Patient Safety Checklist (PASC) in Surgical Patients

Data Collection Instruments:

Permission to use the scales and the PASC checklist has been obtained from the corresponding authors. Permission for the use of the PASC Checklist, developed by Harris et al. (2022), was obtained in writing from the corresponding author, Assoc. Prof. Kristin Harris, and the content validity process was completed. Written permissions were also obtained via email from Sevinç Meşe for the Surgical Patients' Discharge Education Satisfaction Scale, Eren Can Kalkan for the Healthcare Communication Questionnaire, and Müjdat Yeşildal for the Healthcare Communication Problems Scale.

1. Descriptive Characteristics Form 2. Patient Safety Checklist (PASC) 3. Surgical Patients' Discharge Education Satisfaction Scale 4. Healthcare Communication Questionnaire 5. Healthcare Communication Problems Scale Data Collection Process The study will be conducted among patients undergoing elective general surgery at the Ondokuz Mayıs University Health Practice and Research Center. Patients attending the General Surgery Outpatient Clinic who are scheduled for elective surgery will be assessed for eligibility by the researchers. All patients meeting the eligibility criteria will be consecutively enrolled in the study. Following the provision of written informed consent, participants will be randomized to either the intervention or the control group.

The Patient Safety Checklist (PASC) was developed for patient self-use. Data will be collected using both printed and online forms. All participants will receive printed written instructions explaining how to complete the study forms. Participants assigned to the intervention group will additionally receive written instructions regarding the appropriate use of the PASC and the criteria that will be used to evaluate adherence to the checklist.

The 132 patients randomized to the intervention group will receive the Descriptive Characteristics Form and the Patient Safety Checklist (PASC) on the day the decision for surgery is made. Participants will be instructed to use the PASC throughout the entire perioperative period, from the preoperative phase until hospital discharge. The completed PASC will be collected by the researcher on the day of discharge. On the day of discharge, participants in the intervention group will complete the Surgical Patients' Discharge Education Satisfaction Scale, the Healthcare Communication Questionnaire, and the Health Communication Problems Scale using online forms.

The 132 patients randomized to the control group will complete only the Descriptive Characteristics Form at enrollment and will receive routine standard care throughout the perioperative period. On the day of discharge, participants in the control group will also complete the Surgical Patients' Discharge Education Satisfaction Scale, the Healthcare Communication Questionnaire, and the Health Communication Problems Scale using online forms. All printed study materials from both groups will be collected by the researcher during the discharge process.

Ethical Considerations:

The trial was approved by the Clinical Research Ethics Committee (Ethical IRB: OMÜ KAEK 2025/479-15.10.2025 Sayı: B.30.2. ODM.0.20.08/669-884). All procedures adhered to the ethical principles for human experimentation and the World Medical Association Declaration of Helsinki. Prior to data collection, institutional permissions will be obtained from the hospitals where the study will be conducted. Participants will receive detailed information about the study procedures and will sign a voluntary participation consent form.

Sample size calculation:

The required sample size was calculated using G\*Power 3.1.9.7. A total of 210 participants (105 per group) will be enrolled, based on an effect size (Cohen's d) of 0.50, a power of 95%, and a two-sided significance level of α = 0.05. Since no comparable study reporting an expected dropout rate was identified, a 20 % attrition rate was assumed based on common practice in experimental clinical studies. The sample size obtained from the power analysis was inflated accordingly to account for potential dropouts. Accordingly, the total sample size was determined to be 264 participants, with 132 participants allocated to each group.

Randomization and allocation Participants will be stratified according to the treating surgeon to minimize potential confounding related to differences in surgical practice and perioperative care. Within each stratum, participants will be randomized in a 1:1 ratio to either the intervention or control group using block randomization generated by Randomizer.org. The randomization sequence will be generated by an independent statistician before participant recruitment begins. To ensure allocation concealment, each randomly generated allocation and its corresponding group assignment will be placed in sequentially numbered, sealed, opaque envelopes. After written informed consent has been obtained and eligibility has been confirmed, participants will be assigned to either the PASC intervention group or the standard care control group according to the next envelope in sequence. All eligible patients will be consecutively screened and recorded.

The intervention will be delivered to all participants in the intervention group according to a standardized protocol, and outcome assessments will be conducted at the same time point using validated measurement instruments. To reduce analytical bias, study groups will be coded as Group 1 and Group 2 before data analysis, and all statistical analyses will be performed by an independent statistician blinded to group allocation. Treating surgeons will also be blinded to treatment allocation. However, due to the nature of the intervention, neither the researcher delivering the intervention nor the participants can be blinded.