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Impact of a minimal monitoring HCV treatment approach on Health-Related Quality of Life.
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-28 DOI: 10.1007/s11136-025-03922-1
Thiago S Torres, Pooja T Saha, Laura Smeaton, Chanelle Wimbish, Dimas Alexandre Kliemann, Anchalee Avihingsanon, Cissy Kityo, Jaclyn Ann Bennet, Marije Van Schalkwyk, Benjamin Linas, Estevao Portela Nunes, Gregory K Robbins, David Wyles, Susanna Naggie, Mark Sulkowski, Sandra Wagner Cardoso, Sunil Solomon
<p><strong>Background: </strong>Direct-acting antivirals (DAA) are highly effective for the management of HCV disease. This study aims to evaluate changes in health-related quality of life (HQoL) among people with HCV who were treated with DAAs using a minimal monitoring (MINMON) approach.</p><p><strong>Methods: </strong>ACTG A5360 was a multicenter, international (Brazil, South Africa, Thailand, Uganda, and USA) trial to assess the feasibility and efficacy of MINMON approach in people with HCV. We measured HQoL using EQ-5D-3L at baseline, sustained virological evaluation visit, week 48 and week 72, and described using EQ-5D summary index (ranges:0-1) and visual analog scale (VAS) score (ranges 0-100). We used paired T-tests to evaluate the change in EQ-5D summary and multivariable linear regression for changes in VAS scores.</p><p><strong>Results: </strong>Overall, 394 individuals were included; most did not have cirrhosis (360; 91%) or problematic alcohol use (278; 71%). We found HQoL improvements for participants from Brazil and Thailand, but not for the USA. Participants reported high rates of pain/discomfort and anxiety/depression, with decreases over time only for Brazil. Factors associated with larger improvements in VAS scores included: cirrhosis at baseline, and non-use or problematic use of other substances (apart from tobacco/marijuana) compared to non-problematic use.</p><p><strong>Conclusion: </strong>We found HQoL improvements among people with HCV following DAA treatment with variability across countries. Our findings reinforce the importance of DAA treatment, especially among those with advanced HCV disease. Continuous mental health care including depression and substance use support should be offered to individuals after HCV treatment.</p><p><strong>Trial registration number: </strong>NCT03512210 (22-Oct-2018) Direct-acting antivirals are highly effective for the management of hepatitis C disease. Recent studies have shown that hepatitis C treatment with direct-acting antivirals has a positive impact on quality of life. However, no studies have assessed quality of life among individuals starting direct-acting antivirals treatment across multiple countries representing high-, middle- and low-income settings. In this study, we evaluated changes in health-related quality of life among people with hepatitis C who were treated with direct-acting antivirals using a simplified treatment delivery and offering minimal in-person monitoring. We found quality of life improvements among persons with hepatitis C after direct-acting antivirals treatment, with differences across countries. Although direct-acting antivirals treatment works well and should be available to all persons with hepatitis C, we found that participants with cirrhosis (liver damage) had higher improvements in quality of life, reinforcing the importance of starting treatment among people with advanced hepatitis C. We also found high rates of anxiety and depression, pointing
{"title":"Impact of a minimal monitoring HCV treatment approach on Health-Related Quality of Life.","authors":"Thiago S Torres, Pooja T Saha, Laura Smeaton, Chanelle Wimbish, Dimas Alexandre Kliemann, Anchalee Avihingsanon, Cissy Kityo, Jaclyn Ann Bennet, Marije Van Schalkwyk, Benjamin Linas, Estevao Portela Nunes, Gregory K Robbins, David Wyles, Susanna Naggie, Mark Sulkowski, Sandra Wagner Cardoso, Sunil Solomon","doi":"10.1007/s11136-025-03922-1","DOIUrl":"https://doi.org/10.1007/s11136-025-03922-1","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Direct-acting antivirals (DAA) are highly effective for the management of HCV disease. This study aims to evaluate changes in health-related quality of life (HQoL) among people with HCV who were treated with DAAs using a minimal monitoring (MINMON) approach.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;ACTG A5360 was a multicenter, international (Brazil, South Africa, Thailand, Uganda, and USA) trial to assess the feasibility and efficacy of MINMON approach in people with HCV. We measured HQoL using EQ-5D-3L at baseline, sustained virological evaluation visit, week 48 and week 72, and described using EQ-5D summary index (ranges:0-1) and visual analog scale (VAS) score (ranges 0-100). We used paired T-tests to evaluate the change in EQ-5D summary and multivariable linear regression for changes in VAS scores.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Overall, 394 individuals were included; most did not have cirrhosis (360; 91%) or problematic alcohol use (278; 71%). We found HQoL improvements for participants from Brazil and Thailand, but not for the USA. Participants reported high rates of pain/discomfort and anxiety/depression, with decreases over time only for Brazil. Factors associated with larger improvements in VAS scores included: cirrhosis at baseline, and non-use or problematic use of other substances (apart from tobacco/marijuana) compared to non-problematic use.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;We found HQoL improvements among people with HCV following DAA treatment with variability across countries. Our findings reinforce the importance of DAA treatment, especially among those with advanced HCV disease. Continuous mental health care including depression and substance use support should be offered to individuals after HCV treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration number: &lt;/strong&gt;NCT03512210 (22-Oct-2018) Direct-acting antivirals are highly effective for the management of hepatitis C disease. Recent studies have shown that hepatitis C treatment with direct-acting antivirals has a positive impact on quality of life. However, no studies have assessed quality of life among individuals starting direct-acting antivirals treatment across multiple countries representing high-, middle- and low-income settings. In this study, we evaluated changes in health-related quality of life among people with hepatitis C who were treated with direct-acting antivirals using a simplified treatment delivery and offering minimal in-person monitoring. We found quality of life improvements among persons with hepatitis C after direct-acting antivirals treatment, with differences across countries. Although direct-acting antivirals treatment works well and should be available to all persons with hepatitis C, we found that participants with cirrhosis (liver damage) had higher improvements in quality of life, reinforcing the importance of starting treatment among people with advanced hepatitis C. We also found high rates of anxiety and depression, pointing","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143524205","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Associations between 24-h movement behaviors and health-related quality of life(HRQoL) in preschool children: a cross-sectional study.
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-26 DOI: 10.1007/s11136-024-03883-x
Haowen Zhang, Zhaoxu Lu, Ting Zhang, Jin Guo, Yihua Bao, Fang Wang, Haoyang Sun, Hongyan Guan, Jian Wu

