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1.
Cochrane Database Syst Rev ; 2: CD001797, 2024 02 14.
Artigo em Inglês | MEDLINE | ID: mdl-38353301

RESUMO

BACKGROUND: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) causes progressive or relapsing weakness and numbness of the limbs, which lasts for at least two months. Uncontrolled studies have suggested that intravenous immunoglobulin (IVIg) could help to reduce symptoms. This is an update of a review first published in 2002 and last updated in 2013. OBJECTIVES: To assess the efficacy and safety of intravenous immunoglobulin in people with chronic inflammatory demyelinating polyradiculoneuropathy. SEARCH METHODS: We searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, and two trials registers on 8 March 2023. SELECTION CRITERIA: We selected randomised controlled trials (RCTs) and quasi-RCTs that tested any dose of IVIg versus placebo, plasma exchange, or corticosteroids in people with definite or probable CIDP. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcome was significant improvement in disability within six weeks after the start of treatment, as determined and defined by the study authors. Our secondary outcomes were change in mean disability score within six weeks, change in muscle strength (Medical Research Council (MRC) sum score) within six weeks, change in mean disability score at 24 weeks or later, frequency of serious adverse events, and frequency of any adverse events. We used GRADE to assess the certainty of evidence for our main outcomes. MAIN RESULTS: We included nine RCTs with 372 participants (235 male) from Europe, North America, South America, and Israel. There was low statistical heterogeneity between the trial results, and the overall risk of bias was low for all trials that contributed data to the analysis. Five trials (235 participants) compared IVIg with placebo, one trial (20 participants) compared IVIg with plasma exchange, two trials (72 participants) compared IVIg with prednisolone, and one trial (45 participants) compared IVIg with intravenous methylprednisolone (IVMP). We included one new trial in this update, though it contributed no data to any meta-analyses. IVIg compared with placebo increases the probability of significant improvement in disability within six weeks of the start of treatment (risk ratio (RR) 2.40, 95% confidence interval (CI) 1.72 to 3.36; number needed to treat for an additional beneficial outcome (NNTB) 4, 95% CI 3 to 5; 5 trials, 269 participants; high-certainty evidence). Since each trial used a different disability scale and definition of significant improvement, we were unable to evaluate the clinical relevance of the pooled effect. IVIg compared with placebo improves disability measured on the Rankin scale (0 to 6, lower is better) two to six weeks after the start of treatment (mean difference (MD) -0.26 points, 95% CI -0.48 to -0.05; 3 trials, 90 participants; high-certainty evidence). IVIg compared with placebo probably improves disability measured on the Inflammatory Neuropathy Cause and Treatment (INCAT) scale (1 to 10, lower is better) after 24 weeks (MD 0.80 points, 95% CI 0.23 to 1.37; 1 trial, 117 participants; moderate-certainty evidence). There is probably little or no difference between IVIg and placebo in the frequency of serious adverse events (RR 0.82, 95% CI 0.36 to 1.87; 3 trials, 315 participants; moderate-certainty evidence). The trial comparing IVIg with plasma exchange reported none of our main outcomes. IVIg compared with prednisolone probably has little or no effect on the probability of significant improvement in disability four weeks after the start of treatment (RR 0.91, 95% CI 0.50 to 1.68; 1 trial, 29 participants; moderate-certainty evidence), and little or no effect on change in mean disability measured on the Rankin scale (MD 0.21 points, 95% CI -0.19 to 0.61; 1 trial, 24 participants; moderate-certainty evidence). There is probably little or no difference between IVIg and prednisolone in the frequency of serious adverse events (RR 0.45, 95% CI 0.04 to 4.69; 1 cross-over trial, 32 participants; moderate-certainty evidence). IVIg compared with IVMP probably increases the likelihood of significant improvement in disability two weeks after starting treatment (RR 1.46, 95% CI 0.40 to 5.38; 1 trial, 45 participants; moderate-certainty evidence). IVIg compared with IVMP probably has little or no effect on change in disability measured on the Rankin scale two weeks after the start of treatment (MD 0.24 points, 95% CI -0.15 to 0.63; 1 trial, 45 participants; moderate-certainty evidence) or on change in mean disability measured with the Overall Neuropathy Limitation Scale (ONLS, 1 to 12, lower is better) 24 weeks after the start of treatment (MD 0.03 points, 95% CI -0.91 to 0.97; 1 trial, 45 participants; moderate-certainty evidence). The frequency of serious adverse events may be higher with IVIg compared with IVMP (RR 4.40, 95% CI 0.22 to 86.78; 1 trial, 45 participants, moderate-certainty evidence). AUTHORS' CONCLUSIONS: Evidence from RCTs shows that IVIg improves disability for at least two to six weeks compared with placebo, with an NNTB of 4. During this period, IVIg probably has similar efficacy to oral prednisolone and IVMP. Further placebo-controlled trials are unlikely to change these conclusions. In one large trial, the benefit of IVIg compared with placebo in terms of improved disability score persisted for 24 weeks. Further research is needed to assess the long-term benefits and harms of IVIg relative to other treatments.


