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Antiphospholipid Antibody Syndrome (APS)

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General Information

Description

  • systemic autoimmune disorder characterized by thrombotic events or pregnancy morbidity and persistently elevated titers of antiphospholipid antibodies 1, 2, 3
  • most common acquired form of thrombophilia (Rheumatology (Oxford) 2018 Apr 1;57(4):661OpenInNew)
  • most common manifestations of antiphospholipid syndrome include 1, 2
    • venous thrombosis, especially lower extremity deep vein thrombosis and pulmonary embolism
    • arterial thrombosis, most commonly stroke and transient ischemic attack
    • recurrent miscarriages, fetal deaths, and late pregnancy complications such as pre-eclampsia and intrauterine growth restriction
  • patients may also present with other manifestations that include livedo reticularis, nephropathy, thrombocytopenia, hemolytic anemia, and cardiac valve disease1, 2,3

Also called

  • antiphospholipid syndrome
  • aPL syndrome
  • lupus inhibitor syndrome
  • Hughes Syndrome

Definitions

  • antiphospholipid antibodies (aPLs) comprise a heterogeneous family of autoimmune antibodies that may be detected by enzyme-linked immunosorbent assay (ELISA) based solid phase tests (anticardiolipin antibodies [aCL] and antibeta-2 glycoprotein 1 antibodies [GP1] or functional liquid phase tests [lupus anticoagulant (LA)]) 2
    • aCLs are directed against a phospholipid contained in cell membranes called cardiolipin
    • antibeta-2 GP1 antibodies are directed against a cardiolipin-binding factor called beta-2 glycoprotein 1
    • LA is a mixture of various aPL autoantibodies which are detected by the prolongation of phospholipid-dependent coagulation tests ; LA is a misnomer because
      • LA are not specific for (or diagnostic of) lupus
      • anticoagulant properties of LA interfere with phospholipid-mediated clotting in vitro whereas in vivo LA are pro-coagulant
    • Reference - Pathology 2014 Oct;46(6):481OpenInNew
  • primary APS
  • secondary APS is defined as APS associated with another systemic autoimmune disease usually SLE (2)
  • thrombotic APS is APS characterized by venous, arterial, or microvascular thrombosis (1)
  • obstetrical APS is APS characterized by fetal loss after the 10th week of gestation, recurrent early miscarriages, intrauterine growth restriction, or severe preeclampsia (1)
  • seronegative APS is a controversial term used to describe patients who present a clinical picture highly suggestive of APS, but who are persistently negative for criteria aPLs (LA, IgG, and IgM aCL, and IgG and IgM antibeta-2 GP1) when tested on 2 separate occasions
  • catastrophic APS (Asherson syndrome) is a rare and life-threatening form of the disease, defined as intravascular thrombosis affecting ≥ 3 organs or systems and/or tissues simultaneously or within 1 week with histological confirmation of small vessel occlusion 2,3

