Modeling Zero-inflated Count Data Using Generalized Poisson and Ordinal Logistic Regression Models in Medical Research.

Objectives: In medical research, the study's design and statistical methods are pivotal, as they guide interpretation and conclusion. Selecting appropriate statistical models hinges on the distribution of the outcome measure. Count data, frequently used in medical research, often exhibit over-dispersion or zero inflation. Occasionally, count data are considered ordinal (with a maximum outcome value of 5), and this calls for the application of ordinal regression models. Various models exist for analyzing over-dispersed data such as negative binomial, generalized Poisson (GP), and ordinal regression model. This study aims to examine whether the GP model is a superior alternative to the ordinal logistic regression (OLR) model, specifically in the context of zero-inflated Poisson models using both simulated and real-time data. Methods: Simulated data were generated with varied estimates of regression coefficients, sample sizes, and various proportions of zeros. The GP and OLR models were compared using fit statistics. Additionally, comparisons were made using real-time datasets. Results: The simulated results consistently revealed lower bias and mean squared error values in the GP model compared to the OLR model. The same trend was observed in real-time datasets, with the GP model consistently demonstrating lower standard errors. Except when the sample size was 1000 and the proportions of zeros were 30% and 40%, the Bayesian information criterion consistently favored the GP model over the OLR model. Conclusions: This study establishes that the proposed GP model offers a more advantageous alternative to the OLR model. Moreover, the GP model facilitates easier modeling and interpretation when compared to the OLR model.

Comparable outcomes with low-dose and standard-dose horse anti-thymocyte globulin in the treatment of severe aplastic anemia.

BACKGROUND: The standard dose (SD) of horse anti-thymocyte globulin (hATG) ATGAM (Pfizer, USA) or its biosimilar thymogam (Bharat Serum, India) for the treatment of Aplastic Anemia (AA) is 40 mg/kg/day for 4 days in combination with cyclosporine. Data on the impact of hATG dose on long-term outcomes are limited. Here, we describe our comparative experience using 25 mg/kg/day (low-dose [LD]) hATG for 4 days with SD for the treatment of AA. METHODS: We retrospectively studied patients with AA (age > 12 years) who received two doses of hATG combined with cyclosporine. Among 93 AA patients who received hATG, 62 (66.7%) and 31 (33.3%) patients received LD and SD hATG with cyclosporine, respectively. Among these,seventeen(18.2%) patients also received eltrombopag with hATG and cyclosporine. Overall response rates [complete response (CR) and partial response (PR)] of LD and SD hATG groups at 3 months (50% vs. 48.4%; p = 0.88), 6 months (63.8% vs. 71.4%; p = 0.67), and 12 months (69.6% vs. 79.2%; p = 0.167) were comparable. The mean (Standard Deviation) 5-year Kaplan-Meier estimate of overall survival and event-free survival was 82.1 (4.6)% and 70.9 (5.5)% for the study population. The mean (standard deviation) 5-year Kaplan-Meier estimate of overall survival and event-free survival of those who received LD hATG versus SD hATG dose was 82.9 (5·3)% versus 74.8 (10·3)% (P = 0·439), and 75.2 (6.2)% versus 61.4(11.2)% (P = 0·441). CONCLUSION: Our study revealed that the response rates of patients with AA and LD were similar to those of patients with SD to hATG combined with cyclosporine in a real-world setting.

Extent of Smartphone Addiction and its Association with Physical Activity Level, Anthropometric Indices, and Quality of Sleep in Young Adults: A Cross-Sectional Study.

