Factors associated with mortality among moderate and severe patients with COVID-19 in India: a secondary analysis of a randomised controlled trial.

OBJECTIVE: Large data on the clinical characteristics and outcome of COVID-19 in the Indian population are scarce. We analysed the factors associated with mortality in a cohort of moderately and severely ill patients with COVID-19 enrolled in a randomised trial on convalescent plasma. DESIGN: Secondary analysis of data from a Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications in Moderate Disease. SETTING: 39 public and private hospitals across India during the study period from 22 April to 14 July 2020. PARTICIPANTS: Of the 464 patients recruited, two were lost to follow-up, nine withdrew consent and two patients did not receive the intervention after randomisation. The cohort of 451 participants with known outcome at 28 days was analysed. PRIMARY OUTCOME MEASURE: Factors associated with all-cause mortality at 28 days after enrolment. RESULTS: The mean (SD) age was 51±12.4 years; 76.7% were males. Admission Sequential Organ Failure Assessment score was 2.4±1.1. Non-invasive ventilation, invasive ventilation and vasopressor therapy were required in 98.9%, 8.4% and 4.0%, respectively. The 28-day mortality was 14.4%. Median time from symptom onset to hospital admission was similar in survivors (4 days; IQR 3-7) and non-survivors (4 days; IQR 3-6). Patients with two or more comorbidities had 2.25 (95% CI 1.18 to 4.29, p=0.014) times risk of death. When compared with survivors, admission interleukin-6 levels were higher (p<0.001) in non-survivors and increased further on day 3. On multivariable Fine and Gray model, severity of illness (subdistribution HR 1.22, 95% CI 1.11 to 1.35, p<0.001), PaO2/FiO2 ratio <100 (3.47, 1.64-7.37, p=0.001), neutrophil lymphocyte ratio >10 (9.97, 3.65-27.13, p<0.001), D-dimer >1.0 mg/L (2.50, 1.14-5.48, p=0.022), ferritin ≥500 ng/mL (2.67, 1.44-4.96, p=0.002) and lactate dehydrogenase ≥450 IU/L (2.96, 1.60-5.45, p=0.001) were significantly associated with death. CONCLUSION: In this cohort of moderately and severely ill patients with COVID-19, severity of illness, underlying comorbidities and elevated levels of inflammatory markers were significantly associated with death. TRIAL REGISTRATION NUMBER: CTRI/2020/04/024775.

Should we apply suction during fine needle cytology of thyroid lesions? A prospective study of 200 cases.

INTRODUCTION: Fine needle aspiration cytology (FNAC) is a well-established first line diagnostic tool in evaluating palpable thyroid lesions. However, the technique depends on suction and thus is at times painful, sometimes traumatic and yield haemorrhagic material for cytological study. In more recent times, a modified technique called fine needle sampling without aspiration (FNS) has come into vogue which obviates the use of suction and therefore is more patient friendly. AIMS/OBJECTIVES: To investigate whether fine needle sampling without aspiration (FNS) gives quantitatively and qualitatively superior cytologic material as compared to the conventional technique of fine needle aspiration (FNAC) in thyroid lesions. MATERIALS AND METHODS: It is a prospective study of 200 cases carried out in the Department of Pathology during two years period. Both techniques were executed on the same thyroid swelling / nodule in the same clinical session beginning with FNS followed by FNAC. The observation recorded by two pathologists were based on the scoring system proposed by Mair et al., Statistical analysis was done by Student's paired t-test using SPSS 13 software. Observation/Results: A total of 200 cases were studied. The non-aspiration technique yielded less diagnostically adequate but more diagnostically superior smears when compared with aspiration technique. The average score per case was 5.31 by aspiration technique and 6.35 by non-aspiration technique. CONCLUSION: Both the techniques have their own merits and demerits and neither is absolutely superior to the other. A combination of both the technique gives better result.