Calculation of sample size for stroke trials assessing functional outcome: comparison of binary and ordinal approaches

Background Many acute stroke trials have given neutral results. Sub-optimal statistical analyses may be failing to detect efficacy. Methods which take account of the ordinal nature of functional outcome data are more efficient. We compare sample size calculations for dichotomous and ordinal outcomes for use in stroke trials. Methods Data from stroke trials studying the effects of interventions known to positively or negatively alter functional outcome – Rankin Scale and Barthel Index – were assessed. Sample size was calculated using comparisons of proportions, means, medians (according to Payne), and ordinal data (according to Whitehead). The sample sizes gained from each method were compared using Friedman 2 way ANOVA. Results Fifty-five comparisons (54 173 patients) of active vs. control treatment were assessed. Estimated sample sizes differed significantly depending on the method of calculation (Po00001). The ordering of the methods showed that the ordinal method of Whitehead and comparison of means produced significantly lower sample sizes than the other methods. The ordinal data method on average reduced sample size by 28% (inter-quartile range 14–53%) compared with the comparison of proportions; however, a 22% increase in sample size was seen with the ordinal method for trials assessing thrombolysis. The comparison of medians method of Payne gave the largest sample sizes. Conclusions Choosing an ordinal rather than binary method of analysis allows most trials to be, on average, smaller by approximately 28% for a given statistical power. Smaller trial sample sizes may help by reducing time to completion, complexity, and financial expense. However, ordinal methods may not be optimal for interventions which both improve functional outcome

Incidence of debris discs around FGK stars in the solar neighbourhood

Context. Debris discs are a consequence of the planet formation process and constitute the fingerprints of planetesimal systems. Their counterparts in the solar system are the asteroid and Edgeworth-Kuiper belts. Aims. The aim of this paper is to provide robust numbers for the incidence of debris discs around FGK stars in the solar neighbourhood. Methods. The full sample of 177 FGK stars with d ≤ 20 pc proposed for the DUst around NEarby Stars (DUNES) survey is presented. Herschel/PACS observations at 100 and 160 μm were obtained, and were complemented in some cases with data at 70 μm and at 250, 350, and 500 μm SPIRE photometry. The 123 objects observed by the DUNES collaboration were presented in a previous paper. The remaining 54 stars, shared with the Disc Emission via a Bias-free Reconnaissance in IR and Sub-mm (DEBRIS) consortium and observed by them, and the combined full sample are studied in this paper. The incidence of debris discs per spectral type is analysed and put into context together with other parameters of the sample, like metallicity, rotation and activity, and age. Results. The subsample of 105 stars with d ≤ 15 pc containing 23 F, 33 G, and 49 K stars is complete for F stars, almost complete for G stars, and contains a substantial number of K stars from which we draw solid conclusions on objects of this spectral type. The incidence rates of debris discs per spectral type are 0.26^+0.21_-0.14 (6 objects with excesses out of 23 F stars), 0.21^+0.17_-0.11 (7 out of 33 G stars), and 0.20^+0.14_-0.09 (10 out of 49 K stars); the fraction for all three spectral types together is 0.22^+0.08_-0.07 (23 out of 105 stars). The uncertainties correspond to a 95% confidence level. The medians of the upper limits of L_dust/L_∗ for each spectral type are 7.8 × 10^-7 (F), 1.4 × 10^-6 (G), and 2.2 × 10^-6 (K); the lowest values are around 4.0 × 10^-7. The incidence of debris discs is similar for active (young) and inactive (old) stars. The fractional luminosity tends to drop with increasing age, as expected from collisional erosion of the debris belts.

Skeletal maturity and socio-economic status in portuguese children and youths: the Madeira growth study

Skeletal maturity is used to evaluate biological maturity status. Information about the association between socio-economic status (SES) and skeletal maturity is limited in Portugal. Aims: The aim of this study is to document the skeletal maturity of youths in Madeira and to evaluate variation in maturity associated with SES. Subjects and methods: The study involved 507 subjects (256 boys and 251 girls) from the Madeira Growth Study, a mixed-longitudinal study of five cohorts (8, 10, 12, 14 and 16 years of age) followed at yearly intervals over 3 years (1996–1998). A total of 1493 observations were made. Skeletal age was estimated from radiographs of the hand and wrist using the Tanner–Whitehouse 2 method (TW2). Social class rankings were based on Graffar’s (1956) method. Five social rankings were subsequently grouped into three SES categories: high, average and low. Results: Median for the radius, ulna and short finger bones (RUS scores) in the total sample of boys and girls increased curvilinearly across age whereas median for the 7 (without pisiform) carpal bones (Carpal scores) increased almost linearly. The 20-bone maturity scores demonstrated distinctive trends by gender: the medians for boys increased almost linearly while the medians for girls increased curvilinearly. SES differences were minimal. Only among children aged 10–11 years were high SES boys and girls advanced in skeletal maturity. Madeira adolescents were advanced in skeletal maturity compared with Belgian reference values. Conclusion: The data suggests population variation in TW2 estimates of skeletal maturation. Skeletal maturity was not related to SES in youths from Madeira.

