1.1 Subjects of the survey
The convenience sampling method was employed to select substitute decision-mkers for critically ill patients who were admitted to a tertiary hospital in Jinan, Shandong Province, between September 2023 and November 2023 following cardiac surgery. The inclusion criteria for both patients and their substitute decision-mkers were as follows: (1) The participants in this study fulfilled the diagnostic criteria for critical illness, as determined by a scoring system known as the Acute Physiology and Chronic Health Evaluation II (APACHE II), with a score of greater than 15 points[6]. (2) patients were admitted to the intensive care unit (ICU) for a minimum duration of 24 hours, exhibiting impaired consciousness and a Glasgow Coma Scale (GCS) score of 8 points or less. (3) All of them were >18 years old.(4) Responsible for signing the informed consent for patient's treatment.(5) Able to complete the questionnaire independently.(6) Voluntarily participated in this study. Exclusion criteria: (1) those who gave up resuscitation.(2) those with severe hearing impairment or verbal communication disorders.(3) those with a family history of genetic mental illness. This study was a cross-sectional survey study, and according to the requirements of statistical variable analysis, the sample size of the study on the factors influencing the variables was at least 5-10 times the number of variables[7]. This study encompassed a comprehensive set of 18 study variables, accounting for a 10% sample attrition rate, necessitating a minimum of 99-198 samples. Ultimately, the final sample size for this study consisted of 200 cases. All investigators provided informed consent and willingly participated in the study, which received approval from the Ethics Committee of Biomedical Research Involving Human Beings of Shandong Provincial Hospital.(SWYX:NO.2023-523)
1.2 Survey instruments
1.2.1 General information questionnaire
The selection of predictors in this study was informed by a comprehensive review of both domestic and international literature, as well as consultations with relevant experts. The researcher developed a questionnaire encompassing various aspects, including general patient information (such as gender, age, and hospital admission history) and general substitute decision maker information (such as gender, age, education level, marital status, monthly household income, relationship with the patient, occupation type, awareness of the patient's disease, and place of residence).
1.2.2 Decision Conflict Scale
The decision conflict scale (DCS) was effectively developed by Canadian nursing scholar O'Connor in 1995 to assess the degree of decision conflict experienced by patients during hospitalization[8]. Additionally, the family version of the decision conflict scale (FDCS) was derived from the DCS by Chinese scholars Liao Zongfeng[9]. The scale utilized in this study was developed based on the Decisional Conflict Scale (DCS) and underwent testing to assess its reliability and validity within families of neurological ICU inpatients. This self-assessment scale was designed specifically for alternative decision-mkers involved in the care of hospitalized patients. Comprising of 16 items, the scale is divided into three dimensions: decision uncertainty (4 items), factors contributing to decision uncertainty (5 items), and perceived validity of the decision (7 items). Each item is scored on a 5-point Likert scale, ranging from "Strongly Agree" to "Strongly Disagree" in descending order. Each participant's response was evaluated using this 5-point Likert scale. All scores were standardized using the following formula: total score = sum of items scores /16*25. The resulting total scale score ranged from 0 to 100. A transformed total score below 25.0 indicated a valid decision with no conflict. Scores between 25.0 and 37.5 suggested a medium level of decision conflict, while scores above 37.5 indicated a high level of decision conflict, suggesting that participants experienced delays in their decision-making process. A higher score for the substitute decision maker indicated a higher level of decision conflict. .The Cronbach's alpha coefficient of the scale in this study is 0.888.
