Pub Date : 2024-07-19DOI: 10.1016/j.lanwpc.2024.101147
Yang Liu , Xin Liu , Shiran Sun , Yaqian Han , Mei Feng , Ye Zhang , Kai Wang , Yuan Qu , Xuesong Chen , Jianghu Zhang , Jingwei Luo , Runye Wu , Yexiong Li , Xiaodong Huang , Shanshan Guo , Jingbo Wang , Junlin Yi
Background
The survival rates of patients with nasopharyngeal carcinoma (NPC) have improved significantly, but there is no consensus on whether they can be considered cured. We aimed to determine whether a statistical cure could be achieved for patients with NPC in the contemporary therapeutic landscape.
Methods
This retrospective multicenter study enrolled 6315 patients with nonmetastatic NPC from nonendemic and endemic regions of China from 2007 to 2020. We applied mixture and nonmixture cure models to estimate the cure probabilities and cure times by incorporating background mortality for the general population, matching by gender, age, and diagnosed year.
Findings
With death as the uncured event, the probability of patients with NPC achieving a life expectancy at par with the general population was 78.1%. Considering progression as the uncured event, the likelihood of patients attaining a life expectancy without progression equivalent to that of the general population was 72.4%. For individuals, the probabilities of achieving cure were conditional and time-dependent, requiring approximately 7.1 and 4.7 years with 95% certainty, respectively. The corresponding cure times for uncured patients were 8.9 and 6.8 years, respectively. The cure probability was correlated with age, Eastern Cooperative Oncology Group score, TNM staging, Epstein–Barr virus DNA copies, and lactate dehydrogenase. The correlation was excellent between 5-year overall survival/progression-free survival and cure fractions.
Interpretation
Statistical cure is potentially achievable among patients with NPC undergoing contemporary treatment modalities. The results hold significant potential implications for both clinical practice and patient perspectives.
Funding
National High Level Hospital Clinical Research Funding; Beijing Xisike Clinical Oncology Research Foundation; Beijing hope run fund.
{"title":"Evidence of being cured for nasopharyngeal carcinoma: results of a multicenter patient-based study in China","authors":"Yang Liu , Xin Liu , Shiran Sun , Yaqian Han , Mei Feng , Ye Zhang , Kai Wang , Yuan Qu , Xuesong Chen , Jianghu Zhang , Jingwei Luo , Runye Wu , Yexiong Li , Xiaodong Huang , Shanshan Guo , Jingbo Wang , Junlin Yi","doi":"10.1016/j.lanwpc.2024.101147","DOIUrl":"10.1016/j.lanwpc.2024.101147","url":null,"abstract":"<div><h3>Background</h3><p>The survival rates of patients with nasopharyngeal carcinoma (NPC) have improved significantly, but there is no consensus on whether they can be considered cured. We aimed to determine whether a statistical cure could be achieved for patients with NPC in the contemporary therapeutic landscape.</p></div><div><h3>Methods</h3><p>This retrospective multicenter study enrolled 6315 patients with nonmetastatic NPC from nonendemic and endemic regions of China from 2007 to 2020. We applied mixture and nonmixture cure models to estimate the cure probabilities and cure times by incorporating background mortality for the general population, matching by gender, age, and diagnosed year.</p></div><div><h3>Findings</h3><p>With death as the uncured event, the probability of patients with NPC achieving a life expectancy at par with the general population was 78.1%. Considering progression as the uncured event, the likelihood of patients attaining a life expectancy without progression equivalent to that of the general population was 72.4%. For individuals, the probabilities of achieving cure were conditional and time-dependent, requiring approximately 7.1 and 4.7 years with 95% certainty, respectively. The corresponding cure times for uncured patients were 8.9 and 6.8 years, respectively. The cure probability was correlated with age, Eastern Cooperative Oncology Group score, TNM staging, Epstein–Barr virus DNA copies, and lactate dehydrogenase. The correlation was excellent between 5-year overall survival/progression-free survival and cure fractions.</p></div><div><h3>Interpretation</h3><p>Statistical cure is potentially achievable among patients with NPC undergoing contemporary treatment modalities. The results hold significant potential implications for both clinical practice and patient perspectives.</p></div><div><h3>Funding</h3><p><span>National High Level Hospital Clinical Research Funding</span>; <span>Beijing Xisike Clinical Oncology Research Foundation</span>; <span>Beijing hope run fund</span>.</p></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"49 ","pages":"Article 101147"},"PeriodicalIF":7.6,"publicationDate":"2024-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S266660652400141X/pdfft?md5=fe0bf7c108c0e2318848c2a7774b78f0&pid=1-s2.0-S266660652400141X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141728978","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-18DOI: 10.1016/j.lanwpc.2024.101143
Fujie Zhang , Hao Wu , Weiping Cai , Ping Ma , Qingxia Zhao , Hongxia Wei , Hongzhou Lu , Hui Wang , Shenghua He , Zhu Chen , Yaokai Chen , Min Wang , Wan Wan , Heliang Fu , Hong Qin
<div><h3>Background</h3><p>We compared the efficacy and safety profiles of ainuovirine (ANV), a new-generation non-nucleoside reverse transcriptase inhibitor (NNRTI), with boosted elvitegravir (EVG), both coformulated with two nucleoside reverse transcriptase inhibitors (NRTIs), in people living with HIV-1 (PLWH) who had achieved virological suppression on previous NNRTI-based antiretroviral (ARV) regimen.</p></div><div><h3>Methods</h3><p>This study was a multi-centre, randomised, double-blind, active-controlled, non-inferiority trial recruiting PLWH from 10 clinical centres across China. Main inclusion criteria included age of 18–65 years (inclusive), and stably staying on an ARV regimen combining an NNRTI with a two-drug NRTI backbone for at least 12 months. Eligible participants must have maintained plasma HIV-1 ribonucleic acid (RNA) titre below 50 copies per mL confirmed on two successive tests at an interval of at least one month prior to randomisation. Participants were randomly assigned to receive ANV 150 mg plus lamivudine (3TC) 300 mg, and tenofovir disoproxil fumarate (TDF) 300 mg (ANV/3TC/TDF), or cobicistat (Cobi) 150 mg boosted EVG plus emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg. The primary efficacy endpoint was the proportion of participants with HIV-1 RNA titre at 50 copies per mL or above at week 48 using the US Food and Drug Administration snapshot algorithm, with a non-inferiority margin of 4 percentage points at a two-side 95% confidence level. This trial is active, but not recruiting, and is registered with Chinese Clinical Trial Registry (ChiCTR), number ChiCTR2100051605.