Chronic obstructive pulmonary disease (COPD) is one of the common respiratory diseases, and the acute exacerbation of COPD is an acute event that severely reduces the quality of life in patients with COPD. We searched PubMed, CNKI, Wanfang Data Knowledge Service Platform, Vip.com and Chinese Biomedical Literature, sifted out 69 representative literatures according to the inclusion and exclusion criteria, and found that there were 23 patient-reported outcome (PRO) assessment tools used in patients with acute exacerbation of COPD. Except for the EXACT-PRO, all of them directly use PRO assessment tools of stable patients. These assessment tools are divided into general, disease-specific and symptom-specific assessment tools, mainly involving symptoms, physiological field, social field, psychological emotion, daily activities and other fields. The number of items is from one to 100, and the response scale is mostly in the form of Likert, and its development and assessment are based on classical test theory. It is suggested that future studies on quality of life of patients with acute exacerbation of COPD should focus on the following points: strengthening the research on specific assessment tools; attaching importance to the combined application of classical test theory, item response theory and generalizability theory; paying attention to the study of the minimal clinically important difference of assessment tools; selecting assessment tools appropriately.

There is a high prevalence of polypharmacy among elderly patients with severe situation. There is an urgent need for more comprehensive and objective tools to assess the benefits and risks of medication use in patients to ensure maximum length of life and quality of life for patients.

To translate the Patient-reported Outcomes Measure of Pharmaceutical Therapy for Quality of Life (PROMPT-QoL) Scale into Chinese and evaluate its reliability and validity among elderly patients with polypharmacy.

With the authorization of the original author, Brislin's translation model of forward-back translation, cultural adaptation, and cognitive interviews were used to develop a test draft of the Chinese version of the PROMPT-QoL. Elderly patients with polypharmacy who visited outpatient clinics, received health checkups and took medicine at community health centers of Gongyuan street, Beishan street and Henan street, Yanji Hospital and Yanbian University Hospital from June to August in 2022 were selected as the survey respondents. Item analysis was conducted using the item-dimension correlation analysis and the critical ratio (CR). The content validity of the scale was evaluated using the item-level content validity index (I-CVI), universal agreement scale-level CVI (S-CVI/UA) and average scale-level CVI (S-CVI/AVE). Structural validity was evaluated using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). Internal consistency tests (Cronbach's alpha coefficient) and the split-half coefficient were used to assess reliability.

A total of 590 patients were investigated and 564 valid data were recovered, with a recovery rate of 95.8%. Among them, 234 data were applied to the item analysis and EFA in the first stage, and 330 data were applied to the CFA in the second stage. The correlation coefficients between the scores of each item and the scores of each dimension ranged from 0.504~0.915 (P<0.01), and the CR value of each item was >3.0 (P<0.05). The I-CVI ranged from 0.89 to 1.00, the S-CVI/UA was 0.91>0.80, and the S-CVI/Ave was 0.99>0.90. A total of 8 common factors were extracted from EFA, which were basically consistent with the results of the source questionnaire, among which item G34 had a loading of <0.40 on the common factor to which it belonged, so this item was deleted. CFA was performed on the remaining 41 items as follows: χ²/df=2.160, goodness of fit index (GFI) =0.791, normed fit index (NFI) =0.848, incremental fit index (IFI) =0.912, comparative fit idex (CFI) =0.911, Tucker-Lewis index (TLI) =0.902, root mean square error of approximation (RMSEA) =0.059. In the reliability test, Cronbach's α coefficient for the scale was 0.839, Cronbach's α coefficient for each dimension ranged from 0.823 to 0.955, and the split-half coefficient of each dimension ranged from 0.815 to 0.957.

The Chinese version of the PROMPT-QoL scale has good reliability and validity, and can be applied to evaluate the pharmaceutical therapy-related quality of life of elderly patients with polypharmacy in China.

The reported outcome level of patients with inflammatory bowel disease (IBD) has received attention. There are few mature outcome scales with Chinese cultural characteristics for patients with IBD, and the developed scales need strict evaluation.

