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1.
Pacing Clin Electrophysiol ; 42(3): 381-387, 2019 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-30687931

RESUMEN

INTRODUCTION: The MARVEL study demonstrated at a single time point that accelerometer (ACC)-based atrial sensing improves atrioventricular (AV) synchrony (AVS) in patients with AV block and a Micra pacemaker (Medtronic, Minneapolis, MN, USA). The purpose of the MARVEL Evolve substudy was to assess the performance over time. METHODS: This prospective single-center study compared AVS and ACC signals at two visits ≥6 months apart. Custom software was temporarily downloaded into the Micra at each visit and AVS was measured during 30 min at rest. RESULTS: Nine patients from the MARVEL study were enrolled. The mean (±standard deviation) age was 82.3 ± 6.0 years old, 67% were male, and a Micra was implanted for 6.0 ± 6.4 months. High-degree AV block was present in four patients, whereas five with predominantly intrinsic conduction required intermittent pacing for bradycardia. The mean interval between visits was 7.1 ± 0.6 months. Seven patients had normal sinus node function at both visits and were included in a paired analysis. Both ACC signal amplitude (visit 2-visit 1 = 1.4 mG; 95% confidence interval [CI] [-25.8 to 28.4 mG]; P = 0.933) and AVS (visit 1: 90.8%, 95% CI [72.4, 97.4] and visit 2: 91.4%, 95% CI [63.8, 98.5]; P = 0.740) remained stable. Three patients had spontaneous atrial tachycardia. During atrial fibrillation, no atrial contraction was detected or tracked. During atrial flutter, intermittent tracking resulted in a ventricular rate of 60 ± 8 beats per minute (bpm); there was no ventricular pacing >100 bpm. CONCLUSION: ACC signals amplitude and performance of AVS pacing were stable over time. During atrial arrhythmias, the AV synchronous pacing mode behaved safely.


Asunto(s)
Bloqueo Atrioventricular/fisiopatología , Bloqueo Atrioventricular/terapia , Bradicardia/fisiopatología , Bradicardia/terapia , Estimulación Cardíaca Artificial/métodos , Marcapaso Artificial , Acelerometría , Anciano , Anciano de 80 o más Años , Ecocardiografía , Femenino , Humanos , Masculino , Estudios Prospectivos
2.
Stat Med ; 37(1): 12-27, 2018 Jan 15.
Artículo en Inglés | MEDLINE | ID: mdl-28948651

RESUMEN

At the design stage of a study, it is crucial to compute the sample size needed for treatment effect estimation with maximum precision and power. The optimal design depends on the costs, which may be known at the design stage, and on the outcome variances, which are unknown. A balanced design, optimal for homogeneous costs and variances, is typically used. An alternative to the balanced design is a design optimal for the known and possibly heterogeneous costs, and homogeneous variances, called costs considering design. Both designs suffer from loss of efficiency, compared with optimal designs for heterogeneous costs and variances. For 2 × 2 multicenter trials, we compute the relative efficiency of the balanced and the costs considering designs, relative to the optimal designs. We consider 2 heterogeneous costs and variance scenarios (in 1 scenario, 2 treatment conditions have small and 2 have large costs and variances; in the other scenario, 1 treatment condition has small, 2 have intermediate, and 1 has large costs and variances). Within these scenarios, we examine the relative efficiency of the balanced design and of the costs considering design as a function of the extents of heterogeneity of the costs and of the variances and of their congruence (congruent when the cheapest treatment has the smallest variance, incongruent when the cheapest treatment has the largest variance). We find that the costs considering design is generally more efficient than the balanced design, and we illustrate this theory on a 2 × 2 multicenter trial on lifestyle improvement of patients in general practices.


