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1.
BJOG ; 131(3): 256-266, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-37691262

RESUMEN

OBJECTIVE: To compare two quality improvement (QI) interventions to improve antenatal magnesium sulphate (MgSO4 ) uptake in preterm births for the prevention of cerebral palsy. DESIGN: Unblinded cluster randomised controlled trial. SETTING: Academic Health Sciences Network, England, 2018. SAMPLE: Maternity units with ≥10 preterm deliveries annually and MgSO4 uptake of ≤70%; 40 (27 NPP, 13 enhanced support) were included (randomisation stratified by MgSO4 uptake). METHODS: The National PReCePT Programme (NPP) gave maternity units QI materials (clinical guidance, training), regional support, and midwife backfill funding. Enhanced support units received this plus extra backfill funding and unit-level QI coaching. MAIN OUTCOME MEASURES: MgSO4 uptake was compared using routine data and multivariable linear regression. Net monetary benefit was estimated, based on implementation costs, lifetime quality-adjusted life-years and societal costs. The implementation process was assessed through qualitative interviews. RESULTS: MgSO4 uptake increased in all units, with no evidence of any difference between groups (0.84 percentage points lower uptake in the enhanced group, 95% CI -5.03 to 3.35). The probability of enhanced support being cost-effective was <30%. NPP midwives gave more than their funded hours for implementation. Units varied in their support needs. Enhanced support units reported better understanding, engagement and perinatal teamwork. CONCLUSIONS: PReCePT improved MgSO4 uptake in all maternity units. Enhanced support did not further improve uptake but may improve teamwork, and more accurately represented the time needed for implementation. Targeted enhanced support, sustainability of improvements and the possible indirect benefits of stronger teamwork associated with enhanced support should be explored further.


Asunto(s)
Parálisis Cerebral , Nacimiento Prematuro , Recién Nacido , Femenino , Embarazo , Humanos , Nacimiento Prematuro/prevención & control , Nacimiento Prematuro/tratamiento farmacológico , Sulfato de Magnesio/uso terapéutico , Parálisis Cerebral/prevención & control , Mejoramiento de la Calidad , Parto
2.
Acta Obstet Gynecol Scand ; 98(10): 1292-1300, 2019 10.
Artículo en Inglés | MEDLINE | ID: mdl-31032879

RESUMEN

INTRODUCTION: The ProTWIN trial previously showed no beneficial effect of treatment with a cervical pessary vs usual care to prevent preterm birth in women with a multiple pregnancy. However, in women with a midtrimester short cervix (<38 mm), pessary did reduce the composite outcome of neonatal morbidity and mortality. This follow-up study evaluates the long-term outcomes of all children born to mothers who participated in the ProTWIN trial at 4 years of age. MATERIAL AND METHODS: Parents received the Ages and Stages Questionnaire, Strength and Difficulties Questionnaire and a health questionnaire. All questionnaires were reported separately and as a combined outcome (abnormal child outcome). A linear mixed effects model was used to adjust for correlated data in twins and correction for confounders was performed. In exploratory analysis, a composite outcome of death or survival with abnormal child outcome was used by combining extrapolated data on child outcome with survival data. All data were analyzed for the total group and the subgroup of women with midtrimester short cervix. RESULTS: Of the original 813 women of the ProTWIN trial, we approached 579, of whom 258 participated (45%) in follow-up. We received questionnaires of 514 children (281 pessary vs 233 control), with 119 children in the subgroup of women with midtrimester short cervix. An abnormal child outcome was found in 23% in the pessary group vs 16% in the control group (odds ratio 1.58; 95% confidence interval 0.94-2.65). In exploratory analysis with extrapolated data on child outcome (n = 815), no difference in abnormal child outcome was seen between the pessary and control group. In the subgroup of women with a short cervix (n = 268), this composite outcome indicated a favorable outcome for children born to mothers with pessary. CONCLUSIONS: In women with a multiple pregnancy, the use of a cervical pessary did not improve development, behavior or physical outcomes of the surviving children at age 4.


Asunto(s)
Cuello del Útero , Pesarios , Embarazo Múltiple , Nacimiento Prematuro/prevención & control , Adulto , Medición de Longitud Cervical , Preescolar , Femenino , Estudios de Seguimiento , Humanos , Lactante , Recién Nacido , Embarazo , Resultado del Embarazo , Encuestas y Cuestionarios
3.
Lancet ; 387(10033): 2117-2124, 2016 May 21.
Artículo en Inglés | MEDLINE | ID: mdl-26944026

RESUMEN

BACKGROUND: In women with threatened preterm birth, delay of delivery by 48 h allows antenatal corticosteroids to improve neonatal outcomes. For this reason, tocolytics are often administered for 48 h; however, there is no consensus about which drug results in the best maternal and neonatal outcomes. In the APOSTEL III trial we aimed to compare the effectiveness and safety of the calcium-channel blocker nifedipine and the oxytocin inhibitor atosiban in women with threatened preterm birth. METHODS: We did this multicentre, randomised controlled trial in ten tertiary and nine teaching hospitals in the Netherlands and Belgium. Women with threatened preterm birth (gestational age 25-34 weeks) were randomly assigned (1:1) to either oral nifedipine or intravenous atosiban for 48 h. An independent data manager used a web-based computerised programme to randomly assign women in permuted block sizes of four, with groups stratified by centre. Clinicians, outcome assessors, and women were not masked to treatment group. The primary outcome was a composite of adverse perinatal outcomes, which included perinatal mortality, bronchopulmonary dysplasia, sepsis, intraventricular haemorrhage, periventricular leukomalacia, and necrotising enterocolitis. Analysis was done in all women and babies with follow-up data. The study is registered at the Dutch Clinical Trial Registry, number NTR2947. FINDINGS: Between July 6, 2011, and July 7, 2014, we randomly assigned 254 women to nifedipine and 256 to atosiban. Primary outcome data were available for 248 women and 297 babies in the nifedipine group and 255 women and 294 babies in the atosiban group. The primary outcome occurred in 42 babies (14%) in the nifedipine group and in 45 (15%) in the atosiban group (relative risk [RR] 0·91, 95% CI 0·61-1·37). 16 (5%) babies died in the nifedipine group and seven (2%) died in the atosiban group (RR 2·20, 95% CI 0·91-5·33); all deaths were deemed unlikely to be related to the study drug. Maternal adverse events did not differ between groups. INTERPRETATION: In women with threatened preterm birth, 48 h of tocolysis with nifedipine or atosiban results in similar perinatal outcomes. Future clinical research should focus on large placebo-controlled trials, powered for perinatal outcomes. FUNDING: ZonMw (the Netherlands Organisation for Health Research and Development).


