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【Objective:】 To understand the real psychological feelings of cancer patients after withdrawing from drug clinical trials, and provide reference for clinical healthcare professionals to serve personalized care for patients in the transitional period after withdrawing from drug clinical trials. 【Methods:】 With the descriptive phenomenology method, 11 subjects who withdrew from drug clinical trials in the oncology department of a tertiary hospital in Shandong Province were selected by intentional sampling method to conduct semi-structured in-depth interviews. Colaizzi seven-step analysis method was used to analyze and sort out records, and refine themes. 【Results:】 The psychological experiences of cancer patients after withdrawing from drug clinical trials were summarized into four themes: benefits of participating in clinical trials, losses of withdrawing from clinical trials, attitudes towards future treatment, and expectations of receiving help. 【Conclusion:】 Cancer patients face great psychological pressure after withdrawing from drug clinical trials and require deep emotional support and humanistic care. Nursing staff should take personalized care measures to meet the special problems of patients’ psychological needs, so as to help patients smoothly pass through the withdrawal stage and enter subsequent treatment.
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Abstract@#The study elaborates on the historical development of the home-school-community partnership in the United States, as well as physical activity strategies to prevent overweight and obesity in school age children. Feasible suggestions are proposed for implementing the home-school-community collaboration in China. The finding suggests that in addition to cooperation with schools, families and communities need to take initiatives to actively support children s participation in various physical activities and provide facilities and guarantees. Schools should also do a top level design that links with families and communities, and incorporate their participation into long term physical education planning, making them an integral part of a closely interconnected collaborative network to further prevent overweight and obesity in school age children.
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Objective:To analyze the risk factors for the occurrence of intradialytic hypotension (IDH) in elderly maintenance hemodialysis (MHD) patients based on longitudinal multidimensional data.Methods:This was a single-center, retrospective observational study. Data of MHD patients were retrospectively analyzed from April 3, 2017 to December 31, 2021 in the blood purification center of National Clinical Research Center for Kidney Diseases, General Hospital of Eastern Theater Command. IDH defined by the Kidney Disease Outcomes Quality Initiative was used as outcome indicator. Generalized estimating equations were used for univariate and multivariate regression analysis. The importance of each factor on the occurrence of IDH was evaluated by chi-square statistic minus degrees of freedom, and sensitivity analysis was performed by 5-fold interpolation of missing data.Results:A total of 156 elderly patients were enrolled, 91(58.3%) of whom were male, and 2 681 dialysis data recordings were included. The incidence of IDH from 2017 to 2021 fluctuated from 8.3% to 13.2%, with an average incidence of 11.0% by 2021. The results of multivariate regression showed pre-dialysis systolic pressure of 140-159 mmHg (1 mmHg=0.133 kPa, 90-139 mmHg as reference: OR=0.482, 95% CI 0.273-0.851, P=0.012), pre-dialysis diastolic pressure ≥ 90 mmHg (60-89 mmHg as reference, 90-99 mmHg: OR=4.081, 95% CI 2.132-7.809, P < 0.001; ≥ 100 mmHg: OR=8.547, 95% CI 3.233-22.597, P < 0.001), albumin (34-48 as reference, < 34 g/L: OR=2.677, 95% CI 1.592-4.502, P < 0.001; > 48 g/L: OR=2.692, 95% CI 1.102-6.577, P=0.030), C-reactive protein ≥ 8 mg/L (< 8 mg/L as reference: OR=1.787, 95% CI 1.216-2.628, P=0.003), hemodiafiltration as the dialysis mode (hemodialysis as the reference: OR=2.256, 95% CI 1.395-3.648, P=0.001), actual ultrafiltration volume/dry body mass (per 1% increase, OR=1.539, 95% CI 1.139-2.080, P=0.005), and ultrafiltration rate (per 100 ml/h increase, OR=1.641, 95% CI 1.389-1.939, P < 0.001) were independently associated with the occurrence of IDH. Contribution analysis showed that the top three factors related to IDH were ultrafiltration rate ( χ 2- df=32.798), pre-dialysis diastolic pressure ( χ 2- df=20.757) and albumin ( χ 2- df=19.971). The sensitivity analysis showed that the regression results were robust. Conclusions:The risk factors of IDH in elderly MHD patients are increasing ultrafiltration rate, higher pre-dialysis diastolic pressure(≥ 90 mmHg), lower albumin (< 34 g/L), HDF, higher c-reactive protein(≥ 8 mg/L) and increasing actual ultrafiltration volume/dry body mass. Higher pre-dialysis systolic pressure (140-159 mmHg) is a protective factor.