Asunto(s)
Ensayos Clínicos como Asunto/métodos , Bioestadística , Ensayos Clínicos como Asunto/economía , Ensayos Clínicos como Asunto/estadística & datos numéricos , Medicina General , Costos de la Atención en Salud , Promoción de la Salud , Humanos , Estilo de Vida , Modelos Lineales , Modelos Estadísticos , Estudios Multicéntricos como Asunto/estadística & datos numéricos , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Tamaño de la Muestra , Resultado del Tratamiento
3.
Stat Med ; 35(24): 4320-4334, 2016 10 30.
Artículo en Inglés | MEDLINE | ID: mdl-27271007

RESUMEN

Typically, clusters and individuals in cluster randomized trials are allocated across treatment conditions in a balanced fashion. This is optimal under homogeneous costs and outcome variances. However, both the costs and the variances may be heterogeneous. Then, an unbalanced allocation is more efficient but impractical as the outcome variance is unknown in the design stage of a study. A practical alternative to the balanced design could be a design optimal for known and possibly heterogeneous costs and homogeneous variances. However, when costs and variances are heterogeneous, both designs suffer from loss of efficiency, compared with the optimal design. Focusing on cluster randomized trials with a 2 × 2 design, the relative efficiency of the balanced design and of the design optimal for heterogeneous costs and homogeneous variances is evaluated, relative to the optimal design. We consider two heterogeneous scenarios (two treatment arms with small, and two with large, costs or variances, or one small, two intermediate, and one large costs or variances) at each design level (cluster, individual, and both). Within these scenarios, we compute the relative efficiency of the two designs as a function of the extents of heterogeneity of the costs and variances, and the congruence (the cheapest treatment has the smallest variance) and incongruence (the cheapest treatment has the largest variance) between costs and variances. We find that the design optimal for heterogeneous costs and homogeneous variances is generally more efficient than the balanced design and we illustrate this theory on a trial that examines methods to reduce radiological referrals from general practices. Copyright © 2016 John Wiley & Sons, Ltd.


Asunto(s)
Interpretación Estadística de Datos , Modelos Estadísticos , Ensayos Clínicos Controlados Aleatorios como Asunto , Análisis por Conglomerados , Humanos , Tamaño de la Muestra
4.
Infect Dis Ther ; 13(3): 463-480, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38319540

RESUMEN

INTRODUCTION: Respiratory syncytial virus (RSV) causes a substantial disease burden among infants. In older children and adults, incidence is underestimated due to nonspecific symptoms and limited standard-of-care testing. We aimed to estimate RSV-attributable hospitalizations and deaths in Spain during 2016-2019. METHODS: Nationally representative hospitalization and mortality databases were obtained from the Ministry of Health and the National Statistical Office. A quasi-Poisson regression model was fitted to estimate the number of hospitalizations and deaths attributable to RSV as a function of periodic and aperiodic time trends and viral activity, while allowing for potential overdispersion. RESULTS: In children, the RSV-attributable respiratory hospitalization incidence was highest among infants aged 0-5 months (3998-5453 cases/100,000 person-years, representing 72% of all respiratory hospitalizations) and decreased with age. In 2019, estimated rates in children 0-5, 6-11, 12-23 months and 6-17 years were approximately 1.3, 1.4, 1.5, and 6.5 times higher than those based on standard-of-care RSV-specific codes. In adults, the RSV-attributable cardiorespiratory hospitalization rate increased with age and was highest among persons ≥ 80 years (1325-1506 cases/100,000, 6.5% of all cardiorespiratory hospitalizations). In 2019, for persons aged 18-49, 50-59, 60-79, and ≥ 80 years, estimated rates were approximately 8, 6, 8, and 16 times higher than those based on standard-of-care RSV-specific codes. The RSV-attributable cardiorespiratory mortality rate was highest among ≥ 80 age group (126-150 deaths/100,000, 3.5-4.1% of all cardiorespiratory deaths), when reported mortality rate ranged between 0 and 0.5/100,000. CONCLUSIONS: When accounting for under-ascertainment, estimated RSV-attributable hospitalizations were higher than those reported based on standard-of-care RSV-specific codes in all age groups but particularly among older children and older adults. Like other respiratory viruses, RSV contributes to both respiratory and cardiovascular complications. Efficacious RSV vaccines could have a high public health impact in these age and risk groups.

