Does Centralization of Radical Prostatectomy Reduce the Incidence of Postoperative Urinary Incontinence?

Background: On the basis of previous analyses of the incidence of urinary incontinence (UI) after radical prostatectomy (RP), the hospital RP volume threshold in the Netherlands was gradually increased from 20 per year in 2017, to 50 in 2018 and 100 from 2019 onwards. Objective: To evaluate the impact of hospital RP volumes on the incidence and risk of UI after RP (RP-UI). Design setting and participants: Patients who underwent RP during 2016-2020 were identified in the claims database of the largest health insurance company in the Netherlands. Incontinence was defined as an insurance claim for ≥1 pads/d. Outcome measurements and statistical analysis: The relationship between hospital RP volume (HV) and RP-UI was assessed via multivariable analysis adjusted for age, comorbidity, postoperative radiotherapy, and lymph node dissection. Results and limitations: RP-UI incidence nationwide and by RP volume category did not decrease significantly during the study period, and 5-yr RP-UI rates varied greatly among hospitals (19-85%). However, low-volume hospitals (≤120 RPs/yr) had a higher percentage of patients with RP-UI and higher variation in comparison to high-volume hospitals (>120 RPs/yr). In comparison to hospitals with low RP volumes throughout the study period, the risk of RP-UI was 29% lower in hospitals shifting from the low-volume to the high-volume category (>120 RPs/yr) and 52% lower in hospitals with a high RP volume throughout the study period (>120 RPs/yr for 5 yr). Conclusions: A focus on increasing hospital RP volumes alone does not seem to be sufficient to reduce the incidence of RP-UI, at least in the short term. Measurement of outcomes, preferably per surgeon, and the introduction of quality assurance programs are recommended. Patient summary: In the Netherlands, centralization of surgery to remove the prostate (RP) because of cancer has not yet improved the occurrence of urinary incontinence (UI) after surgery. Hospitals performing more than 120 RP operations per year had better UI outcomes. However, there was a big difference in UI outcomes between hospitals.

Outcomes After Lumbar Disk Herniation Surgery in the Dutch Population.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: There is only limited data on the outcome of primary surgery of lumbar disk herniation (LDH) in Dutch patients. The objective of this study is to describe undesirable outcomes after primary LDH. METHODS: The National Claims Database (Vektis) was searched for primary LDH operations performed from July 2015 until June 2016, for reoperations within 18 months, prescription of opioids between 6 to 12 months and nerve root block within 1 year. A combined outcome measure was also made. Group comparisons were analyzed with the Student's t-test. RESULTS: Primary LDH surgery was performed in 6895 patients in 70 hospitals. Weighted mean of reoperations was 7.3%, nerve root block 6.7% and opioid use 15.6%. In total, 23.0% of patients had one or more undesirable outcomes after surgery. The 95% CI interval exceeded the 50% incidence line for 14 out of 26 hospitals with less than 50 surgical interventions per year. Although the data suggested a volume effect on undesired outcomes, the t-tests between hospitals with volume thresholds of 100, 150 and 200 interventions per year did not support this (P values 0.078, 0.129, 0.114). CONCLUSION: This unique nationwide claims-based study provides insight into patient-relevant undesirable outcomes such as reoperation, nerve root block and opioid use after LDH surgery. About a quarter of the patients had a serious complication in the first follow up year that prompted further medical treatment. There is a wide variation in complication rates between hospitals with a trend that supports concentration of LDH care.

Targeting self-efficacy more important than dysfunctional behavioral cognitions in patients with longstanding chronic low back pain; a longitudinal study.