An in-depth characterisation of neonatal seizures by early continuous video-EEG analysis

Introduction Seizures are harmful to the neonatal brain; this compels many clinicians and researchers to persevere further in optimizing every aspects of managing neonatal seizures. Aims To delineate the seizure profile between non-cooled versus cooled neonates with hypoxic-ischaemic encephalopathy (HIE), in neonates with stroke, the response of seizure burden to phenobarbitone and to quantify the degree of electroclinical dissociation (ECD) of seizures. Methods The multichannel video-EEG was used in this research study as the gold standard to detect seizures, allowing accurate quantification of seizure burden to be ascertained in term neonates. The entire EEG recording for each neonate was independently reviewed by at least 1 experienced neurophysiologist. Data were expressed in medians and interquartile ranges. Linear mixed models results were presented as mean (95% confidence interval); p values <0.05 were deemed as significant. Results Seizure burden in cooled neonates was lower than in non-cooled neonates [60(39-224) vs 203(141-406) minutes; p=0.027]. Seizure burden was reduced in cooled neonates with moderate HIE [49(26-89) vs 162(97-262) minutes; p=0.020] when compared with severe HIE. In neonates with stroke, the background pattern showed suppression over the infarcted side and seizures demonstrated a characteristic pattern. Compared with 10 mg/kg, phenobarbitone doses at 20 mg/kg reduced seizure burden (p=0.004). Seizure burden was reduced within 1 hour of phenobarbitone administration [mean (95% confidence interval): -14(-20 to -8) minutes/hour; p<0.001], but seizures returned to pre-treatment levels within 4 hours (p=0.064). The ECD index in cooled, non-cooled neonates with HIE, stroke and in neonates with other diagnoses were 88%, 94%, 64% and 75% respectively. Conclusions Further research exploring the treatment effects on seizure burden in the neonatal brain is required. A change to our current treatment strategy is warranted as we continue to strive for more effective seizure control, anchored with use of the multichannel EEG as the surveillance tool.

Skeletal maturity and socio-economic status in portuguese children and youths: the Madeira growth study

Skeletal maturity is used to evaluate biological maturity status. Information about the association between socio-economic status (SES) and skeletal maturity is limited in Portugal. Aims: The aim of this study is to document the skeletal maturity of youths in Madeira and to evaluate variation in maturity associated with SES. Subjects and methods: The study involved 507 subjects (256 boys and 251 girls) from the Madeira Growth Study, a mixed-longitudinal study of five cohorts (8, 10, 12, 14 and 16 years of age) followed at yearly intervals over 3 years (1996–1998). A total of 1493 observations were made. Skeletal age was estimated from radiographs of the hand and wrist using the Tanner–Whitehouse 2 method (TW2). Social class rankings were based on Graffar’s (1956) method. Five social rankings were subsequently grouped into three SES categories: high, average and low. Results: Median for the radius, ulna and short finger bones (RUS scores) in the total sample of boys and girls increased curvilinearly across age whereas median for the 7 (without pisiform) carpal bones (Carpal scores) increased almost linearly. The 20-bone maturity scores demonstrated distinctive trends by gender: the medians for boys increased almost linearly while the medians for girls increased curvilinearly. SES differences were minimal. Only among children aged 10–11 years were high SES boys and girls advanced in skeletal maturity. Madeira adolescents were advanced in skeletal maturity compared with Belgian reference values. Conclusion: The data suggests population variation in TW2 estimates of skeletal maturation. Skeletal maturity was not related to SES in youths from Madeira.

Impacto de la resiliencia en pacientes con Artritis Reumatoide

Introducción: La artritis reumatoide (AR) es una enfermedad autoinmune-inflamatoria, que compromete las articulaciones diartrodiales. Tiene una importante repercusión sistémica que incluye la depresión; por lo tanto, tiene un severo impacto sobre la calidad de vida. Es posible que mecanismos de defensa, tales como la resiliencia, puedan amortiguar dicho impacto. Metodología: estudio de corte transversal, multicéntrico (análisis inicial dentro del grupo AR, con muestra no probabilística de 66 pacientes, posterior selección aleatoria simple de 16 pacientes de la muestra inicial y selección de 16 individuos sanos pareados). Posteriormente, se comparó la resiliencia entre sujetos con AR y sujetos sanos, mediante las escalas RS y CD-RISC25. Adicionalmente, se aplicaron las escalas EEAE, EADZ, SF-36 y PANAS. Los datos fueron evaluados mediante el coeficiente de correlación de Spearman, las pruebas U Mann-Whitney, Kruskall-Wallis, T de Student y análisis de varianza. Resultados: se encontraron diferencias significativas en las estrategias de afrontamiento no espirituales en grupos de resiliencia baja, media y alta; diferencias en las medianas de resiliencia en los grupos de depresión por EAZD en los pacientes. No se encontraron resultados significativos en las variables clínicas de la AR ni en la comparación con sujetos sanos. Conclusiones: el uso de estrategias de afrontamiento no espirituales y la ausencia de depresión, se asoció a mayores niveles de resiliencia en los pacientes con AR, por lo cual, los componentes emocionales y cognitivos se asocian a la resiliencia.