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1.
Gut ; 2021 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-34544843

RESUMO

OBJECTIVE: A considerable proportion of patients with irritable bowel syndrome (IBS) may be wheat-sensitive and respond to a gluten-free diet (GFD) although they do not have coeliac disease. However, a diagnostic test for wheat sensitivity (WS) is missing. Our study evaluated the diagnostic accuracy (sensitivity and specificity) of confocal laser endomicroscopy (CLE) for the identification of WS as primary outcome. DESIGN: In this prospective, double-blind diagnostic study 147 non-coeliac patients fulfilling the Rome III criteria for IBS were tested by CLE for duodenal changes after wheat (index test), soy, yeast or milk exposure. Patients with IBS responding to 2 months of GFD were classified as having WS (reference test) using response criteria recommended by regulatory bodies for pharmaceutical trials of patients with IBS. After 2 months, CLE results were unblinded and patients were advised to exclude those food components that had led to a positive CLE reaction. The clinical response was assessed at follow-up after 6 and 12 months. RESULTS: Of 130 patients who completed the study per protocol, 74 (56.9%) responded to GFD and were classified as WS after 2 months, and 38 of these 74 patients were correctly identified by CLE (sensitivity 51.4%; 97.5% CI: 38.7% to 63.9%). A total of 38 of 56 patients without WS were correctly identified by CLE (specificity 67.9%; 97.5% CI: 52.9% to 79.9%). At 6 months follow-up, CLE correctly identified 49 of 59 food-sensitive patients (sensitivity 83.1%; 97.5% CI: 69.9% to 91.3%) but specificity was only 32% (97.5% CI: 15.7% to 54.3%). CONCLUSION: In light of the high proportion of patients with IBS responding to GFD, the diagnostic accuracy of CLE is too low to recommend widespread use of this invasive procedure. TRAIL REGISTRATION NUMBER: This study was registered as clinical trial in the German Registry for Clinical Studies (DRKS00010123).

2.
J Endocr Soc ; 5(8): bvab103, 2021 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-34258493

RESUMO

Context: Little is known about the physical health of individuals with 46,XY disorders of sex development (DSD). Objective: To assess physical and reported subjective health of individuals with XY DSD. Methods: As part of the dsd-LIFE study, patients with an XY DSD condition were analyzed in different diagnosis groups for metabolic parameters, comorbidities, metabolic syndrome, bone outcomes, and reported subjective health. Findings were evaluated by descriptive statistics. Results: A total of 222 patients with XY DSD were included with a mean age of 28.8 ±â€…12.2 years, mean height of 175.3 ±â€…7.7 cm, mean weight of 74.3 ±â€…20.0 kg, and mean body mass index of 24.1 ±â€…6.0 kg/m2. Obesity rate was not increased when descriptively compared with Eurostat data. Fourteen patients had metabolic syndrome (14/175; 8.0%). In descriptive comparison with data from the DECODE study and World Health Organization, subjects fared better in the categories waist circumference, glucose, triglyceride, cholesterol, and high-density lipoprotein. Of participants with available bone health data, 19/122 (15.6%) patients had a Z-score ≤ -2.0 at lumbar spine indicating lowered bone mineral density (BMD). Mostly gonadectomized individuals with complete androgen insensitivity syndrome (CAIS) and no estrogen therapy had lowered BMD at lumbar spine. Individuals with XY DSD performed poorly in the category subjective health in descriptive comparison with Eurostat data. Conclusion: Participants reported a lower subjective health status than Eurostat data but their overall metabolic health status was good. Decreased BMD at lumbar spine was especially present in gonadectomized individuals with CAIS and no estrogen therapy.

3.
ESC Heart Fail ; 8(4): 3070-3081, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33955699

RESUMO

AIMS: We aimed to test whether the endogenous filtration markers serum creatinine or cystatin C and equation-based estimates of glomerular filtration rate (GFR) based on these markers appropriately reflect changes of measured GFR in patients with acute heart failure. METHODS: In this prospective cohort study of 50 hospitalized acute heart failure patients undergoing decongestive therapy, we applied an intravenous visible fluorescent injectate (VFI), consisting of a low molecular weight component to measure GFR and a high molecular weight component to correct for measured plasma volume. Thirty-eight patients had two sequential GFR measurements 48 h apart. The co-primary endpoints of the study were safety of VFI and plasma stability of the high molecular weight component. A key secondary endpoint was to compare changes in measured GFR (mGFR) to changes of serum creatinine, cystatin C and estimated GFR. RESULTS: VFI-based GFR measurements were safe and consistent with plasma stability of the high molecular weight component and glomerular filtration of the low molecular weight component. Filtration marker-based point estimates of GFR, when compared with mGFR, provided only moderate correlation (Pearson's r, range 0.80-0.88, depending on equation used), precision (r2 , range 0.65-0.78) and accuracy (56%-74% of estimates scored within 30% of mGFR). Correlations of 48-h changes GFR estimates and changes of mGFR were significant (P < 0.05) but weak (Pearson's r, range 0.35-0.39). Observed decreases of eGFR by more than 15% had a low sensitivity (range 38%-46%, depending on equation used) in detecting true worsening mGFR, defined by a >15% decrease in mGFR. CONCLUSIONS: In patients hospitalized for acute heart failure, serum creatinine- and cystatin C-based predictions performed poorly in detecting actual changes of GFR. These data challenge current clinical strategies to evaluate dynamics of kidney function in acute heart failure.