</p></div><div><h3>Findings</h3><p>Between October 2021 and February 2022, 923 patients were screened for eligibility, among whom 762 participants were randomized and had received at least one dose of ANV/3TC/TDF (n = 381) or EVG/Cobi/FTC/TAF (n = 381). At week 48, 7 (1.8%) participants on ANV/3TC/TDF and 6 (1.6%) participants on EVG/Cobi/FTC/TAF had plasma HIV-1 RNA titre at 50 copies per mL or above, including missing virological data within the time window (the Cochran-Mantel-Haenszel method, estimated treatment difference [ETD], 0.3%, 95% CI −1.6 to 2.1), establishing the non-inferiority of ANV/3TC/TDF to EVG/Cobi/FTC/TAF. The proportions of participants experiencing at least one treatment-emergent adverse events (AEs) were comparable between the two arms (97.6% <em>versus</em> 97.6%). A small proportion of participants discontinued study drug due to AEs (0.3% <em>versus</em> 0.3%). Serious AEs occurred in 11 (2.9%) participants on ANV/3TC/TDF and 9 (2.4%) participants on EVG/Cobi/FTC/TAF, respectively, none of which was considered related to study drug at the jurisdiction of the investigator. At week 48, participants on ANV/3TC/TDF showed a significantly less weight gain from baseline compared to those on EVG/Cobi/FTC/TAF (least square mean, 1.16 <em>versus</em> 2.05 kg, ETD −0.90 kg, 95% CI, −1.43 to −0.37). The changes in serum
{"title":"Switch to fixed-dose ainuovirine, lamivudine, and tenofovir DF versus elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in virologically suppressed people living with HIV-1: the 48-week results of the SPRINT trial, a multi-centre, randomised, double-blind, active-controlled, phase 3, non-inferiority trial","authors":"Fujie Zhang , Hao Wu , Weiping Cai , Ping Ma , Qingxia Zhao , Hongxia Wei , Hongzhou Lu , Hui Wang , Shenghua He , Zhu Chen , Yaokai Chen , Min Wang , Wan Wan , Heliang Fu , Hong Qin","doi":"10.1016/j.lanwpc.2024.101143","DOIUrl":"10.1016/j.lanwpc.2024.101143","url":null,"abstract":"<div><h3>Background</h3><p>We compared the efficacy and safety profiles of ainuovirine (ANV), a new-generation non-nucleoside reverse transcriptase inhibitor (NNRTI), with boosted elvitegravir (EVG), both coformulated with two nucleoside reverse transcriptase inhibitors (NRTIs), in people living with HIV-1 (PLWH) who had achieved virological suppression on previous NNRTI-based antiretroviral (ARV) regimen.</p></div><div><h3>Methods</h3><p>This study was a multi-centre, randomised, double-blind, active-controlled, non-inferiority trial recruiting PLWH from 10 clinical centres across China. Main inclusion criteria included age of 18–65 years (inclusive), and stably staying on an ARV regimen combining an NNRTI with a two-drug NRTI backbone for at least 12 months. Eligible participants must have maintained plasma HIV-1 ribonucleic acid (RNA) titre below 50 copies per mL confirmed on two successive tests at an interval of at least one month prior to randomisation. Participants were randomly assigned to receive ANV 150 mg plus lamivudine (3TC) 300 mg, and tenofovir disoproxil fumarate (TDF) 300 mg (ANV/3TC/TDF), or cobicistat (Cobi) 150 mg boosted EVG plus emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg. The primary efficacy endpoint was the proportion of participants with HIV-1 RNA titre at 50 copies per mL or above at week 48 using the US Food and Drug Administration snapshot algorithm, with a non-inferiority margin of 4 percentage points at a two-side 95% confidence level. This trial is active, but not recruiting, and is registered with Chinese Clinical Trial Registry (ChiCTR), number ChiCTR2100051605.</p></div><div><h3>Findings</h3><p>Between October 2021 and February 2022, 923 patients were screened for eligibility, among whom 762 participants were randomized and had received at least one dose of ANV/3TC/TDF (n = 381) or EVG/Cobi/FTC/TAF (n = 381). At week 48, 7 (1.8%) participants on ANV/3TC/TDF and 6 (1.6%) participants on EVG/Cobi/FTC/TAF had plasma HIV-1 RNA titre at 50 copies per mL or above, including missing virological data within the time window (the Cochran-Mantel-Haenszel method, estimated treatment difference [ETD], 0.3%, 95% CI −1.6 to 2.1), establishing the non-inferiority of ANV/3TC/TDF to EVG/Cobi/FTC/TAF. The proportions of participants experiencing at least one treatment-emergent adverse events (AEs) were comparable between the two arms (97.6% <em>versus</em> 97.6%). A small proportion of participants discontinued study drug due to AEs (0.3% <em>versus</em> 0.3%). Serious AEs occurred in 11 (2.9%) participants on ANV/3TC/TDF and 9 (2.4%) participants on EVG/Cobi/FTC/TAF, respectively, none of which was considered related to study drug at the jurisdiction of the investigator. At week 48, participants on ANV/3TC/TDF showed a significantly less weight gain from baseline compared to those on EVG/Cobi/FTC/TAF (least square mean, 1.16 <em>versus</em> 2.05 kg, ETD −0.90 kg, 95% CI, −1.43 to −0.37). The changes in serum","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"49 ","pages":"Article 101143"},"PeriodicalIF":7.6,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666606524001378/pdfft?md5=7de64b7b467fafddfa5c5f9cd3171c4a&pid=1-s2.0-S2666606524001378-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141729081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-17DOI: 10.1016/j.lanwpc.2024.101148
Shweta Bohora , Shiva Raj Mishra , Tim Wilson , Tony Blakely
Background
We estimated the health gains and health inequality impacts for the Australian population alive in 2021 (n = 25.0 million) in the next 20 years and over their remaining lifespan, from shifting everyone above a BMI of 25 kg/m2 to 25 kg/m2 compared to the BMI distribution in 2021 persisting into the future.