Types

  • classification of APS by presence of other clinical conditions 3
  • classification of APS based on predominant clinical phenotype(1)
    • thrombotic APS - characterized by venous, arterial, or microvascular thrombosis
    • obstetrical APS - characterized by fetal loss after the 10th week of gestation, recurrent early miscarriages, intrauterine growth restriction, or severe preeclampsia
    • catastrophic APS - rapidly recurring vascular occlusions, predominantly affecting small vessels simultaneously or over a short period of time, and at multiple site (J Autoimmun 2018 Aug;92:1OpenInNew)
  • classification
    • definite APS (revised Sapporo classification criteria)
      • ≥ 1 of clinical criteria and ≥ 1 of laboratory criteria; clinical and laboratory criteria should be separated by > 12 weeks and < 5 years
      • clinical criteria
        • vascular thrombosis
          • including clinical episodes of arterial, venous, or small vessel thrombosis in any organ or tissue
          • thrombosis should be confirmed by objective testing including appropriate imaging studies or histopathology (without significant inflammation in vessel wall)
        • pregnancy morbidity (1 of)
          • ≥ 1 unexplained deaths of morphologically normal fetus ≥ 10 weeks gestational age; normal fetal morphology confirmed by ultrasound or by direct examination of fetus
          • ≥ 1 premature births of morphologically normal neonate < 34 weeks gestational age due to eclampsia, severe pre-eclampsia, or placental insufficiency
          • ≥ 3 unexplained abortions before 10 weeks gestation (maternal anatomic or hormonal abnormalities and parental chromosomal causes excluded)
      • laboratory criteria (on ≥ 2 occasions ≥ 12 weeks apart)
        • lupus anticoagulant in plasma
        • immunoglobulin (IgG and/or IgM) anticardiolipin antibody in serum or plasma (titer > 40 glycopeptidolipid [GPL] or monophosphoryl lipid A [MPL] or > 99th percentile) as measured by enzyme-linked immunosorbent assay (ELISA)
        • IgG or IgM antibeta-2 glycoprotein 1 antibody in serum or plasma (titer > 99th percentile) as measured by ELISA
      • Reference - J Thromb Haemost 2006 Feb;4(2):295OpenInNewfull-textOpenInNew, commentary can be found in J Thromb Haemost 2006 Oct;4(10):2276OpenInNew, Lupus 2008 Aug;17(8):770OpenInNew
    • probable APS (also known as features associated with APS or noncriteria features of APS)
      • features common in APS but not specific, therefore cannot not be used as alternate criteria for definite APS
      • aPL-associated nephropathy
        • presence of aPL with either or both of
          • histopathologic detection of thrombotic microangiopathy involving both arterioles and glomerular capillaries
          • ≥ 1 of
            • fibrous intimal hyperplasia involving organized thrombi with or without recanalization
            • fibrous and/or fibrocellular occlusions of arteries and arterioles
            • focal cortical atrophy
            • tubular thyroidization (large zones of atrophic tubules containing eosinophilic casts)
        • if SLE is also present, above lesions should be differentiated from those resulting from lupus nephropathy
        • excludes vasculitis, thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, malignant hypertension, and other causes for chronic renal ischemia
      • aPL-associated livedo reticularis (LR)
        • presence of both aPL and LR
        • LR is persistent, violaceous, red or blue, reticular or mottled, pattern of skin of trunk, arms or leg that is not reversible with rewarming
        • pathologic changes are confirmative, but not required; include
          • partial or complete occlusion of lumen of small- to medium-sized arteries and/or arterioles at dermis-subcutis border
          • no evidence of perivascular inflammatory infiltrate
          • negative direct immunofluorescence exam
      • aPL-associated thrombocytopenia
        • presence of aPL with thrombocytopenia (< 100 × 109 /L), confirmed ≥ 2 times, 12 weeks apart
        • excludes
          • thrombotic thrombocytopenic purpura
          • disseminated intravascular coagulation
          • pseudo-thrombocytopenia
          • heparin-induced thrombocytopenia
        • can be further categorized by presence or absence of SLE
      • aPL-associated cardiac valve disease
        • presence of aPL with either or both
          • echocardiographic detection of lesions
          • any combination of regurgitation and/or stenosis of mitral and/or aortic valve
        • presence or history of rheumatic fever and infective endocarditis should be excluded
        • may be confirmed by histopathological findings of Libman-Sacks endocarditis in patients with SLE
      • Reference - J Thromb Haemost 2006 Feb;4(2):295OpenInNew full-text, commentary can be found in J Thromb Haemost 2006 Oct;4(10):2276OpenInNew, Lupus 2008 Aug;17(8):770OpenInNew
  • classification according to age
    • pediatric APS
      • reported in neonates and throughout adolescent period
      • currently there is no universally accepted validated diagnostic criteria for pediatric APS; adult criteria for APS reported to be specific for pediatric-onset disease but lacked sensitivity
      • Reference - Front Pediatr 2018;6:362OpenInNewfull-textOpenInNew
    • adult APS
  • classification of APS based on serological findings
    • seropositive APS - patients with definite APS
    • seronegative APS - patients with clinical features highly suggestive of APS but persistently negative results for antiphospholipid antibodies tested using conventional antiphospholipid testing
    • Reference - J Rheumatol 2017 Nov;44(11):1597OpenInNewfull-textOpenInNew