Asunto(s)
Bloqueadores de los Canales de Calcio/administración & dosificación , Nifedipino/administración & dosificación , Nacimiento Prematuro/prevención & control , Tocolíticos/administración & dosificación , Vasotocina/análogos & derivados , Administración Intravenosa , Administración Oftálmica , Adulto , Bélgica , Femenino , Humanos , Recién Nacido , Países Bajos , Mortalidad Perinatal , Embarazo , Resultado del Embarazo , Resultado del Tratamiento , Vasotocina/administración & dosificación
4.
J Antimicrob Chemother ; 72(11): 3213-3221, 2017 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-28981722

RESUMEN

OBJECTIVES: An antibiotic checklist was introduced in nine Dutch hospitals to improve appropriate antibiotic use. We estimated the cost-effectiveness of checklist use. METHODS: We compared 853 patients treated with an antibiotic before checklist introduction (usual care group) with 1207 patients treated after introduction (checklist group). We calculated the change of costs between these groups per unit effect [incremental cost-effectiveness ratio (ICER)]: per extra patient receiving appropriate treatment; and per day reduction in length of hospital stay (LOS). We also calculated the benefit-to-cost ratio per day reduction in LOS. Finally, we estimated the number of checklists after which the expected benefits would compensate for costs in one hospital. RESULTS: The cost of checklist use per patient was €10.10. Of the usual care patients, 48.8% received appropriate antibiotic treatment compared with 67.5% of the checklist patients (+18.7%). The ICER was €54.01 (1010/18.7) per extra patient with appropriate treatment. In a model calculation the expected effect of appropriate antibiotic use was a reduction in LOS of 1.05 days, which was extrapolated to a reduction of 19.64 hospital days per 100 patients. The ICER was €51.43 (1010/19.64) per day reduction in LOS. The estimated benefit of a 1 day reduction was €611. The benefit-to-cost ratio was 11.9 (611/51.43) per day reduction in LOS, indicating a cost saving of €12 for every euro spent on checklist use. The benefits would compensate for costs after use of 11 checklists. CONCLUSIONS: Efforts for further implementation of the antibiotic checklist can be justified by potential economic benefits.


Asunto(s)
Antibacterianos/economía , Programas de Optimización del Uso de los Antimicrobianos , Lista de Verificación/economía , Antibacterianos/uso terapéutico , Programas de Optimización del Uso de los Antimicrobianos/economía , Programas de Optimización del Uso de los Antimicrobianos/métodos , Análisis Costo-Beneficio , Femenino , Hospitales/estadística & datos numéricos , Humanos , Tiempo de Internación/economía , Masculino , Persona de Mediana Edad
5.
Gynecol Oncol ; 146(3): 449-456, 2017 09.
Artículo en Inglés | MEDLINE | ID: mdl-28645428

RESUMEN

OBJECTIVE: To evaluate the cost-effectiveness of a diagnostic laparoscopy prior to primary cytoreductive surgery to prevent futile primary cytoreductive surgery (i.e. leaving >1cm residual disease) in patients suspected of advanced stage ovarian cancer. METHODS: An economic analysis was conducted alongside a randomized controlled trial in which patients suspected of advanced stage ovarian cancer who qualified for primary cytoreductive surgery were randomized to either laparoscopy or primary cytoreductive surgery. Direct medical costs from a health care perspective over a 6-month time horizon were analyzed. Health outcomes were expressed in quality-adjusted life-years (QALYs) and utility was based on patient's response to the EQ-5D questionnaires. We primarily focused on direct medical costs based on Dutch standard prices. RESULTS: We studied 201 patients, of whom 102 were randomized to laparoscopy and 99 to primary cytoreductive surgery. No significant difference in QALYs (utility=0.01; 95% CI 0.006 to 0.02) was observed. Laparoscopy reduced the number of futile laparotomies from 39% to 10%, while its costs were € 1400 per intervention, making the overall costs of both strategies comparable (difference € -80 per patient (95% CI -470 to 300)). Findings were consistent across various sensitivity analyses. CONCLUSION: In patients with suspected advanced stage ovarian cancer, a diagnostic laparoscopy reduced the number of futile laparotomies, without increasing total direct medical health care costs, or adversely affecting complications or quality of life.


