scholarly journals Systematic review and meta-analysis of within-subject and between-subject biological variation estimates of 20 haematological parameters

2019 ◽  
Vol 58 (1) ◽  
pp. 25-32 ◽  
Author(s):  
Abdurrahman Coskun ◽  
Federica Braga ◽  
Anna Carobene ◽  
Xavier Tejedor Ganduxe ◽  
Aasne K. Aarsand ◽  
...  
Keyword(s):  
Systematic Review ◽  
Critical Appraisal ◽  
Complete Blood Count ◽  
Clinical Chemistry ◽  
Meta Analysis ◽  
Biological Variation ◽  
European Federation ◽  
Global Estimates ◽  
Using Data

Abstract Background Interpretation of the complete blood count (CBC) parameters requires reliable biological variation (BV) data. The aims of this study were to appraise the quality of publications reporting BV data for CBC parameters by applying the BV Data Critical Appraisal Checklist (BIVAC) and to deliver global BV estimates based on BIVAC compliant studies. Methods Relevant publications were identified by a systematic literature search and evaluated for their compliance with the 14 BIVAC criteria, scored as A, B, C or D, indicating decreasing compliance. Global CVI and CVG estimates with 95% CI were delivered by a meta-analysis approach using data from BIVAC compliant papers (grades A–C). Results In total, 32 studies were identified; four received a BIVAC grade A, 2 B, 20 C and 6 D. Meta-analysis derived CVI and CVG estimates were generally lower or in line with those published in a historical BV database available online. Except for reticulocytes, CVI estimates of erythrocyte related parameters were below 3%, whereas platelet (except MPV and PDW) and leukocyte related parameters ranged from 5% to 15%. Conclusions A systematic review of CBC parameters has provided updated, global estimates of CVI and CVG that will be included in the newly published European Federation of Clinical Chemistry and Laboratory Medicine BV Database.

scholarly journals The Biological Variation Data Critical Appraisal Checklist: A Standard for Evaluating Studies on Biological Variation

2018 ◽  
Vol 64 (3) ◽  
pp. 501-514 ◽  
Author(s):  
Aasne K Aarsand ◽  
Thomas Røraas ◽  
Pilar Fernandez-Calle ◽  
Carmen Ricos ◽  
Jorge Díaz-Garzón ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Critical Appraisal ◽  
Clinical Chemistry ◽  
Essential Elements ◽  
Biological Variation ◽  
European Federation ◽  
Variation Data ◽  
Global Estimates ◽  
Variance Homogeneity

Abstract BACKGROUND Concern has been raised about the quality of available biological variation (BV) estimates and the effect of their application in clinical practice. A European Federation of Clinical Chemistry and Laboratory Medicine Task and Finish Group has addressed this issue. The aim of this report is to (a) describe the Biological Variation Data Critical Appraisal Checklist (BIVAC), which verifies whether publications have included all essential elements that may impact the veracity of associated BV estimates, (b) use the BIVAC to critically appraise existing BV publications on enzymes, lipids, kidney, and diabetes-related measurands, and (c) apply metaanalysis to deliver a global within-subject BV (CVI) estimate for alanine aminotransferase (ALT). METHODS In the BIVAC, publications were rated as A, B, C, or D, indicating descending compliance for 14 BIVAC quality items, focusing on study design, methodology, and statistical handling. A D grade indicated that associated BV estimates should not be applied in clinical practice. Systematic searches were applied to identify BV studies for 28 different measurands. RESULTS In total, 128 publications were identified, providing 935 different BV estimates. Nine percent achieved D scores. Outlier analysis and variance homogeneity testing were scored as C in >60% of 847 cases. Metaanalysis delivered a CVI estimate for ALT of 15.4%. CONCLUSIONS Application of BIVAC to BV publications identified deficiencies in required study detail and delivery, especially for statistical analysis. Those deficiencies impact the veracity of BV estimates. BV data from BIVAC-compliant studies can be combined to deliver robust global estimates for safe clinical application.

scholarly journals Critical appraisal and meta-analysis of biological variation studies on glycosylated albumin, glucose and HbA1c

