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Contains fulltext : 118353.pdf (Publisher’s version ) (Closed access) Multidisciplinary care is considered an optimal model to manage Parkinson's disease (PD), but supporting evidence is limited. We performed a randomized, controlled trial (RCT) to establish whether a multidisciplinary/specialist team offers better outcomes, compared to stand-alone care from a general neurologist. Patients with PD were randomly allocated to an intervention group (care from a movement disorders specialist, PD nurses, and social worker) or a control group (care from general neurologists). Both interventions lasted 8 months. Clinicians and researchers were blinded for group allocation. The primary outcome was the change in quality of life (Parkinson's Disease Questionnaire; PDQ-39) from baseline to 8 months. Other outcomes were the UPDRS, depression (Montgomery-Asberg Depression Scale; MADRS), psychosocial functioning (Scales for Outcomes in Parkinson's disease-Psychosocial; SCOPA-PS), and caregiver strain (Caregiver Strain Index; CSI). Group differences were analyzed using analysis of covariance adjusted for baseline values and presence of response fluctuations. A total of 122 patients were randomized and 100 completed the study (intervention, n = 51; control, n = 49). Compared to controls, the intervention group improved significantly on PDQ-39 (difference, 3.4; 95% confidence interval [CI]: 0.5-6.2) and UPDRS motor scores (4.1; 95% CI: 0.8-7.3). UPDRS total score (5.6; 95% CI: 0.9-10.3), MADRS (3.7; 95% CI: 1.4-5.9), and SCOPA-PS (2.1; 95% CI: 0.5-3.7) also improved significantly. This RCT gives credence to a multidisciplinary/specialist team approach. We interpret these positive findings cautiously because of the limitations in study design. Further research is required to assess teams involving additional disciplines and to evaluate cost-effectiveness of integrated approaches. (c) 2012 Movement Disorder Society.

Contains fulltext : 69122.pdf (Publisher’s version ) (Closed access) BACKGROUND: The effectiveness of community-based geriatric intervention models for vulnerable older adults is controversial. We evaluated a problem-based multidisciplinary intervention targeting vulnerable older adults at home that promised efficacy through better timing and increased commitment of patients and primary care physicians. This study compared the effects of this new model to usual care. METHODS: Primary care physicians referred older people for problems with cognition, nutrition, behavior, mood, or mobility. One hundred fifty-one participants (mean age 82.2 years, 74.8% women) were included in a pseudocluster randomized trial with 6-month follow-up for the primary outcomes. Eighty-five participants received the new intervention, and 66 usual care. In the intervention arm, geriatric nurses visited patients at home for geriatric assessment and management in cooperation with primary care physicians and geriatricians. Modified intention-to-treat analyses focused on differences between treatment arms in functional abilities (Groningen Activity Restriction Scale-3) and mental well-being (subscale mental health Medical Outcomes Study [MOS]-20), using a mixed linear model. RESULTS: After 3 months, treatment arms showed significant differences in favor of the new intervention. Functional abilities improved 2.2 points (95% confidence interval [CI], 0.3-4.2) and well-being 5.8 points (95% CI, 0.1-11.4). After 6 months, the favorable effect increased for well-being (9.1; 95% CI, 2.4-15.9), but the effect on functional abilities was no longer significant (1.6; 95% CI, -0.7 to 3.9). CONCLUSIONS: This problem-based geriatric intervention improved functional abilities and mental well-being of vulnerable older people. Problem-based interventions can increase the effectiveness of primary care for this population.

Contains fulltext : 168663.pdf (Publisher’s version ) (Closed access) Auditory startle reflexes can accelerate simple voluntary reaction times (StartReact effect). To investigate the role of startle reflexes on more complex motor behaviour we formulated two questions: (1) can auditory startle reflexes shorten choice reaction times?; (2) is the StartReact effect differentially modulated when startling auditory stimuli are delivered ipsilaterally or contralaterally to an imperative ‘go’ signal? We instructed 16 healthy subjects to rotate their head as rapidly as possible to the left or to right in response to a guiding visual imperative stimulus (IS), in both a simple and choice reaction protocol. Startling acoustic stimuli (113 dB) were delivered simultaneously with the IS (from either the same or opposite side) to induce the StartReact effect. We recorded kinematics of head rotations and electromyographic responses.TheStartReact effect was present during choice reaction tasks (56 ms onset reduction; P

