Study design
A cross-sectional design was employed to collect data from July to December 2022 in Yunnan Province, China. The selection of study sites was based on geographical characteristics, economic development status, and the distribution of ethnic minority populations. Consequently, five counties representing diverse ethnic minority settlements and varying levels of economic development were chosen from the eastern, central and western regions of the province. Within each selected county, one township and two villages were randomly selected for respondents recruitment. The inclusion criteria for participants included individuals aged 45 years or older as of 2022 with a residency duration of at least three consecutive months in the local area and without significant intellectual or mental disorders. The recruitment of all potential participants from each village was conducted using cluster sampling. Participants were given the choice to either independently complete the survey or receive assistance from an interviewer. All participants were volunteers who had provided informed consent prior to face-to-face interviews using a structured questionnaire. Our interviewers, who possessed expertise in population-based surveys, underwent standardized training specifically tailored for this study.
A total of 2,730 individuals were invited to participate in the survey. However, upon careful examination of the collected data, 15 participants were excluded due to missing key variables and 5 participants were excluded as their age was below 45 years. As a result, the final sample size for analysis consisted of 2,710 participants, including 814 Han majority (30.04%), 1,036 Zhiguo ethnic groups (38.23%), and 860 other ethnic minorities (31.73%). Our study protocol underwent review and approval by the Ethics Review Committee of Kunming Medical University.
Measurements
Falls
Falls were operationally defined as unexpected incidents resulting in participants coming to rest on the ground, floor, or a lower level[28]. In our study, participants were asked the following question, "Have you experienced any falls within the preceding 12 months?" The response options provided were binary (Yes or No).
Frailty
The Tilburg Frailty Indicator (TFI), a standardized self-reported questionnaire with 15-item across three domains [29, 30], was utilized to assess frailty. The physical domain consists of eight items encompassing aspects such as physical health, unexplained weight loss, difficulty in walking, balance, hearing problems, vision problems, and weak strength in hand, and physical tiredness. Each item is scored on a scale ranging from 0 to 8 points. The psychological domain includes four items assessing cognition, depressive symptoms, anxiety levels and coping mechanisms. These items are also scored on a scale ranging from 0 to 4 points. Lastly, the social domain includes three items evaluating living arrangements, social relationships and social support with scores ranging from 0 to 3 points. The total TFI score ranges from 0 to 15. An individual with a score of ≥5 is considered frailty: higher scores indicate greater degrees of frailty. Previous studies have demonstrated the reliability and validity of the TFI among the Chinese population[31]. In this study, The Cronbach's alpha coefficient for the TFI was 0.735.
Chronic pain
Chronic pain was defined as persistent or recurrent bodily discomfort lasting for more than 3 months[32, 33]. In our survey, respondents were asked to indicate whether they frequently experienced discomfort due to pain over the past three months with binary options (Yes or No). To further evaluate the intensity of participants’ pain, we utilized a numerical rating scale (NRS) consisting of 10 points. Participants were instructed to select a score ranging from 0 to 10 to describe the severity of their pain[34]. The assigned values for pain points were interpreted as follows: 0 denoted no pain, while scores between 1 and 3 represented mild pain, scores between 4 and 6 indicated moderate pain, and scores between 7 and 10 signified severe pain[35, 36].
Covariates
The covariates consist of two aspects: demographic characteristics and health-related factors. Demographic characteristics encompass ethnicity, age (45-59, 60-69, and ≥70), sex, marital status (whether there is a partner), education level (illiterate, uncompleted primary school, completed primary school, middle school or above), occupation (farmers, non-farm workers), and monthly household income (<1000 RMB, 1000-2999 RMB, 3000-4999 RMB, ≥5000 RMB). To assess the disparities among ethnic minority groups, we categorized them into three groups: Han majority population, Zhiguo ethnic minorities, and other ethnic minorities. The Zhiguo ethnic minorities, also known as "ethnic minority groups directly entering-socialism", refer to those ethnic groups that existed in a primitive or slave society prior to the establishment of the People's Republic of China and transitioned directly into a socialist society without undergoing democratic reforms. Most Zhiguo ethnic minorities inhabit in Yunnan Province. Among the 11 officially recognized Zhiguo ethnic minorities, we have selected six as representatives for this study: Jino, Nu, Bulang, Lisu, Lahu and Wa. Other ethnic minorities included in this study consist of Dai, Bai, Zhuang, Miao, Hui, Yi, Hani, and Yao.
Covariates regarding health-related factors at the individual level included chronic diseases, smoking behavior, drinking habit, and activities of daily living (ADL) as they have been previously associated with frailty in older adults [4, 37, 38]. Respondents were asked to report if they had any of the following chronic conditions: diabetes mellitus, hypertension, dyslipidemia, heart disease, cerebrovascular disease, chronic gastritis, chronic lung disease, chronic nephritis, rheumatoid arthritis, intervertebral disc disease, osteoporosis, ventilation disorder, hyperthyroidism, hypothyroidism, cancer, leukemia, chronic anemia, or other chronic diseases. Chronic diseases were defined as having at least one chronic disease (Yes or No). Smoking status was determined by whether respondents currently smoked or had ever smoked (Yes or No). Alcohol consumption within the past week was also assessed (Yes or No). The Activity of Daily Living Scale[39] was employed to evaluate the ADL status encompassing two components: Physical Activities of Daily Living (PADL) and Instrumental Activities of Daily Living (IADL). PADL consists of six behavioral abilities, namely toileting, feeding, dressing, grooming, walking, and bathing; whereas IADL encompasses eight behavioral abilities including phone usage, shopping skills, meal preparation, housework competence, laundry management capability, transportation aptitude as well as medication and financial management. The total score ranges from 14 to 56 with higher scores indicating greater impairment in daily living functionality for the participant. A score of 14 indicates absence of disabilities while a range of 15-21 represents mild disabilities and a score above or equal to 22 signifies severe disabilities [40].
Statistical analyses
The demographic characteristics and health-related factors of the respondents were described using frequencies (percentages). Chi-square tests were used to compare differences between groups. Spearman correlation analysis was conducted to determine the correlation between chronic pain, falls and frailty were correlated. Baron and Kenny’s causal steps method was used to explore the mediating effect of chronic pain on the relationship between falls and frailty[41]. Following the proposed procedures of this method, a three-step estimation approach was applied to analyze the mediating variable. The mediation effect analysis needs to meet the following conditions: (1) falls was significantly associated with frailty (Total effect; Path c); (2) falls was significantly associated with chronic pain (Path a); (3) controlling for falls, chronic pain was significantly associated with frailty (Path b); (4) the relationship between falls and frailty was reduced (Direct effect, Path c’) when controlling for chronic pain (Indirect effect, a×b). Full mediation occurs when inclusion of the mediation variable reduces the observed relationship between independent variable and dependent variable to zero. Partial mediation occurs when inclusion of mediation effect weakens the observed relationship between independent and dependent variable. Recent studies have shown that bootstrap confidence interval is one of the most reliable tests for conducting a mediation analysis[42, 43]. We set bootstrap confidence interval (CI) at 95% with 5,000 bootstrap samples. If zero is not included in 95% CI, it indicates a significant mediating effect[44]. Liner regression models were used for multivariable regression analyses involving continuous outcomes such as chronic pain score and frailty score. All analyses were performed using Stata v.15 software with statistical significance considered at p-value < 0.05.