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  • Online Resource  (12)
  • BMJ  (12)
  • 1
    Online Resource
    Online Resource
    Targeting the anterior superior iliac spine yields significantly longer bone marrow cores
    BMJ ; 2018
    In:  Journal of Clinical Pathology Vol. 71, No. 2 ( 2018-02), p. 172-173
    Details
    In: Journal of Clinical Pathology, BMJ, Vol. 71, No. 2 ( 2018-02), p. 172-173
    Abstract: Pathologists and haematologists generally agree that the length of the biopsy core is a good surrogate for the diagnostic quality of the bone marrow. Previous studies suggested that the angulation of the biopsy needle from the posterior superior iliac spine (PSIS) could influence the length of the biopsy cores, targeting the anterior superior iliac spine (ASIS) from the PSIS would yield longer specimens than the traditional angulation technique (TAT), where the biopsy needle is directed straight in, perpendicular to the plane of the back. Twenty five adult haematology patients were prospectively recruited by haematologists-in-training (HITs), who were trained to target the ASIS using a lateral angulationtechnique (LAT). The mean length of biopsy cores was 16 mm and that was significantly longer (p=0.003) than a comparable group of bone marrow biopsies previously obtained by HITs using the TAT approach. These results support the LAT as a new standard of haematology practice. Trial registration number NCT 02524613
    Type of Medium: Online Resource
    ISSN: 0021-9746 , 1472-4146
    URL: Article
    DOI: 10.1136/jclinpath-2017-204686
    RVK:
    XA 10000
    Language: English
    Publisher: BMJ
    Publication Date: 2018
    detail.hit.zdb_id: 2028928-5
    detail.hit.zdb_id: 80261-X
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  • 2
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    Factors associated with long-term cardiac dysfunction in neonatal lupus
    BMJ ; 2020
    In:  Annals of the Rheumatic Diseases Vol. 79, No. 2 ( 2020-02), p. 217-224
    Details
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 79, No. 2 ( 2020-02), p. 217-224
    Abstract: Cardiac manifestations of neonatal lupus (NL) have been associated with significant morbidity and mortality; however, there is minimal information on long-term outcomes of affected individuals. This study was initiated to evaluate the presence of and the risk factors associated with cardiac dysfunction in NL after birth in multiple age groups to improve counselling, to further understand pathogenesis and to provide potential preventative strategies. Methods Echocardiogram reports were evaluated in 239 individuals with cardiac NL: 143 from age 0–1 year, 176 from age 〉 1–17 years and 64 from age 〉 17 years. Logistic regression analyses evaluated associations of cardiac dysfunction at each age group with demographic, fetal and postnatal factors, using imputation to address missing data. Results Cardiac dysfunction was identified in 22.4% at age 0–1 year, 14.8% at age 〉 1–17 years and 28.1% at age 〉 17 years. Dysfunction in various age groups was significantly associated with male sex, black race, lower fetal heart rates, fetal extranodal cardiac disease and length of time paced. In 106 children with echocardiograms at ages 0–1 year and 〉 1–17 years, 43.8% with dysfunction at age 0–1 year were also affected at age 〉 1–17 years, while the others reverted to normal. Of children without dysfunction at age 0–1 year, 8.9% developed new dysfunction between ages 〉 1 and 17 years. Among 34 with echocardiograms at ages 〉 1–17 years and 〉 17 years, 6.5% with normal function at age 〉 1–17 years developed dysfunction in adulthood. Conclusions Risk factors in fetal life can influence cardiac morbidity into adulthood. Although limited by a small number of cases, cardiac dysfunction in the first year often normalises by later childhood. New-onset dysfunction, although rare, can occur de novo after the first year.