BACKGROUND: Multidisciplinary pain management programs based on cognitive behavioral training (CBT) principles have been shown moderately effective in improving daily functioning in patients with chronic low back pain (CLBP). To optimize health-related outcomes as daily functioning, a clear understanding of the working mechanisms of these programs is warranted. Being confident to achieve a desired outcome, i.e. self-efficacy, is suggested to be a more potent determinant for beneficial treatment outcomes than restructuring the patient's dysfunctional behavioral cognitions (pain catastrophizing and fear of movement [FoM]), but the evidence is scarce. The objective of this study was twofold: 1) to determine whether a two-week pain management program resulted in post-treatment improvements in self-efficacy and decreased dysfunctional behavioral cognitions in patients with CLBP, and 2) to examine the unique contribution of self-efficacy to improvement in post-treatment disability. METHODS: A secondary analysis of an historical cohort study was performed, including 524 patients (59% females). PRIMARY OUTCOME: functional status (Oswestry Disability Index v2.1a). SECONDARY OUTCOMES: catastrophizing (Pain Catastrophizing Scale), FoM (Tampa Scale for Kinesiophobia), and self-efficacy (Pain Self-Efficacy Questionnaire). ASSESSMENTS: pre-, post-treatment, 1, and 12-months follow-up. Paired Student's t-tests were applied and clinical relevancy of improvements was described using minimal clinical important changes. Adjusted multivariate linear regression analyses were performed to explore the unique contribution of self-efficacy. RESULTS: The mean age of patients was 46 (SD = 9.5) years and they had longstanding CLBP (mean 12.5 [SD = 10.8] years). Mean functional status, self-efficacy, and dysfunctional behavioral cognitions improved significantly at post-treatment, with improvements maintained at 12 months follow-up. Post-treatment relevant improvements in self-efficacy and dysfunctional behavioral cognitions ranged from 62.4% (FoM) to 68.7% (self-efficacy). Post-treatment self-efficacy improved the model explaining post-treatment functional disability (basic model R2 = 0.49, F(6,517) = 83.67, p < 0.001; final model R2 = 0.57, F(8,515) = 85.20, p < 0.001). This was further substantiated by the relative contribution (standardized betas) of self-efficacy: 5.67 times more than catastrophizing and 9.75 times more than FoM. CONCLUSIONS: Targeting self-efficacy contributes to fast improvement in functional status for selected and motivated patients with persistent CLBP. In pain management programs and (online) self-management programs for CLBP, targeting patients' self-efficacy should have a prominent place.

[Increase in opioid prescribing in extramural care in the Netherlands: assessment of use and prescription behaviour, based on claims data]. / Toename in extramuraal opioïdgebruik in Nederland.

OBJECTIVE: Describe the trends in extramural prescription of opioids in the Netherlands. DESIGN: Descriptive, retrospective research based on claims data of Dutch health insurers. METHOD: For each healthcare-insured Dutch resident we selected claims data for all opioids, except codeine and buprenorphine, for the period 2010-2017. We calculated the total numbers of opioid and oxycodone users, and stratified these numbers by age and sex. The average number of prescribed Defined Daily Doses (DDD), the chronicity of use, the type of prescriber, and regional patterns in opioid use were investigated. RESULTS: A total of 3,655,265 different insured persons used opioids during the research period. The yearly number of opioid users increased from 650,864 in 2010 to 1,010,474 in 2017. This increase was mainly driven by an increase in oxycodone prescriptions. Elderly and female patients were more frequent users of opioids. The ratio of short- versus long-term opioid users remained steady during the research period, with opioids being used for four months or longer in 21% of cases. General practitioners prescribed 82% of the DDDs of all opioids in 2017. The percentage of DDDs of oxycodone prescribed by medical specialists increased from 2.8% in 2010 to 14.2% in 2017. CONCLUSION: Opioid use is increasing in the Netherlands, but the long-term vs short-term use ratio has not changed in recent years. General practitioners prescribe the largest share of opioids, but a growing number of prescriptions originates from medical specialists.

PEEK Cages in Lumbar Fusion: Mid-term Clinical Outcome and Radiologic Fusion.