Purpose: To investigate the association between preschool children's 24-h movement behaviors and health-related quality of life (HRQoL), exploring the impact of time reallocation among these behaviors and examining gender differences.

Methods: This study analysed HRQoL and 24-h movement behaviors of 349 preschool children in three kindergartens in Beijing, China, selected through convenience sampling using a cross-sectional study design. A t-test and multivariate analysis of variance methods were used to investigate gender differences. The study examined the relationship between 24-h movement behaviors and HRQoL using component data analysis and component isochronic substitution model methods, with an investigation into gender differences in the overall association.

Results: The study found a negative correlation between sedentary behavior (SB) and overall HRQoL score (γ = - 11.92, p < 0.05) in the entire sample, particularly affecting physical health score (γ = - 14.39, p < 0.01). Among boys, SB was negatively correlated with the HRQoL total score (γ = - 15.83, p < 0.05), while sleep was positively correlated with psychosocial health scores (γ = 17.814, p = 0.01). However, there was no significant association found between 24-h movement behaviors and HRQoL in girls. When using the component isochronic substitution model, reallocating 30 min from sedentary behavior to sleep increased the total HRQoL score of preschool children by 0.865 points (95% CI 0.071, 1.658). In contrast, reallocating 30 min from sleep to sedentary behavior resulted in a decrease of 0.850 points (95% CI - 1.638, - 0.062) in the total HRQoL score.

Conclusions: To improve preschool children's HRQoL, it is recommended to reduce their sedentary behavior time and increase their sleep time. Public health policymakers should consider this when developing 24-h movement behavior guidelines for preschoolers.

{"title":"Associations between 24-h movement behaviors and health-related quality of life(HRQoL) in preschool children: a cross-sectional study.","authors":"Haowen Zhang, Zhaoxu Lu, Ting Zhang, Jin Guo, Yihua Bao, Fang Wang, Haoyang Sun, Hongyan Guan, Jian Wu","doi":"10.1007/s11136-024-03883-x","DOIUrl":"https://doi.org/10.1007/s11136-024-03883-x","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate the association between preschool children's 24-h movement behaviors and health-related quality of life (HRQoL), exploring the impact of time reallocation among these behaviors and examining gender differences.</p><p><strong>Methods: </strong>This study analysed HRQoL and 24-h movement behaviors of 349 preschool children in three kindergartens in Beijing, China, selected through convenience sampling using a cross-sectional study design. A t-test and multivariate analysis of variance methods were used to investigate gender differences. The study examined the relationship between 24-h movement behaviors and HRQoL using component data analysis and component isochronic substitution model methods, with an investigation into gender differences in the overall association.</p><p><strong>Results: </strong>The study found a negative correlation between sedentary behavior (SB) and overall HRQoL score (γ = - 11.92, p < 0.05) in the entire sample, particularly affecting physical health score (γ = - 14.39, p < 0.01). Among boys, SB was negatively correlated with the HRQoL total score (γ = - 15.83, p < 0.05), while sleep was positively correlated with psychosocial health scores (γ = 17.814, p = 0.01). However, there was no significant association found between 24-h movement behaviors and HRQoL in girls. When using the component isochronic substitution model, reallocating 30 min from sedentary behavior to sleep increased the total HRQoL score of preschool children by 0.865 points (95% CI 0.071, 1.658). In contrast, reallocating 30 min from sleep to sedentary behavior resulted in a decrease of 0.850 points (95% CI - 1.638, - 0.062) in the total HRQoL score.</p><p><strong>Conclusions: </strong>To improve preschool children's HRQoL, it is recommended to reduce their sedentary behavior time and increase their sleep time. Public health policymakers should consider this when developing 24-h movement behavior guidelines for preschoolers.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143516497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Proxy reporting in health: a scoping review of instructions, perspectives, and reporting experiences.
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-26 DOI: 10.1007/s11136-025-03929-8
Henok Dagne, Kathleen Doherty, Julie Campbell, Alice Saul, Jessica Roydhouse

Background: Informal carers ('proxies'), who typically provide unpaid care and have a personal relationship with the care recipient, are often asked to report on the health of individuals who are unable to self-report. However, this task is not without its challenges. Little is known about how proxies approach this task, which poses challenges for optimal questionnaire design.

