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A Systematic Review and Quality Assessment of Cardiovascular Disease-Specific Health-Related Quality-of-Life Instruments Part I: Instrument Development and Content Validity
Objectives: Health-related quality-of-life (HRQoL) instruments for cardiovascular diseases (CVD) have been commonly used to measure important patient-reported outcomes (PROs) in clinical trials and practices. This study aimed at systematically identifying and assessing the content validity of CVD-specific HRQoL instruments in clinical studies. Methods: The research team searched Cumulative Index to Nursing and Allied Health Literature, Embase, and PubMed from inception to January 20, 2022. The research team included studies that reported the development and content validity for CVD-specific instruments. Two reviewers independently assessed the methodological quality using the Consensus-based Standards for the Selection of Health Measurement Instruments methods on evaluating content validity of PROs. Content analysis was used to categorize the items included in the instruments. Results: The research team found 69 studies reporting the content validity of 40 instruments specifically developed for CVD. Fourteen (35.0%) were rated "sufficient" with very low to moderate quality of evidence. For PRO development, all instruments were rated "doubtful" or "inadequate." Twenty-eight (70.0%) instruments cover the core concepts of HRQoL. Conclusions: The quality of development and content validity vary among existing CVD-specific instruments. The evidence on the content validity should be considered when choosing HRQoL instrument in CVD clinical studies and health economic evaluations.
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Validation of China Health-Related Outcomes Measures-Cardiovascular Disease
Objectives: China Health -Related Outcomes Measures (CHROME) was an initiative aimed at developing a system of preference -based health -related quality of life instruments for China. CHROME -cardiovascular disease (CVD) is a CVD-specific instrument with 14 items developed under this initiative. This study aimed to test the psychometric properties of CHROME-CVD. Methods: This validation study was conducted using cross-sectional questionnaire survey in China. Eligible patients with CVD were recruited and asked to complete the CHROME-CVD, the EQ-5D-5L, and a CVD-specific nonpreference-based healthrelated quality of life instrument selected according to the confirmed diagnosis of the patients. Item evaluation, internal consistency, measurement invariance, test -retest reliability, structural validity, and construct validity were tested using classic test theory. Item response theory was used to evaluate item -level performance. Results: A total of 444 patients with CVD (coronary artery disease, n = 276, heart failure, n = 104, angina, n = 33, and atrial fibrillation, n =16) from 6 provinces in China were enrolled for the validation. Exploratory factor analysis identified 4 factors: chest pain, other symptoms, physical health, and mental and social health. Cronbach 's alpha and intraclass correlation coefficient were .0.8. A total of 20 of 26 (76.9%), and 90 of 95 (94.7%) predefined hypotheses were met for convergent and discriminant validities, respectively. No important difference was identified between subgroups of gender and residency. Response options of 10 items were found overlapped based on categorical response curves, which led to modification to 4 -level response options. Wording of 3 items were modified by referring wordings of reference instruments. Conclusion: The validation of the CHROME-CVD demonstrated generally good psychometric properties. Further validation on the modified CHROME-CVD is needed.
