Personalized medicine emphasizes individualized and dynamic treatment decisions. There is an urgent need for a new efficacy evaluation system that can adapt to this approach. By reviewing past clinical research practices， this article pointed out the innovative needs of traditional Chinese medicine （TCM） efficacy evaluation from the perspective of personalized medicine in terms of ethical review， trial design， data management， and statistical analysis. Focusing on these needs， the article has proposed a strategic framework using syndrome differentiation and treatment in TCM as an example. The framework includes a method based on subgroup dynamic-static parallel group design and analysis， a safeguard mechanism of continuous review， dynamic informed consent， and multicenter ethical review， a technological support platform for personalized clinical efficacy evaluation and evidence support， and a statistical strategy integrating Bayesian and traditional analysis methods， aiming to promote the development of personalized TCM diagnosis and treatment.

Objective:To explore the current status of instrumental activities of daily living among community-dwelling older adults (≥ 75 years old) in China, and analyze its influencing factors.Methods:This study was a cross-sectional study. From January to May 2023, multi-stage sampling was used to select 1 832 older adults from 27 community health service centers in 9 provinces and cities across China as the research subject. A survey was conducted on older adults using the General Information Questionnaire and the Lawton-Brody Instrumental Activities of Daily Living Scale. Binomial Logistic regression was used to analyze the influencing factors of instrumental activities of daily living among older adults in the community. A total of 1 832 questionnaires were distributed, and 1 746 valid questionnaires were collected, with an effective response rate of 95.30%.Results:Among 1 746 older adults in the community, 1 194 (68.4%) had functional dependence of instrumental activities of daily living. Binomial Logistic regression showed that age, educational level, type of residence, type of chronic disease, regular exercise, self-reported social support, self-reported visual impairment, and self-reported hearing impairment were the influencing factors for the functional dependence of instrumental activities of daily living among older adults in the community ( P<0.05) . Conclusions:The instrumental activities of daily living among older adults in communities in China needs to be improved. Nurses can identify high-risk populations in the early stages and develop intervention measures based on the influencing factors of older adults' instrumental activities of daily living.

Objective:To investigate the effect of somatostatin receptor ligands (SRLs) on bone metabolism in patients with acromegaly.Methods:Retrospective analysis of clinical data of acromegaly patients( n=100) received surgery or SRLs alone for 3 months. The changes of growth hormone (GH), insulin-like growth factor-1 (IGF-1), osteocalcin (OC), N-mid fragment of osteocalcin (N-MID), amino-terminal peptide of type I procollagen (P1NP) and C-terminal peptide degradation product of type I collagen(CTX) were compared before and after treatment. Patients were divided into drug treatment group and surgical group according to treatment methods. According to the decline of GH after medication, patients in the drug treatment group were further divided into drug sensitive group and drug insensitive group. Results:The average dynamic GH and IGF-1 indexes in the drug treatment group were significantly decreased after treatment compared with before treatment (both P<0.05), and CTX was also significantly decreased after treatment [1.25 (0.67, 1.40) ng/mL vs 1.34 (0.57, 1.68) ng/mL, P<0.05]. The mean dynamic GH, IGF-1 index, OC, N-MID, P1NP, and CTX in surgical group were significantly decreased after treatment compared with before treatment (all P<0.01). In the surgical group, there was a positive correlation between GH difference (ΔGH) and N-mid difference (ΔN-MID; r=0.454, P=0.026), and there was a positive correlation between IGF-1 index difference (ΔIGF-1 index) and CTX difference (ΔCTX; r=0.339, P=0.036). After treatment, the mean dynamic GH, IGF-1 index, CTX, P1NP, and N-MID in drug treatment group were significantly higher than those in surgical group (all P<0.001). CTX and N-MID decreased significantly after treatment in drug sensitive group compared with drug insensitive group (35.3% vs 7.2%, P<0.001; 24.1% vs 11.8%, P<0.05), and ΔGH was positively correlated with ΔCTX ( r=0.328, P=0.004). Conclusion:SRLs treatment can reduce bone formation marker N-MID and bone resorption marker CTX, improving the high turnover state of bone metabolism in patients with acromegaly, which may attribute to the reduction of GH and IGF-1 levels.