Purpose: The review had three aims: (1) to identify the questionnaire perspective instructions provided to proxies i.e., whether the proxy was asked to answer from their own (proxy-proxy) or the person's (proxy-patient) perspective when reporting, (2) identify which perspective instruction the proxies followed, if reported, and (3) what information, if any, was captured about the proxy's experience of reporting about someone else. In the proxy-proxy perspective, proxies report from their own perspective, but in the proxy-patient perspective they report from the perspective of the person living with the condition.

Methods: A systematic search was conducted across Medline, Psych Info, CINAHL, and Embase. Only published articles meeting the criteria of informal carers providing proxy reports for adults were considered.

Results: Of 5816 publications, 60 articles were eligible for full-text review, and 12 were included for data extraction. Instructions varied, with proxies asked to adopt both proxy-proxy and proxy-patient perspectives in eight studies and only the proxy-patient in four of them. Whether proxies followed the provided instructions consistently is not known. Proxies' reporting experiences were not reported in the included studies.

Conclusion: Proxies are provided with different perspective instructions, but proxy adherence to instructions is not known. Additionally, proxy reporting experience was not described. Providing clear instructions, evaulating proxy adherence to instructions and collecting proxies' reporting experiences can inform optimal questionnaire design to help proxies better report about the health of others.

Review registration: Registered at open science framework: https://osf.io/j4t87 .

{"title":"Proxy reporting in health: a scoping review of instructions, perspectives, and reporting experiences.","authors":"Henok Dagne, Kathleen Doherty, Julie Campbell, Alice Saul, Jessica Roydhouse","doi":"10.1007/s11136-025-03929-8","DOIUrl":"https://doi.org/10.1007/s11136-025-03929-8","url":null,"abstract":"<p><strong>Background: </strong>Informal carers ('proxies'), who typically provide unpaid care and have a personal relationship with the care recipient, are often asked to report on the health of individuals who are unable to self-report. However, this task is not without its challenges. Little is known about how proxies approach this task, which poses challenges for optimal questionnaire design.</p><p><strong>Purpose: </strong>The review had three aims: (1) to identify the questionnaire perspective instructions provided to proxies i.e., whether the proxy was asked to answer from their own (proxy-proxy) or the person's (proxy-patient) perspective when reporting, (2) identify which perspective instruction the proxies followed, if reported, and (3) what information, if any, was captured about the proxy's experience of reporting about someone else. In the proxy-proxy perspective, proxies report from their own perspective, but in the proxy-patient perspective they report from the perspective of the person living with the condition.</p><p><strong>Methods: </strong>A systematic search was conducted across Medline, Psych Info, CINAHL, and Embase. Only published articles meeting the criteria of informal carers providing proxy reports for adults were considered.</p><p><strong>Results: </strong>Of 5816 publications, 60 articles were eligible for full-text review, and 12 were included for data extraction. Instructions varied, with proxies asked to adopt both proxy-proxy and proxy-patient perspectives in eight studies and only the proxy-patient in four of them. Whether proxies followed the provided instructions consistently is not known. Proxies' reporting experiences were not reported in the included studies.</p><p><strong>Conclusion: </strong>Proxies are provided with different perspective instructions, but proxy adherence to instructions is not known. Additionally, proxy reporting experience was not described. Providing clear instructions, evaulating proxy adherence to instructions and collecting proxies' reporting experiences can inform optimal questionnaire design to help proxies better report about the health of others.</p><p><strong>Review registration: </strong>Registered at open science framework: https://osf.io/j4t87 .</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143516500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Associations between financial toxicity, health-related quality of life, and well-being in Indonesian patients with breast cancer.
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-25 DOI: 10.1007/s11136-025-03925-y
Stevanus Pangestu, Fredrick Dermawan Purba, Hari Setyowibowo, Clara Mukuria, Fanni Rencz

Objectives: Financial toxicity (FT) is the impairment of financial well-being experienced by patients with cancer, categorized into subjective (SFT) and objective (OFT) forms. This study aimed to investigate the associations between FT, health-related quality of life, and overall well-being in patients with breast cancer.

Methods: We analyzed baseline data from a single-center longitudinal study in Indonesia. Patients completed the EQ-5D-5L, EQ Health and Wellbeing (EQ-HWB), COST: A FACIT Measure of Financial Toxicity (FACIT-COST, for measuring SFT), and OFT-related questions. Ordinal logistic regression was used to examine the associations between FT and selected EQ-5D-5L and EQ-HWB items. Multivariable linear regression was used to assess the associations of FT and EQ-5D-5L and EQ-HWB-S index values. The main regression models were adjusted for socio-demographic and clinical factors such as age, income, metastasis status, and symptoms.