Assuntos
Cistatina C , Insuficiência Cardíaca , Creatinina , Taxa de Filtração Glomerular , Insuficiência Cardíaca/diagnóstico , Humanos , Estudos Prospectivos
4.
Infection ; 49(4): 703-714, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33890243

RESUMO

PURPOSE: Adequate patient allocation is pivotal for optimal resource management in strained healthcare systems, and requires detailed knowledge of clinical and virological disease trajectories. The purpose of this work was to identify risk factors associated with need for invasive mechanical ventilation (IMV), to analyse viral kinetics in patients with and without IMV and to provide a comprehensive description of clinical course. METHODS: A cohort of 168 hospitalised adult COVID-19 patients enrolled in a prospective observational study at a large European tertiary care centre was analysed. RESULTS: Forty-four per cent (71/161) of patients required invasive mechanical ventilation (IMV). Shorter duration of symptoms before admission (aOR 1.22 per day less, 95% CI 1.10-1.37, p < 0.01) and history of hypertension (aOR 5.55, 95% CI 2.00-16.82, p < 0.01) were associated with need for IMV. Patients on IMV had higher maximal concentrations, slower decline rates, and longer shedding of SARS-CoV-2 than non-IMV patients (33 days, IQR 26-46.75, vs 18 days, IQR 16-46.75, respectively, p < 0.01). Median duration of hospitalisation was 9 days (IQR 6-15.5) for non-IMV and 49.5 days (IQR 36.8-82.5) for IMV patients. CONCLUSIONS: Our results indicate a short duration of symptoms before admission as a risk factor for severe disease that merits further investigation and different viral load kinetics in severely affected patients. Median duration of hospitalisation of IMV patients was longer than described for acute respiratory distress syndrome unrelated to COVID-19.


Assuntos
COVID-19/epidemiologia , COVID-19/virologia , SARS-CoV-2/fisiologia , COVID-19/terapia , Estudos de Coortes , Alemanha/epidemiologia , Hospitalização , Humanos , Hipertensão/complicações , Cinética , Estudos Prospectivos , Respiração Artificial , Fatores de Risco , Centros de Atenção Terciária , Fatores de Tempo , Carga Viral , Eliminação de Partículas Virais
5.
Sci Rep ; 11(1): 5903, 2021 03 15.
Artigo em Inglês | MEDLINE | ID: mdl-33723315

RESUMO

Degeneration of the sacroiliac joints (SIJs) is a common finding, while its underlying cause and development remain incompletely understood. The aim of this investigation was to describe the spatial distribution of degenerative SIJ changes across age groups and to investigate for the first time their relationship to anatomical form and sex. For this IRB-approved investigation, demographic data of 818 patients without SIJ disease were retrieved from electronic patient records. High-resolution computed tomography (CT) datasets of all patients were analysed retrospectively for seven predefined age groups (ten-year increments, from < 25 to ≥ 75). A structured scoring system was applied to assess sclerosis, osteophytes, joint space alterations, and anatomical form. Chi-square tests were used to compare frequencies of degenerative lesions, and logistic regression analyses were performed to investigate associations between demographic data, anatomical form, and the presence of structural lesions. Sclerosis and osteophytes were common findings, with an overall prevalence of 45.7% and 46.8%, respectively. Female sex had an odds ratio (OR) of 0.15 (95% CI: 0.08-0.27) for the presence of ventral osteophytes and of 4.42 (95% CI: 2.77-7.04) for dorsal osteophytes. Atypical joint forms were significantly more prevalent in women with 62.1% vs. 14.1% in men (p < 0.001). Accessory joints increased the likelihood of dorsal sclerosis (OR 2.735; 95% CI 1.376-5.436) while a typical joint form decreased its likelihood (OR 0.174; 95% CI 0.104-0.293). Sex and anatomical joint form have a major impact on the development of degenerative lesions of the SIJs and their spatial distribution.

6.
Curr Rev Clin Exp Pharmacol ; 16(4): 357-368, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33588739

RESUMO

BACKGROUND/OBJECTIVE: Tacrolimus HEXAL®/Crilomus® is an approved generic immunosuppressant for the prevention and treatment of rejection following renal transplantation. For safe and socioeconomically efficient conversion of the innovator into a generic formulation, high- -quality data are necessary, in view of the different and country-specific comorbidities and pharmacokinetics in kidney transplant recipients. PATIENTS AND METHODS: From 2014 to 2017, we enrolled 32 kidney transplant recipients, receiving newly prescribed Tacrolimus HEXAL®/Crilomus® in 5 German centers. Efficacy and safety data were collected over 6-8 months and retrospectively compared to the period prior to conversion. RESULTS: The mean tacrolimus trough level was 4.91 ng/mL Standard Deviation (SD) (SD ±1.7) before and 5.06 ng/mL (SD ±1.97) after conversion. Mean tacrolimus trough concentration-dose-ratio (+/- SD) was 187.1 ng/mL/mg/kg/day (SD 99.2) for the reference and 205.1 ng/mL/mg/kg/day (SD 133) for the generic product, resulting in a non-significant difference of 18.0 ng/mL/mg/kg/day (SD 71.8) (p=0.84, Wilcoxon V=180). Overall, dosing had to be changed in 4 (14.8%) patients. Graft function remained stable and no rejections occurred. CONCLUSION: In conclusion, conversion to the generic tacrolimus formulation can be considered safe and feasible in long-term kidney transplant recipients in Germany. As suggested by guidelines, vigilant therapeutic drug monitoring is recommended to account for possible tacrolimus concentration variability on the individual patient level.

