696 Are Group and Save Samples Necessary for Common Urological Procedures?

Aim Blood tests are routinely performed as a part of pre-operative assessment (pre-op). We looked at the number of group and save (G+S) samples taken at pre-op and compared that to the number of patients needing blood transfusion having undergone common Urological procedures at our hospital. Our objective was to assess the utility of this invasive procedure in this clinical setting. Method Data was retrospectively collected from electronic patient records on 413 patients undergoing elective urological procedures 1st June 2020 to 30th September 2020 at Colchester General Hospital. Major procedures like radical prostatectomies, nephrectomies were excluded. Patients who had G+S samples done prior to surgery were checked. This was compared to the patients who required transfusions. Results Amongst 413 patients who underwent an elective urological procedure, 169(41%) were day-case endoscopic, 151(37%) were inpatient, and 93(22%) were penoscrotal procedures. 104(25%) patients had G+S taken, with only 5 patients (1.2%) requiring transfusion. 24(14.2%) patients undergoing day case procedures,79(52.3%) patients undergoing inpatient procedures and 1(1.1%) patient undergoing penoscrotal procedures had G+S tests done. Only 7(1.7%) patients had a baseline haemoglobin of less than 100. Conclusions Our data showed that many G+S samples were unnecessary. TURBTs (transurethral resection of bladder tumours) were most likely to need transfusion. Education was fed-back to those running pre-operative assessment clinics that G+S should be considered for TURBTs and those with Hb < 100. We recommend running this audit again to further quantify the G+S tests which could be avoided.

Assessing the effectiveness of a Telemedicine Initiative in Clinical Management of Children Living with HIV/AIDS in Maharashtra, India

Aims: To evaluate the effectiveness of telemedicine in clinical management of children living with HIV/AIDS in resource limited settings. Background: Telemedicine is an important mechanism for service delivery in health care settings, both in resource rich and resource poor settings. Such service delivery mechanisms have shown to be associated with virologic suppression and higher CD4 counts. These services are also associated with improved access, shorter visiting times, and higher patient satisfaction. Objective: We designed the present two-group comparison study to compare the clinical evaluation and management of children in the antiretroviral therapy (ART) centres linked to telemedicine facility with those who are not linked to this facility in Maharashtra, India. Methods: We analysed clinical records from six ART centres in Maharashtra; of these 250 children were in the linked ART centres and 301 were in the non-linked ART centres. The outcomes were classified according to investigations, management, and monitoring. For management, we evaluated: 1) initiation of cotrimoxazole prophylaxis; 2) Children not initiated on ART when required; 3) ART regime after appropriate investigations; and 4) Change of regime (if immunologically indicated). For monitoring, we assessed the haematological monitoring of children on ART. Result: The mean (SD) ages of children in linked and non-linked ART centres were 10.8 (4.6) and 10.9 (4.6) years respectively (p=0.80). After adjusting for individual and structural level variables, physical examination (OR: 2.0, 95% CI; 1.2, 3.2), screening for tuberculosis (OR: 12.9, 95% CI: 2.0, 82.9) and cotrimoxazole prophylaxis was significantly more likely in the linked centres compared with non-linked centres (OR: 1.8, 95% CI: 1.4, 2.2). A higher proportion of children eligible for ART were not initiated on treatment in the non-linked centres compared with linked centres (26% vs. 8%, p=0.06). Children were less likely to be initiated on zidovudine-based regimens without baseline haemoglobin or with baseline haemoglobin of less than 9 gm% in linked centres (OR: 0.7, 95% CI: 0.6, 0.8). Similarly, children in the linked centres were less likely to have been started on nevirapine based regimens without baseline liver enzymes (OR: 0.8, 95% CI: 0.7, 0.9). Conclusions: Thus, the overall clinical management of Children Living with HIV/ AIDS (CLHA) was better in ART centres linked with the telemedicine initiative compared with those which were not linked. Children in the linked ART centres were more likely to have a complete baseline assessment (physical, hematological, radiological, and screening for TB), Presence of pediatrician in the centres was helpful.