STUDY DESIGN: Historical cohort analysis. OBJECTIVE: Evaluation of mid-term clinical outcome and radiologic fusion in patients treated with a polyetheretherketone (PEEK) cage. SUMMARY OF BACKGROUND DATA: Anterior lumbar interbody fusion can be a good alternative in chronic low back pain when conservative treatment fails. Although titanium alloy cages give good fusion rates, disadvantages are the subsidence of the cage in the adjacent vertebrae and problematic radiologic evaluation of fusion. PEEK cages such as the Synfix-LR cage (Synthes, Switzerland) should overcome this. METHODS: From December 2004 until August 2007, 95 patients (21 double-level and 74 single-level) with degenerative disk disease from L3-S1 were operated by a single surgeon. The number of reoperations was counted. Radiologic fusion on computed tomography scan was scored with a new scoring system by an independent skeletal radiologist and orthopedic surgeon. Intraobserver agreement and specificity were assessed. Clinical improvement was measured by the Oswestry Disability Index score. The median duration of clinical follow-up was 47.7 months (range 29.9-61.6). RESULTS: In total, 26 patients were reoperated after a median period of 17.6 months (range 6.7-46.9) of the initial surgery. Of the 26 patients, 23 patients (18 single-level and 5 double-level) were reoperated for symptomatic pseudarthrosis. A moderate agreement (κ=0.36) and a specificity of 70% and 37% for the radiologist and orthopedic surgeon, respectively, were found for scoring bony bridging. The Oswestry Disability Index score improved after initial surgery; however, reoperated patients reported a significantly lower improvement. CONCLUSIONS: A high number of reoperations after an anterior lumbar interbody fusion procedure with the Synfix-LR cage were found, mainly because of symptomatic pseudarthrosis. The absence of posterior fixation in combination with lower stiffness and the hydrophobic characteristics of PEEK probably lead to insufficient initial stability, creating suboptimal conditions for bony bridging, and thus solid fusion. The proposed ease of the evaluation of radiologic fusion could not be supported. Clinicians should be alert on pseudarthrosis when patients treated with the Synfix-LR cage presented with persisted or aggravated complaints.

Reproducibility of 3D kinematics and surface electromyography measurements of mastication.

The aim of this study was to determine the measurement reproducibility for a procedure evaluating the mastication process and to estimate the smallest detectable differences of 3D kinematic and surface electromyography (sEMG) variables. Kinematics of mandible movements and sEMG activity of the masticatory muscles were obtained over two sessions with four conditions: two food textures (biscuit and bread) of two sizes (small and large). Twelve healthy adults (mean age 29.1 years) completed the study. The second to the fifth chewing cycle of 5 bites were used for analyses. The reproducibility per outcome variable was calculated with an intraclass correlation coefficient (ICC) and a Bland-Altman analysis was applied to determine the standard error of measurement relative error of measurement and smallest detectable differences of all variables. ICCs ranged from 0.71 to 0.98 for all outcome variables. The outcome variables consisted of four bite and fourteen chewing cycle variables. The relative standard error of measurement of the bite variables was up to 17.3% for 'time-to-swallow', 'time-to-transport' and 'number of chewing cycles', but ranged from 31.5% to 57.0% for 'change of chewing side'. The relative standard error of measurement ranged from 4.1% to 24.7% for chewing cycle variables and was smaller for kinematic variables than sEMG variables. In general, measurements obtained with 3D kinematics and sEMG are reproducible techniques to assess the mastication process. The duration of the chewing cycle and frequency of chewing were the best reproducible measurements. Change of chewing side could not be reproduced. The published measurement error and smallest detectable differences will aid the interpretation of the results of future clinical studies using the same study variables.

Construct Validity of the Trunk Impairment Classification System in Relation to Objective Measures of Trunk Impairment.

