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1.
Dev Neurorehabil ; 27(3-4): 126-133, 2024.
Article in English | MEDLINE | ID: mdl-38907992

ABSTRACT

Rett syndrome is a neurodevelopmental disorder in which scoliosis is a common orthopedic complication. This explorative study aims to identify predictors for rapid progression of scoliosis in Rett syndrome to enable variable selection for future prediction model development. A univariable logistic regression model was used to identify variables that discriminate between individuals with and without rapid progression of scoliosis (>10 ∘Cobb angle/6 months) based on multi-center data. Predictors were identified using univariable logistic regression with OR (95% CI) and AUC (95% CI). Age at inclusion, Cobb angle at baseline and epilepsy have the highest discriminative ability for rapid progression of scoliosis in Rett syndrome.


Subject(s)
Disease Progression , Rett Syndrome , Scoliosis , Humans , Scoliosis/diagnostic imaging , Rett Syndrome/complications , Rett Syndrome/physiopathology , Female , Child , Adolescent , Child, Preschool , Male
2.
Trials ; 25(1): 104, 2024 Feb 03.
Article in English | MEDLINE | ID: mdl-38308317

ABSTRACT

BACKGROUND: Neuroimaging studies suggest an association between apathy after deep brain stimulation (DBS) and stimulation of the ventral part of the subthalamic nucleus (STN) due to the associative fibers connected to the non-motor limbic circuits that are involved in emotion regulation and motivation. We have previously described three patients with severe apathy that could be fully treated after switching stimulation from a ventral electrode contact point to a more dorsal contact point. OBJECTIVES: To determine whether more dorsal stimulation of the STN decreases apathy compared to standard care in a multicenter randomized controlled trial with a crossover design. METHODS: We will include 26 patients with a Starkstein Apathy Scale (SAS) score of 14 or more after subthalamic nucleus (STN) deep brain stimulation (DBS) for refractory Parkinson's disease. This is a multicenter trial conducted in two teaching hospitals and one university medical center in the Netherlands after at least 3 months of STN DBS. Our intervention will consist of 1 month of unilateral dorsal STN stimulation compared to treatment as usual. The primary outcome is a change in SAS score following 1 month of DBS on the original contact compared to the SAS score following 1 month of DBS on the more dorsal contact. Secondary outcomes are symptom changes on the Movement Disorders Society-Unified Parkinson's Disease Rating Scale motor part III, Montgomery-Åsberg Depression Rating Scale, 39-item Parkinson's disease questionnaire, Parkinson's disease impulsive-compulsive disorders questionnaire, changes in levodopa-equivalent daily dosage, apathy rated by the caregiver, and burden and quality of life of the caregiver. TRIAL REGISTRATION: ClinicalTrials.gov NL8279. Registered on January 10, 2020.


Subject(s)
Apathy , Deep Brain Stimulation , Parkinson Disease , Subthalamic Nucleus , Humans , Parkinson Disease/therapy , Parkinson Disease/psychology , Cross-Over Studies , Deep Brain Stimulation/adverse effects , Deep Brain Stimulation/methods , Quality of Life , Treatment Outcome , Randomized Controlled Trials as Topic , Multicenter Studies as Topic
3.
Brain Stimul ; 16(5): 1289-1291, 2023.
Article in English | MEDLINE | ID: mdl-37619890

ABSTRACT

BACKGROUND: Apathy is reported after subthalamic nucleus deep brain stimulation (STN DBS) and associated with a decreased quality of life in Parkinson's disease (PD) patients. Recent studies hypothesized that the location of active DBS contact point relative to the STN subdivisions (motor, associative and limbic) could be related to an increase of apathy. METHODS: 22 PD-patients that underwent STN DBS between January 2019 and February 2020 were divided in an apathy and non-apathy group using the change in the Starkstein Apathy Scale (SAS) after six months of DBS. For both groups the location of DBS electrodes was determined based on 7T MRI subthalamic network analysis, enabling visualization of the subdivisions and their projections relative to the active contact point. MDS-UPDRS III scores were included to evaluate DBS effect. RESULTS: In six patients a post-DBS increase in apathy score was assessed, versus 16 non-apathy patients. Network analysis showed that active contacts in apathy patients were more often positioned in or close to the area within the STN with high density of surrounding projections to associative cortex areas than in non-apathy patients; 63% apathy versus 42% (P = 0.02). The density of surrounding motor projections was lower in the group with increased apathy (18%) than in the group without increased apathy (38%, P = 0.01). Motor UPDRS improvement for the apathy group was 39% and for the non-apathy group 58% (n.s.) CONCLUSION: This new approach in patient-specific subthalamic 7T MRI network analysis visualized an anatomical connectivity substrate for apathy in DBS, with active electrode contacts predominantly in the associative STN.