Changes in selected haematological parameters associated with JAK1/JAK2 inhibition observed in patients with rheumatoid arthritis treated with baricitinib

ObjectiveTo characterise changes in selected haematological parameters following once-daily oral baricitinib dosing.MethodsData were pooled from eight randomised clinical trials (four phase 3, three phase 2, one phase 1b) and one long-term extension. Changes in haematological parameters were evaluated up to 128 weeks (N=2387); overall safety of baricitinib was assessed up to 6 years (N=3492).ResultsMean absolute neutrophil counts decreased (−1.36×109/L) within 1 month, followed by stabilisation within the normal reference range through week 128. The incidence of serious infections was not elevated in patients with neutropenia during the 24-week placebo-controlled period. Mean lymphocyte counts increased (+0.30×109/L) within 1 month, then decreased to baseline (weeks 12–24). Mean platelet counts increased at week 2 (+51×109/L), then decreased towards baseline. Overall, mean haemoglobin concentrations decreased (−0.12 mmol/L), then returned to baseline; however, reduced baseline haemoglobin concentrations observed in the highest baseline high-sensitivity C reactive protein quartile increased over time. Permanent drug discontinuation occurred due to laboratory abnormalities related to neutrophil count in 8 (0.2%), lymphocyte counts in 6 (0.2%), platelet counts in 8 (0.2%), and haemoglobin levels in 16 (0.5%) of all baricitinib-treated patients (N=3492 with 7993 total person-years of exposure).ConclusionsModerate decreases in neutrophils were seen during baricitinib treatment; however, serious infection was uncommon in patients with neutropenia. Transient increases were observed in lymphocytes and platelets, which returned to baseline over time. Changes in haemoglobin concentration were generally small. Haematological abnormalities seldom led to drug discontinuation.

P216 Effects of filgotinib on anaemia, thrombocytopoenia and leukopoenia: results from a Phase 3 study in patients with active RA and prior inadequate response or intolerance to bDMARDs

Background Cytopoenias are common in patients treated for rheumatoid arthritis (RA) with non-janus kinase 1 (JAK1)-selective inhibitors, possibly due to JAK2-mediated haematopoietic growth factor inhibition. We investigated the extent of cytopoenia in patients with active RA, despite prior treatment with biological disease-modifying antirheumatic drugs (bDMARDs), treated with the JAK1-selective inhibitor filgotinib (FIL), in a Phase 3 trial (FINCH2; NCT02873936). Methods In the double-blind, Phase 3 FINCH2 trial, patients were randomised 1:1:1 to receive oral FIL 200mg, 100mg, or placebo (PBO) once daily for 24 weeks (W) + conventional synthetic DMARDs. We assessed shifts from baseline at 12 and 24 weeks in haemoglobin, platelets, neutrophils and lymphocytes. Results 448 patients were treated: FIL 200mg, n = 147; FIL 100mg, n = 153; PBO, n = 148. Overall, haemoglobin, platelet, lymphocyte and neutrophil levels remained consistent throughout the study. At baseline, 129 (28.8%), 4 (0.9%), 10 (2.2%) and 26 (5.8%) patients had mild-moderate low levels of haemoglobin, platelets, neutrophils and lymphocytes, respectively, and 5 (1.1%) had severely low levels of lymphocytes. Of the patients with mild-moderate low haemoglobin levels at baseline, 10-13% achieved normal levels by W24 vs 8% receiving PBO (Table). Of those with normal baseline haemoglobin levels, 6-10% had mild low levels at W24. All patients with baseline mild-moderate low platelets and neutrophils had normal levels at W24, except one patient with mild neutropoenia receiving FIL 100mg. Of the patients with normal platelet and neutrophil levels at baseline, >94% maintained these at W24 in all treatment groups. By W24, 3.2%, 5.2% and 2.2% of patients treated with FIL 200mg, FIL 100mg and PBO, respectively in the baseline mild-moderate subgroup and 1.7% in the severe subgroup treated with FIL 100mg had normal lymphocyte counts. Conclusion In this study, most patients in the baseline normal cell count subgroups maintained this status over 24 weeks of FIL treatment. Of the patients with mild-to-moderately low haemoglobin at baseline, >9% shifted towards haemoglobin normalisation. Similar patterns of improvement from baseline were observed for platelet, lymphocyte and neutrophil counts. FIL appears not to increase the incidence of cytopenias in patients with active RA despite prior biologic therapies. Disclosures D. Walker: Other; Received support from Lilly, Pfizer, Novartis, Roche. M.C. Genovese: Other; Received support from Gilead Sciences Inc., Galapagos NV, AbbVie Inc. Eli Lilly and Company, Pfizer. K. Kalunian: Grants/research support; Grand support from Gilead. J. Gottenberg: None. B. Bartok: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. Y. Tan: Corporate appointments; Employee of Gilead Sciences, Inc... Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. Y. Guo: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. C. Tasset: Other; Employee of Galapagos. J.S. Sundy: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. K. de Vlam: None. T. Takeuchi: None.

