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.
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.
ObjectiveTo explore the necessity of routine X-ray examination after lung surgery based on patient symptom burden. MethodsA retrospective study was conducted on the patients who underwent thoracoscopic lung resection at the Department of Thoracic Surgery of Guangdong Provincial People's Hospital from March 2020 to April 2023. The routine chest X-ray examination results and symptom burden of postoperative patients were analyzed. Symptom burden was evaluated using the Perioperative Symptom Assessment Lung inventory. Results A total of 2 101 patients were collected, including 915 males and 1 100 femals, with a median age of 56 years. Among patients who underwent routine postoperative chest X-ray, only 1.0% patients accepted intervention. Among patients who had chest X-ray after chest tube removal, only 0.5% of them needed intervention. Among patients who had chest X-ray one month after discharge, only 1.3% of them required intervention. The intervention group had significantly worse shortness of breath (3 points vs. 2 points, P=0.015), pain (2 points vs. 1 point, P=0.039), and disturbed sleep (3 points vs. 2 points, P=0.036) compared with the normal group. Conclusion Very few routine postoperative chest X-ray examinations change patients’ management, and patients who need extra-intervention tended to have more severe symptom burden after surgery.
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.
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.
ObjectiveTo categorize and describe stroke-patients based on factors related to patient reported outcomes. MethodsA questionnaire survey was conducted among stroke-patients in nine hospitals and communities in Shanxi Province. The general information questionnaire and stroke-patient reported outcome manual (Stroke-PROM) were completed. Latent profile analysis was used to analyze the scores of Stroke-PROM, and the explicit variables of the model were the final scores of each dimension. ANOVA and correlation analysis were used to measure the correlation between the factors and subtypes. ResultsFour unique stroke-patient profiles emerged, including a low physiological and low social group (9%), a high physiological and middle social group (40%), a middle physiological and middle social group (26%), and a middle physiological and high social group (25%). There were significant differences in scores of four areas among patients with different subtypes (P<0.05). Moreover, there was a correlation between age, payment, exercise and subtypes (P<0.05). ConclusionThere are obvious grouping characteristics for stroke patients. It is necessary to focus on stroke patients who are advanced in age, have a self-funded status and lack exercise, and provide targeted nursing measures to improve their quality of life.
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.
ObjectiveTo compare the differences in patient satisfaction and health-related quality of life after total mastectomy and breast-conserving surgery for breast cancer. MethodsBreast cancer patients who underwent surgical treatment in the First Hospital of Shanxi Medical University and The People’s Hospital of Shanxi Province from March to June 2021 were selected as the research objects by convenient sampling method. Self-designed questionnaires were used to evaluate the general situation of the patients. Patients’ satisfaction and quality of life were investigated by using the postoperative scale of the BREAST-Q module of total mastectomy (to investigate patients after total mastectomy) and the postoperative scale of the breast-conserving plastic surgery module (to investigate patients after breast-conserving surgery), and the patient-reported outcomes of total mastectomy and breast-conserving surgery were compared, including breast satisfaction, psychosocial health, chest and upper limb physical health, sexual health, medical team satisfaction, and information satisfaction. ResultsIn this study, there were 100 patients in the total mastectomy group and 50 patients in the breast conserving group. There were no significant differences between the two groups in marital status, monthly family income, education, body mass index, whether combined with other physical diseases, chemotherapy, targeted therapy, axillary lymph node dissection, tumor stage, and molecular typing (P>0.05). The rates of radiotherapy and endocrine therapy in the breast conserving group were higher than those in total mastectomy group ( χ2=48.701, P<0.001; χ2=15.891, P<0.001). The scores of quality of life and patient satisfaction scores of the breast conserving group including breast satisfaction, satisfactions of breast doctors, nurses and other doctors, social and mental health, sexual health score were higher than those of the total mastectomy group (P<0.001), but there was no significant difference in the physical health of chest and upper limbs score between the two groups (P>0.05). In addition, the satisfaction score of radiotherapy information in the breast conserving group was 69.40±20.44 and that of medical information given by breast surgeons was 87.04±19.46. ConclusionScores of breast satisfaction, psychosocial health, sexual health, and health-related quality of life in breast-conserving patients are higher than those in total mastectomy patients.
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.
The estimation of the minimal important difference (MID) in patient-reported outcomes (PRO) relies on various selection principles and statistical methods, resulting in varying degrees of credibility among studies. When applying these findings, it is crucial to consider their evaluation outcomes. In the context of widely accepted MID studies based on the anchoring method, the credibility of the MID of PRO is influenced by the selection of anchors and the statistical methods employed for estimation. Variations in the anchors utilized, differences in clinical trial designs, disparities in the characteristics of measurement subjects and environment, as well as the control of biases in studies, can all contribute to inconsistencies in the MID of PRO. In response to this, McMaster University in Canada has developed a credibility evaluation tool specifically for MID studies in PRO. The tool comprises five core items and four additional items. The five core items encompass an evaluation framework that assesses: (1) Is the patient or necessary proxy responding directly to both the PRO and the anchor? (2) Is the anchor easily understandable and relevant for patients or necessary proxy? (3)Has the anchor shown good correlation with the PRO? (4) Is the MID precise? (5) Does the threshold or difference between groups on the anchor used to estimate the MID reflect a small but important difference? The four additional items concerning transition-rated anchors assess: (1) Is the amount of elapsed time between baseline and follow-up measurement for MID estimation optimal? (2) Does the transition item have a satisfactory correlation with the PRO score at follow-up? (3) Does the transition item correlate with the PRO score at baseline? (4) Is the correlation of the transition item with the PRO change score appreciably greater than the correlation of the transition item with the PRO score at follow-up? Given the relative weights of each item in the tool are uncertain and environment-dependent, items are not scored; instead, an overall judgment is made using a qualitative rating approach. This article introduces the specific items of this tool and illustrates the evaluation process through a case study to improve its use in optimizing PRO results presentation and interpretation in clinical trials, reviews, assessments, and guidelines.