Asunto(s)
Procedimientos Quirúrgicos de Citorreducción/economía , Costos de la Atención en Salud , Laparoscopía/economía , Neoplasias Ováricas/diagnóstico , Neoplasias Ováricas/cirugía , Quimioterapia Adyuvante/economía , Análisis Costo-Beneficio , Técnicas de Diagnóstico Quirúrgico/economía , Femenino , Humanos , Inutilidad Médica , Persona de Mediana Edad , Terapia Neoadyuvante/economía , Estadificación de Neoplasias , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/patología , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida
6.
BMC Infect Dis ; 17(1): 53, 2017 01 10.
Artículo en Inglés | MEDLINE | ID: mdl-28068924

RESUMEN

BACKGROUND: Urinary and (peripheral and central) intravenous catheters are widely used in hospitalized patients. However, up to 56% of the catheters do not have an appropriate indication and some serious complications with the use of these catheters can occur. The main objective of our quality improvement project is to reduce the use of catheters without an appropriate indication by 25-50%, and to evaluate the affecting factors of our de-implementation strategy. METHODS: In a multicenter, prospective interrupted time series analysis, several interventions to avoid inappropriate use of catheters will be conducted in seven hospitals in the Netherlands. Firstly, we will define a list of appropriate indications for urinary and (peripheral and central) intravenous catheters, which will restrict the use of catheters and urge catheter removal when the indication is no longer appropriate. Secondly, after the baseline measurements, the intervention will take place, which consists of a kick-off meeting, including a competitive feedback report of the baseline measurements, and education of healthcare workers and patients. Additional strategies based on the baseline data and local conditions are optional. The primary endpoint is the percentage of catheters with an inappropriate indication on the day of data collection before and after the de-implementation strategy. Secondary endpoints are catheter-related infections or other complications, catheter re-insertion rate, length of hospital (and ICU) stay and mortality. In addition, the cost-effectiveness of the de-implementation strategy will be calculated. DISCUSSION: This study aims to reduce the use of urinary and intravenous catheters with an inappropriate indication, and as a result reduce the catheter-related complications. If (cost-) effective it provides a tool for a nationwide approach to reduce catheter-related infections and other complications. TRIAL REGISTRATION: Dutch trial registry: NTR6015 . Registered 9 August 2016.


Asunto(s)
Bacteriemia/prevención & control , Infecciones Relacionadas con Catéteres/prevención & control , Cateterismo Venoso Central/estadística & datos numéricos , Cateterismo Periférico/estadística & datos numéricos , Catéteres de Permanencia/estadística & datos numéricos , Cateterismo Urinario/estadística & datos numéricos , Catéteres Urinarios/virología , Infecciones Urinarias/prevención & control , Bacteriemia/economía , Bacteriemia/etiología , Infecciones Relacionadas con Catéteres/economía , Infecciones Relacionadas con Catéteres/etiología , Cateterismo Venoso Central/efectos adversos , Cateterismo Periférico/efectos adversos , Catéteres de Permanencia/efectos adversos , Análisis Costo-Beneficio , Femenino , Humanos , Análisis de Series de Tiempo Interrumpido , Masculino , Países Bajos , Estudios Prospectivos , Mejoramiento de la Calidad , Procedimientos Innecesarios , Cateterismo Urinario/efectos adversos , Catéteres Urinarios/efectos adversos , Infecciones Urinarias/economía , Infecciones Urinarias/etiología
7.
Int Urogynecol J ; 28(11): 1725-1731, 2017 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-28432409

RESUMEN

INTRODUCTION AND HYPOTHESIS: Urinary incontinence is a common condition in women, with a reported prevalence ranging from 25% to 51%. Of these women, an estimated 38% suffer from stress urinary incontinence (SUI). A European research consortium is investigating an innovative system based on information and communication technology for the conservative treatment of women with SUI. When introducing a new intervention, implementation barriers arise and need to be identified. Therefore, we investigated healthcare providers' experience with and attitude towards innovative care options. METHODS: We performed an online survey to assess (1) the characteristics and practice of healthcare providers, (2) current protocols for SUI, (3) current use of biofeedback, and (4) knowledge about serious gaming. The survey was sent to members of professional societies in Europe (EUGA), UK (BSUG) and The Netherlands (DPFS). RESULTS: Of 341 questionnaires analyzed (response rate between 18% and 30%), 64% of the respondents had access to a protocol for the treatment of SUI, and 31% used biofeedback when treating patients with SUI. However, 92% considered that biofeedback has a clear or probable added value, and 97% of those who did not use biofeedback would change their practice if research evidence supported its use. Finally, 89% of respondents indicated that they had no experience of serious gaming, but 92% considered that it could be useful. CONCLUSIONS: Although inexperienced, European urogynecologists and physical therapists welcome innovative treatment options for the conservative treatment of SUI such as portable wireless biofeedback and serious gaming. Scientific evidence is considered a prerequisite to incorporate such innovations into clinical practice.


Asunto(s)
Actitud del Personal de Salud , Biorretroalimentación Psicológica , Modalidades de Fisioterapia , Incontinencia Urinaria de Esfuerzo/terapia , Adulto , Femenino , Humanos , Encuestas y Cuestionarios , Juegos de Video
8.
BMC Pregnancy Childbirth ; 16(1): 154, 2016 07 12.
Artículo en Inglés | MEDLINE | ID: mdl-27405353