Subject(s)
Apathy , Deep Brain Stimulation , Parkinson Disease , Humans , Parkinson Disease/diagnostic imaging , Parkinson Disease/therapy , Deep Brain Stimulation/adverse effects , Quality of Life , Treatment Outcome , Magnetic Resonance Imaging
4.
Clin Park Relat Disord ; 9: 100200, 2023.
Article in English | MEDLINE | ID: mdl-37252676

ABSTRACT

Introduction: There are currently no effective treatments for primary orthostatic tremor (POT). An adequate disease-specific POT severity scale is a prerequisite to conduct clinical trials and monitor disease severity in clinical practice. Recently, the English OT-10 scale has been developed for this purpose. Here we aimed to obtain a scale to measure the severity of POT in Dutch speaking individuals. Methods: An established translation, adaptation and validation approach was employed to obtain a Dutch version of the OT-10 scale. Validation was performed in a Dutch POT cohort (n = 46). Results: A Dutch OT-10 scale was obtained which showed good internal consistency (Cronbach's alpha > 0.80), total score test-retest reliability (intraclass correlation coefficient > 0.80), and concurrent validity (Pearson correlation > 0.80). Item-to-total correlation was good (weighted kappa > 0.40) for all items, and item test-retest reliability was good (weighted kappa > 0.40) for eight out of ten items. Overall, the Dutch OT-10 scale demonstrated acceptable validity. Conclusions: We obtained and validated a Dutch version of the OT-10 scale, capturing POT severity. Next to its use in clinical practice, translation and validation of the OT-10 scale in more languages will help to find evidence-based treatments for POT.

5.
BMC Neurol ; 23(1): 160, 2023 Apr 21.
Article in English | MEDLINE | ID: mdl-37085773

ABSTRACT

BACKGROUND: Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is an established treatment for disabling motor symptoms of Parkinson's disease (PD) that persist despite optimal pharmacological treatment. Currently, DBS is not performed if there is concomitant significant cognitive impairment based on concerns of cognitive deterioration, higher complication rate and less functional improvement. However, this has not been investigated so far. METHODS: A single center, prospective, randomized, open-label, blinded end-point (PROBE design) pilot clinical trial is being performed. Patients are eligible for the trial if they have PD dementia (PDD), are able to provide informed consent, and experience disabling motor response fluctuations, bradykinesia, dyskinesia, or painful dystonia, despite optimal pharmacological treatment. In total 44 patients will be randomized to either STN-DBS accompanied by best medical treatment (DBS group) or to best medical treatment alone (BMT group). The primary outcome measure is the change from baseline to 30 weeks on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale part III score in a standardized off-drug phase. The main secondary outcome measures consist of scales assessing cognitive aspects of daily living, neuropsychiatric symptoms and impulsive compulsive disorders. Additional secondary outcome measures include motor signs during on-drug phase, dyskinesia, motor fluctuations, cognitive performance, (severe) adverse events, treatment satisfaction, and caregiver burden. Patients will be followed during 52 weeks after randomization. DISCUSSION: The Deep Brain Stimulation for MOtor symptoms in patients with Parkinson's disease DEmentia (DBS-MODE) trial directly compares the effectiveness and safety of DBS with BMT in patients with PDD. TRIAL REGISTRATION: The DBS-MODE trial has been registered in the International Clinical Trial Registry Platform (NL9361) on the 24th of March 2021 ( https://trialsearch.who.int/Trial2.aspx?TrialID=NL9361 ).