Background: Smartphone addiction among young adults is a growing concern that is often underestimated despite its significant health hazards. The objective of this study was to assess the extent of smartphone addiction and its association with physical activity level, anthropometric indices, and quality of sleep in young adults. Material and Methods: This cross-sectional study was conducted among 138 allied health sciences undergraduates of a tertiary care medical school in Puducherry, South India. The participants' extent of smartphone addiction, physical activity, and sleep quality were assessed using the Smartphone Addiction Scale (SAS), International Physical Activity Questionnaire, and Pittsburgh Sleep Quality Index (PSQI), respectively. Anthropometric indices (body mass index [BMI], waist-to-hip [W: H] ratio, waist-to-height [W: Ht] ratio, Conicity Index, and A Body Shape Index [ABSI]) were also measured following standardized procedures. Correlations between smartphone addiction, physical activity, anthropometric indices, and sleep quality were evaluated using Pearson's/Spearman's rank correlation coefficient. P <0.05 was considered statistically significant. Result: Over 50% of participants showed smartphone addiction and poor sleep quality. Although a significant negative correlation was observed between SAS scores and physical activity levels, significant positive correlations were noted between SAS scores and BMI and SAS and PSQI scores. Conclusion: Smartphone addiction is associated with decreased physical activity, increased BMI, and poor sleep quality in young adults.

Effects of complete revascularization according to age in patients with ST-segment elevation myocardial infarction and multivessel disease (COMPLETE-AGE).

BACKGROUND: In ST-segment elevation myocardial infarction (STEMI), complete revascularization with percutaneous coronary intervention (PCI) reduces major cardiovascular events compared with culprit-lesion-only PCI. Whether age influences these results remains unknown. METHODS: COMPLETE was a multinational, randomized trial evaluating a strategy of staged complete revascularization, consisting of angiography-guided PCI of all suitable nonculprit lesions, versus a strategy of culprit-lesion-only PCI. In this prespecified subgroup analysis, treatment effect according to age (≥65 years vs <65 years) was determined for the first coprimary outcome of cardiovascular (CV) death or new myocardial infarction (MI) and the second coprimary outcome of CV death, new MI, or ischemia-driven revascularization (IDR). Median follow-up was 35.8 months (interquartile range [IQR]: 27.6-44.3 months). RESULTS: Of 4,041 patients randomized in COMPLETE, 1,613 were aged ≥ 65 years (39.9%). Higher event rates were observed for both coprimary outcomes in patients aged ≥ 65 years comparted with those aged < 65 years (11.2% vs 7.9%, HR 1.49, 95% CI 1.22-1.83; 14.4% vs 11.8%, HR 1.28, 95% CI 1.07-1.52, respectively). Complete revascularization reduced the first coprimary outcome in patients ≥ 65 years (9.7% vs 12.5%, HR 0.77; 95% CI, 0.58-1.04) and < 65 years (6.7% vs 9.1%, HR 0.72; 95% CI, 0.54-0.96)(interaction P = .74). The second coprimary outcome was reduced in those ≥ 65 years (HR 0.56, 95% CI, 0.43-0.74) and < 65 years (HR 0.48, 95% CI, 0.37-0.61 (interaction P = .37). A sensitivity analysis was performed with consistent results demonstrated using a 75-year threshold (albeit attenuated). CONCLUSIONS: In patients with STEMI and multivessel CAD, complete revascularization compared with culprit-lesion-only PCI reduced major cardiovascular events regardless of patient age and could be considered as a revascularization strategy in older adults.

Complete Revascularization Versus Culprit-Lesion-Only PCI in STEMI Patients With Diabetes and Multivessel Coronary Artery Disease: Results From the COMPLETE Trial.

BACKGROUND: In the COMPLETE trial (Complete Versus Culprit-Only Revascularization to Treat Multivessel Disease After Early PCI for STEMI), a strategy of complete revascularization reduced the risk of major cardiovascular events compared with culprit-lesion-only percutaneous coronary intervention in patients presenting with ST-segment-elevation myocardial infarction (STEMI) and multivessel coronary artery disease. Patients with diabetes have a worse prognosis following STEMI. We evaluated the consistency of the effects of complete revascularization in patients with and without diabetes. METHODS: The COMPLETE trial randomized a strategy of complete revascularization, consisting of angiography-guided percutaneous coronary intervention of all suitable nonculprit lesions, versus a strategy of culprit-lesion-only percutaneous coronary intervention (guideline-directed medical therapy alone). In prespecified analyses, treatment effects were determined in patients with and without diabetes on the first coprimary outcome of cardiovascular death or new myocardial infarction and the second coprimary outcome of cardiovascular death, new myocardial infarction, or ischemia-driven revascularization. Interaction P values were calculated to evaluate whether there was a differential treatment effect in patients with and without diabetes. RESULTS: Of the 4041 patients enrolled in the COMPLETE trial, 787 patients (19.5%) had diabetes. The median HbA1c (glycated hemoglobin) was 7.7% in the diabetes group and 5.7% in the nondiabetes group. Complete revascularization consistently reduced the first coprimary outcome in patients with diabetes (hazard ratio, 0.87 [95% CI, 0.59-1.29]) and without diabetes (hazard ratio, 0.70 [95% CI, 0.55-0.90]), with no evidence of a differential treatment effect (interaction P=0.36). Similarly, for the second coprimary outcome, no differential treatment effect (interaction P=0.27) of complete revascularization was found in patients with diabetes (hazard ratio, 0.61 [95% CI, 0.43-0.87]) and without diabetes (hazard ratio, 0.48 [95% CI, 0.39-0.60]). CONCLUSIONS: Among patients presenting with STEMI and multivessel disease, the benefit of complete revascularization over a culprit-lesion-only percutaneous coronary intervention strategy was consistent regardless of the presence or absence of diabetes.

