1.Expert consensus on digital restoration of complete dentures.
Yue FENG ; Zhihong FENG ; Jing LI ; Jihua CHEN ; Haiyang YU ; Xinquan JIANG ; Yongsheng ZHOU ; Yumei ZHANG ; Cui HUANG ; Baiping FU ; Yan WANG ; Hui CHENG ; Jianfeng MA ; Qingsong JIANG ; Hongbing LIAO ; Chufan MA ; Weicai LIU ; Guofeng WU ; Sheng YANG ; Zhe WU ; Shizhu BAI ; Ming FANG ; Yan DONG ; Jiang WU ; Lin NIU ; Ling ZHANG ; Fu WANG ; Lina NIU
International Journal of Oral Science 2025;17(1):58-58
Digital technologies have become an integral part of complete denture restoration. With advancement in computer-aided design and computer-aided manufacturing (CAD/CAM), tools such as intraoral scanning, facial scanning, 3D printing, and numerical control machining are reshaping the workflow of complete denture restoration. Unlike conventional methods that rely heavily on clinical experience and manual techniques, digital technologies offer greater precision, predictability, and efficacy. They also streamline the process by reducing the number of patient visits and improving overall comfort. Despite these improvements, the clinical application of digital complete denture restoration still faces challenges that require further standardization. The major issues include appropriate case selection, establishing consistent digital workflows, and evaluating long-term outcomes. To address these challenges and provide clinical guidance for practitioners, this expert consensus outlines the principles, advantages, and limitations of digital complete denture technology. The aim of this review was to offer practical recommendations on indications, clinical procedures and precautions, evaluation metrics, and outcome assessment to support digital restoration of complete denture in clinical practice.
Humans
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Denture, Complete
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Computer-Aided Design
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Denture Design/methods*
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Consensus
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Printing, Three-Dimensional
2.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.
3.Dosimetric evaluation of intensity modulated proton therapy and photon volumetric modulated arc therapy for bilateral breast cancer
Zhongkai JIANG ; Chunfeng FANG ; Lulu LI ; Zishen WANG ; Yumei LI ; Shouping XU
Chinese Journal of Radiological Medicine and Protection 2025;45(7):647-654
Objective:To evaluate the dosimetric characteristics of intensity-modulated proton therapy (IMPT) and photon volumetric modulated arc therapy (VMAT) in radiation therapy planning for patients with bilateral breast cancer after breast-conserving surgery.Methods:On the computed tomography localization images of 18 patients with bilateral breast cancer, target volumes and organs at risk were contoured to develop both IMPT and VMAT plans for each patient. Two IMPT plans were designed based on the clinical target volume (CTV) with robust optimization (RO-IMPT) and the planning target volume (PTV) without RO (NonRO-IMPT), respectively. The RO-IMPT, NonRO-IMPT, and VMAT plans were normalized such that the prescription dose could cover 95% of the target volume. The dosimetric parameters of target volumes and organs at risk were evaluated, and the dosimetric characteristics of the two techniques were compared.Results:In terms of target volumes, the RO-IMPT group showed significantly lower D1%, Dmean, and homogeneity index (HI) and a significantly higher D99% of the CTV than those of the PTV in the VMAT group ( t=-8.96, -8.21, -8.13, 4.96, P<0.05). The NonRO-IMPT group showed significantly lower D1%, Dmean, and HI and a significantly higher conformity index of the PTV than those of the PTV in the VMAT group ( t=-7.75, -6.25, -6.11, 7.53, P<0.05). In terms of organs at risk, the two IMPT groups showed significantly lower values than the VMAT group for the V5- V30 and Dmean of the whole lungs, V5- V40 and Dmean of the heart, D1% and Dmean of the left anterior descending coronary artery, D1% of the spinal cord, Dmean of normal tissues, and Dmean of the skin ( t= -28.47 to -3.25, P<0.05). There was no significant difference in any other evaluation indices ( P>0.05). Conclusions:Both IMPT and VMAT can meet the clinical requirements of radiotherapy plans following breast-conserving surgery for bilateral breast cancer. IMPT has apparent advantages over VMAT in protecting organs at risk.