References

General references used

  1. Garcia D, Erkan D. Diagnosis and Management of the Antiphospholipid Syndrome. N Engl J Med. 2018 May 24;378(21):2010-2021OpenInNew, commentary can be found in N Engl J Med 2018 Sep 27;379(13):1289OpenInNew
  2. Schreiber K, Sciascia S, de Groot PG, et al. Antiphospholipid syndrome. Nat Rev Dis Primers. 2018 Jan 11;4:17103OpenInNew
  3. Gómez-Puerta JA, Cervera R. Diagnosis and classification of the antiphospholipid syndrome. J Autoimmun. 2014 Feb;48-49:20-5OpenInNew
  4. Keeling D, Mackie I, Moore GW, Greer IA, Greaves M, British Committee for Standards in Haematology. Guidelines on the investigation and management of antiphospholipid syndrome. Br J Haematol. 2012 Apr;157(1):47-58OpenInNew

Recommendation grading systems used

  • American College of Chest Physicians (ACCP) grades
    • Grade 1 - strong recommendation based on clear risk/benefit balance
    • Grade 2 - weak recommendation based on unclear or close risk/benefit balance
    • Grade A - high-quality evidence based on consistent evidence from randomized trials without important limitations or exceptionally strong evidence from observational studies
    • Grade B - moderate-quality evidence based on randomized trials with important limitations (inconsistent results, methodologic flaws, indirect or imprecise results) or very strong evidence from observational studies
    • Grade C - low- or very low-quality evidence based on evidence for ≥ 1 critical outcome from observational studies, case series, or randomized trials with serious flaws or indirect evidence
    • Reference - ACCP evidence-based clinical practice guideline on methodology for development of antithrombotic therapy and prevention of thrombosis (22315256Chest 2012 Feb;141(2 Suppl):53SOpenInNewfull-textOpenInNew), commentary can be found in 23546508Chest 2013 Apr;143(4):1190OpenInNew
  • American College of Obstetrics and Gynecology (ACOG) grades of recommendation
    • Level A - based on good and consistent scientific evidence
    • Level B - based on limited or inconsistent scientific evidence
    • Level C - based primarily on consensus and expert opinion
    • Reference - ACOG Practice Bulletin 132 on antiphospholipid syndrome (23168789Obstet Gynecol 2012 Dec;120(6):1514OpenInNew), reaffirmed 2015 Jun
  • American Society for Apheresis (ASFA) recommendation grading system
    • categories of indications for therapeutic apheresis
      • Category I - disorders for which apheresis is accepted as first-line therapy, either as primary stand-alone treatment or in conjunction with other modes of treatment
      • Category II - disorders for which apheresis is accepted as second-line therapy, either as stand-alone treatment or in conjunction with other modes of treatment
      • Category III - optimum role of apheresis therapy is not established and decision-making should be individualized
      • Category IV - disorders in which published evidence demonstrates or suggests apheresis to be ineffective or harmful; Institutional Review Board (IRB) approval is desirable if apheresis treatment is undertaken in these circumstances
    • grades of recommendations
      • Grade 1A - strong recommendation, high-quality evidence
        • can apply to most patients in most circumstances without reservation
        • supported by randomized controlled trials (RCTs) without important limitations or overwhelming evidence from observational studies
      • Grade 1B - strong recommendation, moderate-quality evidence
        • can apply to most patients in most circumstances without reservation
        • supported by RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies
      • Grade 1C - strong recommendation, low- or very low-quality evidence
        • recommendation may change when higher quality evidence becomes available
        • supported by observational studies or case series
      • Grade 2A - weak recommendation, high-quality evidence
        • best action may differ depending on circumstances of patients' or societal values
        • supported by RCTs without important limitations or overwhelming evidence from observational studies
      • Grade 2B - weak recommendation, moderate-quality evidence
        • best action may differ depending on circumstances of patients' or societal values
        • supported by RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies
      • Grade 2C - weak recommendation, low- or very low-quality evidence
        • very weak recommendation; other alternatives may be equally reasonable
        • supported by observational studies or case series
    • PubMed31180581Journal of clinical apheresisJ Clin Apher20190601343171-354171Reference - ASFA guideline on use of therapeutic apheresis in clinical practice (J Clin Apher 2019 Jun;34(3):171OpenInNew)
  • British Society for Haematology (BSH/BCSH) GRADE system
    • strength of recommendation
      • Grade 1
        • strong recommendations made when there is confidence that benefits do or do not outweigh harm and burden
        • can be applied uniformly to most patients
        • regard as "recommend"
      • Grade 2
        • weak recommendations made where magnitude of benefit or not is less certain
        • require judicious application to individual patients
        • regard as "suggest"
    • quality of evidence
      • A - high
        • further research very unlikely to change confidence in estimate of effect
