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1.
Curr Urol ; 13(2): 64-69, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31768171

RESUMO

Objectives: To generate an algorithm for systematic development and validation of written patient information in accordance with well-established and validated psychometric and statistical methods that can be applied to different fields of medicine. Methods: A literature search was carried out in PubMed and Google Scholar. Methods were selected and combined to an algorithm. Feasibility and practicability is tested by the development of patient education materials on "ureteral stenting". Results: The algorithm includes 4 study phases. After internal audit expert, readability of the first version is objectified using the Flesch Reading Ease formula. This draft is tested by a few patients performing semi-structured interviews using "The think aloud method" by Someren et al. Content validity is evaluated by a written survey by external consultants in accordance with Lawshe's "Quantitative approach to content validity". The final leaflet is developed at a consensus meeting and validated by patients based on the Consumer Information Rating Form. The new algorithm could be tested by the development of patient education materials on "ureteral stenting" as a test run. Conclusion: We developed an algorithm for systematic development and validation of written patient information in accordance with well-established, validated psychometric and statistical methods. This algorithm can be applied to arbitrary fields of medicine.

2.
Ann Rheum Dis ; 78(9): 1242-1248, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31227488

RESUMO

OBJECTIVES: Mortality and worsening of organ function are desirable endpoints for clinical trials in systemic sclerosis (SSc). The aim of this study was to identify factors that allow enrichment of patients with these endpoints, in a population of patients from the European Scleroderma Trials and Research group database. METHODS: Inclusion criteria were diagnosis of diffuse SSc and follow-up over 12±3 months. Disease worsening/organ progression was fulfilled if any of the following events occurred: new renal crisis; decrease of lung or heart function; new echocardiography-suspected pulmonary hypertension or death. In total, 42 clinical parameters were chosen as predictors for the analysis by using (1) imputation of missing data on the basis of multivariate imputation and (2) least absolute shrinkage and selection operator regression. RESULTS: Of 1451 patients meeting the inclusion criteria, 706 had complete data on outcome parameters and were included in the analysis. Of the 42 outcome predictors, eight remained in the final regression model. There was substantial evidence for a strong association between disease progression and age, active digital ulcer (DU), lung fibrosis, muscle weakness and elevated C-reactive protein (CRP) level. Active DU, CRP elevation, lung fibrosis and muscle weakness were also associated with a significantly shorter time to disease progression. A bootstrap validation step with 10 000 repetitions successfully validated the model. CONCLUSIONS: The use of the predictive factors presented here could enable cohort enrichment with patients at risk for overall disease worsening in SSc clinical trials.

3.
J Neurol ; 265(12): 2783-2788, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30232608

RESUMO

INTRODUCTION: Although not curative, enzyme replacement therapy (ERT) with recombinant human acid alpha-glucosidase enzyme has shown to be effective in the treatment of late-onset Pompe disease (LOPD). For this potentially life-long treatment, little is known on the clinical effect of cessation and resuming ERT. Due to a Swiss supreme court decision on ERT reimbursement, a temporary stop of ERT occurred in our study population. The aim of this study was to report the 36-months follow-up assessments after resuming ERT. METHODS: After resuming ERT, seven patients suffering from genetically and enzymatically confirmed LOPD had periodic, mandatory, prospective assessments of pulmonary function tests, muscle strength summary scores, distances walked in timed walking tests, and patient-reported questionnaires. Data were statistically analyzed for significant differences between time points at ERT cessation, at ERT resuming, and 36 months thereafter. RESULTS: After resuming ERT forced vital capacity (p = 0.007) and distance walked in the 6 min walk test (6-MWT, p = 0.011) significantly increased at 36 months. Compared to before ERT cessation, distance walked in 6-MWT at 36 months still remained significantly lower (p = 0.005). Self-reported scores in the fatigue severity scale significantly declined at 36 months after resuming ERT (p = 0.019). No other functional or reported parameter significantly changed at 36 months after resuming ERT. CONCLUSIONS: Our data suggests that long-term interruption of ERT in LOPD may lead to deterioration of clinical meaningful parameters and quality of life. In addition, a clinical restoration after ERT cessation is possible for most of the LOPD patients within a 36 months follow-up.


