1.Bone Tomography Scan Optimization in SPECT/CT Equipment of Nuclear Medicine
Yuankai WANG ; Huiqing ZHU ; Miao LIU ; Congjin LIU ; Xingdang LIU
Chinese Journal of Medical Instrumentation 2016;40(5):377-379
Objective To study and search for a balance between the image quality and acquisition speed in tomography of whole body bone scan.Methods Adjustments of acquisition conditions were carried out gradualy every two months since April 2014. The qualities of fused SPECT/CT images were diagnosed by three doctors. Then the picture would be evaluated comprehensively by analyzing image quality and image resolution after adjusting image acquisition conditions.Results Seven kinds of image acquisition conditions taken were in line with diagnostic requirements. The third method is extended to clinical work best.Conclusion To obtain a high colection effi ciency, parameters of bone tomography acquisition can be set a frame of 5 seconds, total 64 (5.625o), automatic probe close and continuous scanning. Also recommends the use of "continuous" instead of "step and shoot" approach in bone SPECT acquisition. tomography, emission-computed, single-photon, bone tomography, program optimization.
2.Demand and supply of community-based care services for the elderly in China and its influencing factors
Shuang ZHAO ; Miao MIAO ; Qingqing WANG ; Han YANG ; Haijuan ZHAO ; Huiqing YAO ; Fei LIU ; Xin WANG
Chinese Journal of Geriatrics 2023;42(1):92-97
Objective:To explore the demand and actual supply of community-based care services for the elderly residents and the factors that affecting care mode for them in the context of rapid urbanization and population aging in China.Methods:Based on the cross-sectional data of the seventh China Longitudinal Survey on Health and Longevity(CLHLS)(2018), 15 854 elderly residents aged 60 and above were selected as the research population.Logistic regression method was used to analyze the patterns of community-based care services and their influencing factors.Results:Among 15 854 elderly residents, 6 912(43.60%)were male and 8 942(56.40%)were female.The results of activities of daily living(ADL)evaluation showed that 11 109 elderly residents could take care of themselves completely, and 3 889 elderly residents were disabled.The disability rate was 25.93%.The proportion of social services that elderly town dwellers expect the community to provide is higher than those living in cities and rural areas in terms of daily care, spiritual care, providing health care knowledge, and dealing with neighborhood disputes.From the perspective of social services actually provided by the community, in addition to providing home-based care, the proportion of community services available to the elderly living in towns and rural areas are similar, but significantly lower than the proportion of social services provided for elderly city dwellers.Age, marital status, residence, cultural differences, health status, source of life and living preference had significant impacts on the choice of care demand patterns.Those of older age( OR=2.29, 95% CI: 1.04-5.03 for 70-79 years old; OR=2.94, 95% CI: 1.38-6.25 for elderly 80 years old or above), having no spouse( OR=3.50, 95% CI: 2.49-4.92), and with higher levels of disability( OR=4.24, 95% CI: 3.12-5.77 for mild disability; OR=7.54, 95% CI: 5.19-10.95 for moderate disability; OR=10.50, 95% CI: 7.59-14.53 for severe disability)are more inclined to choose socialized care. Conclusions:In the process of rapid urbanization in China, the demands for care services of elderly living in towns has increased, but the actual care services provided for them by the communities are yet to be improved.Moreover, elderly town dwellers are still inclined to family care, the same as those of elderly rural dwellers.
