Biological variation data (BV) can be used for different applications, but this depends on the availability of robust and relevant BV data. In this study, we aimed to summarize and appraise BV ...studies for tumor markers, to examine the influence of study population characteristics and concentrations on BV estimates and to discuss the applicability of BV data for tumor markers in clinical practice.
Studies reporting BV data for tumor markers related to gastrointestinal, prostate, breast, ovarian, haematological, lung, and dermatological cancers were identified by a systematic literature search. Relevant studies were evaluated by the Biological Variation Data Critical Appraisal Checklist (BIVAC) and meta-analyses were performed for BIVAC compliant studies to deliver global estimates of within-subject (CV
) and between-subject (CV
) BV with 95% CI.
The systematic review identified 49 studies delivering results for 22 tumor markers; four papers received BIVAC grade A, 3 B, 27 C and 15 D. Out of these, 29 CV
and 29 CV
estimates met the criteria to be included in the meta-analysis. Robust data are lacking to conclude on the relationship between BV and different disease states and tumor marker concentrations.
This review identifies a lack of high-quality BV studies for many tumor markers and a need for delivery of BIVAC compliant studies, including in different disease states and tumor marker concentrations. As of yet, the state-of-the-art may still be the most appropriate model to establish analytical performance specifications for the majority of tumor markers.
Abstract
Objectives
The estimates of biological variation (BV) have traditionally been determined using direct methods, which present limitations. In response to this issue, two papers have been ...published addressing these limitations by employing indirect methods. Here, we present a new procedure, based on indirect methods that analyses data collected within a multicenter pilot study. Using this method, we obtain CV
I
estimates and calculate confidence intervals (CI), using the EFLM-BVD CV
I
estimates as gold standard for comparison.
Methods
Data were collected over a 18-month period for 7 measurands, from 3 Spanish hospitals; inclusion criteria: patients 18–75 years with more than two determinations. For each measurand, four different strategies were carried out based on the coefficient of variation ratio (rCoeV) and based on the use of the bootstrap method (OS1, RS2 and RS3). RS2 and RS3 use symmetry reference change value (RCV) to clean database.
Results
RS2 and RS3 had the best correlation for the CV
I
estimates with respect to EFLM-BVD. RS2 used the symmetric RCV value without eliminating outliers, while RS3 combined RCV and outliers. When using the rCoeV and OS1 strategies, an overestimation of the CV
I
value was obtained.
Conclusions
Our study presents a new strategy for obtaining robust CV
I
estimates using an indirect method together with the value of symmetric RCV to select the target population. The CV
I
estimates obtained show a good correlation with those published in the EFLM-BVD database. Furthermore, our strategy can resolve some of the limitations encountered when using direct methods such as calculating confidence intervals.
Aging populations are driving a shift in emphasis toward enhancing chronic disease care, reflected in Catalonia's regional plan which prioritizes standardized nursing care plans in primary care ...settings. To achieve this, the ARES-AP program was established with a focus on harmonizing standards and supporting routine nursing clinical decision-making. This study evaluates nurses' perceptions of ARES-AP's standardized care plans for chronic diseases.
A mixed-methods approach based on an ad hoc questionnaire (n = 141) and a focus group (n = 14) was used. Quantitative data were statistically analysed, setting significance at
< 0.05. Qualitative data were explored via content analysis.
ARES-AP training was assessed positively. The resources for motivational interviewing and care plans for the most prevalent chronic diseases were rated very positively. This study identified key factors influencing program implementation, including facilitators such as structured information and nursing autonomy, barriers such as resistance to change, motivators such as managerial support, and suggested improvements such as technological improvements and time management strategies.
This study identifies areas for improvement in implementing standardized nursing care plans, including additional time, motivation, enhanced IT infrastructure, and collaboration among primary care professionals. It enhances understanding of these plans in primary care, especially in managing chronic diseases in aging populations. Further research should assess the program's long-term impact on chronic patients. This study was not registered.
ObjectivesNumerous biological variation (BV) studies have been performed over the years, but the quality of these studies vary. The objectives of this study were to perform a systematic review and ...critical appraisal of BV studies on glycosylated albumin and to deliver updated BV estimates for glucose and HbA1c, including recently published high-quality studies such as the European Biological Variation study (EuBIVAS). MethodsSystematic literature searches were performed to identify BV studies. Nine publications not included in a previous review were identified; four for glycosylated albumin, three for glucose, and three for HbA1c. Relevant studies were appraised by the Biological Variation Data Critical Appraisal Checklist (BIVAC). Global BV estimates were derived by meta-analysis of BIVAC-compliant studies in healthy subjects with similar study design. ResultsOne study received BIVAC grade A, 2B, and 6C. In most cases, the C-grade was associated with deficiencies in statistical analysis. BV estimates for glycosylated albumin were: CVI=1.4% (1.2-2.1) and CVG=5.7% (4.7-10.6), whereas estimates for HbA1c, CVI=1.2% (0.3-2.5), CVG=5.4% (3.3-7.3), and glucose, CVI=5.0% (4.1-12.0), CVG=8.1% (2.7-10.8) did not differ from previously published global estimates. ConclusionsThe critical appraisal and rating of BV studies according to their methodological quality, followed by a meta-analysis, generate robust, and reliable BV estimates. This study delivers updated and evidence-based BV estimates for glycosylated albumin, glucose and HbA1c.