Subject(s)
Alzheimer Disease , Deep Brain Stimulation , Dementia , Dyskinesias , Parkinson Disease , Humans , Parkinson Disease/therapy , Parkinson Disease/drug therapy , Deep Brain Stimulation/adverse effects , Deep Brain Stimulation/methods , Prospective Studies , Treatment Outcome , Alzheimer Disease/therapy , Randomized Controlled Trials as Topic
6.
N Am Spine Soc J ; 13: 100199, 2023 Mar.
Article in English | MEDLINE | ID: mdl-36747986

ABSTRACT

Background Context: Fluoroscopic devices can be used to visualize subcutaneous and osseous tissue, a useful feature during pedicle screw insertion in lumbar fusion surgery. It is important that both patient and surgeon are exposed as little as possible, since these devices use potential harmful ionizing radiation. Purpose: This study aims to compare radiation exposure of different image-guided techniques in lumbar fusion surgery with pedicle screw insertion. Study Design: Systematic review. Methods: Cochrane, Embase, PubMed and Web of Science databases were used to acquire relevant studies. Eligibility criteria were lumbar and/or sacral spine, pedicle screw, mGray and/or Sievert and/or mrem, radiation dose and/or radiation exposure. Image-guided techniques were divided in five groups: conventional C-arm, C-arm navigation, C-arm robotic, O-arm navigation and O-arm robotic. Comparisons were made based on effective dose for patients and surgeons, absorbed dose for patients and surgeons and exposure. Risk of bias was assessed using the 2017 Cochrane Risk of Bias tool on RCTs and the Cochrane ROBINS-I tool on NRCTs. Level of evidence was assessed using the guidelines of Oxford Centre for Evidence-based Medicine 2011. Results: A total of 1423 studies were identified of which 38 were included in the analysis and assigned to one of the five groups. Results of radiation dose per procedure and per pedicle screw were described in dose ranges. Conventional C-arm appeared to result in higher effective dose for surgeons, higher absorbed dose for patients and higher exposure, compared to C-arm navigation/robotic and O-arm navigation/robotic. Level of evidence was 3 to 4 in 29 studies. Risk of bias of RCTs was intermediate, mostly due to inadequate blinding. Overall risk of bias score in NRCTs was determined as 'serious'. Conclusions: Ranges of radiation doses using different modalities during pedicle screw insertion in lumbar fusion surgery are wide. Based on the highest numbers in the ranges, conventional C-arm tends to lead to a higher effective dose for surgeons, higher absorbed dose for patients and higher exposure, compared to C-arm-, and O-arm navigation/robotic. The level of evidence is low and risk of bias is fairly high. In future studies, heterogeneity should be limited by standardizing measurement methods and thoroughly describing the image-guided technique settings.

7.
Clin Neurophysiol ; 146: 147-161, 2023 02.
Article in English | MEDLINE | ID: mdl-36543611

ABSTRACT

OBJECTIVE: Local field potential (LFP) recordings from deep brain stimulation (DBS) electrodes are often contaminated with electrocardiographic (ECG) artifacts that hinder the detection of disease-specific electrical brain activity. METHODS: Three ECG suppression methods were evaluated: (1) QRS interpolation of the Perceive toolbox, (2) template subtraction, and (3) singular value decomposition (SVD). LFPs were recorded with the Medtronic PerceptTM PC system in nine Parkinson's disease patients with stimulation OFF ("OFF-DBS"; anode disconnected) and ON at 0 mA ("ON-DBS 0 mA"; anode connected). Findings were verified with simulated ECG-contaminated time series. RESULTS: ECG artifacts were present in 10 out of 18 ON-DBS 0 mA recordings. All ECG suppression methods drastically reduced artifact-induced beta band (13-35 Hz) power and at least partly recovered the beta peak and beta burst dynamics. Using external ECG recordings and lengthening artifact epoch length improved the performance of the suppression methods. Increasing epoch length, however, elevated the risk of flattening the beta peak and losing beta burst dynamics. CONCLUSIONS: The SVD method formed the preferred trade-off between artifact cleaning and signal loss, as long as its parameter settings are adequately chosen. SIGNIFICANCE: ECG suppression methods enable analysis of disease-specific neural activity from signals affected by ECG artifacts.