OBJECTIVE: To determine the validity of the Trunk Impairment Classification system (TIC) with 4 possible scores (0, most impaired; 0.5; 1.0; 1.5, least impaired) in relation to objective, instrumented measures of impairment. DESIGN: Cross-sectional design. SETTING: National wheelchair rugby and basketball competitions of The Netherlands and Belgium. PARTICIPANTS: Volunteer sample of athletes (N=34) with a minimum of 1-year experience in their sport. INTERVENTIONS: Static sitting balance tasks on a stable and unstable surface; dynamic sitting balance tasks in anterior-posterior, left-right, and oblique directions; and trunk muscle strength tasks in forward, left, right, and backward directions. MAIN OUTCOME MEASURES: Sway area of the center of pressure in static sitting balance, maximum excursion of center of pressure displacement in dynamic sitting balance, and maximum isometric force in trunk muscle strength. RESULTS: Athletes with TIC score 0 were not able to sit unsupported. The Kruskal-Wallis test showed a significant difference in trunk muscle strength (P<.001) and dynamic balance in the oblique direction forward to the left and backward to the right between the TIC scores (P=.012). Post hoc analysis showed a significant difference between TIC score 0 and the other TIC scores for trunk muscle strength in all directions. There was a significant difference between TIC score 1.5 on one hand and TIC scores 0.5 and 1.0 on the other hand for dynamic balance in the right oblique direction. CONCLUSIONS: The TIC is a valid scale for trunk impairment, which measures neuromusculoskeletal trunk impairment, independent of the health condition causing the impairment. Additional research is needed for coordination impairment and to assess whether TIC scores 0.5 and 1.0 should continue as separate scores.

The impact of trunk impairment on performance of wheelchair activities with a focus on wheelchair court sports: a systematic review.

BACKGROUND: Trunk impairment seems to impact significantly on performance in wheelchair court sports, but evidence to support this impression has never been systematically assessed. The objective of this study is to systematically review, describe and synthesise the literature investigating the impact of trunk impairment on wheelchair activities in court sports. METHODS: This systematic review was performed according to the consensus statement for the meta-analysis of observational studies in epidemiology (MOOSE). The search strategy for original articles comprised Medline (1950- November 2014), Cinahl (1981-November 2014), and Embase (1980- November 2014), using the search terms: trunk, trunk muscles, postural balance, posture and wheelchair. Eligibility criteria for further review were 1) participants included experienced wheelchair users, 2) comparisons were made between a) participants with different levels of trunk impairment or b) between able bodied participants and participants with trunk impairment, or c) between participants with trunk impairment with and without compensatory equipment, and 3) outcome measures were quantitative data on wheelchair activities. For methodological quality assessment, the STROBE (Strengthening the reporting of observational studies in epidemiology) checklist was used. RESULTS: After assessment of 358 potentially relevant studies for the eligibility criteria, 25 studies were appropriate for methodological assessment. Twelve articles fulfilled the predetermined minimum of 15 reported items on the 22-item STROBE checklist. These studies were limited to observational studies with small populations. All but one study were restricted to patients with spinal cord injury (SCI). CONCLUSIONS: Limited evidence was found about the impact of trunk impairment on wheelchair activities. Reach to the front and multidirectional reach was further in able bodied persons than in persons with SCI. In a perturbation that equals deceleration in wheelchair court sports, able bodied persons maintain balance, whereas persons with SCI lose balance. No evidence was found to support a difference in acceleration between persons with partial trunk muscle strength and persons with full trunk muscle strength. For future research, there is a need for a test that includes all types of trunk impairment and identification of activities that determine performance in wheelchair court sports. Furthermore, populations of athletes with all trunk impairment types should be included.

The Oswestry Disability Index (version 2.1a): validation of a Dutch language version.

STUDY DESIGN: A cross-sectional study on baseline data. OBJECTIVE: To translate the Oswestry Disability Index (ODI) version 2.1a into the Dutch language and to validate its use in a cohort of patients with chronic low back pain in secondary spine care. SUMMARY OF BACKGROUND DATA: Patient-reported outcome measures (PROMs) are commonly accepted to evaluate the outcome of spine interventions. Functional status is an important outcome in spine research. The ODI is a recommended condition-specific patient-reported outcome measure used to evaluate functional status in patients with back pain. As yet, no formal translated Dutch version exists. METHODS: The ODI was translated according to established guidelines. The final version was built into the electronic web-based system in addition with the Roland Morris Disability Questionnaire, the numeric rating scale for pain severity, 36-Item Short Form Health Survey Questionnaire for quality of life, and the hospital anxiety and depression scale. Baseline data were used of 244 patients with chronic low back pain who participated in a combined physical and psychological program. Floor and ceiling effects, internal consistency, and the construct validity were evaluated using quality criteria. RESULTS: The mean ODI (standard deviation) was 39.6 (12.3); minimum 6, maximum 70. Most of the participants (88%) were moderately to severely disabled. Factor analysis determined a 1-factor structure (36% explained variance) and the homogeneity of ODI items is shown (Cronbach α = 0.79). The construct validity is supported as all (6:6) the a priori hypotheses were confirmed. Moreover, the ODI and Roland Morris Disability Questionnaire, showed a strong significant correlation (r = 0.68, P < 0.001) and an overlap: mean difference of -18 (95% limits of agreement: -44 to 8). CONCLUSION: The Dutch ODI version 2.1a is a valid and valuable tool for the measurement of functional status and disability among Dutch patients with chronic low back pain. This translated condition-specific patient-reported outcome measure version is recommended for use in future back pain research and to evaluate outcome of back care in the Netherlands.

