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BackgroundLupus is a heterogenous diseases which results in significant premature mortality. Most studies have evaluated risk factors for lupus mortality using regression models which considers the phenotype in isolation. Identifying clusters of patients on the other hand may help overcome the limitations of such analyses.ObjectivesThe objectives of this study were to describe the causes of mortality and to analyze survival across clusters based on clinical phenotype and autoantibodies in patients of the Indian SLE Inception cohort for Research (INSPIRE)MethodsOut of all patients, enrolled in the INSPIRE database till March 3st 2022, those who had <10% missing variables in the clustering variables were included in the study. The cause of mortality and duration between the recruitment into the cohort and mortality was calculated. Agglomerative unsupervised hierarchical cluster analysis was performed using 25 variables that define SLE phenotype in clinical practice. The number of clusters were fixed using the elbow and silhouette methods. Survival rates were examined using Cox proportional hazards models: unadjusted, adjusted for age at disease onset, socio-economic status, steroid pulse, CYC, MMF usage and cluster of the patients.ResultsIndian patients with lupus have significant early mortality and the majority of deaths occurs outside the hospital setting.Out of 2211 patients in the cohort, 2072 were included into the analysis. The median (IQR) age of the patients was 26 (20-33) years and 91.7% were females. There were 288 (13.1%) patients with juvenile onset lupus. The median (range) duration of follow up of the patients was 37 (6-42) months. There were 170 deaths, with only 77 deaths occurring in a health care setting. Death within 6 months of enrollment occured in in 80 (47.1%) patients. Majority (n=87) succumbed to disease activity, 23 to infections, 24 to coexisting disease activity and infection and 21 to other causes. Pneumonia was the leading cause of death (n=24). Pneumococcal infection led to death in 11 patients and SARS-COV2 infection in 7 patients. The hierarchical clustering resulted in 4 clusters and the characteristics of these clusters are represented in a heatmap (Figure-1A,B). The mean (95% confidence interval [95% CI] survival was 39.17 (38.45-39.90), 39.52 (38.71-40.34), 37.73 (36.77-38.70) and 35.80 (34.10-37.49) months (p<0.001) in clusters 1, 2, 3 and 4, respectively with an HR (95% CI) of 2.34 (1.56, 3.49) for cluster 4 with cluster 1 as reference(Figure 1C). The adjusted model showed an HR (95%CI) for cluster 4 of 2.22 (1.48, 3.22) with an HR(95%CI) of 1.78 (1.29, 2.45) for low socioeconomic status as opposed to a high socioeconomic status (Table 1).ConclusionIndian patients with lupus have significant early mortality and the majority of deaths occurs outside the hospital setting. Disease activity as determined by the traditional activity measures may not be sufficient to understand the true magnitude of organ involvement resulting in mortality. Clinically relevant clusters can help clinicians identify those at high risk for mortality with greater accuracy.Table 1.Univariate and multivariate Cox regression models predicting mortalityUnivariateMultivariateVariablesHazard ratio (95% Confidence interval)P valueHazard ratio (95% Confidence interval)P valueCluster1Reference-Reference-20.87 (0.57, 1.34)0.5320.89 (0.57, 1.38)0.59831.22 (0.81, 1.84)0.3371.15 (0.76, 1.73)0.51342.34 (1.56, 3.49)<0.0012.22(1.48, 3.22)<0.001Socioeconomic statusLower1.78 (1.29, 2.45)<0.001Pulse steroidYes1.6 (0.99, 2.58)0.051MMFYes0.71 (0.48, 1.05)0.083CYCYes1.42 (0.99, 2.02)0.052Proliferative LNYes0.99 (0.62, 1.56)0.952Date of birth age0.99 (0.98, 1.01)0.657CYC- cyclophosphamide, MMF- Mycophenolate mofetilFigure 1.A. Agglomerative clustering dendrogram depicting the formation of four clusters. B.Heatmap depicting distribution of variables used in clustering C. Kaplan-Meier curve showing the survival function across the 4 clusters[Figure omitted. See PDF]REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone eclared.