Contains fulltext : 50532.pdf (Publisher’s version ) (Closed access) OBJECTIVE: To estimate a threshold for minimal clinically important radiological progression of joint damage using its longitudinal relation with functional disability in patients with rheumatoid arthritis (RA). To validate existing estimates of minimal clinically important difference (MCID) using this relation with functional disability. METHODS: We reanalyzed published data of 185 patients with early RA followed for a maximum of 9 years. Longitudinal regression (mixed models) was used, relating radiological damage (modified Sharp score) to functional disability (HAQ-DI), correcting for age (age at diagnosis and increasing disease duration), disease activity (DAS28), and demographic variables. Several shapes of the relation were investigated. Based on the observed relationship between radiological damage, functional disability, and the minimal clinically relevant increase in functional disability found in earlier studies, MCID for progression of joint damage was discussed. Existing estimates of MCID were evaluated for their influence on functional disability over the disease course. RESULTS: A longitudinal relation between the modified Sharp score and the HAQ-DI was found. Significant covariates were age, gender, and disease activity. The model indicated that the relation between the Sharp score and the HAQ-DI was dependent on the amount of damage (a threshold effect) and on patients' age. With lower age, no effect of joint damage on functional disability could be demonstrated and with higher age the effect of joint damage increased. With a typical patient from our cohort (age at diagnosis 55 yrs, some baseline damage, and an expected disease duration of 30 yrs), a (constant) progression of 6 points per year led to an increase of about 0.2 on the HAQ score, solely related to damage, over the disease course. This estimate of MCID was close to estimates based on expert opinion and equal or smaller than most estimates based on the smallest detectable difference. CONCLUSIONS: The MCID, defined using longitudinal effect on functional disability, is dependent on age and (progression of) joint damage. However, with a typical patient population this MCID was similar to thresholds based on expert opinion, adding to the validity of these estimates.

Contains fulltext : 58515.pdf (Publisher’s version ) (Closed access) BACKGROUND: Identification of mononuclear cellular infiltrates in skeletal muscle tissue is the histological cornerstone of the diagnosis of idiopathic inflammatory myopathy (IIM). However, these infiltrates are not always present. OBJECTIVE: To determine whether MHC class I antigen expression on the sarcolemma, which is absent in normal muscle tissue, is upregulated in IIM and could serve as an additional diagnostic test. METHODS: Expression of MHC class I antigens was studied in 224 muscle samples of 61 adult patients with IIM (9 dermatomyositis, 23 polymyositis, 29 inclusion body myositis) and 163 controls (normal subjects and patients with various neuromuscular disorders) in a prospective blinded manner. RESULTS: The sensitivity of the test for diagnosing IIM was 78% (95% confidence interval (CI), 66% to 88%), with a specificity of 95% (91% to 98%). The sensitivity before the start of immunosuppressive treatment was 89% (76% to 96%). The sensitivity was not changed by including all patients who had been on immunosuppressive treatment for less than four weeks before muscle biopsy (sensitivity 90% (79% to 97%)). False positive results were found in only seven controls (4%), six of whom had a muscular dystrophy. CONCLUSIONS: Detection of sarcolemmal MHC class I is a valid test for IIM. It is not affected by the short term use of immunosuppressive agents (less than four weeks) and it should be incorporated in the histological evaluation when the diagnosis of IIM is under consideration or needs to be excluded.

