Context: Randomized controlled trials (RCTs) are among the cornerstones for generation of high-quality clinical evidence. However, incomplete or biased reporting of trials can hamper the process of review of trials and their results. Outcome switching, intentional, or otherwise leads to biased reporting and can result in false inferences. Aims: The aim of this study was to analyze the completeness of reporting Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist items and detect if outcome switching had occurred. Settings and Design: This cross-sectional study was conducted in the department of pharmacology. Methods: Online editions of journals published by the Indian association of medical specialties from 2017 to 2019 were accessed, and the full-text versions of the published RCTs in them were downloaded. Reporting of each item in the CONSORT checklist was recorded. The effect of trial registration and CONSORT endorsement on reporting of key methodological parameters was also determined. Protocols of registered trials were accessed, and the outcome switching was assessed. Statistical Analysis Used: Descriptive statistics were used to summarize the data. Results: Average completeness of reporting has significantly improved from 2017 to 2019. Major areas of underreporting were generalizability, protocol availability, trial registration, date of recruitment, allocation concealment, and the patient flow diagram. CONSORT endorsing journals had worse, whereas registered trials had better reporting of key methodological indicators. No overt switching of outcomes was observed in 84 out of 86 registered trials where trial protocols were available online for comparison. Conclusions: Quality of clinical trial reporting in the Indian medical journals has improved but remains inadequate. CONSORT nonendorsement prevents completeness of trial reporting.

Background: Gastroesophageal varices due to portal hypertension in patients with liver cirrhosis is an important cause of morbidity and mortality. Gold standard investigation for varices is esophagogastroduodenoscopy and patients are advised to undergo regular follow up based on the risk stratification. But the invasive nature, risk of procedure-related complication and lack of accessibility and affordability makes it important to identify simpler methods to screen patients. Platelet count/spleen diameter (PSD) ratio has been validated as a marker for oesophageal varices (OV) in multiple studies but with varying results. The present study was conducted to evaluate the accuracy of PSD ratio in OV.Methods: A cross-sectional study was conducted in patients diagnosed with liver cirrhosis. Clinical examination, relevant laboratory investigations, abdominal ultrasound and endoscopy were performed and data were recorded. PSD was calculated. Receiver-operator characteristics curves were plotted to determine cut-off values. Sensitivity, specificity, positive and negative predictive values were calculated.Results: Total 100 patients were included in this study, out of which 25% of patients did not have varices on endoscopy. The mean PSD was for patients without varices 1242.82 (253.45) and 883.51 (582.38467) for patients with OV. The area-under-curve was 0.823, 95% CI=0.734-0.912, p value=0.000001. The cut-off value for PSD was calculated from the ROC analysis was 1077. The sensitivity, specificity, positive and negative predictive values were 76%, 88%, 95% and 55% respectively.Conclusions: PSD ratio is not an efficient parameter for detection of varices in patients with liver cirrhosis. The current evidence does not support its role as a screening test for identification of patients with OV.