To analyze and evaluate the measurement properties of the Inflammatory Bowel Disease Patient-Reported Outcome Measurement Scale〔PROISCD-IBD (V1.0) 〕, to provide basis for scientific evaluation of reported outcomes in patients with IBD.

From October 2020 to January 2022, PROISCD-IBD (V1.0) was used to detect 274 IBD patients who were treated in the Outpatient and Inpatient Departments of Gastroenterology in the First Affiliated Hospital of Kunming Medical University and the Affiliated Hospital of Guangdong Medical University. PROISCD IBD (V1.0) consisted of 1 commonality module and 1 IBD specific module (TIBD) . The commonality module had 30 items, which were divided into 4 domains of physical health (PHD) , mental health (MHD) , social health (SHD) , and spiritual/belief health (SBD) . TIBD covered four aspects of digestive system symptoms (DSS) , extraintestinal symptom (EXS) , special psychological symptoms (SPP) , and treatment side effects (TSE) . Cronbach's α coefficient and split-half coefficient were used to test the reliability. Correlation coefficient method, exploratory factor analysis and structural equation model were used to analyze the structural validity. Clinical validity of each domain was analyzed using t test.

The Cronbach's α coefficients of PHD, MHD, SHD, SBD and TIBD of PROISCD-IBD (V1.0) were 0.732, 0.838, 0.781, 0.673 and 0.884, respectively. Cronbach's α coefficient of total scale was 0.932. The half-score coefficients of PHD, MHD, SHD, SBD and TIBD were 0.669, 0.859, 0.610, 0.494 and 0.795, respectively, and the half-score reliability of the total scale was 0.879. Correlation analysis showed that the phase coefficients of PHD, MHD, SHD and SBD scores and commonality module score were all >0.6 (P<0.05) . Three principal components were extracted from exploratory factor analysis, and the cumulative variance contribution rate was 58.05%. Structural equation model showed that χ²/df=2.568, root-mean-square error of approximation (RMSEA) =0.076, normed fit index (NFI) =0.677, non-normed fit index (NNFI) =0.774, comparative fit index (CFI) =0.772, incremental fit index (IFI) =0.774, SRMR=0.103 1. IBD patients were divided into active stage (n=90) and remission stage (n=184) according to clinical stages. The total scores of various domains, common modules, TIBD and scale in remission stage were higher than those in active stage (P<0.05) .

PROISCD-IBD (V1.0) has good reliability and validity for reporting outcome measures in patients with IBD.

Obstructive sleep apnea (OSA) is a common sleep-related respiratory disorder that can easily induce or aggravate a variety of diseases, often causing different levels of decline in the patient's quality of life. Patient-reported outcome (PRO) assessment tools provide effective means for evaluating both quality of life and clinical efficacy. There are numerous OSA-PRO assessment tools available, primarily developed in foreign countries, mainly covering domains such as symptoms, daily activities, social activities, and psychological emotions, with items ranging in number from one to 84, and Likert scale as the main type of response scale. The development and evaluation of these tools employ the classical test theory (CTT). We provide the following recommendations for future research: evaluating the psychometric properties and methodological quality of OSA-PRO assessment tools; combining CTT with modern test theory to develop, revise, and evaluate OSA-PRO assessment tools; strengthening the research on the minimal clinically important difference of OSA-PRO assessment tools; developing OSA-PRO assessment tools highlighting the clinical efficacy of traditional Chinese medicine.

Scale assessment for irritable bowel syndrome (IBS) has been widely implemented in clinical practice, how to choose an appropriate assessment tool is very important. In view of this, we used literature research methodology to search patient-reported outcomes and disease-specific health-related quality of life instruments for IBS, summarized their main contents and psychometric properties, then put forward recommendations on the selection of the instruments. A total of 37 commonly used instruments for IBS were retrieved, which have proven to have good reliability, validity and responsiveness, and can be better applied in clinical practice. We suggest medical professionals and researchers choose an assessment instrument for IBS according to the purpose and content of their research.