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Background: Vaccine against COVID-19 is an effective preventive measure;however, systemic lupus erythematosus (SLE) patients were excluded from the vaccine trials, which leads to questions regarding vaccine safety and efficacy, giving rise to vaccine hesitancy. We aim to study the prevalence of vaccine hesitancy among SLE patients and study the factors affecting it. Method(s): The study is a cross-sectional telephone-based survey done on SLE patients. The questionnaire included a series of 15 questions pertaining to their baseline characteristics, COVID-19 infection and vaccination details, and their perceptions regarding the COVID-19 vaccine. Nonvaccinated individuals were defined as 'willing' and 'hesitant' based on their intent to get vaccinated. Result(s): Among 418 (93% women) participants, about 8% had contracted COVID-19 infection in the past. Nearly half had been vaccinated against COVID-19, and 83% had experienced one or more side effects which were largely mild. Out of the 215 nonvaccinated participants, 84% were 'willing' and 16% were 'hesitant.' Among the reasons for hesitancy, hasty vaccine production, fear of SLE flares, general vaccine refusal and limited transport facilities were significant. On the whole, 65.1% had a positive attitude toward the vaccine. Conclusion(s): Despite a low-hesitancy rate, the number of SLE patients with a negative attitude toward the COVID-19 vaccine is reasonably high, with more than half of the patients yet to be vaccinated. This highlights that the mistrust and negative perceptions of the vaccine still persists. The role of health-care providers in vaccine acceptance in SLE patients is crucial. Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.
Résumé
Introduction/Background MIRRORS (Minimally Invasive Robotic surgery, Role in optimal debulking Ovarian cancer, Recovery & Survival) is the largest prospective cohort study of robotic interval debulking surgery (IDS) in women with advanced-stage epithelial ovarian cancer (EOC) to date. MIRRORS has investigated the feasibility of obtaining consent from women, the acceptability and success of robotic IDS and its impact on short-term surgical outcomes and quality of life. Methodology Eligibility Women with FIGO IIIc-IVb EOC undergoing neoadjuvant chemotherapy and suitable for IDS. Exclusions: pelvic mass >8cm, extensive HPB and/or extensive bowel involvement. Surgery commenced with an initial laparoscopic assessment, for all women recruited, followed by a decision to proceed immediately to robotic or open IDS. Result(s) 23/24 eligible women recruited. Following initial diagnostic laparoscopy, 20 women proceeded directly to robotic IDS, 3 women received open IDS. All patients were debulked with maximal surgical effort to R<1, 39% to R=0. No robotic cases were converted to open. Median EBL for robotic IDS: 50ml, open: 2026ml, median operating time 05:58 robotic vs 05:38 open, length of stay (LOS) 1.5 days robotic vs 6 days open. Bowel resection with stapled anastomosis 15% (3/20), diaphragmatic stripping 60% (12/20), fullthickness diaphragmatic resection 5% (1/20), pelvic peritoneal stripping 70% (14/20). Conclusion MIRRORS has shown significantly enhanced recovery with short LOS, reduced blood loss and reduced HDU/ITU demands, enabling faster re-commencement of chemotherapy in women with FIGO IIIc-IVb EOC. This proved to be greatly beneficial during the COVID-19 pandemic. In experienced hands robotic IDS proved feasible in cases with a pelvic mass up to 8cm. Robotic surgery is not suitable for peritoneal disease covering the anterior abdominal wall close to port sites but does facilitate pelvic and diaphragmatic stripping and arguably provides better visualisation of these peritoneal surfaces in women with high BMI. The planned multicentre MIRRORS-RCT will assess whether robotic IDS offers improved quality of life and recovery with non-inferior progression-free and overall survival. We present the evolution of our surgical technique with illustrative surgical videos and qualitative patient feedback, supported by the objective surgical outcomes for this trial.