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
    URL: Article
    DOI: 10.1136/annrheumdis-2019-215900
    RVK:
    XA 10000
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 1481557-6
    detail.hit.zdb_id: 7090-7
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  • 3
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    Complement activation predicts adverse pregnancy outcome in patients with systemic lupus erythematosus and/or antiphospholipid antibodies
    BMJ ; 2018
    In:  Annals of the Rheumatic Diseases Vol. 77, No. 4 ( 2018-04), p. 549-555
    Details
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 77, No. 4 ( 2018-04), p. 549-555
    Abstract: Studies in mouse models implicate complement activation as a causative factor in adverse pregnancy outcomes (APOs). We investigated whether activation of complement early in pregnancy predicts APOs in women with systemic lupus erythematosus (SLE) and/or antiphospholipid (aPL) antibodies. Methods The PROMISSE Study enrolled pregnant women with SLE and/or aPL antibodies (n=487) and pregnant healthy controls (n=204) at 〈 12 weeks gestation and evaluated them monthly. APOs were: fetal/neonatal death, preterm delivery 〈 36 weeks because of placental insufficiency or preeclampsia and/or growth restriction 〈 5th percentile. Complement activation products were measured on serial blood samples obtained at each monthly visit. Results APO occurred in 20.5% of SLE and/or aPL pregnancies. As early as 12–15 weeks, levels of Bb and sC5b-9 were significantly higher in patients with APOs and remained elevated through 31 weeks compared with those with normal outcomes. Moreover, Bb and sC5b-9 were significantly higher in patients with SLE and/or aPL without APOs compared with healthy controls. In logistic regression analyses, Bb and sC5b-9 at 12–15 weeks remained significantly associated with APO (OR adj =1.41 per SD increase; 95% CI 1.06 to 1.89; P=0.019 and OR adj =1.37 per SD increase; 95% CI 1.05 to 1.80; P=0.022, respectively) after controlling for demographic and clinical risk factors for APOs in PROMISSE. When analyses were restricted to patients with aPL (n=161), associations between Bb at 12–15 weeks and APOs became stronger (OR adj =2.01 per SD increase; 95% CI 1.16 to 3.49; P=0.013). Conclusion In pregnant patients with SLE and/or aPL, increased Bb and sC5b-9 detectable early in pregnancy are strongly predictive of APOs and support activation of complement, particularly the alternative pathway, as a contributor to APOs.
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    DOI: 10.1136/annrheumdis-2017-212224
    DOI: 10.1136/annrheumdis-2017-212224.supp1
    DOI: 10.1136/annrheumdis-2017-212224.supp2
    DOI: 10.1136/annrheumdis-2017-212224.supp3
    DOI: 10.1136/annrheumdis-2017-212224.supp4
    DOI: 10.1136/annrheumdis-2017-212224.supp5
    DOI: 10.1136/annrheumdis-2017-212224.supp6
    RVK:
    XA 10000
    Language: English
    Publisher: BMJ
    Publication Date: 2018
    detail.hit.zdb_id: 1481557-6
    detail.hit.zdb_id: 7090-7
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  • 4
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    Cost-effectiveness analysis of probiotic peanut oral immunotherapy (PPOIT) versus placebo in Australian children with peanut allergy alongside a randomised trial
    BMJ ; 2023
    In:  BMJ Open Vol. 13, No. 12 ( 2023-12), p. e075521-
    Details
    In: BMJ Open, BMJ, Vol. 13, No. 12 ( 2023-12), p. e075521-
    Abstract: To compared the cost-effectiveness of coadministration of a probiotic adjuvant with peanut oral immunotherapy (PPOIT) with placebo (no treatment) in children with peanut allergy. Design Prospectively planned cost-effectiveness analysis alongside a randomised control trial. Setting The Royal Children’s Hospital, Melbourne, Australia. Participants 56 children with peanut allergy aged 1–10 years at recruitment. Intervention A daily dose of probiotic Lactobacillus rhamnosus CGMCC 1.3724 (NCC4007) and peanut oral immunotherapy administered for 1.5 years. Main outcomes measures Costs were considered from a healthcare system perspective and included costs of treatment delivery and adverse events. Effectiveness outcomes included rate of sustained unresponsiveness (SU) and quality-adjusted life years (QALYs). The cost-effectiveness of PPOIT versus placebo was analysed using patient-level data. Time horizon was 10 years from commencement of PPOIT treatment, comprising 1.5 years of treatment (actual data), 4 years of post-treatment follow-up (actual data), and 4.5 years of extrapolation thereafter (modelling). Results Healthcare cost per patient over 10 years was higher for PPOIT compared with placebo ($A9355 vs $A1031, p 〈 0.001). Over half of the per patient healthcare cost (53%) in the PPOIT group was attributable to treatment delivery, while the remaining cost was attributable to adverse events. Both measures of effectiveness were superior in the PPOIT group: the average SU rate over 10 years was 54% for PPOIT versus 6% for placebo (p 〈 0.001); QALYs over 10 years were 9.05 for PPOIT versus 8.63 for placebo (p 〈 0.001). Overall, cost per year of SU achieved was $A1694 (range $A1678, $A1709) for PPOIT compared with placebo, and cost per additional QALY gained was $A19 386 (range $A19 024, $A19 774). Conclusions Cost per QALY gained using PPOIT compared with no treatment is approximately $A20 000 (£10 000) and is well below the conventional value judgement threshold of $A50 000 (£25 000) per QALY gained, thus deemed good value for money ($A1= £0.5 approximately). Trial registration number Australian New Zealand Clinical Trials Registry ACTRN12608000594325; Post-results.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2023-075521