Methods
National Health Survey 2017–2018 was used to estimate BMI distributions by sex, age and, socio-economic status (Socio-Economic Indexes for Areas; SEIFA). A proportional multistate life table linking BMI to 19 associated diseases and allowing for time lags and competing morbidity and mortality, was used to estimate the future stream of health adjusted life years (HALYs) gained from eradicating high BMI.
Findings
Undiscounted health gains in the first 20 years and lifetime of the population were, respectively, 2.00 million (95% uncertainty interval 1.70–2.32) and 20.4 million (17.0–24.2) (at a 3% annual discount rate, HALY gains were 1.37 and 5.77 million, respectively). Reductions in the incidence of cardio metabolic diseases contributed 61% (95% UI: 54%–68%) of the undiscounted health gains in the first 20 years, musculoskeletal diseases contributed 26% (20%–32%) and cancer 5% (3%–8%). HALY gains in the first 20 years and lifetime, per person alive in 2021, were 2.5 (2.4–2.5) and 1.9 (1.9–2.0) times higher for the most compared to the least deprived SEIFA quintile.
Interpretation
The total theoretical envelope of health gains, and health inequality reductions, through eradication of BMI is substantial. Our modeling infrastructure can be used to estimate the health impacts and cost effectiveness of many actual interventions.
{"title":"Health gains from achieving optimal body mass index in Australia: a simulation study","authors":"Shweta Bohora , Shiva Raj Mishra , Tim Wilson , Tony Blakely","doi":"10.1016/j.lanwpc.2024.101148","DOIUrl":"10.1016/j.lanwpc.2024.101148","url":null,"abstract":"<div><h3>Background</h3><p>We estimated the health gains and health inequality impacts for the Australian population alive in 2021 (n = 25.0 million) in the next 20 years and over their remaining lifespan, from shifting everyone above a BMI of 25 kg/m<sup>2</sup> to 25 kg/m<sup>2</sup> compared to the BMI distribution in 2021 persisting into the future.</p></div><div><h3>Methods</h3><p>National Health Survey 2017–2018 was used to estimate BMI distributions by sex, age and, socio-economic status (Socio-Economic Indexes for Areas; SEIFA). A proportional multistate life table linking BMI to 19 associated diseases and allowing for time lags and competing morbidity and mortality, was used to estimate the future stream of health adjusted life years (HALYs) gained from eradicating high BMI.</p></div><div><h3>Findings</h3><p>Undiscounted health gains in the first 20 years and lifetime of the population were, respectively, 2.00 million (95% uncertainty interval 1.70–2.32) and 20.4 million (17.0–24.2) (at a 3% annual discount rate, HALY gains were 1.37 and 5.77 million, respectively). Reductions in the incidence of cardio metabolic diseases contributed 61% (95% UI: 54%–68%) of the undiscounted health gains in the first 20 years, musculoskeletal diseases contributed 26% (20%–32%) and cancer 5% (3%–8%). HALY gains in the first 20 years and lifetime, per person alive in 2021, were 2.5 (2.4–2.5) and 1.9 (1.9–2.0) times higher for the most compared to the least deprived SEIFA quintile.</p></div><div><h3>Interpretation</h3><p>The total theoretical envelope of health gains, and health inequality reductions, through eradication of BMI is substantial. Our modeling infrastructure can be used to estimate the health impacts and cost effectiveness of many actual interventions.</p></div><div><h3>Funding</h3><p>No funding was received for the study.</p></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"49 ","pages":"Article 101148"},"PeriodicalIF":7.6,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666606524001421/pdfft?md5=589a934b0ec24b857b68e495da45a35f&pid=1-s2.0-S2666606524001421-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141637334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-16DOI: 10.1016/j.lanwpc.2024.101140
Zhijia Sun , Yu Ma , Canqing Yu , Dianjianyi Sun , Yuanjie Pang , Pei Pei , Ling Yang , Yiping Chen , Huaidong Du , Hao Zhang , Xiaoming Yang , Maxim Barnard , Robert Clarke , Junshi Chen , Zhengming Chen , Liming Li , Jun Lv
<div><h3>Background</h3><p>In non-high-risk individuals, risk-category-based atherosclerotic cardiovascular disease (ASCVD) screening strategies may be more cost-effective than one-size-fits-all approaches. However, current decisions are constrained by a lack of research evidence. We aimed to explore appropriate risk-category-based screening interval strategies for non-high-risk individuals in ASCVD primary prevention in the Chinese population.</p></div><div><h3>Methods</h3><p>We used data from 28,624 participants in the China Kadoorie Biobank (CKB) who had completed at least two field surveys. The risk assessment tools were the 10-year ASCVD risk prediction models developed based on the CKB cohort. We constructed multistate Markov models to model disease progression and estimate transition probabilities between different risk categories. The total person-years spent unidentified in the high-risk state over a 10-year period were calculated for each screening interval protocol. We also estimated the number of ASCVD events prevented, quality-adjusted life years (QALYs) gained, and costs saved when compared to the 3-yearly screening protocol.</p></div><div><h3>Findings</h3><p>When compared to the uniform 3-yearly protocol, most risk-category-based screening interval protocols would identify more high-risk individuals timely, thus preventing more ASCVD events and gaining QALYs. A few of them would reduce total health-care costs. The protocol, which used 6-year, 3-year, and 2-year screening intervals for low-risk, intermediate-low-risk, and intermediate-high risk individuals, was optimal, and would reduce the person-years spent unidentified in the high-risk category by 17.9% (95% CI: 13.1%–21.9%), thus preventing an estimated 113 thousand (95% CI: 83–138) hard ASCVD events for Chinese adults aged 30–79 over a 10-year period. When using a lower cost of statin therapy, more screening protocols would gain QALYs while saving costs.