Assuntos
Imunoglobulinas Intravenosas , Polirradiculoneuropatia Desmielinizante Inflamatória Crônica , Masculino , Humanos , Imunoglobulinas Intravenosas/uso terapêutico , Polirradiculoneuropatia Desmielinizante Inflamatória Crônica/tratamento farmacológico , Recidiva Local de Neoplasia/tratamento farmacológico , Corticosteroides/uso terapêutico , Metilprednisolona/uso terapêutico
2.
Eur Arch Otorhinolaryngol ; 280(1): 61-68, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-35767062

RESUMO

PURPOSE: Few data are available regarding subjective complaints and quality of life (QoL) after subtotal petrosectomy (STP). The purpose of our study was to assess long-term surgical results after STP, and to evaluate disease-specific, patient-reported outcomes including QoL and subjective hearing. METHODS: A retrospective cohort study, including a postal survey, was performed in the Amsterdam University Medical Centers (Amsterdam UMC) location Academic Medical Centre (AMC). All patients who underwent a STP between 1990 and 2018 were included. Patient characteristics, indication for surgery, adverse events, disease recidivism, and patient-reported health outcomes were evaluated. RESULTS: 181 patients (183 ears) underwent a STP for several indications. The main indication was chronic otitis media (COM) with or without cholesteatoma (69%). In the total cohort, 8 residual cholesteatoma (5%) and 6 inclusion cholesteatoma 4% were detected. Postoperative (functional) health outcomes showed a significant negative impact on QoL in the STP cohort compared to normative data. Compared to patients without ear problems, the postoperative STP patients scored worse on almost all domains of the Chronic Ear Survey (CES) (p < 0.001). SF-36 scores of postoperative STP data showed negative Z-scores in almost all subscales, indicating lower levels of QoL compared to Dutch reference values. Most subscales of the Amsterdam Inventory for Auditory Disability and Handicap (AIADH) demonstrate a large-effect size in disadvantage of the STP cohort when compared to Dutch reference values. CONCLUSION: STP is a suitable technique to tackle severe ear disease. Despite its favourable surgical results, STP has a negative impact on several domains of patient's QoL.


Assuntos
Colesteatoma da Orelha Média , Colesteatoma , Otite Média , Humanos , Qualidade de Vida , Estudos Retrospectivos , Otite Média/cirurgia , Colesteatoma/cirurgia , Craniotomia/métodos , Resultado do Tratamento , Colesteatoma da Orelha Média/cirurgia , Processo Mastoide/cirurgia
3.
BMJ Open ; 12(4): e057641, 2022 04 06.
Artigo em Inglês | MEDLINE | ID: mdl-35387826

RESUMO

INTRODUCTION: Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy. The optimal treatment strategy is still unknown. The objective of the Dutch Injection versus Surgery TRIal in patients with CTS (DISTRICTS) is to investigate if initial surgery of CTS results in a better clinical outcome and is more cost-effective when compared with initial treatment with corticosteroid injection. METHODS AND ANALYSIS: The DISTRICTS is an ongoing multicenter, open-label randomised controlled trial. Participants with CTS are randomised to treatment with surgery or with a corticosteroid injection. If needed, any additional treatments after this first treatment are allowed and these are not dictated by the study protocol. The primary outcome is the difference between the groups in the proportion of participants recovered at 18 months. Recovery is defined as having no or mild symptoms as measured with the 6-item carpal tunnel symptoms scale. Secondary outcome measurements are among others: time to recovery, hand function, patient satisfaction, quality of life, additional treatments, adverse events, and use of care and health-related costs. ETHICS AND DISSEMINATION: The study was approved by the Medical Ethical Committee of the Amsterdam University Medical Centers (study number 2017-171). Study results will be disseminated in peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER: ISRCTN Registry: 13164336.


Assuntos
Síndrome do Túnel Carpal , Corticosteroides/uso terapêutico , Síndrome do Túnel Carpal/tratamento farmacológico , Síndrome do Túnel Carpal/cirurgia , Humanos , Injeções , Estudos Multicêntricos como Assunto , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Punho
4.
Rheumatology (Oxford) ; 60(4): 1784-1792, 2021 04 06.
Artigo em Inglês | MEDLINE | ID: mdl-33099648

RESUMO

OBJECTIVES: We explored efficacy and safety of IVIg as first-line treatment in patients with an idiopathic inflammatory myopathy. METHODS: In this investigator-initiated phase 2 open-label study, we included 20 adults with a newly diagnosed, biopsy-proven idiopathic inflammatory myopathy, and a disease duration of less than 9 months. Patients with IBM and prior use of immunosuppressants were excluded. The standard treatment regimen consisted of IVIg (Privigen) monotherapy for 9 weeks: a loading dose (2 g/kg body weight) and two subsequent maintenance doses (1 g/kg body weight) with a 3-week interval. The primary outcome was the number of patients with at least moderate improvement on the 2016 ACR/EULAR Total Improvement Score. Secondary outcomes included time to improvement, the number of patients requiring rescue medication and serious adverse events. RESULTS: We included patients with DM (n = 9), immune-mediated necrotizing myopathy (n = 6), non-specific myositis/overlap myositis (n = 4) and anti-synthetase syndrome (n = 1). One patient was excluded from analyses because of minimal weakness resulting in a ceiling effect. Eight patients (8/19 = 42.0%; Clopper-Pearson 95% CI: 19.6, 64.6) had at least moderate improvement by 9 weeks. Of these, six reached improvement by 3 weeks. Seven patients required rescue medication due to insufficient efficacy and prematurely ended the study. Three serious adverse events occurred, of which one was pulmonary embolism. CONCLUSION: First-line IVIg monotherapy led to at least moderate improvement in nearly half of patients with a fast clinical response in the majority of responders. TRIAL REGISTRATION: Netherlands Trial Register identifier, NTR6160.