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In hospital performance evaluation, significant differences in the work objects, work content and economic operation of various departments result in the lack of indicators comparability between different departments. This has become a prominent problem that hospitals have been unable to effectively solve for a long time, and has also affected the fairness of performance distribution to a certain extent. Starting from the dilemma of cost-benefit evaluation, the authors put forward the basic concepts of the sequence advance and retreat method, and comprehensively elaborated the implementation steps and operating points of the performance assessment using the sequence advance and retreat method. It is pointed out that the sequence advance and retreat method has four characteristics: weakening the differences between departments by vertical and horizontal combination, avoiding the deviation of guidance by scientific comparison, highlighting the incentive effect by grade differentiation, and reflecting the advantages and disadvantages by end adjustment. The value of this method in the hospital performance appraisal system is discussed from three aspects: promoting the de-profitization process of hospitals, achieving fair distribution of hospital performance, and strengthening the guidance of hospital performance management. Based on such studies, this article provides new methods and ideas for building a more scientific and fair performance evaluation system.
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In hospital performance evaluation, significant differences in the work objects, work content and economic operation of various departments result in the lack of indicators comparability between different departments. This has become a prominent problem that hospitals have been unable to effectively solve for a long time, and has also affected the fairness of performance distribution to a certain extent. Starting from the dilemma of cost-benefit evaluation, the authors put forward the basic concepts of the sequence advance and retreat method, and comprehensively elaborated the implementation steps and operating points of the performance assessment using the sequence advance and retreat method. It is pointed out that the sequence advance and retreat method has four characteristics: weakening the differences between departments by vertical and horizontal combination, avoiding the deviation of guidance by scientific comparison, highlighting the incentive effect by grade differentiation, and reflecting the advantages and disadvantages by end adjustment. The value of this method in the hospital performance appraisal system is discussed from three aspects: promoting the de-profitization process of hospitals, achieving fair distribution of hospital performance, and strengthening the guidance of hospital performance management. Based on such studies, this article provides new methods and ideas for building a more scientific and fair performance evaluation system.
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Objective To explore the effect of medical and nursing integration notification on the truth knowing rate,anxiety,depression and quality of life in cancer patients undergoing chemotherapy. Meth-ods From February to March 2017,34 patients for the first time needing chemotherapy were included as control group,using normal disclosure.From June to July 2017,35 cases for the first time needing chemother-apy were included as the experimental group. The experimental group was informed of the medical and nurs-ing integration notification. The truth knowing rate,anxiety,depression and quality of life were compared be-fore and after three cycles of chemotherapy. Results After three cycles of chemotherapy,the truth knowing rate of patients in the experimental group (completely 57.14%,partly 34.29% and none 8.57%) was signifi-cantly different with the control group (completely 29.42%,partly 35.29% and none 35.29%,P＜0.01). The scores of anxiety and depression in the experimental group(39.43±4.60,41.86±5.23) were significantly low-er than those before chemotherapy(42.37±4.76,45.69±5.49,P＜0.01). The scores of anxiety and depression in the control group (45.74±5.20,49.74±5.42) were significantly higher than those before chemotherapy (42.77±5.62,45.56±6.27,P＜0.01).After three cycles of chemotherapy,the scores of anxiety and depression in the experimental group were lower than the control group (P＜0.01). After three cycles of chemotherapy, the total health status,body function,role function,emotional function,cognitive function,social function,fa-tigue,nausea and vomiting,and loss of appetite were statistically significant between the experimental group and control group (P＜0.05). Conclusion The medical and nursing integration notification has a positive effect on the truth knowing rate,anxiety,depression and quality of life in cancer patients undergoing chemo-therapy.