5.
J Infect Dis ; 206(5): 678-86, 2012 Sep 01.
Artículo en Inglés | MEDLINE | ID: mdl-22711908

RESUMEN

BACKGROUND: We compared vaccine coverage achieved by 2 different delivery strategies for the quadrivalent human papillomavirus (HPV) vaccine in Tanzanian schoolgirls. METHODS: In a cluster-randomized trial of HPV vaccination conducted in Tanzania, 134 primary schools were randomly assigned to class-based (girls enrolled in primary school grade [class] 6) or age-based (girls born in 1998; 67 schools per arm) vaccine delivery. The primary outcome was coverage by dose. RESULTS: There were 3352 and 2180 eligible girls in schools randomized to class-based and age-based delivery, respectively. HPV vaccine coverage was 84.7% for dose 1, 81.4% for dose 2, and 76.1% for dose 3. For each dose, coverage was higher in class-based schools than in age-based schools (dose 1: 86.4% vs 82.0% [P = .30]; dose 2: 83.8% vs 77.8% [P = .05]; and dose 3: 78.7% vs 72.1% [P = .04]). Vaccine-related adverse events were rare. Reasons for not vaccinating included absenteeism (6.3%) and parent refusal (6.7%). School absenteeism rates prior to vaccination ranged from 8.1% to 23.5%. CONCLUSIONS: HPV vaccine can be delivered with high coverage in schools in sub-Saharan Africa. Compared with age-based vaccination, class-based vaccination located more eligible pupils and achieved higher coverage. HPV vaccination did not increase absenteeism rates in selected schools. Innovative strategies will be needed to reach out-of-school girls. CLINICAL TRIALS REGISTRATION: NCT01173900.


Asunto(s)
Papillomaviridae/inmunología , Infecciones por Papillomavirus/prevención & control , Vacunas contra Papillomavirus/administración & dosificación , Vacunación/métodos , Adolescente , Niño , Análisis por Conglomerados , Femenino , Humanos , Infecciones por Papillomavirus/virología , Vacunas contra Papillomavirus/inmunología , Población Rural , Tanzanía , Población Urbana
6.
Front Cardiovasc Med ; 9: 901267, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35647062

RESUMEN

The aim of the SYNSEQ (Left Ventricular Synchronous vs. Sequential MultiSpot Pacing for CRT) study was to evaluate the acute hemodynamic response (AHR) of simultaneous (3P-MPP syn) or sequential (3P-MPP seq) multi-3-point-left-ventricular (LV) pacing vs. single point pacing (SPP) in a group of patients at risk of a suboptimal response to cardiac resynchronization therapy (CRT). Twenty five patients with myocardial scar or QRS ≤ 150 or the absence of LBBB (age: 66 ± 12 years, QRS: 159 ± 12 ms, NYHA class II/III, LVEF ≤ 35%) underwent acute hemodynamic assessment by LV + dP/dtmax with a variety of LV pacing configurations at an optimized AV delay. The change in LV + dP/dt max (%ΔLV + dP/dt max) with 3P-MPP syn (15.6%, 95% CI: 8.8%-22.5%) was neither statistically significantly different to 3P-MPP seq (11.8%, 95% CI: 7.6-16.0%) nor to SPP basal (11.5%, 95% CI:7.1-15.9%) or SPP mid (12.2%, 95% CI:7.9-16.5%), but higher than SPP apical (10.6%, 95% CI:5.3-15.9%, p = 0.03). AHR (defined as a %ΔLV + dP/dt max ≥ 10%) varied between pacing configurations: 36% (9/25) for SPP apical, 44% (11/25) for SPP basal, 54% (13/24) for SPP mid, 56% (14/25) for 3P-MPP syn and 48% (11/23) for 3P-MPP seq.Fifteen patients (15/25, 60%) had an AHR in at least one pacing configuration. AHR was observed in 10/13 (77%) patients with a LBBB but only in 5/12 (42%) patients with a non-LBBB (p = 0.11). To conclude, simultaneous or sequential multipoint pacing compared to single point pacing did not improve the acute hemodynamic effect in a suboptimal CRT response population. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT02914457.

