Study Design
A cross-sectional survey was conducted in Changsha, Hunan Province, China, from June 19 to July 16 in 2021. The study employed the HSOPSC and utilized a multistage random sampling method.
Setting and Sample
Changsha, the capital city of Hunan Province, is located in central China and has an annual per capita income of $8,000. The city is home to 29 tertiary state-owned hospitals [25]. Eligible participants were hospital clinical managers including physicians’ directors and head nurses working in different clinical departments of these hospitals.
Inclusion criteria required participants to be clinical managers aged 20 to 60 years, with at least one year of experience in their managerial role, and to have received patient safety culture training in hospitals. Exclusion criteria encompassed clinical managers who were no longer on duty or not currently working in the hospital due to reasons such as overseas assignments, illness, or maternity leave.
The sample size was calculated based on a power of 0.80, an alpha of 0.05, and an allowable error of 0.001. The calculation was performed using the mean and standard deviation of the “overall patient safety grade” among managers (4.0 ± 1.0) obtained from previous studies [26]. Taking into account a potential nonresponse rate of 10–20%, a final sample size of 560 participants was determined [27].
A multistage random sampling method was used to account for variations in perceptions of a patient safety culture based on geographic regions and hospital scale. (Supplementary Fig. 1). Two areas (east and west) were randomly selected from Changsha City, and from each area, one large hospital (with more than 2000 beds) and one small hospital (with fewer than 2000 beds) were chosen. Finally, four hospitals were selected, including a general hospital, a maternal and child health hospital, an oncology hospital, and a tuberculosis hospital. All clinical managers from these hospitals were invited to participate, resulting in a total distribution of 560 questionnaires with a response rate of 98.9%. After removing 15 repetitive questionnaires, 539 valid questionnaires were included in the analysis.
Measures
Participant Information
Demographic and background information was collected, including gender, age, educational level, marital status, occupation, professional title, form of employment, work department, working years in hospitals, time delays per shift, number of night shifts per month, direct contact with patients, hospital scale and hospital nature.
Hospital Survey on Patient Safety Culture (HSOPSC)
The HSOPSC was utilized to assess the perceived patient safety culture among clinical managers in hospitals [28]. It consisted of 42 items grouped into 12 dimensions, including “teamwork within units”, “feedback and communication about errors”, “supervisor/manager expectations” “actions promoting patient safety”, “overall perceptions of patient safety”, “organizational learning and continuous improvement”, “teamwork across units”, “communication openness”, “frequency of events reported, “handoffs and transitions”, “management support for patient safety”, “staffing”, and “nonpunitive response to errors” dimensions [10]. Each item was rated on a five-point Likert scale from 1= “strongly disagree” to 5= “strongly agree” for agreement or from 1= “never” to 5= “always” for frequency. Eighteen negatively worded items were reverse-scored. The linearly converted scores of each dimension or item ranged between 0 and 100 [26], with higher scores indicating a stronger patient safety culture [11]. To determine the strength of each item or dimension, a positive response rate (PRR) was calculated based on responses of “strongly agree/agree” or “always/most of the time”. PRRs above 75% were considered strengths, while those below 50% indicated areas for improvement [11]. Additionally, two items were added to measure the level of patient safety and the number of adverse events reported over the past 12 months. The scale was translated into Chinese, revised, and piloted in a Chinese tertiary hospital [29]. The total HSPSC showed an acceptable Cronbach's α coefficient of 0.88, and Cronbach’s α coefficient of each dimension ranged from 0.88 to 0.89 [29].
Data Collection
All eligible clinical managers were recruited to participate in the study via a prenotification email sent to hospital managers. The permissions for the survey participants were obtained from them during patient safety training among managers. Data were collected using an online survey tool called Wenjuanxing (https://www.wjx.cn). Participants received a survey link through WeChat (the primary means of mobile communication in China) to increase response rates. Clear instructions were provided at the beginning of the questionnaires to ensure data integrity and accuracy.
To minimize missing values, the questionnaire was designed with a function that reminded respondents to answer any unanswered questions before submitting the survey. Participants completed the questionnaires voluntarily, indicating their informed consent. Questionnaires with identical responses for each item in sections A, B, C, and F were excluded because these sections contain both positively and negatively worded items [11]. Two researchers independently recorded and verified the collected questionnaires.
Statistical Analysis
The categorical variable is presented as frequency and percentage; continuous data are reported as mean (M) and standard deviation (SD). Data were checked for normality using Kolmogorov–Smirnov testing. PRRs were defined as the proportion of positive responses for each dimension or item. Independent t-tests, one-way analysis of variance, or Welch analysis of variance were used for group comparisons. Additionally, comparisons were made between the total scores of the HSOPSC and its dimensions based on time delays per shift. Multivariate linear regression analysis was performed, treating demographic and background variables as independent variables and the total score of the HSOPSC as the dependent variable. Dummy variables were used to represent demographic and background variables, and a forward LR approach was employed.
Bivariate and multiple logistic regression analyses were conducted to examine the relationship between the outcome variables (number of adverse events reported and overall patient safety grade) and the explanatory variables (social-demographic variables and 10 dimensions of patient safety culture). The outcome variable “overall patient safety grade” was dichotomized into positive (i.e., “excellent” and “very good”) and negative (i.e., “failing” to “acceptable”). The variable “number of events reported” was dichotomized as “no event reports” and “one event report or more”. A two-sided p-value of less than 0.05 represented statistical significance. Data analysis was performed using SPSS version 28.
Ethical Considerations
The study was approved by the ethical committee of Xiangya Hospital of Central South University (202011159). Informed consent to participate in the research was received from clinical managers in the study. Participants were also guaranteed the personal anonymity and confidentiality of the data. Participants were also assured of individual anonymity and confidentiality of data without individual identifiers used. The researchers clearly stated the objectives, benefits, and potential risks to participants. They guaranteed the right of participants to withdraw from the study. Data were secure and only accessible to researchers. They were also responsible for data management and data storage.