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Contains fulltext : 118354.pdf (Publisher’s version ) (Open Access) BACKGROUND: Occupational therapists may have an added value in the care of patients with Parkinson's disease whose daily functioning is compromised, as well as for their immediate caregivers. Evidence for this added value is inconclusive due to a lack of rigorous studies. The aim of this trial is to evaluate the (cost) effectiveness of occupational therapy in improving daily functioning of patients with Parkinson's disease. METHODS/DESIGN: A multicenter, assessor-blinded, two-armed randomized controlled clinical trial will be conducted, with evaluations at three and six months. One hundred ninety-two home-dwelling patients with Parkinson's disease and with an occupational therapy indication will be assigned to the experimental group or to the control group (2:1). Patients and their caregivers in the experimental group will receive ten weeks of home-based occupational therapy according to recent Dutch guidelines. The intervention will be delivered by occupational therapists who have been specifically trained to treat patients according to these guidelines. Participants in the control group will not receive occupational therapy during the study period. The primary outcome for the patient is self-perceived daily functioning at three months, assessed with the Canadian Occupational Performance Measure. Secondary patient-related outcomes include: objective performance of daily activities, self-perceived satisfaction with performance in daily activities, participation, impact of fatigue, proactive coping skills, health-related quality of life, overall quality of life, health-related costs, and effectiveness at six months. All outcomes at the caregiver level will be secondary and will include self-perceived burden of care, objective burden of care, proactive coping skills, overall quality of life, and care-related costs. Effectiveness will be evaluated using a covariance analysis of the difference in outcome at three months. An economic evaluation from a societal perspective will be conducted, as well as a process evaluation. DISCUSSION: This is the first large-scale trial specifically evaluating occupational therapy in Parkinson's disease. It is expected to generate important new information about the possible added value of occupational therapy on daily functioning of patients with Parkinson's disease. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01336127.

Item does not contain fulltext OBJECTIVE: To evaluate whether a multifaceted behavioural change programme increases physical activities in patients with Parkinson's disease. DESIGN: Multicentre randomised controlled trial. SETTING: 32 community hospitals in the Netherlands, collaborating in a nationwide network (ParkinsonNet). PARTICIPANTS: 586 sedentary patients with idiopathic Parkinson's disease aged between 40 and 75 years with mild to moderate disease severity (Hoehn and Yahr stage

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Item does not contain fulltext OBJECTIVE: Balance of prognostic factors between treatment groups is desirable because it improves the accuracy, precision, and credibility of the results. In cluster-controlled trials, imbalance can easily occur by chance when the number of cluster is small. If all clusters are known at the start of the study, the "best balance" allocation method (BB) can be used to obtain optimal balance. This method will be compared with other allocation methods. STUDY DESIGN AND SETTING: We carried out a simulation study to compare the balance obtained with BB, minimization, unrestricted randomization, and matching for four to 20 clusters and one to five categorical prognostic factors at cluster level. RESULTS: BB resulted in a better balance than randomization in 13-100% of the situations, in 0-61% for minimization, and in 0-88% for matching. The superior performance of BB increased as the number of clusters and/or the number of factors increased. CONCLUSION: BB results in a better balance of prognostic factors than randomization, minimization, stratification, and matching in most situations. Furthermore, BB cannot result in a worse balance of prognostic factors than the other methods. 01 februari 2012

Contains fulltext : 98191.pdf (Publisher’s version ) (Closed access) Drooling is an incapacitating feature of Parkinson's disease. Better pathophysiological insights are needed to improve treatment. In this study, we tested the hypothesis that the cause of drooling is multifactorial. We examined 15 patients with Parkinson's disease with distinct diurnal saliva loss ("droolers") and 15 patients with Parkinson's disease without drooling complaints ("nondroolers"). We evaluated all factors that could potentially contribute to drooling: swallowing capacity (maximum volume), functional swallowing (assessed with the dysphagia subscale of the Therapy Outcome Measures for rehabilitation specialists), unintentional mouth opening due to hypomimia (Unified Parkinson's Disease Rating Scale item), posture (quantified from sagittal photographs), and nose-breathing ability. We also quantified the frequency of spontaneous swallowing during 45 minutes of quiet sitting, using polygraphy. Droolers had more advanced Parkinson's disease than nondroolers (Unified Parkinson's Disease Rating Scale motor score 31 vs 22; P=.014). Droolers also scored significantly worse on all recorded variables except for nose breathing. Swallowing frequency tended to be higher, possibly to compensate for less efficient swallowing. Logistic regression with adjustment for age and disease severity showed that hypomimia correlated best with drooling. Linear regression with hypomimia as the dependent variable identified disease severity, dysphagia, and male sex as significant explanatory factors. Drooling in Parkinson's disease results from multiple risk factors, with hypomimia being the most prominent. When monitored, patients appear to compensate by increasing their swallowing frequency, much like the increased cadence that is used to compensate for stepping akinesia. These findings can provide a rationale for behavioral approaches to treat drooling.

