Patient-reported outcome measures (PROM) measure attribute studies refer to studies conducted by investigators to validate the measurement attributes of PROM. The consensus-based standards for the selection of health measurement instruments (COSMIN), an international consensus standard for the selection of health measurement instruments, divides this attribute into three aspects: reliability, validity and responsiveness, and adds interpretability as an additional important feature for evaluating PROM. The purpose of this paper is to introduce the verification methods and principles of the three major measurement attributes in the COSMIN consensus, as well as the significance and direction of interpretability evaluation, and to provide international methodological experience and reference for the development of high-quality PROM psychometric attribute verification in China.
ObjectiveTo determine the symptom burden and functional status of patients with early-stage lung cancer at 4 weeks after discharge, and to investigate the influencing factors. MethodsAn analysis was conducted on the clinical data of patients with early-stage lung cancer in a multicenter prospective cohort study conducted in six hospitals in China from November 2017 to January 2020. The MD Anderson Symptom Assessment Scale-Lung Cancer Module (MDASI-LC) was used to evaluate symptoms and functions. Binary logistic regression analysis was used to analyze the influencing factors of moderate to severe functional impairment (≥2 points) and moderate to severe symptoms affecting recovery (≥4 points). ResultsA total of 158 patients were included, including 59 males and 99 females, with an average age of (55.5±9.9) years. At 4 weeks of discharge, the three most severe moderate to severe symptoms were cough (30.4%), shortness of breath (25.3%), and disturbed sleep (22.2%). The proportions of patients with moderate to severe physical and psychological impairment were 53.2% and 38.6%, respectively. Multivariate analysis results showed that shortness of breath was an independent risk factor for moderate to severe postoperative physical impairment [OR=10.12, 95%CI (1.51, 67.60), P=0.017]; cough [OR=5.66, 95%CI (1.52-21.15), P=0.007], pain [OR=12.35, 95%CI (1.21, 126.39), P=0.034], and female sex [OR=4.01, 95%CI (1.10, 14.67), P=0.036] were independent risk factors for moderate to severe psychological impairment; forced expiratory volume in the first second <1.5 L [OR=0.10, 95%CI (0.02, 0.58), P=0.010] and female [OR=2.80, 95%CI (1.17, 6.66), P=0.020] were independent risk factors for moderate to severe shortness of breath; open surgery [OR=6.18, 95%CI (1.54, 24.80), P=0.010] and female [OR=7.33, 95%CI (1.84, 29.20), P=0.005] were independent risk factors for moderate to severe pain. ConclusionPatients with early-stage lung cancer still have a significant symptom burden and functional impairment 4 weeks after discharge. Preoperative attention should be given to patients with poor lung function and female patients. During the operation, open surgery should be avoided as much as possible. Effective management of shortness of breath, pain, and cough symptoms in the postoperative period can promote the functional recovery of patients with early-stage lung cancer.
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.
Cardiac surgery is often associated with significant trauma, which can lead to a suboptimal recovery experience for patients. With advancements in cardiovascular surgical techniques, the rates of surgical mortality and complications have significantly decreased, leading to increased attention on patients' subjective recovery experiences after the surgery. Patient-reported outcomes (PROs) refer to the feedback provided directly by patients regarding their health status, functional abilities, and treatment experiences. Accurate assessment and timely intervention of PROs have become a growing area of interest in the academic community, with improvements in certain PROs showing significant correlations with prognostic benefits. However, there remains controversy regarding which dimensions of PROs should be prioritized in the postoperative recovery of cardiac surgery patients and how to select appropriate evaluation scales for these dimensions. We referenced the research progress both domestically and internationally, combined with clinical practices from around the world, and widely solicited expert opinions to reach a consensus on the evaluation dimensions of postoperative PROs for cardiac surgery patients. This includes the overall recovery status of patients (surgical recovery, quality of life) and its nine dimensions (pain, physiology, sleep, thirst, frailty, activity, cognition, mental health, and social support). This consensus comprehensively considers the application of PROs scales, and introduces 1-3 scales with the widest application and most solid evidence for each dimension, aiming to further standardize the evaluation dimensions of PROs after cardiac surgery in China and the selection of scales for each dimension.
ObjectiveTo summarize the applied research status on the evaluation tools of patient-reported outcome at home and abroad in patients with venous thromboembolism (VTE). MethodBy searching and analyzing the literatures, this paper summarized the concept, evaluation tools and application status of patient-reported outcome in the field of VTE. ResultsThe patient-reported outcomes can more comprehensively and accurately evaluate the disease burden and treatment effect of patients with venous thromboembolism, and can help doctors better understand patients' needs and guide individualized treatment and rehabilitation plans. ConclusionsPatient-reported outcome has a broad application prospect in the field of venous thromboembolism. Further promotion and application of patient-reported outcome can promote the development of medical research and provide reference guidelines for improving the management of patients with venous thromboembolism.
Cardiac surgery is associated with high risks, significant trauma, and long recovery periods. With advances in cardiac surgery techniques, the mortality rate and incidence of complications have been steadily decreasing. Patient-reported outcomes (PROs) have gradually become an important area of research in postoperative recovery of cardiac surgery. The use of patient-reported outcome measures (PROMs) in this field helps to reflect patients' physiological, psychological, and social functioning during recovery, and provides scientific evidence for clinical interventions, which may further improve prognosis and enhance patient recovery experience. This paper reviews the dimensions of PROMs in the field of cardiac surgery recovery, the current status of existing PROMs scales, and the progress of their application, while also identifying the limitations of the existing tools. Finally, it explores future research directions for PROMs in cardiac surgery patients.
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.
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 includes six items: chest tightness, palpitations, pain, shortness of breath, foreign body sensation of the steel plate, and distress; while the impact on daily functions includes 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 is 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.
Objective To comprehensively analyze the research trends in the reported outcomes for lung cancer patients and related management, reveal research hotspots and trends, and provide references for future related research. Methods We searched for relevant literature in the Web of Science core collection, PubMed, and Scopus databases from inception to December 31, 2023. CiteSpace bibliometric software was used to analyze the distribution of authors, countries and regions, research institutions, keyword co-occurrence, keyword burst, and to generate keyword clusters and timeline analysis maps. Results A total of 478 qualified publications were included, and the number of published papers showed an overall upward trend. The highest number of articles was published in the United States. The journal with the highest number of articles was Journal of Pain and Symptom Management, and the journal with the highest citation frequency was Journal of Clinical Oncology. The results of keyword burst analysis showed that hot topics mainly focused on areas such as prospective study, physical activity, exercise, vomiting, survival. ConclusionAlthough the research on lung cancer surgical treatment and the management of patients is developing rapidly, the application of management based on reported outcomes of lung cancer patients is still at a nascent stage, and needs to be continuously improved in clinical research and practice. The establishment of relevant assessment systems needs to be improved. In the future, more researchers need to focus on this area, strengthen multi-regional and multi-institutional collaborations, and accelerate research progress in the management of reported outcomes in lung cancer patients.
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.