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Treatment with JianPiYiFei II granules for patients with moderate to very severe chronic obstructive pulmonary disease: A 52-week randomised, double-blinded, placebo-controlled, multicentre trial
Background: Complementary and alternative therapy is widely used to treat chronic obstructive pulmonary disease (COPD). A Chinese herbal medicine, JianPiYiFei (JPYF) II granules, have been shown to improve COPD patients' quality of life, however long-term effectiveness has not been examined. Purpose: To investigate whether long-term treatment with JPYF II granules is effective and safe for patients with stable, moderate to very severe COPD. Study design and methods: A multicentre, randomised, double-blinded, placebo-controlled trial was conducted. Eligible participants from six hospitals were randomly assigned 1:1 to receive either JPYF II granules or placebo for 52 weeks. The primary outcome was the change in St. George's Respiratory Questionnaire (SGRQ) score during treatment. Secondary outcomes included the frequency of acute exacerbations during treatment, COPD Assessment Test (CAT), 6-minute walking test (6MWT), lung function, body mass index, airflow obstruction, dyspnoea, exercise capacity (BODE) index, and peripheral capillary oxygen saturation (SpO2) at the end of treatment. Results: A total of 276 patients (138 in each group) were included in the analysis. JPYF II granules led to a significantly greater reduction in SGRQ score (-7.33 points, 95% CI -10.59 to -4.07; p < 0.0001) which reflects improved quality of life. JPYF II granules improved CAT (-3.49 points, 95% CI -5.12 to -1.86; p < 0.0001) and 6MWT (45.61 metres, 95% CI 20.26 to 70.95; p = 0.0005), compared with placebo. Acute exacerbations were less frequent with JPYF II granules than with placebo (0.87 vs. 1.34 events per patient; p = 0.0043). There were no significant differences between the groups in lung function, BODE index and SpO2. JPYF II granules were well tolerated and no significant adverse effects were noted. Conclusions: Long-term treatment with JPYF II granules is effective in moderate to very severe COPD, improving quality of life and exercise capacity, decreasing the risk of acute exacerbation, and relieving symptoms.
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Topical treatments for atopic dermatitis (eczema): Systematic review and network meta-analysis of randomized trials
Background:Atopic dermatitis (AD) is a common skin condition with multiple topical treatment options, but uncertain comparative effects. Objective:We sought to systematically synthesize the benefits and harms of AD prescription topical treatments. Methods:For the 2023 American Academy of Allergy, Asthma & Immunology and American College of Allergy, Asthma, and Immunology Joint Task Force on Practice Parameters AD guidelines, we searched MEDLINE, EMBASE, CENTRAL, CINAHL, LILACS, ICTRP, and GREAT databases to September 5, 2022, for randomized trials addressing AD topical treatments. Paired reviewers independently screened records, extracted data, and assessed risk of bias. Random-effects network meta-analyses addressed AD severity, itch, sleep, AD-related quality of life, flares, and harms. The Grading of Recommendations Assessment, Development and Evaluation approach informed certainty of evidence ratings. We classified topical corticosteroids (TCS) using 7 groups-group 1 being most potent. This review is registered in the Open Science Framework (https://osf.io/q5m6s). Results:The 219 included trials (43,123 patients) evaluated 68 interventions. With high-certainty evidence, pimecrolimus improved 6 of 7 outcomes-among the best for 2; high-dose tacrolimus (0.1%) improved 5-among the best for 2; low-dose tacrolimus (0.03%) improved 5-among the best for 1. With moderate- to high-certainty evidence, group 5 TCS improved 6-among the best for 3; group 4 TCS and delgocitinib improved 4-among the best for 2; ruxolitinib improved 4-among the best for 1; group 1 TCS improved 3-among the best for 2. These interventions did not increase harm. Crisaborole and difamilast were intermediately effective, but with uncertain harm. Topical antibiotics alone or in combination may be among the least effective. To maintain AD control, group 5 TCS were among the most effective, followed by tacrolimus and pimecrolimus. Conclusions:For individuals with AD, pimecrolimus, tacrolimus, and moderate-potency TCS are among the most effective in improving and maintaining multiple AD outcomes. Topical antibiotics may be among the least effective.