        • current evidence derived from randomized clinical trials without important limitations
      • B - moderate
        • further research may well have important impact on confidence in estimate of effect and may change estimate
        • current evidence derived from randomized clinical trials with important limitations or very strong evidence from observational studies or case series
      • C - low
        • further research likely to have important impact on confidence in estimate of effect and likely to change estimate
        • current evidence from observational studies, case series, or just opinion
    • Reference - BSH Grading of Recommendations Assessment, Development and Evaluation (GRADE) system PDFPictureAsPdf
  • European League Against Rheumatism (EULAR) grading system for recommendations
    • strength of recommendations
      • Grade A - directly based on category 1 evidence
      • Grade B - directly based on category 2 evidence or extrapolated recommendations from category 1 evidence
      • Grade C - directly based on category 3 evidence or extrapolated recommendations from category 1 or 2 evidence
      • Grade D - directly based on category 4 evidence or extrapolated recommendations from category 2 or 3 evidence
    • levels of evidence
      • Category 1A - meta-analysis of randomized controlled trials
      • Category 1B - ≥ 1 randomized controlled trial
      • Category 2A - ≥ 1 controlled study without randomization
      • Category 2B - ≥ 1 type of quasi-experimental study
      • Category 3 - descriptive studies, such as comparative studies, correlation studies, or case-control studies
      • Category 4 - expert committee reports or opinions and/or clinical experience of respected authorities
    • Reference - EULAR recommendations for patients with systemic lupus erythematosus (SLE) and antiphospholipid antibodies (aPLs) (17504841Ann Rheum Dis 2008 Feb;67(2):195OpenInNewfull-textOpenInNew)
  • European League Against Rheumatism (EULAR) 2019 grading system for recommendations
    • grade of recommendation
      • Grade A - consistent level 1 studies
      • Grade B - consistent level 2 or 3 studies, or extrapolations from level 1 studies
      • Grade C - level 4 studies or extrapolations from level 2 or 3 studies
      • Grade D - level 5 evidence or troublingly inconsistent or inconclusive studies of any level
    • level of evidence
      • Level 1a - systematic review of randomized controlled trials (RCTs)
      • Level 1b - individual RCT
      • Level 2a - systematic review of cohort studies
      • Level 2b - individual cohort study (and low-quality RCT)
      • Level 3a - systematic review of case control studies
      • Level 3b - individual case control study
      • Level 4 - case series and poor quality cohort and case control studies
      • Level 5 - expert opinion without explicit critical appraisal, or based on physiology, bench research or ‘first principles’
    • References -
  • McMaster RARE-Bestpractices grading recommendations
    • recommendations
      • Strong recommendation - benefits clearly outweigh risk and burdens, or vice versa
      • Conditional recommendation - benefits closely balanced with risks and burden
    • levels of evidence
      • High-quality evidence - randomized controlled trials (RCTs) without important limitations or overwhelming evidence from observational studies
      • Moderate-quality evidence - RCTs with important limitations (inconsistent results, methodological flaws, indirect or imprecise) or exceptionally strong evidence from observational studies
      • Low- or very low-quality evidence - observational studies or case series
    • Reference - McMaster RARE-Bestpractices clinical practice guideline on diagnosis and management of the catastrophic antiphospholipid syndrome (J Thromb Haemost 2018 Jun 7 early onlineOpenInNew)
  • International Congress on Antiphospholipid Antibodies (ICAA) Task Force grades of recommendation
    • grade of recommendation
      • Grade 1 - strong recommendation, desirable effects clearly outweigh undesirable effects, or vice versa
      • Grade 2 - weak recommendation, desirable effects closely balanced with undesirable effects
    • quality of evidence
      • Level A - consistent evidence from randomized controlled trials (RCTs) without important limitations, or exceptionally strong evidence from observational studies
      • Level B - evidence from RCTs with important limitations (inconsistent results, methodological flaws, indirect or imprecise), or very strong evidence from observational studies
      • Level C - Evidence from ≥ 1 critical outcome from observational studies, case series, or from RCTs with serious flaws or indirect evidence
    • Reference - 13th International Congress on antiphospholipid antibodies evidence-based recommendations for the prevention and long-term management of thrombosis in antiphospholipid antibody-positive patients (Lupus 2011 Feb;20(2):206OpenInNew)
  • Pan-American League of Associations of Rheumatology (PANLAR) uses Grades of Recommendation, Assessment, Development, and Evaluation (GRADE)
    • strength of recommendation
      • Strong recommendation - benefits clearly outweighs harms and burdens, or vice versa
      • Moderate recommendation - benefit from following recommendation, despite some level of uncertainty about magnitude of benefit of intervention or relative net benefit of alternative courses of action