Objective:To Investigate comprehensive predictive ability of first-trimester complete blood count combined with maternal characteristics for gestational diabetes mellitus (GDM).Methods:From May 2015 to July 2018, 1 412 pregnant women were retrospectively screened at the Fifth People′s Hospital of Shanghai, Fudan University. We recruited 258 women who developed GDM and 1 154 women who had normal glucose level during pregnancy. At the first visit, clinical data and complete blood count result were obtained. GDM prediction models were established through logistic regression analysis of GDM related risk factors and the prediction abilities of each model were compared.Results:Logistic regression analyses identified age, pre-pregnancy body mass index, previous GDM history, family history of diabetes mellitus, the neutrophil-to-lymphocyte ratio, leukocyte, neutrophil, and monocyte counts were significantly independent predictors of GDM. In the entire cohort, the predictive ability of neutrophil and monocyte counts together with maternal basal characteristics model for the development of GDM [areas under the receiver operating characteristic curve (AUC-ROC)=0.809, integrated discrimination improvement (IDI)=0.056, P=0.001] was the best among various models (basal characteristics model, AUC-ROC=0.753; Monocyte count+ basal characteristics model, AUC-ROC=0.764; neutrophil count + basal characteristics model, AUC-ROC=0.775). Similar results obtained by the same way in all pregnant women without previous GDM history. Conclusion:It could improve the prediction of GDM with model incorporated maternal characteristics and first-trimester neutrophil and monocyte counts.

【Objective】 To improve the efficiency and screening strategy by evaluating the performance of HBsAg screening before blood donation in Dalian. 【Methods】 The confirmed HBsAg positive samples were detected qualitatively and quantitatively, and retested with HBsAg rapid testing kit pre-donational used parallelly. Efficiency of HBsAg screening before donation was calculated, and compared between first-time and repeated donors. 【Results】 The pre-donation HBsAg screening was conducted for 199 553 cases, including 95 321 first-time donors (63.2%) and 55 396 repeated donors(36.8%).1 015 donors (first-time/repeated: 999/16) were reactive in HBsAg rapid testing. 113 samples (first-time/repeated: 108/5), initially negative in HBsAg rapid testing, were confirmed HBsAg positive by laboratory testing. The efficiency of pre-donation HBsAg screening for first-time donors(10.9‰) was significantly higher than that of repeated donors(0.3‰)(P<0.05). The positive rate of retesting was 41.1% (39/95), among which 70% were classified as median or strong positive.Significant difference was observed among HBsAg values(IU/mL) [median(range)] of negative, weak positive, median positive and strong positive samples (P<0.05) which were 0.41 (<0.05-11.35), 6.71 (2.49-23.15), 36.48 (7.01->130) and 92.44 (18.7->130), respectively. 【Conclusion】 The HBsAg rapid testing kit used in Dalian Blood Center could meet requirements for blood donor screening before donation, while good efficiency of HBsAg pre-donation screening could be achieved only in first-time blood donors.

Objective:To explore the demand for suffocation prevention training for nursing staff in elderly care institutions and analyze its influencing factors to provide reference for improving training strategies.Methods:In this cross-sectional study, from December 2020 to January 2021, the caregivers from 43 elderly nursing institutions under China Geriatric Care Alliance were selected by convenient sampling. Self-made questionnaires were used to collect personal information of caregivers as well as related experience and training needs of suffocation prevention for the elderly. Totally 526 questionnaires were recovered, of which 412 were valid, with an effective rate of 78.33%.Results:Among the 412 caregivers, 53 (12.86%) were registered nurses and 359 (87.14%) were senior caregivers. They had a high demand for suffocation prevention, identification, and emergency treatment training. The top three most demanded are the common causes of suffocation, the risk factors of suffocation for special elderly people, and the identification of abnormal physical signs to detect suffocation in time. There were statistically significant differences in the scores of content requirements for suffocation prevention training between institutions which had and had not experienced suffocation and caregivers who knew or did not know the medication status or suffocation history of the care recipients ( P<0.05) . Conclusions:Caregivers in elderly care institutions have a high demand for suffocation prevention training. It is recommended that elderly care institutions apply pre-prevention to the management of suffocation prevention for the elderly, and guide caregivers to fully understand the medication status, suffocation history, and swallowing function of the care recipients, and provide registered nurses and elderly caregivers with systematic training related to suffocation prevention.