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At present, the teaching management department is facing a big puzzle in the education of medical professional postgraduate degree. How to strengthen the appropriate scientific research training while successfully completing the 33-months clinical rotation. With the social development and increasing demands, the original training model that training professional technical personnel and scientific academic personnel seperately has been confirmed unable to adapt to the current requirements. Combining with the practi-cal experience of the medical postgraduate degree education, we put forward some constructive suggestions of boosting the innovation of the medical postgraduate degree education from several aspects, such as optimizing the training process, strengthening the stage man-agement, improving the quality of the tutor team, smoothing the communication mechanism between teachers and students, cultivating clinical research thinking, etc.
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With the social development, the importance of medical records has become increasingly prominent.This paper analyzes the methods and shortcomings of the current medical record quality control and proposes a new mode under two-level randomized blind method combining with the experience of our own hospital.This new mode, through reconstructing the work team, adjusting work pattern and task allocation, supervising problems rectification, combining with experts′ supervising terminal record, inspecting link record randomly, handling dissent, evaluating connotation quality and assessing performance, effectively reduced the defect rate of medical records, improved the archiving rate and promoted the quality of medical records, which is worth promoting.
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Objective The incidence rate of pressure ulcer is high in critical patients and off-loading mattresses and reposi-tioning are known as effective interventions for the prevention of pressure ulcers .However, evidence is lacking for selection of the right type of mattresses and suitable interval of repositioning .This study was to compare the effects of two types of off-loading mattresses with two different repositioning intervals in preventing pressure ulcers in critical patients . Methods According to the design of this ran-domized controlled trial , we made a training plan concerning the participants , methods of intervention and comparison , criteria and methods of observation , and methods of recording , and trained 26 nurses from 7 hospitals .Using non-inferiority design and the method of stratified blocked randomization , we divided 1194 patients with the risk of pressure ulcer into a trial group ( n=596) and a control group ( n=598) , a viscoelastic sponge mattress with every-four-hours repositioning used for the former and an automatic aeration mat-tress with every-two-hours repositioning for the latter , both for 7 successive days .We examined the patients every day , recorded the in-cidence and stages of pressure ulcer , and compared the data obtained between the two groups of patients . Results The total inci-dence rate of pressure ulcer was 1.09%(13/1194), significantly lower in the trial than in the control group (0.34%[2/596] vs 1.84%[11/598], P=0.012). Conclusion A viscoelastic sponge mattress with every-four-hours repositioning is superior to an automatic aeration mattress with every-two-hours repositioning and therefore is preferred to the latter in preventing the incidence of pressure ulcer in critical patients in the ICU .
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Objective Random allocation concealment is important in ensuring high-guality randomized controlled clinical trial.In this paper , we aimed to design a more convenient and effective two couplet random allocation method through improving the random allocation concealment technology which uses the envelope method . Methods According to the randomized sequence , a two-couplet random allocation should be prepared for every subject and bound into a book in order , which named random assignment book with cover and instructions .The first couplet is to collect the enroll information and the second couplet is to show the allocation informa -tion.The serial numbers of the two couplets which around sealant are the same , and leave blank at the same areas of the two couplets for signing the enter information .The content of the first couplet can be completely copied to the second couplet .In order to avoid expo-sing the allocation information in advance , the back of the second couplet should be black-printed. When the subjects are sure qualified, the researchers selected the corresponding two couplet in a sequential order .Exposing the allocation infromation in the second couplet, and the subjects will be allocated to the group designated on the second couplet .This random allocation book should be entrusted to professional printing mechanism ,printing according to the random assignment sequence table and in the strict quality control .For the multicenter clinical trials , it can be printed in parts . Results The method has been implemented in nearly ten randomized controlled trials and obtained the consistent high praise . Conclusion The random allocation book method is easy to produce , simple operation and convenient in monitoring , which can effectively achieve the random allocation concealment in a clinical trial as well as having a sig -nificantly practical value in ensuring the quality of randomization .
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Growth of demand for endoscopic services and limited medical resources have brought the efficiency of endoscopic services in spotlight in the world .A retrospective efficiency analysis of endoscopic centers in the United States , as made by the authors , revealed their selection of efficiency indicators , benchmark establishment , evaluation and intervention .These efforts help summarize the experiences of improving efficiency and provide references for such centers in China to improve their efficiency .