Improvement of the classification system for wheelchair rugby: athlete priorities.

A representative sample (N=302) of the wheelchair rugby population responded to a survey about the classification system based on prioritized items by International Wheelchair Rugby Federation members. Respondents stated, "The classification system is accurate but needs adjustments" (56%), "Any athlete with tetraequivalent impairment should be allowed to compete" (72%), "Athletes with cerebral palsy and other coordination impairments should be classified with a system different than the current one" (75%), and "The maximal value for trunk should be increased from 1.0 to 1.5" (67%). A minority stated, "Wheelchair rugby should only be open to spinal cord injury and other neurological conditions" (36%) and "There should be a 4.0 class" (33%). Results strongly indicated that athletes and stakeholders want adjustments to the classification system in two areas: a focus on evaluation of athletes with impairments other than loss of muscle power caused by spinal cord injury and changes in classification of trunk impairment.

The Nijmegen decision tool for chronic low back pain. Development of a clinical decision tool for secondary or tertiary spine care specialists.

BACKGROUND: In Western Europe, low back pain has the greatest burden of all diseases. When back pain persists, different medical specialists are involved and a lack of consensus exists among these specialists for medical decision-making in Chronic Low Back Pain (CLBP). OBJECTIVE: To develop a decision tool for secondary or tertiary spine care specialists to decide which patients with CLBP should be seen by a spine surgeon or by other non-surgical medical specialists. METHODS: A Delphi study was performed to identify indicators predicting the outcome of interventions. In the preparatory stage evidence from international guidelines and literature were summarized. Eligible studies were reviews and longitudinal studies. Inclusion criteria: surgical or non-surgical interventions and persistence of complaints, CLBP-patients aged 18-65 years, reported baseline measures of predictive indicators, and one or more reported outcomes had to assess functional status, quality of life, pain intensity, employment status or a composite score. Subsequently, a three-round Delphi procedure, to reach consensus on candidate indicators, was performed among a multidisciplinary panel of 29 CLBP-professionals (>five years CLBP-experience). The pre-set threshold for general agreement was ≥70%. The final indicator set was used to develop a clinical decision tool. RESULTS: A draft list with 53 candidate indicators (38 with conclusive evidence and 15 with inconclusive evidence) was included for the Delphi study. Consensus was reached to include 47 indicators. A first version of the decision tool was developed, consisting of a web-based screening questionnaire and a provisional decision algorithm. CONCLUSIONS: This is the first clinical decision tool based on current scientific evidence and formal multidisciplinary consensus that helps referring the patient for consultation to a spine surgeon or a non-surgical spine care specialist. We expect that this tool considerably helps in clinical decision-making spine care, thereby improving efficient use of scarce sources and the outcomes of spinal interventions.

Validity and reliability of the Mastication Observation and Evaluation (MOE) instrument.