4.Quantitative analysis of policy text on the pilot work of health impact assessment system in Zhejiang province
Zhaohua WANG ; Ziyue HUANG ; Zeng LIN ; Bo XU ; Xingyu ZHU ; Yumei FANG ; Luxia YU ; Shuai GUAN ; Meng ZHANG
Chinese Journal of Hospital Administration 2025;41(1):8-14
Objective:To construct analytical dimensions for policy texts related to the pilot work of Health Impact Assessment (HIA) system in Zhejiang Province and conduct quantitative analysis, thereby providing references for improving the pilot work.Methods:Policy texts issued by Zhejiang Province between February 11, 2018, and February 29, 2024, which involved HIA content, were selected. The policy instruments theory was employed to construct an analytical framework around the dimensions of policy instruments, policy objectives, policy actors, and the interactions between policy instruments and policy objectives, and between policy instruments and policy actors. Based on this framework, a combination of literature analysis and content analysis was used to conduct a multi-dimensional quantitative analysis of the policy texts related to the pilot work of HIA system in Zhejiang Province.Results:Fifty core policy texts were included and 1 588 codes were obtained. In terms of policy instruments, environmental-type instruments were the most widely used (852 items), with internal responsibilities and methodological measures being the most frequently used; supply-type instruments were the second most used (459 items), with mechanism improvement being the most frequently used; demand-type instruments were the least used (277 items), with multi-stakeholder participation being the most frequently used. In terms of policy objectives, the objective of system construction dominated (701 articles, accounting for 56.45%), while the proportion of policy coverage, evaluation technology, and effectiveness evaluation was relatively low. In terms of policy subjects, the Party committee and government were the main policy subjects (434 articles, accounting for 39.20%), followed by health departments and public policy-making departments, while the proportion of public health institutions and social forces was extremely low. In the interaction between policy instruments and policy objectives, policy coverage, system construction, and effectiveness evaluation objectives all responded most frequently to environmental-type instruments, while the evaluation technology objectives responded more frequently to supply-type instruments. In the interaction between policy instruments and policy subjects, the Party committee and government played a dominant role in the use of policy instruments, with the health department and public policy-making department in the middle.Conclusions:The pilot work of the HIA system in Zhejiang Province presented a " environment-driven, system-construction-priority, Party-committee-and-government-led" policy characteristic. The main challenges were the imbalanced structure of policy instruments, insufficient synergy among policy objectives, and the need for greater participation of multiple stakeholders.
5.Development and psychometric testing of a Home-based Self-management Efficacy Questionnaire for Stable Chronic Obstructive Pulmonary Disease Patients
Fang LIU ; Yimei MA ; Xuemei LI ; Yumei LI
Chinese Journal of Modern Nursing 2025;31(3):333-339
Objective:To develop the Home-based Self-management Efficacy Questionnaire for Stable Chronic Obstructive Pulmonary Disease (COPD) Patients and test its reliability and validity.Methods:Guided by the individual and family self-management theory and self-management efficacy theory, a preliminary questionnaire was developed through literature analysis, semi-structured interviews, and expert inquiries. From September to November 2022, convenience sampling was used to select stable COPD patients of the Respiratory Department of Tongji University Shanghai Pulmonary Hospital as participants for investigation for project analysis and exploratory factor analysis of the questionnaire. From December 2022 to January 2023, a survey was conducted on stable COPD patients who visited the Respiratory Department of Tongji University Shanghai Pulmonary Hospital and Yancheng Third People's Hospital to conduct confirmatory factor analysis and reliability testing on the questionnaire.Results:A total of 220 and 290 questionnaires were distributed respectively, and 214 and 280 valid questionnaires were collected, with effective response rates of 97.27% (214/220) and 96.55% (280/290), respectively. The Home-based Self-management Efficacy Questionnaire for COPD Patients included six dimensions and 28 items. The questionnaire's total Cronbach's α coefficient was 0.910, and the half-confidence coefficient was 0.806. The content validity index at the questionnaire level was 0.928, and the content validity index at the item level was 0.800 to 1.000. The exploratory factor analysis showed that a total of six common factors were extracted, with a cumulative variance contribution rate of 63.943%. Confirmatory factor analysis showed that the model fitted well and the questionnaire factor structure was stable.Conclusions:The the Home-based Self-management Efficacy Questionnaire for Stable COPD has been developed with good reliability and validity, providing a reference for medical and nursing staff to evaluate the home self-management efficacy of stable COPD patients.
6.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.