Assuntos
Imunoglobulinas Intravenosas/administração & dosagem , Miosite/tratamento farmacológico , Adulto , Idoso , Creatina Quinase/sangue , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Foliculite/induzido quimicamente , Humanos , Imunoglobulinas Intravenosas/efeitos adversos , Masculino , Pessoa de Meia-Idade , Debilidade Muscular/induzido quimicamente , Projetos Piloto , Embolia Pulmonar/induzido quimicamente
6.
Am J Sports Med ; 44(5): 1292-300, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-26903214

RESUMO

BACKGROUND: Osteochondral defects (OCDs) of the talus usually affect athletic patients. The primary surgical treatment consists of arthroscopic debridement and microfracture. Various possibilities have been suggested to improve the recovery process after debridement and microfracture. A potential solution to obtain this goal is the application of pulsed electromagnetic fields (PEMFs), which stimulate the repair process of bone and cartilage. HYPOTHESIS: The use of PEMFs after arthroscopic debridement and microfracture of an OCD of the talus leads to earlier resumption of sports and an increased number of patients that resume sports. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 68 patients were randomized to receive either PEMFs (n = 36) or placebo (n = 32) after arthroscopic treatment of an OCD of the talus. The primary outcomes (ie, the number of patients who resumed sports and time to resumption of sports) were analyzed with Kaplan-Meier curves as well as Mann-Whitney U, chi-square, and log-rank tests. Secondary functional outcomes were assessed with questionnaires (American Orthopaedic Foot and Ankle Society ankle-hindfoot score, Foot and Ankle Outcome Score, EuroQol, and numeric rating scales for pain and satisfaction) at multiple time points up to 1-year follow-up. To assess bone repair, computed tomography scans were obtained at 2 weeks and 1 year postoperatively. RESULTS: Almost all outcome measures improved significantly in both groups. The percentage of sport resumption (PEMF, 79%; placebo, 80%; P = .95) and median time to sport resumption (PEMF, 17 weeks; placebo, 16 weeks; P = .69) did not differ significantly between the treatment groups. Likewise, there were no significant between-group differences with regard to the secondary functional outcomes and the computed tomography results. CONCLUSION: PEMF does not lead to a higher percentage of patients who resume sports or to earlier resumption of sports after arthroscopic debridement and microfracture of talar OCDs. Furthermore, no differences were found in bone repair between groups. REGISTRATION: Netherlands Trial Register NTR1636.


Assuntos
Artroscopia , Magnetoterapia/estatística & dados numéricos , Volta ao Esporte/estatística & dados numéricos , Tálus/cirurgia , Adulto , Desbridamento , Método Duplo-Cego , Feminino , Humanos , Masculino , Países Baixos , Tálus/anormalidades , Tomografia Computadorizada por Raios X , Resultado do Tratamento , Adulto Jovem
7.
Neurology ; 86(8): 755-61, 2016 Feb 23.
Artigo em Inglês | MEDLINE | ID: mdl-26819458

RESUMO

OBJECTIVE: To compare motor symptoms, cognition, mood, and behavior 3 years after deep brain stimulation (DBS) of the globus pallidus pars interna (GPi) and subthalamic nucleus (STN) in advanced Parkinson disease (PD). METHODS: Patients with PD eligible for DBS were randomized to bilateral GPi DBS and bilateral STN DBS (1:1). The primary outcome measures were (1) improvement in motor symptoms in off-drug phase measured with the Unified Parkinson Disease Rating Scale (UPDRS) and (2) a composite score for cognitive, mood, and behavioral effects, and inability to complete follow-up at 36 months after surgery. RESULTS: Of the 128 patients enrolled, 90 were able to complete the 3-year follow-up. We found significantly more improvement of motor symptoms after STN DBS (median [interquartile range (IQR)] at 3 years, GPi 33 [23-41], STN 28 [20-36], p = 0.04). No between-group differences were observed on the composite score (GPi 83%, STN 86%). Secondary outcomes showed larger improvement in off-drug functioning in the AMC Linear Disability Scale score after STN DBS (mean ± SD, GPi 65.2 ± 20.1, STN 72.6 ± 18.0, p = 0.05). Medication was reduced more after STN DBS (median levodopa equivalent dose [IQR] at 3 years, GPi 1,060 [657-1,860], STN 605 [411-875], p < 0.001). No differences in adverse effects were recorded, apart from more reoperations to a different target after GPi DBS (GPi n = 8, STN n = 1). CONCLUSIONS: Off-drug phase motor symptoms and functioning improve more after STN DBS than after GPi DBS. No between-group differences were observed on a composite score for cognition, mood, and behavior, and the inability to participate in follow-up. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that STN DBS provides more off-phase motor improvement than GPi DBS, but with a similar risk for cognitive, mood, and behavioral complications.