Contains fulltext : 88345.pdf (Publisher’s version ) (Open Access) BACKGROUND: Many patients with Parkinson's disease (PD) lead a sedentary lifestyle. Promotion of physical activities may beneficially affect the clinical presentation of PD, and perhaps even modify the course of PD. However, because of physical and cognitive impairments, patients with PD require specific support to increase their level of physical activity. METHODS: We developed the ParkFit Program: a PD-specific and multifaceted behavioral program to promote physical activity. The emphasis is on creating a behavioral change, using a combination of accepted behavioral motivation techniques. In addition, we designed a multicentre randomized clinical trial to investigate whether this ParkFit Program increases physical activity levels over two years in sedentary PD patients. We intended to include 700 sedentary patients. Primary endpoint is the time spent on physical activities per week, which will be measured every six months using an interview-based 7-day recall. RESULTS: In total 3453 PD patients were invited to participate. Ultimately, 586 patients--with a mean (SD) age of 64.1 (7.6) years and disease duration of 5.3 (4.5) years--entered the study. Study participants were younger, had a shorter disease duration and were less sedentary compared with eligible PD patients not willing to participate. DISCUSSION: The ParkFit trial is expected to yield important new evidence about behavioral interventions to promote physical activity in sedentary patients with PD. The results of the trial are expected in 2012. TRIAL REGISTRATION: http://clinicaltrials.gov (nr NCT00748488).

Contains fulltext : 88929.pdf (Publisher’s version ) (Closed access) AIM: A considerable number of patients who undergo surgery for a lumbosacral radicular syndrome (LRS) continue to experience disability, pain, and loss of work capacity. The goal of the study is to develop a brief screening instrument to identify these patients at risk of residual complaints. METHODS: In a prospective study of 277 patients, the predictors for the outcomes disability, pain, and loss of work capacity were investigated. The best predictive model was constructed using a stepwise selection procedure (forward selection), which calculates the discriminative power of the model. Based on the relationship between regression coefficients, a clinical prediction rule was derived that predicted the probability of residual complaints after surgery for LRS. RESULTS: At 6 month follow-up 141 patients (51%) had residual complaints. The discriminative power of the instrument was .78 (AUC). The "Nijmegen Outcome of Lumbar Disc surgery Screening-instrument" (NOLDS) was based on the variables "lower education level", "younger age", "pain 3 days postoperatively", "passive pain coping", and "fear of movement/(re)injury". CONCLUSION: The results of the study are promising, showing that a brief clinical screening instrument can be used to identify patients at risk of residual complaints at 6 months after surgery for LRS. The early identification of patients at risk having residual complaints may make it possible to start tailored treatment early in the rehabilitation process. 01 december 2010

Contains fulltext : 70918.pdf (Publisher’s version ) (Closed access) We examined the effect of bilateral subthalamic nucleus stimulation on levodopa-resistant balance impairment in 14 patients with Parkinson's disease and 18 matched controls. Instability was quantitatively assessed using standardized multidirectional dynamic posturography. Patients were tested after taking a suprathreshold dose of levodopa, both with stimulators turned on and off. Patients with stimulators turned off were more unstable than controls following backward directed perturbations. Overall, patients' instability did not improve with STN stimulation, and considerable inter-individual variability was noted. Of note, marked levodopa- resistant axial motor symptoms before surgery correlated with an adverse treatment effect. We conclude that STN stimulation does not alleviate levodopa-resistant postural instability in Parkinson's disease.