Assuntos
Terapia de Reposição de Enzimas , Doença de Depósito de Glicogênio Tipo II/tratamento farmacológico , Feminino , Seguimentos , Doença de Depósito de Glicogênio Tipo II/fisiopatologia , Humanos , Masculino , Estudos Prospectivos , Sistema de Registros , Estudos Retrospectivos , Suíça , Resultado do Tratamento
4.
J Clin Med ; 7(3)2018 Mar 13.
Artigo em Inglês | MEDLINE | ID: mdl-29533997

RESUMO

OBJECTIVES: There is little information on the relation between disease duration, disability and radiographic outcome since the introduction of biologics into the therapy of rheumatoid arthritis (RA). No long -term cohort studies have been conducted on this subject so far. To analyse radiographic damage, disability, and disease activity in RA-patients dependent on disease duration in the Swiss national RA cohort (SCQM). METHODS: The primary outcome was the association between the radiographic destruction, assessed by Ratingen scores, and disease duration. All patients with at least one clinical visit were analysed with polynomial and multiple negative binomial models. RESULTS: The disease duration in the 8678 patients with available radiographs analysed ranged between less than 1 and more than 65 years (median 8.3). Disease duration and radiographic destruction were significantly associated with an average increase of Ratingen scores by 8.3% per year. Apart from disease duration, positive rheumatoid factor was the strongest predictor for radiographic destruction. While DAS28-scores remained stable in patients with a disease duration of more than 5 years (median DAS28 2.8), HAQ-DI scores increased continuously by 0.018 for each additional year. CONCLUSION: In this RA cohort, patients show a continuous increase of articular destruction and physical disability in parallel with disease duration. Even when nowadays a satisfactory control of disease activity can be achieved in most patients, RA remains a destructive disease leading to joint destruction and physical disability in many patients.

5.
J Neurol ; 264(11): 2313-2317, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28993873

RESUMO

The objective is to prospectively investigate short- and mid-term changes of heart rate variability (HRV) in patients with relapsing-remitting multiple sclerosis (RRMS), being started on fingolimod. In this prospective clinical trial, patient (n = 33) with RRMS starting treatment with fingolimod underwent a time-domain-based analysis of HRV (breathing at rest, deep breath, and in response to the Valsalva maneuver) shortly before, 4.5 h and 3 months after first intake. Blood pressure changes after the Valsalva maneuver were used as a marker of the sympathetic noradrenergic system. We used a non-invasive continuous beat-to-beat heart rate and blood pressure monitoring. In addition, the Fatigue Severity Scale and the refined and abbreviated Composite Autonomic Symptom Score were applied. Significant changes in HRV in RRMS patients, following treatment with fingolimod, were detected. After an initial increase in HRV, measured 4.5 h after the first intake of fingolimod, a substantial decrease in HRV occurred within 3 months on continuous treatment. There is a growing body of evidence for short-term cardiovascular side effects in continuous treatment with fingolimod, driven by the ANS. The mechanisms and the clinical relevance of the observed changes in HRV need further evaluation, especially in longer and larger prospective studies.


Assuntos
Cloridrato de Fingolimode/efeitos adversos , Cardiopatias/induzido quimicamente , Frequência Cardíaca/efeitos dos fármacos , Imunossupressores/efeitos adversos , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Adolescente , Adulto , Pressão Sanguínea/efeitos dos fármacos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla Recidivante-Remitente/fisiopatologia , Estudos Retrospectivos , Fatores de Tempo , Manobra de Valsalva/efeitos dos fármacos , Adulto Jovem
6.
Head Neck ; 39(10): 2004-2015, 2017 10.
Artigo em Inglês | MEDLINE | ID: mdl-28691255

RESUMO

BACKGROUND: Knowledge about prognostic factors in surgically treated patients with oropharyngeal squamous cell carcinoma (SCC) is limited. The purpose of this study was to identify influential factors on survival in a large cohort of patients with surgically treated oropharyngeal SCC. METHODS: Retrospective analysis of survival estimates in patients with surgically treated oropharyngeal SCC using tumoral positivity for human papillomavirus (HPV) and risk-of-death categories according to a study from 2010 as stratification factors. RESULTS: The 5-year overall survival (OS) and disease-specific survival (DSS) rates after surgery alone were higher in HPV-associated oropharyngeal SCC (OS 80% vs 62%; P = .01; DSS 92% vs 76%; P = .03). Patients in the low-risk category had higher survival rates (OS 91%; DSS 99%) than patients in the intermediate-risk group (OS 63%; DSS 83%), and high-risk group (OS 61%; DSS 75%). CONCLUSION: Nonsmokers with HPV-positive oropharyngeal SCC have a better prognosis than smokers with HPV-positive oropharyngeal SCC and also than patients with HPV-negative tumors when treated by surgery alone.