Clinical significance of end of induction measurable residual disease monitoring in B-cell acute lymphoblastic leukemia: A single center experience.

The assessment of measurable residual disease (MRD) has emerged as a powerful prognostic tool for both pediatric and adult acute lymphoblastic leukemia (ALL). This retrospective study aimed to evaluate the prognostic relevance of the end of induction MRD in B-cell acute lymphoblastic leukemia (B ALL) patients. The study included 481 patients who underwent treatment for B ALL between August 2012 and March 2019 and had their MRD at the end of induction assessed by flow cytometry. Baseline demographic characteristics were collected from the patient's clinical records. Event free survival (EFS) and relapse free survival (RFS) were calculated using Kaplan-Meier analysis and survival estimates were compared using the log-rank test. End of induction MRD and baseline karyotype were the strongest predictors of EFS and RFS on multivariate analysis. The EFS was inversely related to the MRD value and the outcomes were similar in patients without morphological remission at the end of induction and patients in remission with MRD ≥1.0%. Even within the subgroups of ALL based on age, karyotype, BCR::ABL1 translocation and the treatment protocol, end of induction MRD positive patients had poor outcomes compared to patients who were MRD negative. The study outcome would help draft end of induction MRD-based treatment guidelines for the management of B ALL patients.

Low Serum Hepcidin Levels in Patients with Ulcerative Colitis - Implications for Treatment of Co-existent Iron-Deficiency Anemia.

Ulcerative colitis (UC) is often associated with anemia. Hepcidin, the central regulator of iron homeostasis, is known to be induced by inflammation and suppressed by anemia. It is not clear how hepcidin is affected in those with UC, when both inflammation and anemia may co-exist.Such knowledge may hold implications for treatment. Hematological and iron-related parameters, C-reactive protein (CRP), growth differentiation factor 15 (GDF-15) and erythroferrone (ERFE) (erythroid regulators of hepcidin) levels were estimated in blood from those with UC and in control subjects. Values for hematological and iron-related parameters showed evidence of iron-deficiency and resultant anemia, in patients with UC. The presence of UC was significantly associated with inflammation. Serum levels of ERFE, but not of GDF-15, were significantly higher in patients with UC than in control patients, while hepcidin levels were significantly lower. Serum hepcidin concentrations in patients with UC correlated positively with serum iron, ferritin and GDF-15, and negatively with serum ERFE. The iron status and serum hepcidin levels in UC patients with co-existent anemia were significantly lower and serum ERFE values significantly higher than in those with UC without anemia. The effect of anemia on hepcidin predominated over that of inflammation in patients with UC, resulting in suppressed hepcidin levels. This effect is possibly mediated through erythroferrone. We suggest that a serum hepcidin-guided approach may be useful to guide use of oral iron supplements to treat co-existent iron-deficiency anemia in patients with UC and other chronic inflammatory diseases.

Trends in prevalence and determinants of severe and moderate anaemia among women of reproductive age during the last 15 years in India.