Subject(s)
Deep Brain Stimulation , Parkinson Disease , Humans , Artifacts , Deep Brain Stimulation/methods , Parkinson Disease/diagnosis , Parkinson Disease/therapy , Electrodes , Electrocardiography
8.
J Peripher Nerv Syst ; 28(1): 58-68, 2023 03.
Article in English | MEDLINE | ID: mdl-36571466

ABSTRACT

Tremor in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is common, often unresponsive to treatment, and may contribute to disability. We aim to investigate whether tremor is associated with disability as measured in daily practice and clinical trials, independent of other impairments. We included 76 CIDP patients in this cross-sectional study. We assessed tremor with the Tremor Research Group essential tremor rating assessment scale (TETRAS) and the Fahn-Tolosa-Marin clinical rating scale (FTM). Disability was measured with the inflammatory Rasch-built overall disability scale (I-RODS) and the adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT-DS, categorized separately in arm score, or total score). Impairments including strength, sensory impairment, and fatigue were measured using specific impairment scales. We tested whether "the presence of a clinically relevant tremor" (based on TETRAS and FTM) or "tremor severity" (FTM part B sum score) was associated with disability scores (I-RODS, INCAT-DS total score, and INCAT-DS arm score), independent of the impairment scores, using multivariate regression. Both "the presence of a clinically relevant tremor" and "tremor severity" were significantly associated with disability measured by the INCAT-DS (arm score and total score), but not the I-RODS, independent of strength, sensory impairment, and fatigue. The explained variances were low. Clinically relevant tremor can (partly) explain disability in CIDP, as measured with the INCAT-DS, independent of muscle strength, sensory deficits, and fatigue. To assess disease activity in CIDP patients with tremor, both impairment and disability outcomes should be assessed, as disability is caused partly by tremor while the effect of immunotherapy on tremor seems limited.


Subject(s)
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating , Humans , Polyradiculoneuropathy, Chronic Inflammatory Demyelinating/complications , Polyradiculoneuropathy, Chronic Inflammatory Demyelinating/diagnosis , Tremor/diagnosis , Tremor/complications , Cross-Sectional Studies , Disability Evaluation , Fatigue/diagnosis , Fatigue/etiology
9.
BMC Public Health ; 22(1): 1997, 2022 11 01.
Article in English | MEDLINE | ID: mdl-36319990

ABSTRACT

BACKGROUND: The preconception period provides a window of opportunity for interventions aiming to reduce unhealthy lifestyle behaviours and their negative effect on pregnancy outcomes. This study aimed to assess the effectiveness of a locally tailored preconception care (PCC) intervention in a hybrid-II effectiveness implementation design. METHODS: A stepped-wedge cluster randomized controlled trial was performed in four Dutch municipalities. The intervention contained a social marketing strategy aiming to improve the uptake (prospective parents) and the provision (healthcare providers) of PCC. Prospective parents participated by administering a questionnaire in early pregnancy recalling their preconceptional behaviours. Experiences of healthcare providers were also evaluated through questionnaires. The composite primary outcome was adherence to at least three out of four preconceptional lifestyle recommendations (early initiation of folic acid supplements, healthy nutrition, no smoking or alcohol use). Secondary outcomes were preconceptional lifestyle behaviour change, (online) reach of the intervention and improved knowledge among healthcare providers. RESULTS: A total of 850 women and 154 men participated in the control phase and 213 women and 39 men in the intervention phase. The composite primary outcome significantly improved among women participating in the municipality where the reach of the intervention was highest (Relative Risk (RR) 1.57 (95% Confidence Interval (CI) 1.11-2.22). Among women, vegetable intake had significantly improved in the intervention phase (RR 1.82 (95%CI 1.14-2.91)). The aimed online reach- and engagement rate of the intervention was achieved most of the time. Also, after the intervention, more healthcare providers were aware of PCC-risk factors (54.5% vs. 47.7%; p = 0.040) and more healthcare providers considered it easier to start a conversation about PCC (75.0% vs. 47.9%; p = 0.030). CONCLUSION: The intervention showed some tentative positive effects on lifestyle behaviours among prospective parents. Primarily on vegetable intake and the knowledge and competence of healthcare providers. The results of this study contribute to the evidence regarding successfully implementing PCC-interventions to optimize the health of prospective parents and future generations. TRIAL REGISTRATION: Dutch Trial Register: NL7784 (Registered 06/06/2019).