7.Dosimetric evaluation of intensity modulated proton therapy and photon volumetric modulated arc therapy for bilateral breast cancer
Zhongkai JIANG ; Chunfeng FANG ; Lulu LI ; Zishen WANG ; Yumei LI ; Shouping XU
Chinese Journal of Radiological Medicine and Protection 2025;45(7):647-654
Objective:To evaluate the dosimetric characteristics of intensity-modulated proton therapy (IMPT) and photon volumetric modulated arc therapy (VMAT) in radiation therapy planning for patients with bilateral breast cancer after breast-conserving surgery.Methods:On the computed tomography localization images of 18 patients with bilateral breast cancer, target volumes and organs at risk were contoured to develop both IMPT and VMAT plans for each patient. Two IMPT plans were designed based on the clinical target volume (CTV) with robust optimization (RO-IMPT) and the planning target volume (PTV) without RO (NonRO-IMPT), respectively. The RO-IMPT, NonRO-IMPT, and VMAT plans were normalized such that the prescription dose could cover 95% of the target volume. The dosimetric parameters of target volumes and organs at risk were evaluated, and the dosimetric characteristics of the two techniques were compared.Results:In terms of target volumes, the RO-IMPT group showed significantly lower D1%, Dmean, and homogeneity index (HI) and a significantly higher D99% of the CTV than those of the PTV in the VMAT group ( t=-8.96, -8.21, -8.13, 4.96, P<0.05). The NonRO-IMPT group showed significantly lower D1%, Dmean, and HI and a significantly higher conformity index of the PTV than those of the PTV in the VMAT group ( t=-7.75, -6.25, -6.11, 7.53, P<0.05). In terms of organs at risk, the two IMPT groups showed significantly lower values than the VMAT group for the V5- V30 and Dmean of the whole lungs, V5- V40 and Dmean of the heart, D1% and Dmean of the left anterior descending coronary artery, D1% of the spinal cord, Dmean of normal tissues, and Dmean of the skin ( t= -28.47 to -3.25, P<0.05). There was no significant difference in any other evaluation indices ( P>0.05). Conclusions:Both IMPT and VMAT can meet the clinical requirements of radiotherapy plans following breast-conserving surgery for bilateral breast cancer. IMPT has apparent advantages over VMAT in protecting organs at risk.
8.Development and psychometric testing of a Home-based Self-management Efficacy Questionnaire for Stable Chronic Obstructive Pulmonary Disease Patients
Fang LIU ; Yimei MA ; Xuemei LI ; Yumei LI
Chinese Journal of Modern Nursing 2025;31(3):333-339
Objective:To develop the Home-based Self-management Efficacy Questionnaire for Stable Chronic Obstructive Pulmonary Disease (COPD) Patients and test its reliability and validity.Methods:Guided by the individual and family self-management theory and self-management efficacy theory, a preliminary questionnaire was developed through literature analysis, semi-structured interviews, and expert inquiries. From September to November 2022, convenience sampling was used to select stable COPD patients of the Respiratory Department of Tongji University Shanghai Pulmonary Hospital as participants for investigation for project analysis and exploratory factor analysis of the questionnaire. From December 2022 to January 2023, a survey was conducted on stable COPD patients who visited the Respiratory Department of Tongji University Shanghai Pulmonary Hospital and Yancheng Third People's Hospital to conduct confirmatory factor analysis and reliability testing on the questionnaire.Results:A total of 220 and 290 questionnaires were distributed respectively, and 214 and 280 valid questionnaires were collected, with effective response rates of 97.27% (214/220) and 96.55% (280/290), respectively. The Home-based Self-management Efficacy Questionnaire for COPD Patients included six dimensions and 28 items. The questionnaire's total Cronbach's α coefficient was 0.910, and the half-confidence coefficient was 0.806. The content validity index at the questionnaire level was 0.928, and the content validity index at the item level was 0.800 to 1.000. The exploratory factor analysis showed that a total of six common factors were extracted, with a cumulative variance contribution rate of 63.943%. Confirmatory factor analysis showed that the model fitted well and the questionnaire factor structure was stable.Conclusions:The the Home-based Self-management Efficacy Questionnaire for Stable COPD has been developed with good reliability and validity, providing a reference for medical and nursing staff to evaluate the home self-management efficacy of stable COPD patients.