2020 ◽  
Vol 1 (3) ◽  
Author(s):  
Carmen Ricós ◽  
Pilar Fernández-Calle ◽  
Elisabet Gonzalez-Lao ◽  
Margarida Simón ◽  
Jorge Díaz-Garzón ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Critical Appraisal ◽  
Meta Analysis ◽  
Biological Variation ◽  
Evidence Based ◽  
Literature Searches ◽  
Variation Data ◽  
Global Estimates ◽  
Systematic Literature Searches

AbstractObjectivesNumerous 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.

scholarly journals Harmonization initiatives in the generation, reporting and application of biological variation data

2018 ◽  
Vol 56 (10) ◽  
pp. 1629-1636 ◽  
Author(s):  
Aasne K. Aarsand ◽  
Thomas Røraas ◽  
William A. Bartlett ◽  
Abdurrahman Coşkun ◽  
Anna Carobene ◽  
...  
Keyword(s):  
Critical Appraisal ◽  
Clinical Chemistry ◽  
Meta Analysis ◽  
Laboratory Medicine ◽  
Biological Variation ◽  
Quality Data ◽  
European Federation ◽  
High Quality ◽  
Wide Range ◽  
Variation Data

Abstract Biological variation (BV) data have many applications in laboratory medicine. However, concern has been raised that some BV estimates in use today may be irrelevant or of unacceptable quality. A number of initiatives have been launched by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and other parties to deliver a more harmonized practice in the generation, reporting and application of BV data. Resulting from a necessary focus upon the veracity of historical BV studies, critical appraisal and meta-analysis of published BV studies is possible through application of the Biological Variation Data Critical Appraisal Checklist (BIVAC), published in 2017. The BIVAC compliant large-scale European Biological Variation Study delivers updated high-quality BV data for a wide range of measurands. Other significant developments include the publication of a Medical Subject Heading term for BV and recommendations for common terminology for reporting of BV data. In the near future, global BV estimates derived from meta-analysis of BIVAC appraised publications will be accessible in a Biological Variation Database at the EFLM website. The availability of these high-quality data, which have many applications that impact on the quality and interpretation of clinical laboratory results, will afford improved patient care.

scholarly journals What does my neighbourhood have to do with my weight? A protocol for systematic review and meta-analysis of the association between neighbourhood socioeconomic status and body weight

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017567
Author(s):  
Shimels Hussien Mohammed ◽  
Mulugeta Molla Birhanu ◽  
Tesfamichael Awoke Sissay ◽  
Tesfa Dejenie Habtewold ◽  
Balewgizie Sileshi Tegegn ◽  
...  
Keyword(s):  
Systematic Review ◽  
Socioeconomic Status ◽  
Data Extraction ◽  
Meta Analysis ◽  
Cross Sectional ◽  
Registration Number ◽  
Newcastle Ottawa Scale ◽  
Neighbourhood Socioeconomic Status ◽  
Using Data

IntroductionIndividuals living in poor neighbourhoods are at a higher risk of overweight/obesity. There is no systematic review and meta-analysis study on the association of neighbourhood socioeconomic status (NSES) with overweight/obesity. We aimed to systematically review and meta-analyse the existing evidence on the association of NSES with overweight/obesity.Methods and analysisCross-sectional, case–control and cohort studies published in English from inception to 15 May 2017 will be systematically searched using the following databases: PubMed, EMBASE, Web of Sciences and Google Scholar. Selection, screening, reviewing and data extraction will be done by two reviewers, independently and in duplicate. The Newcastle–Ottawa Scale (NOS) will be used to assess the quality of evidence. Publication bias will be checked by visual inspection of funnel plots and Egger’s regression test. Heterogeneity will be checked by Higgins’s method (I2statistics). Meta-analysis will be done to estimate the pooled OR. Narrative synthesis will be performed if meta-analysis is not feasible due to high heterogeneity of studies.Ethics and disseminationEthical clearance is not required as we will be using data from published articles. Findings will be communicated through a publication in a peer-reviewed journal and presentations at professional conferences.PROSPERO registration numberCRD42017063889.

scholarly journals Anxiety disorders and risk of stroke: A systematic review and meta-analysis