Subject(s)
Life Style , Preconception Care , Pregnancy , Male , Female , Humans , Preconception Care/methods , Prospective Studies , Netherlands , Prenatal Care
13.
Clin Neurophysiol Pract ; 7: 103-106, 2022.
Article in English | MEDLINE | ID: mdl-35345863

ABSTRACT

Background: Essential tremor (ET) is one of the most common movement disorders, and continuous deep brain stimulation (DBS) is an established treatment for medication-refractory cases. However, the need for increasing stimulation intensities, with unpleasant side effects, and DBS tolerance over time can be problematic. The advent of novel DBS devices now provides the opportunity to longitudinally record LFPs using the implanted pulse generator, which opens up possibilities to implement adaptive DBS algorithms in a real-life setting. Methods: Here we report a case of thalamic LFP activity recorded using a commercially available sensing-enabled DBS pulse generator (Medtronic Percept PC). Results: In the OFF-stimulation condition, a peak tremor frequency of 3.8 Hz was identified during tremor evoking movements as assessed by video and accelerometers. Activity at the same and supraharmonic frequency was seen in the frequency spectrum of the LFP data from the left vim nucleus during motor tasks. Coherence analysis showed that peripherally recorded tremor was coherent with the LFP signal at the tremor frequency and supraharmonic frequency. Conclusion: This is the first report of recorded tremor-related thalamic activity using the electrodes and pulse generator of an implanted DBS system. Larger studies are needed to evaluate the clinical potential of these fully implantable systems, and ultimately pulse generators with sensing-coupled algorithms driving stimulation, to really close the loop.

14.
Trials ; 23(1): 141, 2022 Feb 14.
Article in English | MEDLINE | ID: mdl-35164821

ABSTRACT

INTRODUCTION: Organizing and executing a large clinical trial is a complex process, and often recruitment targets are not met. We describe the organization of the Levodopa in the Early Parkinson's disease (LEAP) trial and the results of an external assessment of the recruitment process. METHODS: Several strategies were used to ensure that recruitment for the trial was effective and efficient. We analyzed the patterns in referrals, inclusions, and non-inclusions to investigate whether there were bottlenecks in the referral and inclusion process. For the external assessment of the recruitment process, the QuinteT Recruitment Intervention (QRI-Two) was used retrospectively, focusing on finding possible issues impeding recruitment that are less easily recognized. RESULTS: Recruitment took 57 months, which was 27 months longer than initially expected. 6.8% of the estimated eligible patients in the Netherlands were included. The number of referrals differed widely between participating centers and regions in the Netherlands, with the region of the principal study center having the most referrals. Reasons of exclusion varied across regions, as in some regions more patients already started, wanted to start, or did not want to start with Parkinson medication compared to other regions. DISCUSSION: Executing a large, investigator-initiated clinical trial on a limited budget still remains possible by focusing on minimizing administrative and organizational procedures. Our study suggests that centers with closer institutional ties to a principal study center tend to have a higher referral rate. The review of the LEAP trial recruitment strategies and data using the QRI-Two suggested that the variations in referrals and reasons of non-inclusion could indicate the presence of issues related to clinical equipoise, patient eligibility, or study presentation. Integrating a recruitment intervention could have explored issues with study presentation and equipoise that might have increased recruitment efficiency. TRIAL REGISTRATION: ISRCTN ISRCTN30518857 . The registration was initiated on 02/08/2011 and finalized on 25/08/2011. Recruitment started on 17/08/2011, after the initiation of public registration.