Assuntos
Carcinoma de Células Escamosas/terapia , Neoplasias de Cabeça e Pescoço/terapia , Neoplasias Orofaríngeas/terapia , Infecções por Papillomavirus/complicações , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma de Células Escamosas/mortalidade , Carcinoma de Células Escamosas/virologia , Quimiorradioterapia/métodos , Feminino , Neoplasias de Cabeça e Pescoço/mortalidade , Neoplasias de Cabeça e Pescoço/virologia , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias Orofaríngeas/mortalidade , Neoplasias Orofaríngeas/patologia , Neoplasias Orofaríngeas/virologia , Papillomaviridae/genética , Infecções por Papillomavirus/epidemiologia , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Carcinoma de Células Escamosas de Cabeça e Pescoço , Taxa de Sobrevida , Análise Serial de Tecidos
7.
Clin Neurophysiol ; 128(7): 1142-1147, 2017 07.
Artigo em Inglês | MEDLINE | ID: mdl-28511126

RESUMO

OBJECTIVE: Idiopathic adult onset cervical dystonia (IAOCD) is considered to be a partially penetrant autosomal dominant genetic condition. Dystonia may result from genetic and environmental factors. In this view, part of the physiology should be an endophenotype stemming from the genetic background. We assessed the most discriminative test to separate patients with IAOCD and healthy controls for further endophenotyping in non-affected 1st degree relatives. METHODS: We included patients with IAOCD, their 1st degree relatives and healthy controls. Tests performed: (1) Sensory temporal discrimination (visual, tactile, visuo-tactile), (2) Paired pulse paradigms using transcranial magnetic stimulation (TMS), (3) Mental rotation paradigms. RESULTS: 45 patients with IAOCD, 23 healthy controls and 14 non-affected 1st degree relatives were recruited. Visuo-tactile temporal discrimination separated best between controls and patients as well as between controls and 1st degree relatives. 36% of the latter had an abnormal visuo-tactile temporal discrimination. No difference between patients and healthy controls was found for the other paradigms. CONCLUSIONS: Visuo-tactile temporal discrimination separates controls from patients with IAOCD and its 1st degree relatives. 36% of the latter had abnormal visuo-tactile thresholds supporting the role of visuo-tactile temporal discrimination as an endophenotype for IAOCD. SIGNIFICANCE: Even though the study was of exploratory design, our findings expand the understanding of endophenotypes in IAOCD.


Assuntos
Endofenótipos , Torcicolo/diagnóstico , Torcicolo/fisiopatologia , Tato/fisiologia , Estimulação Magnética Transcraniana/métodos , Percepção Visual/fisiologia , Adulto , Idoso , Aprendizagem por Discriminação/fisiologia , Distúrbios Distônicos/diagnóstico , Distúrbios Distônicos/fisiopatologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estimulação Luminosa/métodos , Distribuição Aleatória , Adulto Jovem
8.
J Endourol ; 31(4): 380-383, 2017 04.
Artigo em Inglês | MEDLINE | ID: mdl-28156134

RESUMO

PURPOSE: To assess the prevalence and extent of irrigation fluid absorption during thulium laser vaporization of the prostate. MATERIAL AND METHODS: Fifty-four patients undergoing thulium laser vaporization of the prostate were prospectively included into the trial at a tertiary referral center. Isotonic saline containing 1% ethanol was used for intraoperative irrigation. Absorption of irrigation fluid was measured periodically during the operation using the expired breath ethanol technique. Among others, intra- and postoperative changes in biochemical and hematological laboratory findings were assessed. RESULTS: Absorption of irrigation fluid was detected in 7 out of 54 (13%) patients with a median absorption volume of 265 mL (227-615). No significant differences of intra- and postoperative blood parameters were observed between absorbers and nonabsorbers. No risk factor (i.e., age, prostate size, surgery duration, applied energy, and amount of irrigation fluid) for the occurrence of fluid absorption could be identified. CONCLUSION: Absorption of irrigation fluid also occurs during thulium laser vaporization of the prostate and should be kept in mind, especially in patients at a high cardiovascular risk. However, compared with previously assessed resection and vaporization techniques, thulium vaporization might have a favorable safety profile regarding fluid absorption.


