Application of Patient-Reported Outcome Measurements in Adult Tumor Clinical Trials in China: Cross-Sectional Study.

BACKGROUND: International health policies and researchers have emphasized the value of evaluating patient-reported outcomes (PROs) in clinical studies. However, the characteristics of PROs in adult tumor clinical trials in China remain insufficiently elucidated. OBJECTIVE: This study aims to assess the application and characteristics of PRO instruments as primary or secondary outcomes in adult randomized clinical trials related to tumors in China. METHODS: This cross-sectional study identified tumor-focused randomized clinical trials conducted in China between January 1, 2010, and June 30, 2022. The ClinicalTrials.gov database and the Chinese Clinical Trial Registry were selected as the databases. Trials were classified into four groups based on the use of PRO instruments: (1) trials listing PRO instruments as primary outcomes, (2) trials listing PRO instruments as secondary outcomes, (3) trials listing PRO instruments as coprimary outcomes, and (4) trials without any mention of PRO instruments. Pertinent data, including study phase, settings, geographic regions, centers, participant demographics (age and sex), funding sources, intervention types, target diseases, and the names of PRO instruments, were extracted from these trials. The target diseases involved in the trials were grouped according to the American Joint Committee on Cancer Staging Manual, 8th Edition. RESULTS: Among the 6445 trials examined, 2390 (37.08%) incorporated PRO instruments as part of their outcomes. Within this subset, 26.82% (641/2390) listed PRO instruments as primary outcomes, 52.72% (1260/2390) as secondary outcomes, and 20.46% (489/2390) as coprimary outcomes. Among the 2,155,306 participants included in these trials, PRO instruments were used to collect data from 613,648 (28.47%) patients as primary or secondary outcomes and from 74,287 (3.45%) patients as coprimary outcomes. The most common conditions explicitly using specified PRO instruments included thorax tumors (217/1280, 16.95%), breast tumors (176/1280, 13.75%), and lower gastrointestinal tract tumors (173/1280, 13.52%). Frequently used PRO instruments included the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire-30, the visual analog scale, the numeric rating scale, the Traditional Chinese Medicine Symptom Scale, and the Pittsburgh Sleep Quality Index. CONCLUSIONS: Over recent years, the incorporation of PROs has demonstrated an upward trajectory in adult randomized clinical trials on tumors in China. Nonetheless, the infrequent measurement of the patient's voice remains noteworthy. Disease-specific PRO instruments should be more effectively incorporated into various tumor disease categories in clinical trials, and there is room for improvement in the inclusion of PRO instruments as clinical trial end points.

Dietary Intake of Nutrients and Lifestyle Affect the Risk of Mild Cognitive Impairment in the Chinese Elderly Population: A Cross-Sectional Study.

Mild cognitive impairment (MCI) is a pre-clinical stage of Alzheimer's disease afflicting a large number of the elderly throughout the world. However, modifiable risk factors for the onset and progression of MCI remain unclear. A cross-sectional study was performed to explore whether and how daily dietary nutrients intake and lifestyle impacted the risk of MCI in the Chinese elderly. We examined 2,892 elderly subjects, including 768 MCI patients and 2,124 subjects with normal cognition in three different Provinces of China. Dietary intake of nutrients were collected by using a 33-item food frequency questionnaire and calculated based on the Chinese Food Composition database. The MCI patients were first screened by Montreal Cognitive Assessment and then diagnosed by medical neurologists. Multivariate logistic regression and exploratory factor analyses were applied to identify and rank the risk factors. Three dietary nutrient intake combination patterns were identified as the major protective factors of MCI, with eigenvalues of 14.11, 2.26, and 1.51 and adjusted odds ratios (OR) of 0.77, 0.81, and 0.83 (P < 0.05), respectively. The most protective combination was featured with eight vitamins and six minerals, and OR for the third and fourth quartiles of these nutrients intake ranged from 0.48 to 0.74 (P < 0.05). Carotenoids, vitamin C, and vitamin B6 exhibited the highest protective factor loadings of 0.97, 0.95, and 0.92 (P < 0.05), respectively. Education, computer use, reading, and drinking represented the most protective lifestyle factors (OR = 0.25 to 0.85, P < 0.05), whereas smoking and peripheral vascular diseases were associated with higher (OR = 1.40 and 1.76, P < 0.05) risk of MCI. Adequate dietary intake of monounsaturated fatty acids and cholesterol were significantly associated with decreased risk of MCI. In conclusion, adequate or enhanced intake of micronutrients seemed to lower the risk of MCI in the Chinese elderly. In addition, improving education and lifestyle such as reading, computer use and moderate drinking might also help to decrease the risk of MCI.