Subject(s)
Clinical Trials as Topic , Parkinson Disease , Patient Selection , Eligibility Determination , Humans , Netherlands , Parkinson Disease/drug therapy , Retrospective Studies
15.
BMC Sports Sci Med Rehabil ; 13(1): 122, 2021 Oct 09.
Article in English | MEDLINE | ID: mdl-34627356

ABSTRACT

BACKGROUND: The therapeutic alliance (TA) is the bond between a patient and a physiotherapist during collaboration on recovery or training. Previous studies focused on the TA between physiotherapists and patients of the general population. Little information exists on whether this is similar in the demanding environment of elite athletes. The aim of this study was to investigate the components of TA between elite athletes and physiotherapists. METHODS: Ten elite athletes and ten physiotherapists were interviewed using one-on-one semi-structured interviews between June 2020 and October 2020. Athletes were included if they competed at national or international championships. Physiotherapists had to treat elite athletes on a regular basis. Interview questions were based on TA components of the general physiotherapy population. The interviews were transcribed and coded using inductive thematic analysis. RESULTS: The analysis resulted in an elite athlete TA framework which consists of nine themes and ten subthemes that could influence the TA. The nine themes are trust, communication, professional bond, social bond, elite athlete, physiotherapist, time, pressure and adversity, and external factors. This showed that the TA consists of bonds on different social levels, depends on the traits of both elite athletes and physiotherapists, and can be positively and negatively influenced by the external environment. The influences from the external environment seem to be more present in the elite athlete TA compared to the TA in the general physiotherapy setting. Multiple relations between themes were discovered. Trust is regarded as the main connecting theme. CONCLUSION: This study provides a framework to better understand the complex reality of the TA between elite athletes and physiotherapists. Compared to the general physiotherapy setting, new themes emerged. The created framework can help elite athletes and physiotherapists to reflect and improve their TA and subsequently improve treatment outcomes.

16.
Eur Spine J ; 29(7): 1553-1572, 2020 07.
Article in English | MEDLINE | ID: mdl-32240375

ABSTRACT

PURPOSE: A systematic review, to study treatment effects for osteoporotic vertebral fractures (OVFs) in the elderly including all available evidence from controlled trials on percutaneous cement augmentation. METHODS: Primary studies, published up to December, 2019, were searched in PubMed and the Cochrane Library. Selected were all prospective controlled studies including patients > 65 years of age and reporting on at least one main outcome. Main outcomes were pain, disability and quality of life (QOL) 1 day post-intervention and at 6 months postoperatively. Excluded were meta-analyses or reviews, retrospective or non-controlled studies, case studies, patients' groups with neoplastic and/or traumatic fractures and/or neurologically compromised patients. RESULTS: Eighteen studies comprising 2165 patients (n = 1117 percutaneous cement augmentation, n = 800 conservative treatment (CT), n = 248 placebo) with a mean follow-up of up to 12 months were included. Pooled results showed significant pain relief in favor of percutaneous cement augmentation compared to CT, direct postoperative and at 6 months follow-up. At 6 months, a significant difference was observed for functional disability scores in favor of percutaneous cement augmentation. When comparing percutaneous cement augmentation to placebo, no significant differences were observed. CONCLUSION: This review incorporates all current available evidence (RCTs and non-RCTs) on the efficacy of percutaneous cement augmentation in the treatment of OVFs in the elderly. Despite methodological heterogeneity of the included studies, this review shows overall significant sustained pain relief and superior functional effect in the short- and long term for percutaneous cement augmentation compared to conservative treatment. These slides can be retrieved under Electronic Supplementary Material.


Subject(s)
Fractures, Compression , Kyphoplasty , Osteoporotic Fractures , Spinal Fractures , Vertebroplasty , Aged , Bone Cements/therapeutic use , Humans , Osteoporotic Fractures/surgery , Quality of Life , Retrospective Studies , Spinal Fractures/surgery , Treatment Outcome
17.
BMC Pregnancy Childbirth ; 20(1): 117, 2020 Feb 19.
Article in English | MEDLINE | ID: mdl-32075598