RESUMEN

BACKGROUND: Preterm birth is a major cause of neonatal mortality and morbidity. As preventive strategies are largely ineffective, threatened preterm labor is a frequent problem that affects approximately 10 % of pregnancies. In recent years, risk assessment in these women has incorporated cervical length measurement and fetal fibronectin testing, and this has improved the capacity to identify women at increased risk for delivery within 14 days. Despite these improvements, risk for preterm birth continues to be increased in women who did not deliver after an episode of threatened preterm labor, as indicated by a preterm birth rate between 30 to 60 % in this group of women. Currently no effective treatment is available. Studies on maintenance tocolysis and progesterone have shown ambiguous results. The pessary has not been evaluated in women with threatened preterm labor, however studies in asymptomatic women with a short cervix show reduced rates of preterm birth rates as well as perinatal complications. The APOSTEL VI trial aims to assess the effectiveness of a cervical pessary in women who did not deliver within 48 h after an episode of threatened preterm labor. METHODS/DESIGN: This is a nationwide multicenter open-label randomized clinical trial. Women with a singleton or twin gestation with intact membranes, who were admitted for threatened preterm labor, at a gestational age between 24 and 34 weeks, a cervical length between 15 and 30 mm and a positive fibronectin test or a cervical length below 15 mm, who did not deliver after 48 h will be eligible for inclusion. Women will be allocated to a pessary or no intervention (usual care). Primary outcome is preterm delivery < 37 weeks. Secondary outcomes are amongst others a composite of perinatal morbidity and mortality. Sample size is based on an expected 50 % reduction of preterm birth before 37 weeks (two-sided test, α 0.05 and ß 0.2). Two hundred women with a singleton pregnancy need to be randomized. Analysis will be done by intention to treat. DISCUSSION: The APOSTEL VI trial will provide evidence whether a pessary is effective in preventing preterm birth in women who did not deliver 48 h after admission for threatened preterm labor and who remain at high risk for preterm birth. TRIAL REGISTRATION: Trial is registered at the Dutch Trial Register: http://www.trialregister.nl , NTR4210, date of registration: October 16th 2013.


Asunto(s)
Cuello del Útero/anatomía & histología , Trabajo de Parto Prematuro , Pesarios , Nacimiento Prematuro/prevención & control , Medición de Longitud Cervical , Cuello del Útero/diagnóstico por imagen , Femenino , Fibronectinas/sangre , Humanos , Tamaño de los Órganos , Embarazo , Proyectos de Investigación , Factores de Tiempo
9.
BMC Infect Dis ; 15: 134, 2015 Mar 19.
Artículo en Inglés | MEDLINE | ID: mdl-25888180

RESUMEN

BACKGROUND: Recently we developed and validated generic quality indicators that define 'appropriate antibiotic use' in hospitalized adults treated for a (suspected) bacterial infection. Previous studies have shown that with appropriate antibiotic use a reduction of 13% of length of hospital stay can be achieved. Our main objective in this project is to provide hospitals with an antibiotic checklist based on these quality indicators, and to evaluate the introduction of this checklist in terms of (cost-) effectiveness. METHODS/DESIGN: The checklist applies to hospitalized adults with a suspected bacterial infection for whom antibiotic therapy is initiated, at first via the intravenous route. A stepped wedge study design will be used, comparing outcomes before and after introduction of the checklist in nine hospitals in the Netherlands. At least 810 patients will be included in both the control and the intervention group. The primary endpoint is length of hospital stay. Secondary endpoints are appropriate antibiotic use measured by the quality indicators, admission to and duration of intensive care unit stay, readmission within 30 days, mortality, total antibiotic use, and costs associated with implementation and hospital stay. Differences in numerical endpoints between the two periods will be evaluated with mixed linear models; for dichotomous outcomes generalized estimating equation models will be used. A process evaluation will be performed to evaluate the professionals' compliance with use of the checklist. The key question for the economic evaluation is whether the benefits of the checklist, which include reduced antibiotic use, reduced length of stay and associated costs, justify the costs associated with implementation activities as well as daily use of the checklist. DISCUSSION: If (cost-) effective, the AB-checklist will provide physicians with a tool to support appropriate antibiotic use in adult hospitalized patients who start with intravenous antibiotics. TRIAL REGISTRATION: Dutch trial registry: NTR4872.


Asunto(s)
Antibacterianos/uso terapéutico , Infecciones Bacterianas/tratamiento farmacológico , Lista de Verificación , Indicadores de Calidad de la Atención de Salud , Adulto , Antibacterianos/economía , Infecciones Bacterianas/economía , Infecciones Bacterianas/epidemiología , Lista de Verificación/economía , Lista de Verificación/métodos , Lista de Verificación/normas , Análisis Costo-Beneficio , Femenino , Implementación de Plan de Salud , Humanos , Unidades de Cuidados Intensivos/economía , Unidades de Cuidados Intensivos/estadística & datos numéricos , Tiempo de Internación/economía , Tiempo de Internación/estadística & datos numéricos , Países Bajos/epidemiología , Planificación de Atención al Paciente/economía , Planificación de Atención al Paciente/organización & administración , Planificación de Atención al Paciente/normas , Indicadores de Calidad de la Atención de Salud/normas , Sistema de Registros/estadística & datos numéricos , Proyectos de Investigación
10.
BMC Psychiatry ; 15: 113, 2015 May 12.
Artículo en Inglés | MEDLINE | ID: mdl-25963994