The Mastication Observation and Evaluation (MOE) instrument was developed to allow objective assessment of a child's mastication process. It contains 14 items and was developed over three Delphi rounds. The present study concerns the further development of the MOE using the COSMIN (Consensus based Standard for the Selection of Measurement Instruments) and investigated the instrument's internal consistency, inter-observer reliability, construct validity and floor and ceiling effects. Consumption of three bites of bread and biscuit was evaluated using the MOE. Data of 59 healthy children (6-48 mths) and 38 children (bread) and 37 children (biscuit) with cerebral palsy (24-72 mths) were used. Four items were excluded before analysis due to zero variance. Principal Components Analysis showed one factor with 8 items. Internal consistency was >0.70 (Chronbach's alpha) for both food consistencies and for both groups of children. Inter-observer reliability varied from 0.51 to 0.98 (weighted Gwet's agreement coefficient). The total MOE scores for both groups showed normal distribution for the population. There were no floor or ceiling effects. The revised MOE now contains 8 items that (a) have a consistent concept for mastication and can be scored on a 4-point scale with sufficient reliability and (b) are sensitive to stages of chewing development in young children. The removed items are retained as part of a criterion referenced list within the MOE.

Predictive factors for successful clinical outcome 1 year after an intensive combined physical and psychological programme for chronic low back pain.

PURPOSE: The aim of this longitudinal study is to determine the factors which predict a successful 1-year outcome from an intensive combined physical and psychological (CPP) programme in chronic low back pain (CLBP) patients. METHODS: A prospective cohort of 524 selected consecutive CLBP patients was followed. Potential predictive factors included demographic characteristics, disability, pain and cognitive behavioural factors as measured at pre-treatment assessment. The primary outcome measure was the oswestry disability index (ODI). A successful 1-year follow-up outcome was defined as a functional status equivalent to 'normal' and healthy populations (ODI ≤22). The 2-week residential programme fulfills the recommendations in international guidelines. For statistical analysis we divided the database into two equal samples. A random sample was used to develop a prediction model with multivariate logistic regression. The remaining cases were used to validate this model. RESULTS: The final predictive model suggested being 'in employment' at pre-treatment [OR 3.61 (95 % CI 1.80-7.26)] and an initial 'disability score' [OR 0.94 (95 % CI 0.92-0.97)] as significant predictive factors for a successful 1-year outcome (R (2) = 22 %; 67 % correctly classified). There was no predictive value from measures of psychological distress. CONCLUSION: CLBP patients who are in work and mild to moderately disabled at the start of a CPP programme are most likely to benefit from it and to have a successful treatment outcome. In these patients, the disability score falls to values seen in healthy populations. This small set of factors is easily identified, allowing selection for programme entry and triage to alternative treatment regimes.

Identity: empirical contribution. Changes in the identity integration of adolescents in treatment for personality disorders.

A renewed interest in identity as one of the core markers of personality disorders has been introduced by the DSM-5 Level of Personality Functioning Scale. However, little is known about the utility of the construct of identity in children and adolescents. This study aimed to broaden the knowledge of identity integration as a core component of personality functioning in adolescents. The authors investigated levels of identity integration, as measured by the Severity Indices of Personality Problems (SIPP-118; Verheul et al., 2008), in adolescents in both normal (n = 406) and clinical populations (n = 285). Furthermore, changes in levels of identity integration during treatment were investigated in a clinical subsample (n = 76). Levels of identity integration were not associated with age. They were, however, associated with the absence or presence of personality pathology. Most adolescents receiving inpatient psychotherapy gradually changed toward more healthy levels of identity integration; a significant number, however, remained at maladaptive levels of identity functioning after intensive psychotherapy.

CNS effects of indomethacin: should patients be cautioned about decreased mental alertness and motor coordination?

AIMS: In many European countries as well as in the USA, the leaflet, or even the packaging of indomethacin, contains a specific warning to refrain from activities requiring mental alertness and motor coordination, such as driving a car. In this placebo-controlled randomized study with a crossover design we attempted to find evidence for that warning. METHODS: Indomethacin 75 mg slow release or a visually identical placebo with similar flavour was taken orally twice daily for 2.5 days. It was suggested that indomethacin affects the motor coordination required to avoid obstacles successfully during walking and that this effect will be even stronger when simultaneously performing a cognitive task that puts mental alertness to the test. Nineteen healthy middle-aged individuals (60 ± 4.7 years, eight female) performed an obstacle avoidance task on a treadmill), combined with a cognitive secondary task. Biceps femoris (BF) muscle response times, obstacle avoidance failure rates and composite scores ((100 × accuracy)/verbal response time) were used to evaluate the data. RESULTS: No differences between indomethacin and placebo were found on the outcome measures regarding motor coordination, avoidance failure rates (P = 0.81) and BF response times (P = 0.47), nor on the performance on the secondary cognitive task (P = 0.12). CONCLUSIONS: Even though surrogate methods were used, the current study provides evidence to suggest that there might be no need to caution patients who experience CNS side effects after indomethacin use to avoid activities requiring quick and adequate reactions, such as walking under challenging circumstances and maybe also driving a car.