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FDA clearly provides the rules for drug submission and requires that all the studies which are suitable in electronic format should follow CDISC standard.Due to the detailed contents of submission package,it's always a big challenge to submission institution and staff.It usually costs a lot of time for company or member to complete the validation before submission to FDA.Based on the ADaM submission package,this paper gives a clear picture of validation checkpoint checklist.For every checkpoint,it will see and find the ways to automatically validate through SAS macros or tools.So that it will decrease the manual checking workload,saving the time and shorten the submission period.
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Objective To evaluate the wound healing efficacy of negative pressure wound therapy (NPWT) combined with topical oxygen therapy ( TOT ) on the traumatic chronic wounds , and to explore new conception and method for traumatic chronic wounds . Methods Sixty-four patients with traumatic chronic wounds were randomized into two groups ( n=32 ) .Patients in the control group were treated by NPWT , and those in the intervention group were treated by NPWT and NPWT with TOT 3L/min.The treatment time lasted 12 days, and the dressing and tubes were changed every three days in the two groups .After 12 days, all the pa-tients were treated by standard moist therapy or surgery until healing or three months .Indicators of observation: The pressure ulcer scale for healing (PUSH) scores and granulation covered rate at 0, 3, 6, 9, and 12 days were measured, and healing rate and healing time during three months were calculated in the two groups . Results The PUSH scores were declined with intervention time during 12 days in the two groups , indicating the treatment was effective , but there was no significant difference between the two groups ( P>0 .05 ) .The granulation covered rate was increased with intervention time , and the granulation covered rate was higher in the intervention group than in the control group(P<0.001).The healing rate was higher in the intervention group than in the control group (87.50%vs 59.38%, P<0.05 ).The healing time of 14 days was shortened in the intervention group compared with the control group (P<0.001). Conclusion NPWT combined with TOT is an effective and feasible method for complicated traumatic chronic wounds , which can en-hance granulation growth , rise healing rate and shorten healing time .
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Objective Mechanical ventilation is an important life support treatment in ICU, however, patients are at high risk for ventilator?associated pneumonia(VAP) and other complications which can increase the risk of death. In the article, comparative investigation was made on ventilation effects of different degrees of semirecumbent positions and preventive effects of VAP and pressure ulcers in order to provide evidence for preferred position. Methods 46 patients were divided into 30° group and 45° group in halves according to the angle of semirecumbent position. Patient position changes were performed among semirecumbent, right and left laterally inclined positions every two hours in both groups for consecutive 7 days. The peak airway pressure (PAP) and minute ventilation (MV) changes were measured every half an hour in two hours after semire?cumbent positioning every day during ventilation. The pressure of arte?rial oxygen(PaO2), pressure of arterial carbenoxide (PaCO2) and PaO2/FiO2(fraction of inspired oxygen,FiO2) were tested every day during intervention, along with the observation on the incidence of VAP and pressure ulcers. Results MV at each time point was normal in two hours after semirecumbent positioning in both groups with no changes to prolonged time ( P0.05). Conclusion Both 45° and 30°semirecumbent po?sitions can be applied in ventilated patients and the patient′s medical condition and tolerance are the keys when choosing preferred posi?tion and duration.
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[Abstract ] Enhanced recovery after surgery (ERAS) is a kind of multi-discipline technology which is based on evidence-based medicine and aims to optimize the current peri-operative management, reduce the stress and complications during the periopera-tive period and enhance recovery aftery surgery.The introduction and successful practice and generalization of ERAS promote the trans-formation of medical quality management thought, innovation of the clinical technologies and patients'rehabilitation process.In the era of ERAS, we should make efforts to promote the medical quality management by fully using new technologies from the aspects of impro-ving the understanding, strengthening team work and optimizaing information support.
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Objective Diagnosis related groups ( DRGs) is a system to classify hospital cases into groups , which is effective in the control of medical cost .The article was to explore the DRGs grouping method and quality control indexes of cerebrovascular dis -ease in Nanjing first-class hospitals at grade 3. Methods Polytomous logistic regression for ordinal response was used in the factor analysis of hospitalization cost .E -CHAID decision tree method was applied in the DRGs grouping of cerebrovascular patients . Results Totally 9095 cases were enrolled in this study with the average age was (64.52 ±14.85).The average of stay lengths and expenses were (11.77 ±9.26)d and (25921.04 ±23096.76)rmb respectively.Hospitalization expense was associated with neurologi-cal surgery, main diagnosis, interventional surgery, main complication and ICU days.Taking neurological surgery as the first forced variable, cerebrovascular cases could be divided into 14 DRGs groups. Conclusion The terminal quality control index , the step warning index and case maximum index of cerebrovascular disease established by the DRGs grouping method are suitable in the area .