7.
Clin Pharmacol Ther ; 109(4): 1055-1062, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-32770831

RESUMO

HIV remains a major burden to the health care system and neuropathic pain is the most common neurological complication of HIV infection. Because current treatment strategies often lack satisfying pain relief, cannabinoids (CBs) are discussed as a new option. We investigated cannabidivarin (CBDV) as treatment for HIV-associated neuropathic pain. We conducted a randomized, double-blind, placebo-controlled crossover study. Patients underwent two successive treatment phases (4 weeks each) and were treated with CBDV (400 mg/day) or placebo in a randomized order. A 3-week washout phase was designed to eliminate potential carry-over effects. Patients were followed up for 3 weeks after the end of the second treatment phase. The primary end point was pain intensity on an 11-point numeric rating scale, recorded in a diary. Secondary end points were additional pain medication, pain characteristics, and quality of life. We included 32 patients. The mean pain intensity under CBDV was 0.62 points higher compared with placebo (P = 0.16, 95% confidence interval -0.27 to 1.51). CBDV did not influence the amount of additional pain medication, pain characteristics, or quality of life. The incidence of adverse events was similar during both treatments. No suspected unexpected adverse reactions occurred during either treatment. CBDV was safe but failed to reduce neuropathic pain in patients with HIV. This may be explained by a lack of CB receptor activation, as indicated by preclinical experiments. Although a larger patient number might be desirable, we would not expect a change in the conclusions because the present differences are far from statistical significance. Therefore, we would currently not consider CBDV as a clinically meaningful treatment option for neuropathic pain.


Assuntos
Canabinoides/uso terapêutico , Infecções por HIV/complicações , Neuralgia/tratamento farmacológico , Neuralgia/etiologia , Adulto , Idoso , Analgésicos , Canabinoides/administração & dosagem , Canabinoides/efeitos adversos , Estudos Cross-Over , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Qualidade de Vida
8.
J Pediatr Urol ; 17(3): 353-365, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33358555

RESUMO

BACKGROUND: Surgery is performed in many individuals with disorders/differences of sex development (DSD). Irreversibility of some surgical procedures, lack of information about the procedures, and lack of follow-up care for physical and psychological outcomes, lead to wish for more knowledge from both surgeons and patients. After the consensus conference in 2006, multidisciplinary care is provided to a higher degree with psychological support and more restricted surgical procedures. Outcome studies after genital surgery often lack of patient's perspective. OBJECTIVE: To describe surgical procedures in relation to diagnosis, to evaluate the outcomes of surgery through genital examination, and through patient's and observer's satisfaction with the anatomical and functional result after genital surgery. STUDY DESIGN: In a cross-sectional clinical study performed in six European countries in 2014/15, we have included 500 participants where surgery was performed, from a total of 1040 adolescents (≥16years) and adults with a DSD. Diagnoses included Turner syndrome (n = 301), mixed gonadal dysgenesis (45,XO/46,XY; n = 45), Klinefelter syndrome (n = 218), XYY (n = 1), 46, XY DSD (n = 222) and 46, XX DSD (n = 253). Study protocol included clinical report files, an optional gynecological or urological examination, patient reported outcomes including received surgical interventions, satisfaction with appearance and function after surgery, and impact of the surgical procedure on life. RESULTS: Five hundred participants had received genital or breast surgery, with the highest rate in 46, XY DSD and the lowest in Turner syndrome. Altogether; 240 participants had feminizing surgery, 112 had masculinizing surgery, and 217 underwent gonadectomy. Physicians evaluated anatomical appearance at genital examination as poor in less than 10%. Dissatisfaction with anatomical appearance was reported by 22% of the participants, dissatisfaction with function by 20%. Being (very) dissatisfied with anatomical appearance and function was reported by 13% of the study participants. Most participants reported no impact, or positive impact, of the surgical procedures on their lives, but 29% experienced a negative effect of gonadectomy on their life. DISCUSSION: There might be a selection bias and/or a recall bias for participating in our studies. Due to poor data quality about surgical procedures performed in the past, we also relied on participants memory about surgical procedures in their past. Ideally, patient reported outcomes should be evaluated both before and after surgical procedures. CONCLUSION: A vast majority are satisfied with appearance and function, but still genital or breast surgery have a long-lasting effect on patient's life. Self-reported satisfaction is usually lower than the observer's evaluation regarding both appearance and function.