Pharmacokinetics of 450 mg ropivacaine with and without epinephrine for combined femoral and sciatic nerve block in lower extremity surgery. A pilot study.

AIMS: No pharmacokinetic data exist on doses of ropivacaine larger than 300 mg for peripheral nerve block in man, although in clinical practice higher doses are frequently used. The purpose of the present study was to describe the pharmacokinetic profile in serum of 450 mg ropivacaine with and without epinephrine in patients undergoing anterior cruciate ligament reconstruction. METHODS: Twelve patients were randomly allocated to receive a single shot combined sciatic/femoral nerve block with 60 ml of either ropivacaine 0.75% alone (group R, n = 6) or ropivacaine 0.75% plus epinephrine 5 µg ml(-1) (group RE, n = 6). Venous blood samples for total and free ropivacaine serum concentrations were obtained during 48 h following block placement. Pharmacokinetic parameters were calculated using a non-compartmental approach. RESULTS: Results are given as mean (SD) for group R vs. group RE (95% CI of the difference). Total Cmax was 2.81 (0.94) µg ml(-1) vs. 2.16 (0.21) µg ml(-1) (95% CI -0.23, 1.53). tmax was 1.17 (0.30) h vs. 1.67 (0.94) h (95% CI -1.40, 0.40). The highest free ropivacaine concentration per patient was 0.16 (0.08) µg ml(-1) vs. 0.12 (0.04) µg ml(-1) (95% CI -0.04, 0.12). t(1/2) was 6.82 (2.26) h vs. 5.48 (1.69) h (95% CI -1.23, 3.91). AUC was 28.35 (5.92) µg ml(-1) h vs. 29.12 (7.34) µg ml(-1) h (95% CI -9.35, 7.81). CONCLUSIONS: Free serum concentrations of ropivacaine with and without epinephrine remained well below the assumed threshold of 0.56 µg ml(-1) for systemic toxicity. Changes in pharmacokinetics with epinephrine co-administration did not reach statistical significance.

Dual-tasking interferes with obstacle avoidance reactions in healthy seniors.

Dual-tasking can lead to falls, as does a deterioration of obstacle avoidance (OA) skills. Hence, it is expected that a combination of both would be even more detrimental, especially when OA is time-critical. Previous studies confirmed this expectation, however, due to several limitations in their design it is yet too early to draw any definitive conclusions on the allocation of attentional resources in OA under dual-task conditions. Therefore, attentionally demanding primary and secondary tasks were used with the instruction to perform as well as possible on both tasks. Nineteen healthy senior individuals (60±4.7 years, 8 females) performed an OA task on a treadmill while walking at 3 km/h as a single task and combined with an auditory Stroop task. Biceps femoris (BF) muscle response times, OA failure rates and composite scores were used to evaluate the data. Increased OA failure rates (3%, p=0.03) and delayed BF response times (21 ms, p<0.001) were found under dual-task conditions. Composite scores were reduced during (p<0.001) and just after obstacle crossing (p=0.003). In conclusion, dual-tasking during time-critical OA affects the motor as well as the cognitive task when subjects are instructed to keep up performance on both tasks. This adds to the evidence indicating an increased risk of tripping or falling when attention is divided during walking in the presence of unexpected obstacles.

What could predict effectiveness of Botulinum Toxin to treat drooling: a search for evidence of discriminatory factors on the level of body functions or structures.