3.Representative analysis of elderly subjects in clinical trials of prostate cancer drugs
Huiqing YAO ; Haijuan ZHAO ; Miao MIAO ; Qingqing WANG ; Fei LIU ; Lang ZHAO ; Yao LIU ; Ying ZHANG ; Xin WANG
Chinese Journal of Geriatrics 2022;41(10):1197-1201
Objective:To analyze whether the sample of elderly subjects in clinical trials of prostate cancer drugs is representative.Methods:From the level of trial design, the age distribution of subjects in clinical trials of prostate cancer drugs for elderly patients from January 2019 to December 2021 was inquired on the platform of drug clinical trial registration and information disclosure.From the actual enrollment level, the prostate cancer drug clinical trials initiated and completed by a hospital from January 2010 to June 2022 were collected.The age information of subjects in all centers was collected for multicenter trials with a summary report, and the age data of subjects in the center was collected for trials without a summary report or single-center trials.The average age of prostate cancer onset and the incidence of prostate cancer in different age groups were compared with the Chinese Cancer Registry System, so as to compare whether the two were consistent.Results:Most of the trials(72.1%、44/61)did not set upper age limit at the protocol design level.Phase Ⅲ and phase Ⅳ trials did not set an upper age limit for enrolled subjects in the protocol.From the actual enrollment level, a total of 19 studies were included in this study, with 1 402 subjects, and the average age of subjects was 67.1±8.6 years old, which was significantly different from the average age of prostate cancer in China and Beijing(all P<0.001). The age group with the largest number of participants was 60-64 years old(34.2%、479/1 402). The population aged ≥75 years was the least(21.5%, 301/1 402), which was different from the high incidence age group of prostate cancer in China in 2017(421.77/100 000). Conclusions:Clinical trials of prostate cancer drugs are designed to cover all age groups of elderly patients, but the actual sample representation of the enrolled elderly subjects is insufficient.Under the premise of protecting the safety of subjects, the trial population who are matched for the average age of prostate cancer onset and the incidence of prostate cancer in age groups, should be gradually increased.
4.Study on the influencing factors of clinical trial initiation efficiency
Qingqing WANG ; Miao MIAO ; Haijuan ZHAO ; Fei LIU ; Huiqing YAO ; Tianyang WANG ; Xin WANG
Chinese Journal of Medical Science Research Management 2022;35(5):391-395
Objective:To analyze the time cost in the start-up stages of clinical trials and to investigate the influencing factors of the initiation efficiency.Methods:We retrospectively analyzed time-cost of the review and approval of drug clinical trials initiated in Beijing Hospital from January 2020 to June 2021.The contract signing time and trial starting time of drug clinical trials in different situations were compared.Results:The mean time to sign the contract in our hospital was 19(11~26) days, and the mean time to start experiment was 235(175~317) days. There was no significant difference in the contract signature time between clinical trials with different stages, different sponsors, different types of drugs and whether to be the leading site ( P>0.05). Compared with other phases, phase Ⅲ drug trials took the longest time to start, and the mean initiation time of clinical trials initiated by foreign pharmaceutical companies was 136 days longer than that initiated by domestic pharmaceutical companies ( P<0.05). Conclusions:Clinical trial institutions should optimize the project management process, better organize the contract review and ethics review, encourage the sponsor to use our template document. Every department may set up a GCP contact to be responsible for clinical trials; The sponsor should improve the efficiency of internal circulation and communication, submit the review materials as soon as possible according to the requirements of the institution, and establish a good communication and feedback mechanism between both sides, may shorten the start-up time of clinical trials and improve the initiation efficiency.
5.Analysis of clinical features and prognostic risk factors in elderly lung adenocarcinoma patients
Shuang ZHAO ; Han YANG ; Haijuan ZHAO ; Miao MIAO ; Qingqing WANG ; Yaru WANG ; Yuying YIN ; Huiqing YAO ; Fei LIU ; Xin WANG
Chinese Journal of Geriatrics 2024;43(11):1402-1408
Objective:This study aims to analyze the clinical characteristics of elderly patients with lung adenocarcinoma and to construct a predictive model for assessing their survival.Methods:We conducted a retrospective analysis of clinical data sourced from the SEER database for patients aged 60 years or older who were diagnosed with lung adenocarcinoma between 2013 and 2018.Cox regression analysis was employed to identify independent prognostic factors affecting the survival of elderly lung adenocarcinoma patients, leading to the development of a nomogram model.The discriminative ability and calibration of the nomogram were assessed using the C-index and calibration curve.Each patient's total risk score was calculated based on the predictive model, and patients were stratified according to the quartiles of their total risk scores.The Kaplan-Meier method and Log-rank test were utilized to evaluate survival differences among the identified risk groups.Results:Among 38, 852 lung adenocarcinoma patients, 17, 200 were males and 21, 652 were females.Significant differences in survival rates were observed among lung adenocarcinoma patients based on age, gender, marital status, histological grade, TNM stage, tumor size, and the presence of bone, brain, or liver metastases, as well as the type of treatment received, including surgical treatment, radiation therapy, and chemotherapy(all P<0.001).The C-index of the training model was 0.815(95% CI: 0.811-0.819), while the validation model yielded a C-index of 0.810(95% CI: 0.804-0.816).The prediction model demonstrated higher Area Under Curve(AUC)values of 0.746, 0.768, and 0.775 for 1-year, 3-year, and 5-year survival in the modeling dataset, respectively, and 0.747, 0.770, and 0.777 in the validation dataset.Furthermore, the risk stratification model effectively distinguished patients at varying levels of risk( P<0.001). Conclusions:Age, gender, marital status, histological grade, TNM stage, tumor size, and the presence of bone, brain, and liver metastases, along with treatment modalities such as surgery, radiotherapy, and chemotherapy, were identified as independent prognostic factors for elderly patients with lung adenocarcinoma.The risk prediction model developed in this study effectively differentiates between patients at varying levels of risk, which holds significant implications for predicting treatment responses in elderly lung adenocarcinoma patients and advancing the practice of precision medicine.