Assuntos
Transtornos do Desenvolvimento Sexual , Desenvolvimento Sexual , Adolescente , Adulto , Estudos Transversais , Transtornos do Desenvolvimento Sexual/cirurgia , Europa (Continente) , Humanos , Medidas de Resultados Relatados pelo Paciente , Procedimentos Cirúrgicos Urogenitais
9.
EuroIntervention ; 15(17): 1506-1513, 2020 Apr 17.
Artigo em Inglês | MEDLINE | ID: mdl-31929100

RESUMO

AIMS: The aim of our study was to compare the impact of implantation of a balloon-expandable transcatheter valve into the inferior vena cava (CAVI) on exercise capacity with optimal medical therapy (OMT) in patients with severe tricuspid regurgitation (TR) and high surgical risk. METHODS AND RESULTS: Twenty-eight patients were randomised to OMT (n=14) or CAVI (n=14). The primary endpoint was maximal oxygen uptake at the three-month follow-up. Secondary endpoints included six-minute walk test, NYHA class, NT-proBNP levels, right heart function, unscheduled heart failure hospitalisation, and quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Patients underwent follow-up examinations one, three, six, and twelve months after randomisation. Maximal oxygen uptake did not change significantly in either group after three months and there was no difference between the OMT and CAVI groups (-0.1±1.8 ml∙kg-1∙min-1 vs -1.0±1.6 ml∙kg-1∙min-1, p=0.4995). Compared to baseline, CAVI improved NYHA class, dyspnoea, and quality of life after three months. However, there were no statistically significant differences in the secondary endpoints between the groups. Four periprocedural complications occurred after CAVI, resulting in open heart surgery. Four patients in the OMT group and eight patients (including four after conversion to surgery) in the CAVI group died from right heart failure, sepsis or haemorrhage. CONCLUSIONS: CAVI did not result in a superior functional outcome compared to OMT. Due to an unexpectedly high rate of valve dislocations, the study was stopped for safety reasons.


Assuntos
Cateterismo Cardíaco/métodos , Cateterismo Venoso Central/métodos , Insuficiência Cardíaca/complicações , Implante de Prótese de Valva Cardíaca/métodos , Insuficiência da Valva Tricúspide/cirurgia , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/mortalidade , Cateterismo Venoso Central/efeitos adversos , Cateterismo Venoso Central/instrumentação , Causas de Morte , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/mortalidade , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Humanos , Minnesota/epidemiologia , Desenho de Prótese , Qualidade de Vida , Índice de Gravidade de Doença , Taxa de Sobrevida , Resultado do Tratamento , Valva Tricúspide/fisiopatologia , Insuficiência da Valva Tricúspide/complicações , Insuficiência da Valva Tricúspide/epidemiologia , Veia Cava Inferior/fisiopatologia
10.
Clin Endocrinol (Oxf) ; 92(4): 284-294, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31886890

RESUMO

BACKGROUND: In patients with congenital adrenal hyperplasia (CAH) type and doses of glucocorticoids used as well as sex hormone secretion during puberty have important actions on bone mineral density (BMD) in adulthood. AIM: To evaluate BMD in adult CAH patients depending on current glucocorticoid therapy and on androgen levels in adulthood and at age 16 years. METHODS: We included 244 CAH patients from the dsd-LIFE cohort (women n = 147, men n = 97; salt-wasting n = 148, simple-virilizing n = 71, nonclassical n = 25) in which BMD and bloods were available. Clinical and hormonal data at age 16years were retrieved from patients' files. RESULTS: Simple-virilizing women showed lower BMD compared to salt-wasting women at trochanter (0.65 ± 0.12 vs 0.75 ± 0.15 g/cm2 ; P < .050), whole femur T-score (-0.87 ± 1.08 vs -0.16 ± 1.24; P < .05) and lumbar T-score (-0.81 ± 1.34 vs 0.09 ± 1.3; P < .050). Fracture prevalence did not differ significantly between the CAH groups. Prednisolone vs. hydrocortisone only therapy caused worse trochanter Z-score (-1.38 ± 1.46 vs -0.47 ± 1.16; P < .050). In women lumbar spine, BMD correlated negatively with hydrocortisone-equivalent dose per body surface (r2  = 0.695, P < .001). Furthermore, BMI at age 16years correlated positively with lumbar spine T-score (r2  = 0.439, P = .003) and BMD (r2  = 0.420, P = .002) in women. The androstenedione/testosterone ratio at age 16years correlated positively with lumbar spine Z-score in women (r2  = 0.284, P = .024) and trochanter Z-score in men (r2  = 0.600, P = .025). CONCLUSION: Higher glucocorticoid doses seemed to cause lower BMD especially in women. Prednisolone appeared to have more detrimental effects on BMD than hydrocortisone. Higher glucocorticoid doses (lower androstenedione/testosterone ratio) during adolescence may cause lower BMD in adulthood.