Results: The survey included 300 female patients with breast cancer undergoing treatment (mean age = 51). Overall, 21% experienced high SFT (FACIT-COST ≤ 17.5) and 51% reported any OFT (e.g., incurring debt). Adjusted for covariates, higher SFT was associated with more problems in EQ-5D-5L pain/discomfort and anxiety/depression, and in EQ-HWB exhaustion, anxiety, sadness/depression, frustration, pain, and discomfort. OFT was associated with more problems in exhaustion. Higher SFT was associated with lower EQ-5D-5L and EQ-HWB-S index values, with explained variances of 46.3% for EQ-HWB-S and 31.2% for EQ-5D-5L.

Conclusions: This study is the first to explore the associations between financial toxicity, EQ-5D-5L, and EQ-HWB outcomes in breast cancer. Our findings provide insight into the cancer burden and its link to health and well-being.

{"title":"Associations between financial toxicity, health-related quality of life, and well-being in Indonesian patients with breast cancer.","authors":"Stevanus Pangestu, Fredrick Dermawan Purba, Hari Setyowibowo, Clara Mukuria, Fanni Rencz","doi":"10.1007/s11136-025-03925-y","DOIUrl":"https://doi.org/10.1007/s11136-025-03925-y","url":null,"abstract":"<p><strong>Objectives: </strong>Financial toxicity (FT) is the impairment of financial well-being experienced by patients with cancer, categorized into subjective (SFT) and objective (OFT) forms. This study aimed to investigate the associations between FT, health-related quality of life, and overall well-being in patients with breast cancer.</p><p><strong>Methods: </strong>We analyzed baseline data from a single-center longitudinal study in Indonesia. Patients completed the EQ-5D-5L, EQ Health and Wellbeing (EQ-HWB), COST: A FACIT Measure of Financial Toxicity (FACIT-COST, for measuring SFT), and OFT-related questions. Ordinal logistic regression was used to examine the associations between FT and selected EQ-5D-5L and EQ-HWB items. Multivariable linear regression was used to assess the associations of FT and EQ-5D-5L and EQ-HWB-S index values. The main regression models were adjusted for socio-demographic and clinical factors such as age, income, metastasis status, and symptoms.</p><p><strong>Results: </strong>The survey included 300 female patients with breast cancer undergoing treatment (mean age = 51). Overall, 21% experienced high SFT (FACIT-COST ≤ 17.5) and 51% reported any OFT (e.g., incurring debt). Adjusted for covariates, higher SFT was associated with more problems in EQ-5D-5L pain/discomfort and anxiety/depression, and in EQ-HWB exhaustion, anxiety, sadness/depression, frustration, pain, and discomfort. OFT was associated with more problems in exhaustion. Higher SFT was associated with lower EQ-5D-5L and EQ-HWB-S index values, with explained variances of 46.3% for EQ-HWB-S and 31.2% for EQ-5D-5L.</p><p><strong>Conclusions: </strong>This study is the first to explore the associations between financial toxicity, EQ-5D-5L, and EQ-HWB outcomes in breast cancer. Our findings provide insight into the cancer burden and its link to health and well-being.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143493451","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Placebo response variability on health-related quality of life outcomes in irritable bowel syndrome: an arm-based network meta-analysis.
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-25 DOI: 10.1007/s11136-025-03927-w
Zhenzhi Wang, Yukun Chen, Xinyu Li, Li Lin, Bozhu Chen, Min Chen, Hui Zheng

Objectives: The impact of placebo response on health outcomes in various diseases, including IBS, is significant. To better understand the effect of different placebo administration methods on the observed outcomes in IBS studies, this meta-analysis aims to explore research findings on the degree of improvement.

Methods: The meta-analysis included 45 randomized, double-blind, placebo-controlled clinical trials involving 5174 patients with confirmed IBS (excluding those with significant comorbidities). The trials were designed to compare the efficacy of different placebo interventions. The primary outcome was the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS), and secondary outcomes included the Irritable Bowel Syndrome Quality of Life Instrument (IBS-QoL) and the IBS Symptom Visual Analog Scale (VAS). An arm-based Bayesian network meta-analysis was performed to examine the relative effectiveness of the placebo interventions on the outcomes.

Results: The analysis revealed that sham moxibustion exhibited the most significant efficacy in reducing IBS-SSS (MD -260.00, 95% CrIs: -288.00 to -232.00). Additionally, sham FMT resulted in significant improvements in IBS-QOL scores (MD 9.23, 95% CrIs - 3.69 to 22.30). Meanwhile, placebo tablet interventions were found to be the most effective in reducing VAS scores (MD 4.71, 95% CrIs, -1.14 to 11.10). Overall, this synthesis provides detailed insights into the effectiveness of placebos in addressing different outcome measures.

Conclusions: Sham moxibustion appears to provide subjective benefits for patients' IBS symptoms. However, the evidence for its efficacy is less robust compared to other interventions, as assessed by GRADE. Understanding the placebo effect in IBS management is crucial for clinical practice and drug development, particularly in placebo comparisons.

Registration id: INPLASY2024110111. https://doi.org/10.37766/inplasy2024.11.0111 .