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Objective To investigate the significance of thyroid function screening in high-risk pregnant women with gestational diabetes (GDM) in early pregnancy.Methods A total of 194 cases with GDM were selected as our subjects.The patients were divided into group A(three normal items,a total of 109 cases),group B (one abnormal item,a total of 57 cases) and group C (two abnormal items,a total of 28 cases).The levels of serum anti-thyroglobulin antibody (TGAb),anti-thyroid peroxidase antibody (TPOAb),serum three triiodothyronine(TT3),thyroxine (TT4),free three triiodothyronine (FT3),free thyroxine (FT4) and thyroidstimulating hormone (TSH) were screened.Results TSH levels in group A was (1.45 ± 0.43) mU/L,significantly lower than in group B and group C((1.77±0.53),(1.89±0.74) mU/L).FT4 levels in group A was (11.62±0.98) nmol/L,significantly higher in group B and group C((10.23±0.75),(9.87±0.88) nmol/L)).Proportion of TPOAb,TGAb positive in group A were 9.17％(10/109) and 21.05％(12/57),significantly lower than that of group B and group C((28.57％(8/28) and 3.67％(4/109),7.02％(5/57) and 17.86％(5/28)).And the differences were significant (P＜ 0.05).And TPOAb + TGAb in group A was 0.92％(1/109),significantly lower than that of group B and group C(7.02％ (4/57),17.86％ (5/28);P ＜0.05).Conclusion The importance of screening thyroid function in early pregnancy in women at high risk for gestational diabetes is worthy of clinical promotion.
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According to the infection characteristics of batches of patients with extensive burns in dust explosion, the article focused on the concept and mode of whole-range fine management.Based on the characteristics and rules of infection prevention in bat-ches of patients with extensive burns, the measurement and examination of infection management were refined, the infection monitoring indexes were designed scientifically, the infection prevention scheme and monitoring table were formulated.By early and whole-range intervention of infection prevention, quantitative evaluation, fine management and precise control at different times, all levels of infec-tion management teams could fully serve their purposes in order to realize effective infection prevention.
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Safety assessment in clinical trials is dependent on an in-depth analysis of the adverse events to a great extent. However, there are difficulties in summary classification, data management and statistical analysis of the adverse events because of the different expressions on the same adverse events caused by regional, linguistic, ethnic, cultural and other differences. In order to ensure the normative expressions, it's necessary to standardize the terms in recording the adverse events. MedDRA (medical dictionary for regulatory activities) has been widely recommended and applied in the world as a powerful support for the adverse events reporting in clinical trials. In this paper, the development history, applicable scope, hierarchy structure, encoding term selection and standardized query strategies of the MedDRA is introduced. Furthermore, the practical process of adverse events encoding with MedDRA is proposed. Finally, the framework of statistical analysis about adverse events is discussed.
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Source data and its source documents are the foundation of clinical research. Proper source data management plays an essential role for compliance with regulatory and GCP requirements. Both paper and electronic source data co-exist in China. Due to the increasing use of electronic technology in pharmaceutical and health care industry, electronic data source becomes an upcoming trend with clear advantages. To face new opportunities and to ensure data integrity, quality and traceability from source data to regulatory submission, this document demonstrates important concepts, principles and best practices during managing source data. It includes but not limited to: (1) important concepts of source data (e.g., source data originator, source data elements, source data identifier for audit trail, etc.); (2) various modalities of source data collection in paper and electronic methods (e.g., paper CRF, EDC, Patient Report Outcomes/eCOA, etc.); (3) seven main principles recommended in the aspect of data collection, traceability, quality standards, access control, quality control, certified copy and security during source data management; (4) a life cycle from source data creation to obsolete is used as an example to illustrate consideration and implementation of source data management.