ABSTRACT
Surgical antibiotic prophylaxis (SAP) has been a boon in the prevention of surgical site infections (SSIs). This study was conducted to assess and evaluate the selection, timing, and duration of administration of SAP and their compliance with national and international guidelines in a tertiary care teaching hospital in India. This retrospective study included the data collected from the central records department in a tertiary care teaching hospital on major surgeries conducted between January 1, 2018, and December 31, 2018, from the departments of ENT, general surgery, orthopedic surgery, and obstetrics and gynecology. The data was analyzed for the appropriateness of their indication for SAP administration, choice, timing, and duration of antibiotics, and compliance with the American Society of Health-System Pharmacists (ASHP) and Indian Council of Medical Research (ICMR) guidelines. Results and interpretation Out of the total 394 case records included, only 2.53% (n = 10) of the cases were given an appropriate antibiotic. The duration of SAP was appropriate only in 6.53% (n = 24), and the timing of SAP administration was appropriate only in 50.76% (n = 204). The most commonly used antibiotic was ceftriaxone (pre-operative 58.12% (n = 229) and post-operative 43.14% (n = 170)). Major inappropriateness was observed in the selection of antibiotics which may be attributed to the non-availability of cefazolin in the institute. The inappropriateness of the duration of the SAP may be attributed to the extra precautions taken by the treating physicians to prevent SSIs. The overall compliance of the surgical cases with respect to the ASHP and ICMR guidelines was less than 1%. Conclusion This study identified the lacuna between the guidelines for SAP and the clinical application of the same. It also identified the areas where quality improvement was needed which can be improved by implementing antimicrobial stewardship, especially the choice and the duration of SAP administration.
ABSTRACT
Poorly published trials may result in biased and erroneous healthcare decisions. We conducted this systematic review to evaluate the reporting quality of drug-related randomized controlled trials (RCTs) conducted in India and published in MEDLINE-indexed Indian journals over a decade (between January 1, 2011, and December 31, 2020), as per the Consolidated Standards of Reporting Trials (CONSORT) Checklist 2010. An extensive literature search was conducted using the terms "Randomized controlled trial AND India." The full-length papers were extracted for RCTs related to drugs. Two independent investigators assessed each article against the checklist containing 37 criteria. Each article was scored 1 or 0 against each criterion which was finally summed up and evaluated. None of the articles fulfilled all 37 criteria. A compliance rate of >75% was seen in only 15.5% of articles. More than 75% of articles fulfilled a minimum of 16 criteria. Major checklist points observed to be deficient were "important changes to methods after trial commencement" (7%), "interim analysis and stopping guidelines" (7%), and "description of similarity of interventions while blinding" (4%). There remains ample room for improvement regarding research methodology and manuscript preparation in India. Moreover, journals should stringently implement the CONSORT Checklist 2010 to enhance the standard and quality of publications.