Assuntos
Hiperplasia Suprarrenal Congênita , Fraturas Ósseas , Absorciometria de Fóton , Adolescente , Hiperplasia Suprarrenal Congênita/tratamento farmacológico , Adulto , Densidade Óssea , Feminino , Fraturas Ósseas/etiologia , Glucocorticoides/efeitos adversos , Humanos , Recém-Nascido , Vértebras Lombares/diagnóstico por imagem , Masculino
11.
PLoS One ; 14(8): e0216790, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31425504

RESUMO

L-5-methyltetrahydrofolate is the predominant folate form in human milk but is currently not approved as a folate source for infant and follow-on formula. We aimed to assess the suitability of L-5-methyltetrahydrofolate as a folate source for infants. Growth and tolerance in healthy term infants fed formulae containing equimolar doses of L-5-methyltetrahydrofolate (10.4 µg/ 100 ml, n = 120, intervention group) or folic acid (10.0 µg/ 100 ml, n = 120, control group) was assessed in a randomized, double-blind, parallel, controlled trial. A reference group of breastfed infants was followed. Both formulae were well accepted without differences in tolerance or occurrence of adverse events. The most common adverse events were common cold, poor weight gain or growth, rash, eczema, or dry skin and respiratory tract infection. Weight gain (the primary outcome) was equivalent in the two groups (95% CI -2.11; 1.68 g/d). In line with this, there was only a small difference in absolute body weight adjusted for birth weight and sex at visit 4 (95% CI -235; 135 g). Equivalence was also shown for gain in head circumference but not for recumbent length gain and increase in calorie intake. Given the nature of the test, this does not indicate an actual difference, and adjusted means at visit 4 were not significantly different for any of these parameters. Infants receiving formula containing L-5-methyltetrahydrofolate had lower mean plasma levels of unmetabolized folic acid (intervention: 0.73 nmol/L, control: 1.15 nmol/L, p<0.0001) and higher levels of red cell folate (intervention: 907.0 ±192.8 nmol/L, control: 839.4 ±142.4 nmol/L, p = 0.0095). We conclude that L-5-methyltetrahydrofolate is suitable for use in infant and follow-on formula, and there are no indications of untoward effects. Trial registration: This trial was registered at ClinicalTrials.gov (NCT02437721).


Assuntos
Ácido Fólico/administração & dosagem , Fórmulas Infantis/química , Tetra-Hidrofolatos/administração & dosagem , Aleitamento Materno , Método Duplo-Cego , Feminino , Ácido Fólico/sangue , Genótipo , Alemanha , Humanos , Lactente , Fenômenos Fisiológicos da Nutrição do Lactente , Recém-Nascido , Masculino , Metilenotetra-Hidrofolato Redutase (NADPH2)/genética , Metilenotetra-Hidrofolato Redutase (NADPH2)/metabolismo , Leite Humano/química , Polimorfismo de Nucleotídeo Único , Ganho de Peso
12.
Eur J Radiol ; 119: 108626, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31430661

RESUMO

PURPOSE: To investigate the image quality, diagnostic accuracy, and dose reduction potential of a split-bolus protocol(SBP) compared with a multiphasic protocol(MPP) in the detection of recurrent or progressive pancreatic ductal adenocarcinoma(PDAC) or cholangiocarcinoma(CC) using contrast- enhanced computed tomography(CECT). MATERIALS AND METHODS: This prospective study included 56 patients who underwent CECT, 28 with our institutional standard MPP(100 ml contrast bolus) and 28 with a novel SBP(110 ml). Radiation exposure was determined in terms of total dose- length product(DLP) and computed tomography dose index(CTDI). Image quality was measured objectively by analysis of attenuation in Hounsfield units(HU) in regions of interest(ROIs) and subjectively by two blinded readers using a Likert scale. Diagnostic accuracy and interreader variability were tested. RESULTS: The total DLP of the SBP group(498.1 ± 43.7 mGy*cm) was significantly lower than in the MPP group(1,092.5 ± 106.9 mGy*cm; p < 0.001). The SBP showed higher contrast enhancement of all critical anatomical structures including portal vein, liver, and pancreas compared with the MPP, except for the aorta(SBP: 326.9 ± 15.7 HU vs. MPP: 246.7 ± 12.2 HU; p < 0.001). Subjective analysis revealed poorer image quality ratings for important landmarks with the MPP (resection surface: p = 0.624, portal vein: p = 0.395, liver p = 0.361). The two blinded readers correlated significantly. Sensitivity, specificity, positive and negative predictive values (PPV/NPV), and overall interreader variabilities correlated significantly. Furthermore, significantly fewer slices per exam were required for the SBP(1,823 vs. 3,235; p < 0.001). CONCLUSION: The SBP provides the same image quality and diagnostic accuracy as an MPP while significantly lowering radiation exposure in CT follow-up of PDAC or CC.