Objective:To explore the status quo and influencing factors of community medical workers' knowledge, attitude and practice (KAP) of comprehensive geriatric assessment (CGA) , and provide a reference for introducing and promoting CGA.Methods:From May to July 2015, totally 215 community medical workers from 6 districts and counties in Beijing were investigated with a self-designed CGA-KAP questionnaire. A total of 215 questionnaires were distributed, and 215 valid questionnaires were collected, accounting for an effective recovery rate of 100%.Results:The knowledge, attitude, and practice scores of the CGA-KAP questionnaire among the 215 community medical workers were 87.50 (75.00, 93.75) , 3.91 (3.64, 4.18) , and 1.89 (1.33, 2.89) , respectively. Univariate analysis showed that there were statistically significant differences in the CGA-knowledge scores between community medical workers of different ages, occupation types, titles, and educational backgrounds ( H=10.492; 6.513, 18.138, 6.394; P<0.05) ; there were statistically significant differences in the CGA-attitude scores between community medical workers with different administrative positions and who have or have not received CGA training ( H=12.063, Z=-2.036; P <0.05) ; there were statistically significant differences in the CGA-practice scores between community medical workers with different ages, occupation types, titles, working years, whether they were medical staff members of family doctors, whether they have heard of CGA, whether they have received CGA training, and whether they held a position in academic associations ( H=13.181, 10.770, 11.830, 9.198, Z=-2.014 , 3.167, 3.614, 4.297; P<0.05) . Logistic regression analysis revealed that being a member of the family doctor, having received CGA training, holding a position in academic associations, and attitude were the influencing factors of the CGA-practice of community medical workers ( P<0.05) . Conclusions:Community medical workers have high levels of CGA knowledge and attitude, but low levels of practice. Further actions are required to improve the system and strengthen the development and promotion of CGA in the community.

Objective:To establish a disease risk prediction model for the newborn screening system of inherited metabolic diseases by artificial intelligence technology.Methods:This was a retrospectively study. Newborn screening data ( n=5 907 547) from February 2010 to May 2019 from 31 hospitals in China and verified data ( n=3 028) from 34 hospitals of the same period were collected to establish the artificial intelligence model for the prediction of inherited metabolic diseases in neonates. The validity of the artificial intelligence disease risk prediction model was verified by 360 814 newborns ' screening data from January 2018 to September 2018 through a single-blind experiment. The effectiveness of the artificial intelligence disease risk prediction model was verified by comparing the detection rate of clinically confirmed cases, the positive rate of initial screening and the positive predictive value between the clinicians and the artificial intelligence prediction model of inherited metabolic diseases. Results:A total of 3 665 697 newborns ' screening data were collected including 3 019 cases ' positive data to establish the 16 artificial intelligence models for 32 inherited metabolic diseases. The single-blind experiment ( n=360 814) showed that 45 clinically diagnosed infants were detected by both artificial intelligence model and clinicians. A total of 2 684 cases were positive in tandem mass spectrometry screening and 1 694 cases were with high risk in artificial intelligence prediction model of inherited metabolic diseases, with the positive rates of tandem 0.74% (2 684/360 814)and 0.46% (1 694/360 814), respectively. Compared to clinicians, the positive rate of newborns was reduced by 36.89% (990/2 684) after the application of the artificial intelligence model, and the positive predictive values of clinicians and artificial intelligence prediction model of inherited metabolic diseases were 1.68% (45/2 684) and 2.66% (45/1 694) respectively. Conclusion:An accurate, fast, and the lower false positive rate auxiliary diagnosis system for neonatal inherited metabolic diseases by artificial intelligence technology has been established, which may have an important clinical value.