</p></div><div><h3>Interpretation</h3><p>For the primary prevention of ASCVD, risk-category-based screening protocols outperformed the one-size-fits-all approach in the Chinese population.</p></div><div><h3>Funding</h3><p>This work was supported by <span>National Natural Science Foundation of China</span> (<span><span>82192904</span></span>, <span><span>82388102</span></span>, <span><span>82192900</span></span>) and grants (<span><span>2023YFC2509400</span></span>) from the <span>National Key R&D Program</span> of China. The CKB baseline survey and the first re-survey were supported by a grant from the <span>Kadoorie Charitable Foundation</span> in Hong Kong. The long-term follow-up is supported by grants from the UK <span>Wellcome Trust</span> (212946/Z/18/Z, 202922/Z/16/Z, 104085/Z/14/Z, 088158/Z/09/Z), grants (<span><span>2016YFC0900500</span></span>) from the <span>National Key R&D Program</span> of China, <span>National Natural Science Foundation of China</span> (<span><span>81390540</span></span>, <span><span>91846
{"title":"One-size-fits-all versus risk-category-based screening interval strategies for cardiovascular disease prevention in Chinese adults: a prospective cohort study","authors":"Zhijia Sun , Yu Ma , Canqing Yu , Dianjianyi Sun , Yuanjie Pang , Pei Pei , Ling Yang , Yiping Chen , Huaidong Du , Hao Zhang , Xiaoming Yang , Maxim Barnard , Robert Clarke , Junshi Chen , Zhengming Chen , Liming Li , Jun Lv","doi":"10.1016/j.lanwpc.2024.101140","DOIUrl":"10.1016/j.lanwpc.2024.101140","url":null,"abstract":"<div><h3>Background</h3><p>In non-high-risk individuals, risk-category-based atherosclerotic cardiovascular disease (ASCVD) screening strategies may be more cost-effective than one-size-fits-all approaches. However, current decisions are constrained by a lack of research evidence. We aimed to explore appropriate risk-category-based screening interval strategies for non-high-risk individuals in ASCVD primary prevention in the Chinese population.</p></div><div><h3>Methods</h3><p>We used data from 28,624 participants in the China Kadoorie Biobank (CKB) who had completed at least two field surveys. The risk assessment tools were the 10-year ASCVD risk prediction models developed based on the CKB cohort. We constructed multistate Markov models to model disease progression and estimate transition probabilities between different risk categories. The total person-years spent unidentified in the high-risk state over a 10-year period were calculated for each screening interval protocol. We also estimated the number of ASCVD events prevented, quality-adjusted life years (QALYs) gained, and costs saved when compared to the 3-yearly screening protocol.</p></div><div><h3>Findings</h3><p>When compared to the uniform 3-yearly protocol, most risk-category-based screening interval protocols would identify more high-risk individuals timely, thus preventing more ASCVD events and gaining QALYs. A few of them would reduce total health-care costs. The protocol, which used 6-year, 3-year, and 2-year screening intervals for low-risk, intermediate-low-risk, and intermediate-high risk individuals, was optimal, and would reduce the person-years spent unidentified in the high-risk category by 17.9% (95% CI: 13.1%–21.9%), thus preventing an estimated 113 thousand (95% CI: 83–138) hard ASCVD events for Chinese adults aged 30–79 over a 10-year period. When using a lower cost of statin therapy, more screening protocols would gain QALYs while saving costs.</p></div><div><h3>Interpretation</h3><p>For the primary prevention of ASCVD, risk-category-based screening protocols outperformed the one-size-fits-all approach in the Chinese population.</p></div><div><h3>Funding</h3><p>This work was supported by <span>National Natural Science Foundation of China</span> (<span><span>82192904</span></span>, <span><span>82388102</span></span>, <span><span>82192900</span></span>) and grants (<span><span>2023YFC2509400</span></span>) from the <span>National Key R&D Program</span> of China. The CKB baseline survey and the first re-survey were supported by a grant from the <span>Kadoorie Charitable Foundation</span> in Hong Kong. The long-term follow-up is supported by grants from the UK <span>Wellcome Trust</span> (212946/Z/18/Z, 202922/Z/16/Z, 104085/Z/14/Z, 088158/Z/09/Z), grants (<span><span>2016YFC0900500</span></span>) from the <span>National Key R&D Program</span> of China, <span>National Natural Science Foundation of China</span> (<span><span>81390540</span></span>, <span><span>91846","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"49 ","pages":"Article 101140"},"PeriodicalIF":7.6,"publicationDate":"2024-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666606524001342/pdfft?md5=9ae6631907ee84ff28070c32cb5de990&pid=1-s2.0-S2666606524001342-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141630792","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-13DOI: 10.1016/j.lanwpc.2024.101144
Amanda Gwee , Andrew Steer , Khampheng Phongluxa , Chanthaly Luangphaxay , Khanpaseuth Senggnam , Ammala Philavanh , Alice Lei , April Martinez , Shan Huang , Brett McWhinney , Jacobus Ungerer , Stephen Duffull , Wenyu Yang , Xiao Zhu , Ben Coghlan
Background
Ivermectin, an effective treatment for scabies, is not licensed for children weighing <15 kg. Pharmacokinetic modelling has shown a 3 mg dose in young children (2–4 years, weighing 10–14 kg) achieves comparable drug exposure to a 200 μg/kg dose in children aged ≥5 years. This trial evaluated a 3 mg dose in young children.
Methods
Multicentre, phase 2 trial in five health centres in Lao PDR. Children aged 2–4 years, weighing 10–14 kg with scabies received 3 mg ivermectin and had two plasma concentrations determined (Clinicaltrials.gov ID NCT05500326). On day 14, clinical outcomes and adverse effects were assessed, and a second dose given to complete treatment. The primary outcome was the mean plasma ivermectin exposure (AUC0-∞) after the first dose (compared to a historical control of Indigenous Australian children aged ≥5 years weighing ≥15 kg receiving 200 μg/kg). Secondary outcomes were clinical improvement and adverse effects.