2017 ◽  
Vol 41 (1) ◽  
pp. 102-108 ◽  
Author(s):  
M. Pérez-Piñar ◽  
L. Ayerbe ◽  
E. González ◽  
R. Mathur ◽  
Q. Foguet-Boreu ◽  
...  
Keyword(s):  
Systematic Review ◽  
Anxiety Disorders ◽  
Critical Appraisal ◽  
Web Of Science ◽  
Meta Analysis ◽  
Significant Heterogeneity ◽  
Explanatory Factors ◽  
Increased Risk ◽  
Severe Anxiety

AbstractBackgroundAnxiety disorders are the most common mental health problem worldwide. However, the evidence on the association between anxiety disorders and risk of stroke is limited. This systematic review and meta-analysis presents a critical appraisal and summary of the available evidence on the association between anxiety disorders and risk of stroke.MethodsCohort studies reporting risk of stroke among patients with anxiety disorders were searched in PubMed, Embase, PsycINFO, Scopus, and the Web of Science, from database inception to June 2016. The quality of the studies was assessed using standard criteria. A meta-analysis was undertaken to obtain pooled estimates of the risk of stroke among patients with anxiety disorders.ResultsEight studies, including 950,759 patients, from the 11,764 references initially identified, were included in this review. A significantly increased risk of stroke for patients with anxiety disorders was observed, with an overall hazard ratio: 1.24 (1.09–1.41), P = 0.001. No significant heterogeneity between studies was detected and the funnel plot suggested that publication bias was unlikely. Limited evidence suggests that the risk of stroke is increased shortly after the diagnosis of anxiety and that risk of stroke may be higher for patients with severe anxiety.ConclusionsAnxiety disorders are a very prevalent modifiable condition associated with risk of stroke increased by 24%. This evidence could inform the development of interventions for the management of anxiety and the prevention of stroke. Further studies on the risk of stroke in patients with anxiety, and the explanatory factors for this association, are required.

Sample collections from healthy volunteers for biological variation estimates’ update: a new project undertaken by the Working Group on Biological Variation established by the European Federation of Clinical Chemistry and Laboratory Medicine

2016 ◽  
Vol 54 (10) ◽  
Author(s):  
Anna Carobene ◽  
Marta Strollo ◽  
Niels Jonker ◽  
Gerhard Barla ◽  
William A. Bartlett ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Biological Variation ◽  
European Federation ◽  
Laboratory Measurements ◽  
Controlled Conditions ◽  
Edta Plasma ◽  
Blood Specimens

AbstractBackground:Biological variation (BV) data have many fundamental applications in laboratory medicine. At the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) the reliability and limitations of current BV data were discussed. The EFLM Working Group on Biological Variation is working to increase the quality of BV data by developing a European project to establish a biobank of samples from healthy subjects to be used to produce high quality BV data.Methods:The project involved six European laboratories (Milan, Italy; Bergen, Norway; Madrid, Spain; Padua, Italy; Istanbul, Turkey; Assen, The Netherlands). Blood samples were collected from 97 volunteers (44 men, aged 20–60 years; 43 women, aged 20–50 years; 10 women, aged 55–69 years). Initial subject inclusion required that participants completed an enrolment questionnaire to verify their health status. The volunteers provided blood specimens once per week for 10 weeks. A short questionnaire was completed and some laboratory tests were performed at each sampling consisting of blood collected under controlled conditions to provide serum, KResults:Samples from six out of the 97 enroled subjects were discarded as a consequence of abnormal laboratory measurements. A biobank of 18,000 aliquots was established consisting of 120 aliquots of serum, 40 of EDTA-plasma, and 40 of citrated-plasma from each subject. The samples were stored at –80 °C.Conclusions:A biobank of well-characterised samples collected under controlled conditions has been established delivering a European resource to enable production of contemporary BV data.

scholarly journals Glycaemic control at risk? - Impact of temperature, humidity and other physical factors on the analytical quality of point of care testing of blood glucose, a systematic review protocol

2021 ◽  
Author(s):  
Cilia Maria Katharina Sindt ◽  
Lene Noehr-Jensen
Keyword(s):  
Systematic Review ◽  
Blood Glucose ◽  
Environmental Factors ◽  
Search Strategy ◽  
Critical Appraisal ◽  
Current Knowledge ◽  
Meta Analysis ◽  
Review Protocol ◽  
Comprehensive Search