      • Weak recommendation
        • with high- or moderate-quality evidence, benefits closely balanced with harms and burdens
        • with low-quality evidence, uncertainty in estimates of benefits, harms, and burdens; benefits may be closely balanced with harms and burdens
        • with very low-quality evidence, major uncertainty in estimates of benefits, harms, and burdens; benefits may or may not be balanced with harms and burdens
    • level of evidence
      • High - consistent evidence from well-performed randomized controlled trials (RCTs) or exceptionally strong evidence from unbiased observational studies
      • Moderate - evidence from RCTs with important limitations (inconsistent results, methodological flaws, indirect or imprecise evidence) or unusually strong evidence from unbiased observation studies
      • Low - evidence for ≥ 1 critical outcome from observational studies, from RCTs with serious flaws, or indirect evidence
      • Very low - evidence for ≥ 1 of the critical outcomes from unsystematic clinical observations or very indirect evidence
    • consensus statements
      • Consensus - Panel expertise - expert knowledge, practice experience, and ability to extrapolate evidence from nonsickle cell disease populations when
        • systematic reviews conducted by methodology team revealed minimal or no supporting evidence
        • systematic review not feasible due to anticipated low or no yield
      • Consensus - Adapted - based on expert knowledge to adapt recommendations from existing guidelines and synthesized evidence developed by other professional societies
    • Reference - Latin American Group for the Study of Lupus (Grupo Latino Americano de Estudio del Lupus [GLADEL] - PANLAR First Latin American clinical practice guidelines for the treatment of systemic lupus erythematosus (Ann Rheum Dis 2018 Nov;77(11):1549OpenInNew)
  • Royal College of Obstetricians and Gynaecologists (RCOG) grades of recommendations and classification of evidence levels
    • grades of recommendation
      • Grade A
        • ≥ 1 meta-analysis, systematic review, or randomized controlled trial rated as 1++ and directly applicable to target population, or
        • systematic review of randomized controlled trials or body of evidence consisting principally of studies rated as 1+ directly applicable to target population and demonstrating overall consistency of results
      • Grade B
        • body of evidence including studies rated as 2++ directly applicable to target population and demonstrating overall consistency of results, or
        • extrapolated evidence from studies rated as 1++ or 1+
      • Grade C
        • body of evidence including studies rated as 2+ directly applicable to target population and demonstrating overall consistency of results, or
        • extrapolated evidence from studies rated as 2++
      • Grade D
        • evidence level 3 or 4, or
        • extrapolated evidence from studies rated as 2+
      • Good practice point (GPP) - recommended best practice based on clinical experience of guideline development group
    • classification of evidence levels
      • Level 1++ - high-quality meta-analyses, systematic reviews of randomized controlled trials, or randomized controlled trials with very low risk of bias
      • Level 1+ - well-conducted meta-analyses, systematic reviews of randomized controlled trials, or randomized controlled trials with low risk of bias
      • Level 1- - meta-analyses, systematic reviews of randomized controlled trials, or randomized controlled trials with high risk of bias
      • Level 2++ - high-quality systematic reviews of case-control or cohort studies or high-quality case-control or cohort studies with very low risk of confounding, bias, or chance and high probability that relationship is causal
      • Level 2+ - well-conducted case-control or cohort studies with low risk of confounding, bias, or chance and moderate probability that relationship is causal
      • Level 2- - case-control or cohort studies with high risk of confounding, bias, or chance and significant risk that relationship is not causal
      • Level 3 - nonanalytical studies, such as case reports or case series
      • Level 4 - expert opinion
    • Reference - RCOG investigation and treatment of couples with recurrent first-trimester and second-trimester miscarriage (RCOG 2011 MayPictureAsPdf)
  • European Society of Human Reproduction and Embryology (ESHRE) guideline recommendations
    • recommendation
      • Strong - most individuals would want the recommended course of action, adherence to the recommendation could be used as a quality criterion or performance indicator, recommendation can be adopted as policy in most situations
      • Conditional - majority of individuals would want suggested course of action, but many would not; different choices will be appropriate for individual patients, each patient must arrive at a management decision consistent with his or her values and preferences, decision aids may be useful
      • Good practice point (GPP) - no recommendation, based on clinical expertise
    • levels of evidence
      • High
      • Moderate
      • Low
      • Very-low
    • Reference - ESHRE guideline on recurrent pregnancy loss (ESHRE 2018 MarPictureAsPdf)