RESUMEN

BACKGROUND: Children and their parents are at risk of posttraumatic stress disorder (PTSD) following injury due to pediatric accidental trauma. Screening could help predict those at greatest risk and provide an opportunity for monitoring so that early intervention may be provided. The purpose of this study was to evaluate the Screening Tool for Early Predictors of Posttraumatic Stress Disorder (STEPP) in a mixed-trauma sample in a non-English speaking country (the Netherlands). METHODS: Children aged 8-18 and one of their parents were recruited in two academic level I trauma centers. The STEPP was assessed in 161 children (mean age 13.9 years) and 156 parents within one week of the accident. Three months later, clinical diagnoses and symptoms of PTSD were assessed in 147 children and 135 parents. We used the Anxiety Disorders Interview Schedule for DSM-IV - Child and Parent version, the Children's Revised Impact of Event Scale and the Impact of Event Scale-Revised. Receiver Operating Characteristic analyses were performed to estimate the Areas Under the Curve as a measure of performance and to determine the optimal cut-off score in our sample. Sensitivity, specificity, positive and negative predictive values were calculated. The aim was to maximize both sensitivity and negative predictive values. RESULTS: PTSD was diagnosed in 12% of the children; 10% of their parents scored above the cut-off point for PTSD. At the originally recommended cut-off scores (4 for children, 3 for parents), the sensitivity in our sample was 41% for children and 54% for parents. Negative predictive values were 92% for both groups. Adjusting the cut-off scores to 2 improved sensitivity to 82% for children and 92% for parents, with negative predictive values of 92% and 96%, respectively. CONCLUSIONS: With adjusted cut-off scores, the STEPP performed well: 82% of the children and 92% of the parents with a subsequent positive diagnosis were identified correctly. Special attention in the screening procedure is required because of a high rate of false positives. The STEPP appears to be a valid and useful instrument that can be used in the Netherlands as a first screening method in stepped psychotrauma care following accidents.


Asunto(s)
Accidentes/psicología , Adaptación Psicológica , Tamizaje Masivo/métodos , Padres/psicología , Trastornos por Estrés Postraumático , Adolescente , Adulto , Niño , Manual Diagnóstico y Estadístico de los Trastornos Mentales , Femenino , Humanos , Masculino , Países Bajos , Valor Predictivo de las Pruebas , Pronóstico , Técnicas Psicológicas , Curva ROC , Sensibilidad y Especificidad , Trastornos por Estrés Postraumático/diagnóstico , Trastornos por Estrés Postraumático/etiología , Trastornos por Estrés Postraumático/psicología
11.
Acta Obstet Gynecol Scand ; 94(5): 518-26, 2015 May.
Artículo en Inglés | MEDLINE | ID: mdl-25682778

RESUMEN

OBJECTIVE: To determine the effectiveness of a client or care-provider strategy to improve the implementation of external cephalic version. DESIGN: Cluster randomized controlled trial. SETTING: Twenty-five clusters; hospitals and their referring midwifery practices randomly selected in the Netherlands. POPULATION: Singleton breech presentation from 32 weeks of gestation onwards. METHODS: We randomized clusters to a client strategy (written information leaflets and decision aid), a care-provider strategy (1-day counseling course focused on knowledge and counseling skills), a combined client and care-provider strategy and care-as-usual strategy. We performed an intention-to-treat analysis. MAIN OUTCOME MEASURES: Rate of external cephalic version in various strategies. Secondary outcomes were the percentage of women counseled and opting for a version attempt. RESULTS: The overall implementation rate of external cephalic version was 72% (1169 of 1613 eligible clients) with a range between clusters of 8-95%. Neither the client strategy (OR 0.8, 95% CI 0.4-1.5) nor the care-provider strategy (OR 1.2, 95% CI 0.6-2.3) showed significant improvements. Results were comparable when we limited the analysis to those women who were actually offered intervention (OR 0.6, 95% CI 0.3-1.4 and OR 2.0, 95% CI 0.7-4.5). CONCLUSIONS: Neither a client nor a care-provider strategy improved the external cephalic version implementation rate for breech presentation, neither with regard to the number of version attempts offered nor the number of women accepting the procedure.


Asunto(s)
Presentación de Nalgas/terapia , Versión Fetal , Adolescente , Adulto , Análisis por Conglomerados , Técnicas de Apoyo para la Decisión , Consejo Dirigido , Femenino , Humanos , Persona de Mediana Edad , Países Bajos , Evaluación de Resultado en la Atención de Salud , Educación del Paciente como Asunto , Embarazo , Resultado del Tratamiento , Adulto Joven
12.
Acta Obstet Gynecol Scand ; 94(7): 715-721, 2015 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-25845495

RESUMEN

OBJECTIVE: To stratify the risk of spontaneous preterm delivery using cervical length (CL) and fetal fibronectin (fFN) in women with threatened preterm labor who remained pregnant after 7 days. DESIGN: Prospective observational study. SETTING: Nationwide cohort of women with threatened preterm labor from the Netherlands. POPULATION: Women with threatened preterm labor between 24 and 34 weeks with a valid CL and fFN measurement and remaining pregnant 7 days after admission. METHODS: Kaplan-Meier and Cox proportional hazards models were used to estimate cumulative percentages and hazard ratios (HR) for spontaneous delivery. MAIN OUTCOME MEASURES: Spontaneous delivery between 7 and 14 days after initial presentation and spontaneous preterm delivery before 34 weeks. RESULTS: The risk of delivery between 7 and 14 days was significantly increased for women with a CL < 15 mm or a CL ≥15 to <30 mm and a positive fFN, compared with women with a CL ≥30 mm: HR 22.3 [95% confidence interval (CI) 2.6-191] and 14 (95% CI 1.8-118), respectively. For spontaneous preterm delivery before 34 weeks the risk was increased for women with a CL < 15 mm [HR 6.3 (95% CI 2.6-15)] or with a CL ≥15 to <30 mm with either positive fFN [HR 3.6 (95% CI 1.5-8.7)] or negative fFN [HR 3.0 (95% CI 1.2-7.1)] compared with women with a CL ≥ 30 mm. CONCLUSIONS: In women remaining pregnant 7 days after threatened preterm labor, CL and fFN results can be used in risk stratification for spontaneous delivery.