7.
JACC Asia ; 2(5): 559-571, 2022 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-36518723

RESUMEN

Background: Implantable cardioverter-defibrillator (ICD) implantation to prevent sudden cardiac death (SCD) in post-myocardial infarction (MI) patients varies by geography but remains low in many regions despite guideline recommendations. Objectives: This study aimed to characterize the care pathway of post-MI patients and understand barriers to referral for further SCD risk stratification and management in patients meeting referral criteria. Methods: This prospective, nonrandomized, multi-nation study included patients ≥18 years of age, with an acute MI ≤30 days and left ventricular ejection fraction <50% ≤14 days post-MI. The primary endpoint was defined as the physician's decision to refer a patient for SCD stratification and management. Results: In total, 1,491 post-MI patients were enrolled (60.2 ± 12.0 years of age, 82.4% male). During the study, 26.7% (n = 398) of patients met criteria for further SCD risk stratification; however, only 59.3% of those meeting criteria (n = 236; 95% CI: 54.4%-64.0%) were referred for a visit. Of patients referred for SCD risk stratification and management, 94.9% (n = 224) attended the visit of which 56.7% (n =127; 95% CI: 50.1%-63.0%) met ICD indication criteria. Of patients who met ICD indication criteria, 14.2% (n = 18) were implanted. Conclusions: We found that ∼40% of patients meeting criteria were not referred for further SCD risk stratification and management and ∼85% of patients who met ICD indications did not receive a guideline-directed ICD. Physician and patient reasons for refusing referral to SCD risk stratification and management or ICD implant varied by geography suggesting that improvement will require both physician- and patient-focused approaches. (Improve Sudden Cardiac Arrest [SCA] Bridge Study; NCT03715790).

8.
Br J Clin Pharmacol ; 71(6): 907-16, 2011 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-21223356

RESUMEN

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: • Several lines of evidence suggest a possible role of 5-HT(6) receptor antagonists in dementia or cognitive dysfunction of schizophrenia. SB-742457 is a potent 5-HT(6) antagonist and has shown efficacy in different animal models of cognitive impairment. It is currently in development as a cognitive enhancer. Risperidone, commonly used to control agitation and psychotic features in both schizophrenia and Alzheimer's disease, is a D(2)/5-HT(2A ) antagonist with low affinity for 5-HT(6) receptors and limited effects on cognitive parameters. WHAT THIS STUDY ADDS: • As the combination of risperidone and SB-742457 may constitute a reasonable combination in cognitively impaired patients, pharmacodynamic interaction effects were investigated in this study. The only significant drug-drug interaction was a small increase of electroencephalogram (EEG) alpha and beta bands, which might suggest mild arousing activity of SB-742457 on the central nervous system-depressant effects of risperidone. The clinical relevance of these findings in patients remains to be established. Additionally, this study provided an extensive multidimensional pharmacodynamic profile of risperidone in healthy volunteers, showing that this antipsychotic suppresses motor performance (eye-hand coordination, finger tapping and postural stability), alertness, memory and neurophysiological functions (saccadic eye movements and EEG power spectrum). AIM: Several lines of evidence suggest a possible role of 5-HT(6 ) receptor antagonists in cognitive dysfunction of schizophrenia. Atypical antipsychotics, such as risperidone, are currently used in these disorders. Therefore, the pharmacological interactions between the 5-HT(6) antagonist SB-742457 and risperidone were investigated in the light of possible co-medication. METHODS: A randomized, double-blind, two-way crossover design was used to study the interaction between multiple doses SB-742457 50 mg and a single dose risperidone 2 mg in 18 healthy subjects. RESULTS: Treatment was well tolerated. The most common adverse event was somnolence in 83% during the combination vs. 50% of subjects after risperidone, 32% after placebo and 11% after SB-742457. Combination treatment produced a statistically significant increase in the maximum plasma concentration of risperidone and had no effect on SB-742457 pharmacokinetics. Risperidone decreased saccadic peak velocity, finger tapping, adaptive tracking, subjective alertness, delayed word recognition and body sway and increased electroencephalogram (EEG) theta power and prolactin. The only pharmacodynamic interaction of risperidone and SB-742457 was an increase of absolute EEG alpha (ratio = 1.25, 95% CI = 1.11, 1.40, P= 0.0004) and beta power (ratio = 1.14, 95% CI = 1.03, 1.27, P= 0.016). No significant effects of SB-742457 alone were found. CONCLUSION: The pharmacokinetic interactions between SB-742457 and risperidone detected in this study were not clinically relevant. The increase in EEG alpha and beta power is incompatible with enhanced risperidone activity, but could point to mild arousing effects of the combination. Most pharmacodynamic changes of risperidone are consistent with previously reported data. The potential cognitive effects of SB-742457 remain to be established.