Synthesized Recommendation Grading System for DynaMed

  • DynaMed systematically monitors clinical evidence to continuously provide a synthesis of the most valid relevant evidence to support clinical decision-making (see 7-Step Evidence-Based MethodologyOpenInNew).
  • Guideline recommendations summarized in the body of a DynaMed topic are provided with the recommendation grading system used in the original guideline(s), and allow DynaMed users to quickly see where guidelines agree and where guidelines differ from each other and from the current evidence.
  • In DynaMed (DM), we synthesize the current evidence, current guidelines from leading authorities, and clinical expertise to provide recommendations to support clinical decision-making in the Overview & Recommendations section.
  • We use the Grading of Recommendations Assessment, Development and Evaluation (GRADE)OpenInNew to classify synthesized recommendations as Strong or Weak.
    • Strong recommendations are used when, based on the available evidence, clinicians (without conflicts of interest) consistently have a high degree of confidence that the desirable consequences (health benefits, decreased costs and burdens) outweigh the undesirable consequences (harms, costs, burdens).
    • Weak recommendations are used when, based on the available evidence, clinicians believe that desirable and undesirable consequences are finely balanced, or appreciable uncertainty exists about the magnitude of expected consequences (benefits and harms). Weak recommendations are used when clinicians disagree in judgments of relative benefit and harm, or have limited confidence in their judgments. Weak recommendations are also used when the range of patient values and preferences suggests that informed patients are likely to make different choices.
  • DynaMed (DM) synthesized recommendations (in the Overview & Recommendations section) are determined with a systematic methodology:
    • Recommendations are initially drafted by clinical editors (including ≥ 1 with methodological expertise and ≥ 1 with content domain expertise) aware of the best current evidence for benefits and harms, and the recommendations from guidelines.
    • Recommendations are phrased to match the strength of recommendation. Strong recommendations use "should do" phrasing, or phrasing implying an expectation to perform the recommended action for most patients. Weak recommendations use "consider" or "suggested" phrasing.
    • Recommendations are explicitly labeled as Strong recommendations or Weak recommendations when a qualified group has explicitly deliberated on making such a recommendation. Group deliberation may occur during guideline development. When group deliberation occurs through DynaMed-initiated groups:
      • Clinical questions will be formulated using the PICO (Population, Intervention, Comparison, Outcome) framework for all outcomes of interest specific to the recommendation to be developed.
      • Systematic searches will be conducted for any clinical questions where systematic searches were not already completed through DynaMed content development.
      • Evidence will be summarized for recommendation panel review including for each outcome, the relative importance of the outcome, the estimated effects comparing intervention and comparison, the sample size, and the overall quality rating for the body of evidence.
      • Recommendation panel members will be selected to include at least 3 members that together have sufficient clinical expertise for the subject(s) pertinent to the recommendation, methodological expertise for the evidence being considered, and experience with guideline development.
      • All recommendation panel members must disclose any potential conflicts of interest (professional, intellectual, and financial), and will not be included for the specific panel if a significant conflict exists for the recommendation in question.
