosinophilic inflammatory response proved to be statistically significantly related to metastasis of skin tumours. Breslow depth, plasma cells and grading appeared to be statistically significantly related to metastasis of SCC of the lips. CONCLUSIONS: A typical metastatic SCC showed: a tumour width of at least 15 mm, a vertical tumour thickness (=Breslow) of at least 2 mm, less differentiation, presence of desmoplasia and an inflammatory response with eosinophils and plasma cells.

Body composition in children with galactosaemia.

Body composition in classical galactosaemia has not been studied. Patients with classical galactosaemia, an inherited disorder of galactose metabolism caused by deficiency of galactose-1-phosphate uridyltransferase (GALT, EC 2.7.7.10), might be at risk for an abnormal body composition because of intrinsic factors related to galactosaemia and/or diet-related factors. The aim of this study was to evaluate the body composition of children with classical galactosaemia. The studied population was a previously reported group of classical galactosaemia patients (13 male and 27 female, ages 3-17 years) with decreased height, weight, weight-for-height and insulin-like growth factor-I (IGF-I) Z-scores. Body composition data were obtained by dual-energy X-ray absorptiometry (DXA). In order to correct for height, fat mass (FM) and lean tissue mass (LTM) were divided by squared height. Mid-parental target height Z-scores were assessed and compared to actual height Z-scores. Linear and multiple regression analysis were done to investigate the relationship between body composition and IGF-I, dietary intake and growth data. We found decreased height Z-scores when compared to mid-parental target height Z-scores. Mean scores for FM and LTM (both adjusted for height) were decreased. LTM (adjusted for height) and height Z-score were correlated with IGF-I Z-score. FM (adjusted for height) was correlated with soy intake. No correlation was found between soy intake and IGF-I Z-score. In this limited group of patients, height is decreased and body composition is abnormal. The decreased levels of IGF-I and/or soy nutrition might play a role in these findings.

Bone metabolism in galactosemia.

Classical galactosemia is an autosomal recessively inherited disorder of galactose metabolism. Treatment consists of life-long dietary restriction of galactose. Despite treatment, long-term complications occur such as a decreased bone mineral density (BMD). A decreased BMD might be the result of either dietary deficiencies secondary to the galactose-restricted diet or unknown intrinsic factors. In this study, 40 children with classical galactosemia (13 males and 27 females, aged 3-17 years) on dietary treatment were included to gain insight in the bone metabolism of galactosemics. We found weight and height Z scores significantly decreased in galactosemics. Mean areal BMD Z scores of lumbar spine and of femoral neck as measured by Dual energy X-ray Absorptiometry (DXA) were -0.6 (P < 0.001) and -0.3 (P = 0.066), respectively. Mean volumetric BMD of the femoral neck was significant lower in galactosemics (P < 0.001). The recommended dietary allowances (RDA) for calcium, magnesium, zinc, vitamin D, and protein were met in all patients. Mean serum levels of calcium, phosphate, magnesium, zinc, 1,25-dihydroxy vitamin D (1,25OHD), parathormone (PTH), 17-beta estradiol, bone alkaline phosphatase (BAP), and under-carboxylated osteocalcin (ucOC) were normal. Serum levels of IGF-1 Z score, carboxylated osteocalcin (cOC), N-terminal telopeptide (NTX), and C-terminal telopeptide (CTX) were significantly lower in galactosemics than in control subjects. The different bone markers were strongly correlated. The low levels of IGF-1 Z score, formation marker cOC, and resorption markers NTX and CTX suggest a decreased bone metabolism in galactosemics.

Problems in interhospital pediatric intensive care transport in The Netherlands: results from a survey of general pediatricians.

OBJECTIVE: Interhospital pediatric intensive care transport accompanied by non-trained specialists usually occurs with inadequate equipment and has been associated with high incidence of complications. These facts have serious consequences for patients but also can be very disconcerting for specialists. This survey was undertaken to gain insight into the problems encountered in organizing pediatric intensive care transport in The Netherlands to measure the specialist's satisfaction or dissatisfaction with the current state of affairs in the organization of such transports, and additional workload and feelings of insecurity experienced during self-organized transports. DESIGN: Survey, retrospective. SETTING: A postal questionnaire sent to all pediatricians of community hospitals in The Netherlands. METHODS: Results of direct questioning are given as discrete frequencies. After factor and reliability analysis 5-point Likert scale items are summed up in scale constructions. Relationships between scales are examined in regression analysis. RESULTS: Pediatricians appear to be satisfied with current specialist retrieval teams if these teams are available in their region, and highly dissatisfied if not available. Many nontrained specialists consider these transports burdening tasks with a high workload, and they feel insecure during these transports, especially if they report lack of knowledge of the transport equipment. CONCLUSIONS: The need for pediatric specialist retrieval teams in The Netherlands is seen not only in the insufficient level of care delivered by accompanying nontrained specialists and the reported high incidence of complications as shown in the literature but also in the dissatisfaction and high stress of these specialists.

Predictive factors for sacral neuromodulation in chronic lower urinary tract dysfunction.

OBJECTIVES: To investigate data from 211 patients who underwent a trial stimulation (percutaneous nerve evaluation [PNE]) to determine the clinical parameters that can enhance the prediction of PNE success. The advantageous effect of sacral neuromodulation depends on the accurate identification of suitable candidates during the preimplantation PNE. METHODS: A total of 211 patients (161 women and 50 men), with refractory urge incontinence, urgency-frequency syndrome, and urinary retention, underwent a PNE. Patient data (demographics, medical history, urologic investigations, and diagnosis) were collected. The PNE results were evaluated from a voiding diary and patient history. More than 50% improvement of voiding parameters was considered a successful PNE, and those patients were selected for implantation. Logistic regression analysis was performed. The factors tested for predicting the test result were sex, patient age, diagnosis, previous surgery, neurogenic bladder dysfunction, duration of complaints, and previous treatments. RESULTS: The PNEs were positive in 85 patients (40.3%) and negative in 105 patients (49.8%). In 18 patients (8.5%), the test electrode had migrated; 3 more patients were not assessable and were also excluded. Missing data on the variable "duration of complaints" reduced the number of patients in the analyses from 190 to 174 patients. CONCLUSIONS: Intervertebral disk prolapse, duration of complaints, neurogenic bladder dysfunction, and urge incontinence were found to be significant predictive factors. However, a PNE remains necessary to evaluate a patient's chance of implant success objectively.

Population pharmacokinetics and relationship between demographic and clinical variables and pharmacokinetics of gentamicin in neonates.

Population pharmacokinetic parameter estimates were calculated from 725 routine plasma gentamicin concentrations obtained in 177 neonates of 24 to 42 weeks' gestational age in their first week of life. Kel increases and V/W decreases with increasing gestational age. Almost identical results were obtained with iterative two-stage Bayesian fitting (MW\PHARM 3.30) as with a non-parametric maximization algorithm (NPEM2). The effect of various covariates on drug disposition was investigated retrospectively using multiple regression analysis. Predictive power for Kel increases with rising gestational age. For neonates 28.5 weeks and 30.9 weeks (r2 = 0.482), with gestational age, postnatal age, and Apgar score at 5 minutes being predictors. A very strong correlation existed between volume of distribution and weight (r2 = 0.83). Volume as a function of weight could be described with low predictivity by gestational age and to a lesser degree by Apgar score at 5 minutes (r2 = 0.298). The developed models need appropriate prospective clinical validation.