Assuntos
Estimulação Encefálica Profunda/tendências , Globo Pálido , Doença de Parkinson/diagnóstico , Doença de Parkinson/terapia , Núcleo Subtalâmico , Idoso , Estimulação Encefálica Profunda/métodos , Feminino , Seguimentos , Globo Pálido/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Doença de Parkinson/epidemiologia , Núcleo Subtalâmico/fisiologia , Resultado do Tratamento
8.
Nutr Clin Pract ; 30(2): 249-56, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25107953

RESUMO

BACKGROUND: Bioelectrical impedance analysis (BIA) is a method used to estimate body compartments such as fat-free mass (FFM) and fat mass (FM). Two BIA devices, a single-frequency BIA (SF-BIA) device and a bioimpedance spectroscopy (BIS) approach, were compared to evaluate their reliability and to study whether their estimations resulted in similar classifications of body composition. MATERIALS AND METHODS: In a prospective observational study, body composition was estimated by SF-BIA and BIS in 123 adult patients scheduled for major abdominal surgery. Measurement agreement for the continuous variables FFM and FM were analyzed by using the intraclass correlation coefficient (ICC), the mean differences, and their limits of agreement. Measurement differences were also visualized by Bland-Altman plots. For the dichotomized FFM index (FFMI) and FM index (FMI), interobserver agreement was calculated using Cohen κ statistics; the McNemar test was performed to compare the paired proportions. RESULTS: Agreement for the continuous variables was almost perfect for FM (.86; 95% confidence interval [CI], .80-.90) and substantial for FFM (.78; 95% CI, .70-.84). For the dichotomous variables, the agreement was substantial for FMI (.67; 95% CI, .51-.83) and slight for FFMI (.19; 95% CI, .01-.37). BIS classified a larger proportion having a low FFMI and a high FMI. CONCLUSION: There were good ICCs between SF-BIA and BIS for FFM and FM. However, the mean differences were substantial, whereas the classification of body composition based on FFMI and FMI was influenced by the device. Therefore, BIA devices are not interchangeable.


Assuntos
Abdome/cirurgia , Composição Corporal , Pletismografia de Impedância/instrumentação , Cuidados Pré-Operatórios/instrumentação , Tecido Adiposo , Adulto , Idoso , Idoso de 80 Anos ou mais , Impedância Elétrica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Reprodutibilidade dos Testes , Adulto Jovem
9.
CMAJ ; 186(14): E547-56, 2014 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-25183726

RESUMO

BACKGROUND: Disturbance of the sleep-wake cycle is a characteristic of delirium. In addition, changes in melatonin rhythm influence the circadian rhythm and are associated with delirium. We compared the effect of melatonin and placebo on the incidence and duration of delirium. METHODS: We performed this multicentre, double-blind, randomized controlled trial between November 2008 and May 2012 in 1 academic and 2 nonacademic hospitals. Patients aged 65 years or older who were scheduled for acute hip surgery were eligible for inclusion. Patients received melatonin 3 mg or placebo in the evening for 5 consecutive days, starting within 24 hours after admission. The primary outcome was incidence of delirium within 8 days of admission. We also monitored the duration of delirium. RESULTS: A total of 452 patients were randomly assigned to the 2 study groups. We subsequently excluded 74 patients for whom the primary end point could not be measured or who had delirium before the second day of the study. After these postrandomization exclusions, data for 378 patients were included in the main analysis. The overall mean age was 84 years, 238 (63.0%) of the patients lived at home before admission, and 210 (55.6%) had cognitive impairment. We observed no effect of melatonin on the incidence of delirium: 55/186 (29.6%) in the melatonin group v. 49/192 (25.5%) in the placebo group; difference 4.1 (95% confidence interval -0.05 to 13.1) percentage points. There were no between-group differences in mortality or in cognitive or functional outcomes at 3-month follow-up. INTERPRETATION: In this older population with hip fracture, treatment with melatonin did not reduce the incidence of delirium. TRIAL REGISTRATION: Netherlands Trial Registry, NTR1576: MAPLE (Melatonin Against PLacebo in Elderly patients) study; www.trialregister.nl/trialreg/admin/rctview.asp?TC=1576.


Assuntos
Delírio/prevenção & controle , Fraturas do Quadril/complicações , Melatonina/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Artroplastia de Quadril/efeitos adversos , Artroplastia de Quadril/métodos , Delírio/epidemiologia , Delírio/etiologia , Método Duplo-Cego , Feminino , Fixação Interna de Fraturas/efeitos adversos , Fixação Interna de Fraturas/métodos , Fraturas do Quadril/cirurgia , Humanos , Incidência , Masculino
10.
J Trauma Acute Care Surg ; 74(2): 546-57, 2013 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-23354249