Asunto(s)
Antipsicóticos/farmacocinética , Sistema Nervioso Central/efectos de los fármacos , Antagonistas de Dopamina/farmacocinética , Receptores de Serotonina/efectos de los fármacos , Risperidona/farmacocinética , Adolescente , Adulto , Atención/efectos de los fármacos , Cognición/efectos de los fármacos , Estudios Cruzados , Interacciones Farmacológicas , Humanos , Masculino , Desempeño Psicomotor/efectos de los fármacos , Adulto Joven
9.
Br J Educ Psychol ; 76(Pt 3): 553-76, 2006 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-16953962

RESUMEN

BACKGROUND: Comparison of teachers' and pupils' definitions of bullying is important for considering the implications for reports of its incidence in schools, for the study of developmental trends in children's and adolescents' perceptions of the phenomenon and for evaluating the effectiveness of interventions designed to combat bullying. AIMS: To investigate the effects of gender, teacher/pupil status and, for pupils, bullied/non-bullied (target/non-target) status and age on the definition of bullying. SAMPLES: Teachers (N=225: 158 women, 67 men) and pupils (N=1,820: 466 boys, 460 girls were 11-12 years old, year 7, and 415 boys, 479 girls were 13-14 years, year 9) in 51 UK secondary schools participated in a questionnaire survey. A total of 557 of the pupils (117 girls and 117 boys aged 11-12 years, and 197 girls and 126 boys aged 13-14 years) reported that they had been bullied at some time in their present school. METHODS: Written questionnaire responses to the question, 'Say what you think bullying is' have been content analysed to derive two sets of categories, one of bullying behaviour and the other of effects of bullying on the target. RESULTS: Regarding both bullying behaviour and the effects of bullying on the target, teachers - by comparison with pupils - have been found to express more comprehensive ideas in their definitions. Specifically, pupils compared with teachers are more likely to restrict their definitions to direct bullying (verbal and/or physical abuse) and are less likely to refer to social exclusion, a power imbalance in the bully's favour and the bully's intention to cause the target hurt or harm and to feel threatened. Analysis of definitions on the bases of sex, pupil age and target/non-target status show that: targets are more likely than non-targets are to refer to the bully's physically and verbally abusive behaviour, and for Year 7 compared with Year 9 pupils, to suggest that bullies socially exclude targets; girls are more likely than boys are to mention verbal abuse and the effects on the target of 'Feels hurt/harm', but boys are more likely than girls are to construe bullying as involving repetition; older pupils are more likely than younger ones are to refer to a power imbalance in the bully's favour but, for bully targets, younger ones compared with older ones are more likely to invoke the idea of social exclusion in their definitions. CONCLUSIONS: The most important implication of the findings of this study that there are important differences between teachers' and pupils' definitions of bullying is that teachers need to listen carefully to what pupils have to say about bullying and work with and help them to develop their conceptions of the phenomenon. Some teachers, too, need to develop their conceptions of bullying.