Assuntos
Etanol/metabolismo , Terapia a Laser/métodos , Próstata/cirurgia , Cloreto de Sódio/metabolismo , Irrigação Terapêutica/métodos , Idoso , Idoso de 80 Anos ou mais , Testes Respiratórios , Doenças Cardiovasculares , Etanol/análise , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Fatores de Risco , Túlio , Volatilização
9.
Biometrics ; 73(1): 242-251, 2017 03.
Artigo em Inglês | MEDLINE | ID: mdl-27192504

RESUMO

The prior distribution is a key ingredient in Bayesian inference. Prior information on regression coefficients may come from different sources and may or may not be in conflict with the observed data. Various methods have been proposed to quantify a potential prior-data conflict, such as Box's p-value. However, there are no clear recommendations how to react to possible prior-data conflict in generalized regression models. To address this deficiency, we propose to adaptively weight a prespecified multivariate normal prior distribution on the regression coefficients. To this end, we relate empirical Bayes estimates of prior weight to Box's p-value and propose alternative fully Bayesian approaches. Prior weighting can be done for the joint prior distribution of the regression coefficients or-under prior independence-separately for prespecified blocks of regression coefficients. We outline how the proposed methodology can be implemented using integrated nested Laplace approximations (INLA) and illustrate the applicability with a Bayesian logistic regression model for data from a cross-sectional study. We also provide a simulation study that shows excellent performance of our approach in the case of prior misspecification in terms of root mean squared error and coverage. Supplementary Materials give details on software implementation and code and another application to binary longitudinal data from a randomized clinical trial using a Bayesian generalized linear mixed model.


Assuntos
Modelos Logísticos , Teorema de Bayes , Simulação por Computador , Estudos Transversais , Interpretação Estatística de Dados , Humanos , Modelos Estatísticos , Ensaios Clínicos Controlados Aleatórios como Assunto
10.
Br J Haematol ; 176(5): 770-782, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27983764

RESUMO

The combination of lenalidomide (Revlimid® , R) and dexamethasone (d) is a standard regimen for patients with relapsed/refractory multiple myeloma (rrMM). With this regimen, only a small fraction of patients will achieve high quality responses [≥ very good partial response (VGPR)]. The combination of bendamustine (B), lenalidomide and dexamethasone (BRd) has shown high efficacy in patients with advanced rrMM. However, dose-limiting haematotoxicity restricted its use in extensively pre-treated patient populations. This prospective, multicentre Phase II study evaluated the efficacy and safety of BRd in rrMM patients with one prior line of therapy. Fifty patients were enrolled (median age 68·5 years [range 46-83]) and were treated with B 75 mg/m2  days 1, 2; R 25 mg days 1-21 and d (40/20 mg) days 1, 8, 15 and 22, for 6 28-day induction cycles, followed by 12 cycles with Rd alone. Pegfilgrastim was administered according to protocol-defined criteria. The study aimed to demonstrate a complete response (CR)/VGPR rate of >40% after induction therapy. Of 45 evaluable patients, 23 (51%) achieved a CR/VGPR. Grade 4 neutropenia or thrombocytopenia occurred in 17 (34%) and 8 (16%) of patients, respectively. BRd is a safe and efficacious regimen as a second line treatment for rrMM, leading to high quality responses in a considerable proportion of patients.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Mieloma Múltiplo/tratamento farmacológico , Terapia de Salvação/métodos , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Cloridrato de Bendamustina/efeitos adversos , Dexametasona/administração & dosagem , Humanos , Lenalidomida , Pessoa de Meia-Idade , Mieloma Múltiplo/complicações , Neutropenia/induzido quimicamente , Indução de Remissão/métodos , Talidomida/administração & dosagem , Talidomida/análogos & derivados , Trombocitopenia/induzido quimicamente , Trombocitopenia/complicações , Resultado do Tratamento
11.
Medicine (Baltimore) ; 95(42): e5094, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-27759638