Survival and prognostic factors in HIV-infected adults treated with Antiretroviral Therapy in a Malaysian referral hospital: A retrospective cohort study

Background: It is well established that antiretroviral therapy (ART) is beneficial in reducing the mortality among patients with human immunodeficiency virus (HIV). In Malaysia, there is lack of study and information regarding the overall survival rates and prognostic factors for survival in HIV-infected adults treated with ART. Therefore, this study aimed to assess and compare the survival rates as well as to identify the prognostic factors for survival among HIV adults in Malaysia.Methods: A retrospective cohort study was conducted by reviewing the medical records of HIV patients who started ART between year 2007 and 2016 at a tertiary referral hospital in Malaysia. ART-naive adults aged 15 years and above were included and those who were transferred out were excluded. After applying inclusion and exclusion criteria, there were 339 cases eligible in this study. Systematic sampling method was applied. Kaplan Meier survival curve and log-rank test were used to compare the overall survival rates. Cox proportional hazards regression was applied to determine the prognostic factors for survival.Results: The estimated overall survival rates were 95.9%, 93.8%, 90.4%, 84.9%, and 72.8% at 6 months, 1 year, 3 years, 5 years and 10 years, respectively. The overall survival rates were significantly different according to age group (p<0.001), employment status (p<0.001), transmission mode (p=0.003), and history of illicit drug use (p=0.017), baseline CD4 cell count (p<0.001), baseline haemoglobin level (p<0.001), tuberculosis co-infection (p<0.001), hepatitis co-infection (p=0.008), first NRTI (p<0.001) and history of defaults (p=0.021). Based on multiple Cox regression, patients who were anaemic had 3.76 times (95% CI: 1.97, 7.18; p<0.001) higher hazard of death than their non-anaemic counterparts. The hazard risk was 2.09 times (95% CI: 1.10, 3.96; p=0.024) higher among HIV patients co-infected with tuberculosis compared to those who were not. Conclusion: Overall survival rates were higher than low-income countries but lower than in high-income countries, and comparable with middle-income countries. Low baseline haemoglobin level and tuberculosis co-infection were strong prognostic factors for HIV survival

Impact of persistent anaemia on mortality in patients hospitalised with acute pulmonary embolism: an Australian retrospective observational study

ObjectivesAnaemia is associated with increased mortality in acute pulmonary embolism (PE) patients. However, prior studies have not examined the prognostic impact of trends in plasma haemoglobin during admission. This study investigates the impact of changes in haemoglobin level on mortality during hospital stay in acute PE.Study designA retrospective observational study.SettingTertiary-referral centre in Australia.ParticipantsConsecutive patients from 2000 to 2012 admitted with confirmed acute PE were identified from a dedicated PE database. Haemoglobin levels on days 1, 3–4, 5–6 and 7 of admission were retrieved. Patients without both baseline haemoglobin and subsequent haemoglobin levels were excluded (n=327), leaving 1099 patients as the study cohort. Anaemia was defined as haemoglobin <130 g/L for men and <120 g/L for women. There were 576 patients without anaemia throughout admission, 65 with transient anaemia (anaemic on day 1, but subsequently normalised during admission), 122 with acquired anaemia (normal on day 1 but developed anaemia during admission) and 336 with persistent anaemia. A total of 71 patients received blood transfusion during admission.Main outcome measure6-month mortality was tracked from a state-wide death database and analysed using multivariable modelling.ResultsAfter adjusting for transfusion, patietns with persistent anaemia had a significantly increased 6-month mortality risk (adjusted HR 1.97, 95% CI 1.26 to 3.09, p=0.003) compared with patients without anaemia. There was no difference in mortality between patients with transient or acquired anaemia and patients without anaemia.ConclusionAmong patients who had anaemia during their admission for acute PE, only the subgroup with persistent anaemia demonstrated worse outcomes.