      • Panel members will make Strong recommendations if and only if there is consistent agreement in a high confidence in the likelihood that desirable consequences outweigh undesirable consequences across the majority of expected patient values and preferences. Panel members will make Weak recommendations if there is limited confidence (or inconsistent assessment or dissenting opinions) that desirable consequences outweigh undesirable consequences across the majority of expected patient values and preferences. No recommendation will be made if there is insufficient confidence to make a recommendation.
      • All steps in this process (including evidence summaries which were shared with the panel, and identification of panel members) will be transparent and accessible in support of the recommendation.
    • Recommendations are verified by ≥ 1 editor with methodological expertise, not involved in recommendation drafting or development, with explicit confirmation that Strong recommendations are adequately supported.
    • Recommendations are published only after consensus is established with agreement in phrasing and strength of recommendation by all editors.
    • If consensus cannot be reached then the recommendation can be published with a notation of "dissenting commentary" and the dissenting commentary is included in the topic details.
    • If recommendations are questioned during peer review or post publication by a qualified individual, or reevaluation is warranted based on new information detected through systematic literature surveillance, the recommendation is subject to additional internal review.

DynaMed Editorial Process

Special acknowledgements

On behalf of the American College of Physicians
  • Barbara Turner, MD, MSEd, MACP, ACP Deputy Editor, Clinical Decision Resource, as part of the ACP-EBSCO Health collaboration, managed the ACP peer review of the Overview and Recommendations section and related clinical content in this topic.
  • DynaMed topics are written and edited through the collaborative efforts of the above individuals. Deputy Editors, Section Editors, and Topic Editors are active in clinical or academic medical practice. Recommendations Editors are actively involved in development and/or evaluation of guidelines.
  • Editorial Team role definitions
    Topic Editors define the scope and focus of each topic by formulating a set of clinical questions and suggesting important guidelines, clinical trials, and other data to be addressed within each topic. Topic Editors also serve as consultants for the internal DynaMed Editorial Team during the writing and editing process, and review the final topic drafts prior to publication.
    Section Editors have similar responsibilities to Topic Editors but have a broader role that includes the review of multiple topics, oversight of Topic Editors, and systematic surveillance of the medical literature.
    Recommendations Editors provide explicit review of DynaMed Overview and Recommendations sections to ensure that all recommendations are sound, supported, and evidence-based. This process is described in "Synthesized Recommendation Grading."
    Deputy Editors are employees of DynaMed and oversee DynaMed internal publishing groups. Each is responsible for all content published within that group, including supervising topic development at all stages of the writing and editing process, final review of all topics prior to publication, and direction of an internal team.

How to cite

National Library of Medicine, or "Vancouver style" (International Committee of Medical Journal Editors):

  • DynaMed [Internet]. Ipswich (MA): EBSCO Information Services. 1995 - . Record No. T115478, Antiphospholipid Antibody Syndrome (APS); [updated 2018 Nov 30, cited place cited date here]. Available from https://www.dynamed.com/topics/dmp~AN~T115478. Registration and login required.

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