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

Author(s):  
Carmen Ricós ◽  
Pilar Fernández-Calle ◽  
Elisabet Gonzalez-Lao ◽  
Margarida Simón ◽  
Jorge Díaz-Garzón ◽  
...  

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.

Author(s):  
Niels Jonker ◽  
Berna Aslan ◽  
Beatriz Boned ◽  
Fernando Marqués-García ◽  
Carmen Ricós ◽  
...  

AbstractObjectiveKidney markers are some of the most frequently used laboratory tests in patient care, and correct clinical decision making depends upon knowledge and correct application of biological variation (BV) data. The aim of this study was to review available BV data and to provide updated BV estimates for the following kidney markers in serum and plasma; albumin, creatinine, cystatin C, chloride, potassium, sodium and urea.ContentRelevant studies were identified from a historical BV database as well as by systematic literature searches. Retrieved publications were appraised by the Biological Variation Data Critical Appraisal Checklist (BIVAC). Meta-analyses of BIVAC compliant studies with similar design were performed to deliver global estimates of within-subject (CVI) and between-subject (CVG) BV estimates. Out of the 61 identified papers, three received a BIVAC grade A, four grade B, 48 grade C, five grade D grade and one was not appraised as it did not report numerical BV estimates. Most studies were identified for creatinine (n=48). BV estimates derived from the meta-analysis were in general lower than previously reported estimates for all analytes except urea. For some measurands, BV estimates may be influenced by age or states of health, but further data are required.SummaryThis review provides updated global BV estimates for kidney related measurands. For all measurands except for urea, these estimates were lower than previously reported.OutlookFor the measurands analyzed in this review, there are sufficient well-designed studies available to publish a trustworthy estimate of BV. However, for a number of newly appearing kidney markers no suitable data is available and additional studies are required.


2018 ◽  
Vol 64 (3) ◽  
pp. 501-514 ◽  
Author(s):  
Aasne K Aarsand ◽  
Thomas Røraas ◽  
Pilar Fernandez-Calle ◽  
Carmen Ricos ◽  
Jorge Díaz-Garzón ◽  
...  

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.


2019 ◽  
Vol 58 (1) ◽  
pp. 25-32 ◽  
Author(s):  
Abdurrahman Coskun ◽  
Federica Braga ◽  
Anna Carobene ◽  
Xavier Tejedor Ganduxe ◽  
Aasne K. Aarsand ◽  
...  

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.


2021 ◽  
Vol 1 (2) ◽  
pp. 122-126
Author(s):  
Pallavi Patro ◽  
Durga Prasanna Misra

Systematic reviews are considered as the highest rung in the ladder of evidence-based medicine. They are bound by a pre-defined structure and requirement for extensive literature searches, when compared with the more liberal format of narrative reviews. Systematic review protocols should ideally be pre-registered to avoid duplication or redundancy. After defining clear review question(s), thorough literature searches form the basis of systematic reviews. Presentation of results should be qualitative or quantitative (meta-analysis) if the data is homogenous enough to permit pooling across multiple studies. Quality of individual studies by Cochrane risk of bias 2 tool for interventional studies and other suitable scales for observational studies, as well as appropriate assessment of publication bias are recommended. Certainty of outcomes should be assessed by the GRADE profiler. Finally, systematic reviews should conclude with recommendations for future research, based on their findings.


2018 ◽  
Vol 56 (10) ◽  
pp. 1629-1636 ◽  
Author(s):  
Aasne K. Aarsand ◽  
Thomas Røraas ◽  
William A. Bartlett ◽  
Abdurrahman Coşkun ◽  
Anna Carobene ◽  
...  

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.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
E Bossi ◽  
M Tringali ◽  
P Colombo ◽  
C Mazzali ◽  
G Puleo ◽  
...  

Abstract Issue With population aging, increased demand for healthcare and limited availability of economic and human resources, well-functioning and sustainable health systems have to rely on rigorous and evidence-based assessments of complex technologies' clinical effectiveness and safety. The Lombardy Region in Northern Italy has a well-established HTA program that offers technical support to its hospitals' network to produce and to review Health Technology Assessment (HTA) reports. Description of the Problem To better coordinate the HTA network and to reduce self-referencing of University and Community hospitals, Lombardy Region carried out an intense field training and distance learning from year 2017, with a project aimed at involving health care professionals in an accurate evaluation of technologies in 18 HTA reports. The regional HTA Supporting Centre developed a Toolkit for the critical appraisal of reports and supporting literature to improve the quality of hospital-based reports. Results In compliance with the regional Law DGR XI/1046 17.12.2018 and the framework proposed, during year 2019 hospitals used the Toolkit to help writing complete and good quality HTA reports on 37 different technologies. With a Public Health resident internship, the Toolkit was revised, extended and then used in 2020 by the hospital's HTA network during the double blinded peer review, mandated by the regional Law DGR XI/2672 16.12.2019, of the year 2019 HTA reports. Detailed results will be presented at the conference. Lessons We observed an increase in number of HTA reports from 2018 to 2019, a greater language's and format's homogeneity and an improvement in the quality of some reports, which will be submitted to the Regional HTA Committee for appraisal and reimbursement. Key messages The development and use of a Critical Appraisal Toolkit in an Regional HTA program can help hospitals write complete and good quality HTA reports. A centrally supported quality improvement of distributed assessment activities in a network of hospitals can enhance the production of HTA reports, relevant to the needs of a local healthcare system.


