Participants
Between March 2017 and March 2018, 150 outpatients and inpatients from the Department of Neurology in the First Hospital of Shanxi Medical University in China were recruited to this cross-sectional study. Our study received ethics approval from Shanxi Medical University Ethics Committee and informed consent was obtained from all participants. The selection criteria for patients were as follows: (1) Diagnosis of PD in accordance with the 2015 PD criteria of the International Association for Dyskinesia. (2) Ability to understand and complete all questionnaires. The exclusion criteria were: (1) Parkinson’s syndrome caused by other factors, like brain trauma. (2) Patients with idiopathic tremor. We used face-to-face interviews to collect data, and investigators monitored and assisted participants in completing the questionnaires. Patients with PD were asked to provide general information about gender, age, marital status, educational level, family population, smoking and drinking behavior.
Patient assessment
The Modified Hoehn and Yahr (HY) Scale [16] was used to assess PD severity. Compared with the original HY scale, the Modified HY scale contains 0.5 level increments. Advantages of the HY scale include its wide utilization and suitability for assessing PD severity. It provides an overall assessment of severity based on functional disability. Higher HY stages indicate worse disease state [17].
The Mini-Mental State Examination (MMSE) [18] was used to assess cognitive function, which scores range from 0 to 30. A score of 23 points or less is generally considered to indicate cognitive impairment. The MMSE has satisfactory predictive validity and is an adequate measure of cognition.
The Unified Parkinson’s Disease Rating Scale (UPDRS II) [19] was used to evaluate ADL. The UPDRS has been used in studies of early PD, mild PD, moderate but stable PD, and motion fluctuations, and is increasingly used as a gold standard reference scale. The UPDRS II contains 13 items relating to symptom interference with ADL. Scores range from 0 to 52, higher scores indicate lower ADL [20].
The Geriatric Depression Scale (GDS) [21] was used to assess depression over the previous few weeks. The GDS is a self-administered, 30-item yes/no questionnaire. The GDS performs well in differentiating depressed from non-depressed PD patients and is a reliable and valid self-rating depression screening scale for older people [22].
The MOS 36-item Short-Form Health Survey (SF-36) [23] was used to measure QOL. The SF-36 is a well-validated 36-item general health status measure and provides two summary scores: physical component summary (PCS) and mental component summary (MCS). Higher SF-36 scores indicate better QOL [12].
Statistical analysis
We used EpiData 3.1 (EpiData Association, Odense, Denmark) to record data twice to ensure data accuracy and reliability. We used SAS 9.4 (SAS Institute, Cary, NC, USA) for statistical description, t-tests or one-way analysis of variance to describe demographic characteristics, and examined the difference between MCS and PCS scores. Spearman’s rank correlation coefficients were used to explore the associations among the factors affecting QOL. A p-value of 0.05 was considered significant.
Multiple mediation models were developed with PD severity and cognitive function as the independent variables, PCS and MCS as the dependent variables, and ADL and depression as chain mediators[24].We used a maximum likelihood structural equation model (ML-SEM) for variable analysis, as this type of model has robust test efficiency when the sample data set is small and subject to skewed distribution, especially for complex models [25]. Mediation analysis was performed using Amos 20.0 (IBM SPSS, Armonk NY). We used the Monte Carlo extension method to test the multiple mediation models, as this method is not dependent on a specific method of estimation or software package, and so is very versatile. The confidence interval (CI) was estimated using the Monte Carlo method, if the interval did not contain a zero, the mediation effect was significant [26].