BACKGROUND: Anaemia is a serious global public health problem that disproportionally affects children, adolescent girls, and women of reproductive age, especially pregnant women. Women of reproductive age are more vulnerable to anaemia, particularly severe and moderate anaemia leads to adverse outcomes among pregnant women. Despite continuous Government efforts, anaemia burden still poses a serious challenge in India. The objective of this study is to assess the trends in prevalence and determinants of severe and moderate anaemia among women of reproductive age between 15 and 49 years. METHOD: We used three rounds of the large-scale National Family Health Survey (NFHS) India, conducted on a representative sample of households using a cross-sectional design across the country in 2005-06, 2015-16 and 2019-2021. We included all the women aged 15 to 49 years in our analysis. We used the same haemoglobin (Hb) cut-off values for all the three rounds of surveys to ensure comparability. Generalized linear regression analyses with log link were done. Survey weights were incorporated in the analysis. RESULTS: The prevalence of severe or moderate Anaemia (SMA) in non-pregnant women was 14.20%, 12.43% and 13.98%; it was 31.11%, 25.98% and 26.66% for pregnant women in 2006, 2016 and 2021 respectively. The decline in SMA prevalence was 1.54% in non-pregnant women, whereas it was 14.30% in pregnant women in 15 years. Women who were poor, and without any formal education had a higher risk for severe and moderate Anaemia. CONCLUSION: Despite the intensive anaemia control program in India, SMA has not declined appreciably in non-pregnant women during the last two decades. Despite the decline, the prevalence of SMA was about 26% in pregnant women which calls for a comprehensive review of the existing anaemia control programmes and there must be targeted programmes for the most vulnerable and high-risk women such as rural, poor and illiterate women of reproductive age to reduce the burden of anaemia among them.

Quantification of Organophosphorus Insecticide Removed by Gastric Lavage in Acutely Poisoned Patients: An Observational Study.

Introduction: The effectiveness of gastric lavage in organophosphorus (OP) poisoning has not been established. We assessed the ability of gastric lavage to remove OP insecticides as a preliminary stage in assessing effectiveness. Patients and methods: Organophosphorus poisoning patients presenting within 6 hours were included, irrespective of prior gastric lavage. A nasogastric tube was placed and gastric contents aspirated, followed by at least three cycles of gastric lavage with 200 mL of water. Samples from the initial aspirate and the first three lavage cycles were sent for identification and quantification of the OP compounds. Patients were monitored for complications of gastric lavage. Results: Around 42 patients underwent gastric lavage. Eight (19.0%) patients were excluded from the study because of a lack of analytical standards for ingested compounds. Insecticides were detectable in the lavage samples of 24 of 34 (70.6%) patients. Lipophilic OP compounds were detected in 23 of 24 patients, while no hydrophilic OP compounds could be detected in six patients with reported ingestion of hydrophilic compounds. For chlorpyrifos poisoning (n = 10), only 0.65 mg (SD 1.2) of the estimated ingested amount (n = 5) of 8,600 mg (SD 3,200) was recovered by gastric lavage. The mean proportion of the compound removed by initial gastric aspirate was 79.4% and subsequent three cycles removed 11.5, 6.6, and 2.7%. Conclusion: Lipophilic OP insecticides could be quantified in the stomach contents of OP poisoning patients with the first aspiration or lavage being most effective. The amount removed was very low; hence, routine use of gastric lavage for OP poisoning patients arriving within 6 hours is unlikely to be beneficial. How to cite this article: Mathansingh AJ, Jose A, Fleming JJ, Abhilash KPP, Chandiraseharan VK, Lenin A, et al. Quantification of Organophosphorus Insecticide Removed by Gastric Lavage in Acutely Poisoned Patients: An Observational Study. Indian J Crit Care Med 2023;27(6):397-402.

Exact correction factor for estimating the OR in the presence of sparse data with a zero cell in 2 × 2 tables.

In case-control studies, odds ratios (OR) are calculated from 2 × 2 tables and in some instances, we observe small cell counts or zero counts in one of the cells. The corrections to calculate the ORs in the presence of empty cells are available in literature. Some of these include Yates continuity correction and Agresti and Coull correction. However, the available methods provided different corrections and the situations where each could be applied are not very apparent. Therefore, the current research proposes an iterative algorithm of estimating an exact (optimum) correction factor for the respective sample size. This was evaluated by simulating data with varying proportions and sample sizes. The estimated correction factor was considered after obtaining the bias, standard error of odds ratio, root mean square error and the coverage probability. Also, we have presented a linear function to identify the exact correction factor using sample size and proportion.