    DOI: 10.1136/bmjopen-2023-075521.supp1
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2599832-8
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  • 5
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    Evaluating duration of response to treatment in systemic lupus erythematosus clinical trials
    BMJ ; 2018
    In:  Lupus Science & Medicine Vol. 5, No. 1 ( 2018-08), p. e000266-
    Details
    In: Lupus Science & Medicine, BMJ, Vol. 5, No. 1 ( 2018-08), p. e000266-
    Abstract: To evaluate response duration and identify predictors of transitioning into and out of the response state in patients with SLE receiving standard of care (SoC) in 52-week clinical trials. Methods A multistate model (MSM) allowing for bidirectional transitions between response and non-response states was fit to data on 759 patients with SLE with active disease randomised to SoC. The probability of being in response at 52 weeks, average duration of response (sojourn time) and mean total time in response for SLE Responder Index (SRI-4, SRI-5, SRI-6) and BILAG-based Composite Lupus Assessment (BICLA) were estimated. Predictors of attainment and loss of SRI-5 response were also assessed. Results The MSM estimated probability of being in response at 52 weeks ranged from 42% (SRI-6) to 61% (SRI-4). Mean duration of response ranged from 20.4 weeks (BICLA) to 31.5 weeks (SRI-4). Mean total time in response was 16.4–24.8 weeks. Baseline characteristics predictive of shorter SRI-5 response duration were African descent (p=0.005), longer history of disease (p=0.03), higher anti-dsDNA antibody titres (p=0.039), lower lymphocyte count (p=0.008) and lower haemoglobin (p=0.006). Younger age (p 〈 0.001) and higher protein/creatinine ratio (p 〈 0.001) were associated with higher likelihood of achieving SRI-5 but also shorter response duration. Conclusion Factors associated with disease severity were more predictive of shorter response duration than of 52-week response status. Analysing landmark response rates and response duration using MSM may be a more powerful way to distinguish effective investigational treatments from background SoC, although this remains to be evaluated in future trials.
    Type of Medium: Online Resource
    ISSN: 2053-8790
    URL: Article
    URL: Article
    DOI: 10.1136/lupus-2018-000266
    DOI: 10.1136/lupus-2018-000266.supp1
    Language: English
    Publisher: BMJ
    Publication Date: 2018
    detail.hit.zdb_id: 2779620-6
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  • 6
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    SLE clinical trials: impact of missing data on estimating treatment effects
    BMJ ; 2019
    In:  Lupus Science & Medicine Vol. 6, No. 1 ( 2019-10), p. e000348-
    Details
    In: Lupus Science & Medicine, BMJ, Vol. 6, No. 1 ( 2019-10), p. e000348-
    Abstract: A common problem in clinical trials is missing data due to participant dropout and loss to follow-up, an issue which continues to receive considerable attention in the clinical research community. Our objective was to examine and compare current and alternative methods for handling missing data in SLE trials with a particular focus on multiple imputation, a flexible technique that has been applied in different disease settings but not to address missing data in the primary outcome of an SLE trial. Methods Data on 279 patients with SLE randomised to standard of care (SoC) and also receiving mycophenolate mofetil (MMF), azathioprine or methotrexate were obtained from the Lupus Foundation of America-Collective Data Analysis Initiative Database. Complete case analysis (CC), last observation carried forward (LOCF), non-responder imputation (NRI) and multiple imputation (MI) were applied to handle missing data in an analysis to assess differences in SLE Responder Index-5 (SRI-5) response rates at 52 weeks between patients on SoC treated with MMF versus other immunosuppressants (non-MMF). Results The rates of missing data were 32% in the MMF and 23% in the non-MMF groups. As expected, the NRI missing data approach yielded the lowest estimated response rates. The smallest and least significant estimates of differences between groups were observed with LOCF, and precision was lowest with the CC method. Estimated between-group differences were magnified with the MI approach, and imputing SRI-5 directly versus deriving SRI-5 after separately imputing its individual components yielded similar results. Conclusion The potential advantages of applying MI to address missing data in an SLE trial include reduced bias when estimating treatment effects, and measures of precision that properly reflect uncertainty in the imputations. However, results can vary depending on the imputation model used, and the underlying assumptions should be plausible. Sensitivity analysis should be conducted to demonstrate robustness of results, especially when missing data proportions are high.