Assuntos
Neoplasias dos Ductos Biliares/diagnóstico por imagem , Carcinoma Ductal Pancreático/diagnóstico por imagem , Colangiocarcinoma/diagnóstico por imagem , Meios de Contraste/administração & dosagem , Neoplasias Pancreáticas/diagnóstico por imagem , Idoso , Ductos Biliares/diagnóstico por imagem , Ductos Biliares/efeitos da radiação , Protocolos Clínicos , Feminino , Humanos , Iohexol/administração & dosagem , Iohexol/análogos & derivados , Iopamidol/administração & dosagem , Iopamidol/análogos & derivados , Fígado/diagnóstico por imagem , Fígado/efeitos da radiação , Masculino , Tomografia Computadorizada Multidetectores/métodos , Recidiva Local de Neoplasia/diagnóstico por imagem , Pâncreas/diagnóstico por imagem , Pâncreas/efeitos da radiação , Veia Porta/diagnóstico por imagem , Veia Porta/efeitos da radiação , Estudos Prospectivos , Doses de Radiação , Exposição à Radiação , Sensibilidade e Especificidade
13.
Psychosom Med ; 81(7): 629-640, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31232913

RESUMO

OBJECTIVE: The aim of the study was to evaluate psychiatric symptoms among 1022 persons with various disorders of sex development (DSDs). METHODS: The study was a European multicenter cross-sectional clinical evaluation in six countries. The mean (SD) age of participants was 32.1 (13.4) years. The cohort consisted of 325 individuals with Turner syndrome, 219 individuals with Klinefelter syndrome (KS), female individuals with various XY-DSD conditions (107 with and 67 without androgenization), 87 male individuals with XY-DSD conditions, and 221 female individuals with congenital adrenal hyperplasia. The Hospital Anxiety and Depression Scale, the Short Autism Spectrum Quotient, the Adult Attention-Deficit/Hyperactivity Disorder Self-Report Scale, and self-reported mental health history were used to assess psychiatric symptoms. RESULTS: Across the six DSD diagnostic groups, clinical cutoff symptom scores were reached in 19.5% of participants for anxiety, in 7.1% for depression, in 4.1% for attention-deficit/hyperactivity disorder, and in 9.1% for autism. The mean depression and anxiety scores were higher compared with population norms in men with KS and men with XY-DSD. Compared with participants with other DSD conditions, men with KS reported significantly more mental health symptoms. Self-esteem, satisfaction with care, body dissatisfaction, and experiences of shame were associated with psychiatric symptoms in many DSD conditions. CONCLUSIONS: A substantial minority of adults with DSD, with KS in particular, experience psychiatric morbidity. Across DSD conditions, adults may share feelings of shame. Developing a positive self-esteem and body image may be challenging. Multidisciplinary DSD care that involves specialized mental health support can be of important value. TRIAL REGISTRATION: German Clinical Trials Register DRKS00006072.


Assuntos
Ansiedade/epidemiologia , Transtorno do Deficit de Atenção com Hiperatividade/epidemiologia , Transtorno do Espectro Autista/epidemiologia , Depressão/epidemiologia , Transtornos do Desenvolvimento Sexual/epidemiologia , Autoimagem , Adolescente , Adulto , Comorbidade , Estudos Transversais , Europa (Continente)/epidemiologia , Feminino , Humanos , Síndrome de Klinefelter/epidemiologia , Masculino , Pessoa de Meia-Idade , Adulto Jovem
14.
Front Psychiatry ; 10: 264, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31065245

RESUMO

Background: Although there is evidence that individuals who suffer from severe mental disorders are at higher risk for aggressive behavior, only a minority eventually become violent. In 2017, Fazel et al. developed a risk calculator (Oxford Mental Illness and Violence tool, OxMIV) to identify the risk of violent crime in patients with mental disorders. For the first time, we tested the predictive validity of the OxMIV in the department of psychiatry at the prison hospital in Berlin, Germany, and presented findings from our internal validation. Materials and Methods: We designed a cohort study with 474 patients aged 16-65 years old who met the inclusion criteria of schizophrenia-spectrum or bipolar disorder and classified the patients into two groups: a violent group with 191 patients and a nonviolent group with 283 patients. Violence was defined as the aggressive behavior of a patient with the necessity of special observation. We obtained all the required information retrospectively through patient files, applied the OxMIV tool on each subject, and compared the results of both groups. Sensitivity, specificity, and positive/negative predictive values were determined. We used logistic regression including variable selection and internal validation to identify relevant predictors of aggressive behavior in our cohort. Results: The OxMIV score was significantly higher in the violent group [median 4.21%; Interquartile range (IQR) 8.51%] compared to the nonviolent group (median 1.77%; IQR 2.01%; p < 0.0001). For the risk of violent behavior, using the 5% cutoff for "increased risk," the sensitivity was 44%, and the specificity was 89%, with a positive predictive value of 72% and a negative predictive value of 70%. Applying logistic regression, four items were statistically significant in predicting violent behavior: previous violent crime (adjusted odds ratio 5.29 [95% CI 3.10-9.05], p < 0.0001), previous drug abuse (1.80 [1.08-3.02], p = 0.025), and previous alcohol abuse (1.89 [1.21-2.95], p = 0.005). The item recent antidepressant treatment (0.28 [0.17-0.47]. p < 0.0001) had a statistically significant risk reduction effect. Conclusions: In our opinion, the risk assessment tool OxMIV succeeded in predicting violent behavior in imprisoned psychiatric patients. As a result, it may be applicable for identification of patients with special needs in a prison environment and, thus, improving prison safety.