Objective:To investigate the effect and necessity of fine operation on the improvement of the preparation outcome of paclitaxel (albumin-binding) intravenous infusion for injection.Methods:The detailed refinement of the preparation method in the specification of paclitaxel (albumin-binding) for injection was developed. The fine operation of paclitaxel (albumin-binding) for injection mainly consists of two parts: The mixing method of solvent and drug: including syringe needle length into drug vial, solvent injection speed, state of drug waiting for dissolution, and the shaking speed of the drug vial. The method of extracting the dissolved liquid in the drug vial and injecting it into a 100 ml sterile empty 0.9% sodium chloride injection bottle: including the speed of refilling the 100 ml sterile empty 0.9% sodium chloride injection bottle, and restoring the pressure balance inside and outside the infusion bottle. The effect of fine operation on the preparation of paclitaxel (albumin-binding) for injection was evaluated by comparing the production of foam and the preparation time before and after the implementation of fine operation.Results:Before and after the implementation of fine operation, the foaming rate of the foam in the drug vial decreased from 28.57% (10/35) to 12.50% (12/96), the difference was statistically significant ( χ2 value was 4.471, P=0.029); and the foaming rate of the mixed liquid from the drug vial into the 100 ml sterile empty 0.9% sodium chloride injection bottle decreased from 46.15% (6/13) to 9.09% (3/33), the difference was statistically significant ( χ2 value was 8.140, P value was 0.004); and the preparation time of single drug was reduced by 3.37 minutes after the implementation of fine operation, the difference was statistically significant ( t value was 79.744, P<0.05). Conclusion:The preparation method of fine operation of paclitaxel (albumin-binding) for injection is operable, safe and reliable. After implementation, it can effectively reduce the production of foam in the drug vial and infusion bottle, improve the stability of drug preparation, shorten the preparation time, and ensure the safe, timely and effective medication for patients.

Objective To build demand scale for Post-hospital intestinal colostomy patients and test the reliability and validity. Methods Through the investigation of relevant literature at home and abroad,Based on the Maslow's Need Hierarchy Theory, in combination with intestinal colostomy patients psychological scale, using qualitative research, a semi-structured interview was conducted in 12 patients with colostomy A thorough understanding of colostomy patients Post-hospital care needs content (interview time as follows:September-October 2015), to analysis the interview recording data, the item pool of the scale for post-hospital care needs in patients with colostomy was constructed. Choosing 200 patients from the department of Proctology of third-grade class-A hospitals of Jilin province, and carries on the scale of clinical testing, after collecting the relative data , and make use of Critical Ration、the correlation coefficient method and the internal consistency coefficient method、further concludes that the scale items should be added or not, and picking up the internal consistency reliability 1/2 reliability retest reliability content validity and structure validity to analysis each item. Results The demand scale for Post-hospital intestinal colostomy patients included 6 dimensions and 24 items. The total content validity index (S-CVI) of the scale was 0.968, and the content validity index (I-CVI) of each item was 0.78-1.00. By exploratory factor analysis, 6 principal components were extracted, and the cumulative explanation variation of 6 principal components was 91.753％. This indicated that the scale had good validity. The total Cronbach a coefficient of the scale was 0.751, and the Cronbach a coefficient of each dimension was 0.968-0.974, all above 0.7, which indicated that the internal consistency was good. The half-fold reliability and retest reliability of the scale were 0.794 and 0.827 respectively. Conclusion The scale designed in this study has good reliability and validity, and can be used as an effective assessment tool for nursing needs of patients after discharge from enterotomy.