Review of statistical methodologies used to compare (bio)assays

Dewé, Walthère

doi:10.1016/j.jchromb.2009.01.027

Cited by 12 publications

(8 citation statements)

References 14 publications

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“…In over 25% of patients, treatment AUCs would have been more than 20% different from predicted due to reduced clearance of treatment doses compared to test doses. This is not surprising, since close correlation between two tests does not at all represent agreement [25,26]. Additionally, correlation does not take into account the variation due to residual error, nor does correlation provide any measure of systematic differences.…”

Section: Discussionmentioning

confidence: 99%

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Phase I study of dose-escalated busulfan with fludarabine and alemtuzumab as conditioning for allogeneic hematopoietic stem cell transplant: reduced clearance at high doses and occurrence of late sinusoidal obstruction syndrome/veno-occlusive disease

O’Donnell¹,

Artz²,

Undevia³

et al. 2010

Leukemia & Lymphoma

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Disease recurrence after allogeneic hematopoietic cell transplant (alloHCT) remains common, making improvements in conditioning regimens desirable. A dose-response relationship between busulfan exposure and outcome is known. Using individual real-time monitoring of the busulfan area under the curve (AUC), we aimed to determine the maximum-tolerated busulfan AUC in a conditioning regimen with fludarabine/alemtuzumab. Thirty-six patients with advanced hematologic malignancies were treated. Busulfan levels after a test dose and conditioning dose 1 allowed targeting of subsequent AUCs and dose-escalation above the starting AUC of 4800 μmol-min/L. Clearance of busulfan test doses was not always sufficiently predictive of treatment dose AUC and, on average, test dose clearance was faster than treatment dose clearance. When the study was modified to use conditioning dose 1 pharmacokinetics instead, accurately targeted treatment AUCs were achieved, and dose-escalation was possible. Severe, late-occurring sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) was the dose-limiting toxicity seen in 5/8 patients at an AUC level of 6800 μmol-min/L. The risk for SOS/VOD correlated with the highest observed AUC (AUCmax) rather than with the average cumulative AUC (AUCavg). Busulfan dose-escalation to a maximum-tolerated AUC of 5800 μmol-min/L—higher than that achieved by current standard busulfan regimens—was accurate and achievable using real-time pharmacokinetics monitoring of the first conditioning dose. This AUC is now being studied in phase II for patients receiving busulfan/fludarabine/alemtuzumab as alloHCT conditioning.

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Section: Discussionmentioning

confidence: 99%

“…p -Values are two-sided and not adjusted for multiple comparisons. For comparison of clearance of the test dose with that of treatment doses, the Bland–Altman method was used [25,26]. The limits of agreement were defined as ±10%.…”

Section: Methodsmentioning

confidence: 99%

Phase I study of dose-escalated busulfan with fludarabine and alemtuzumab as conditioning for allogeneic hematopoietic stem cell transplant: reduced clearance at high doses and occurrence of late sinusoidal obstruction syndrome/veno-occlusive disease

O’Donnell¹,

Artz²,

Undevia³

et al. 2010

Leukemia & Lymphoma

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“…The reality is that adequate controls and blanks are often not included, limits of detection are not determined, quantitative parameters are not assessed, and the findings are not extensively replicated. Studies of this nature require method validation including the determination of key parameters such as accuracy, precision, limits of detection and quantification (Thompson, Ellison, & Wood, ; Duncan, ; Araujo, ; Dewé, ; Stöckl, D'Hondt, & Thiepont, ). Finally, much of this work has been based on non‐physiologic and non‐pathologic conditions (i.e., extraordinarily high concentrations of nitrating agents) and this brings into question the relevance of some of these findings (Palamalai et al, ).…”

Section: Introductionmentioning

confidence: 99%

Mass spectrometry and 3-nitrotyrosine: Strategies, controversies, and our current perspective

