These are considered the first guidelines using the GRADE method for the monitoring of SLE. Existing evidence is largely of low to moderate quality, resulting in more conditional than strong recommendations. Additional rigorous studies and special attention to pediatric SLE populations and patient preferences are needed.
Background Despite validated clinical measures and indices of disease activity and damage, utilisation of these indices in clinical practice varies, as evidenced by a recent practice pattern survey of Canadian rheumatologists. In this review, we aimed to identify the impact of disease activity and damage on outcomes of mortality and damage to inform upcoming Canadian SLE recommendations utilising the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method. Materials and methods Following GRADE methodology to fill in evidence-to-decision tables to create recommendations for "minimal investigations needed to monitor SLE patients at baseline and subsequent visits", a systematic review of the literature including all relevant articles from 1946 to November 2014 was performed searching Medline and Embase. The impact of disease activity and damage measured by commonly utilised indices of disease activity [eg SLEDAI-2K (SLE Disease Activity Index-2000), BILAG (British Isles Lupus Assessment Group), SLAM (SLE Activity Measure), ECLAM (European Consensus Lupus Activity Measurement)], Mexican SLEDAI, and damage [SDI [SLICC/ACR (Systemic Lupus International Collaborating Clinics/ACR Damage Index)] on mortality, damage, and disease flares was evaluated with meta-analyses performed when available. Study quality was assessed by the Newcastle Ottawa scale for observational studies. Results A title screen of 2797 articles identified 771 papers for full paper review, 106 meeting inclusion criteria and 88 with extractable data. Fifty-five articles describing outcomes with disease activity indices (including BILAG, ECLAM, Mexican SLE-DAI, SLEDAI-2K/SELENA-SLEDAI and SLAM) and twenty-four articles describing outcomes with damage based on SDI were identified. Mortality was associated with higher SLEDAI-2K in 6 observational studies [HR 1.14 (95% CI: 1.06,1.22)] and in 5 observational studies with higher SDI scores at baseline and/or immediately prior to death [HR 1.53 (95% CI: 1.28, 1.83)]. Higher SLAM scores were associated with increased risk of damage (SDI > 0) in 3 observational studies [OR 1.06 (95% CI: 1.04, 1.08]. Mean total BILAG was associated with mortality in one observational study with HR of 1.15. Conclusions Active lupus disease activity and presence of damage as represented by multiple clinical indices are associated with greater mortality and morbidity in lupus patients. Given the complexity of clinical assessments in SLE patients, the utilisation of validated measures for disease activity and damage is important and will serve to inform upcoming Canadian recommendations for the diagnosis and monitoring of SLE.
ACR damage index (SDI) and HR-QoL by EQ-5D were measured. Bivariate analysis through chi squared and U Mann Whitney Multivariate analysis was performed by logistic regression to adjust for significant associations. Statistical analysis for related samples was evaluated with Mc. Nemar test. Results We analyzed 400 Colombian patients. Baseline median age was 49 years (15 IQR) with median age at diagnosis and disease duration of 37 years (17 IQR) and 9 years (13 IQR) respectively. There were 94% female patients and 17.3% late onset SLE. Most frequent clinical manifestations were hematological (82.8%), mucocutaneous (75.3%) and nephritis (33.8%). Only 4.5% had neurological involvement. The mean SLEDAI were 1.18 and 0.65 at first and second measurement respectively, in the first measurement 97.1% of the patients had a SLEDAI £4. The mean SDI was 0.7275 at first measurement and 0.985 at the second measurement. Although SDI was associated to various dimensions of HR-QoL measured by ED-5D, disease activity was not related (See table 1). Conclusions In SLE Colombian patients with a stablished disease and an altered HR-QoL, low disease activity is not related with HR-QoL when measured by EQ-5d. In the present study, it is highlighted that while disease activity decreases, damage increases. Damage accrual has a relation with HR-QoL in the short term. The impact and correlation must be better defined in a long-term follow-up. The associated effect on HRQOL emphasizes the need for strategies to reduce the risk of cumulative organ damage.
INTRODUCTION Thrombophilia is associated with an increased risk of venous thromboembolism (VTE). Despite this link, determining the presence or absence of such conditions has no role in VTE management including determining the choice or duration of anticoagulant therapy. Testing can be potentially harmful when results are misinterpreted or impact patient anxiety and insurance eligibility. METHODS We performed a retrospective chart review of adult patients presenting to the emergency department (ED) or were admitted to the University of Alberta Hospital (UAH), Royal Alexandra Hospital (RAH) and Grey Nuns Hospital (GNH) and underwent any number of thrombophilia tests (including factor V Leiden [FVL], prothrombin gene mutation [PT20210], protein C [PC], protein S [PS], antithrombin [AT] and antiphospholipid antibody testing). To assess for appropriateness of testing, categories of data were collected including presence of other strong risk factors obviating the need to look for other causes, indicators for higher yield (age of patient, presence of family history of VTE, idiopathic nature of VTE), presence of factors that confound testing (such as therapeutic anticoagulation) and relevant follow up (appropriate repeat testing when necessary). We also collected basic patient demographics, VTE details and ordering physician/service details to evaluate under what circumstances testing may be ordered more frequently. RESULTS 134 charts of patients tested for thrombophilia were reviewed between 2007-2013 at UAH and RAH Hospitals. A total of 965 thrombophilia tests were done (see analysis table). 13.4% of the testing was ordered by hematologists, 23.1% by neurologists, 52.2% by other internists. Overall, all patients had tests performed inappropriately, lacked appropriate follow up or had uninterpretable results and none had documented counseling prior to thrombophilia testing. CONCLUSIONS Thrombophilia testing is frequently ordered inappropriately and not adequately followed up. Strategies to educate physicians on indications and limitations of testing are warranted. These strategies can help decrease over/under/misinterpretation of thrombophilia testing as well as result in significant savings to the health care system if testing can be reduced. Table 1. Demographics Sample Size Males Females Total 74 (55.22%) 60 (44.78%) 134 (100%) Age at time of testing (Yrs) Range 19-88 Average 48.7 Patients' Test Results Test Times Performed Abnormal Results APCR 134 (100%) 32 (23.8%) FVL genetic test 58 (43%) 21 (39%) PT20210 105 (77%) 4 (3.8%) Protein C 100 (74.1%) 8 (8%) Protein S 99 (73.3%) 16 (16.2%) AT levels 99 (73.3%) 19 (19.2%) Anticardiolipin Ab 117 (86.7%) 4 (3.4%) Lupus Anticoagulant 109 (81.3%) 10 (10.2%) Provoking Factors Patients with One or More Provoking Factors Major 10 7.4% Moderate 74 56% Minor 29 21.8% No Provoking Factors 49 36.8% Family History of VTE 12 8.9% Protein C and Protein S Testing Done During Acute VTE 64 64% Patient was on Warfarin 25 25% Number of Abnormal Test Results 24 16% Number of Repeated Abnormal Tests 0 0% AT Testing Total Tests Performed 99 73.3% Done During Acute VTE 62 63% Patient was on Therap. Heparin or LMWH 62 62.6% Number of Abnormal Test Results 19 19.2% Abnormal Tests Repeated? 7 37% Repeat Tests Showing Normal Results 3 57% APA Testing Tests were Repeated After 12 Weeks for Confirmation 11% Disclosures Wu: Leo Pharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees.
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