Approved Protocol

Abstract: Aims All health related research carried out within New Zealand requires appraisal from an accredited ethics committee. The purpose of this project was to pilot an active monitoring programme and to assess the effectiveness of such a programme for future monitoring by ethics committees. Methods In this qualitative study interviews were undertaken by representatives from the Wellington and Manawatu-Whanganui ethics committees with principal investigators for sixteen research proposals which had been given ethical approval from the appropriate ethics committee. Issues discussed during the interviews included the protocol and any changes to the methods or research personnel, recruitment of participants, issues arising from informed consent, reporting of adverse events, funding and payment to researchers. Researchers were given the opportunity to provide feedback on the ethical review process and suggestions for improvement. Results The most significant deviation from the approved protocol concerned access to patient information. Some minor discrepancies between the approved protocols and subsequent research undertaken and the requirements for extending ethical approval of projects beyond the initial approval date were also discussed. Conclusions The monitoring programme fulfilled an educational role, providing an opportunity for information sharing between ethics committees and researchers. An active monitoring programme by an ethics committee can detect deviations from the approved protocol beyond the current requirements for researchers to provide annual progress reports. Future monitoring should include, where relevant, access to consent forms and patients' notes.

Abstract: Background and Objective: A Pharmacist-Assisted Warfarin Dosing (PAWD) program was implemented for patients in the cardiac program of the authors’ hospital in 1996. Within the PAWD program, certified pharmacists, under the direction of physicians, are responsible for warfarin dosing according to an approved protocol. The aim of the program was to have the international normalized ratio (INR) of at least 70% of patients within the therapeutic range at day 4 or 5 after initiation of therapy. However, a preliminary assessment showed that pharmacists were able to use the approved protocol for only 50% of the doses ordered, and only 61% of patients reached the therapeutic range by day 4. A quality improvement initiative was undertaken, and the warfarin protocol was modified. The current study reports the results of a retrospective comparison of outcomes before and after the quality improvement initiative. Methods: The authors compared outcomes for 59 patients enrolled in the PAWD program under the original protocol and 28 patients under the updated protocol. Results: Pharmacists were able to follow the updated protocol in a greater proportion of cases than had been the case with the original protocol. In addition, the mean INR was more often within the therapeutic range when the updated protocol was used, reaching statistical significance on days 5 and 6. Bleeding developed infrequently with either protocol, and vitamin K was used sparingly. Thrombosis did not occur in any patients. Conclusions: Through a continuous quality improvement process, the PAWD program was enhanced and the number of days on which INR was within the therapeutic range increased. These improvements should reduce the frequency of negative patient outcomes (e.g., adverse or thromboembolic events).

Abstract: In order to improve the clinical use of antibiotics in surgical departments of Morozovskaya Children City Clinical Hospital of Moscow Healthcare Department authors prepared, discussed and agreed upon a protocol for perioperative and post-exposure antimicrobial prophylaxis. The choice of antibiotics for systemic use was made according to the Antimicrobial Stewardship Program (ASP) stratification both for patients of type I (community-acquired infection without risk for shedding of polyresistant infectious agents) and type II (community-acquired infections with risk factors for shedding of polyresistant infectious agents). Study determined indications for post-exposure antimicrobial prophylaxis within the approved protocol. Following that the Chief Physician issued an Order On Division of Responsibility of all Members of the Operating Team and On Approval of the Protocol for Conducting Perioperative and Post-Exposure Antimicrobial Prophylaxis. As a result of the implementation of the protocol, by the end of 2020 clinical use of antibiotics in surgical departments has improved. For citation: Vlasova AV, Smirnova EV, Tenovskaya TA, et al. Protocol for Perioperative and Post-exposure Antibiotic Prophylaxis at the State Budgetary Healthcare Institution «Morozovskaya Children’s City Clinical Hospital of Moscow Healthcare Department». City Healthсare. 2021; 2(2): 46-64. doi: 10.47619/2713-2617.zm.2021.v2i2;46-64