1.2.3 Inpatient Family Communication Scale
The Family Inpatient Communication Survey (FICS) is a measurement tool specifically designed for assessing the level of satisfaction among family members of hospitalized patients who lack decision-making capacity, regarding the quality of communication pertaining to medical decisions. The scale was developed by Torke[10] team in 2016, and later developed by our scholars Li Jie[11]. The scale was culturally adapted to suit the Chinese context and subsequently assessed for its dependability among families of intensive care unit (ICU) inpatients. Comprising a total of 30 items, the scale was categorized into two dimensions: information support (consisting of 18 items) and emotional support (comprising 12 items). Each item was evaluated using a 5-point Likert scale, ranging from "strongly disagree" to "strongly agree", with scores ranging from 1 to 5. The cumulative scores for each item were then summed to obtain a total score, ranging from 30 to 150. Higher scores on the scale indicated greater satisfaction among family members regarding the efficacy of medical communication. The satisfaction of the patient's family with the impact of medical communication is positively correlated with higher scores. The Chinese version of the scale demonstrated a Cronbach's alpha coefficient of 0.926 and a content validity index of 0.952. In this study, the Cronbach's alpha coefficient for the Chinese version of the scale was 0.921.
1.2.4 Decisional Engagement Scale
Decisional Engagement Scale (DES-10) was developed by American scholars Hoerger[12]and compiled in 2016. It was later Chineseized by our scholars Wang Liping[13]Sinicized it to evaluate the subjects' expectation of participating in medical decision-making. It comprises four dimensions, encompassing a total of ten entries. These dimensions include the decision empowerment dimension (consisting of three entries), information needs dimension (consisting of three entries), disease acceptance dimension (consisting of two entries), and future planning dimension (consisting of two entries). Each entry is rated on a scale ranging from 0 to 10, representing the degree of disagreement to agreement. The scores for each entry are then summed to obtain a total score. with higher scores indicating a greater expectation of participation in medical decision-making. The Cronbach's alpha coefficient for the Chinese version of the scale was found to be 0.850, indicating a high level of internal consistency. Additionally, the content validity index was determined to be 0.900, suggesting that the scale effectively measures the intended construct.
1.3 Data collection and quality control methods
The present study was undertaken by the researcher who developed a questionnaire based on the content of each scale. The electronic questionnaire was then distributed through the questionnaire platform for data collection. Additionally, an informed consent form was included, and all questionnaire items were designated as mandatory, ensuring that respondents could only submit their responses once all questions were completed. This measure aimed to guarantee the integrity of the questionnaire completion. Furthermore, IP addresses were restricted to prevent duplicate submissions.. Prior to commencing the survey, the researchers underwent comprehensive training on the fundamental concepts encompassed in the questionnaire, the guidelines, and potential challenges that may arise during the survey procedure. This training aimed to guarantee that each researcher could provide a precise and consistent interpretation of the survey's content. During the survey, the respondents were initially briefed on the study's objectives, the survey methodology, and the principle of confidentiality. Only after the respondents fully comprehended and consented, they were instructed to scan the QR code via the WeChat platform to access the official response platform and during the questionnaire completion process, respondents were individually addressed regarding any queries they had. Subsequently, a survey was conducted on-site to assess the reliability of the questionnaire, identifying and rectifying any errors or omissions through prompt communication with the respondents. On the final day of data collection, two researchers meticulously examined the collected data to ensure its accuracy, and error-free data was subsequently entered into Excel. The study involved the distribution of 200 questionnaires on-site, resulting in the recovery of 200 valid questionnaires, indicating a 100% retrieval rate for valid responses.
1.4 Methods of statistical analysis
The data processing and analysis in this study were conducted using SPSS 25.0 statistical software. For measurement data that followed a normal distribution, descriptive statistics were employed, including mean ± standard deviation for description, independent sample t-test for comparison between two groups, and analysis of variance (ANOVA) for comparison between multiple groups. Median and quartiles were used to describe measurement data that did not follow a normal distribution. Count data were described using frequency and constitutive ratios. The conformity of data to a normal distribution was assessed using the K-S test, and descriptive statistics were applied for the general information, decision conflict, family inpatient communication, and decisional engagement scores of patients and decision substitutes. Pearson correlation analysis was employed to examine the correlation among decision conflict, family inpatient communication, and decisional engagement. Variables that exhibited statistical significance in the one-way mid-analysis were subsequently considered as independent variables in the multiple linear stepwise regression analysis, with an alpha level of 0.05 for inclusion and 0.10 for exclusion. A significance level of P<0.05 was utilized to indicate statistical significance.