Item does not contain fulltext Nucleoside reverse transcriptase inhibitors used in antiretroviral therapy may cause mitochondrial toxicity. Mitochondrial dysfunction leads to disturbance of the glucose metabolism, resulting in an accumulation of L-lactate. We tested the hypothesis that an oral glucose tolerance test (OGTT) can be used to detect mitochondrial toxicity in patients on antiretroviral nucleoside analogues. An OGTT was performed in 30 subjects: 16 HIV-infected treated patients without adverse events (group 1) and 14 HIV-infected patients with adverse events related to nucleoside reverse transcriptase inhibitor-induced mitochondrial toxicity (group 2). Lactate was measured at baseline and 60 and 120 min after glucose loading. At all time points the lactate levels were higher in the adverse events group compared to the other group, with the highest levels of lactate at t = 60 min (mean 1912 micromol/L, SD +/- 609); mean lactates in the group without adverse events was 1429 micromol/L (SD +/- 464). When levels above the upper limit of normal of 1800 micromol/L were used as an indication for mitochondrial toxicity, the sensitivity and specificity were 57% and 81%, respectively. The area under the ROC curve was 0.75. For L-lactate levels > 2000 micromol/L the specificity was 90%. An OGTT with measurement of lactate at baseline and one hour after glucose loading can detect (occult) hyperlactataemia in patients with mitochondrial impairment. From our study we suggest to perform an OGTT as an additional test in patients with symptoms suspect for adverse events to discern mitochondrial toxicity.

No important influence of limited steroid exposure on bone mass during the first year after renal transplantation: a prospective, randomized, multicenter study. ter Meulen CG, van Riemsdijk I, Hene RJ, Christiaans MH, Borm GF, Corstens FH, van Gelder T, Hilbrands LB, Weimar W, Hoitsma AJ. Division of Nephrology, University Medical Centre Nijmegen, The Netherlands. R.t.meulen@cwz.nl BACKGROUND: Steroid-related bone loss is a recognized complication after renal transplantation. In a prospective, randomized, multicenter study we compared the influence of a steroid-free immunosuppressive regimen with a regimen with limited steroid exposure on the changes in bone mass after renal transplantation. METHODS: A total of 364 recipients of a renal transplant were randomized to receive either daclizumab (1 mg/kg on days 0 and 10 after transplantation; steroid-free group n=186) or prednisone (0.3 mg/kg per day tapered to 0 mg at week 16 after transplantation; steroids group n=178). All patients received tacrolimus, mycophenolate mofetil, and, during the first 3 days, 100 mg prednisolone intravenously. Changes in bone mineral density (BMD) were evaluated in 135 and 126 patients in the steroid-free and steroids group, respectively. RESULTS: The mean (+/- SD) BMD of the lumbar spine decreased slightly in both groups during the first 3 months after transplantation (steroid-free -1.3 +/- 4.0% [P

Contains fulltext : 58573.pdf (Publisher’s version ) (Closed access) Issues such as life expectancy after diagnosis, the number of life years gained by early diagnosis through screening, the probability of dying from breast cancer or of dying from other causes during the lead time period or thereafter can be derived from information on complete survival after diagnosis. A method is presented to estimate complete survival and relevant outcomes after diagnosis of screen-detected cancer when the follow-up period is substantially shorter than the maximum follow-up possible. Survival after diagnosis until death from breast cancer is modelled as the sum of the lead time (LT) and the post-lead time (PLT), where both time periods follow exponential distributions and are assumed to be independent. The survival period after diagnosis until death from causes other than breast cancer (X) is assumed to follow a Gompertz distribution. The survival period after diagnosis until death from any cause (Z) is modelled as the minimum of LT+PLT and X. Maximum likelihood methods were then used to estimate all parameters of Z. This procedure for obtaining maximum likelihood estimates of Z does not need the cause of death (breast cancer or other), which is an advantage over most other methods. Especially in older patients, it may be difficult or even impossible to ascertain the true cause of death. The model was applied to data from the long-term breast cancer screening programme in Nijmegen, the Netherlands. Complete survival was estimated on the basis of survival data on 528 screen-detected breast cancer patients, diagnosed in 1975-1997 and with a mean follow-up of 8.9 years. Estimated life expectancy ranged between 22.3 and 9.0 years for patients diagnosed at the age of 50 and 79 years, respectively, that is, 6.1 and 0.7 life years gained by screening. Through early diagnosis and treatment, screen-detected patients diagnosed at the age of 50 years may have reduced their lifetime risk of dying from breast cancer from 79 per cent to 56 per cent; at the age of 79 the reduction of risk is reduced from 23 per cent to 13 per cent.