15.
J Sex Marital Ther ; 45(8): 688-705, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31034334

RESUMO

For various reasons, sexuality of individuals with differences/disorders of sex development (DSD) may be affected. The aim of the study was to describe sexual activity, satisfaction with sex life, satisfaction with genital function, and sexual problems in people with different DSD conditions. Data were collected from 1,040 participants in Europe. Many people with a variety of DSD conditions do not appear to be satisfied with their sex life, experience a variety of sexual problems, and are less sexually active than the general population; therefore sexuality should be explicitly addressed in the care of people with DSD.


Assuntos
Transtornos do Desenvolvimento Sexual/psicologia , Nível de Saúde , Satisfação Pessoal , Desenvolvimento Psicossexual , Qualidade de Vida/psicologia , Comportamento Sexual/psicologia , Adulto , Imagem Corporal/psicologia , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sexualidade/psicologia
16.
BMC Health Serv Res ; 18(1): 527, 2018 07 05.
Artigo em Inglês | MEDLINE | ID: mdl-29976186

RESUMO

BACKGROUND: To investigate the association between the structural quality of care and patient satisfaction with care in individuals with disorders/ differences of sex development (DSD). METHODS: A multicenter cross-sectional comparative study was conducted in 14 clinics in six European countries. We assessed the level of structural quality of care in each center using a self-constructed measure (Center Score) and the level of participant satisfaction with care using the customer satisfaction questionnaire (CSQ-4) and an adopted version of the Youth Health Care - Satisfaction, Utilization & Needs (YHC-SUN-SF). Data were obtained from individuals with Turner Syndrome (261), Klinefelter Syndrome (173), 46, XX congenital adrenal hyperplasia (190) and XY-DSD (257). RESULTS: We found large variations between the scores for structural quality of care both within a diagnostic group and within a country; the overall association between participant satisfaction with the center score was significant. CONCLUSIONS: Comparative effectiveness research across Europe can lead to more insight on beneficial structures and processes and the overall strategy to care for people with rare diseases in general and specific conditions such as disorders/ differences of sex development. Appreciation of higher levels of structural quality of the centers in this study supports the concept of comprehensive care. TRIAL REGISTRATION: German Clinical Trials Register: Registration identification number: DRKS00006072 , date of registration April 17th, 2014. DRKS00006072 (German Clinical Trials Register).


Assuntos
Transtornos do Desenvolvimento Sexual/terapia , Qualidade da Assistência à Saúde/normas , Saúde Sexual , Adolescente , Adulto , Estudos Transversais , Transtornos do Desenvolvimento Sexual/psicologia , Europa (Continente) , Feminino , Humanos , Masculino , Satisfação do Paciente , Qualidade de Vida , Doenças Raras/terapia , Adulto Jovem
17.
Eur Radiol ; 28(11): 4919-4921, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-29858635

RESUMO

The original version of this article, published on 19 March 2018, unfortunately contained a mistake. The following correction has therefore been made in the original: The names of the authors Philipp A. Kaufmann, Ronny Ralf Buechel and Bernhard A. Herzog were presented incorrectly.

18.
J Sex Med ; 15(5): 777-785, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29606626

RESUMO

BACKGROUND: Information on the psychosexual outcome of individuals with disorders of sex development (DSDs) and intersex conditions is of great importance for sex assignment at birth of newborns with DSD. AIM: To assess gender change and gender dysphoria in a large sample of individuals with different DSDs. METHODS: A cross-sectional study was conducted in 14 European centers with 1,040 participants (717 female-identifying and 311 male-identifying persons and 12 persons identifying with another gender) with different forms of DSD. The cohort (mean age = 32.36 years, SD = 13.57) was divided into 6 major subgroups: women with 45,X DSD and variants (Turner syndrome; n = 325), men with 47,XXY DSD and variants (Klinefelter syndrome; n = 219), women with XY DSD without androgen effects (n = 107) and with androgen effects (n = 63), men with XY DSD (n = 87), and women with 46,XX congenital adrenal hyperplasia (n = 221). Data on psychosexual outcome were gathered by medical interviews and questionnaires. OUTCOMES: Gender change and gender dysphoria. RESULTS: Although gender changes were reported by 5% of participants, only in 1% (3% if those with Klinefelter and Turner syndromes-conditions in which gender issues are not prominent-are excluded) did the gender change take place after puberty and was likely initiated by the patient. 39 participants (4%) reported gender variance: between male and female, a gender other than male or female, or gender queer, alternating gender roles, or a gender expression that differed from the reported gender. This group had lower self-esteem and more anxiety and depression than the other participants. CLINICAL IMPLICATIONS: Clinicians should be aware of and sensitive to the possibility that their patients with DSD not only might have transgender feelings and a desire to change gender, but also identify as different from male or female. The complexity of their feelings might require counseling for some patients. STRENGTHS AND LIMITATIONS: The study is unique in the large number of participants from many different clinics, with sizable numbers in most subgroups, and in the large number of aspects that were measured. However, the very broadness of the study made it impossible to focus in detail on gender issues. Also, there is a need for instruments specifically measuring gender dysphoria in individuals with DSD that take non-binary genders into account. CONCLUSION: To make appropriate gender care possible for people with DSD, the gender-normative and gender-variant development of children with DSD should be studied in longitudinal studies. Kreukels BPC, Köhler B, Nordenström A, et al. Gender Dysphoria and Gender Change in Disorders of Sex Development/Intersex Conditions: Results From the dsd-LIFE Study. J Sex Med 2018;15:777-785.