    Type of Medium: Online Resource
    ISSN: 2053-8790
    URL: Article
    DOI: 10.1136/lupus-2019-000348
    Language: English
    Publisher: BMJ
    Publication Date: 2019
    detail.hit.zdb_id: 2779620-6
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  • 7
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    Lupus anticoagulant is the main predictor of adverse pregnancy outcomes in aPL-positive patients: validation of PROMISSE study results
    BMJ ; 2016
    In:  Lupus Science & Medicine Vol. 3, No. 1 ( 2016-01), p. e000131-
    Details
    In: Lupus Science & Medicine, BMJ, Vol. 3, No. 1 ( 2016-01), p. e000131-
    Abstract: We previously reported that lupus anticoagulant (LAC) is the main predictor of poor pregnancy outcome in antiphospholipid antibody (aPL)-positive patients. We sought to confirm this finding in an independent group of patients who were subsequently recruited into the PROMISSE study. Methods The PROMISSE study is a multicentre, prospective, observational study of pregnancy outcomes in women with aPL and/or systemic lupus erythematosus (SLE) that enrolled patients from 2003 to 2015. All consecutive, aPL-positive patients from the PROMISSE study who completed their pregnancy between April 2011 and January 2015 (after the previous PROMISSE report) are included in the current report. Patients were followed monthly until delivery, and aPL was tested at first, second and third trimesters of pregnancy and at 12 weeks post partum. Adverse pregnancy outcomes (APOs) were defined as fetal death after 12 weeks of gestation, neonatal death, delivery prior to 36 weeks of gestation due to pre-eclampsia or placental insufficiency or small-for-gestational age (birth weight 〈 5th percentile). Results Forty-four aPL-positive patients are included in this paper. Thirteen patients had APOs, which occurred in 80% of cases during the second trimester of pregnancy. LAC was present in 69% of patients with APOs compared with 27% of patients without APOs (p=0.01). No association was found between anticardiolipin antibodies (aCL) or anti-β2 glycoprotein I antibodies (aβ2GPI) IgG or IgM positivity and APOs. Definite antiphospholipid syndrome (history of thrombosis and/or pregnancy morbidity and aPL) was found in 92% of patients with any APOs compared with 45% of patients without APOs (p=0.004). Conversely, the frequency of SLE was not statistically different between those with and without APOs (30% vs 39%). Conclusions Our findings, in an independent group of aPL-positive patients from the PROMISSE study, confirm that LAC, but not aCL and aβ2GPI, is predictive of poor pregnancy outcomes after 12 weeks of pregnancy. Trial registration number NCT00198068.
    Type of Medium: Online Resource
    ISSN: 2053-8790
    URL: Article
    DOI: 10.1136/lupus-2015-000131
    Language: English
    Publisher: BMJ
    Publication Date: 2016
    detail.hit.zdb_id: 2779620-6
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  • 8
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    Protocol for virtual physical examination in an observational, longitudinal study evaluating virtual outcome measures in SLE
    BMJ ; 2023
    In:  Lupus Science & Medicine Vol. 10, No. 2 ( 2023-07), p. e000952-
    Details
    In: Lupus Science & Medicine, BMJ, Vol. 10, No. 2 ( 2023-07), p. e000952-
    Abstract: There is a lack of data on the use of telemedicine (TM) in SLE. SLE outcome measures remain complex, and clinicians and clinical trialists have raised concerns about the accuracy of virtual disease activity measures. This study evaluates the level of agreement between virtual SLE outcome measures and face-to-face (F2F) encounter. Here, we describe the study design, virtual physical examination protocol and demographics for the first 50 patients evaluated. Methods and analysis This is an observational, longitudinal study of 200 patients with SLE with varying levels of disease activity from 4 academic lupus centres serving diverse populations. Each study participant will be evaluated at a baseline and a follow-up visit. At each visit, participants are evaluated by the same physician first via a videoconference-based TM and then a F2F encounter. For this protocol, virtual physical examination guidelines relying on physician-directed patient self-examination were established. SLE disease activity measures will be completed immediately after the TM encounter and repeated after the F2F encounter for each visit. The degree of agreement between TM and F2F disease activity measures will be analysed using the Bland-Altman method. An interim analysis is planned after the enrolment of the first 50 participants. Ethics and dissemination This study has been reviewed by the Columbia University Medical Center Institutional Review Board (IRB Protocol #: AAAT6574). The full results of this study will be published after the final data analysis of 200 patients. The abrupt shift to TM visits due to the COVID-19 pandemic disrupted clinical practice and clinical trials. Establishing a high level of agreement between SLE disease activity measures obtained with videoconference TM and F2F at the same time point, will allow for improved assessment of disease activity when F2F data cannot be acquired. This information may guide both medical decision-making and provide reliable outcome measures for clinical research.