2021 ◽  
Author(s):  
Luísa Prada ◽  
Ana Prada ◽  
Miguel Antunes ◽  
Ricardo Fernandes ◽  
João Costa ◽  
...  

Abstract Introduction:Over the last years, the number of systematic reviews published is steadily increasing due to the global interest in this type of evidence synthesis. However, little is known about the characteristics of this research published in Portuguese medical journals. This study aims to evaluate the publication trends and overall quality of these systematic reviews.Material and Methods:Systematic reviews were identified through an electronic search up to August 2020, targeting Portuguese Medical journals indexed in MEDLINE. Systematic reviews selection and data extraction were done independently by three authors. The overall quality critical appraisal using the A MeaSurement Tool to Assess systematic Reviews (AMSTAR II) was independently assessed by three authors. Disagreements were solved by consensus.Results:Seventy systematic reviews published in 5 Portuguese medical journals were included. Most (n=57; 81,4%) were systematic reviews without meta-analysis. Until 2010, the number of systematic reviews per year increased. Since then, the number of reviews published has not remained stable and no less than 3 SRs were published per year. According to the systematic reviews’ typology, most have been predominantly conducted to assess the effectiveness of health interventions (n=28; 40,0%). General and Internal Medicine (n=26; 37,1%) was the most addressed field. Most systematic reviews (n=45; 64,3%) were rated as being of “critically low-quality”.Conclusions:There were consistent flaws in the methodological quality report of the systematic reviews included, particularly in establishing a prior protocol and not assessing the potential impact of the risk of bias on the results.Through the years, the number of systematic reviews published increased, yet their quality is suboptimal. There is a need to improve the reporting of systematic reviews in Portuguese medical journals, which can be achieved by better adherence to quality checklists/tools.Systematic review registration: INPLASY202090105


Author(s):  
Paul Harrison ◽  
Philip Cowen ◽  
Tom Burns ◽  
Mina Fazel

‘Evidence-based approaches to psychiatry’ describes the application of evidence-based medicine (EBM) to psychiatric practice. The chapter covers the key processes in EBM, including the formulation of a clinically relevant question, the systematic search for high-quality evidence and the meta-analytic synthesis of data. It demonstrates how evidence-based approaches to psychiatry have led to important developments showing quantitative effects of different treatments through advanced meta-analysis of data from randomized trials. This has underpinned the development of clinical guidelines that have the aim of improving the reliability and quality of treatments that patients receive. The chapter also describes how meta-analyses should be critically reviewed, as well as their problems and limitations. Not all relevant questions in psychiatric research are susceptible to the quantitative approach offered by EBM, and the chapter also outlines how qualitative methodologies can play a key role in answering important questions related, for example, to the patient experience.


2020 ◽  
Vol 48 (4) ◽  
pp. 437-454
Author(s):  
Tomas Lindegaard ◽  
Matilda Berg ◽  
Gerhard Andersson

Recent years have seen an increase of internet-delivered interventions based on psychodynamic treatment models. To test the efficacy of internet-delivered psychodynamic therapy (IPDT), we conducted a systematic review and meta-analysis of randomized controlled trials. Following literature searches, we identified seven studies meeting inclusion criteria. The total number of participants was 528 in the treatment group and 552 in the control conditions. We found small effects favoring IPDT compared to inactive control conditions for main outcomes (g = 0.44), depression (g = 0.46), anxiety (g = 0.20), and quality of life (g = 0.40). There was significant heterogeneity between studies for main outcomes and depression. Within-group effects ranged from Hedges's g = 0.32–0.99. The effects of IPDT were maintained or increased at follow-up. Study quality varied but was generally high. No indications of publication bias were found. In conclusion, IPDT is a promising treatment alternative, especially for depression, although the small number of studies limits the generalizability of the findings.


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