Abstract Background Diabetes is a chronic metabolic disease characterized by increased blood glucose concentration. Self-monitoring of blood glucose (SMBG) is a corner stone in lowering the risk of vascular complications of diabetes and requires reliable measurements by the blood glucose meter and test strips (BG System). Environmental factors as temperature, humidity, altitude, and electromagnetic radiation may affect the measurement of blood glucose to a level that might compromise the glycaemic control. Manufactures often restrict the validation and approved use a limited span of environmental conditions and there is a considerable risk of exposing the equipment to temperature outside the range recommended by manufacturers. This systematic review aims to explore, aggregate, and present the current knowledge of the effect of environmental factors on the quality of results measured by BG systems. Methods Relevant studies will be found by using a comprehensive search strategy in the following databases: EMBASE, PubMed, CINAHL, Academic Search Premier, SweMed+, DANS Easy and Cochrane Library. The search strategy will assess if there is an impact on precision and accuracy of BG systems under varying environmental conditions compared to precision recommended by manufacturers. Both authors will screen titles and in case of disagreement, the study will be included for screening by abstract. After screening of all titles, the procedure will be repeated for screening and reading of abstracts. Full text of papers selected by abstract will be assessed according to in- and exclusions criteria. Homogenous results will be pooled and summarized statistically for meta-analysis. Narrative synthesis will be performed for heterogeneous data that cannot be pooled for meta-analysis. Reporting will follow the Preferred Items for Systematic Reviews and Meta-Analysis 2020 (PRISMA 2020). The risk of bias will be evaluated by choosing an appropriate tool from acknowledged institutions I.e., Joanna Briggs Critical Appraisal for Systematic Reviews Checklist tools or the Critical Appraisal Skills Program (CASP). Discussion This systematic review protocol utilizes rigorous methodology to provide a comprehensive search for outcomes of the impact of environmental factors on BG systems. The outcomes will be examined, and a summary of the current knowledge will be provided.

Long-term biological variation estimates of 13 hematological parameters in healthy Chinese subjects

2020 ◽  
Vol 58 (8) ◽  
pp. 1282-1290 ◽  
Author(s):  
Chenbin Li ◽  
Mingting Peng ◽  
Ji Wu ◽  
Zhongli Du ◽  
Hong Lu ◽  
...  
Keyword(s):  
Complete Blood Count ◽  
Clinical Chemistry ◽  
Hematological Parameters ◽  
Age Distribution ◽  
Turnover Time ◽  
Biological Variation ◽  
European Federation ◽  
Mean Values ◽  
Healthy Chinese ◽  
Chinese Subjects

AbstractBackgroundThe complete blood count (CBC) is a basic test routinely ordered by physicians as a part of initial diagnostic work-up on their patients. To ensure safe clinical application of the CBC, reliable biological variation (BV) data are needed to establish analytical performance specifications. Our aim was to define the BV of CBC parameters using a rigorous protocol that is compliant with the Biological Variation Data Critical Appraisal Checklist (BIVAC) provided by the European Federation of Clinical Chemistry and Laboratory Medicine.MethodsBlood samples drawn from 41 healthy Chinese subjects (22 females and 19 males; 23–59 years of age) once monthly for 6 consecutive months were analyzed using an ABX Pentra 80 instrument. The instrument was precisely calibrated. All samples were analyzed in duplicate for 13 CBC parameters. The data were assessed for outliers, normality, and variance homogeneity prior to nested ANOVA. Gender-stratified within-subject (CVI) and between-subject (CVG) BV estimates were calculated.ResultsThe number of remaining data for each subject was 442–484 after removing outliers. No significant differences existed between female/male CVI estimates. Except for leukocytes, neutrophils, and lymphocytes, the mean values of 10 parameters differed significantly between genders, rendering partitioning of CVG data between genders. No significant differences were detected between most BV estimates and recently published estimates representing a Europid population.ConclusionsMost BV estimates in BIVAC-compliant studies are similar. The turnover time of blood cells and age distribution of participants should be considered in a CBC BV study. Our study will contribute to global BV estimates and future studies.

scholarly journals Interventions to prevent anastomotic leak after esophageal surgery: A systematic review and meta-analysis