ABSTRACT

BACKGROUND: Pelvic floor muscles (PFM) and rectus abdominis muscles (RAM) of pregnant diabetic rats exhibit atrophy, co-localization of fast and slow fibers and an increased collagen type I/III ratio. However, the role of similar PFM or RAM hyperglycemic-related myopathy in women with gestational diabetes mellitus (GDM) remains poorly investigated. This study aims to assess the frequency of pelvic floor muscle disorders and pregnancy-specific urinary incontinence (PS-UI) 12 months after the Cesarean (C) section in women with GDM. Specifically, differences in PFM/RAM hyperglycemic myopathy will be evaluated. METHODS: The Diamater is an ongoing cohort study of four groups of 59 pregnant women each from the Perinatal Diabetes Research Centre (PDRC), Botucatu Medical School (FMB)-UNESP (São Paulo State University), Brazil. Diagnosis of GDM and PS-UI will be made at 24-26 weeks, with a follow-up at 34-38 weeks of gestation. Inclusion in the study will occur at the time of C-section, and patients will be followed at 24-48 h, 6 weeks and 6 and 12 months postpartum. Study groups will be classified as (1) GDM plus PS-UI; (2) GDM without PS-UI; (3) Non-GDM plus PS-UI; and (4) Non-GDM without PS-UI. We will analyze relationships between GDM, PS-UI and hyperglycemic myopathy at 12 months after C-section. The mediator variables to be evaluated include digital palpation, vaginal squeeze pressure, 3D pelvic floor ultrasound, and 3D RAM ultrasound. RAM samples obtained during C-section will be analyzed for ex-vivo contractility, morphological, molecular and OMICS profiles to further characterize the hyperglycemic myopathy. Additional variables to be evaluated include maternal age, socioeconomic status, educational level, ethnicity, body mass index, weight gain during pregnancy, quality of glycemic control and insulin therapy. DISCUSSION: To our knowledge, this will be the first study to provide data on the prevalence of PS-UI and RAM and PFM physical and biomolecular muscle profiles after C-section in mothers with GDM. The longitudinal design allows for the assessment of cause-effect relationships between GDM, PS-UI, and PFMs and RAMs myopathy. The findings may reveal previously undetermined consequences of GDM.


Subject(s)
Diabetes, Gestational/physiopathology , Muscular Diseases/physiopathology , Urinary Incontinence/physiopathology , Adult , Brazil , Cesarean Section , Cohort Studies , Female , Gestational Age , Gestational Weight Gain , Humans , Maternal Age , Muscle Contraction/physiology , Muscle Strength/physiology , Palpation , Pelvic Floor/physiopathology , Postpartum Period , Pregnancy , Rectus Abdominis/physiopathology , Vagina
18.
BMC Neurol ; 20(1): 40, 2020 Jan 31.
Article in English | MEDLINE | ID: mdl-32005175

ABSTRACT

BACKGROUND: Both Deep Brain Stimulation (DBS) and Continuous intrajejunal Levodopa Infusion (CLI) are effective therapies for the treatment of Parkinson's disease (PD). To our knowledge, no direct head-to-head comparison of DBS and CLI has been performed, whilst the costs probably differ significantly. In the INfusion VErsus STimulation (INVEST) study, costs and effectiveness of DBS and CLI are compared in a randomized controlled trial (RCT) in patients with PD, to study whether higher costs of one of the therapies are justified by superiority of that treatment. METHODS: A prospective open label multicentre RCT is being performed, with ancillary patient preference observational arms. Patients with PD who, despite optimal pharmacological treatment, have severe response fluctuations, bradykinesia, dyskinesias, or painful dystonia are eligible for inclusion. A total of 66 patients will be randomized. There is no minimal inclusion in the patient preference arms. The primary health economic outcomes are costs per unit on the Parkinson's Disease Questionnaire-39 (PDQ-39) and costs per unit Quality-Adjusted Life Year (QALY) at 12 months. The main clinical outcome is patient-reported quality of life measured with the PDQ-39 at 12 months. Patients will additionally be followed during 36 months after initiation of the study treatment. DISCUSSION: The INVEST trial directly compares the costs and effectiveness of the advanced therapies DBS and CLI. TRIAL REGISTRATION: Dutch Trial Register identifier 4753, registered November 3rd, 2014; EudraCT number 2014-001501-32, Clinicaltrials.gov: NCT02480803.