RESUMO

Plasma HIV viral load is related to declining CD4 lymphocytes. The extent to which CD8 cells, in addition to RNA viral load, predict the depletion of CD4 cells is not well characterized so far. We examine if CD8 cell count is a prognostic factor for CD4 cell counts during an HIV infection.A longitudinal analysis is conducted using data from the Swiss HIV cohort study collected between January 2000 and October 2014. Linear mixed regression models were applied to observations from HIV-1-infected treatment naive patients (NAIVE) and cART-treated patients to predict the short-term evolution of CD4 cell counts. For each subgroup, it was quantified to which extent CD8 cell counts or CD4/CD8 ratios are prognostic factors for disease progression.In both subgroups, 2500 NAIVE and 8902 cART patients, past CD4 cells are positively (P < 0.0001) and past viral load is negatively (P < 0.0001) associated with the outcome. Including additionally past CD8 cell counts improves the fit significantly (P < 0.0001) and increases the marginal explained variation 31.7% to 40.7% for the NAIVE and from 44.1% to 50.7% for the cART group. The past CD4/CD8 ratio (instead of the past CD8 level) is positively associated with the outcome, increasing the explained variation further to 41.8% for NAIVE and 51.9% for cART.


Assuntos
Terapia Antirretroviral de Alta Atividade/métodos , Linfócitos T CD4-Positivos/patologia , Linfócitos T CD8-Positivos/patologia , Infecções por HIV/tratamento farmacológico , HIV-1/genética , RNA Viral/análise , Relação CD4-CD8 , Progressão da Doença , Feminino , Seguimentos , Infecções por HIV/diagnóstico , Infecções por HIV/virologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Carga Viral
12.
Urol Int ; 97(1): 91-7, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26795568

RESUMO

OBJECTIVE: To assess the economic burden of temporary ureteral stenting. METHODS: The German version of the ureteral stent symptom questionnaire was completed by 74 patients with unilateral inserted indwelling stents. Cost accounting was performed considering the costs of ureteral stents, drugs, consultation of healthcare professionals, hospitalization, stent extraction and work incapacity due to stent-related problems. RESULTS: Total costs arising from stent-related problems amounted to US dollars (USD) 133,355, median USD 455 (113-11,948) for the entire stent indwelling time, and USD 15 (4-398) per patient per day. Costs (USD total/median (range)) arose mainly from work incapacity (104,154/0 (0-11, 498)), followed by healthcare professional consultation (9,177/0 (0-612)), drug costs (8,736/111 (0-427)), stent material (8,390/113), stent removal (2,235/0 (0-1,769)) and outpatient hospital care (663/0 (0-663)). Most patients also showed a reduced capacity for work due to symptoms associated with indwelling stents. CONCLUSION: The economic burden of morbidity associated with indwelling ureteral stents is considerably high and should be taken into account when performing ureteral stenting, especially in cases where it is not strictly indicated and when stent removal is scheduled.


Assuntos
Efeitos Psicossociais da Doença , Complicações Pós-Operatórias/economia , Complicações Pós-Operatórias/etiologia , Stents/efeitos adversos , Stents/economia , Ureter/cirurgia , Feminino , Humanos , Masculino , Estudos Prospectivos
13.
Biom J ; 57(6): 1038-50, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26360927

RESUMO

Analyzing the collected evidence of a systematic review in form of a network meta-analysis (NMA) enjoys increasing popularity and provides a valuable instrument for decision making. Bayesian inference of NMA models is often propagated, especially if correlated random effects for multiarm trials are included. The standard choice for Bayesian inference is Markov chain Monte Carlo (MCMC) sampling, which is computationally intensive. An alternative to MCMC sampling is the recently suggested approximate Bayesian method of integrated nested Laplace approximations (INLA) that dramatically saves computation time without any substantial loss in accuracy. We show how INLA apply to NMA models for summary level as well as trial-arm level data. Specifically, we outline the modeling of multiarm trials and inference for functional contrasts with INLA. We demonstrate how INLA facilitate the assessment of network inconsistency with node-splitting. Three applications illustrate the use of INLA for a NMA.


Assuntos
Biometria/métodos , Metanálise como Assunto , Doença Aguda , Teorema de Bayes , Ensaios Clínicos como Assunto , Fibrinolíticos/uso terapêutico , Humanos , Cadeias de Markov , Método de Monte Carlo , Infarto do Miocárdio/tratamento farmacológico , Abandono do Hábito de Fumar , Software
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