RESUMO

BACKGROUND: Contradictory findings are reported in the literature concerning prognostic factors for failure of nonoperative management (NOM) in the treatment of adults with blunt splenic injury. The objective of this systematic review was to identify prognostic factors for failure of NOM, with or without angiography and embolization. METHODS: MEDLINE, Embase, and the Cochrane Library databases were searched. Prospective or retrospective cohort studies addressing failure of nonoperative treatment, with and/or without angiography and embolization, of blunt abdominal injuries were included. Methodological quality of the studies was assessed. RESULTS: A total of 335 titles and abstracts were screened, of which 31 fulfilled the inclusion criteria. No randomized controlled trials were found. Ten articles were qualified as high-quality articles and used for data extraction (best-evidence synthesis). A total of 25 prognostic factors were investigated, of which 14 were statistically significant in one or more studies. Strong evidence exists that age of 40 years or above, Injury Severity Score (ISS) of 25 or greater, and splenic injury grade of 3 or greater are prognostic factors for failure of NOM. Moderate evidence was found for a splenic Abbreviated Injury Scale score of 3 or greater, trauma and ISS of less than 0.80, the presence of an intraparenchymal contrast blush, as well as transfusion of 1 unit of packed red blood cells or more. Limited evidence was found for large hemoperitoneum, lower Revised Trauma Score, lower Glasgow Coma Scale score, lower systolic blood pressure, male sex, the presence of traumatic brain injury, and splenic embolization as protective factor for failure of NOM. CONCLUSION: Awareness for failure of NOM is required in patients aged 40 years or older, in patients with an ISS of 25 or higher or those with splenic injury grade 3 or higher. The prognostic factors for failure that we identified should be confirmed in future prospective cohort studies or meta-analyses using individual patient data. LEVEL OF EVIDENCE: Systematic review, level III.


Assuntos
Baço/lesões , Ferimentos não Penetrantes/terapia , Adulto , Fatores Etários , Idoso , Angiografia , Embolização Terapêutica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Fatores Sexuais , Baço/irrigação sanguínea , Resultado do Tratamento , Ferimentos não Penetrantes/diagnóstico
11.
Lancet Neurol ; 12(1): 37-44, 2013 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-23168021

RESUMO

BACKGROUND: Patients with advanced Parkinson's disease often have rapid swings between mobility and immobility, and many respond unsatisfactorily to adjustments in pharmacological treatment. We assessed whether globus pallidus pars interna (GPi) deep brain stimulation (DBS) gives greater functional improvement than does subthalamic nucleus (STN) DBS. METHODS: We recruited patients from five centres in the Netherlands who were aged 18 years or older, had idiopathic Parkinson's disease, and had, despite optimum pharmacological treatment, at least one of the following symptoms: severe response fluctuations, dyskinesias, painful dystonias, or bradykinesia. By use of a computer-generated randomisation sequence, we randomly assigned patients to receive either GPi DBS or STN DBS (1:1), applying a minimisation procedure according to drug use (levodopa equivalent dose <1000 mg vs ≥1000 mg) and treatment centre. Patients and study assessors (but not those who assessed adverse events) were masked to treatment allocation. We had two primary outcomes: functional health as measured by the weighted Academic Medical Center Linear Disability Scale (ALDS; weighted by time spent in the off phase and on phase) and a composite score for cognitive, mood, and behavioural effects up to 1 year after surgery. Secondary outcomes were symptom scales, activities of daily living scales, a quality-of-life questionnaire, the occurrence of adverse events, and drug use. We used the intention-to-treat principle for all analyses. This trial is registered with www.controlled-trials.com, number ISRCTN85542074. FINDINGS: Between Feb 1, 2007, and March 29, 2011, we enrolled 128 patients, assigning 65 to GPi DBS and 63 to STN DBS. We found no statistically significant difference in either of our primary outcomes: mean change in weighted ALDS (3·0 [SD 14·5] in the GPi group vs 7·7 [23·2] in the STN group; p=0·28) and the number of patients with cognitive, mood, and behavioural side-effects (36 [58%] of 62 patients in the GPi group vs 35 [56%] of 63 patients in the STN group; p=0·94). Secondary outcomes showed larger improvements in off-drug phase in the STN group compared with the GPi group in the mean change in unified Parkinson's disease rating scale motor examination scores (20·3 [16·3] vs 11·4 [16·1]; p=0·03), the mean change in ALDS scores (20·3 [27·1] vs 11·8 [18·9]; p=0·04), and medication (mean levodopa equivalent drug reduction: 546 [SD 561] vs 208 [521]; p=0·01). We recorded no difference in the occurrence of adverse events between the two groups. Other secondary endpoints showed no difference between the groups. INTERPRETATION: Although there was no difference in our primary outcomes, our findings suggest that STN could be the preferred target for DBS in patients with advanced Parkinson's disease. FUNDING: Stichting Internationaal Parkinson Fonds, Prinses Beatrix Fonds, and Parkinson Vereniging.