Tsikas

Duncan

2013

Mass Spec Rev

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Reactive-nitrogen species (RNS) such as peroxynitrite (ONOO(-)), that is, the reaction product of nitric oxide ((•)NO) and superoxide (O2(-•)), nitryl chloride (NO2Cl) and (•)NO2 react with the activated aromatic ring of tyrosine to form 3-nitrotyrosine. This modification, which has been known for more than a century, occurs to both the free form of the amino acid (i.e., soluble/free tyrosine) and to tyrosine residues covalently bound within the backbone of peptides and proteins. Nitration of tyrosine is thought to be of biological significance and has been linked to health and disease, but determining its role has proved challenging. Several key questions have been the focus of much of the research activity: (a) to what extent is free/soluble tyrosine nitrated in biological tissues and fluids, and (b) are there specific site(s) of nitration within peptides/proteins and to what extent (i.e., stoichiometry) does this modification occur? These issues have been addressed in a wide range of sample types (e.g., blood, urine, CSF, exhaled breath condensate and various tissues) and a diverse array of physiological/pathophysiological scenarios. The accurate determination of nitrated tyrosine is, however, a stumbling block. Despite extensive study, the extent to which nitration occurs in vivo, the specificity of the nitration reaction, and its importance in health and disease, remain unclear. In this review, we highlight the analytical challenges and discuss the approaches adopted to address them. Mass spectrometry, in combination with either gas chromatography (GC-MS, GC-MS/MS) or liquid chromatography (LC-MS/MS), has played the central role in the analysis of 3-nitrotyrosine and tyrosine-nitrated biological macromolecules. We discuss its unique attributes and highlight the role of stable-isotope labeled 3-nitrotyrosine analogs in both accurate quantification, and in helping to define the biological relevance of tyrosine nitration. We show that the application of sophisticated mass spectrometric techniques is advantageous if not essential, but that this alone is by no means a guarantee of accurate findings. We discuss the important analytical challenges in quantifying 3-nitrotyrosine, possible workarounds, and we attempt to make sense of the disparate findings that have been reported so far.

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“…Los valores para el ρc se pueden encontrar en -1 y +1. Se considera que el pc presenta alta reproducibilidad (casi perfecta) si los valores son mayores a 0.99, sustancial; si se encuentra entre 0.95 y 0.99, moderada; pobre, si está por debajo de 0.90 (45)(46)(47).…”

Section: Coeficiente De Correlación Intraclase (Cci)unclassified

Técnicas para estimar la estabilidad de una escala de medición en salud.

2016

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Introducción: la estabilidad de las escalas para medición de diferentes condiciones de salud es necesaria e imprescindible antes de su aplicación en poblaciones específicas.Objetivo: describir las pruebas estadísticas de uso frecuente para estimar la estabilidadde una escala de medición en salud.Materiales y método: se llevó a cabo una revisión narrativa de la literatura impresay electrónica desde el año 1965 aproximadamente, hasta la primera semana de enerode 2014.Resultados: el desempeño psicométrico de una escala se centra en la medición de la validez y la confiabilidad. Sin embargo, el análisis de la confiabilidad test-retest (aplicación múltiple de un instrumento con un intervalo de tiempo definido) pocas veces se informa. La medición de la estabilidad se basa en la aplicación de pruebas como t de Student, correlación de Pearson, coeficiente de correlación intraclase, coeficiente de correlación y concordancia de Lin o el coeficiente de concordancia de Bland y Altman.Los aspectos a tener en cuenta para la utilización de alguna de estas pruebas están en el tamaño de la muestra y la comprobación de supuestos de normalidad, entre otros.Conclusión: la estabilidad se debe cuantificar para una escala en diferentes poblaciones.Cada prueba estadística a utilizar muestra ventajas y desventajas, de acuerdo a las características de la prueba. Probablemente, los valores similares en los diferentes coeficientes garantizan la estabilidad de una escala de medición en salud. Rev.cienc. biomed. 2016;7(1):104-111.

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Review of statistical methodologies used to compare (bio)assays

Cited by 12 publications

References 14 publications

Phase I study of dose-escalated busulfan with fludarabine and alemtuzumab as conditioning for allogeneic hematopoietic stem cell transplant: reduced clearance at high doses and occurrence of late sinusoidal obstruction syndrome/veno-occlusive disease

Phase I study of dose-escalated busulfan with fludarabine and alemtuzumab as conditioning for allogeneic hematopoietic stem cell transplant: reduced clearance at high doses and occurrence of late sinusoidal obstruction syndrome/veno-occlusive disease

Mass spectrometry and 3-nitrotyrosine: Strategies, controversies, and our current perspective

Técnicas para estimar la estabilidad de una escala de medición en salud.

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