Objective To investigate the scientificity of patient-reported outcomes instrument for asthma ( Asthma-PRO) , which maybe used to evaluate the efficacy of anti-asthma drugs in clinical trials and clinical practice.Methods 366 asthma patients and 100 healthy subjects were face-to-face interviewed by well-trained investigators, and the data of Asthma-PRO instrument were collected. The psychometric performance such as reliability, validity, responsiveness and clinical feasibility in the Asthma-PRO instrument was evaluated. Results The split-half reliabilities of the Asthma-PRO instrument and each dimension were greater than 0.8. In the analysis of internal consistency of each dimension, the cronbach’s alpha coefficient was greater than 0.7. Factor analysis showed that the instrument has good construct validity. The scores of each of the facets and total scores between the asthma patients and the healthy subjects were different. The recovery rate and the efficient rate of the questionnaire were more than 95%, and the time required to complete a questionnaire was within 20 minutes, indicating that the scale had a high clinical feasibility. Conclusion The Asthma-PRO instrument has good reliability, validity, responsiveness and clinical feasibility.
ObjectiveTo evaluate the reliability,validity and feasibility of a patient-reported outcomes (PRO) scale in the subjects with respiratory failure. Methods364 patients with chronic respiratory failure and 97 healthy subjects were face-to-face interviewed by well-trained investigators,and the data of respiratory failure -PRO instrument were collected. The psychometric performance such as reliability,validity,responsiveness and clinical feasibility in the respiratory failure -PRO instrument was evaluated. ResultsThe Cronbach's alpha coefficient of the respiratory failure -PRO instrument and each dimension were greater than 0.7. Factor analysis showed that the instrument had good construct validity. The scores of each of the facets and total scores between the patients and the healthy subjects were different. The recovery rate and the efficient rate of the questionnaire were more than 95%,and the time required to complete a questionnaire was within 15 minutes,indicating that the scale had a high clinical feasibility. ConclusionThe respiratory failure -PRO instrument has good reliability,validity,responsiveness and clinical feasibility.
The postoperative symptom burden in patients with lung cancer is severe and adversely impairs their quality of life. Symptom management is the cornerstone of medical care. Patient-reported outcome (PRO)-based symptom management is being increasingly recognized as the best "patient-centered care" model in clinical practice. However, the precise implementation of this model in patients undergoing lung cancer surgery is hindered by the lack of a lung cancer surgery-specific scale, implementation standards, clinical application parameters and high-quality researches. The use of a precise and simple PRO scale and an electronic PRO platform may greatly improve the feasibility of implementing this model. Currently, the application of PRO-based symptom management in lung cancer surgery is still being explored and needs to be improved in clinical research and practice.
The COSMIN-RoB checklist includes three sections with a total of 10 boxes, which is used to evaluate risk of bias of studies on content validity, internal structure, and other measurement properties. COSMIN classifies reliability, measurement error, criteria validity, hypothesis testing for construct validity, and responsiveness as other measurement properties, which primarily focus on the quality of the (sub)scale as a whole, rather than on the item level. Among the five measurement properties, reliability, measurement error and criteria validity are the most widely used in the studies. Therefore, this paper aims to interpret COSMIN-RoB checklist with examples to guide researchers to evaluate the risk of bias of the studies on reliability, measurement error and criteria validity of PROMs.
Measurement properties studies of patient-reported outcome measures (PROMs) aims to validate the measurement properties of PROMs. In the process of designing and statistical analysis of these measurement properties studies, bias will occur if there are any defects, which will affect the quality of PROMs. Therefore, the COSMIN (consensus-based standards for the selection of health measurement instruments) team has developed the COSMIN risk of bias (COSMIN-RoB) checklist to evaluate risk of bias of studies on measurement properties of PROMs. The checklist can be used to develop systematic reviews of PROMs measurement properties, and for PROMs developers, it can also be used to guide the research design in the measurement tool development process for reducing bias. At present, similar assessment tools are lacking in China. Therefore, this article aims to introduce the primary contents of COSMIN-RoB checklist and to interpret how to evaluate risk of bias of the internal structure studies of PROMs with examples.
Objective To analyze the changes of perioperative symptoms of lung cancer patients by using patient-reported outcomes at different time points. MethodsA total of 109 patients who underwent thoracoscopic lung cancer resection in the department of thoracic surgery of our hospital from March to April 2021 were selected, including 55 (50.46%) males and 54 (49.54%) females. The mean age was 55.19±12.12 years. The postoperative symptom scale for lung cancer patients was used to investigate the changes of symptoms before surgery, 1 day after surgery, the day of discharge, and 30 days after surgery. Results The mean hospital stay was 6.89±2.25 days. None of the patients reported any clinical symptoms related to lung cancer before surgery. The most prominent symptoms 1 day after surgery were pain (3.33±0.96 points), nausea (2.81±1.18 points), dizziness (2.00±0.85 points), fatigue (1.89±0.79 points) and shortness of breath (1.79±1.37 points). The patients with dizziness, nausea, fatigue and other symptoms gradually decreased, and the symptoms were relieved significantly (P<0.05). However, the symptoms of conscious pain, cough and shortness of breath lasted for a long time. At 30 days after surgery, 70.64%, 64.22% and 33.03% of patients felt pain, cough and shortness of breath, respectively, and the degree of cough was aggravated (P<0.001). Conclusion Pain, cough, dizziness, shortness of breath and fatigue are the core postoperative symptoms of lung cancer patients. Most postoperative adverse symptoms can be effectively controlled in a short period of time, but pain, cough and shortness of breath still present persistent characteristics, which deserve further study.
Patient-reported outcome (PRO) has been paid increasing attention in lung cancer surgery. It has gradually become an important outcome indicator in clinical research of lung cancer surgery and an important tool for symptom management. Commonly used lung cancer-specific PRO measurement tools include: Lung Cancer Symptom Scale, European Organization for Research and Treatment of Cancer-Core Quality of Life Questionnaire and Lung Cancer module, Functional Assessment of Cancer Therapy-Lung, MD Anderson Symptom Inventory-Lung Cancer module, Postoperative Symptom Scale for Lung Cancer Patients, and Perioperative Symptom Assessment for Lung Surgery. The application of lung cancer-specific scales lacks authoritative implementation norms in the field of lung cancer surgery in terms of scale selection, data collection, and outcome application. This review aimed to analyze the current status of application of PRO scales in lung cancer surgery.
With the transformation of modern medical models, patient-reported outcomes, clinician-reported outcomes, observer-reported outcomes, and performance outcomes have become internationally recognized clinical outcome assessment indicators, and scales have also become important evaluation tools, among which translation and cross-cultural adaptation are one of the important sources of scales. However, at present, there are fewer guidelines for scale translation in China. At present, domestic scale translation has not yet been unified and standardized in clinical reporting. Most translation reports provide readers with incomplete information, which affects the development of scale translation, and the methodology related to the translation of clinical outcome assessment scales still focuses on patient-reported outcome scales, which creates a gap in terms of the recommendations for the rest of the types of translations, a gap which leads to inconsistencies in the translation methodology and process. In this paper, we will develop specific translation methods and processes for each of the four current types of clinical outcome assessments by combining scale translation guidelines to support a standardized approach to translation, cross-cultural adaptation, and linguistic validation for use in standardizing the process of recommending translations of patient-reported outcome scales, clinical-reported outcome scales, observer-reported outcome scales, and behavioral outcome scales.