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Thirteen Nonpharmacological Interventions for Increasing the Quality of Life in Patients with Advanced Cancer: A Network Meta-analysis
Background: A variety of nonpharmacological interventions that improve the quality of life of patients with advanced cancer have been difficult for medical staff to select through randomized controlled trials or traditional meta-analyses. Thus, a network meta-analysis is necessary. Objective: This study used network meta-analysis to analyze the effect of 13 different nonpharmacological interventions on improving the living quality of patients with advanced cancer. Methods: Five English databases were searched up to January 2019. The search strategy only included terms relating to or describing the intervention. Results: The study included 13 different nonpharmacological interventions. The overall efficacy was summarized through a holistic study of quality of life. The study found that the combined effect sizes of 13 nonpharmacological interventions crossed the invalid line (weighted mean difference, -13 [95% confidence interval, -33 to 8.5] to 1.7 [95% confidence interval, -18 to 22]), indicating that none of the intervention was significantly different from each other. By evaluating the heterogeneity of this outcome, no significant evidence of heterogeneity ( P > .05) was observed. Probability ranking according to the surface under the cumulative ranking curve showed that there was a great possibility for the CanWalk intervention and structured multidisciplinary intervention to improve outcomes for cancer patients. Conclusions: Thirteen nonpharmacological interventions did not significantly impact quality of life. Regarding the probability rank, CanWalk intervention may be the most promising way that advanced cancer patients can help themselves to a better life. Because of the limitations of the current studies, the conclusion needs further evidence. Implications for practice: Nurses should consider recommending moderate physical activity for patients with advanced cancer.
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Comparison of the measurement properties of the EQ-5D-5L and SF-6Dv2 among overweight and obesity populations in China
Objective To evaluate and compare the measurement properties of the EQ-5D-5L and SF-6Dv2 among Chinese overweight and obesity populations.Methods A representative sample of Chinese overweight and obesity populations was recruited stratified by age, gender, body mass index (BMI), and area of residence. Social-demographic characteristics and self-reported EQ-5D-5L and SF-6Dv2 responses were collected through the online survey. The agreement was assessed using intraclass correlation coefficients (ICC). Convergent validity and known-group validity were examined using Spearman's rank correlation and effect sizes, respectively. The test-retest reliability was assessed using among a subgroup of the total sample. Sensitivity was compared using relative efficiency and receiver operating characteristic.Results A total of 1000 respondents (52.0% male, mean age 51.7 years, 67.7% overweight, 32.3% obesity) were included in this study. A higher ceiling effect was observed in EQ-5D-5L than in SF-6Dv2 (30.6% vs. 2.1%). The mean (SD) utility was 0.851 (0.195) for EQ-5D-5L and 0.734 (0.164) for SF-6Dv2, with the ICC of the total sample was 0.639 (p < 0.001). The Spearman's rank correlation (range: 0.186-0.739) indicated an acceptable convergent validity between the dimensions of EQ-5D-5L and SF-6Dv2. The EQ-5D-5L showed basically equivalent discriminative capacities with the SF-6Dv2 (ES: 0.517-1.885 vs. 0.383-2.329). The ICC between the two tests were 0.939 for EQ-5D-5L and 0.972 for SF-6Dv2 among the subgroup (N = 150). The SF-6Dv2 had 3.7-170.1% higher efficiency than the EQ-5D-5L at detecting differences in self-reported health status, while the EQ-5D-5L was found to be 16.4% more efficient at distinguishing between respondents with diabetes and non-diabetes.Conclusions Both the EQ-5D-5L and SF-6Dv2 showed comparable reliability, validity, and sensitivity when used in Chinese overweight and obesity populations. The two measures may not be interchangeable given the systematic difference in utility values between the EQ-5D-5L and SF-6Dv2. More research is needed to compare the responsiveness.
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Comparison of life quality in older adults living in traditional family versus nursing home: a systematic review and meta-analysis
To assess and compare the QoL of the older people dwelling in traditional family versus nursing home/institution. A comprehensive literature search was performed on 10 January 2018 to identify studies that investigated the QoL of older adults dwelling in family versus nursing home settings. Analyses were run using random-effects meta-analyses. A total of six cross-sectional studies with 1623 people were included. The quality of included studies was moderate. Meta-analysis showed that compared with nursing home support, the family support could significantly improve the physical health (6 studies, SMD = 0.50, 95%CI: 0.32-0.68, p < 0.05), mental status (6 studies, SMD = 0.45, 95%CI: 0.26-0.65, p < 0.05), and social relationship (5 studies, SMD = 0.51, 95%CI: 0.19-0.83, p < 0.05). Traditional family support model demonstrated a significant improvement in the physical health, psychological status and social relationships among older adults. The conclusions were driven by cross-sectional studies, Larger, adequately powered RCTs are required to confirm our finding.