6.Risk signals mining for Fluocinolone acetonide intravitreal implants based on Hainan Province Franchised Drug Monitoring System and FAERS
Huiqing MIAO ; Kai LIN ; Minghong YAO ; Lijun LIN
China Pharmacy 2024;35(12):1505-1510
OBJECTIVE To explore the risk signals of Fluocinolone acetonide intravitreal implants and promote safe and rational drug use for patients. METHODS Based on the data from the Hainan Province Franchised Drug Adverse Reaction Monitoring Subsystem (hereinafter referred to as the “Franchised Drug Monitoring System”) and the FDA Adverse Event Reporting System (FAERS), the adverse drug reaction (ADR)/adverse drug event (ADE) reports of Fluocinolone acetonide intravitreal implants were coded by using system organ classification and preferred terminology, and relevant patient information was collected. Risk signal mining was carried out by using the reporting odds ratio (ROR) method and the comprehensive standards method of the UK Medicines and Healthcare Products Regulatory Agency (hereinafter referred to as the “MHRA method”). RESULTS Among the 72 reports of Fluocinolone acetonide intravitreal implants received by the Franchised Drug Monitoring System, the ratio of male to female was 1∶1.4, the patient’s age was mainly distributed between 18 and 64 years old; ADR/ADE affected 5 systemic organs, with eye organ diseases accounting for 87.7%; among them, there were 9 new and general ADR reports (12.5%) and 4 severe ADR reports (5.6%); ROR method and MHRA method both identified three risk signals: cataracts, glaucoma, and high intraocular pressure. Among the 244 reports received by the FAERS database, the ratio of male to female was 1∶1.5; ADR/ADE damage affected 10 systemic organs, with 46.1% suffering from various injuries, poisoning, and operational complications, and 32.0% suffering from product problems; there were 20 severe ADR reports (8.2%); ROR method and MHRA method both identified 19 risk signals, including implantation complications, medication system issues, etc. CONCLUSIONS When using Fluocinolone acetonide intravitreal implants in clinical practice, in addition to paying attention to eye ADR/ADE such as high intraocular pressure, cataracts, and glaucoma, attention should also be paid to the potential risks caused by ADE due to product quality and unreasonable use.
7.Discussion of data problems and improvement measures in clinical trials: Based on CRC work assessment in a grade A tertiary hospital
Fei LIU ; Qingqing WANG ; Haijuan ZHAO ; Huiqing YAO ; Miao MIAO ; Yue LIU ; Yanhui WANG ; Xin WANG
Chinese Journal of Medical Science Research Management 2022;35(6):416-420
Objective:The Clinical Research Coordinator (CRC) is responsible for transcribing and verifying clinical trial data, and making recommendations to research institutions and sponsors on clinical trial data through analyzing and discussing data problems found in CRC work assessment, thereby improving the quality of clinical trials.Methods:Based on the ALOCA+ Principle, this study analyzed the data problems found in CRC assessment based on clinical trial quality conducted in a grade A tertiary hospital in Beijing from November 2018 to December 2021, and discussed improvement measures for clinical trial data problems.Results:Among the clinical trial data problems, data integrity is the most prominent, followed by accuracy.Conclusions:Research institutions and sponsors should improve the data management system and SOP, strengthen the training for clinical trial participants, optimize a trial plan and process design, strengthen supervision and inspection, and establish a risk-based quality control system, etc., so as to make clinical trial data conform to the international ALOCA+ principle and make clinical trial results accurate and reliable.