{"title":"Placebo response variability on health-related quality of life outcomes in irritable bowel syndrome: an arm-based network meta-analysis.","authors":"Zhenzhi Wang, Yukun Chen, Xinyu Li, Li Lin, Bozhu Chen, Min Chen, Hui Zheng","doi":"10.1007/s11136-025-03927-w","DOIUrl":"https://doi.org/10.1007/s11136-025-03927-w","url":null,"abstract":"<p><strong>Objectives: </strong>The impact of placebo response on health outcomes in various diseases, including IBS, is significant. To better understand the effect of different placebo administration methods on the observed outcomes in IBS studies, this meta-analysis aims to explore research findings on the degree of improvement.</p><p><strong>Methods: </strong>The meta-analysis included 45 randomized, double-blind, placebo-controlled clinical trials involving 5174 patients with confirmed IBS (excluding those with significant comorbidities). The trials were designed to compare the efficacy of different placebo interventions. The primary outcome was the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS), and secondary outcomes included the Irritable Bowel Syndrome Quality of Life Instrument (IBS-QoL) and the IBS Symptom Visual Analog Scale (VAS). An arm-based Bayesian network meta-analysis was performed to examine the relative effectiveness of the placebo interventions on the outcomes.</p><p><strong>Results: </strong>The analysis revealed that sham moxibustion exhibited the most significant efficacy in reducing IBS-SSS (MD -260.00, 95% CrIs: -288.00 to -232.00). Additionally, sham FMT resulted in significant improvements in IBS-QOL scores (MD 9.23, 95% CrIs - 3.69 to 22.30). Meanwhile, placebo tablet interventions were found to be the most effective in reducing VAS scores (MD 4.71, 95% CrIs, -1.14 to 11.10). Overall, this synthesis provides detailed insights into the effectiveness of placebos in addressing different outcome measures.</p><p><strong>Conclusions: </strong>Sham moxibustion appears to provide subjective benefits for patients' IBS symptoms. However, the evidence for its efficacy is less robust compared to other interventions, as assessed by GRADE. Understanding the placebo effect in IBS management is crucial for clinical practice and drug development, particularly in placebo comparisons.</p><p><strong>Registration id: </strong>INPLASY2024110111. https://doi.org/10.37766/inplasy2024.11.0111 .</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143493453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Long-term health-related quality of life among adolescent and young adult breast cancer survivors.
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-21 DOI: 10.1007/s11136-025-03914-1
Noelle J M C Vrancken Peeters, Roos Kerklaan, Carla Vlooswijk, Rhodé M Bijlsma, Suzanne E J Kaal, Jacqueline M Tromp, Monique E M M Bos, Tom van der Hulle, Maaike de Boer, Janine Nuver, Mathilde C M Kouwenhoven, Winette T A van der Graaf, Olga Husson

Purpose: As the prognosis for adolescents and young adults (AYAs) with breast cancer has improved, long-term health-related quality of life (HRQoL) has become increasingly important. This study aimed to analyze the long-term HRQoL of AYA breast cancer survivors compared to an age-matched normative population and to identify factors associated with HRQoL.

Methods: Secondary analyses were conducted using data from the SURVAYA study. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) was used to assess HRQoL. The Mann-Whitney U test was used to compare HRQoL scores of AYA breast cancer survivors with those of the normative population (n = 409). Linear regression models were constructed to identify patient and treatment characteristics associated with HRQoL.

Results: A total of 944 female AYA breast cancer survivors were included, with a median age of 36.0 years and a median follow-up of 12.2 years. AYA breast cancer survivors scored significantly lower on five functional scales: physical, role, emotional, cognitive, and social, and higher on five symptom scales: fatigue, pain, dyspnea, insomnia, and financial impact compared to the normative population. Being in a relationship, having a positive body image, and adaptive coping were positively associated with HRQoL, while older age, chemotherapy, unemployment, and maladaptive coping were negatively associated.

Conclusion: AYA breast cancer survivors experience significantly compromised long-term HRQoL compared to an age-matched normative population. These results highlight the need for tailored follow-up care and long-term support, as well as the importance of shared decision-making about the benefits and risks of treatments before initiation.