Assuntos
Estimulação Encefálica Profunda/métodos , Globo Pálido/fisiologia , Doença de Parkinson/patologia , Doença de Parkinson/terapia , Índice de Gravidade de Doença , Núcleo Subtalâmico/fisiologia , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
12.
Am J Surg ; 203(6): 700-7, 2012 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22365153

RESUMO

BACKGROUND: Preoperative screening for malnutrition has become mandatory in The Netherlands. A sensitive method to diagnose malnutrition would save time and improve effectiveness. METHODS: A prospective cross-sectional study of 488 adult elective preoperative outpatients was performed. The accuracy of self-reported height and weight was compared with measured data and 3 commonly used malnutrition screening tools. Interobserver agreement was calculated by the intraclass correlation coefficient, studied in Bland and Altman plots, and analyzed by using Cohen's κ statistic. Accuracy was expressed in sensitivity, specificity, and false-negative rates. RESULTS: Differences between self-reported and measured data were significant, but clinically irrelevant, because only 1 patient was falsely identified as well nourished. Intraclass correlation coefficient for height, weight, and body mass index was high (.97-.99). Bland-Altman plots showed that the mean ± standard deviation differences and 95% limits of agreement between both methods were as follows: height, .0096 m (±.0262, -.0417 to +.0609 m); weight, -1.28 kg (±2.29, -5.76 to +3.20 kg); body mass index, -.72 kg/m(2) (±1.11, -2.92 to +1.46 kg/m(2)). The κ coefficient was .84 (95% confidence interval, .75-.94). Sensitivity was .97 and specificity was .98. Sensitivity and false-negative rates of self-reported data were better overall compared with the screening tools. CONCLUSIONS: Self-reported data provide highly sensitive information to diagnose malnutrition in preoperative outpatients.


Assuntos
Estatura , Peso Corporal , Desnutrição/diagnóstico , Cuidados Pré-Operatórios/métodos , Autorrelato , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Procedimentos Cirúrgicos Ambulatórios , Estudos Transversais , Procedimentos Cirúrgicos Eletivos , Reações Falso-Negativas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos , Variações Dependentes do Observador , Estudos Prospectivos , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Adulto Jovem
13.
PLoS One ; 6(11): e26951, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-22110598

RESUMO

BACKGROUND: To study the prevalence of eighteen geriatric conditions in older patients at admission, their reporting rate in discharge summaries and the impact of these conditions on mortality and functional decline one year after admission. METHOD: A prospective multicenter cohort study conducted between 2006 and 2008 in two tertiary university teaching hospitals and one regional teaching hospital in the Netherlands. Patients of 65 years and older, acutely admitted and hospitalized for at least 48 hours, were invited to participate. Eighteen geriatric conditions were assessed at hospital admission, and outcomes (mortality, functional decline) were assessed one year after admission. RESULTS: 639 patients were included, with a mean age of 78 years. IADL impairment (83%), polypharmacy (61%), mobility difficulty (59%), high levels of primary caregiver burden (53%), and malnutrition (52%) were most prevalent. Except for polypharmacy and cognitive impairment, the reporting rate of the geriatric conditions in discharge summaries was less than 50%. One year after admission, 35% had died and 33% suffered from functional decline. A high Charlson comorbidity index score, presence of malnutrition, high fall risk, presence of delirium and premorbid IADL impairment were associated with mortality and overall poor outcome (mortality or functional decline). Obesity lowered the risk for mortality. CONCLUSION: Geriatric conditions were highly prevalent and associated with poor health outcomes after admission. Early recognition of these conditions in acutely hospitalized older patients and improving the handover to the general practitioner could lead to better health outcomes and reduce the burden of hospital admission for older patients.


Assuntos
Geriatria/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Prevalência , Idoso , Estudos de Coortes , Seguimentos , Humanos , Técnicas In Vitro , Masculino , Alta do Paciente/estatística & dados numéricos , Prognóstico , Estudos Prospectivos , Análise de Sobrevida
14.
AIDS ; 24(18): 2883-7, 2010 Nov 27.
Artigo em Inglês | MEDLINE | ID: mdl-20871386

RESUMO

Anemia is common in HIV infection, but the pathophysiology is poorly understood. Bone marrow analysis in 329 severely anemic (hemoglobin <5 g/dl) Malawian children with (n = 40) and without (n = 289) HIV infection showed that HIV-infected children had fewer CD34(+) hematopoietic progenitors (median 10 vs. 15‰, P = 0.04) and erythroid progenitors (2.2 vs. 3.4‰, P = 0.05), but there were no differences in erythrocyte viability and maturation in later stages of erythropoiesis. Despite an HIV-associated reduction in early red cell precursors, subsequent erythropoiesis appears to proceed similarly in HIV-infected and HIV-uninfected children with severe anemia.


Assuntos
Anemia/imunologia , Medula Óssea/virologia , Eritropoese/imunologia , Infecções por HIV/imunologia , HIV-1 , Estudos de Casos e Controles , Pré-Escolar , Feminino , Infecções por HIV/complicações , Humanos , Lactente , Masculino , Filogenia
15.
J Pediatr Surg ; 45(5): 1044-9, 2010 May.
Artigo em Inglês | MEDLINE | ID: mdl-20438952