Randomized clinical trial to evaluate ferric carboxymaltose and iron sucrose for treatment of postpartum anaemia in a tertiary hospital

Background: Ferric carboxymaltose and iron sucrose are two iron carbohydrate complexes optimized for iron delivery and extensively used in postpartum anaemia. This study compares the efficacy and safety of ferric carboxymaltose with that of iron sucrose in patients with postpartum anaemia.Methods: One hundred women diagnosed with postpartum anaemia were randomized prospectively in a 1:1 ratio to receive either ferric carboxymaltose or iron sucrose. Fifty patients received intravenous iron carboxymaltose depending on the iron deficit at rate of 1000 mg/week and fifty patients received intravenous iron sucrose at a rate of 200 mg/day on alternate days till the calculated dose is given.Results: Fifty patients were enrolled in each treatment group. Both groups showed increases in mean haemoglobin from baseline at 2 weeks and 6 weeks. The increase in haemoglobin was significantly higher in ferric carboxymaltose group compared to iron sucrose at both week 2 (2.64±0.91 versus 2.17±0.76; p=0.010) and week 6 timepoints (4.65±1.17 versus 3.96±1.06; p=0.005). The proportion of patients achieving target haemoglobin of 12 gm/dl was significantly higher in ferric carboxymaltose group compared to iron sucrose at week 6 (77.3% versus 50.0%; p=0.013). The incidence of adverse events was similar across treatment groups and no specific safety concerns were observed.Conclusions: Both ferric carboxymaltose and iron sucrose caused increase in baseline haemoglobin. Ferric carboxymaltose had significantly higher increases in haemoglobin compared to iron sucrose at both follow up timepoints (week 2 and week 6). It was more likely to achieve target haemoglobin with ferric carboxymaltose within 6 weeks compared to iron sucrose. Ferric carboxymaltose may be considered in women with postpartum anaemia for faster rise in haemoglobin while requiring fewer injections compared to iron sucrose.

Long-term prospective observation suggests that glomerular hyperfiltration is associated with rapid decline in renal filtration function: A multiethnic study

Aim: Glomerular hyperfiltration usually occurs early in development of kidney complications in diabetes. To understand hyperfiltration as a marker of renal disease progression in type 2 diabetes mellitus, we aimed to examine association between glomerular hyperfiltration (estimated glomerular filtration rate ⩾ 120 mL/min/1.73 m2) and rapid renal decline (annual estimated glomerular filtration rate loss ⩾ 3 mL/min/1.73 m2). Methods: This was a prospective cohort comprising 1014 patients with type 2 diabetes mellitus attending a Diabetes Centre of a regional hospital in 2002–2014. A separate prospective cohort, comprising 491 patients who attended Diabetes Centre or primary-care polyclinics, was used for validation. We performed binary mediation analysis to examine role of hyperfiltration on relationship between baseline haemoglobin A1c and rapid renal decline. Results: Among patients in discovery cohort, 5.2% had baseline hyperfiltration. Over mean follow-up of 6 years, 22.9% had rapid glomerular filtration rate decline. Baseline hyperfiltration was significantly associated with greater odds of rapid renal decline after adjusting for demographics, diabetes duration and clinical covariates (odds ratio: 2.57; 95% confidence interval: 1.21–5.46; p = 0.014). Similar finding was found in validation cohort (odds ratio: 2.98; 95% confidence interval: 1.06–8.42; p = 0.034). Hyperfiltration significantly accounted for 35.3% of association between increasing baseline haemoglobin A1c and rapid renal decline. Conclusion: Glomerular hyperfiltration is an independent risk factor of rapid renal decline. It mediates the association between increasing haemoglobin A1c and rapid renal decline.