Asunto(s)
Actitud , Docentes , Psicología/estadística & datos numéricos , Trastorno de la Conducta Social , Estudiantes , Encuestas y Cuestionarios , Terminología como Asunto , Violencia , Adolescente , Adulto , Niño , Femenino , Humanos , Masculino , Variaciones Dependientes del Observador
10.
Stat Methods Med Res ; 24(5): 494-512, 2015 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-24030312

RESUMEN

Cluster randomized and multicenter trials sometimes combine two treatments A and B in a factorial design, with conditions such as A, B, A and B, or none. This results in a two-way nested design. The usual issue of sample size and power now arises for various clinically relevant contrast hypotheses. Assuming a fixed total sample size at each level (number of clusters or centers, number of patients), we derive the optimal proportion of the total sample to be allocated to each treatment arm. We consider treatment assignment first at the highest level (cluster randomized trial) and then at the lowest level (multicenter trial). We derive the optimal allocation ratio for various sets of clinically relevant hypotheses. We then evaluate the efficiency of each allocation and show that the popular balanced design is optimal or highly efficient for a range of research questions except for contrasting one treatment arm with all other treatment arms. We finally present simple equations for the total sample size needed to test each effect of interest in a balanced design, as a function of effect size, power and type I error α. All results are illustrated on a cluster-randomized trial on smoking prevention in primary schools and on a multicenter trial on lifestyle improvement in general practices.


Asunto(s)
Distribución Aleatoria , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Interpretación Estadística de Datos , Humanos , Estudios Multicéntricos como Asunto/métodos , Tamaño de la Muestra
11.
Stat Methods Med Res ; 24(5): 574-93, 2015 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-25911332

RESUMEN

Sample size calculation for cluster randomized trials (CRTs) with a [Formula: see text] factorial design is complicated due to the combination of nesting (of individuals within clusters) with crossing (of two treatments). Typically, clusters and individuals are allocated across treatment conditions in a balanced fashion, which is optimal under homogeneity of variance. However, the variance is likely to be heterogeneous if there is a treatment effect. An unbalanced allocation is then more efficient, but impractical because the optimal allocation depends on the unknown variances. Focusing on CRTs with a [Formula: see text] design, this paper addresses two questions: How much efficiency is lost by having a balanced design when the outcome variance is heterogeneous? How large must the sample size be for a balanced allocation to have sufficient power under heterogeneity of variance? We consider different scenarios of heterogeneous variance. Within each scenario, we determine the relative efficiency of a balanced design, as a function of the level (cluster, individual, both) and amount of heterogeneity of the variance. We then provide a simple correction of the sample size for the loss of power due to heterogeneity of variance when a balanced allocation is used. The theory is illustrated with an example of a published 2 x2 CRT.


Asunto(s)
Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Análisis por Conglomerados , Interpretación Estadística de Datos , Análisis Factorial , Humanos , Modelos Estadísticos , Tamaño de la Muestra
12.
PLoS One ; 8(6): e66287, 2013.
Artículo en Inglés | MEDLINE | ID: mdl-23805209