RESUMO

PURPOSE: Nonoperative management (NOM) is the treatment of choice for hemodymically stable pediatric patients with spleen or liver trauma. The aim of this study was to assess the failure rate of NOM in children with blunt liver and/or splenic injury when a contrast blush is present on a computed tomography (CT) scan. METHODS: A systematic review of the literature published between 1985 and 2009 was performed by searching the EMBASE and MEDLINE database for English and German articles. Articles were eligible if they reported the failure rate of NOM with or without angioembolization (AE) in pediatric patients with splenic and/or liver injuries with a contrast blush on CT and included 2 or more trauma patients. Two reviewers independently assessed the eligibility and the quality of the articles and performed the data extraction. Interrater differences were resolved by discussion. RESULTS: Nine studies were included describing 117 pediatric patients. The median sample size was 5 (range, 2-44). Seven studies (including 71 patients) reported a total of 16 patients with failure after NOM without AE. Failure rates across these studies ranged from 4.5% to 100%; the pooled percentage was 28.2% (95% confidence interval, 8.9%-61.3%). The failure percentages after NOM with or without AE ranged from 0 to 100%; the pooled percentage was 21% (95% confidence interval, 7.5%-46.8%). Two studies (including 46 patients) reported a total of 3 patients (6.5%) with failure after NOM with primary AE. CONCLUSION: Despite the current low level of evidence on failure rate of NOM when a contrast blush is present on CT, we emphasize that there is a significant number of patients in whom NOM fails. We therefore recommend that the management of splenic and hepatic injury in children should not only be based on the physiologic response but should include consideration of the presence of a contrast blush.


Assuntos
Extravasamento de Materiais Terapêuticos e Diagnósticos , Fígado/lesões , Baço/lesões , Tomografia Computadorizada por Raios X , Ferimentos não Penetrantes/diagnóstico por imagem , Ferimentos não Penetrantes/terapia , Criança , Pré-Escolar , Humanos , Fígado/irrigação sanguínea , Fígado/diagnóstico por imagem , Baço/irrigação sanguínea , Baço/diagnóstico por imagem , Falha de Tratamento
16.
BMC Musculoskelet Disord ; 10: 83, 2009 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-19591674

RESUMO

BACKGROUND: Osteochondral talar defects usually affect athletic patients. The primary surgical treatment consists of arthroscopic debridement and microfracturing. Although this is mostly successful, early sport resumption is difficult to achieve, and it can take up to one year to obtain clinical improvement. Pulsed electromagnetic fields (PEMFs) may be effective for talar defects after arthroscopic treatment by promoting tissue healing, suppressing inflammation, and relieving pain. We hypothesize that PEMF-treatment compared to sham-treatment after arthroscopy will lead to earlier resumption of sports, and aim at 25% increase in patients that resume sports. METHODS/DESIGN: A prospective, double-blind, randomized, placebo-controlled trial (RCT) will be conducted in five centers throughout the Netherlands and Belgium. 68 patients will be randomized to either active PEMF-treatment or sham-treatment for 60 days, four hours daily. They will be followed-up for one year. The combined primary outcome measures are (a) the percentage of patients that resume and maintain sports, and (b) the time to resumption of sports, defined by the Ankle Activity Score. Secondary outcome measures include resumption of work, subjective and objective scoring systems (American Orthopaedic Foot and Ankle Society--Ankle-Hindfoot Scale, Foot Ankle Outcome Score, Numeric Rating Scales of pain and satisfaction, EuroQol-5D), and computed tomography. Time to resumption of sports will be analyzed using Kaplan-Meier curves and log-rank tests. DISCUSSION: This trial will provide level-1 evidence on the effectiveness of PEMFs in the management of osteochondral ankle lesions after arthroscopy. TRIAL REGISTRATION: Netherlands Trial Register (NTR1636).


Assuntos
Traumatismos do Tornozelo/terapia , Artroscopia , Traumatismos em Atletas/terapia , Cartilagem Articular/cirurgia , Magnetoterapia , Tálus/cirurgia , Adulto , Traumatismos do Tornozelo/diagnóstico por imagem , Traumatismos do Tornozelo/fisiopatologia , Traumatismos do Tornozelo/cirurgia , Traumatismos em Atletas/diagnóstico por imagem , Traumatismos em Atletas/fisiopatologia , Traumatismos em Atletas/cirurgia , Bélgica , Cartilagem Articular/diagnóstico por imagem , Cartilagem Articular/lesões , Cartilagem Articular/fisiopatologia , Terapia Combinada , Desbridamento , Avaliação da Deficiência , Método Duplo-Cego , Desenho de Equipamento , Feminino , Humanos , Estimativa de Kaplan-Meier , Magnetoterapia/instrumentação , Masculino , Países Baixos , Estudos Prospectivos , Recuperação de Função Fisiológica , Projetos de Pesquisa , Licença Médica , Tálus/diagnóstico por imagem , Tálus/lesões , Tálus/fisiopatologia , Fatores de Tempo , Tomografia Computadorizada por Raios X , Resultado do Tratamento
17.
J Rheumatol ; 34(6): 1222-8, 2007 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-17552054

RESUMO

OBJECTIVE: To determine the psychometric properties of the Academic Medical Center (AMC) Linear Disability Scale (ALDS) item bank in a population of patients with rheumatoid arthritis (RA). METHODS: 129 patients with RA completed the ALDS and Health Assessment Questionnaire Disability Index (HAQ-DI) at baseline, and after 8 and 16 weeks of anti-tumor necrosis factor-alpha treatment. Disease activity assessments at these timepoints included serum levels of C-reactive protein, Disease Activity Score 28, morning stiffness, and visual analog scales for global disease activity and fatigue. RESULTS: Reliability of the ALDS was excellent (homogeneity, Cronbach's alpha = 0.95; test-retest, intraclass correlation coefficient = 0.93). The ALDS results at baseline were strongly correlated with the HAQ-DI (r = -0.75). With regard to known group validity, both instruments discriminated between higher and lower disease activity (ALDS, p < 0.0001; HAQ-DI, p = 0.002) and between non-, moderate, and good responders (ALDS, p = 0.002; HAQ-DI, p < 0.0001), indicating that both instruments differentiate between groups. The ALDS was moderately to highly responsive to changes between baseline and after 8 weeks and 16 weeks of treatment (standardized response mean, range = 0.71-1.19). No substantial floor or ceiling effects were found. CONCLUSION: Our results show that the ALDS is a promising new instrument, with at least equivalent psychometric properties compared to the HAQ-DI. Advantages of the ALDS item bank are its linear structure and an item bank that can be adapted depending on the ability level of the patient.