Findings
Overall, 100 children with a median age of 3.0 years (IQR 2.6–3.9) and weight of 11.9 kg (IQR 11.0–13.1) were enrolled. The mean observed ivermectin AUC0-∞ was comparable to the historical control group aged 5–11 years (815 μg h/L vs 953 μg h/L, p = 0.256). Complete resolution of scabies occurred in 90/99 children by day 14. Adverse effects were mild, occurring in 7/99.
Interpretation
A 3 mg ivermectin dose in children aged 2–4 years and weighing 10–14 kg achieved a mean plasma AUC0-∞ comparable to older children, was highly effective in treating scabies and well tolerated. This study supports extending ivermectin treatment to younger children improving global efforts to control this neglected disease.
Funding
Project funding provided by a Thrasher Foundation Early Career Research Award.
{"title":"Ivermectin therapy for young children with scabies infection: a multicentre phase 2 non-randomized trial","authors":"Amanda Gwee , Andrew Steer , Khampheng Phongluxa , Chanthaly Luangphaxay , Khanpaseuth Senggnam , Ammala Philavanh , Alice Lei , April Martinez , Shan Huang , Brett McWhinney , Jacobus Ungerer , Stephen Duffull , Wenyu Yang , Xiao Zhu , Ben Coghlan","doi":"10.1016/j.lanwpc.2024.101144","DOIUrl":"https://doi.org/10.1016/j.lanwpc.2024.101144","url":null,"abstract":"<div><h3>Background</h3><p>Ivermectin, an effective treatment for scabies, is not licensed for children weighing <15 kg. Pharmacokinetic modelling has shown a 3 mg dose in young children (2–4 years, weighing 10–14 kg) achieves comparable drug exposure to a 200 μg/kg dose in children aged ≥5 years. This trial evaluated a 3 mg dose in young children.</p></div><div><h3>Methods</h3><p>Multicentre, phase 2 trial in five health centres in Lao PDR. Children aged 2–4 years, weighing 10–14 kg with scabies received 3 mg ivermectin and had two plasma concentrations determined (<span>Clinicaltrials.gov</span><svg><path></path></svg> ID <span>NCT05500326</span><svg><path></path></svg>). On day 14, clinical outcomes and adverse effects were assessed, and a second dose given to complete treatment. The primary outcome was the mean plasma ivermectin exposure (AUC<sub>0-∞</sub>) after the first dose (compared to a historical control of Indigenous Australian children aged ≥5 years weighing ≥15 kg receiving 200 μg/kg). Secondary outcomes were clinical improvement and adverse effects.</p></div><div><h3>Findings</h3><p>Overall, 100 children with a median age of 3.0 years (IQR 2.6–3.9) and weight of 11.9 kg (IQR 11.0–13.1) were enrolled. The mean observed ivermectin AUC<sub>0-∞</sub> was comparable to the historical control group aged 5–11 years (815 μg h/L vs 953 μg h/L, p = 0.256). Complete resolution of scabies occurred in 90/99 children by day 14. Adverse effects were mild, occurring in 7/99.</p></div><div><h3>Interpretation</h3><p>A 3 mg ivermectin dose in children aged 2–4 years and weighing 10–14 kg achieved a mean plasma AUC<sub>0-∞</sub> comparable to older children, was highly effective in treating scabies and well tolerated. This study supports extending ivermectin treatment to younger children improving global efforts to control this neglected disease.</p></div><div><h3>Funding</h3><p>Project funding provided by a <span>Thrasher Foundation Early Career Research</span> Award.</p></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"49 ","pages":"Article 101144"},"PeriodicalIF":7.6,"publicationDate":"2024-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S266660652400138X/pdfft?md5=d061c29d9878386d9329d919f8d3c61a&pid=1-s2.0-S266660652400138X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141606708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-10DOI: 10.1016/j.lanwpc.2024.101138
Rachel Sze Jen Goh , Bryan Chong , Jayanth Jayabaskaran , Silingga Metta Jauhari , Siew Pang Chan , Martin Tze Wah Kueh , Kannan Shankar , Henry Li , Yip Han Chin , Gwyneth Kong , Vickram Vijay Anand , Keith Andrew Chan , Indah Sukmawati , Sue Anne Toh , Mark Muthiah , Jiong-Wei Wang , Gary Tse , Anurag Mehta , Alan Fong , Lohendran Baskaran , Nicholas W.S. Chew
Background
Given the rapidly growing burden of cardiovascular disease (CVD) in Asia, this study forecasts the CVD burden and associated risk factors in Asia from 2025 to 2050.
Methods
Data from the Global Burden of Disease 2019 study was used to construct regression models predicting prevalence, mortality, and disability-adjusted life years (DALYs) attributed to CVD and risk factors in Asia in the coming decades.
Findings
Between 2025 and 2050, crude cardiovascular mortality is expected to rise 91.2% despite a 23.0% decrease in the age-standardised cardiovascular mortality rate (ASMR). Ischaemic heart disease (115 deaths per 100,000 population) and stroke (63 deaths per 100,000 population) will remain leading drivers of ASMR in 2050. Central Asia will have the highest ASMR (676 deaths per 100,000 population), more than three-fold that of Asia overall (186 deaths per 100,000 population), while high-income Asia sub-regions will incur an ASMR of 22 deaths per 100,000 in 2050. High systolic blood pressure will contribute the highest ASMR throughout Asia (105 deaths per 100,000 population), except in Central Asia where high fasting plasma glucose will dominate (546 deaths per 100,000 population).
Interpretation
This forecast forewarns an almost doubling in crude cardiovascular mortality by 2050 in Asia, with marked heterogeneity across sub-regions. Atherosclerotic diseases will continue to dominate, while high systolic blood pressure will be the leading risk factor.
Funding
This was supported by the NUHS Seed Fund (NUHSRO/2022/058/RO5+6/Seed-Mar/03), National Medical Research Council Research Training Fellowship (MH 095:003/008-303), National University of Singapore Yong Loo Lin School of Medicine's Junior Academic Fellowship Scheme, NUHS Clinician Scientist Program (NCSP2.0/2024/NUHS/NCWS) and the CArdiovascular DiseasE National Collaborative Enterprise (CADENCE) National Clinical Translational Program (MOH-001277-01).
