A total of 271 in-hospital patients with non-malignant pain were recruited over an eight-month period, among which 30 patients were exclusively used for testing the pre-final version of SC-PCS; 37 patients were removed due to exclusionary criteria and 4 due to floor and ceiling effects. The remaining 200 patients were used in all analysis presented. The inclusion criteria were as follows: (1) age over 18 years, (2) ability to read and write SC and accurately understand SC-PCS and other questionnaires, and (3) pain duration greater than 12 weeks. Exclusion included tumor, inability to comprehend instructions or lack of consent for study participation. All study procedures were approved by the Institutional Review Board of the Second Affiliated Hospital and Yuying’s Children Hospital, Wenzhou Medical University.
The minimum number of participants for evaluating factor analysis and internal consistency, for assessing concurrent validity, and for testing temporal reliability is 100, 52, and 30, respectively.42 (link),43 We anticipated to recruit 150, 75, and 30 patients who would complete SC-PCS, SC-PCS with five other questionnaires, and additional SC-PCS 10 days after the initial query, respectively. Since participants were recruited from a hospital setting, the first two numbers were easily exceeded (N = 200 and 81). However, because most patients were hospitalized for less than one week, the number of patients for assessing temporal reliability was slightly below the anticipation (N = 24).
All patients completed a battery of questionnaires including a 10-item demographic survey regarding age, gender, residence (urban/rural), marriage, education, and employment status as well as pain VAS, pain duration, and the SC-PCS. Eighty-one patients were chosen to complete five additional five questionnaires (BDI, PANAS, PASS, PSQ, and ODI) in order to construct an internal validity of the SC-PCS. A total of 24 patients were chosen to complete the SC-PCS a second time 10 days after the initial completion to assess temporal stability. In order to minimize pain influence in the temporal stability analysis, only patients whose pain VAS remained invariant over a 10-day period completed a second SC-PCS. All questionnaires were collected on an electronic tablet device and were collected using Research Electronic Data Capture (REDCap).44 (link) REDCap is a secure, convenient, and efficient online/offline web application for capturing electronic survey data and is recommended by the National Institutes of Health for data collection in clinical trials.