2020 ◽  
Author(s):  
Emma J.M. Grigor ◽  
Suha Kaaki ◽  
Dean A. Fergusson ◽  
Donna E. Maziak ◽  
Andrew J.E. Seely
Keyword(s):  
Systematic Review ◽  
Critical Appraisal ◽  
Meta Analysis ◽  
Quality Of Evidence ◽  
Randomized Controlled ◽  
Practice Recommendations ◽  
Early Removal ◽  
Tube Removal ◽  
Risk Ratios

Abstract Background: Anastomotic leakage (AL) is a common and serious complication following esophagectomy. We aimed to provide an up-to-date review and critical appraisal of interventions designed to reduce AL risk. Methods: We searched MEDLINE and Embase from 1946 to January 2019 for randomized controlled trials (RCTs) evaluating interventions to minimize esophagogastric AL. Pooled risk ratios (RR) for AL was performed using random effects. Results: Two reviewers screened 441 abstracts and identified 17 RCTs eligible for inclusion; 11 studies were meta-analyzed. Omentoplasty reduced the risk of AL significantly by 78% [RR: 0.22; 95% CI: 0.10, 0.50] compared to no omentoplasty (3 studies, n = 611 patients). Early removal of NG tube reduced AL risk significantly by 62% [RR: 0.38; 95% CI: 0.02, 0.65] compared to prolonged NG tube (2 studies, n = 293 patients); Stapled (vs. hand-sewn) anastomosis did not significantly reduce AL risk [RR: 0.92; 95% CI: 0.45, 1.87] compared to hand-sewn (6 studies, n = 1,454 patients). The quality of evidence was high for omentoplasty (vs. no omentoplasty), moderate for early removal of NG tube (vs. conventional removal), and very low for stapled anastomosis (vs. hand-sewn). Conclusions: This is the first meta-analysis to summarize the graded quality of evidence for all RCT interventions designed to reduce AL following esophagectomy. Our findings demonstrated that omentoplasty reduced the risk of AL with a high quality of evidence. Although early nasogastric tube removal reduced AL risk, there is a need for further research to strengthen the quality of evidence. Evidence profiles presented in our review may help inform the development of clinical practice recommendations. Systematic review registration: CRD42019127181

scholarly journals Ocular Manifestations of COVID-19: A Systematic Review and Meta-analysis

2021 ◽  
Author(s):  
Naser Nasiri ◽  
Hamid Sharifi ◽  
Azam Bazrafshan ◽  
Atefeh Noori ◽  
Mohammad Karamouzian ◽  
...  
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Cross Sectional ◽  
Ocular Manifestations ◽  
Ocular Symptoms ◽  
Body Sensation ◽  
Pooled Prevalence ◽  
Using Data ◽  
Meta Analyses

Several studies have reported the characteristics of Coronavirus disease 2019 (COVID-19), yet there is a gap in our understanding of the ocular manifestations of COVID-19. In this systematic review and meta-analysis, we investigated the prevalence of ocular manifestations in COVID-19 patients. We searched Pubmed, Embase, Scopus, Web of Science, and medRxiv from December 1, 2019 to August 11, 2020. Two independent reviewers screened the articles, abstracted the data, and assessed the quality of included studies in duplicate. Thirty-eight studies were eligible after screening of 895 unique articles, with a total of 8,219 COVID-19 patients (55.3% female; n = 3,486 out of 6,308 patients). Using data extracted from cross-sectional studies, we performed randomeffects meta-analyses to estimate the pooled prevalence of ocular symptoms along with 95% confidence interval (CI). The prevalence of ocular manifestations was estimated to be 11.03% (95% CI: 5.71–17.72). In the studies that reported the details of observed ocular symptoms, the most common ocular manifestations were dry eye or foreign body sensation (n = 138, 16%), redness (n = 114, 13.3%), tearing (n = 111, 12.8%), itching (n = 109, 12.6%), eye pain (n = 83, 9.6%) and discharge (n = 76, 8.8%). Moreover, conjunctivitis had the highest rate among reported ocular diseases in COVID-19 patients (79 out of 89, 88.8%). The results suggest that approximately one out of ten COVID-19 patients show at least one ocular symptom. Attention to ocular manifestations, especially conjunctivitis, can increase the sensitivity of COVID-19 detection among patients.

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