Patient Safety in the Operating Room: Helsinki Declaration Implementation in Ukraine

Athe study to evaluate the implementation of the components of the Declaration of Helsinki in Ukrainian hospitals, as well as other safety measures during surgeries.

Study Overview

• Status: Completed
• Conditions: Safety Issues

Detailed Description

A study was conducted from May 2021 to September 2021 at the Ukrainian hospitals. The study design was approved by the Ethical Committee at Bogomolets National Medical University. The survey was conducted by filling out a standard Google form. The link to the survey was distributed on the official page of the Association of Anesthesiologists of Ukraine, through social networks Facebook and Instagram on the official webpages of the Department of Surgery, Anesthesiology and Intensive Care of the Institute of Postgraduate Education of NMU. O.O. Worshipers. A total of 174 respondents took part in the survey.

To conduct the survey, we formed a questionnaire of 24 items. The questionnaire was designed to ensure sufficient collection of data from respondents on demographics, awareness of the Declaration, and the use in the everyday practice of the measures recommended in it to promote patient safety. However, the structure of the questionnaire allowed people to fill it in a short time. We also provided respondents with more descriptive and detailed answers to some questions if they wished. The survey was conducted in Ukrainian. Practitioners-anesthesiologists, as well as heads of departments, employees of departments, were invited to participate in the survey.

The survey results were imported into a Microsoft Excel spreadsheet for further analysis. Simple descriptive statistics were used for demographic data and numerical answers to individual questions. The answers, which included the free text were grouped by topic using simple qualitative techniques.

• Study Type: Observational
• Enrollment (Actual): 176

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv, Ukraine
    • Bogomolets NMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Experienced anesthesiologists from most regions of Ukraine were interviewed.

Description

Inclusion Criteria:

• experienced anesthesiologists

Exclusion Criteria:

• anesthesiologists out of practice

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The implication of the Helsinki Declaration on Patient Safety in the hospital	The implication of the Helsinki Declaration on Patient Safety in hospital	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The use of clinical protocols	The use of clinical protocols	2 months
Keeping records of anesthesia complications	Keeping records of anesthesia complications	2 months
The use of the WHO Safe Surgery checklist	The use of the WHO Safe Surgery checklist	2 months

Collaborators and Investigators

• Sponsor: Bogomolets National Medical University

Publications and helpful links

General Publications

• Kelley K, Clark B, Brown V, Sitzia J. Good practice in the conduct and reporting of survey research. Int J Qual Health Care. 2003 Jun;15(3):261-6. doi: 10.1093/intqhc/mzg031.
• Staender SE, Mahajan RP. Anesthesia and patient safety: have we reached our limits? Curr Opin Anaesthesiol. 2011 Jun;24(3):349-53. doi: 10.1097/ACO.0b013e328344d90c.
• Horton JB, Reece EM, Broughton G 2nd, Janis JE, Thornton JF, Rohrich RJ. Patient safety in the office-based setting. Plast Reconstr Surg. 2006 Apr;117(4):61e-80e. doi: 10.1097/01.prs.0000204796.65812.68.
• Mellin-Olsen J, Staender S, Whitaker DK, Smith AF. The Helsinki Declaration on Patient Safety in Anaesthesiology. Eur J Anaesthesiol. 2010 Jul;27(7):592-7. doi: 10.1097/EJA.0b013e32833b1adf.
• Balzer F, Spies C, Schaffartzik W, Pappert D, Wernecke KD, Kuhly R, Boemke W. Patient safety in anaesthesia: assessment of status quo in the Berlin-Brandenburg area, Germany. Eur J Anaesthesiol. 2011 Oct;28(10):749-52. doi: 10.1097/EJA.0b013e328348ee35. No abstract available.
• Wu HHL, Lewis SR, Cikkelova M, Wacker J, Smith AF. Patient safety and the role of the Helsinki Declaration on Patient Safety in Anaesthesiology: A European survey. Eur J Anaesthesiol. 2019 Dec;36(12):946-954. doi: 10.1097/EJA.0000000000001043.
• McColl E, Jacoby A, Thomas L, Soutter J, Bamford C, Steen N, Thomas R, Harvey E, Garratt A, Bond J. Design and use of questionnaires: a review of best practice applicable to surveys of health service staff and patients. Health Technol Assess. 2001;5(31):1-256. doi: 10.3310/hta5310. No abstract available.
• Bielka K, Kuchyn I, Semenko N, Kashchii U, Pliuta I. Patient safety during anesthesia in Ukraine: national audit results. BMC Anesthesiol. 2022 May 27;22(1):164. doi: 10.1186/s12871-022-01704-7.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: patient safety; monitoring; Helsinki Declaration
• Other Study ID Numbers: K44YB21yi7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No