Assuntos
Transtornos do Desenvolvimento Sexual/epidemiologia , Transtornos do Desenvolvimento Sexual/psicologia , Disforia de Gênero/epidemiologia , Disforia de Gênero/psicologia , Adulto , Ansiedade/epidemiologia , Estudos de Coortes , Estudos Transversais , Depressão/epidemiologia , Feminino , Humanos , Síndrome de Klinefelter/epidemiologia , Masculino , Pessoa de Meia-Idade , Gravidez , Autoimagem , Caracteres Sexuais , Desenvolvimento Sexual/fisiologia , Síndrome de Turner/epidemiologia , Adulto Jovem
19.
Health Qual Life Outcomes ; 16(1): 54, 2018 Apr 03.
Artigo em Inglês | MEDLINE | ID: mdl-29615040

RESUMO

BACKGROUND: Previous studies in quality of life (QOL) in individuals with disorders/differences of sex development (DSD) have been restricted to subpopulations of the condition. We describe QOL in adult persons with DSD compared to country specific references and assess the impact of diagnosis. METHODS: The multicentre cross-sectional clinical evaluation (dsd-LIFE) took place in 14 specialized clinics in six European countries. Adolescents (≥16 years) and adults having a DSD condition were included from 02/2014 to 09/2015. The main outcome QOL was measured by the WHOQOL-BREF (domains of physical health, psychological, social relationships, and environment). QOL was compared to country specific reference populations by using unpaired t-tests. Linear regression models explained the additional variance of the diagnosis on QOL. RESULTS: Three hundred one individuals with Turner Syndrome, 219 with Klinefelter Syndrome (including XYY), 226 with 46,XX CAH and 294 with rare DSD conditions (gonadal dysgenesis, androgen insensitivity syndrome, severe hypospadias, and androgen synthesis errors or other diagnosis) took part. Compared to healthy European populations, QOL was similar in psychological, slightly worse in physical health, and slightly better in environment. In social relationships, QOL was significantly poorer compared to healthy and non-healthy reference populations. In linear regression models health status was the most important predictor of QOL; additional variance was explained by feelings about household's income in all domains, and the relationship status in social relationships. Diagnosis explained nearly no additional variance. CONCLUSIONS: Except for social relationships, most people with DSD adapt well to their life circumstances and report a good QOL. Not diagnosis, but the individual's health status is much more important than previously thought. Therefore care for people with DSD should focus more on chronic physical or mental health problems both related and unrelated to the diagnosis itself. TRIAL REGISTRATION: German Clinical Trials Register DRKS00006072 .


Assuntos
Transtornos do Desenvolvimento Sexual , Nível de Saúde , Qualidade de Vida , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Transtornos do Desenvolvimento Sexual/fisiopatologia , Transtornos do Desenvolvimento Sexual/psicologia , Europa (Continente) , Feminino , Indicadores Básicos de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida/psicologia , Estudos Retrospectivos , Adulto Jovem
20.
Endocr Connect ; 7(3): 466-478, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29490934

RESUMO

OBJECTIVE: The knowledge about health status in adults with disorder of sex development (DSD) is scarce. DESIGN AND METHODS: A cross-sectional observational study in 14 European tertiary centers recruited 1040 participants (717 females, 311 males, 12 others) with DSD. Mean age was 32.4 ± 13.6 year (range 16-75). The cohort was divided into: Turner (n = 301), Klinefelter (n = 224), XY-DSD (n = 222), XX-DSD (excluding congenital adrenal hyperplasia (CAH) and 46,XX males) (n = 21), 46,XX-CAH (n = 226) and 45,X/46,XY (n = 45). Perceived and objective health statuses were measured and compared to European control data. RESULTS: In DSD, fair to very good general health was reported by 91.4% and only 8.6% reported (very) bad general health (controls 94.0% and 6.0%, P < 0.0001). Longstanding health issues other than DSD and feeling limited in daily life were reported in 51.0% and 38.6%, respectively (controls 24.5% and 13.8%, P < 0.0001 both). Any disorder except DSD was present in 84.3% (controls 24.6%, P < 0.0001). Males reported worse health than females. In the subgroup analysis, Klinefelter and 46,XX-DSD patients reported bad general health in 15.7% and 16.7%, respectively (Turner 3.2% and CAH 7.4%). Comorbidities were prevalent in all DSD subgroups but Klinefelter and Turner were most affected. Early diagnosis of DSD and a healthy lifestyle were associated with less comorbidities. CONCLUSIONS: Overall, general health appeared to be good but a number of medical problems were reported, especially in Klinefelter and Turner. Early diagnosis of DSD and a healthy lifestyle seemed to be important. Lifelong follow-up at specialized centers is necessary.

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