Comparison between the demographic shift clinical severity and outcome of the first two waves of COVID-19 in pregnancy in a tertiary hospital in India.

OBJECTIVE: To study and compare the maternal and neonatal outcomes of COVID-19 in pregnancy during the two waves of the pandemic in India. METHODS: This observational, retrospective cohort study on pregnant women with SARS-CoV-2 infection was conducted in a 2700-bed tertiary referral center in South India from March 1, 2020 to June 30 2021. The clinical presentation, severity, and maternal and neonatal outcomes of COVID-19 were compared between the two waves. RESULTS: A total of 623 pregnant women tested positive for SARS-CoV-2 infection in our institute; 379 (60.8%) were diagnosed during the first wave and 244 (39.2%) in the second wave. Most of the affected women (81.1%) were in their third trimester. Maternal mortality rate was 823 per 100 000 live births. Composite maternal outcome (increasing requirement for ventilation, pulmonary embolism, disease progression) were more pronounced during the second wave (2.1% vs 6.1%). Between the two waves, both maternal (1 vs 3; P = 0.162) and perinatal (3.2% vs 6.7%; P = 0.065) deaths were higher during the second wave. The cesarean section rate was high during the first wave (48% vs 32.4%; P < 0.001). Preterm births were comparable between the two waves (19.5% vs 22%; P < 0.500). CONCLUSION: The women presented with more severe illness during the second wave of COVID-19. There was higher perinatal mortality, but the maternal mortality was similar between the two waves.

Reduction in prevalence of spousal physical violence against women in India: evidence from three national surveys.

Spousal physical violence (PV) against women is considered to be major health issue in developing countries. Lifetime physical violence is a composite outcome consists of hit, kick, beat, slap and threatened with weapon, perpetrated by the husband. The study aims to examine changes in prevalence and specific risk factors for PV from 1998 to 2016 in India. This study analyzed data from a cross sectional epidemiological survey in 1998-1999, NFHS-3 (2005-2006) and NFHS-4 (2015-2016) data. There was a significant decline of about 10% (95% CI: 8.8%-11.1%) in PV. Major risk factors for change in PV were husband's use of alcohol, illiteracy and socio-economic status of the household. The Protection of Women from Domestic Violence Act may have played a role in reducing the PV. Even though there was a decline in PV, actions have to be implemented from the root level to ensure women empowerment.

Effectiveness of GnRH Agonist Short Protocol Versus GnRH Antagonist Protocol in POSEIDON Groups 3 and 4: a Retrospective Cohort Study.

The aim of this study is to compare the ART (assisted reproductive technology) outcomes and cancellation rates between GnRH antagonist protocol and GnRH agonist short protocol in POSEIDON (Patient-Oriented Strategy Encompassing IndividualizeD Oocyte Number) groups 3 and 4. It is a retrospective cohort study conducted in the Department of Reproductive Medicine and Surgery of a tertiary-level hospital. Women who underwent ART treatment with either GnRH antagonist or GnRH agonist short protocol with fresh embryo transfer, between January 2012 and December 2019 belonging to POSEIDON 3 and 4 groups, were included. Among the 295 women who belonged to the POSEIDON groups 3 or 4, 138 women received GnRH antagonist and 157 women received GnRH agonist short protocol. The median total dose of gonadotropin in the GnRH antagonist protocol was not significantly different from GnRH agonist short protocol [3000, IQR (2481-3675) vs. 3175, IQR (2643-3993), p = 0.370]. There was a significant difference in the duration of stimulation between the GnRH antagonist and GnRH agonist short protocol [10, IQR (9-12) vs. 10, IQR (8-11), p = 0.002]. The median number of mature oocytes retrieved was significantly different in the cohort of women receiving GnRH antagonist protocol compared to GnRH agonist short protocol [3, IQR (2-5) vs. 3, IQR (2-4), p = 0.029]. There was no significant difference in the clinical pregnancy rate (24% vs. 20%, p = 0.503) and cycle cancellation rate (29.7% vs. 36.3%, p = 0.290) between the GnRH antagonist and agonist short protocols respectively. Live birth rate was not significantly different between the GnRH antagonist protocol (16.7%) and GnRH agonist short protocol (14.0%) [OR 1.23, 95% CI (0.56-2.68), p = 0.604]. After adjusting for the significant confounding factors, the live birth rate was not significantly associated with the antagonist protocol compared with the short protocol [aOR 1.08, 95% CI (0.44-2.63), p = 0.870]. Though GnRH antagonist protocol results in higher mature oocyte yield when compared with GnRH agonist short protocol, it does not translate into an increase in live birth in POSEIDON groups 3 and 4.