9.Quantitative analysis of policy text on the pilot work of health impact assessment system in Zhejiang province
Zhaohua WANG ; Ziyue HUANG ; Zeng LIN ; Bo XU ; Xingyu ZHU ; Yumei FANG ; Luxia YU ; Shuai GUAN ; Meng ZHANG
Chinese Journal of Hospital Administration 2025;41(1):8-14
Objective:To construct analytical dimensions for policy texts related to the pilot work of Health Impact Assessment (HIA) system in Zhejiang Province and conduct quantitative analysis, thereby providing references for improving the pilot work.Methods:Policy texts issued by Zhejiang Province between February 11, 2018, and February 29, 2024, which involved HIA content, were selected. The policy instruments theory was employed to construct an analytical framework around the dimensions of policy instruments, policy objectives, policy actors, and the interactions between policy instruments and policy objectives, and between policy instruments and policy actors. Based on this framework, a combination of literature analysis and content analysis was used to conduct a multi-dimensional quantitative analysis of the policy texts related to the pilot work of HIA system in Zhejiang Province.Results:Fifty core policy texts were included and 1 588 codes were obtained. In terms of policy instruments, environmental-type instruments were the most widely used (852 items), with internal responsibilities and methodological measures being the most frequently used; supply-type instruments were the second most used (459 items), with mechanism improvement being the most frequently used; demand-type instruments were the least used (277 items), with multi-stakeholder participation being the most frequently used. In terms of policy objectives, the objective of system construction dominated (701 articles, accounting for 56.45%), while the proportion of policy coverage, evaluation technology, and effectiveness evaluation was relatively low. In terms of policy subjects, the Party committee and government were the main policy subjects (434 articles, accounting for 39.20%), followed by health departments and public policy-making departments, while the proportion of public health institutions and social forces was extremely low. In the interaction between policy instruments and policy objectives, policy coverage, system construction, and effectiveness evaluation objectives all responded most frequently to environmental-type instruments, while the evaluation technology objectives responded more frequently to supply-type instruments. In the interaction between policy instruments and policy subjects, the Party committee and government played a dominant role in the use of policy instruments, with the health department and public policy-making department in the middle.Conclusions:The pilot work of the HIA system in Zhejiang Province presented a " environment-driven, system-construction-priority, Party-committee-and-government-led" policy characteristic. The main challenges were the imbalanced structure of policy instruments, insufficient synergy among policy objectives, and the need for greater participation of multiple stakeholders.
10.Comparison of central corneal thickness measured by different devices in myopic patients
Lan YANG ; Yumei HE ; Fang ZHAO ; Yuan HAN ; Guihua XIA ; Man XU
Chinese Journal of Experimental Ophthalmology 2024;42(9):814-819
Objective:To compare the correlation and consistency of central corneal thickness (CCT) measured by four different instruments, specular microscope SP-1P, IOLMaster 700, Pentacam HR and RTVue XR-OCT.Methods:A diagnostic test study was performed.A total of 50 right eyes of 50 consecutive outpatients who planned to undergo corneal refractive surgery at Hanyang Aier Eye Hospital from January to May 2022 were included.CCT was measured with the specular microscope SP-1P, IOLMaster 700, Pentacam HR and RTVue XR-OCT, respectively.The differences of CCT measurements by the four instruments were compared.The correlation and consistency between the CCT values was analyzed by Pearson linear analysis and Bland-Altman test, respectively.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Hanyang Aier Eye Hospital (No.HYEYE20221229JM).Written informed consent was obtained from each subject.Results:The mean CCT values measured by SP-1P, IOLMaster 700, Pentacam HR and RTVue XR-OCT were (522.68±30.08), (544.06±32.85), (541.00±31.75) and (528.86±31.60)μm, respectively, with a statistically significant overall difference ( F=5.09, P=0.002).CCT measurements obtained with SP-1P were lower than those obtained with IOLMaster 700 and Pentacam HR, while the IOLMaster 700 measurements were higher than those of RTVue XR-OCT, showing statistically significant differences (all at P<0.05).Pearson correlation analysis revealed significant positive correlations of CCT measurements between SP-1P and IOLMaster 700, SP-1P and Pentacam HR, SP-1P and RTVue XR-OCT, IOLMaster 700 and Pentacam HR, IOLMaster 700 and RTVue XR-OCT, Pentacam HR and RTVue XR-OCT ( r=0.988, 0.980, 0.988, 0.981, 0.982, 0.973; all at P<0.01).Bland-Altman consistency analysis showed that the 95% limits of agreement (95% LoA) for CCT measurements between SP-1P and RTVue XR-OCT, IOLMaster 700 and Pentacam HR were -16.46-6.14 and -10.56-14.48 μm, respectively, with 3(6%) and 2(4%) data points outside the 95% LoA, respectively.The mean difference lines for the CCT measurements were close to 0, indicating good consistency and clinically acceptable differences without statistical significance. Conclusions:CCT values measured with specular microscope SP-1P and RTVue XR-OCT, as well as those measured with IOLMaster and Pentacam HR, are relatively close in patients with low to moderate myopia, show good consistency and can therefore be considered interchangeable.

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