Asunto(s)
Medición de Longitud Cervical , Fibronectinas/sangre , Trabajo de Parto Prematuro/epidemiología , Medición de Riesgo , Adulto , Femenino , Humanos , Países Bajos/epidemiología , Trabajo de Parto Prematuro/sangre , Embarazo , Nacimiento Prematuro/epidemiología , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Nacimiento a Término
13.
Eur Child Adolesc Psychiatry ; 24(2): 227-36, 2015 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-24965797

RESUMEN

To prevent adverse long-term effects, children who suffer from posttraumatic stress symptoms (PTSS) need treatment. Trauma-focused cognitive behavioral therapy (TF-CBT) is an established treatment for children with PTSS. However, alternatives are important for non-responders or if TF-CBT trained therapists are unavailable. Eye movement desensitization and reprocessing (EMDR) is a promising treatment for which sound comparative evidence is lacking. The current randomized controlled trial investigates the effectiveness and efficiency of both treatments. Forty-eight children (8-18 years) were randomly assigned to eight sessions of TF-CBT or EMDR. The primary outcome was PTSS as measured with the Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA). Secondary outcomes included parental report of child PTSD diagnosis status and questionnaires on comorbid problems. The Children's Revised Impact of Event Scale was administered during the course of treatment. TF-CBT and EMDR showed large reductions from pre- to post-treatment on the CAPS-CA (-20.2; 95% CI -12.2 to -28.1 and -20.9; 95% CI -32.7 to -9.1). The difference in reduction was small and not statistically significant (mean difference of 0.69, 95% CI -13.4 to 14.8). Treatment duration was not significantly shorter for EMDR (p = 0.09). Mixed model analysis of monitored PTSS during treatment showed a significant effect for time (p < 0.001) but not for treatment (p = 0.44) or the interaction of time by treatment (p = 0.74). Parents of children treated with TF-CBT reported a significant reduction of comorbid depressive and hyperactive symptoms. TF-CBT and EMDR are effective and efficient in reducing PTSS in children.


Asunto(s)
Terapia Cognitivo-Conductual/métodos , Desensibilización y Reprocesamiento del Movimiento Ocular/métodos , Trastornos por Estrés Postraumático/terapia , Adolescente , Terapia Conductista , Niño , Femenino , Humanos , Masculino , Trastornos por Estrés Postraumático/psicología , Resultado del Tratamiento
14.
Am J Perinatol ; 32(12): 1151-7, 2015 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-25915138

RESUMEN

OBJECTIVE: Cervical length (CL) is associated with the risk of preterm birth (PTB) in multiple pregnancies. However, the position of CL within the pathophysiological pathway of PTB is unclear, and it is unknown which factors are predictive for CL. This study aims to investigate whether in twin pregnancies baseline maternal and obstetrical characteristics are potential indicators for CL, to improve insight in the pathophysiological pathway of PTB. STUDY DESIGN: Secondary analysis of data on twin pregnancies and CL measurement between 16 and 22 weeks. A set of 10 potential indicators, known to be associated with an increased risk of PTB and/or which have a plausible mechanism resulting in a change of CL were selected. We used multivariable linear regression with backward selection to identify independent indicators for CL. RESULTS: A total of 1,447 women with twin pregnancies were included. Mean CL was 43.7 (±8.9) mm. In multivariable analysis, age (0.27 mm/y; 95% confidence interval [CI] 0.16 to 0.39), use of assisted reproductive technologies (ART) (-1.42 mm, 95% CI -2.6 to -0.25), and having delivered at term in a previous pregnancy (1.32 mm, 95% CI 0.25 to 2.39) were significantly associated with CL. CONCLUSION: This study shows that in twin pregnancies, age, use of ART and having delivered term in a previous pregnancy has an association with CL.


Asunto(s)
Medición de Longitud Cervical , Cuello del Útero/diagnóstico por imagen , Embarazo Gemelar/estadística & datos numéricos , Nacimiento Prematuro/epidemiología , Adulto , Femenino , Humanos , Recién Nacido , Modelos Lineales , Tamizaje Masivo , Análisis Multivariante , Países Bajos , Embarazo , Segundo Trimestre del Embarazo , Técnicas Reproductivas Asistidas
15.
Am J Perinatol ; 32(5): 451-60, 2015 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-25486290

RESUMEN

OBJECTIVE: To evaluate whether tocolysis with nifedipine can be omitted in women with symptoms of preterm labor, a shortened cervix, and negative fetal fibronectin test. STUDY DESIGN: A randomized noninferiority trial was performed in all Dutch perinatal centers. Women with symptoms of preterm labor between 24 and 34 weeks, intact membranes, cervical length between 10 and 30 mm, and negative fibronectin test were randomly allocated to nifedipine (80 mg/day) or placebo. The primary outcome was delivery within 7 days. Secondary outcomes were severe neonatal morbidity and mortality. We also followed all eligible nonrandomized women. RESULTS: We allocated 37 women to nifedipine and 36 women to placebo. In the nifedipine group, three women (8.1%) delivered within 7 days, compared with one woman (2.8%) in the placebo group (difference -5.3%; one-sided 95% confidence limit 4.5%). Median gestational age at delivery were respectively 37 + 0 (interquartile range [IQR] 34 + 6 to 38 + 5) and 38 + 2 (IQR 37 + 0 to 39 + 6) weeks (p = 0.008). In the nifedipine group, three pregnancies (8.1%) had a poor outcome; there were no poor outcomes in the placebo group. We observed similar trends in eligible nonrandomized women. CONCLUSION: In symptomatic women with preterm labor, a shortened cervix, and negative fibronectin test, placebo treatment is not inferior to tocolysis with nifedipine.