A lo largo de los años se han publicado numerosos artículos sobre variación biológica (VB) de diferente calidad. Los objetivos de este trabajo fueron realizar una revisión sistemática y una ...evaluación crítica de los estudios de VB para albúmina glicosilada y proporcionar datos actualizados de VB para glucosa y HbA1c, incluyendo prestigiosos estudios recientemente publicados como el Estudio de Variación Biológica Europea (EuBIVAS).
Resumen
Objetivos
Este artículo ofrece una síntesis de los modelos de control interno de la calidad analítica usados, desde mediados del siglo XX hasta los que están en vigor actualmente y pretende ...dar una proyección de cómo debería ser el futuro en esta materia concreta.
Métodos
El material usado es la recopilación bibliográfica de los distintos modelos de CIC publicados. El método de estudio ha sido el análisis crítico de dichos modelos, debatiendo los pros y contras de cada uno.
Resultados
Los primeros modelos se basaron en el análisis de materiales control y se fijaron como límites de aceptabilidad múltiplos de la desviación estándar del procedimiento analítico. Más adelante se sustituyeron estos límites por valores relacionados con el uso clínico de los exámenes del laboratorio, principalmente los derivados de la variación biológica. Para las pruebas sin material control estable se desarrollaron métodos basados en análisis replicados de especímenes de pacientes, que se han perfeccionado recientemente, así como la métrica sigma, que relaciona la calidad deseada con la prestación analítica para diseñar un protocolo de alta eficacia. La tendencia actual es matizar el control interno teniendo en cuenta la carga de trabajo y el impacto de un fallo analítico en la información sobre el paciente.
Conclusiones
Se indican los puntos fuertes resaltados a la luz de esta revisión, los puntos débiles que todavía se emplean y deberían eliminarse, así como se da una proyección de futuro encaminada a promover la seguridad de los exámenes del laboratorio.
Este artículo ofrece una síntesis de los modelos de control interno de la calidad analítica usados, desde mediados del siglo XX hasta los que están en vigor actualmente y pretende dar una proyección ...de cómo debería ser el futuro en esta materia concreta.
Resumen
Objetivos
A lo largo de los años se han publicado numerosos artículos sobre variación biológica (VB) de diferente calidad. Los objetivos de este trabajo fueron realizar una revisión ...sistemática y una evaluación crítica de los estudios de VB para albúmina glicosilada y proporcionar datos actualizados de VB para glucosa y HbA
1c
, incluyendo prestigiosos estudios recientemente publicados como el Estudio de Variación Biológica Europea (EuBIVAS).
Métodos
Se hizo una búsqueda bibliográfica sistemática para identificar estudios sobre VB, encontrándose 9 estudios no incluidos en la primera revisión: 4 para albúmina glicosilada, 3 para glucosa y 3 para HbA
1c
. Se realizó una evaluación crítica de los estudios relevantes, utilizando la herramienta
Biological Variation Data Critical Appraisal Checklist
(BIVAC). Se obtuvieron los estimados globales de VB mediante meta-análisis de los estudios que cumplían los requisitos BIVAC, realizados en individuos sanos con estudios de diseño similar.
Resultados
Un estudio recibió el grado A, dos el B y 6 el C. en la mayoría de los casos el grado C se asoció a deficiencias en el análisis estadístico de los datos. Los estimados de VB para albúmina glicosilada fueron: CV
I
= 1,4%(1,2–2,1) y CV
G
= 5,7%(4,7–10,6); para HbA
1c
, CV
I
= 1,2%(0,3–2,5), CV
G
= 5,4%(3,3–7,3) y para glucosa, CV
I
= 5,0%(4,1–12,0), CV
G
= 8,1%(2,7–10,8) no difirieron de los estimados globales previamente descritos.
Conclusiones
La evaluación crítica y clasificación de los estudios de VB a tenor de su calidad metodológica, seguido de un meta-análisis, genera estimados de VB robustos y fiables. Este estudio proporciona datos de VB para albúmina glicolisada, glucosa y HbA
1c
actualizados y basados en la evidencia científica.
Numerous biological variation (BV) studies have been performed over the years, but the quality of these studies vary. The objectives of this study were to perform a systematic review and critical ...appraisal of BV studies on glycosylated albumin and to deliver updated BV estimates for glucose and HbA
, including recently published high-quality studies such as the European Biological Variation study (EuBIVAS).
Systematic literature searches were performed to identify BV studies. Nine publications not included in a previous review were identified; four for glycosylated albumin, three for glucose, and three for HbA
. Relevant studies were appraised by the Biological Variation Data Critical Appraisal Checklist (BIVAC). Global BV estimates were derived by meta-analysis of BIVAC-compliant studies in healthy subjects with similar study design.
One study received BIVAC grade A, 2B, and 6C. In most cases, the C-grade was associated with deficiencies in statistical analysis. BV estimates for glycosylated albumin were: CV
=1.4% (1.2-2.1) and CV
=5.7% (4.7-10.6), whereas estimates for HbA
, CV
=1.2% (0.3-2.5), CV
=5.4% (3.3-7.3), and glucose, CV
=5.0% (4.1-12.0), CV
=8.1% (2.7-10.8) did not differ from previously published global estimates.
The critical appraisal and rating of BV studies according to their methodological quality, followed by a meta-analysis, generate robust, and reliable BV estimates. This study delivers updated and evidence-based BV estimates for glycosylated albumin, glucose and HbA
.
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