{"title":"The burden of cardiovascular disease in Asia from 2025 to 2050: a forecast analysis for East Asia, South Asia, South-East Asia, Central Asia, and high-income Asia Pacific regions","authors":"Rachel Sze Jen Goh , Bryan Chong , Jayanth Jayabaskaran , Silingga Metta Jauhari , Siew Pang Chan , Martin Tze Wah Kueh , Kannan Shankar , Henry Li , Yip Han Chin , Gwyneth Kong , Vickram Vijay Anand , Keith Andrew Chan , Indah Sukmawati , Sue Anne Toh , Mark Muthiah , Jiong-Wei Wang , Gary Tse , Anurag Mehta , Alan Fong , Lohendran Baskaran , Nicholas W.S. Chew","doi":"10.1016/j.lanwpc.2024.101138","DOIUrl":"https://doi.org/10.1016/j.lanwpc.2024.101138","url":null,"abstract":"<div><h3>Background</h3><p>Given the rapidly growing burden of cardiovascular disease (CVD) in Asia, this study forecasts the CVD burden and associated risk factors in Asia from 2025 to 2050.</p></div><div><h3>Methods</h3><p>Data from the Global Burden of Disease 2019 study was used to construct regression models predicting prevalence, mortality, and disability-adjusted life years (DALYs) attributed to CVD and risk factors in Asia in the coming decades.</p></div><div><h3>Findings</h3><p>Between 2025 and 2050, crude cardiovascular mortality is expected to rise 91.2% despite a 23.0% decrease in the age-standardised cardiovascular mortality rate (ASMR). Ischaemic heart disease (115 deaths per 100,000 population) and stroke (63 deaths per 100,000 population) will remain leading drivers of ASMR in 2050. Central Asia will have the highest ASMR (676 deaths per 100,000 population), more than three-fold that of Asia overall (186 deaths per 100,000 population), while high-income Asia sub-regions will incur an ASMR of 22 deaths per 100,000 in 2050. High systolic blood pressure will contribute the highest ASMR throughout Asia (105 deaths per 100,000 population), except in Central Asia where high fasting plasma glucose will dominate (546 deaths per 100,000 population).</p></div><div><h3>Interpretation</h3><p>This forecast forewarns an almost doubling in crude cardiovascular mortality by 2050 in Asia, with marked heterogeneity across sub-regions. Atherosclerotic diseases will continue to dominate, while high systolic blood pressure will be the leading risk factor.</p></div><div><h3>Funding</h3><p>This was supported by the <span>NUHS</span> Seed Fund (NUHSRO/2022/058/RO5+6/Seed-Mar/03), <span>National Medical Research Council</span> Research Training Fellowship (MH 095:003/008-303), <span>National University of Singapore</span> Yong Loo Lin School of Medicine's Junior Academic Fellowship Scheme, <span>NUHS</span> Clinician Scientist Program (NCSP2.0/2024/NUHS/NCWS) and the CArdiovascular DiseasE National Collaborative <span>Enterprise</span> (CADENCE) <span>National Clinical Translational Program (MOH-001277-01)</span>.</p></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"49 ","pages":"Article 101138"},"PeriodicalIF":7.6,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666606524001329/pdfft?md5=5a82783d353f53e98e639f02f082160c&pid=1-s2.0-S2666606524001329-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141596477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-08DOI: 10.1016/j.lanwpc.2024.101137
Sumegha Asthana , Sanjana Mukherjee , Alexandra L. Phelan , J.J. Woo , Claire J. Standley
Background
Decision-making during health crises differs from routine decision-making and is constrained by ambiguity about evolving epidemiological situations, urgency of response, lack of evidence, and fear. Recent analyses of governance and decision-making during COVID-19, focusing on leadership qualities, involvement of specific stakeholders, and effective resource management, do not adequately address a persisting gap in understanding the determinants of decision-making during health crises at the national level.
Methods
We undertook a study to understand the processes and characteristics of decision-making during the COVID-19 pandemic in Singapore. We used a case study approach and collected empirical evidence about public health decision-making, using a combination of key informant interviews and focus group discussions with stakeholders from government, academia and civil society organizations.
Findings
We argue that administrative centralization and political legitimacy played important roles in agile governance and decision-making during the pandemic in Singapore. We demonstrate the role of the Singapore government's centralization in creating a unified and coherent governance model for emergency response and the People's Action Party's (PAP) legitimacy in facilitating people's trust in the government. Health system resilience and financial reserves further facilitated an agile response, yet community participation and prioritization of vulnerable migrant populations were insufficient in the governance processes.
Interpretation
Our analysis contributes to the theory and practice of crisis decision-making by highlighting the role of political and administrative determinants in agile crisis decision-making.
Funding
This study is funded by the U.S. Centers for Disease Control and Prevention through a Cooperative Research Agreement (NU2HGH2020000037).
