No abstract
Background: Several factors are associated to negative outcomes of total joint replacement such as inappropriate expectations, contralateral knee pain, higher psychological distress, high body mass index, use of a walking aid, advanced age, female gender, lower OA grade and thyroid disease Nonetheless, these findings are often not consistent across studies and the exact strength of the associations between these factors and the outcomes remain elusive. It thus remains a challenge to identify which TKA candidates will likely do well, or do poorly following TKA. Aim of the study:To study Impact of Socioeconomic Factors on Outcome of Total Knee Arthroplasty. Materials and methods: A total of 60 patients were selected with 30 patients selected from each low socioeconomic group and high socioeconomic group. Patients who had rheumatoid arthritis or were undergoing revision TKA were excluded from the study. Evaluation was done clinically using Knee society score (KSS), VAS Score and Modified Kuppusamy Socioeconomic status scale. Results: VAS score for Group 1 dropped significantly from 1 st postoperative day to 2 nd postoperative day. After 2 nd day, the VAS score decreased gradually. The mean VAS score in Group 2 decreased gradually from 1 st postoperative day to 14 th day postoperatively. On 24 th week postoperatively, the mean VAS score was similar in both the groups. The mean difference between Group 1 and Group 2 Knee society score preoperatively was 7.1. At time of discharge, the mean difference dropped to 3.04 and was observed to be 4 at 3 rd week post-operatively. The mean difference dropped gradually till 6 th month postoperatively. Majority of patients in Group 1 had DVT prophylaxis up to day 6, but it was up to day 9 in Group 2. Thus, low income is more strongly associated with satisfaction and functional outcomes in young patients after TKA than demographic or implant factors. Conclusion:Within the limitations of the present study, it can be concluded that it is certainly possible that socioeconomic factors, particularly household income, is strongly associated with satisfaction and functional results.
Purpose: Sodium-glucose cotransporter 2 (SGLT 2) inhibitors are a novel class of drugs that have emerged as promising therapeutic agents for Diabetes Mellitus, Heart failure as well as chronic kidney disease. Despite their effectiveness, concerns have been raised about the potential side effects of these drugs. To address these concerns, a pharmaco-vigilance study has been designed to evaluate and compare the adverse events reported in clinical trials with those reported in the real-world settings. The study aims to identify any discrepancies between the reported adverse events and assess the safety profile of SGLT2 inhibitors. Methods: We studied diabetic ketoacidosis (DKA), euglycemic DKA, amputation, urinary tract infection (UTI), mycotic genital infection and hypotension associated with empagliflozin, dapagliflozin, canagliflozin and ertugliflozin in RCTs and pharmacovigilance databases. WHO’s VigiBase, FAERS, EMA’s EudraVigilance and DAEN were thoroughly studied to obtain spontaneously reported real-world adverse events. Results: 12 randomized controlled trials (RCTs) for different SGLT2 inhibitors that enrolled 78,802 patients in total were studied for the adverse effects profiles of each drug. Out of the 12 trials included in the current study, UTI was the most reported adverse event in the SGLT2 group, followed by amputation. Out of all the adverse events that were registered in the spontaneous reporting systems, 69,664 were reported for empagliflozin, 51,172 for dapagliflozin, 59,261 for canagliflozin and 1,315 for ertugliflozin. DKA was the most reported adverse event overall. Proportions of composite adverse events were 25.1% in VigiBase, 28.6% in FAERS, 39.1% with EudraVigilance and 55.1% with DAEN. Most of the adverse events were reported by the health care provider. Conclusion: Our study provides comparison of the real world reported adverse events to adverse events reported in the clinical trials studying the efficacy of SGLT 2 inhibitors.
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