Survival outcomes of epithelial ovarian cancer treated at a tertiary-level hospital in India.

BACKGROUND: One needs to choose wisely between primary neoadjuvant chemotherapy and primary cytoreductive surgery in ovarian cancer. The aim was to determine the recurrence free survival and overall survival after surgery for epithelial ovarian cancer and also the risk factors for recurrence and death. METHODS: Electronic medical records of 322 women operated for ovarian, fallopian or primary peritoneal cancer between 2011 and 2015table were reviewed. Descriptive statistics were used to describe patients and their clinical outcomes. Cox proportional hazard models were used for risk factor analysis. Adjusted hazard ratios were obtained for recurrence and death, adjusted for stage, primary treatment modality, residual disease and histology. Kaplan-Meier curves were drawn for probability of recurrence-free survival and overall survival. The log rank test was used to compare survival probabilities. RESULTS: The majority were stage III or stage IV (78%), serous histology (71%) and high grade (64%). Primary cytoreduction was done in 48% and interval cytoreduction in 52%. The median duration of follow up (survival) was 77 months (95% CI 72-82). There were 179 known recurrences (55.6 %). The estimated median time to recurrence was 22 (95% CI 14.5- 29.5) months. The independent risk factors for recurrence were neoadjuvant chemotherapy [HR 2.14, 95% CI 1.48-3.09], stage III/IV [HR 2.75; 95% CI 1.40-5.41], high grade serous histology [HR 1.69; 95% CI 1.12-2.54] and sub-optimal debulking [HR 3.15, 95% CI 2.19-4.55]. There were 78 known deaths (24.2 %) with a mean time to death of 24.3 (SD 16.1) months. The independent risk factors for death were sub-optimal debulking [HR 3.07; 95% CI 1.78-5.29] and stages III and IV cancer [HR 3.07; 95% CI 1.14-8.27]. CONCLUSIONS: Most ovarian cancers recur within 2 years. Risk factors for mortality are advanced stage and sub-optimal debulking. Maximal efforts at down staging and surgical resection will increase survival.

Study protocol: 'a large cohort study of postnatal events in a not-for-profit referral centre in Vellore, South India'.

INTRODUCTION: In a large developing country, with diverse population characteristics and differential access to healthcare, it is important to identify factors that influence postnatal health. This knowledge will help frame recommendations to enhance universal postnatal care. METHODS AND ANALYSIS: A prospective cohort study will be conducted by recruiting all participants who deliver in a referral centre in South India during a 1-year period after written consent is obtained from them. In addition to clinical information pertaining to their delivery and demographics, details of physical health, mental health socioeconomic status and emotional support will also be collected. Every participant will be followed up physically and/or by telephonic consultation at 3, 9 and 18 months of their postnatal period to reassess their status and that of their babies. As there are several independent and dependent variables requiring multivariate analysis, a sample size of 10 000 is considered adequate. Any unplanned visits to a health facility will be enquired into and documented for analysis.During data analysis, the effect of Caesarean section, high-risk characteristics and gestational age of the baby at delivery on various outcome measures and postnatal status will be evaluated. Interpretation of the large volume of collected data will help frame recommendations to improve postnatal care ETHICS AND DISSEMINATION: The study is approved by the Institutional Review Boards (Research and Ethics Committees) of Christian Medical College, Vellore, Tamil Nadu, India (IRB 12178 date 24 June 2020).Women are provided with a detailed information sheet and written consent is obtained. They are reassured that their care will not be compromised if they do not consent to the study. Data will be available on the clinical trial portal to assist in the dissemination of results after the project is published. TRIAL REGISTRATION NUMBER: CTRI/2022/03/041343.

