ObjectiveTo conduct item analysis on the Pulmonary Nodule Symptom Scale preliminarily developed through Delphi consultation, establish the final version of the scale, and evaluate its reliability and validity. MethodsPatients with pulmonary nodules who visited the outpatient department of the First Affiliated Hospital of Guangzhou University of Chinese Medicine from May to October 2024 were enrolled according to diagnostic criteria for pulmonary nodules and predefined inclusion/exclusion standards. Demographic data, medical history, and imaging characteristics of pulmonary nodules were collected, and participants completed the preliminary Pulmonary Nodule Symptom Scale developed through Delphi consultation. Four item analysis methods, including discrete trend method, critical ration method, correlation coefficient method, and Cronbach’s α coefficient, were employed for final item screening to determine the definitive version of the scale. Reliability and validity were systematically assessed via Cronbach’s α, split-half reliability, content validity, and construct validity. ResultsA total of 153 patients with pulmonary nodules were included, comprising 56 (36.60%) males and 97 (63.40%) females, with a mean age of (53.77±12.61) years. The median disease duration was 6 (1, 20) months, and mean nodule diameter was (7.64±4.37) mm, including 38 (24.84%) solitary patients and 115 (75.16%) multiple patients, as well as 39 (25.49%) solid nodules and 114 (74.51%) ground-glass nodules. Based on comprehensive results from four item analysis methods and core group discussion, two items ("symptom severity" and "quality of life") in the overall evaluation dimension were removed. The final scale comprised 15 items across three dimensions: respiratory symptoms, systemic manifestations, and psychological state. The Cronbach’s α coefficient was 0.84, with a Spearman-Brown coefficient of 0.912. Item-level content validity indices ranged from 0.824 to 1.000, while the scale-level content validity index reached 0.933. Kaiser-Meyer-Olkin (KMO) measure was 0.803, with Bartlett’s test of sphericity showing statistical significance (P<0.001). Exploratory factor analysis extracted three factors explaining 52.48% of total variance, and the rotated component matrix distribution generally aligned with the predefined three dimensions. ConclusionThe definitive version of the Pulmonary Nodule Symptom Scale contains 15 items across three dimensions (respiratory symptoms, systemic manifestations, and psychological state). Reliability and validity evaluations demonstrate good reliability and satisfactory validity for the scale.
ObjectiveTo develop a symptom and function assessment scale for patients after Nuss procedure for pectus excavatum and to test its reliability and validity. MethodsFollowing the principles and procedures of patient-reported outcome (PRO) scale development stipulated by the U.S. Food and Drug Administration, an initial draft was formed through literature analysis, qualitative interviews, and Delphi expert consultation. The preliminary draft was used to conduct a pre-survey on patients who underwent Nuss procedure for pectus excavatum at Guangdong Provincial People's Hospital, and the reliability and validity of the scale were tested. ResultsA preliminary PRO-based symptom and function scale was constructed, covering two domains: symptoms and impact on daily functions. The symptom dimension included six items: chest tightness, palpitations, pain, shortness of breath, foreign body sensation of the steel plate, and distress; while the impact on daily functions included four items: difficulty in getting out of bed or lying down, raising arms, bending over, and standing or sitting for a long time. A total of 73 patients who underwent Nuss procedure for pectus excavatum were included in the questionnaire survey, with 70 valid questionnaires collected, including 64 males and 6 females, with 56 patients aged 12-17 years and 14 patients ≥18 years. Through exploratory factor analysis, two common factors were extracted, with a cumulative variance contribution rate of 70%. The Cronbach’s α coefficient of the scale was 0.917. ConclusionThe scale developed in this study has good reliability and validity, high reliability and stability, and can be used as an evaluation tool for the recovery status of patients after Nuss procedure for pectus excavatum.