Risk of Bias and Study Quality Assessment: Linking Evidence to Practice

2020 ◽  
Vol 50 (5) ◽  
pp. 277-279 ◽  
Author(s):  
Steven J. Kamper
2018 ◽  
Author(s):  
Artur Jaschke ◽  
Laura H. P. Eggermont ◽  
Sylka Uhlig ◽  
Erik J. A. Scherder

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 607.2-608
Author(s):  
S. Giambalvo ◽  
C. Garaffoni ◽  
E. Silvagni ◽  
F. Furini ◽  
M. Govoni ◽  
...  

Background:Fertility is thought to be not reduced in women affected by systemic lupus erythematosus (SLE), however disease-related factors, psychosocial effects of chronic disease as well as medication exposure might impair gonadal function.Objectives:The aim of this systematic review was to explore clinical, hormonal, serological, instrumental and management factors associated with fertility outcomes in women of childbearing age with SLE.Methods:This systematic review was conducted following the Preferred Reporting Items for systematic reviews and Meta-analysis (PRISMA) statement. All articles available in English, published from 1972 to 15th August 2020 in Pubmed, EMBASE, Scopus and Cochrane Library. Study selection and data collection were performed by two independent reviewers. All data were extracted using a standardized template. Risk of bias of the included studies was assessed by using the NIH risk-of-bias tool [1].Results:Of 788 abstracts, we included in the review 45 studies of which 1 systematic literature reviews, 16 cross-sectional studies, 15 cohort studies, 12 observational studies and 1 case-series study, with a total of 4656 patients. The mean age was 33.5 ± 5.4 years, while the mean disease duration was 97.4 ± 65.2 months. Figure 1 illustrates the quality of the included studies. Definitions of fertility/premature ovarian failure (POF) adopted in the studies varied in terms of the number of months of amenorrhea considered. Most studies did not use a hormonally based definition of fertility. Clinical factors associated with the development of POF were older age at the time initiation of therapy and older age at the onset of SLE disease. Cyclophosphamide exposure (CYC) and its cumulative dose influenced gonadal function in SLE women, leading to amenorrhoea and ovarian failure, as reported in 19 studies. Mycophenolate, azathioprine, calcineurin inhibitors and steroids seem to be associated with a lower risk of ovarian failure compared to CYC. 3 studies demonstrated that POF was more frequent in patients treated with CYC not receiving gonadotropin-releasing hormone analogues (GnRH) in comparison to those co-treated with GnRH. 11 studies evaluated the impact of damage and disease activity on ovarian reserve in patients with SLE with conflicting evidence. Finally, 18 studies investigated exposure to hormonal and serological factors able to influence fertility outcomes; among others nor Anti-Müllerian Hormone, neither anti-corpus luteum antibodies were associated with POF.Conclusion:The role of disease activity on fertility in SLE patients is contradictory. Regarding management factors associated with fertility in SLE women of childbearing age, the strongest evidence is about the treatment with CYC and its cumulative dose. Hormonal and serological factors did not impact on fertility outcome but might be used as a surrogate of fertility, especially after treatment with disease-specific drugs.References:[1]Study Quality Assessment Tools NIH. https://www.nhlbi.nih.gov/health-topics/study-quality-assessment-tools.[2]Andreoli L. et al. EULAR recommendations for women’s health and the management of family planning, assisted reproduction, pregnancy and menopause in patients with systemic lupus erythematosus and/or antiphospholipid syndrome. Ann Rheum Dis. 2017; 76: 476–485.Disclosure of Interests:None declared


Author(s):  
Marjan Drukker ◽  
Irene Weltens ◽  
Carmen F. M. van Hooijdonk ◽  
Emma Vandenberk ◽  
Maarten Bak

Background: Existing study quality and risk of bias lists for observational studies have important disadvantages. For this reason, a comprehensive widely applicable quality assessment tool for observational studies was developed.Methods: Criteria from three quality lists were merged into a new quality assessment tool: the observational study quality evaluation (OSQE). OSQE consists of a cohort, case–control, and cross-sectional version.Results: The OSQE cohort, the OSQE case–control, and the OSQE cross-sectional version include all items applicable to that type of study, for example, the representativeness of the study population, the validity of the independent and dependent variables, and the statistical methods used. Before scoring the OSQE, the rater is asked to define how to score items, in detail. A study can obtain a star for each item. Each item also has a veto cell. This cell can be checked when poor quality with respect to that specific item results in a low quality of the study despite stars on other items. Although stars add to a sum score, the comment field is the most important part of the OSQE.Conclusion: The OSQE presented in the current article provides a short, comprehensive, and widely applicable list to assess study quality and therewith risk of bias.


2019 ◽  
Author(s):  
MR Little ◽  
S Dupré ◽  
JCR Wormald ◽  
MD Gardiner ◽  
C Gale ◽  
...  

AbstractObjectivesThis systematic review aims to assess the quality of literature supporting surgical interventions for paediatric extravasation injury and to determine and summarize their outcomes.MethodsWe performed a systematic review by searching Ovid MEDLINE and EMBASE as well as AMED, CINAHL, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews and clinicaltrials.gov from inception to February 2019. All studies other than case reports were eligible for inclusion if the population was younger than 18 years old, there was a surgical intervention aimed at treating extravasation injury and they reported on outcomes. Risk of bias was graded according to the National Institutes of Health (NIH) study quality assessment tools.Results26 studies involving 728 children were included – one before-and-after study and 25 case series. Extravasation injuries were mainly confined to skin and subcutaneous tissues but severe complications were also encountered, including amputation (one toe and one below elbow). Of the surgical treatments described, the technique of multiple puncture wounds and instillation of saline and/or hyaluronidase was the most commonly used. However, there were no studies in which its effectiveness was tested against another treatment or a control and details of functional and aesthetic outcomes were generally lacking.ConclusionThere is a lack of high quality evidence to support treatment of extravasation injury in children. A definitive trial of extravasation injuries, or a centralized extravasation register using a universal grading scheme and core outcome set with adequate follow-up, are required to provide evidence to guide clinician decision-making.Strengths and LimitationsA systematic review was performed according to PRISMA guidelines and registered on PROSPEROTwo authors used a bespoke inclusion/exclusion form to independently assess study eligibilityStudies were eligible for inclusion if the population was younger than 18 years old, if there was a surgical intervention aimed at treating extravasation injury in any setting and if they reported on short- or long-term outcomesTwo researchers also independently assessed the included studies’ risk of methodological bias using the National Institutes of Health (NIH) study quality assessment tools18 years old may represent a relatively arbitrary cut-off age to differentiate between ‘paediatric’ and ‘adult’ in terms of extravasation injury


2020 ◽  
Vol 48 (8) ◽  
pp. e730-e730
Author(s):  
Daniël A. Korevaar ◽  
Jérémie F. Cohen ◽  
Josien van Es

2020 ◽  
Vol 334 ◽  
pp. 117-144
Author(s):  
A. Robert Schnatter ◽  
Martijn Rooseboom ◽  
Neslihan Aygun Kocabas ◽  
Colin M. North ◽  
Abigail Dalzell ◽  
...  

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