{"title":"Singapore's COVID-19 crisis decision-making through centralization, legitimacy, and agility: an empirical analysis","authors":"Sumegha Asthana , Sanjana Mukherjee , Alexandra L. Phelan , J.J. Woo , Claire J. Standley","doi":"10.1016/j.lanwpc.2024.101137","DOIUrl":"https://doi.org/10.1016/j.lanwpc.2024.101137","url":null,"abstract":"<div><h3>Background</h3><p>Decision-making during health crises differs from routine decision-making and is constrained by ambiguity about evolving epidemiological situations, urgency of response, lack of evidence, and fear. Recent analyses of governance and decision-making during COVID-19, focusing on leadership qualities, involvement of specific stakeholders, and effective resource management, do not adequately address a persisting gap in understanding the determinants of decision-making during health crises at the national level.</p></div><div><h3>Methods</h3><p>We undertook a study to understand the processes and characteristics of decision-making during the COVID-19 pandemic in Singapore. We used a case study approach and collected empirical evidence about public health decision-making, using a combination of key informant interviews and focus group discussions with stakeholders from government, academia and civil society organizations.</p></div><div><h3>Findings</h3><p>We argue that administrative centralization and political legitimacy played important roles in agile governance and decision-making during the pandemic in Singapore. We demonstrate the role of the Singapore government's centralization in creating a unified and coherent governance model for emergency response and the People's Action Party's (PAP) legitimacy in facilitating people's trust in the government. Health system resilience and financial reserves further facilitated an agile response, yet community participation and prioritization of vulnerable migrant populations were insufficient in the governance processes.</p></div><div><h3>Interpretation</h3><p>Our analysis contributes to the theory and practice of crisis decision-making by highlighting the role of political and administrative determinants in agile crisis decision-making.</p></div><div><h3>Funding</h3><p>This study is funded by the <span>U.S. Centers for Disease Control and Prevention</span> through a Cooperative Research Agreement (NU2HGH2020000037).</p></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"49 ","pages":"Article 101137"},"PeriodicalIF":7.6,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666606524001317/pdfft?md5=65627a88bc07b083c5229d936d88d4a7&pid=1-s2.0-S2666606524001317-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141596476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-06DOI: 10.1016/j.lanwpc.2024.101135
Guangda He , Zenglei Zhang , Chunqi Wang , Wei Wang , Xueke Bai , Linkang He , Shi Chen , Guangyu Li , Yang Yang , Xiaoyan Zhang , Jianlan Cui , Wei Xu , Lijuan Song , Hao Yang , Wenyan He , Yan Zhang , Xi Li , Liang Chen
Background
The triglyceride-glucose (TyG) index has been recognized as a crucial risk factor for cardiovascular diseases. However, the association between the TyG index and mortality in the general population remains elusive.
Methods
Participants were enrolled from the China Health Evaluation And risk Reduction through nationwide Teamwork (ChinaHEART), a nationwide prospective cohort study. The outcomes of interest were all-cause, cardiovascular, and cancer mortality. Restricted cubic splines and Cox regression models were used to assess the associations between the TyG index and outcomes.
Findings
In total, 3,524,459 participants with a median follow-up of 4.6 (IQR, 3.1–5.8) years were included. The associations of the TyG index with all-cause and cardiovascular mortality were reverse L-shaped, with cut-off values of 9.75 for all-cause mortality and 9.85 for cardiovascular mortality. For each 1-unit increase in the TyG index, when below the cut-off values, the TyG index was not significantly associated with all-cause mortality (HR = 1.02, 95% CI: 1.00–1.03) and was only modestly associated with cardiovascular mortality (HR = 1.09, 95% CI: 1.06–1.11). Conversely, when the cut-off values were exceeded, the HRs (95% CI) were 2.10 (1.94–2.29) for all-cause mortality and 1.99 (1.72–2.30) for cardiovascular mortality. However, the association between the TyG index and cancer mortality was linearly negative (HR = 0.97, 95% CI: 0.94–0.99).
Interpretation
The associations of the TyG index with all-cause and cardiovascular mortality displayed reverse L-shaped patterns, while an elevated TyG index showed a slight negative association with cancer mortality. We suggest that <9.75 could be the optimal TyG index cut-off value among the Chinese general population. Individuals at high risk of mortality might benefit from proper management of a high TyG index.
Funding
The National High Level Hospital Clinical Research Funding (2023-GSP-ZD-2, 2023-GSP-RC-01), the Ministry of Finance of China and National Health Commission of China.
{"title":"Association of the triglyceride–glucose index with all-cause and cause-specific mortality: a population-based cohort study of 3.5 million adults in China","authors":"Guangda He , Zenglei Zhang , Chunqi Wang , Wei Wang , Xueke Bai , Linkang He , Shi Chen , Guangyu Li , Yang Yang , Xiaoyan Zhang , Jianlan Cui , Wei Xu , Lijuan Song , Hao Yang , Wenyan He , Yan Zhang , Xi Li , Liang Chen","doi":"10.1016/j.lanwpc.2024.101135","DOIUrl":"https://doi.org/10.1016/j.lanwpc.2024.101135","url":null,"abstract":"<div><h3>Background</h3><p>The triglyceride-glucose (TyG) index has been recognized as a crucial risk factor for cardiovascular diseases. However, the association between the TyG index and mortality in the general population remains elusive.</p></div><div><h3>Methods</h3><p>Participants were enrolled from the China Health Evaluation And risk Reduction through nationwide Teamwork (ChinaHEART), a nationwide prospective cohort study. The outcomes of interest were all-cause, cardiovascular, and cancer mortality. Restricted cubic splines and Cox regression models were used to assess the associations between the TyG index and outcomes.</p></div><div><h3>Findings</h3><p>In total, 3,524,459 participants with a median follow-up of 4.6 (IQR, 3.1–5.8) years were included. The associations of the TyG index with all-cause and cardiovascular mortality were reverse L-shaped, with cut-off values of 9.75 for all-cause mortality and 9.85 for cardiovascular mortality. For each 1-unit increase in the TyG index, when below the cut-off values, the TyG index was not significantly associated with all-cause mortality (HR = 1.02, 95% CI: 1.00–1.03) and was only modestly associated with cardiovascular mortality (HR = 1.09, 95% CI: 1.06–1.11). Conversely, when the cut-off values were exceeded, the HRs (95% CI) were 2.10 (1.94–2.29) for all-cause mortality and 1.99 (1.72–2.30) for cardiovascular mortality. However, the association between the TyG index and cancer mortality was linearly negative (HR = 0.97, 95% CI: 0.94–0.99).</p></div><div><h3>Interpretation</h3><p>The associations of the TyG index with all-cause and cardiovascular mortality displayed reverse L-shaped patterns, while an elevated TyG index showed a slight negative association with cancer mortality. We suggest that <9.75 could be the optimal TyG index cut-off value among the Chinese general population. Individuals at high risk of mortality might benefit from proper management of a high TyG index.</p></div><div><h3>Funding</h3><p><span>The National High Level Hospital Clinical Research Funding</span> (2023-GSP-ZD-2, 2023-GSP-RC-01), the Ministry of Finance of China and National Health Commission of China.</p></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"49 ","pages":"Article 101135"},"PeriodicalIF":7.6,"publicationDate":"2024-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666606524001299/pdfft?md5=46aad433c55c643c8fd8c5522179d744&pid=1-s2.0-S2666606524001299-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141596475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-03DOI: 10.1016/j.lanwpc.2024.101130
Puhong Zhang , Xuanchen Tao , Yuxia Ma , Yaosen Zhang , Xinyan Ma , Hongyi Song , Yu Liu , Anushka Patel , Stephen Jan , David Peiris
Background
There is limited evidence, mainly from high-income countries, that digital health interventions improve type 2 diabetes (T2DM) care. Large-scale implementation studies are lacking.