RESUMEN

BACKGROUND: Young people are at high risk of HIV and developing appropriate prevention programmes requires an understanding of the risk factors for HIV in this age group. We investigated factors associated with HIV among participants aged 15-30 years in a 2007-8 cross-sectional survey nested within a community-randomised trial of the MEMA kwa Vijana intervention in 20 rural communities in northwest Tanzania. METHODS: We analysed data for 7259(53%) males and 6476(47%) females. Using a proximate-determinant conceptual framework and conditional logistic regression, we obtained sex-specific Odds Ratios (ORs) for the association of HIV infection with socio-demographic, knowledge, behavioural and biological factors. RESULTS: HSV-2 infection was strongly associated with HIV infection (females: adjOR 4.4, 95%CI 3.2-6.1; males: adjOR 4.2, 95%CI 2.8-6.2). Several socio-demographic factors (such as age, marital status and mobility), behavioural factors (condom use, number and type of sexual partnerships) and biological factors (blood transfusion, lifetime pregnancies, genital ulcers, Neisseria gonorrhoeae) were also associated with HIV infection. Among females, lifetime sexual partners (linear trend, p<0.001), ≥2 partners in the past year (adjOR 2.0, 95%CI 1.4-2.8), ≥2 new partners in the past year (adjOR 1.9 95%CI 1.2, 3.3) and concurrent partners in the past year (adjOR 1.6 95%CI 1.1, 2.4) were all associated with HIV infection. CONCLUSIONS: Efforts must be intensified to find effective interventions to reduce HSV-2. Effective behavioural interventions focusing on reducing the number of sexual partnerships and risk behaviour within partnerships are also needed. An increase in risky sexual behaviour may occur following marriage dissolution or when a young woman travels outside of her community and interventions addressing the needs of these subgroups of vulnerable women may be important. TRIAL REGISTRATION: ClinicalTrial.gov NCT00248469.


Asunto(s)
Infecciones por VIH/epidemiología , Conocimientos, Actitudes y Práctica en Salud , Conducta Sexual , Adolescente , Adulto , Transfusión Sanguínea , Estudios Transversales , Demografía , Femenino , Infecciones por VIH/complicaciones , Infecciones por VIH/diagnóstico , Herpes Genital/complicaciones , Herpes Genital/diagnóstico , Humanos , Modelos Logísticos , Masculino , Oportunidad Relativa , Factores de Riesgo , Factores Socioeconómicos , Tanzanía/epidemiología , Adulto Joven
13.
Epilepsia ; 49(3): 410-7, 2008 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-17825077

RESUMEN

PURPOSE: To compare the pharmacokinetics (PK) of lamotrigine (LTG) when converting from twice-daily immediate-release (LTG-IR) to once-daily extended-release (LTG-XR) in subjects with epilepsy. METHODS: An open-label, conversion study was conducted, consisting of a 2-week LTG-IR Baseline Phase, followed by a 2-week LTG-XR Treatment Phase and a 1-week LTG-IR Phase. Forty-four subjects (> or =13 years of age) were enrolled and grouped as metabolically neutral (15), induced (15), or inhibited (14) based on the effects of the concomitant antiepileptic drugs (AEDs) on the clearance of LTG. The primary outcome was LTG PK parameters upon conversion. Secondary outcomes included seizure frequency, adverse events, and subject's preference. RESULTS: LTG-XR and LTG-IR regimens were similar with respect to area under curve from 0 to 24 h (AUC (0-24)), apart from the induced group, where the AUC (0-24) of LTG-XR was on average 21% lower than for LTG-IR. A reduction in the LTG Cmax was observed for LTG-XR compared to LTG-IR resulting in a decrease in the peak-to-trough fluctuation in serum LTG concentrations. The steady-state, dose-normalized, trough concentrations for LTG-XR were similar to those of LTG-IR. The median time to peak concentration (Tmax) following administration of LTG-XR ranged from 4 to 6 h, 6 to 10 h, and 9 to 11 h in the induced, neutral, and inhibited groups, respectively. In comparison, the median Tmax following administration of LTG-IR was between 1 and 1.5 h. CONCLUSIONS: Trough concentrations of LTG can be maintained on conversion from twice-daily LTG-IR to once-daily LTG-XR at the same total daily dose.