{"title":"Long-term health-related quality of life among adolescent and young adult breast cancer survivors.","authors":"Noelle J M C Vrancken Peeters, Roos Kerklaan, Carla Vlooswijk, Rhodé M Bijlsma, Suzanne E J Kaal, Jacqueline M Tromp, Monique E M M Bos, Tom van der Hulle, Maaike de Boer, Janine Nuver, Mathilde C M Kouwenhoven, Winette T A van der Graaf, Olga Husson","doi":"10.1007/s11136-025-03914-1","DOIUrl":"https://doi.org/10.1007/s11136-025-03914-1","url":null,"abstract":"<p><strong>Purpose: </strong>As the prognosis for adolescents and young adults (AYAs) with breast cancer has improved, long-term health-related quality of life (HRQoL) has become increasingly important. This study aimed to analyze the long-term HRQoL of AYA breast cancer survivors compared to an age-matched normative population and to identify factors associated with HRQoL.</p><p><strong>Methods: </strong>Secondary analyses were conducted using data from the SURVAYA study. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) was used to assess HRQoL. The Mann-Whitney U test was used to compare HRQoL scores of AYA breast cancer survivors with those of the normative population (n = 409). Linear regression models were constructed to identify patient and treatment characteristics associated with HRQoL.</p><p><strong>Results: </strong>A total of 944 female AYA breast cancer survivors were included, with a median age of 36.0 years and a median follow-up of 12.2 years. AYA breast cancer survivors scored significantly lower on five functional scales: physical, role, emotional, cognitive, and social, and higher on five symptom scales: fatigue, pain, dyspnea, insomnia, and financial impact compared to the normative population. Being in a relationship, having a positive body image, and adaptive coping were positively associated with HRQoL, while older age, chemotherapy, unemployment, and maladaptive coping were negatively associated.</p><p><strong>Conclusion: </strong>AYA breast cancer survivors experience significantly compromised long-term HRQoL compared to an age-matched normative population. These results highlight the need for tailored follow-up care and long-term support, as well as the importance of shared decision-making about the benefits and risks of treatments before initiation.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143468887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Health-related quality of life after major extremity trauma: qualitative research with military service members and clinicians to inform measurement of patient-reported outcomes.
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-20 DOI: 10.1007/s11136-025-03915-0
Callie E Tyner, Pamela A Kisala, Jerry Slotkin, Matthew L Cohen, Jill M Cancio, Alison L Pruziner, Christopher L Dearth, David S Tulsky

Purpose: The purpose of this study was to understand health-related quality of life (HRQOL) factors for adults who experience major extremity trauma, including limb preservation and amputation, to guide the selection and creation of patient-reported outcome (PRO) measures.

Methods: A thematic content qualitative analysis was used to study service members (SMs) with a history of major extremity trauma and clinical providers with expertise in limb trauma, limb loss, and limb preservation/reconstruction. Focus groups were conducted at three Military Treatment Facilities and one Department of Veterans Affairs Medical Center.

Results: Fifty-six SMs and 34 clinicians participated. Thirty-six percent of focus group comments were coded under Physical Health, 31% Emotional Health, and 28% Social Participation. These results were largely consistent across clinicians and SMs, and clinical subgroups, with a few exceptions such as the relevance of fine motor tasks and prosthetic devices for SMs with upper extremity injury/limb loss, and orthotic devices for SMs with limb preservation/reconstruction.

Conclusion: Many HRQOL topics identified are shared with existing general PRO measures-including pain, physical function, anxiety, depression, anger, positive affect and well-being, fatigue, social participation, and loneliness-as well as rehabilitation-focused PRO measures-such as resilience, grief/loss, stigma, self-esteem, mobility, fine motor functioning, self-care, and independence. This qualitative research can be used to inform domains of HRQOL in need of new PRO measures for this population, including satisfaction with orthosis/prosthesis, satisfaction with physical abilities/athleticism, body image, future outlook, and vocational impact.

{"title":"Health-related quality of life after major extremity trauma: qualitative research with military service members and clinicians to inform measurement of patient-reported outcomes.","authors":"Callie E Tyner, Pamela A Kisala, Jerry Slotkin, Matthew L Cohen, Jill M Cancio, Alison L Pruziner, Christopher L Dearth, David S Tulsky","doi":"10.1007/s11136-025-03915-0","DOIUrl":"https://doi.org/10.1007/s11136-025-03915-0","url":null,"abstract":"<p><strong>Purpose: </strong>The purpose of this study was to understand health-related quality of life (HRQOL) factors for adults who experience major extremity trauma, including limb preservation and amputation, to guide the selection and creation of patient-reported outcome (PRO) measures.</p><p><strong>Methods: </strong>A thematic content qualitative analysis was used to study service members (SMs) with a history of major extremity trauma and clinical providers with expertise in limb trauma, limb loss, and limb preservation/reconstruction. Focus groups were conducted at three Military Treatment Facilities and one Department of Veterans Affairs Medical Center.</p><p><strong>Results: </strong>Fifty-six SMs and 34 clinicians participated. Thirty-six percent of focus group comments were coded under Physical Health, 31% Emotional Health, and 28% Social Participation. These results were largely consistent across clinicians and SMs, and clinical subgroups, with a few exceptions such as the relevance of fine motor tasks and prosthetic devices for SMs with upper extremity injury/limb loss, and orthotic devices for SMs with limb preservation/reconstruction.</p><p><strong>Conclusion: </strong>Many HRQOL topics identified are shared with existing general PRO measures-including pain, physical function, anxiety, depression, anger, positive affect and well-being, fatigue, social participation, and loneliness-as well as rehabilitation-focused PRO measures-such as resilience, grief/loss, stigma, self-esteem, mobility, fine motor functioning, self-care, and independence. This qualitative research can be used to inform domains of HRQOL in need of new PRO measures for this population, including satisfaction with orthosis/prosthesis, satisfaction with physical abilities/athleticism, body image, future outlook, and vocational impact.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143459203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A weighted predictive modeling method for estimating thresholds of meaningful within-individual change for patient-reported outcomes.
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-19 DOI: 10.1007/s11136-025-03924-z
Chong-Ye Zhao, Min-Qian Yan, Xiao-Han Xu, Chun-Quan Ou

Purpose: Calculating the threshold for meaningful within-individual change (MWIC) is essential for interpreting patient-reported outcomes (PRO). However, traditional methods of determining MWIC threshold yield varying estimates and lack a standardized approach. We aim to propose a novel method for more accurate MWIC threshold estimation.