BACKGROUND: The treatment of drooling is important to families that experience the daily impact and research to elucidate clinical factors that play a role in the outcome of drooling treatment should be encouraged. AIM: To define clinical factors that influence therapy outcome of submandibular Botulinum Toxin (BoNT-A) injections for drooling. METHODS: Prospectively collected data of 128 children with cerebral palsy were evaluated; 80 spastic and 48 dyskinetic movement disorder, mostly Gross Motor Function Classification System III and higher; over 70% had an IQ <70. In addition, 23 fully ambulant children with exclusively intellectual disability were treated for drooling by ultrasound-guided injections of BoNT-A into the submandibular glands. Salivary flow rates and drooling quotients were measured at baseline and at 8 weeks after injection. Extensive information about the oral motor performance was gathered. Successful clinical response was defined as a 50% reduction of the baseline Drooling Quotient; 85 children were responsive to BoNT-A and 66 children unresponsive. RESULTS: Five nominated clinical factors that possibly could influence saliva reduction (head position, lip seal, voluntary control over the tongue, control of voluntary movement functions, and mental age) did not influence the responsiveness to BoNT-A. INTERPRETATION: Other variables need to be considered to predict the outcome of BoNT-A treatment. This article describes the first attempt to reveal the contribution of body functions and structures to the outcome of BoNT-A submandibular injections.

A short, intensive cognitive behavioral pain management program reduces health-care use in patients with chronic low back pain: two-year follow-up results of a prospective cohort.

PURPOSE: Cognitive behavioral interventions are recommended as non-invasive treatment options for patients with chronic low back pain (CLBP). However, most treatment effects are small and short-lived. Although a 2-week intensive pain management program for patients with CLBP seems to be effective, the long-term results are not known. The purpose of this study is to evaluate the stability of the 2-year follow-up results and whether this is reflected in the use of health-care services. METHODS: A prospective cohort study was performed. Pre-treatment characteristics of patients and data of outcomes obtained at 1-year follow-up were used. At 2-year follow-up a structured interview was conducted following the principles of a post-marketing survey. Outcomes included daily functioning, quality of life, current intensity of pain, disturbance of pain during daily activities, and indicators of the use of pain medication and health-care services. RESULTS: Of the 90 eligible patients 85 (94%) participated in the post-marketing survey. The 1-year clinical relevant effects are maintained at 2-year follow-up. Effect sizes for functioning and quality of life were large. More than 65% reached preset minimal clinically important differences. At pre-treatment all patients consulted their general practitioner (GP) and medical specialist (MS). At 2-year follow-up 73% reported having consulted neither a GP nor an MS during the previous year. Most of the patients indicated not to use any pain medication (57%) and the percentage patients using opioids have decreased (14%). Moreover, 81% reported to be at work. CONCLUSIONS: The gained results from selected and motivated patients with longstanding CLBP at 1-year follow-up are stable at 2-year follow-up. Above all, most of the participants are at work and results indicate that the use of both pain medication and health care have decreased substantially.

Unraveling the association between SSRI use and falls: an experimental study of risk factors for accidental falls in long-term paroxetine users.

Selective serotonin reuptake inhibitors (SSRIs) are widely used to treat depression and are also associated with an increased falls risk. However, the biological mechanism underlying accidental falls with SSRI intake has yet to be elucidated. The present experimental study was designed to investigate whether obstacle avoidance skills in long-term (>90 days), senior paroxetine users (61 ± 5.8 years) are affected during gait, simple and challenging postural balance tasks, as well as during manual reaction time tasks. The performance of the paroxetine users was compared with healthy group-matched controls (60 ± 4.8 years). The results demonstrated impaired postural balance in the paroxetine users, especially during one-legged stance or under various dual-task conditions. Although the deficit in one-legged stance could indicate vestibular involvement, this was deemed unlikely because performance of standing on compliant surface with closed eyes remained unaffected. Paroxetine use also failed to affect manual reaction times or obstacle avoidance performance. It is suggested that paroxetine affects attentional capacities particularly in conjunction with balance control. Compared with healthy seniors, long-term senior users of paroxetine seem to be at an increased risk of falling due to impairments in balance control, especially when attention has to be divided between 2 concurrent activities.