Methods
A multifaceted digital health intervention comprising: (1) a self-management application (‘app’) for patients and lay ‘family health promotors’ (FHPs); and (2) clinical decision support for primary care doctors was evaluated in an open-label, parallel, cluster randomized controlled trial in 80 communities (serviced by a primary care facility for >1000 residents) in Hebei Province, China. People >40 years with T2DM and a glycated haemoglobin (HbA1c) ≥7% were recruited (∼25/community). After baseline assessment, community clusters were randomly assigned to intervention or control groups (1:1) via a web-based system, stratified by locality (rural/urban). Control arm clusters received usual care without access to the digital health application or family health promoters. The primary outcome was at the participant level defined as the proportion with ≥2 “ABC” risk factor targets achieved (HbA1c < 7.0%, blood pressure < 140/80 mmHg and LDL-cholesterol < 2.6 mmol/L) at 24 months.
Findings
A total of 2072 people were recruited from the 80 community clusters (40 urban and 40 rural), with 1872 (90.3%) assessed at 24 months. In the intervention arm, patients used FHPs for support more in rural than urban communities (252 (48.6%) rural vs 92 (21.5%) urban, p < 0.0001). The mean monthly proportion of active app users was 46.4% (SD 7.8%) with no significant difference between urban and rural usage rates. The intervention was associated with improved ABC control rates (339 [35.9%] intervention vs 276 [29.9%] usual care; RR 1.20, 95% CI 1.02–1.40; p = 0.025), with significant heterogeneity by geography (rural 220 [42.6%] vs 158 [31.0%]; urban 119 [27.9%] vs 118 [28.6%]; p = 0.022 for interaction). Risk factor reductions were mainly driven by improved glycaemic control (mean HbA1C difference −0.33%, 95% CI −0.48 to −0.17; p = 0.00025 and mean fasting plasma glucose difference −0.58 mmol, 95% CI −0.89 to −0.27; p = 0.00013). There were no changes in blood pressure and LDL-cholesterol levels.
Interpretation
A multifaceted digital health intervention improved T2DM risk factor control rates, particularly in rural communities where there may be stronger relationships between patients and doctors and greater family member support.
Funding
National Health and Medical Research CouncilGlobal Alliance for Chronic Diseases (ID 1094712).
{"title":"Improving the management of type 2 diabetes in China using a multifaceted digital health intervention in primary health care: the SMARTDiabetes cluster randomised controlled trial","authors":"Puhong Zhang , Xuanchen Tao , Yuxia Ma , Yaosen Zhang , Xinyan Ma , Hongyi Song , Yu Liu , Anushka Patel , Stephen Jan , David Peiris","doi":"10.1016/j.lanwpc.2024.101130","DOIUrl":"https://doi.org/10.1016/j.lanwpc.2024.101130","url":null,"abstract":"<div><h3>Background</h3><p>There is limited evidence, mainly from high-income countries, that digital health interventions improve type 2 diabetes (T2DM) care. Large-scale implementation studies are lacking.</p></div><div><h3>Methods</h3><p>A multifaceted digital health intervention comprising: (1) a self-management application (‘app’) for patients and lay ‘family health promotors’ (FHPs); and (2) clinical decision support for primary care doctors was evaluated in an open-label, parallel, cluster randomized controlled trial in 80 communities (serviced by a primary care facility for >1000 residents) in Hebei Province, China. People >40 years with T2DM and a glycated haemoglobin (HbA1c) ≥7% were recruited (∼25/community). After baseline assessment, community clusters were randomly assigned to intervention or control groups (1:1) via a web-based system, stratified by locality (rural/urban). Control arm clusters received usual care without access to the digital health application or family health promoters. The primary outcome was at the participant level defined as the proportion with ≥2 “ABC” risk factor targets achieved (HbA1c < 7.0%, blood pressure < 140/80 mmHg and LDL-cholesterol < 2.6 mmol/L) at 24 months.</p></div><div><h3>Findings</h3><p>A total of 2072 people were recruited from the 80 community clusters (40 urban and 40 rural), with 1872 (90.3%) assessed at 24 months. In the intervention arm, patients used FHPs for support more in rural than urban communities (252 (48.6%) rural vs 92 (21.5%) urban, p < 0.0001). The mean monthly proportion of active app users was 46.4% (SD 7.8%) with no significant difference between urban and rural usage rates. The intervention was associated with improved ABC control rates (339 [35.9%] intervention vs 276 [29.9%] usual care; RR 1.20, 95% CI 1.02–1.40; p = 0.025), with significant heterogeneity by geography (rural 220 [42.6%] vs 158 [31.0%]; urban 119 [27.9%] vs 118 [28.6%]; p = 0.022 for interaction). Risk factor reductions were mainly driven by improved glycaemic control (mean HbA1C difference −0.33%, 95% CI −0.48 to −0.17; p = 0.00025 and mean fasting plasma glucose difference −0.58 mmol, 95% CI −0.89 to −0.27; p = 0.00013). There were no changes in blood pressure and LDL-cholesterol levels.</p></div><div><h3>Interpretation</h3><p>A multifaceted digital health intervention improved T2DM risk factor control rates, particularly in rural communities where there may be stronger relationships between patients and doctors and greater family member support.</p></div><div><h3>Funding</h3><p><span>National Health and Medical Research Council</span> <span>Global Alliance for Chronic Diseases</span> (ID <span>1094712</span>).</p></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"49 ","pages":"Article 101130"},"PeriodicalIF":7.6,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S266660652400124X/pdfft?md5=58b68f0764eaf451f093d37b874a0c78&pid=1-s2.0-S266660652400124X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141541272","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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