Methods: We developed a weighted predictive modeling method. The weighting involved using the rank difference between PRO score change and the anchor of each individual. A Monte Carlo simulation was conducted to compare the performance of the new method and that of existing state-of-the-art methods. Simulation parameters included distributions of PRO score changes, sample sizes, improvement proportions, and correlation strengths. Statistical performance was assessed using relative bias (rbias), coefficient of variation (CV), and relative root mean squared error (rRMSE).

Results: Distribution-based methods had the largest rbias and rRMSE among all methods. Existing anchor-based methods except for the Terluin 2022 method were biased when the correlation strength was weak or when the improvement proportion was not 50%. The Terluin 2022 method requires estimating an important reliability parameter, and this method had highest CV compared to other predictive modeling methods. The new weighted method demonstrated the smallest rRMSE across most simulation settings. It also maintained relatively high accuracy under weak correlation strength or imbalanced improvement proportion. Similar results were presented under normal or skewed distributions of PRO score changes.

Conclusion: This novel method offers a simple and feasible alternative to existing predictive modeling methods for estimating MWIC threshold, which can facilitate the application of PRO.

{"title":"A weighted predictive modeling method for estimating thresholds of meaningful within-individual change for patient-reported outcomes.","authors":"Chong-Ye Zhao, Min-Qian Yan, Xiao-Han Xu, Chun-Quan Ou","doi":"10.1007/s11136-025-03924-z","DOIUrl":"https://doi.org/10.1007/s11136-025-03924-z","url":null,"abstract":"<p><strong>Purpose: </strong>Calculating the threshold for meaningful within-individual change (MWIC) is essential for interpreting patient-reported outcomes (PRO). However, traditional methods of determining MWIC threshold yield varying estimates and lack a standardized approach. We aim to propose a novel method for more accurate MWIC threshold estimation.</p><p><strong>Methods: </strong>We developed a weighted predictive modeling method. The weighting involved using the rank difference between PRO score change and the anchor of each individual. A Monte Carlo simulation was conducted to compare the performance of the new method and that of existing state-of-the-art methods. Simulation parameters included distributions of PRO score changes, sample sizes, improvement proportions, and correlation strengths. Statistical performance was assessed using relative bias (rbias), coefficient of variation (CV), and relative root mean squared error (rRMSE).</p><p><strong>Results: </strong>Distribution-based methods had the largest rbias and rRMSE among all methods. Existing anchor-based methods except for the Terluin 2022 method were biased when the correlation strength was weak or when the improvement proportion was not 50%. The Terluin 2022 method requires estimating an important reliability parameter, and this method had highest CV compared to other predictive modeling methods. The new weighted method demonstrated the smallest rRMSE across most simulation settings. It also maintained relatively high accuracy under weak correlation strength or imbalanced improvement proportion. Similar results were presented under normal or skewed distributions of PRO score changes.</p><p><strong>Conclusion: </strong>This novel method offers a simple and feasible alternative to existing predictive modeling methods for estimating MWIC threshold, which can facilitate the application of PRO.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143449961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Trajectory of quality of life among patients with cancer at the end of life: a longitudinal survey study.
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-18 DOI: 10.1007/s11136-025-03923-0
Henriette Tind Hasse, Trine Kjær, Søren Rud Kristensen

Purpose: Measuring and understanding the determinants of HRQoL is essential to the delivery of effective and high-quality end-of-life (EoL) care to patients with cancer. Despite this, the evidence base remains sparse and with much of the existing literature relying on data from cross-sectional studies and clinical trials.

Aim: The objective of this study was to describe HRQoL in a population of patients with cancer leading up till death using both the generic preference-based scale European Quality of Life 5 Dimensions 5 Level Version and the disease-specific scale European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire.

Methods: Using a longitudinal prospective study design, HRQoL data was collected in four waves over the course of one year. The population consisted of all patients who received cancer-targeted drug treatment at the Department of Oncology at Odense University Hospital, Denmark. Only patients who died during the data collection period were included.

Results: HRQoL in patients with cancer was stable for most months and close to the level of the general Danish population at the same age but deteriorated considerably in the last three months of life. The same pattern was observed for both HRQoL scales.

Conclusion: Despite current efforts to deliver high-quality EoL care to patients with cancer, we see a general decrease in HRQoL in the months leading up to death. The generic and disease-specific HRQoL scales do capture different dimensions of HRQoL which also, by construct, are weighted differently in the two approaches.

