Meta AnalysisID 2619
化学发光免疫分析法检测β2糖蛋白I结构域1 IgG自身抗体用于识别高危抗磷脂综合征患者：一项系统评价
CRD42022346301
What is the effectiveness of the determination of autoantibodies to domain 1 of beta 2 glycoprotein I (anti-D1 ß2GPI IgG) by chemiluminescence for the detection of patients with antiphospholipid syndrome (APS) at high ri
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Record Fields
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- Meta Analysis Id
- 2619
- Evidence Id
- 11177
- Core Evidence Id
- 11177
- Source Meta Analysis Id
- 2571
- Herb2 Meta Analysis Id
- HBMA002571
- Crd Id
- CRD42022346301
- Title
- Determination of autoantibodies to domain 1 of beta 2 glycoprotein I IgG by chemiluminescence immunoassay for the identification of high-risk antiphospholipid syndrome patients: a systematic review
- Review Question
- What is the effectiveness of the determination of autoantibodies to domain 1 of beta 2 glycoprotein I (anti-D1 ß2GPI IgG) by chemiluminescence for the detection of patients with antiphospholipid syndrome (APS) at high risk of thrombotic or obstetric events? What is the cost-effectiveness of the determination of anti-D1 ß2GPI IgG by chemiluminescence for the detection of patients with APS at high risk of thrombotic or obstetric events? What are the ethical, legal, patient and social, organizational and environmental aspects related to the technology?
- Study Type Included
- Only original published randomized controlled trials (RCTs) will be considered for the assessment of effectiveness. The following designs will be excluded: - Systematic reviews. - Non-randomized clinical trials (non-RCTs ). - Pre-post design. - Longitudinal observational and cross-sectional studies. - Case series/isolated cases. - Animal studies. - In-vitro studies. In the absence of such designs, prospective and retrospective longitudinal and diagnostic performance studies that performed an evaluation of the prognostic and diagnostic value of anti-D1 ß2GPI IgG will be reviewed. For the assessment of cost-effectiveness, only complete economic evaluations in parallel to primary studies or economic models will be included. Depending on the quantity and quality of economic evaluations identified, cost-consequence analysis and partial economic evaluations carried out in Spain will be considered. For the assessment of the ethical, legal, patient, social, organizational and environmental aspects related to technology, observational studies, qualitative and mixed methods studies, systematic and narrative reviews, opinions and editorials will be included.
- Condition Being Studied
- Antiphospholipid syndrome (ICD-10 code D68.61).
- Participant
- Patients suspected of suffering from antiphospholipid syndrome with high risk for thrombotic and/or obstetric events.
- Animal
- Human Disease Modelled
- Intervention
- Determination of anti-D1 ß2GPI IgG by chemiluminescence together with the classic antiphospholipid antibodies: lupus anticoagulant (LA), anticardiolipin antibody (aCL), and anti-beta 2 glycoprotein 1 (anti-ß2GPI).
- Comparator Control
- Determination of the classic antiphospholipid antibodies alone: LA, aCL, anti-ß2GPI.
- Main Outcome
- For the assessment of effectiveness, outcome measures will be maternal morbidity and mortality, prenatal, perinatal and postnatal mortality, thrombotic events, comorbidities, change in treatment decision and patient risk stratification. In the case of including diagnostic performance studies, the main outcome measures will be the diagnostic performance (rate of identification of high-risk APS) and the diagnostic accuracy of the tests (sensitivity, specificity, false negatives, false positives, area under the curve). For the assessment of cost-effectiveness, outcome measures will be incremental cost-effectiveness ratio (ICER), incremental cost-utility ratio, costs in monetary units, quality-adjusted life years (QALYs), life-years gained (LYG), benefits in monetary units or any of the outcome measures selected in the effectiveness review. For the assessment of the ethical, legal, patient and social, organizational and environmental aspects related to technology, the main outcomes will be assessed in agreement with appraisal domains established in the HTA Core Model® on ethical, patient, social, legal and organizational and environmental aspects. Measures of effect Risk ratios (RR), odds ratios (OR) or hazard ratios (HR) for the assessment effectiveness or prognostic. Detection rate of high-risk APS, sensitivity, specificity, false negatives, false positives, and area under the ROC curve for diagnostic evaluation.
- Outcome Measure
- Additional Outcome
- Health-related quality of life (HRQoL), other Patient Reported Outcome Measures (PROMs) or Patient Reported Experiences of Care (PREMs). Measures of effect Mean differences (MDs) or Standardized mean differences (SMDs).
- Study Method
- Cost effectiveness, Diagnostic, Meta-analysis, Prognostic, Synthesis of qualitative studies, Systematic review
- Keyword
- Antibodies, Anticardiolipin; Antiphospholipid Syndrome; Humans; Immunoassay; Immunoglobulin G; Luminescence; beta 2-Glycoprotein I
- Contact
- Tasmania del Pino-Sedeño [email protected]
- Organisational Affiliation
- Canary Islands Health Research Institute Foundation (FIISC) https://fciisc.org/
- Funding Source
- This work is supported by the Spanish Ministry of Health in the framework of the activities developed by the Spanish Network of Agencies for Health Technology Assessment for the National Health Service (RedETS).
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- Spain
- Review Stage
- Review Ongoing
- First Submission Date
- 2022-07-19
- Registration Date
- 2022-07-30
- Anticipated Start Date
- 2022-03-21
- Anticipated Completion Date
- 2023-03-21
- Title Cn
- 化学发光免疫分析法检测β2糖蛋白I结构域1 IgG自身抗体用于识别高危抗磷脂综合征患者：一项系统评价
- Title En
- Determination of autoantibodies to domain 1 of beta 2 glycoprotein I IgG by chemiluminescence immunoassay for the identification of high-risk antiphospholipid syndrome patients: a systematic review
- Bilingual Status
- complete