Subject(s)
Antiparkinson Agents/administration & dosage , Deep Brain Stimulation/methods , Levodopa/administration & dosage , Parkinson Disease/therapy , Aged , Antiparkinson Agents/economics , Costs and Cost Analysis , Deep Brain Stimulation/economics , Female , Humans , Levodopa/economics , Male , Middle Aged , Parkinson Disease/economics , Research Design
19.
Int J Spine Surg ; 14(6): 956-969, 2020 Dec.
Article in English | MEDLINE | ID: mdl-33560256

ABSTRACT

BACKGROUND: A validated classification remains the key to an appropriate treatment algorithm of traumatic thoracolumbar fractures. Considering the development of many classifications, it is remarkable that consensus about treatment is still lacking. We conducted a systematic review to investigate which classification can be used best for treatment decision making in thoracolumbar fractures. METHODS: A comprehensive search was conducted using PubMed, Embase, CINAHL, and Cochrane using the following search terms: classification (mesh), spinal fractures (mesh), and corresponding synonyms. All hits were viewed by 2 independent researchers. Papers were included if analyzing the reliability (kappa values) and clinical usefulness (specificity or sensitivity of an algorithm) of currently most used classifications (Magerl/AO, thoracolumbar injury classification and severity score [TLICS] or thoracolumbar injury severity score, and the new AO spine). RESULTS: Twenty articles are included. The presented kappa values indicate moderate to substantial agreement for all 3 classifications. Regarding the clinical usefulness, > 90% agreement between actual treatment and classification recommendation is reported for most fractures. However, it appears that over 50% of the patients with a stable burst fracture (TLICS 2, AO-A3/A4) in daily practice are operated, so in these cases treatment decision is not primarily based on classification. CONCLUSION: AO, TLICS, and new AO spine classifications have acceptable accuracy (kappa > 0.4), but are limited in clinical usefulness since the treatment recommendation is not always implemented in clinical practice. Differences in treatment decision making arise from several causes, such as surgeon and patient preferences and prognostic factors that are not included in classifications yet. The recently validated thoracolumbar AO spine injury score seems promising for use in clinical practice, because of inclusion of patient-specific modifiers. Future research should prove its definite value in treatment decision making. LEVEL OF EVIDENCE: 2. CLINICAL RELEVANCE: Without the appropriate treatment, the impact of traumatic thoracolumbar fractures can be devastating. Therefore it is important to achieve consensus in the treatment of thoracolumbar fractures.

20.
Occup Med (Lond) ; 68(7): 469-477, 2018 Sep 13.
Article in English | MEDLINE | ID: mdl-30085148

ABSTRACT

BACKGROUND: Musculoskeletal complaints in music students are common. Little is known about effectiveness of interventions. AIMS: To assess whether a biopsychosocial prevention course is better at reducing disability due to musculoskeletal disorders compared with physical activity promotion. METHODS: This was a multicentre randomized controlled trial with intention-to-treat analysis. Participants were first- and second-year students from five conservatories, randomized to experimental or control groups. The experimental group participated in 11 classes on body posture playing the instrument according to postural exercise therapy, and performance-related psychosocial aspects. The control group participated in five classes promoting physical activity according to national guidelines. The primary outcome was disability using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, including the performing arts module. Secondary outcomes were pain, quality of life, playing-related musculoskeletal disorders and health behaviour. Outcomes were assessed at six points, from baseline until 2-year follow-up. RESULTS: One hundred and seventy participants were randomized to experimental (n = 84) or control (n = 86) groups. Loss to follow-up was 40% during the trial and 69% at 2-year follow-up. The dropout rate was equal in both groups. Overall, there were no significant differences between groups for any outcome adjusted for baseline characteristics: percentage disability, odds ratio was 1.31, 95% confidence interval (CI) 0.69-2.51; general DASH, ß = -0.57, 95% CI -3.23 to 2.09; and performing arts module, ß = -0.40, 95% CI 5.12-4.32. CONCLUSIONS: A biopsychosocial prevention course tailored for musicians was not superior to physical activity promotion in reducing disability. Large numbers lost to follow-up warrant cautious interpretation.


Subject(s)
Musculoskeletal Diseases/prevention & control , Music , Students/psychology , Adult , Female , Humans , Male , Odds Ratio , Quality of Life/psychology , Risk Factors , Students/statistics & numerical data , Surveys and Questionnaires
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