Patients with diabetic foot undergoing endovascular therapy for lower extremity arterial disease exhibit poor outcomes and a high mortality rate. It is unclear whether malnutrition assessed by geriatric nutritional risk index (GNRI) is associated with clinical outcomes in these patients.

To investigate the association of baseline malnutrition assessed by GNRI and clinical outcomes of endovascular therapy for lower extremity arterial disease in patients with diabetic foot.

Ninety-five patients who were admitted in Department of Endocrinology, Sun Yat-sen Memorial Hospital due to diabetic foot and lower extremity arterial disease were included from January 2011 to December 2016. All of them received endovascular therapy and followed up for two years. Baseline GNRI was assessed, and divided into three levels: normal nutrition (43 cases) , mild malnutrition (31 cases) and moderate to severe malnutrition (21 cases) . Clinical characteristics were collected, including sex, age, diabetes duration, smoking, body mass index, prevalence of cardiovascular and cerebrovascular diseases, diabetic foot classification, systolic and diastolic blood pressure, and blood test results containing white blood cell count, platelet count, lymphocyte count, neutrophil count, neutrophil-to-lymphocyte ratio, hemoglobin, fasting blood glucose, glycosylated hemoglobin, total cholesterol, triglyceride, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol, albumin, creatinine, and estimated glomerular filtration rate. The primary endpoint was all-cause mortality, and the secondary endpoint was major lower extremity amputation. The Kaplan-Meier curve was used for survival analysis. Univariate and multivariate Cox proportional hazards regression analysis were analyzed to evaluate the risk factors of all-cause mortality.

Fifty-two cases (54.7%) were assessed with malnutrition (GNRI≤98) . Normal nutrition, mild malnutrition, and moderate to severe malnutrition patients had significant differences in average body mass index, leukocyte count, neutrophil count, neutrophil-to-lymphocyte ratio, hemoglobin, triglyceride and albumin (P<0.05) . During the follow-up, 16 patients died, 10 of whom were due to cardiovascular or cerebrovascular diseases; five patients underwent major lower extremity amputation. The two-year survival rate was 92.1%, 75.6% and 50.1% in normal nutrition, mild malnutrition, and moderate to severe malnutrition patients, respectively, showing statistically significant difference (Log-rank test: χ²=10.812, P=0.004) . GNRI≤98〔HR=3.937, 95%CI (1.070, 13.942) , P=0.037〕 was an independent risk factor for all-cause mortality.

The two-year survival rate of patients in normal nutrition group (GNRI>98) was higher than that in malnutrition group (GNRI≤98) . Baseline GNRI-assessed malnutrition may be an independent risk factor for all-cause mortality in diabetic foot patients with lower extremity arterial disease treated by endovascular therapy, so assessing and improving the nutritional status may better improve the clinical outcome of these patients.

The prevalence of inflammatory bowel disease (IBD) increases annually in China. The integrated traditional Chinese and western medicine is helpful to alleviate and control symptoms of IBD. Quality of life (QoL) is an important index to evaluate the clinical efficacy of IBD. However, there are few studies about IBD patient-reported outcomes (PROs) based on TCM theories.

To determine the framework and items, and then use them to develop the IBD PROs scale using TCM theories.

Under the guidance of the TCM theory of "body and mind harmony, and man's adaptation to his total environment" , literature review, core-group discussion and expert consultation were carried out. The conceptual framework and item pool of the draft of an IBD PROs scale were developed, then the corresponding items were determined, forming the draft of the IBD PROs scale. Then the draft scale was pre-tested in IBD patients treated in Department of Spleen and Stomach Diseases, the First Affiliated Hospital of Guangzhou University of Chinese Medicine from January to June 2021. The dispersion tendency, Cronbach's α and correlation analysis were used for further item selection.

The final IBD PROs scale is composed of two domains: body and mind harmony (12 body-related items, and 9 mind-related items) and man's adaptation to his total environment (6 items) .

The IBD PROs scale developed based on theories of TCM could be used to evaluate the QoL of IBD patients. But further clinical research is still needed to verify its reliability and validity.