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Exercise Training for Improving Patient-Reported Outcomes in Patients With Advanced-Stage Cancer: A Systematic Review and Meta-Analysis
Abstract Context Patients with advanced-stage cancer often suffer many physical and psychological symptoms. Exercise has been shown to improve quality of life (QoL), decrease cancer-related symptoms, and maintain or improve functional status in cancer survivors or patients with early stage cancer. However, the effect of exercise on these outcomes in patients with advanced-stage cancer is unclear. Objectives This meta-analysis aimed to assess the effectiveness of exercise interventions for patients with advanced-stage cancer in improving cancer-related symptoms and functional status outcomes. Methods We conducted a comprehensive literature search in PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and Web of Science from their inception to February 3, 2019, to include randomized controlled trials (RCTs) comparing exercise and usual care for improving outcomes in patients with advanced-stage cancer. Two reviewers independently screened the studies, extracted data of interest, and assessed the risk of bias of individual RCTs using the Cochrane Handbook, Version 5.1.0. Results About 15 RCTs enrolling 1208 patients were included. Compared with usual care, exercise showed a significant improvement in QoL (standardized mean difference [SMD] 0.22; 95% CI 0.06–0.38; P = 0.009), fatigue (SMD −0.25; 95% CI −0.45 to −0.04; P = 0.02), insomnia (SMD −0.36; 95% CI −0.56 to −0.17; P = 0.0002), physical function (SMD 0.22; 95% CI 0.05–0.38; P = 0.009), social function (SMD 0.18; 95% CI 0.02–0.34; P = 0.03), and dyspnea reduction (SMD −0.18; 95% CI −0.34 to −0.01; P = 0.03). Conclusion Exercise serves as an effective intervention to improve QoL and alleviate fatigue, insomnia, dyspnea, and physical and social functions for patients with advanced-stage cancer.
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The effectiveness of music therapy for patients with cancer: A systematic review and meta-analysis
Aims To assess the effectiveness of music therapy on the quality of life, anxiety, depression and pain of patients with cancer. Design Systematic review. Data Sources Five electronic databases were searched in September 2018 for randomized controlled trials evaluating music therapy for patients with cancer. Review Methods The quality of the studies was assessed using the risk of bias tool recommended by the Cochrane Handbook Version 5.1.0 and the Revman version 5.3 software was used to perform the meta-analysis. The outcomes were overall quality of life, anxiety, depression and pain. Results A total of 19 trials evaluating 1,548 patients were included in this study, of which 765 were in the control group and 783 in the experimental group. Compared with standard care, music therapy can significantly increase the score of the overall quality of life in patients with cancer. In addition, music therapy was found to be more effective for decreasing the score of anxiety, depression and pain. Conclusion Music therapy can improve the overall quality of life of patients with cancer, with an observed optimal intervention duration of 1-2 months. Meanwhile, anxiety, depression and pain are improved as well. Nevertheless, high-quality trials are still needed to further determine the effects of music intervention in supportive cancer care.
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Quality of life of empty-nest elderly in China: a systematic review and meta-analysis
We performed a systematic review and meta-analysis to evaluate the quality of life (QoL) of the empty-nest elderly in China. We searched five databases up to 20 November 2018, to identify all studies on the QoL of empty-nest elderly in China. Twenty-nine were included in the final review. Compared with the control group, the physiological function, psychological function, social function and total score of QoL of empty nests were lower than those of non-empty nests. In addition, meta-analysis showed that the empty nesters were lower than the non-empty nesters in General Health, Role Physical, Bodily Pain, Role Emotional and Vitality. The existing evidence showed that the QoL of the empty-nest elderly in China was to some extent lower than that of the non-empty nest elderly.
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