Assuntos
Artrite Reumatoide/fisiopatologia , Artrite Reumatoide/psicologia , Avaliação da Deficiência , Índice de Gravidade de Doença , Adulto , Idoso , Idoso de 80 Anos ou mais , Artrite Reumatoide/sangue , Proteína C-Reativa/metabolismo , Feminino , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Psicometria , Reprodutibilidade dos Testes , Sensibilidade e Especificidade
18.
J Neurosurg ; 96(6): 1041-5, 2002 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-12066904

RESUMO

OBJECT: Patients harboring colloid cysts of the third ventricle can present with acute neurological deterioration, or the first indication of the lesion may appear when the patient suddenly dies. The risk of such an occurrence in a patient already identified as harboring a colloid cyst is unknown. The goal of this study was to estimate the risk of acute deterioration in patients with colloid cysts. METHODS: A retrospective study was made of a cohort of patients with newly diagnosed colloid cysts who were recruited in The Netherlands between January 1, 1993, and December 31, 1997. Seventy-eight patients were identified, all of whom displayed symptoms. Twenty-five patients (32%) presented with symptoms of acute deterioration; four patients died suddenly and the cysts were discovered at autopsy. The overall mortality rate was 12%. Results of a multivariate logistic regression analysis demonstrated that no subgroup of patients presenting without acute deterioration could be identified on the basis of patient age, duration of symptoms, cyst size, or the presence of hydrocephalus. The national incidence of colloid cysts in The Netherlands is 1/10(6) person-years; the prevalence was estimated to be 1800 asymptomatic colloid cysts. CONCLUSIONS: Acute deterioration was a frequent presentation among a national cohort of Dutch patients harboring symptomatic colloid cysts. The risk of acute deterioration in a symptomatic patient with a colloid cyst in The Netherlands is estimated to be 34%. The estimated risk for an asymptomatic patient with an incidental colloid cyst is significantly lower. These results strongly advocate the selection of surgical treatment for patients with symptomatic colloid cysts.


Assuntos
Encefalopatias/complicações , Cistos/complicações , Doenças do Sistema Nervoso/etiologia , Terceiro Ventrículo/fisiopatologia , Doença Aguda , Adolescente , Adulto , Idoso , Encefalopatias/epidemiologia , Encefalopatias/fisiopatologia , Estudos de Coortes , Cistos/epidemiologia , Cistos/fisiopatologia , Progressão da Doença , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Doenças do Sistema Nervoso/epidemiologia , Doenças do Sistema Nervoso/fisiopatologia , Países Baixos/epidemiologia , Estudos Retrospectivos , Medição de Risco
19.
Clin Rehabil ; 16(1): 27-35, 2002 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-11841066

RESUMO

OBJECTIVE: To describe the impact of a chronic disabling condition on participation and to identify variables that may explain perceived restrictions in participation. STUDY DESIGN: Cross-sectional. SETTING: People were recruited from the outpatient clinics of two rehabilitation centres and the rehabilitation department of an academic hospital. SUBJECTS: One hundred and twenty-six people from five diagnostic groups (neuromuscular disease, rheumatoid arthritis, spinal cord injury, stroke, fibromyalgia) participated in the study. METHOD: The IPA (Impact on Participation and Autonomy) questionnaire was used to describe perceived participation. Explanatory variables were studied in terms of sociodemographic factors and health status variables. RESULTS: Some restrictions in participation seem comparable among diagnostic groups, others are specific to one or two groups. People with stroke, rheumatoid arthritis or fibromyalgia perceived more restrictions in participation than people with spinal cord injury or neuromuscular disorders. Emotional distress was the most important factor contributing to restrictions in participation. CONCLUSIONS: Perceived participation remains a complex concept in which many factors are involved. To make a contribution to meaningful participation of people with a chronic disabling condition, rehabilitation treatment should address physical, social, emotional and environmental aspects.


Assuntos
Artrite Reumatoide/psicologia , Pessoas com Deficiência/psicologia , Fibromialgia/psicologia , Doenças Neuromusculares/psicologia , Participação do Paciente/psicologia , Autoimagem , Traumatismos da Medula Espinal/psicologia , Acidente Vascular Cerebral/psicologia , Adulto , Idoso , Artrite Reumatoide/reabilitação , Doença Crônica , Estudos Transversais , Pessoas com Deficiência/reabilitação , Feminino , Fibromialgia/reabilitação , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Doenças Neuromusculares/reabilitação , Fatores Socioeconômicos , Traumatismos da Medula Espinal/reabilitação , Reabilitação do Acidente Vascular Cerebral
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