Asunto(s)
Medición de Longitud Cervical , Fibronectinas/análisis , Nifedipino/uso terapéutico , Trabajo de Parto Prematuro/tratamiento farmacológico , Complicaciones del Embarazo/tratamiento farmacológico , Tocolíticos/uso terapéutico , Adulto , Femenino , Edad Gestacional , Humanos , Países Bajos , Trabajo de Parto Prematuro/prevención & control , Embarazo , Complicaciones del Embarazo/prevención & control , Resultado del Tratamiento , Adulto Joven
16.
BMC Infect Dis ; 14: 235, 2014 May 05.
Artículo en Inglés | MEDLINE | ID: mdl-24885384

RESUMEN

BACKGROUND: Recommended therapy duration for patients hospitalized with cellulitis is 10-14 days. Unnecessary use of antibiotics is one of the key factors driving resistance. Recent studies have shown that antibiotic therapy for cellulitis in outpatients can safely be shortened, despite residual inflammation. This study will compare in hospitalized patients the safety and effectiveness of shortening antibiotic therapy for cellulitis from 12 to 6 days. METHODS/DESIGN: In a multicenter, randomized, double-blind, non-inferiority trial, adult patients admitted with cellulitis will be included. Cellulitis is defined as warmth, erythema, and induration of the skin and/or subcutaneous tissue, with or without pain (including erysipelas). All patients will initially be treated with intravenous flucloxacillin, and will be evaluated after 5-6 days. Those who have improved substantially (defined as being afebrile, and having a lower cellulitis severity score) will be randomized at day 6 between additional 6 days of oral flucloxacillin (n = 198) or placebo (n = 198). Treatment success is defined as resolution of cellulitis on day 14 (disappearance of warmth and tenderness, improvement of erythema and edema), without the need of additional antibiotics for cellulitis by day 28. Secondary endpoints are relapse rate (up to day 90), speed of recovery (using a cellulitis severity score until day 28, and VAS scores on pain and swelling until day 90), quality of life (using the SF-36 and EQ-5D questionnaires) and costs (associated with total antibiotic use and health-care resource utilization up to day 90). DISCUSSION: Inclusion is planned to start in Q2 2014. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02032654) and the Netherlands Trial Register (NTR4360).


Asunto(s)
Antibacterianos/administración & dosificación , Celulitis (Flemón)/tratamiento farmacológico , Protocolos Clínicos , Método Doble Ciego , Hospitalización , Humanos , Países Bajos , Calidad de Vida , Encuestas y Cuestionarios , Resultado del Tratamiento
17.
BMC Pregnancy Childbirth ; 14: 93, 2014 Mar 03.
Artículo en Inglés | MEDLINE | ID: mdl-24589124

RESUMEN

BACKGROUND: Preterm birth is the most common cause of neonatal morbidity and mortality. Postponing delivery for 48 hours with tocolytics to allow for maternal steroid administration and antenatal transportation to a centre with neonatal intensive care unit facilities is the standard treatment for women with threatening preterm delivery in most centres. However, there is controversy as to which tocolytic agent is the drug of first choice. Previous trials have focused on tocolytic efficacy and side effects, and are probably underpowered to detect clinically meaningfull differences in neonatal outcome. Thus, the current evidence is inconclusive to support a balanced recommendation for clinical practice. This multicenter randomised clinical trial aims to compare nifedipine and atosiban in terms of neonatal outcome, duration of pregnancy and maternal side effects. METHODS/DESIGN: The Apostel III trial is a nationwide multicenter randomised controlled study. Women with threatened preterm labour (gestational age 25 - 34 weeks) defined as at least 3 contractions per 30 minutes, and 1) a cervical length of ≤ 10 mm or 2) a cervical length of 11-30 mm and a positive Fibronectin test or 3) ruptured membranes will be randomly allocated to treatment with nifedipine or atosiban. Primary outcome is a composite measure of severe neonatal morbidity and mortality. Secondary outcomes will be time to delivery, gestational age at delivery, days on ventilation support, neonatal intensive care (NICU) admittance, length admission in neonatal intensive care, total days in hospital until 3 months corrected age, convulsions, apnoea, asphyxia, proven meningitis, pneumothorax, maternal side effects and costs. Furthermore, an economic evaluation of the treatment will be performed. Analysis will be by intention to treat principle. The power calculation is based on an expected 10% difference in the prevalence of adverse neonatal outcome. This implies that 500 women have to be randomised (two sided test, ß 0.2 at alpha 0.05). DISCUSSION: This trial will provide evidence on the optimal drug of choice in acute tocolysis in threatening preterm labour. CLINICAL TRIAL REGISTRATION: NTR2947, date of registration: June 20th 2011.


Asunto(s)
Nifedipino/administración & dosificación , Trabajo de Parto Prematuro/prevención & control , Evaluación de Resultado en la Atención de Salud , Tocólisis/métodos , Vasotocina/análogos & derivados , Administración Oral , Adolescente , Adulto , Relación Dosis-Respuesta a Droga , Femenino , Estudios de Seguimiento , Humanos , Mortalidad Infantil/tendencias , Recién Nacido , Inyecciones Intravenosas , Mortalidad Materna/tendencias , Países Bajos/epidemiología , Embarazo , Pronóstico , Tocolíticos/administración & dosificación , Vasotocina/administración & dosificación , Adulto Joven
18.
Acta Obstet Gynecol Scand ; 93(4): 374-81, 2014 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-24392746