Asunto(s)
Anticonvulsivantes/farmacocinética , Epilepsia/tratamiento farmacológico , Triazinas/farmacocinética , Administración Oral , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Anticonvulsivantes/efectos adversos , Anticonvulsivantes/sangre , Área Bajo la Curva , Disponibilidad Biológica , Preparaciones de Acción Retardada , Mareo/inducido químicamente , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Quimioterapia Combinada , Epilepsia/sangre , Epilepsia/psicología , Femenino , Cefalea/inducido químicamente , Humanos , Lamotrigina , Análisis de los Mínimos Cuadrados , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Factores de Tiempo , Resultado del Tratamiento , Triazinas/efectos adversos , Triazinas/sangre , Vómitos/inducido químicamente
14.
J Clin Nurs ; 16(7): 1313-22, 2007 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-17584350

RESUMEN

AIMS: To define the demographic and clinical profile of individuals referred to an emergency mental health assessment team. To identify factors associated with being admitted to inpatient psychiatric services or not admitted following an emergency assessment. BACKGROUND: Crisis resolution and home treatment services are being developed across the UK, targeted towards people with severe mental health problems, who would otherwise require hospitalization. Further information about people presenting to an emergency mental health assessment service may clarify the skills that are required to deliver effective crisis resolution and home treatment services. METHOD: Over a six-month period referrals to, and admission decisions by, an emergency mental health assessment team were recorded. Measures used were the Health of the Nation Outcome Scale and the Crisis Triage Rating Scale. Age, sex and postcode data were recorded. Postcode data were used to identify the Townsend Deprivation Index for each individual. Reasons given for the referral were categorized. A preliminary descriptive analysis was performed for all people referred. The Demographic and clinical characteristics of referrals admitted and not admitted were then compared. A multivariate logistic regression was performed in order to investigate the possible impact of demographic and clinical characteristics on admission status. RESULTS: A total of 375 individuals were referred. Forty-eight (12.8%) were admitted. Higher referral rates were significantly associated with more deprived areas of the city. Referrers most frequently identified suicide risk as the reason for referral, followed by deterioration of an existing serious mental health problem. The mean Health of the Nation Outcome Scale score of all people referred was 10.5. Those admitted had a significantly greater mean Health of the Nation Outcome Scale score than those not admitted. The mean Crisis Triage Rating Scale score of all people referred was 11.0. Those admitted had a significantly lower (worse) mean Crisis Triage Rating Scale score than those not admitted. Individuals with lower Crisis Triage Rating Scale scores tended to have a higher (more deprived) Townsend index scores. Crisis Triage Rating Scale and Health of the Nation Outcome Scale scores were significantly negatively correlated. Conclusions. Crisis resolution and home treatments need to target areas of greatest deprivation. Social interventions will be important. Presentations related to suicide risk are likely to be common. The Crisis Triage Rating Scale may be a useful brief alternative to Health of the Nation Outcome Scale. RELEVANCE TO CLINICAL PRACTICE: This study highlights the valuable role of mental health nurses in frontline emergency mental health care in particular mental health nurses skills in conducting a risk assessment in an emergency.


Asunto(s)
Atención Posterior/organización & administración , Intervención en la Crisis (Psiquiatría)/organización & administración , Servicios de Urgencia Psiquiátrica/organización & administración , Admisión del Paciente , Enfermería Psiquiátrica/organización & administración , Derivación y Consulta/organización & administración , Adolescente , Adulto , Anciano , Toma de Decisiones en la Organización , Inglaterra/epidemiología , Femenino , Necesidades y Demandas de Servicios de Salud , Humanos , Modelos Logísticos , Masculino , Trastornos Mentales/diagnóstico , Trastornos Mentales/epidemiología , Trastornos Mentales/terapia , Persona de Mediana Edad , Análisis Multivariante , Rol de la Enfermera , Investigación en Evaluación de Enfermería , Admisión del Paciente/estadística & datos numéricos , Selección de Paciente , Áreas de Pobreza , Triaje/organización & administración
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