    Type of Medium: Online Resource
    ISSN: 2053-8790
    URL: Article
    DOI: 10.1136/lupus-2023-000952
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2779620-6
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  • 9
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    Adverse pregnancy outcomes in women with systemic lupus erythematosus: can we improve predictions with machine learning?
    BMJ ; 2022
    In:  Lupus Science & Medicine Vol. 9, No. 1 ( 2022-09), p. e000769-
    Details
    In: Lupus Science & Medicine, BMJ, Vol. 9, No. 1 ( 2022-09), p. e000769-
    Abstract: Nearly 20% of pregnancies in patients with SLE result in an adverse pregnancy outcome (APO). We previously developed an APO prediction model using logistic regression and data from Predictors of pRegnancy Outcome: bioMarkers In Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus (PROMISSE), a large multicentre study of pregnant women with mild/moderate SLE and/or antiphospholipid antibodies. Our goal was to determine whether machine learning (ML) approaches improve APO prediction and identify other risk factors. Methods The PROMISSE data included 41 predictors from 385 subjects; 18.4% had APO (preterm delivery due to placental insufficiency/pre-eclampsia, fetal/neonatal death, fetal growth restriction). Logistic regression with stepwise selection (LR-S), least absolute shrinkage and selection operator (LASSO), random forest (RF), neural network (NN), support vector machines (SVM-RBF), gradient boosting (GB) and SuperLearner (SL) were compared by cross-validated area under the ROC curve (AUC) and calibration. Results Previously identified APO risk factors, antihypertensive medication use, low platelets, SLE disease activity and lupus anticoagulant (LAC), were confirmed as important with each algorithm. LASSO additionally revealed potential interactions between LAC and anticardiolipin IgG, among others. SL performed the best (AUC=0.78), but was statistically indistinguishable from LASSO, SVM-RBF and RF (AUC=0.77 for all). LR-S, NN and GB had worse AUC (0.71–0.74) and calibration scores. Conclusions We predicted APO with reasonable accuracy using variables routinely assessed prior to the 12th week of pregnancy. LASSO and some ML methods performed better than a standard logistic regression approach. Substantial improvement in APO prediction will likely be realised, not with increasingly complex algorithms but by the discovery of new biomarkers and APO risk factors.
    Type of Medium: Online Resource
    ISSN: 2053-8790
    URL: Article
    DOI: 10.1136/lupus-2022-000769
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2779620-6
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  • 10
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    VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health
    BMJ ; 2015
    In:  BMJ Open Vol. 5, No. 12 ( 2015-12), p. e009377-
    Details
    In: BMJ Open, BMJ, Vol. 5, No. 12 ( 2015-12), p. e009377-
    Abstract: Postnatal vitamin D supplementation may be associated with a reduction in IgE-mediated food allergy, lower respiratory tract infections and improved bone health. Countries in the Northern hemisphere recommend universal infant vitamin D supplementation to optimise early vitamin D levels, despite the absence of large trials proving safety or efficacy for any disease outcome. With the aim of determining the clinical and cost-effectiveness of daily vitamin D supplementation in breastfed infants from age 6–8 weeks to 12 months of age, we have started a double-blind, randomised, placebo-controlled trial of daily 400 IU vitamin D supplementation during the first year of life, VITALITY. Methods nd analysis Infants (n=3012) who are fully breastfed and not receiving vitamin D supplementation will be recruited at the time of their first immunisation, from council-led immunisation clinics throughout metropolitan Melbourne, Australia. The primary outcome is challenge-proven food allergy at 12 months of age. Secondary outcomes are food sensitisation (positive skin prick test), number of lower respiratory infections (through hospital linkage), moderately-severe and persistent eczema (by history and examination) and vitamin D deficiency (serum vitamin D 〈 50 nmol/L) at age 12 months. The trial is underway and the first 130 participants have been recruited. Ethics and dissemination The VITALITY study is approved by the Royal Children's Hospital (RCH) Human Research Ethics Committee (#34168). Outcomes will be disseminated through publication and will be presented at scientific conferences. Trial registration numbers ANZCTR12614000334606 and NCT02112734 ; pre-results.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2015-009377
    Language: English
    Publisher: BMJ
    Publication Date: 2015
    detail.hit.zdb_id: 2599832-8
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