{"title":"Trajectory of quality of life among patients with cancer at the end of life: a longitudinal survey study.","authors":"Henriette Tind Hasse, Trine Kjær, Søren Rud Kristensen","doi":"10.1007/s11136-025-03923-0","DOIUrl":"https://doi.org/10.1007/s11136-025-03923-0","url":null,"abstract":"<p><strong>Purpose: </strong>Measuring and understanding the determinants of HRQoL is essential to the delivery of effective and high-quality end-of-life (EoL) care to patients with cancer. Despite this, the evidence base remains sparse and with much of the existing literature relying on data from cross-sectional studies and clinical trials.</p><p><strong>Aim: </strong>The objective of this study was to describe HRQoL in a population of patients with cancer leading up till death using both the generic preference-based scale European Quality of Life 5 Dimensions 5 Level Version and the disease-specific scale European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire.</p><p><strong>Methods: </strong>Using a longitudinal prospective study design, HRQoL data was collected in four waves over the course of one year. The population consisted of all patients who received cancer-targeted drug treatment at the Department of Oncology at Odense University Hospital, Denmark. Only patients who died during the data collection period were included.</p><p><strong>Results: </strong>HRQoL in patients with cancer was stable for most months and close to the level of the general Danish population at the same age but deteriorated considerably in the last three months of life. The same pattern was observed for both HRQoL scales.</p><p><strong>Conclusion: </strong>Despite current efforts to deliver high-quality EoL care to patients with cancer, we see a general decrease in HRQoL in the months leading up to death. The generic and disease-specific HRQoL scales do capture different dimensions of HRQoL which also, by construct, are weighted differently in the two approaches.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143449964","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Quality of life outcomes in colorectal cancer survivors: insights from an observational study at a tertiary cancer center.
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-18 DOI: 10.1007/s11136-025-03918-x
Pola Marchewczyk, Beatriz Costeira, Francisca Brito da Silva, Daniela Cavadas, Nuno Abecasis, Manuel Limbert, João Maciel

Purpose: Colorectal cancer (CRC) significantly impacts the quality of life (QoL) of survivors, yet detailed assessments of long-term QoL are sparse. This study evaluates QoL among CRC survivors, examining the influence of different treatments and patient characteristics on outcomes.

Methods: We conducted a cross-sectional study at a tertiary cancer center in Portugal, enrolling CRC patients who underwent curative surgery from 2013 to 2022. QoL was assessed using the EORTC QLQ-C30 and QLQ-CR29 at 1-, 3-, 5-, and 10-year follow-up intervals. Subgroup analyses were performed based on tumor location, radiotherapy administration, chemotherapy administration, presence of a stoma, and time since treatment, with sociodemographic and clinical factors examined on univariate and multivariate analysis.

Results: Of the 825 eligible patients, 324 were invited and 179 participated (response rate: 55.2%). Overall, patients reported high global QoL and functional scores with low symptom scores, comparable to those of the general population. However, rectal cancer survivors experienced poorer outcomes in role and social functioning, body image, and symptom management. Those receiving radiotherapy or chemotherapy reported more symptoms, with chemotherapy recipients showing lower functional scores. Patients with a stoma had significantly lower QoL across functional and symptom scales. Long-term survivors reported decreased physical functioning. Multivariate analysis identified female gender, open surgery, and chemotherapy as factors associated with reduced QoL.

Conclusion: This study highlights significant disparities in QoL outcomes between CRC survivors, with QoL influenced by gender, cancer location, radiotherapy or chemotherapy, stoma presence, and survivorship duration, underscoring the need for personalized support programs and tailored care plans.

{"title":"Quality of life outcomes in colorectal cancer survivors: insights from an observational study at a tertiary cancer center.","authors":"Pola Marchewczyk, Beatriz Costeira, Francisca Brito da Silva, Daniela Cavadas, Nuno Abecasis, Manuel Limbert, João Maciel","doi":"10.1007/s11136-025-03918-x","DOIUrl":"https://doi.org/10.1007/s11136-025-03918-x","url":null,"abstract":"<p><strong>Purpose: </strong>Colorectal cancer (CRC) significantly impacts the quality of life (QoL) of survivors, yet detailed assessments of long-term QoL are sparse. This study evaluates QoL among CRC survivors, examining the influence of different treatments and patient characteristics on outcomes.</p><p><strong>Methods: </strong>We conducted a cross-sectional study at a tertiary cancer center in Portugal, enrolling CRC patients who underwent curative surgery from 2013 to 2022. QoL was assessed using the EORTC QLQ-C30 and QLQ-CR29 at 1-, 3-, 5-, and 10-year follow-up intervals. Subgroup analyses were performed based on tumor location, radiotherapy administration, chemotherapy administration, presence of a stoma, and time since treatment, with sociodemographic and clinical factors examined on univariate and multivariate analysis.</p><p><strong>Results: </strong>Of the 825 eligible patients, 324 were invited and 179 participated (response rate: 55.2%). Overall, patients reported high global QoL and functional scores with low symptom scores, comparable to those of the general population. However, rectal cancer survivors experienced poorer outcomes in role and social functioning, body image, and symptom management. Those receiving radiotherapy or chemotherapy reported more symptoms, with chemotherapy recipients showing lower functional scores. Patients with a stoma had significantly lower QoL across functional and symptom scales. Long-term survivors reported decreased physical functioning. Multivariate analysis identified female gender, open surgery, and chemotherapy as factors associated with reduced QoL.</p><p><strong>Conclusion: </strong>This study highlights significant disparities in QoL outcomes between CRC survivors, with QoL influenced by gender, cancer location, radiotherapy or chemotherapy, stoma presence, and survivorship duration, underscoring the need for personalized support programs and tailored care plans.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143449962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Quality of Life Research
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