Feasibility, safety and oncological outcomes of minimally invasive oesophagectomy following neoadjuvant chemoradiotherapy for oesophageal squamous cell carcinoma - Experience from a tertiary care centre.

Background: Neoadjuvant chemoradiotherapy (nCRT) has improved the resectability and survival of operable oesophageal squamous cell carcinoma (OSCC). We aimed to study if nCRT for OSCC makes minimally invasive oesophagectomy (MIO) technically more challenging and if the peri-operative and oncological outcomes are acceptable for MIO following nCRT. Materials and Methods: A retrospective review of patients with OSCC (cT1-2N1-2, cT3-4aN0-2) treated with nCRT and MIO between 2013 and 2019 was performed. The operative details including the technical difficulty in tumour dissection and lymphadenectomy, the post-operative complications and oncological outcomes were studied. Results: Seventy-five patients (male:female - 50:25; mean [range] age - 55.49 ± 8.43 [22-72] years; stage II - 34.7%; stage III - 37.3%; stage IVA - 28.0%) were enrolled. The concurrent chemotherapy course was completed by 25.3% of patients and the most common reason limiting the completion of chemotherapy was neutropaenia (66.0%). A thoraco-laparoscopic (n = 60) or hybrid (n = 15) McKeown's oesophagectomy with a two-field lymphadenectomy was performed. The increased surgical difficulty was reported in 41 (54.7%) patients, particularly for mid-thoracic tumours and tumours exhibiting incomplete response. The 30-day overall and major complication rate was 48.0% and 20.0%, respectively, and there was no mortality. The rate of R0 resection, pathological complete response and median lymph nodal yield were 93.3%, 48% and 8 (range: 1-25), respectively. The mean overall survival (OS) was 62.2 months (95% confidence interval [CI]: 52.6-71.8) and recurrence-free survival (RFS) was 53.5 months (95% CI: 43.5-63.5). The 1-, 2- and 3-year OS and RFS were 89.5%, 78.8% and 64.4% and 71.1%, 61.3% and 56.6%, respectively. Conclusion: Minimally invasive McKeown's oesophagectomy is feasible and safe in patients with OSCC receiving nCRT. The radiation component of nCRT increases the degree of operative difficulty, especially in relation to the supracarinal dissection and lymphadenectomy. However, this drawback did not adversely affect the short-term surgical or the long-term oncological outcomes.

The clinical demand and supply of blood in India: A National level estimation study.

BACKGROUND: Estimating the clinical demand for blood and components arising in a health facility is crucial to ensure timely availability of blood. This study aims to estimate disease-specific clinical demand, supply and utilization of whole blood and components in India. METHODS: We conducted a national level cross-sectional study in five randomly selected states from five regions of the country. We included 251 public and private facilities representing primary, secondary and tertiary care facilities. We collected annual disease-specific demand, supply and utilization of blood and components using a structured tool. We estimated the national demand by extrapolating the study data (demand and beds) to the total number of estimated beds in the country. FINDINGS: According to the study, the total clinical demand of 251 health facilities with 51,562 beds was 474,627 whole blood units. Based on this, the clinical demand for India was estimated at 14·6 million whole blood units (95 CI: 14·59-14·62), an equivalent of 36·3 donations per 1,000 eligible populations, which will address whole blood and component requirement. The medicine specialty accounted for 6·0 million units (41·2%), followed by surgery 4·1 million (27·9%), obstetrics and gynecology 3·3 million (22·4%) and pediatrics 1·2 million (8·5%) units. The supply was 93% which is equivalent to 33·8 donations against the demand. CONCLUSION: The study indicated a demand and supply gap of 2.5 donations per 1,000 eligible persons which is around one million units. The gap emphasises the need for sustained and concerted efforts from all stakeholders and for increasing the awareness about repeat voluntary non-remunerated blood donation (VNRBD); optimizing the availability of blood components through efficient blood component separation units; promoting modern principles of patient blood management and strengthening capacities of human resources in the blood transfusion system in India.