RESUMEN

OBJECTIVE: To compare the costs of induction of labor and expectant management in women with preterm prelabor rupture of membranes (PPROM). DESIGN: Economic analysis based on a randomized clinical trial. SETTING: Obstetric departments of eight academic and 52 non-academic hospitals in the Netherlands. POPULATION: Women with PPROM near term who were not in labor 24 h after PPROM. METHODS: A cost-minimization analysis was done from a health care provider perspective, using a bottom-up approach to estimate resource utilization, valued with unit-costs reflecting actual costs. MAIN OUTCOME MEASURES: Primary health outcome was the incidence of neonatal sepsis. Direct medical costs were estimated from start of randomization to hospital discharge of mother and child. RESULTS: Induction of labor did not significantly reduce the probability of neonatal sepsis [2.6% vs. 4.1%, relative risk 0.64 (95% confidence interval 0.25-1.6)]. Mean costs per woman were €8094 for induction and €7340 for expectant management (difference €754; 95% confidence interval -335 to 1802). This difference predominantly originated in the postpartum period, where the mean costs were €5669 for induction vs. €4801 for expectant management. Delivery costs were higher in women allocated to induction than in women allocated to expectant management (€1777 vs. €1153 per woman). Antepartum costs in the expectant management group were higher because of longer antepartum maternal stays in hospital. CONCLUSIONS: In women with pregnancies complicated by PPROM near term, induction of labor does not reduce neonatal sepsis, whereas costs associated with this strategy are probably higher.


Asunto(s)
Rotura Prematura de Membranas Fetales/economía , Rotura Prematura de Membranas Fetales/terapia , Trabajo de Parto Inducido/economía , Espera Vigilante/economía , Adulto , Analgésicos/administración & dosificación , Analgésicos/economía , Control de Costos , Ahorro de Costo , Análisis Costo-Beneficio , Cuidados Críticos/economía , Parto Obstétrico/economía , Femenino , Humanos , Incidencia , Recién Nacido , Cuidado Intensivo Neonatal/economía , Trabajo de Parto Inducido/métodos , Tiempo de Internación/economía , Monitoreo Fisiológico/economía , Países Bajos/epidemiología , Embarazo , Tercer Trimestre del Embarazo , Sepsis/epidemiología
19.
Birth ; 41(4): 323-9, 2014 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-25288341

RESUMEN

BACKGROUND: External cephalic version (ECV) reduces the rate of elective cesarean sections as a result of breech presentation. Several studies have shown that not all eligible women undergo an ECV attempt. The aim of this study was to evaluate the implementation of ECV in the Netherlands and to explain variation in implementation rates with hospital characteristics and individual factors. METHODS: We invited 40 hospitals to participate in this retrospective cohort study. We reviewed hospital charts for all singleton breech deliveries from 36 weeks' gestation and onwards between January 2008 and December 2009. We documented whether an ECV attempt was performed, reasons for not performing an attempt, mode of delivery, and hospital characteristics. RESULTS: We included 4,770 women from 36 hospitals. ECV was performed in 2,443 women (62.2% of eligible women, range 8.2-83.6% in different hospitals). Implementation rates were higher in teaching hospitals, hospitals with special office hours for ECV, larger obstetric units, and hospitals located in larger cities. Suboptimal implementation was mainly caused by health care providers who did not offer ECV. CONCLUSION: ECV implementation rates vary widely among hospitals. Suboptimal implementation is mostly caused by the care provider not offering the treatment and secondly due to women not opting for the offered attempt. A prerequisite for designing a proper implementation strategy is a detailed understanding of the exact reasons for not offering and not opting for ECV.


Asunto(s)
Presentación de Nalgas/terapia , Cesárea/estadística & datos numéricos , Hospitales/estadística & datos numéricos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Versión Fetal/estadística & datos numéricos , Adulto , Estudios de Cohortes , Parto Obstétrico/estadística & datos numéricos , Procedimientos Quirúrgicos Electivos/estadística & datos numéricos , Femenino , Hospitales de Enseñanza/estadística & datos numéricos , Hospitales Urbanos/estadística & datos numéricos , Humanos , Países Bajos , Embarazo , Estudios Retrospectivos
20.
J Trauma Stress ; 27(3): 338-44, 2014 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-24797017

RESUMEN

Early identification of posttraumatic stress disorder (PTSD) in children is important to offer them appropriate and timely treatment. The Children's Revised Impact of Event Scale (CRIES) is a brief self-report measure designed to screen children for PTSD. Research regarding the diagnostic validity of the CRIES is still insufficient, has been restricted to specific populations, and sample sizes have often been small. This study evaluated the reliability and validity of the 8-item (CRIES-8) and 13-item (CRIES-13) versions of the CRIES in a large clinically referred sample. The measure was completed by 395 Dutch children (7-18 years) who had experienced a wide variety of traumatic events. PTSD was assessed using the Anxiety Disorders Interview Schedule for DSM-IV: Child and Parent version. A cutoff score of 17 on the CRIES-8 and 30 on the CRIES-13 emerged as the best balance between sensitivity and specificity, and correctly classified 78%-81% of all children. The CRIES-13 outperformed the CRIES-8, in that the overall efficiency of the CRIES-13 was slightly superior (.81 and .78, respectively). The CRIES appears to be a reliable and valid measure, which gives clinicians a brief and user-friendly instrument to identify children who may have PTSD and offer them appropriate and timely treatment.


Asunto(s)
Escalas de Valoración Psiquiátrica , Trastornos por Estrés Postraumático/diagnóstico , Adolescente , Área Bajo la Curva , Niño , Manual Diagnóstico y Estadístico de los Trastornos Mentales , Diagnóstico Precoz , Femenino , Humanos , Masculino , Países Bajos , Valor Predictivo de las Pruebas , Curva ROC , Reproducibilidad de los Resultados
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